How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October

Transcription

1 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October MANUAL for authority users Biocides How to run BPR processes with R4BP 3 in Member State competent authorities

2 2 How to run BPR processes with R4BP 3 in Member State competent authorities Reference: ECHA-16-B-33-EN Cat number: ED EN-N ISBN: DOI: / Publ. date: October 2016 Language: EN European Chemicals Agency, 2016 Cover page European Chemicals Agency Legal notice: Neither the European Chemicals Agency nor any person acting on behalf of the European Chemicals Agency is responsible for the use which might be made of the following information. A wealth of additional information on the European Chemicals Agency is available on the Internet. It can be accessed through the ECHA website ( Reproduction is authorised provided the source is fully acknowledged in the form Source: European Chemicals Agency, and provided written notification is given to the ECHA Communications Unit (publications@echa.europa.eu). If you have questions or comments in relation to this document please send them (quote the reference and issue date) using the information request form. The information request form is accessible from the Contact ECHA page at: European Chemicals Agency Mailing address: P.O. Box 400, FI Helsinki, Finland Visiting address: Annankatu 18, Helsinki, Finland

3 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October Version Changes Date Version 1.0 First version. August 2013 Version 2.0 Version 3.0 Version 4.0 Version 5.0 Version 6.0 The manual is updated to incorporate the changes implemented in R4BP 3.1. Six new processes are added, new steps described and streamlined in the process sections, workflow are inserted in the process sections to visualise each single process. New enhanced case event history page has been added. Management of asset document functionality has been added. The manual is updated to incorporate the changes implemented in R4BP Four new processes are added: provisional authorisations, renewal of mutual recognition, and new active substance under BPD. The manual is updated to incorporate the changes implemented in R4BP 3.2. As many as 23 new processes are added. The sequence of the sections has been aligned with that of the industry submission manuals. To avoid repetitions the explanation of the legal framework of each case type (processes) has been referred to the relevant chapters of the BPR practical guide. In the same way the description of the applications requirements is delegated, when relevant, to the respective submission manuals via dedicated links. To further reduce the length of the document the workflows charts have been summarised in one table and are not anymore displayed at the beginning of each section. The manual is updated to describes how the ad hoc communication supports.xml files and the new communication channels for review programme-related case types work. The SPC sections (3.8.1 to 3.8.3) have also been improved. The template for the rejection of an application has been repealed since R4BP 3 manages the process automatically. Three new case types have been added: Approval of an active substance in an additional product type, National authorisation cancellation on request and Union authorisation major change on request. Information about meta SPC concept and migration of SPCs from old to new format has been added in the SPC section (3.8.2 and 3.8.3). The CA supporting documents for CA and SPC agreement have been added as Annex I and II in this manual. April 2014 June 2014 December 2014 February 2016 October 2016

4 4 Table of Contents 1. Introduction What is R4BP 3? Working in R4BP AS-APP Active substance approval AS-EVA Active substance evaluation under Directive 98/8/EC AS-NAS New active substance evaluation under Directive 98/8/EC AS-RNL Renewal of the approval of an active substance AS-NPT Approval of an active substance in an additional product type AN-APP (1-5) Amendment of Annex I AN-APP (6) Amendment of Annex I NA-APP National authorisation NA-APP (WA) Provisional national authorisation Article 55(2) NA-RNL Renewal of National authorisation NA-RNL Renewal of National authorisation subject to mutual recognition NA-MRP Mutual recognition in parallel NA-MRS Mutual recognition in sequence NA-BBP, NA-BBS National authorisation of the same biocidal product NA-ADC National authorisation - Administrative change on request NA-TRS Transfer of a national authorisation NA-MRG Merge of product authorisations in one product family NA-MIC National authorisation - Minor change on request NA-MAC National authorisation - Major change on request NA-AAT Amendment of National authorisation NA-CAT Cancellation of national authorisation NA-CCL National authorisation cancellation on request ET-NOT Notification for experiment or test NA-NPF Notification of product in product family for national authorisation Settlement of disagreements (n/a) NE-NOT Notification of an unexpected or adverse effect national authorisation. 88 PP-APP Parallel Trade PP-AAT Amendment of parallel trade permit PP-CAT Cancellation of parallel trade permit SA-APP National authorisation simplified procedure... 90

5 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October SA-BBS Simplified authorisation of the same biocidal product (authorised) SA-BBP Simplified authorisation of the same biocidal product (pending) SA-CAT Cancellation of simplified authorisation SA-AAT Amendment of simplified authorisation SA-ADC Simplified authorisation administrative change on request SA-TRS Transfer of a simplified authorisation SA-MIC Simplified authorisation minor change on request SA-MAC Simplified authorisation major change on request SA-NPF Notification of product in product family for simplified authorisation SE-NOT Notification of unexpected or adverse effect for SA SN-NOT Notification for placing on the market - simplified procedure UA-APP Union authorisation UA-APP (WA) Provisional Union authorisation UA-MAC Union authorisation major change on request Table of Figures Figure 1: R4BP 3 homepage Figure 2: Searching for a task Figure 3: Tasks list Figure 4: Searching for a message Figure 5: Searching for a case Figure 6: Case list Figure 7: Case details page Figure 8: Case inventory history page Figure 9: Searching for an asset Figure 10: Assets list Figure 11: Asset details page Figure 12: TASKS page Figure 13: MSCA accept page Figure 14: MSCA accept page, release the task function Figure 15: MSCA accept page 1/ Figure 16: MSCA accept page 2/ Figure 17: Complete task confirmation page Figure 18: Validate page of the Validate task Figure 19: Evaluate page of the Evaluate task Figure 20: Evaluate & Decide page of the Evaluate & Decide task Figure 21: Management of SPC files Figure 22: Management of asset document Figure 23: Provide your decision page 1/

6 6 Figure 24: Provide your decision page 2/ Figure 25: Select the Topic page Figure 26: Case details Financial management tab page Figure 27: Financial information page Figure 28: Upload new invoice page Figure 29: Upload new invoice page, select language Figure 30: Financial information - send page Figure 31: Confirmation message page Figure 32: Financial information handle invoices Fee paid page Figure 33: Financial information handle invoices unpaid page Figure 34: Tracking the reference case or asset of a same biocidal product Table of Tables Table 1: Example of process flow chart Table 2: Case type and SPC correlation table... 34

7 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October Introduction 1.1. Objective This manual addresses users working in the competent authorities of the Member States of the European Union as well as of Iceland, Norway, Liechtenstein and Switzerland where appropriate. The purpose of this manual is to describe the key steps authority users need to perform under the Biocidal Products Regulation (BPR). It describes the main steps in the IT-tool Register for Biocidal Products (R4BP 3), to communicate and exchange information with other Member State competent authorities, the European Chemicals Agency (ECHA) or the Commission. This manual focusses on the submission and evaluation process of applications and submissions under the BPR. It will progressively be adapted to cover all the processes foreseen by the BPR Conventions and terminology The following text conventions are used throughout this manual: AS Active substance MR renewals Regulation BP Commission Delegated Regulation (EU) No 492/2014 of 7 March 2014 supplementing Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the rules for the renewal of authorisations of biocidal products subject to mutual recognition Biocidal product BPC Biocidal Products Committee BPR CAR Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Competent authority report (for active substance) cms Concerned Member State eca Evaluating (Member State) competent authority ECHA European Chemicals Agency IUCLID International Uniform Chemical Information Database I6z File format of IUCLID files MSCA Member State competent authority

8 8 PAR Product assessment report R4BP 3 rms PT Register for Biocidal Products, version 3, established and maintained by ECHA Reference Member State (for the process national authorisation receiving Member State) Product-type SPC Summary of biocidal product characteristics UUID BRC EAA MSCA initiated MAA VAL MEV EVL OPN DEC Unique Universal Identifier (it can be related to Company, Dossier) Business Rules Confirmation ECHA Accept MSCA initiated MSCA Accept Validate MSCA Evaluate Evaluate and decide ECHA Opinion COM Decision WA Work around. Another case type is used to cover the process. A supporting document helps to identify the correct process. The following icons are used throughout this manual: Useful information, guidance, assistance Very important note

9 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October Definitions and concepts Applicant Application Asset Asset owner Authorisation holder Authority users Case Case owner Event A legal entity in whose name an application is submitted under the BPR, e.g. an entity applying for the approval of an active substance (AS) or a prospective authorisation holder. The formal request to an authority made by the applicant and evaluated by an authority. In the R4BP 3 context, an asset is a regulatory decision on an application (with a unique asset number) related to either an AS (e.g. a decision on technical equivalence or a decision on the compliance with Article 95) or a biocidal product (BP) (e.g. a national authorisation or a Union authorisation), or a notification (e.g. notification of experiment or test or inquiry). The legal entity in whose name an application or notification is made under the BPR (e.g. the applicant for product authorisation, parallel trade permit, decision on technical equivalence). The person established within the Union who is responsible for the placing on the market of a BP in a particular Member State or in the Union, and specified in the regulatory decision. The authority users are comprised of ECHA, the Member State competent authorities (MSCA) and the Commission. In R4BP 3, a case relates to an application or notification submitted by an industry user that follows a series of tasks to complete a pre-defined workflow. A unique case number identifies a case in R4BP 3. It includes all the steps in the application process, which lead to the creation, or the update, of an asset (the regulatory decision). The case number helps to manage and view the progress of a submission by both industry and authority users. The legal entity which creates the case and is following it through its processing, paying any invoices, providing any additional information requested by authorities, commenting on any draft evaluation reports or opinions, etc. The case owner is either the asset owner or the representative of the asset owner acting on behalf of the asset owner. An event is a step whereby information is submitted that is needed in the handling / processing of an application. Examples include the submission of an application, the submission of additional information on the request of the authorities, fee payment, and the communication of a decision. Industry user The legal entity user registered in R4BP 3. IVA cycle IVA is the acronym for Initiation, Verification and Authorisation users. An IVA cycle is a quality tool using the two to three pair of eyes principle. The first person initiates a task, a second

10 person verifies the correctness of the task and the third person authorises the execution of the task. For MSCAs currently only the I cycle is implemented in R4BP Task A working item created by R4BP 3 and assigned to a specific user group (industry or authority users). A task is created in order to complete certain actions (e.g. request for additional information) that are required from the user. These requests are completed through task items within a defined time period. The task is identified by the task name and is related to a particular case number Structure of the document The structure of the document is as follows: sections 2 and 3 provide a general introduction to the IT-tool R4BP 3 and its main functions, whereas sections 4 to 44 describe, using a stepwise approach, the BPR processes relevant to Member States. An overview of all R4BP 3 processes in which MSCA are involved is given in the table of content at the beginning of this manual. Each section related to a BPR process is divided in subsections: 1. The Introduction subsection provides a link to the relevant chapter(s) of the Practical Guide where an explanation of the regulatory frame is given. 2. It is followed by the description of the workflow types (e.g. BRC > MAA > VAL > EVL). The acronyms are explained in section 1.2. The dark blue colour highlights the tasks under MSCA responsibility. They will be explained in details in each subsection Steps to be followed by MSCAs. 3. The Application requirements subsection describes, sometimes also referring to the industry submission manuals, what it is required in a case type (application or notification) to enable the authority users to correctly receive it. 4. The subsection Steps to be followed by MSCAs explains (only) the tasks expected to be performed by the authority users in a MSCA 1. For information on the tasks performed by the applicant please refer to the relevant industry submission manuals webpage. 5. Eventually, the subsection Supporting documents lists templates (Annex I ans II to this manual) provided by ECHA to facilitate the MSCA s work. Please note that this subsection is only present when supporting documents are required. 6. Table 1: summarises the case types codes, the workflow types and the related workflow charts. The table of content of this manual explains the case type codes used in the first column whereas the acronyms in column two are explained in section In this manual, authority users are users in an MSCA unless otherwise specified.

11 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October Table 1: Example of process flow chart Case types Workflow types Workflow charts NA-MRP NA-MRS BRC > EAA > MAA > VAL > EVL NA-APP NA-RNL NA-MIC NA-MAC NA-BBS NA-BBP SA-BBS SA-BBP BRC > MAA > VAL > EVL NA-ADC NA-TRS NA-MRG PP-APP SA-APP SA-MAC SA-MIC BRC > MAA > EVL NA-NPF ET-NOT SN-NOT SA-NPF SA-ADC SA-TRS SE-NOT NE-NOT NA-CCL BRC > EVL

12 12 NA-AAT NA-CAT PP-AAT PP-CAT SA-AAT SA-CAT MSCA initiated > EVL AS-RNL AS-NAS UA-APP AS-NPT UA-MAC BRC > EAA > VAL > MEV > OPN > DEC AS-APP AS-EVA AN-APP (6) SID > BRC > EAA > VAL > MEV > OPN > DEC AN-APP (1-5) SID > BRC > EAA > MAA > MEV > OPN > DEC

13 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October What is R4BP 3? R4BP 3 is an information system established and maintained by ECHA with the aim of ensuring that the BPR processes are managed by appropriate IT applications, to meet the requirements set out in the BPR. R4BP 3 provides appropriate functions that allow the exchange of information between industry and authority users (ECHA, MSCAs and Commission). R4BP 3 shall be used to record and communicate the decisions on authorisations taken in the MSCA and at Union level (see Article 71(6) of the BPR). R4BP 3 consists of two main independent applications, one for all the authority users and one for industry users Authority application The R4BP 3 authority application enables authority users to support their day-to-day work in the regulatory processes. With input from authority users, the system processes the applications submitted by industry users and facilitates interaction between authority users. The processes relevant to MSCA authority users are described in the following sections Industry application The R4BP 3 industry application enables industry users to submit applications, notifications and information for all processes under the BPR. R4BP 3 also provides the possibility of monitoring applications, notifications, and asset portfolios. Through the industry interface, industry users are able to log in, submit applications, review data, download documents such as invoices, view the status of submitted applications and payments, and receive notifications from the authorities and complete tasks assigned to them by authority users.

14 14 Working in R4BP R4BP 3 homepage After logging into the R4BP 3 portal, you are presented with the Homepage of R4BP 3. The homepage contains the following features (Figure 1): 1. Clicking on the ECHA logo in the top left corner, directs you back to the homepage from any other page. This feature is available on all of the R4BP 3 pages. 2. The taskbar at the top of the page next to the ECHA label contains four main tabs TASKS, MESSAGES, CASES and ASSETS. Each tab allows you to perform certain actions or view information related to all of the applications submitted. This taskbar is available in all of the R4BP 3 pages. More information on each of the tabs is provided in the following sections of this section. 3. The User ID is displayed at the top left corner below the ECHA label, as welcome, < user ID >. This information is displayed in all of the R4BP 3 pages. 4. The log-out button ( button) is available at the top right corner. This feature is available in all of the R4BP 3 pages. 5. A list of the oldest 10 tasks claimed by the user is displayed sorted by submission date. 6. A list of group tasks is displayed. The system shows 10 All open tasks (claimed and unclaimed), sorted by submission date (oldest on top). Group tasks are all tasks that are sent to the MSCA, i.e. EVL (evaluation) task, and REC (reply communication) task. 7. Only the 10 latest messages are displayed. Red messages indicate that the message has not been read yet. The messages are sorted in reversed chronological order by the receiving date. New unread messages and messages that have been read are displayed accordingly in the list. 8. Useful explanations can be found on the right hand side, in the yellow Good to know box. Figure 1: R4BP 3 homepage

15 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October Tasks A task is a working item that is created automatically during the application process by R4BP 3 or by an authority user when requesting further information. A task is characterised by a unique task number and is assigned to a specific industry or authority user. A task is created in order to complete certain actions that are required from the applicant or another authority user. Both tasks and messages are the starting point for an authority user to start working in R4BP 3. Cases and assets are used for reference, i.e., to know more about the terms and conditions of an authorisation, to know more about related cases or to verify in the events history section the status of a case Search for tasks When you select the TASKS tab, a page is displayed with a searchable table containing all of the tasks assigned to you. You can search for a specific task by filling in some search criteria (Figure 2): 1. Filter task items by: All open tasks (default), Completed, Overdue, My group(s) claimed tasks, My group(s) unclaimed tasks, Claimed by me. 2. Task name: e.g. BRC confirmation, MSCA accept, Evaluate & Decide, Reply to communication. 3. IVA steps: For further information please go to section Due date, Submission date, Creation date, Completion date filters can be selected here. 5. The from and to dates, linked to point 4 can be inserted here. 6. You can search here by Task number (please insert only digits). 7. Case number: enter the unique ID of the case. The case number is created in R4BP 3 as soon as an application is submitted. 8. Case types: the codes and a short description of each case types is given in the drop down menu. A list of case types is provided in the table of content of this manual. 9. Product name: for applications related to biocidal products, enter the complete product name. 10. Common name (AS): for IUCLID applications related to active substances, enter the common name. 11. You can export the selected list of tasks in.xls format (excel) by clicking the Export (.xls) button.

16 16 Figure 2: Searching for a task The task list When searching for a product name, you can type part of the name and all the entries containing that letter(s) combination will be displayed. Search in R4BP 3 is not case sensitive. No integrated Back button exists. A new search needs to be performed in R4BP 3 if you select one task and intend to go back to your initial search results. The tasks are displayed in the Tasks list (Figure 3) under the TASKS tab and include the following information: 1. Task name describing the task type (e.g.validate application). The I stands for initiator (you can also find V and A standing for validator and authoriser respectively). The task name is a hyperlink to the corresponding task item. For further information please go to section Case number is a hyperlink to the corresponding Case details page (Figure 6). 3. Product name if provided in the dossier or in the SPC (when submitting a dossier is not mandatory). 4. Active substance name. 5. Case type 6. Submission date of the case. 7. Due date. 8. Tasks can have the following statuses: Unclaimed: all open tasks created and not yet claimed by a specific user. Claimed: a task that is claimed by a specific user in order to perform the actions of a task. Completed: once the claimant of a task performs the task actions and completes the task, its status changes to Completed. The task is considered closed; you can view the task details, but cannot perform any further actions.

17 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October R4BP 3 provides in the task list a reminder feature through which late and soon to be late tasks are highlighted. The task will not be autocompleted even if the deadline is missed but it will appear as late in the users task list. Figure 3: Tasks list 3.3 Messages R4BP 3 is the communication channel between authority and industry users (Article 71(6) BPR). In particular, an authority user will use the messages tab to check the status of the messages received and sent via R4BP 3. Information on how to send messages is given in section 3.10 (ad hoc communication/ new communication). ECHA advises R4BP 3 users to regularly check whether there are any new messages in their message inbox. Note that the messages available in the MESSAGES tab are in read-only format. You cannot reply to a message from this tab. Please see section Any message sent by you as an authority user will be assigned a unique number, i.e. a Communication number or a Decision number. You can search for a specific message by filling in some search criteria like (Figure 4): 1. Sent/Received filter buttons. 2. Communication number. 3. Sender: e.g. Industry, Agency or MSCA. 4. Message status: Read or Unread. 5. The received from and to dates. Figure 4: Searching for a message

18 Message search results The messages are displayed in the Message list under the Messages tab and include the following information: 1. Sender or recipient. 2. Topic: Subject (this is hyperlinked to the communication details) 3. Product/Substance name. 4. Received or Sent Date. 3.4 Cases A case identifies an application or notification upon successful submission of an application or notification in R4BP 3. A series of steps need to be completed by authority users in the application process leading up to the decision according to the BPR. The purpose of a case is to manage and view the progress of the application and its evaluation Search for Cases When you select the Cases tab, a page is displayed with a searchable table containing all of the cases assigned to you. You can search for a specific case by filling in some search criteria (Figure 5a, 5b): 1. Case number: unique code create for each application. 2. Case types: the codes and a short description of each case types is given in the drop down menu. A list of case types is provided in the table of content of this manual. 3. Case status: e.g. In Progress, closed. 4. Dossier UUID: enter the unique universal identifier of the IUCLID dossier (41 alpha-

19 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October numeric code). 5. Evaluating Authority Type: e.g. Agency or MSCA. 6. Evaluating Country (MSCA). 7. Company UUID: enter the unique universal identifier of the relevant company (41 alphanumeric entries). 8. Family, Product or Trade name: for applications related to biocidal products, enter the complete family, product or trade name (Figure 5b). 9. Looking for: for applications related to biocidal products you can seach for Family product authorisation or Single product authorisations (Figure 5b). 10. Active substance: for IUCLID applications related to active substances, enter the common name. 11. Product type: List of the 22 product type as reported in Annex V of the BPR. 12. Submission date From and To. 13. You can export the selected list of cases in.xls format (excel) by clicking the Export (.xls) button. Figure 5a: Searching for a case Figure 5b: The Case list is similar to the Task list.

20 Figure 6: Case list 20

21 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October Case details page Specific information on the cases can be found in the case details page. To display the Case details page (Figure 7) click on one of the case number (Figure 6). The Case details page may contain the following information and tabs, depending on the application type: Product or Active substance information and Case owner details are displayed it the upper part of the Case details page. From the Action button on the top-right you may either initiate an Ad-hoc communication or download the Case in.pdf format. Tabs: 1. Reference details 2. SPC tab: The latest submitted SPC file in case of Single product application or the structure of the latest submitted family SPC file in case of family product applications. 3. Dossiers: List of IUCLID dossiers submitted with the case. 4. Company details: Information about the case owner and asset owner for applications related to biocidal products or Case owner details - Information about the the case owner for applications related to active substances. 5. Events history: The authority Events history displays all the events occurred from initial submission to final decision per case. 6. Documents: Displays all exchanged documents between authority and industry (including documents generated via the ad hoc communication), except for: submitted IUCLID dossiers, which are listed under the Dossiers sub-tab, and financial related documents (i.e. invoices, credit notes), which are listed under the Financial management sub-tab. By default, documents are sorted according to their creation date. 7. Financial management: Under this sub-tab, the authority user attaches and sends invoices/credit notes to the case owner (applicant). You can also change the status of the invoice, e.g. awaiting payment, unpaid, fee paid, credited. 8. Related cases: Information about any case initiated from the context of the presented case (i.e. child cases) and any other cases that have been initiated from the same context as the present case (e.g. cases in other Member States for mutual recognition in parallel, same BP).

22 22 Figure 7: Case details page The screenshot was taken for the case type UA-APP Application for union authorisation. Depending on the case type, the case details page may differ slightly from the one in the screenshot. 3.5 Event history In this specific tab all the steps of a case are displayed in chronological order. This information can be filtered by steps or by the date as shown in Figure 8. The events history page is a useful record of all steps in the sequence of events of a process. The case event history contains useful information for you such as whether the Agency has accepted or not an application, dossier UUID or the stakeholder who performs a particular action. Steps in red italics can be viewed only by administrator users; steps in bold can be viewed by administrators, authority and industry users. The events history tab summarising the submissions from industry or the decisions from the Authority (completion of task items and requests for resubmission) provides also a link to a page that summarises the details of each submission/decision or a link to the communication details page.

23 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October Figure 8: Case inventory history page 3.6 Assets An asset is a positive regulatory decision on an application related mainly to either an AS (e.g. approval of the AS or a decision on technical equivalence) or a BP (e.g. a national authorisation, incl. mutual recognitions, or a Union authorisation), or a notification (e.g. notification of experiment or test). Searching for assets is similar to searching cases. Figure 9a: Searching for an asset

24 The searchable table depends on the type of asset selected: related to a biocidal product or an active substance application (figure 9b). Figure 9b: 24 The available asset records are displayed in the Assets list (Figure 10) Figure 10: Assets list When a product asset is displayed, also the information on the related active substance(s) is given in the next column. When the asset number hyperlink is clicked, the Asset details page is displayed (Figure 11). Figure 11: Asset details page Please note that the create a new case button allows you to short cut the steps needed to perform certain processes e.g. amendment or cancellation of an asset (Figure 11).

25 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October The Asset details page contains different tabs depending on the asset type: e.g. the family info tab only appears for asset related to product family authorisation. Authority users will be able to define, which document will be included in the final asset when finalising the last task item in the workflow before the asset is created or changed. Additionally will also be able to manage this document afterwards from the asset tab. 3.7 Case types An list of BPR processes called case types in R4BP 3 can be found in the table of content of this manual. These processes are described in detail in sections 4 to 47. In addition, a section on settlement of disagreements is included (Section 28). This process is not a separate one in R4BP 3 but is relevant for the finalisation of certain processes and this is the reason why it is included in the present manual. The processes not relevant for MSCAs are not described in this manual. Information on these processes can be found however on the ECHA website dedicated to R4BP 3 submissions and in the appropriate submission manuals for industry also available from the ECHA website. R4BP 3 does not include all BPR processes. It is foreseen that the missing processes will be incorporated in future releases. Meanwhile if some of these processes are necessary, they will be implemented by ECHA in the form of a work around (WA). 3.8 Claiming and completing a task Under the TASKS tab, search for the open tasks in combination with any relevant search criterion. Click on the task listed as MSCA accept, I - Initiator. The screenshot below provides an example for MSCA accept I (Figure 13). Please keep in mind that for certain processes the first step is Validate (Figure 18) Step 1: Step 2: Step 3: Step 4: Click on the TASKS tab Search for the relevant task, e.g. using the product name and/or case type, i.e. national authorisation, mutual recognition in sequence, etc. After selecting relevant tasks, click on Search. Select the task you want to work on.

26 26 Figure 12: TASKS page Claim a task by selecting Start working. The task is then automatically assigned to you and its status is changed to Claimed (Figure 13). Figure 13: MSCA accept page

27 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October As soon as you have claimed the task, you become the user to finalise it. If you need to release the task in order to be claimed by other users (a member of yours or of another institution/ministry) you have the choice to release ( Figure 14) the task. By doing this the status is automatically changed back to Unclaimed. Releasing a task can be necessary if the claimant is absent while the task needs to be completed urgently. Figure 14: MSCA accept page, release the task function.

28 28 Figure 15: MSCA accept page 1/2 Step 1: Step 2: Step 3: Step 4: Step 5: Provide your decision by selecting Accept or Reject from the drop-down list as also explained in section Insert a message to the case owner. Upload the relevant document(s). Select type of document you want to upload, language of the document and level of access (Public, Restricted, Restricted-Authority). Provide any comment. Please note that the comments inserted are only for internal review.

29 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October Step 6: Complete the task actions and finalise your task item by clicking on complete (Figure 16). The complete button is disabled until the mandatory fields, marked with an asterisk ( ), have been filled in correctly. Figure 16: MSCA accept page 2/2 Click Continue to process the task (Figure 17). Figure 17: Complete task confirmation page At the end of a process, the applicant receives a message indicating the outcome of the task. If necessary, a task item to be completed by the applicant might be generated, e.g. if you request additional information.

30 30 Figure 18: Validate page of the Validate task. Figure 19: Evaluate page of the Evaluate task.

31 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October Figure 20: Evaluate & Decide page of the Evaluate & Decide task. Figure 21: Management of SPC files. When more translated SPCs are uploaded, the user needs to define the SPC considered as master SPC. If only one SPC is provided, the available SPC is by default the master SPC. A master SPC identifies the SPC used as a reference to determine what key information of your application shall be displayed in R4BP 3. The Competent Authority can upload the final master SPC and any relevant translations in the Evaluate & Decide step.

32 32

33 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October This area enables the authorities to define the master SPC. You can also amend an asset (using NA-AAT) and define the SPC file(s) that supports the authorisation after it is granted in R4BP 3 (see section 3.8.2). Figure 22: Management of asset document. This area enables the authorities to define the documents (like PAR, CAR) that will be attached to the final decision. You can also manage them afterwards through those case types that support changes in the asset context (e.g. NA-AAT) SPC SPC is the acronym for Summary of Product Caracteristics and it s required by the BPR in almost every process dealing with authorisations (see table 2). The manual on how to compile the SPC editor can be downloaded here. A SPC is always available for you in R4BP 3. The SPC available in R4BP 3 is the starting point for you to work with. R4BP 3 allows you to download a SPC from the case context, i.e., an on-going application, or from the asset context, i.e., amendment of a national authorisation. You must download the SPC provided in the application, insert (potential) missing data and upload the final SPC in R4BP 3 before finalising the task. Depending on the case type, R4BP 3 will require you to upload the final SPC (see table 2). Mini-SPCs are available in the following scenarios: - Cases and assets migrated from R4BP 2; and - Cases and assets submitted via R4BP 3 prior to 2 December Mini-SPCs are SPC templates with minimum information, i.e., active substance and PT

34 34 combination; that ensure the appropriate handling of SPCs in R4BP 3 of already existing data before the SPC became a central part of R4BP 3 in December These SPCs need to be replaced by complete SPCs before further actions can be completed (e.g. changes, mutual recognitions or same product authorisations). Mini SPCs do not have all the information required in a product authorisation. It is important to ensure that the SPCs available in R4BP 3 as mini SPCs are completed: if not completed there may appear authorisations in R4BP 3 without important information like e.g. the AS name. Furthermore, by late 2017 the content of the SPC will be disseminated by ECHA (as per decision of the CA meeting, document CA-Nov15-Doc.4.8) and the content of each SPC should be completed before being disseminated. A complete SPC can be added to an authorisation trough the relevant XX-AAT case types. The terms and conditions of a national authorisation can be found in the SPC available in the asset. R4BP 3 replaces the content of the SPC in the reference asset based on the latest successfully Closed Approved change in R4BP 3. If several changes apply to an asset at the same time, the applicant needs to carefully consider adding up the latest changes in the latter submission since, once approved, the SPC of the latest Closed-Approved case will determine the terms and conditions available in the SPC. The <Compare with> functionality in the SPC editor will help you in assessing what new information is added to the SPC of the latter case. The final SPC must not include confidential information, as it will be publicly available. The final SPC is composed of information transferred from R4BP 3 and the SPC file. More precisely R4BP 3 will transfer the following information: authorisation number, reference number, authorisation date, expiry date. Furthermore, the following information on the authorisation holder will be automatically completed: UUID, name, address, postal code, city and country. The following table summarises in which processes (case types) related to authorisations a SPC is needed in the application. A list of definitions of case types is available in the table of contents of this document. Table 2: Case type and SPC correlation table Case type SPC Case type SPC Case type SPC NA-APP Yes NA-BBS Yes SA-NPF Yes NA-MRP Yes NA-NPF Yes SA-CAT No NA-MRS Yes SA-APP Yes SA-AAT amend NA-RNL Yes (optional)* SN-NOT Yes PP-APP No NA-CAT No SN-AAT amend PP-AAT No NA-AAT amend** SN-CAT No PP-CAT No NA-ADC Yes SA-ADC Yes UA-APP Yes NA-TRS Yes SA-TRS Yes UA-BBP Yes NA-MRG Yes SA-MIC Yes NE-NOT No NA-MIC Yes SA-MAC Yes SE-NOT No NA-MAC Yes SA-BBP Yes UP-APP Yes NA-BBP Yes SA-BBS Yes ET-NOT No NA-CCL No UA-MAC Yes

35 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October * optional means that the SPC is not mandatory but it is suggested ** amend means that the SPC can be submitted by the CA when amending a NA, SA or PP. The uploaded SPC will not be visible in the newly created case until the case has passed the ECHA business rules check (BRC). The following file types are supported: doc/docx/pdf/xls/xlsx/ppt/txt; maximum file size is 3GB Handling SPC families in R4BP 3 With the release of SPC Editor 2.0, the meta SPC concept has been introduced for a family SPC. A meta SPC is a structure of a group of products within a family with a similar composition, similar uses, same hazard and precautionary statements and a common set of first aid instructions, disposal, storage and shelf life. For information on the tasks performed by the applicant please refer to the SPC Editor manual available on ECHA webpage. A BPF (biocidal product family) can consist of one or more meta SPCs, a meta level might consist of one or more products. As part of a biocidal product family application, an applicant needs to include a meta family SPC containing all members for which an authorisation is sought. The eca needs to download the family meta SPC available in the application, edit it and upload it as part of the final SPC before a national or union authorisation is granted. As a result, R4BP 3 will generate an asset number ending in related to the family meta SPC and asset members starting with the same root and ending in 0001, -0002, for each member of the family. The guidance document for implementing of the new concept of biocidal product families is available on CircaBC (CA-Nov14-Doc.5.8 Final.rev3) File migration from SPC 1.0 to SPC 2.0 As a result of the adaptation to the new family structure, ECHA: - migrated all existing family SPCs in R4BP 3 to the new family structure; and - updated the SPC online editor to allow structured family applications. ECHA carried out the automatic migration of existing SPCs for family applications in the cases/assets available in R4BP 3. The automatic migration process ensures that no data previously contained in SPCs is lost. However some adaptations may have to be applied to family SPC anytime R4BP 3 requires their upload in a specific case type. This may happen for: 1) on-going cases where applicants have followed the workaround solution proposed by ECHA in July 2015 and the new family structure has not been provided yet in structured format; or 2) when information available in the SPC had to be duplicated. For point one if there are family cases without any member, the system will add one meta level and one empty product in the converted family SPC. In this scenario you will need to

36 add all the relevant information for the product in the third level of the SPC which appears empty after the migration. If there are family assets without any member, the system will create one meta level and one new member asset in the converted family SPC. In this case as well you will need to add all the relevant information for the product in the third level of the SPC, which will appear empty after the migration, by amending the asset with an XX-AAT. Point two implies that when updating the new family SPC, you will also need to pay special attention to the removal of any possible duplicates of information, which were necessary in order to avoid loss of data in the migration procedure. More in detail, please check the following fields at family level: 1) Manufacturers of the product 2) Manufacturers of the substance and at meta-spc level 3) Authorised uses 4) General instructions for use Please check also the content of the field Other information where the trade names that used to be in the old family SPC are migrated as free text. In any case for the migration to be finalised, for all open cases, you will have to download the family SPC, and upload it as part of the final SPC. In the Evaluation step, the eca needs to download the existing family SPC (evaluate it) and then upload it in order to finalise the migration. Furthermore for already authorised assets, you may update the migrated SPCs by using the amendment for authorisations (XX-AAT) case types in R4BP 3. A consultation with applicants via ad hoc communication may be recommended, in order to give them the chance to update the SPC. Please consider that if there were cases or assets containing family SPC in language A and member SPCs in language B, the system will generate as many family SPCs as many different languages were present in the old SPC package (family and member SPCs). Choose only one of them before finalising any relevant task. No changes will apply to SPCs for applications for single biocidal products Agreeing on and replacing the SPC In all those processes where an exchange of SPC among CAs is needed before the final approval/non approval of the application (NA-MRP, NA-MRS, NA-RNL, NA-MIC, NA-MAC, SA-MIC, SA-MAC and UA-MAC) the RMS/cMS can exchange the draft SPC, for the purposes of agreeing on the SPC, via ad hoc communication (see section 3.10). The same approach can be used to agree on the final SPC with the applicant in relevant cases (if the agreed SPC is requested via the request additional info task the action will stop the clock as described in section 3.9). 36 The final, agreed SPC in.xml format, must be uploaded by the CA before finalising the EVL task (Figure 21). If the SPC of an authorisation needs to be amended, the final SPC can also be uploaded, at a later stage, by the CA using the relevant XX-AAT case types ( amend case type in Table 2).

37 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October Request additional information with resubmit task This task needs to be used when the BPR allows additional information to be requested and a stop the clock process is foreseen. Step 1: Search for the relevant task, e.g. using the product name and/or case type. Step 2: Claim the task by selecting Start working. Step 3: Select Request additional Info in the field Please select one of the following allowed actions based on your decision (Figure 23). Figure 23: Provide your decision page 1/2 Step 4: Type a message to the applicant and set the due date for when your request needs to be completed (Figure 24). Step 5: In addition to the field Message to the owner, you may also upload a document describing your request for additional information, set the language in which the

38 38 request is written and put the relevant classification type (Figure 26) Step 6: Complete the task. Figure 24: Provide your decision page 2/2 The following file types are supported: doc/docx/pdf/xls/xlsx/ppt/txt; maximum file size is 3GB Ad hoc communication (New communication) An ad hoc communication (also known as new communication) may be used to Member States and ECHA about decisions taken by a MSCA or to create a task for applicant for which no submission of data by the applicant is necessary (e.g. to the payment of an invoice or exchange a SPC.xml file). Using the financial tab ( Figure 27) will generate only a message to the applicant; using the ad hoc communication will also create a task to the applicant.

39 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October Step 1: Step 2: Step 3: Search for the relevant case, e.g. using the product name and/or case type (Figure 5 a,b). In the relevant Case details page, press the Actions button and select New communication (Figure 7). Fill in the requested fields in the Ad hoc communication box to create a new communication. In the field Topic, select the best fitting option. Figure 25: Select the Topic page For authority users, only some subjects from the dropdown menu are relevant, e.g. evaluation, ad hoc invoicing, comments, opinion, SPC, product sameness and validation. Step 4: Tick the box Reply required and set the appropriate deadline in days. Only when the box Reply required is ticked a task to the recipient will be created. In other cases, the message will be delivered to the Messages tab. Step 5: By selecting the click box reply required and pressing Send the communication is forwarded to the applicant, the appropriate MSCAs or to ECHA. A task will be created for the user to which you have sent your communication.

40 Under the Events history sub-tab in the Case details page (Figure 8), you can see that the message was sent out. The documents you attached to the ad hoc communication are accessible via the Documents sub-tab in the Case details page. 40 Step 6: Click Continue to proceed. With the ad hoc communication in R4BP 3, no IUCLID dossier or SPC can be requested (and be update automatically). Should you require a IUCLID dossier or an amended SPC from the applicant, you need to use the Request additional information with the resubmit task (section 3.9). Choose the topic Comment in the topic field, if no better selection is available in the dropdown menu. The Request additional information function (section 3.9) stops the clock and puts on hold the running time the MSCA has for a task (legal period). Therefore, to ask for clarification to resolve small inconsistencies in the dossier, or in all cases where a stop of the clock is not foreseen by the BPR, the MSCA may use the ad hoc communication, which does not have any effect on the task duration and does not trigger the possibility for resubmission of a IUCLID file. With the ad hoc communication you can request an SPC in.xml format but it will not be uploaded automatically. You still need to upload it manually before approving the case. The following file types are supported: doc/docx/pdf/xls/xlsx/ppt/txt; maximum file size is 3 GB Invoicing, financial information The creation of national invoices is out of the scope of R4BP 3. Therefore, each MSCA should use its own system to prepare invoices. However, R4BP 3 needs to be used for sending the invoice to the applicant and to record the status of the payments. MSCA should invoice only after a relevant task has been created by the system e.g. MSCA accept or Validate. By failing to do so there is a risk that an invoice is sent before the previous step is actually completed and the invoice have to be refunded if the application is rejected in the previous step. Step 1: Step 2: Search for the relevant case, e.g. using the product name and/or case type. Open the Case details by clicking on the case number hyperlink.

41 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October Step 3: Under Case details, select the Financial management sub-tab. Figure 26: Case details Financial management tab page Step 4: Under Financial management, click the Upload invoice button in the Handle invoices section ( Step 5: Figure 27). Figure 27: Financial information page

42 42 Step 6: Fill in the fields and upload the pdf file of your original invoice. Choose the language in which the invoice has been created (Figure 28 and Figure 29). Figure 28: Upload new invoice page Figure 29: Upload new invoice page, select language Step 7: Click Send in order to send the invoice to the applicant (Figure 30). Figure 30: Financial information - send page

43 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October Step 8: Click Continue to proceed. Figure 31: Confirmation message page Step 9: Once you have received the payment, change the fee status from Awaiting payment to Fee paid in the Financial management sub-tab of the relevant case (Figure 32). The applicant will be informed automatically via R4BP 3. Figure 32: Financial information handle invoices Fee paid page Step 10: If the fee has not been paid within 30 days, change the fee status to Fee unpaid in the Financial management tab of the relevant case (Figure 33). According to the BPR, the application is to be rejected if the fees are not paid within 30 days.

44 44 Figure 33: Financial information handle invoices unpaid page For all national processes (i.e. except those relevant at Union level), you can reject a case yourself, if the payment is not done within 30 days. For processes related to Union level, an ad hoc communication needs to be sent to ECHA requesting the rejection of the application due to non-payment of the invoice. ECHA will then reject the application in R4BP 3. Processes at Union level include: active substance approval (including renewal, amendment and review of active substance approval) and Union authorisation of biocidal products (including a change, authorisation of the same and renewal of Union authorisation). Cancelling and changing invoices can be recorded by setting the status of the invoice to Credited. You can then upload the credit note and the corrected invoice. By clicking Send, both documents are sent to the applicant Acceptance, validation, evaluation, approval/rejection Generally, the workflow of biocides processes follows the pattern of acceptance, validation, evaluation and ends resulting in an approval, non-approval or a rejection of an application. Rejection can be the outcome at any of the steps. Please note that these terms are not related to legal acts (decisions, regulations) but only to the applications themselves. Acceptance is the first step in the processing of an application and it is finalised once the payment is received. If an invoice is not paid within the given deadline, the application will be rejected at this stage. The acceptance step has to be finalised within the 30 days deadline. The validation is understood to be a verification step to ensure the application is complete. The time for the MSCAs to finalise the validation step is usually 30 days from acceptance date. More information on which issues need to be validated is described in the sections of the specific processes in this manual. If the application is found to be invalid, a request for additional information can be made that must be completed by the industry user within a defined deadline. In some processes, the validation step was used for confirmation whether the full evaluation is needed or not.

45 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October The evaluation of the applications follows the validation step. Once the validation is finalised, the evaluation of the application can start. The evaluation time of the eca (or the rms) depends on the process. If further information is needed during this step, a request for additional information can be made that must be completed by the industry user within a defined deadline. This action will stop the clock and the eca (or the rms) will need to specify the deadline industry has to comply with the request. Approval is the positive outcome of the process after the evaluation step (for those case types managed by the MSCA). For cases having SPC the authority user should further review and update, if required, the SPC package (in the correct.xml format) of the final SPC files attached for the specific case. Non-approval is the negative outcome of the process after the evaluation step (for those case types managed by the MSCA). Rejection is a negative outcome, that can occur in the acceptance, the validation or the evaluation steps. Rejection is appropriate to use in cases of non-payment of the fee or failure to submit additional information requested by the authority (where this is justifiable by the legislation). To approve, non-approve or reject an application in R4BP 3, select the appropriate option from the drop-down menu of the relevant task page and upload the decision and, where relevant, the appropriate documents (e.g. SPC). Complete the task page to move to the following task or to close the application. Applications for approval of active substances and for Union authorisation of biocidal products can only be approved or nonapproved by Commission in R4BP 3. If the applicant fails to pay the fee within the 30-day deadline, the MSCA should reject the application and complete the task or inform ECHA if it relates to an application for which a MSCA cannot reject Business rules quality of dossiers Before applications are accepted by ECHA they pass through the ECHA submission pipeline. This includes a virus check, format validation and a check of process specific business rules. It also applies for resubmit tasks when a new dossier is required (request for additional information). You can find more information on the submission to ECHA in Chapter 6 How ECHA handles your submission of the Biocides Submission Manual - Technical guide: using R4BP 3 for biocide applications directed at applicants Classification of documents Access level Authorities have to classify the documents they upload: Public: meaning that the document may be disseminated as uploaded and visible to both industry and authority users in the asset/case/task/message context that it is uploaded in. Restricted: meaning that the document is visible to both industry and authority users in the asset/case/task/message context in which it is uploaded, but it will not be disseminated as uploaded. Restricted Authority: meaning that the document is only visible to authority users in the asset/case/task/message context in which it is uploaded and will not be disseminated as uploaded

46 46 Important note about the access level: When uploading your supporting documents in the R4BP 3, you are required to indicate an access level as either public, Restricted or Restricted to Authority. The access level is purely indicative and is in no way binding on ECHA What to do if you need support ECHA offers a dedicated service to the MSCAs in using the Agency s information systems and performing their duties in the context of the BPR. You can address your questions via the contact form:

47 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October AS-APP Active substance approval 4.1 Introduction Please consult this chapter of the BPR Practical Guide for a description of the regulatory requirements and the related process. 4.2 Workflow BRC > EAA > VAL > MEV > OPN > DEC 4.3 Application requirements Please consult this Biocides Submission Manual for a description of the application requirements related to this process. 4.4 Steps to be followed by the MSCA The eca needs to claim the task during the approval process and can request further information through the task item. Step 1: Claim the Validate task. Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant via the Case details Financial management sub-tab in R4BP 3 (see section 3.11). If the fee is not paid within 30 days reject the application (see section 3.12) Step 3: Complete the actions in the Validation page (Figure 18). Validate the application within 30 days of receiving the task from ECHA according to BPR Articles 7(3). This validation includes verifying whether: a. the information requirements for the active substance are fulfilled; b. the information requirements for the representative product(s) are fulfilled; c. BPR Article 5(2) is applicable if exclusion criteria are met according to BPR Article 5(1); d. Justifications have been submitted for the adaptation of information requirements. The validation should not include an assessment of the quality or the adequacy of the data or justifications submitted. e. If the information requirements are fulfilled, complete the validation task and follow on with Step 4. f. If the information requirements described above are not fulfilled, inform the applicant what additional information is required for validating the application (further information in sections 3.9). Set a reasonable time limit for the submission of the additional information. This shall normally not exceed 90 days. g. Validate the application within 30 days of receipt of the additional information. Reject the application if the applicant fails to submit the requested information

48 within the deadline or the information requirements remain incomplete. In such case, part of the fees paid by the applicant to the eca may need to be reimbursed. 48 Step 4: Claim the Evaluate task and complete the actions in the Evaluation page (Figure 19). Evaluate the application within 365 days (BPR Article 8(1)). The following tasks related to R4BP 3 can be considered during the evaluation: a. Annotate IUCLID 2 file where relevant. b. via the request additional information function you can request further information and stop the clock. Set a reasonable time limit for the submission of the additional information. This shall normally not exceed 180 days. Reject the application (see section 3.12) if the applicant fails to submit the requested information within the deadline. The applicant will be automatically notified. c. Inform ECHA via ad hoc communication (see section 3.10) as soon as possible on issues identified that may need to be discussed at a working group meeting already before submitting the competent authority report (CAR) and the dossier enters the peer review phase. d. Inform ECHA via ad hoc communication if the active substance is a potential candidate for substitution. e. Perform confidentiality claims check by evaluating the justifications submitted by the applicant. f. According to the ECHA s procedures it is suggested that not later than 60 days before the end of the 365-day evaluation period, the eca would send the CAR and conclusions for a 30-day commenting period to the applicant. Reply to the applicant s comments and adapt the CAR accordingly if necessary. Step 5: Peer review Send the CAR to ECHA for initiation of the peer review stage. According to the Working procedure for active substance approval, Table 1, the CAR should be submitted via R4BP Supporting documents Template agreement to act as CA. AS-EVA Active substance evaluation under Directive 98/8/EC 5.1 Introduction Please consult this chapter of the BPR Practical Guide for a description of the regulatory requirements and the related process. 2 Guidance on IUCLID is available on ECHA website here:

49 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October Workflow BRC > EAA > VAL > MEV > OPN > DEC 5.3 Application requirements This process derives from the assessment of the existing active substances under the BPD and is supported by Article 90 of the BPR and the Review Programme Regulation (EU) No 1062/2014. The only application requirement is for the active substance to be in the review programme. All AS/PT combinations have been created in R4BP 3. The case owner is either the participant or the task force leader. The management of participants (Article 95 list management) takes place outside R4BP Steps to be followed by the MSCA Step 1: Complete the actions in the Validation page (Figure 18). a. If the application is incomplete, inform the applicant that additional information is required for validation. Through request additional information (see section 3.9) a resubmission task item for the applicant is created. Set a reasonable time limit for the submission of the additional information. This shall normally not exceed 90 days. Reject the application if the applicant fails to submit the requested information by the deadline (see section 3.12). b. If the information requirements are fulfilled, complete the validation task within 30 days of receipt additional information and follow on with Step 2. c. Reject the application if the applicant fails to submit the requested information by the deadline (see section 3.12). The applicant and ECHA will be notified accordingly. Step 2: Claim the Evaluate task and complete the task actions (Figure 19). Evaluate the application (the Review Regulation sets PT-dependent deadlines Annex III). The following tasks related to R4BP 3 can be considered during the evaluation: a. When relevant, annotate IUCLID file and/or the study summaries. b. Consult with ECHA via ad hoc communication if additional information is required. Request additional information ( stop the clock ) as described in Step 3 b above to the applicant. If you stop the clock, please inform ECHA via ad hoc communication (see sections 3.9). c. Inform ECHA on issues identified that may need to be discussed at a working group meeting via ad hoc communication already before submitting the CAR and the dossier enters the peer review phase. d. Inform ECHA if the active substance is a potential candidate for substitution via ad hoc communication. e. Perform the confidentiality claims check by evaluating the justifications submitted by the applicant. f. According to the ECHA s procedures it is suggested that not later than 60 days before the end of the evaluation period, the eca would send the CAR and the conclusions for a 30-day-commenting period to the applicant. Reply to the applicant s comments and adapt the CAR accordingly if necessary.

50 50 Step 3: Peer review Send the CAR to ECHA for initiation of the peer review stage. According to the Working procedure for active substance approval, Table 1, the CAR should be submitted via R4BP 3. AS-NAS New active substance evaluation under Directive 98/8/EC 6.1 Introduction Please consult this chapter of the BPR Practical Guide for a description of the regulatory requirements and the related process. All AS/PT combinations have been created in R4BP 3. The case owner is either the participant or the task force lead. The management of participants (Article 95 list management) is lead outside R4BP 3. MEV > OPN > DEC 6.2 Workflow 6.3 Application requirements This process derives from the assessment of the new active substances under the BPD and is supported by Article 90 of the BPR. The only application requirement is that an approval request was submitted for a new active substance under the BPD. 6.4 Steps to be followed by the MSCA Please follow the steps 4 and 5 in section Supporting documents Template agreement to act as eca. AS-RNL Renewal of the approval of an active substance 7.1 Introduction Please consult this chapter of the BPR Practical Guide for a description of the regulatory requirements and the related process. 7.2 Workflow BRC > EAA > VAL > MEV > OPN > DEC Please note that in this case type the validation task is used by eca to decide whether a full evaluation is required or not. 7.3 Application requirements Please consult this Biocides Submission Manual for a description of the application requirements related to this process.

51 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October See section Steps to be followed by the MSCA 7.5 Supporting documents Template agreement to act as eca. AS-NPT Approval of an active substance in an additional product type 8.1 Introduction Please consult this chapter of the BPR Practical Guide for a description of the regulatory requirements and the related process. 8.2 Workflow BRC > EAA > VAL > MEV > OPN > DEC 8.3 Application requirements Please consult this Biocides Submission Manual for a description of the application requirements related to this process. See section Steps to be followed by the MSCA 8.5 Supporting documents Template agreement to act as eca (it should be the same eca of the original dossier). AN-APP (1-5) Amendment of Annex I 9.1 Introduction The process relates to the amendment of category 1 to 5 of Annex I to the BPR. Please consult this chapter of the BPR Practical Guide for a description of the regulatory requirements and the related process. 9.2 Workflow BRC > EAA > MAA > MEV > OPN > DEC 9.3 Application requirements Please consult this Biocides Submission Manual for a description of the application requirements related to this process.

52 Steps to be followed by the MSCA Step 1: Step 2: Claim the MSCA accept task. Issue an invoice according to Article 80(2) of the BPR and send it to the applicant via the Case details Financial management sub-tab in R4BP 3 (see section 3.11). Step 3: Complete the actions in the MSCA accept page (Figure 17). Check whether the fee has been paid within 30 days (3a) or not (3b). a. If the fee has been paid, accept the application and proceed with Step 4. The applicant will be notified accordingly by the system. b. If the fee has not been paid, reject the application. The applicant will be automatically notified. Step 4: Claim the Evaluate task and complete the actions in the Evaluation page (Figure 19). Evaluate the application within 180 days. The following tasks related to R4BP 3 can be considered during the evaluation: a. via the request additional information function you can request further information and stop the clock. Set a reasonable time limit for the submission of the additional information. This shall normally not exceed 180 days. Reject the application (see section 3.12) if the applicant fails to submit the requested information within the deadline. The applicant and ECHA shall be notified. b. Inform ECHA via ad hoc communication (see section 3.10) as soon as possible on issues identified that may need to be discussed at a working group meeting already before submitting the competent authority report (CAR) and the dossier enters the peer review phase. c. Perform confidentiality claims check by evaluating the justifications submitted by the applicant. d. ECHA suggests that not later than 60 days before the end of the 180-day evaluation period, the eca would send the CAR and conclusions for a 30-day commenting period to the applicant. Reply to the applicant s comments and adapt the CAR accordingly if necessary. e. Complete the Evaluate task selecting Submit evaluation. Step 5: Peer review Send the CAR to ECHA for initiation of the peer review stage. According to the Working procedure for active substance approval, Table 1, the CAR should be submitted via R4BP Supporting documents Template agreement to act as CA.

53 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October AN-APP (6) Amendment of Annex I 10.1 Introduction The process relates to the amendment of category 6 of Annex I to the BPR. Please consult this chapter of the BPR Practical Guide for a description of the regulatory requirements and the related process Workflow BRC > EAA > VAL > MEV > OPN > DEC 10.3 Application requirements Please consult this Biocides Submission Manual for a description of the application requirements related to this process Steps to be followed by the MSCA The procedure to be followed is the same of AS-APP or AS-EVA. Please See section Supporting documents Template agreement to act as CA. NA-APP National authorisation 11.1 Introduction Please consult this chapter of the BPR Practical Guide for a description of the regulatory requirements and the related process. BRC > MAA > VAL > EVL 11.2 Workflow 11.3 Application requirements Please consult this Biocides Submission Manual for a description of the application requirements related to this process Steps to be followed by the MSCA The steps described here are not relevant for applications for mutual recognition in parallel. If you are the rms for an application, which shall be mutually recognised in parallel, please refer to section 15. Step 1: Step 2: Claim the MSCA accept task. Issue an invoice according to Article 80(2) of the BPR and send it to the applicant via the Case details Financial management sub-tab in R4BP 3 (see section

54 ). Step 3: Complete the actions in the MSCA accept page (Figure 17). Check whether the fee has been paid within 30 days (3a) or not (3b). a. If the fee has been paid, accept the application and proceed with Step 4. The applicant will be notified accordingly by the system. b. If the fee has not been paid, reject the application. The applicant will be automatically notified. Step 4: Claim the Validate task and complete the actions in the Validation page (Figure 18). Validate the application within 30 days of the acceptance date. According to the BPR (Article 29(2)), the validation includes verifying: whether the relevant information described in Article 20 of the BPR has been submitted; that the statement of the applicant that no application for national authorisation of the same biocidal product for the same use has been submitted to any other MSCA. A template is provided by ECHA on the website and should be included in the application by the applicant as a supporting document. The validation shall not include an assessment of the quality or adequacy of the data or justifications submitted. a. If the information requirements described above are fulfilled, complete and proceed with Step 5. b. If the information requirements described above are not fulfilled, inform the applicant of the additional information that is required for validation. Through request additional information (see section 3.9) a resubmission task item for the applicant is created to submit an updated IUCLID dossier or other file type supported by the case type wizard. Set a reasonable time frame for the submission of the additional information which should normally not exceed 90 days. Validate the application within 30 days of receipt of the additional information. Reject the application if the applicant fails to submit the requested information by the deadline (see section 3.12). c. If the applicant has already submitted an application for national authorisation for the same biocidal product and the same use in another Member State, reject the application and inform the applicant of the possibility of seeking mutual recognition. As R4BP 3 does not allow checking this by searching the data base at the moment, this has been implemented by the obligatory inclusion of the above mentioned supporting document by the applicant.

55 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October Step 5: Claim the Evaluate & Decide task Within 365 days, evaluate whether an authorisation can be granted in accordance with Article 19 of the BPR. This evaluation step takes place outside R4BP 3. The following tasks related to R4BP 3 can be performed during the evaluation: a. Annotate IUCLID file where relevant. b. Request additional information from the applicant if necessary to carry out the evaluation. Through request additional information (see section 3.9) a resubmission task item for the applicant is created to submit a new IUCLID dossier or other file type and it will stop the clock. Set a reasonable period for the submission of the additional information, which should normally not exceed 180 days in total. Reject the application (see section 3.12) if the applicant fails to submit the requested information within the deadline. The applicant will be automatically notified. c. Draft a product assessment report (PAR) summarising the conclusions of the assessment and the reasons for authorising or refusing to grant the authorisation. Amend if necessary the draft SPC generated by the applicant. Send an electronic copy of the PAR and the SPC to the applicant through ad hoc communication (see section 3.10) and provide the opportunity to submit comments within 30 days (request reply). d. Finalise the assessment taking into account the comments provided by the applicant. e. Perform a confidentiality claims check by evaluating the justifications submitted by the applicant. f. Complete the actions in the Evaluate & Decide page by selecting Approve application (Figure 20). Close the task by approving or not approving the application for the product authorisation (see section 3.12) and at the same time upload the final PAR and SPC to R4BP 3. The final SPC must not include confidential information, as it will be made publicly available. Applications for authorisation of the same biocidal product will appear as related asset of the reference product (see Article 7 of the Implementing Regulation (EU) No 414/2013, amended by Regulation No 2016/1802). Whenever an authorisation is granted or not, the related cases should be checked as the connections are not automated. NA-APP (WA) Provisional national authorisation Article 55(2) 12.1 Introduction Please consult this chapter of the BPR Practical Guide for a description of the regulatory requirements and the related process.

56 56 BRC > MAA > VAL > EVL 12.2 Workflow 12.3 Application requirements Please consult this Biocides Submission Manual for a description of the application requirements related to this process Steps to be followed by the MSCA Step 1: Claim the MSCA accept task (see section 3.8). Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant via the Case details Financial management sub-tab in R4BP 3 (see section 3.11). Step 3: Complete the actions in the MSCA accept page (Figure 17). Check in your national invoicing system whether the fee has been paid within 30 days (3a) or not (3b). a. If the fee has been paid, complete and proceed with Step 4. The applicant will be notified accordingly. b. If the fee has not been paid, reject the application. The applicant will be automatically notified. Step 4: Claim the Validate task and complete the actions in the Validation page (Figure 18). Validate the application within 30 days of the acceptance date. According to the BPR (Article 29(2)), the validation includes verifying: i. whether the evaluating competent authority has given a recommendation for approval in the CAR (please check the CAR uploaded in the R4BP 3 or CIRCA BC page under the new active folders); ii. whether the relevant information described in Article 20 of the BPR has been submitted; The validation shall not include an assessment of the quality or adequacy of the data or justifications submitted. a. If the information requirements described above are fulfilled, complete and proceed with Step 5 by selecting Validate. b. If the information requirements described above are not fulfilled, inform the applicant of the additional information that is required for validation. Through request additional information (see section 3.9) a resubmission task item for the applicant is created to submit an updated IUCLID dossier. i. Set a reasonable time frame for the submission of the additional information which should normally not exceed 90 days. Validate the application within 30 days of receipt of the additional information. ii. Reject the application if the applicant fails to submit the requested information

57 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October by the deadline (see section 3.12). c. If the applicant has already submitted an application for national authorisation for the same biocidal product and the same use in another Member State, reject the application and inform the applicant of the possibility of seeking mutual recognition. As R4BP 3 does not allow checking this by searching the data base at the moment, this has been implemented by the obligatory inclusion of the above mentioned supporting document by the applicant. Step 5: Claim the Evaluate & Decide task Evaluate whether an authorisation can be granted in accordance with Article 19 of the BPR. The duration of the evaluation period is still under discussion by the COM services. The following tasks related to R4BP 3 can be considered during the evaluation: a. Annotate IUCLID file where relevant. b. Request additional information from the applicant if necessary to carry out the evaluation. Inform the applicant what additional information is required. Through request additional information (see section 3.9) a resubmission task item for the applicant is created to submit a new IUCLID dossier or other file type and it will stop the clock. Set a reasonable period for the submission of the additional information which should normally not exceed 180 days in total. Reject the application (see section 3.12) if the applicant fails to submit the requested information within the deadline. The applicant will be automatically notified. c. Draft a product assessment report (PAR) summarising the conclusions of the assessment and the reasons for authorising or refusing to grant the authorisation. Amend if necessary the draft SPC generated by the applicant. d. Perform a confidentiality claims check by evaluating the justifications submitted by the applicant. e. Send an electronic copy of the PAR and the SPC to the applicant through ad hoc communication (see section 3.10) and provide the opportunity to submit comments within 30 days (request reply). Finalise the assessment taking into account the comments provided by the applicant. f. Complete the actions in the Evaluate & Decide page by selecting Approve application (Figure 20). Close the task by approving or not approving the application for the product authorisation (see section 3.12) and the same time upload the final PAR and SPC to R4BP 3. The final SPC must not include confidential information, as it will be publicly available (see section 3.8.1). Applications for authorisation of the same biocidal product will appear as related asset of the reference product (see Article 7 of the Implementing Regulation (EU) No 414/2013, amended by Regulation No 2016/1802). Whenever an authorisation is granted or not, the related cases should be checked as the connections are not automated. * The duration of the evaluation period is still under discussion within the COM

58 58 services. NA-RNL Renewal of National authorisation 13.1 Introduction Please consult this chapter of the BPR Practical Guide for a description of the regulatory requirements and the related process. BRC > MAA > VAL > EVL 13.2 Workflow 13.3 Application requirements Please consult this Biocides Submission Manual for a description of the application requirements related to this process. MSCAs need to determine whether they are rms or cms Steps to be followed by the MSCA Step 1: Step 2: Step 3: Claim the MSCA accept task. Check that there is no supporting document in the document tab and proceed directly with Step 3. In case there is a supporting document this means that the case refers to a mutual recognition renewal and you should refer to section 14. Issue an invoice according to Article 80(2) of the BPR and send it to the applicant via the Case details Financial management sub-tab in R4BP 3 (see section 3.11). Step 4: Complete the actions in the MSCA accept page (Figure 17). Check whether the fee has been paid within 30 days (3a) or not (3b). a. If the fee has been paid accept the application and proceed with Step 4. The applicant will be notified accordingly. b. If the fee has not been paid, reject the application (see section 3.12) and inform the applicant accordingly through ad hoc communication (see section 3.10). Similarly, inform the rms if relevant (if a supporting document is present in the application). Step 5: Claim the Validate task and complete the actions in the Validation page (Figure 18). Decide within 90 days of accepting an application whether a full evaluation of the application for renewal is necessary taking account of all product-types for which renewal is needed. A tick box is provided in R4BP 3 to support this option. Step 6: Claim the Evaluate & Decide task and complete the actions in the Evaluate & Decide page (Figure 20). In case a full evaluation of the application is necessary, evaluate it within 365 days whether a renewal of an authorisation can be granted in accordance with Article 30 of the BPR. This

59 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October evaluation step takes place outside R4BP 3. The following tasks related to R4BP 3 can be performed during the evaluation: a. Annotate IUCLID file where relevant. b. Request additional information from the applicant if necessary to carry out the evaluation. Through request additional information (see section 3.9) a resubmission task item for the applicant is created to submit a new IUCLID dossier or other file type and it will stop the clock. c. Set a reasonable time frame for the submission of the additional information which should normally not exceed 180 days in total. Reject the application (see section 3.12) if the applicant fails to submit the requested information within the deadline. The applicant will be automatically notified. d. Draft a product assessment report (PAR) summarising the conclusions of the assessment and the reasons for authorising or refusing to grant the authorisation. Amend if necessary the draft SPC generated by the applicant. e. Send an electronic copy of the PAR and SPC to the applicant through ad hoc communication (see section 3.10) and provide the opportunity to submit comments within 30 days (request reply). Finalise the assessment taking into account the comments provided by the applicant. In case a full evaluation of the application is not necessary evaluate it within 180 days of accepting the application. Complete the actions in the Evaluate & Decide page by selecting Approve application (Figure 20). Close the task by approving or not approving the application for the renewal of national authorisation (see section 3.12) and at the same time, if relevant, upload the final PAR and SPC to R4BP 3. The final SPC must not include confidential information, as it will be publicly available (see section 3.8.1). NA-RNL Renewal of National authorisation subject to mutual recognition 14.1 Introduction This is in practice the same case type used for single product authorisation renewal except that the applicant will request in a single submission the renewal of all (or some) the assets related by mutual recognition. Communication with concerned MSCA is therefore needed. Please consult this chapter of the BPR Practical Guide for a description of the regulatory requirements and the related process. BRC > MAA > VAL > EVL 14.2 Workflow

60 Application requirements Please consult this Biocides Submission Manual for a description of the application requirements related to this process. MSCAs need first to determine whether they are rms or cms by checking the supporting document. The grouped submission of renewal application is the principle introduced by the Commission Regulation No 492/2014 in order to avoid unnecessary duplication of the evaluation procedures by the Competent Authorities (CA). This practical approach is also recommended for the sake of consistency during the evaluation process. However, in case of mutually recognised authorisations, which have different Authorisation Holders the grouped submission is not mandatory and up to the Authorisation Holder choice to nominate another company making the grouped application for renewals. In case companies decide to submit the applications for renewal separately, these separate applications may not be linked together and could therefore be evaluated separately by the (possibly different) receiving MSs as it is described in Article 31 of the BPR (taking into account exceptions for biocidal products containing chlorophacinone, bromadiolone or coumatetralyl). Note also technical limitations explained below due to which two or more submissions may need to be combined for evaluation by a single rms under the Commission Regulation No 492/ Steps to be followed by the reference MSCA Step 1: Step 2: Step 3: Claim the MSCA accept task. A supporting document (Renewal of authorisation subject to mutual recognition) should be present under the Documents tab. If there is no supporting document this means that the case refers to a renewal not involving any mutual recognition and you should refer to section 13. If there is such supporting document, check in the supporting document whether you are rms or cms. Please note that this information or the related cases cannot be read from the case details. Furthermore, since there may be missing links in the R4BP 3 database among the related NA assets, applicants may need to apply under the regulation 492/2014 in more than one submissions. The kind of submission (main or additional) can be deduced from the supporting document(s). The rms is given by the asset from which the applicant starts the main submission. The additional submissions cover related assets that could not be included in the main submission for which the corresponding competent authorities become cmss. In order to ensure the information on the rms/cms and the additional submissions is available to all rms/cms and to potentially enable their combined assessment with the main submission, ECHA will send the supporting documents of the main and additional submissions to the rms and the cms through ad hoc communication. For cms next steps refer to section Step 4: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant via the Case details Financial management sub-tab in R4BP 3 (see section 3.11).

61 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October Step 5: Complete the actions in the MSCA accept page (Figure 17). Check whether the fee has been paid within 30 days (3a) or not (3b). a. If the fee has been paid accept the application and proceed with Step 6. The applicant will be notified accordingly. b. If the fee has not been paid, reject the application (see section 3.12). The applicant will be notified accordingly. Inform the concerned CA through ad hoc communication (see section 3.10). Step 6: Claim the Validate task and complete the actions in the Validation page (Figure 18). Within 30 days of the acceptance in the reference Member State, that Member State shall validate the application if it contains all the relevant information referred to in Article 2. a. If the information requirements described above are fulfilled, select Validate complete and proceed with Step 6. b. If the information requirements described above are not fulfilled, request additional information (section 3.9) and set a reasonable period for the submission of the additional information, which should normally not exceed 90 days in total. c. Select reject if the additional information are not sufficient to validate the application. d. Decide within 90 days of accepting an application whether a full evaluation of the application for renewal is necessary taking account of all product-types for which renewal is requested. A tick box is provided in R4BP 3 in the validation page to support this option. The reference CA must send an ad hoc communication to the concerned CAs to inform them about the evaluation type of their choice. Step 7: Claim the Evaluate & Decide task and complete the actions in the Evaluate & Decide page (Figure 20). In case a full evaluation of the application is necessary, evaluate it within 365 days* whether a renewal of an authorisation can be granted in accordance with Article 30 of the BPR. The following tasks related to R4BP 3 can be considered during the full evaluation: a. Annotate IUCLID file where relevant. b. Request additional information from the applicant if necessary to carry out the evaluation. Through request additional information (see section 3.9) a resubmission task item for the applicant is created to submit a new IUCLID dossier or other file type and it will stop the clock. Set a reasonable time frame for the submission of the additional information which should normally not exceed 180 days in total. Reject the application (see section 3.12) if the applicant fails to submit the requested information within the deadline. The applicant will be automatically notified. c. Draft a product assessment report (PAR) summarising the conclusions of the assessment and the reasons for renewal or refusing to renew the authorisation. Amend if necessary the draft SPC generated by the applicant. d. Send an the PAR and SPC to the applicant through ad hoc communication (see

62 section 3.10) and provide the opportunity to submit comments within 30 days (request reply). Finalise the assessment taking into account the comments provided by the applicant. e. Within 365 days of validating the application, the rms shall send draft PAR and SPC through ad hoc communication to the cms and to the applicant. *In case a full evaluation of the application is not necessary evaluate it within 180 days of validating the application. Please note that in this case step 6(b) does not apply. Agreement by cms and decision taking: a. All the cmss express their position on the draft SPC within 90 days of the receipt of the draft PAR and SPC from rms by sending their decision on the agreement through ad hoc communication to the rms, the other cmss and the applicant. If a cms expresses a disagreement with the draft SPC and the PAR prepared by the rms, the rms shall refer the detailed explanation of the points of disagreement and the reasons for position received from the cms to the Coordination Group without delay (see section 28). b. Following the 90 days, the rms will take a decision on the renewal of the national authorisation within 30 days and close the task by approving or not approving the application for the renewal of national authorisation (see section 3.12). The rms uploads the agreed SPC and the final PAR in R4BP 3 together with any agreed terms and conditions on the making available on the market or use of the biocidal product. The final SPC must not include confidential information, as it will be publicly available Steps to be followed by the concerned MSCAs Step 1: Step 2: Claim the MSCA accept task. Check whether there is a supporting document (Renewal of authorisation subject to mutual recognition) under the Documents tab (sent to you by ECHA) which indicates who the rms and the respective cmss are. The supporting documents you receive should be giving you the status of cms. This information or the related cases cannot be read from the case details in the R4BP 3. Furthermore, since there may be incorrect links in the R4BP 3 database among the NA assets, applicants may need to apply under the regulation 492/2014 in more than one submissions. The kind of submission (main or additional) can be deduced from the supporting document(s). The rms is given by the asset from which the applicant starts the main submission. The additional submissions cover related assets that could not be included in the main submission for which the corresponding competent authorities become cmss. In order to ensure the information on the rms/cms and the additional submissions is available to all rms/cms and to potentially enable their combined assessment with the main submission, ECHA will send the supporting documents of the additional submissions to the rms and the cms through ad hoc communication. Step 3: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant

63 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October via the Case details Financial management sub-tab in R4BP 3 (see section 3.11). Step 4: Complete the actions in the MSCA accept page (Figure 17). Check whether the fee has been paid within 30 days (3a) or not (3b). a. If the fee has been paid, complete and proceed with Step 4. The applicant will be notified accordingly. b. If the fee has not been paid, reject the application (see section 3.12). The applicant will be automatically notified. Send the information also to the rms and where relevant other cmss through ad hoc communication (see section 3.10) using the template mentioned in the supporting documents section below. Step 5: Claim the Validate task. Provided that the rms has validated the application, within 30 days of the acceptance the concerned Member State(s) will verify that the application it has received falls within the scope of the supplementary rules for renewal as per Article 1(2) and (3) of Commission Delegated Regulation (EU) No 492/2014. If not, the application for renewal must be processed under the regular renewal procedures set out in Article 31 of the BPR. In this case the MSs shall inform the other concerned MS via ad hoc communication. Such MS should process the application following the steps described in section A tick box is provided in this task to indicate which kind of evaluation will be performed by the rms and the cms must select the same evaluation type chosen by the rms. Step 6: Claim the Evaluate & Decide task. In case a full evaluation of the application is necessary, within 365 days* of validating an application, the rms shall evaluate the application and draft a PAR in accordance with Article 30(3) and send it together with the SPC through ad hoc communication to the cmss and to the applicant. a. All the cmss express their position on the draft SPC within 90 day of the receipt of the draft PAR and SPC from rms by sending their decision on the agreement through ad hoc communication to the rms, the other cmss and the applicant using the template from the supporting documents sections below. b. In case a given cms agrees with the draft SPC and the PAR (a positive assessment report), the cms completes the actions in the Evaluate & Decide page (Figure 20) and renews the authorisation within 30 days of reaching the agreement in conformity with the agreed SPC and closes the task by approving the application for the renewal of national authorisation (see section 3.12). Within 7 days after agreement, SPC should be translated by the applicant in all applicable languages. The finalised respective language version of the SPC must be uploaded by the cms when approving the renewal. (The rms shall upload the agreed SPC and the final PAR in R4BP 3 together with any agreed terms and conditions on the making available on the market or use of the biocidal product when approving the application for the renewal of national authorisation.) Make sure to assign the same expiry date as for the reference product. To find the expiry date of the reference product go to the related cases tab of your case s details page and copy the reference number of the reference product

64 (see point 8 of Figure 7). Search for the reference authorisation using this number. c. If you disagree with the draft SPC, send a detailed explanation of the points of disagreement and the reasons for your position to the rms, the other cmss, the applicant and, where applicable, the authorisation holder through ad hoc communication. This shall be referred by the rms to the Coordination Group without delay (see section 28). d. If you refuse to grant the authorisation of the BP or want to adjust the terms and conditions of the authorisation to be granted according to Article 37 of the BPR, and on the grounds of Article 7 of Regulation (EU) No 492/2014, communicate a detailed statement of the grounds for seeking a derogation to the applicant via ad hoc communication and seek an agreement. If the agreement between the two is not reached, the cms informs COM via ad hoc communication who takes the final decision. *In case a full evaluation of the application is not necessary the rms will evaluate it within 180 days of validating the application. Please note that in this case step 6(b) of section 13.4 does not apply. The final SPC must not include confidential information, as it will be publicly available Supporting documents 64 Template agreement/disagreement on SPC. NA-MRP Mutual recognition in parallel 15.1 Introduction Please consult this chapter of the BPR Practical Guide for a description of the regulatory requirements and the related process Workflow BRC > EAA > MAA > VAL > EVL 15.3 Application requirements Please consult this Biocides Submission Manual for a description of the application requirements related to this process Steps to be followed by the MSCA Steps to be followed by the rms Step 1: Claim the MSCA accept task (see section 3.8). Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant via the Case details Financial management sub-tab in R4BP 3 (see section 3.11). Complete the actions in the MSCA accept page (Figure 17). Check whether the

65 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October fee has been paid within 30 days (3a) or not (3b). a. If the fee has been paid, accept the application and proceed with Step 3. The applicant will be notified accordingly. b. If the fee has not been paid within 30 days, reject the application and inform via ad hoc communication the cms. Step 3: Claim the Validate task and complete the actions in the Validation page (Figure 18). Validate the application within 30 days of the acceptance date in accordance with Article 29(2) and (3) of the BPR. The validation includes verifying: whether the relevant information described in Article 20 of the BPR has been submitted, the statement of the applicant that no application for national authorisation of the same biocidal product for the same use has been submitted to any other MSCA. A template is provided by ECHA on the website and should be included in the application by the applicant as a supporting document. The validation should not include an assessment of the quality or adequacy of the data or justifications submitted. a. If the information requirements described above are fulfilled, select Validate complete and proceed with Step 4. b. If the information requirements described above are not fulfilled, inform the applicant of the additional information that is required for the validation. Through request additional information (see section 3.9) a resubmission task item for the applicant is created to submit a new IUCLID dossier or other file type. Set a reasonable period for the submission of the additional information which should normally not exceed 90 days. Validate the application within 30 days of receipt of the additional information. Reject the application if the applicant fails to submit the requested information by the deadline (see section 3.12) and inform the cms accordingly through ad hoc communication (see section 3.10) using the template mentioned in the supporting documents section below. c. If the applicant has already submitted an application for national authorisation for the biocidal product with the same use in another Member State, reject the application and inform the applicant of the possibility of seeking mutual recognition. Step 4 Claim the Evaluate & Decide task. Within 365 days of validating the application, evaluate the application whether an authorisation can be granted in accordance with Article 19. The following tasks related to R4BP 3 can be considered during the evaluation: a. Annotate IUCLID file where relevant. b. Request additional information from the applicant if necessary to carry out the evaluation. Through request additional information (see section 3.9) a resubmission task item for the applicant is created to submit a new IUCLID dossier or other file type and it will stop the clock. Set a reasonable time frame for the

66 submission of the additional information which should normally not exceed 180 days in total. Reject the application (see section 3.12) if the applicant fails to submit the requested information within the deadline. The applicant will be automatically notified. c. Draft a product assessment report (PAR) summarising the conclusions of the assessment and the reasons for authorising or refusing to grant the authorisation. Amend if necessary the draft SPC generated by the applicant. d. Perform a confidentiality claims check by evaluating the justifications submitted by the applicant. e. Send an electronic copy of the PAR and the SPC to the applicant through ad hoc communication (see section 3.10) and provide the opportunity to submit comments within 30 days (request reply). Finalise the assessment taking into account the comments provided by the applicant. f. Within 365 days of validating an application, the rms shall send draft PAR and SPC (see section and 3.10) through ad hoc communication to the cms and to the applicant. Agreement by cms and decision taking: a. All the cmss express their position on the draft SPC within 90 days of the receipt of the draft PAR and SPC from rms by sending the agreement through ad hoc communication to the rms, the other cmss and the applicant. If a cms expresses a disagreement with the draft SPC prepared by the rms, the rms shall refer the detailed explanation of the points of disagreement and the reasons for position received from the cms to the Coordination Group without delay (see section 28). b. Following the 90 days, the rms will take a decision on the national authorisation, the rms grants the national authorisation within 30 days and close the task by approving or not approving the application for the renewal of national authorisation (see section 3.12). The rms uploads the agreed SPC and the final PAR in R4BP 3 together with any agreed terms and conditions on the making available on the market or use of the biocidal product (see Figure 24 and section 3.8.2) Steps to be followed by the cms Step 1: Claim the MSCA accept task (see section 3.8). 66 Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant via the Case details Financial management sub-tab in R4BP 3 (see section 3.11). Complete the actions in the MSCA accept page (Figure 17). Check whether the fee has been paid within 30 days (3a) or not (3b). a. If the fee has been paid, accept the application and proceed with Step 4. The applicant will be notified accordingly. b. If the fee has not been paid within 30 days, reject the application and inform via ad hoc communication the cms. Step 3: Claim the Validate task (see section 3.8). Complete the actions in the Validation page (Figure 18). Select validate or reject in line with the decision of the rms.

67 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October Step 4: Claim the Evaluate & Decide task. Within 365 days of validating an application, the rms shall evaluate the application and draft a PAR in accordance with Article 30(3) and send it together with the SPC through ad hoc communication to the cms and to the applicant. Please check the status of the reference asset to verify the progress of the application. a. All the cmss express their position on the draft SPC within 90 days of the receipt of the draft PAR and SPC from rms by sending decision on the agreement through ad hoc communication to the rms, the other cmss and the applicant (see section 3.8.2). b. In case a given cms agrees with the draft SPC, the cms, completes the actions in the Evaluate & Decide page (Figure 20) and grant the authorisation within 30 days of reaching the agreement in conformity with the agreed SPC and close the task by approving the application for granting a national authorisation (see section 3.12). Within 7 days after agreement, SPC should be translated by applicant in all applicable languages (as requested by the cms). The finalised respective language version of the SPC must be uploaded by the cms when approving the authorisation. (The rms shall upload the agreed SPC and the final PAR in R4BP 3 together with any agreed terms and conditions on the making available on the market or use of the biocidal product when approving the application for granting a national authorisation (see section 3.8.2)). Make sure to assign the same expiry date as for the reference product. To find the expiry date of the reference product go to the related cases tab of your case s details page and copy the reference number of the reference product (see point 8 of Figure 7). Search for the reference authorisation using this number. c. If you disagree with the draft SPC prepared by the rms, send a detailed explanation of the points of disagreement and the reasons for your position to the rms, the other cmss, and the applicant through ad hoc communication. This shall be referred by the rms to the Coordination Group without delay (see section 28). d. If you refuse to grant the authorisation of the BP or want to adjust the terms and conditions of the authorisation to be granted according to Article 37 of the BPR, communicate a detailed statement of the grounds for seeking a derogation to the applicant through ad hoc communication and seek to reach an agreement on the proposed derogations Supporting documents Template agreement/disagreement on SPC. NA-MRS Mutual recognition in sequence 16.1 Introduction Please consult this chapter of the BPR Practical Guide for a description of the regulatory requirements and the related process Workflow BRC > EAA > MAA > VAL > EVL

68 Application requirements Please consult this Biocides Submission Manual for a description of the application requirements related to this process Steps to be followed by the MSCA Step 1: Claim the MSCA accept task (see section 3.8). Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant via the Case details Financial management sub-tab in R4BP 3 (see section 3.11). Step 3: Complete the actions in the MSCA accept page (Figure 17). Check whether the fee has been paid within 30 days (3a) or not (3b). a. If the fee has been paid accept and proceed with Step 4. The applicant will be automatically notified. b. If the fee has not been paid, reject the application. The applicant will be automatically notified (see section 3.12). If there are applications for mutual recognition in sequence in other Member States, inform the other cmss accordingly through ad hoc communication (see section 3.10). Step 4: Claim the Validate task and complete the actions in the Validation page (Figure 18). Validate the application within 30 days of the acceptance date in accordance with Article 33(2) of the BPR and proceed with Step 5. Step 5: Claim the Evaluate & Decide task. Within 90 days of validating the application, a. If you agree on the SPC, record your agreement by sending the agreement through ad hoc communication to the applicant and, if applicable, to the other cmss (see section on how to agree on the SPC). In case the cms agree on the SPC, the cms complete the actions in the Evaluate & Decide page (Figure 20) and grants the authorisations within 30 days of reaching agreement in conformity with the agreed SPC and closes the task by approving the application for the national authorisations (see section 3.12). Before closing the task, upload the agreed SPC in R4BP 3 (see section 3.8.2). Within 7 days after agreement, SPC should be translated by applicant in all applicable languages (as requested by the cms). The finalised respective language versions of the SPC must be uploaded by the cms when approving the authorisation. Make sure to assign the same expiry date as for the reference product. To find the expiry date of the reference product go to the related cases tab of your case s details page and copy the reference number of the reference product (see point 8 of Figure 7). Search for the reference authorisation using this number. b. If you consider that the BP assessed by the rms does not meet the conditions laid down in Article 19 of the BPR, send a detailed explanation of the points of disagreement and the reasons for your position to the rms, the other cmss, and the applicant through ad hoc communication. This shall be referred by the rms to

69 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October the Coordination Group without delay (see section 28). c. If you refuse to grant the authorisation of the BP or want to adjust the terms and conditions of the authorisation to be granted according to Article 37 of the BPR, communicate to the applicant a detailed statement of the grounds for seeking a derogation through ad hoc communication and seek to reach an agreement on the proposed derogations Supporting documents Template agreement/disagreement on SPC. Particular case: Mutual recognition in sequence related to applications submitted under the BPD regime Introduction Please consult this chapter of the BPR Practical Guide for a description of the regulatory requirements and the related process. The case is related to an application for a national authorisation to the rms and an application for mutual recognition to cmss submitted before 1 September The reference number (in the R4BP 3 this is the asset number) of the initiating application for national authorisation can be found in the General sub-tab in the Case details page of the application for mutual recognition. The application must contain the translation of the original authorisation in the rms, SPC in an editable format in a language accepted by the cms and relevant documents for each cms as referred to in Annex II to "Notes for guidance to applicants for product authorisation and mutual recognition" (CA-Sept12-Doc.6.2.a Final.Rev2-28/01/2013) Workflow BRC > EAA > MAA > VAL > EVL 16.8 Application requirements Step 1: The applicant has submitted an application for a national authorisation to the rms and an incomplete application for mutual recognition or an intention to submit an application for mutual recognition after the first authorisation will have been granted to cmss before 1 September 2013; The rms grants the first authorisation after the 1 September 2013 without prior transmission of its assessment report and SPC to the cmss Steps to be followed by the MSCA Claim the MSCA accept task (see section 3.8) and complete the actions in the MSCA accept page (Figure 17). Fees under this step have already being paid at the time of the submission before the BPR entered into operation. Step 2: Claim the Validate task and complete the actions in the Validation page (Figure

70 70 18). Validate the application within 30 days of the acceptance date in accordance with Article 33(2) of the BPR and proceed with Step 5. Step 3: Claim the Evaluate & Decide task. Within 90 days of validating the application, a. If you agree on the SPC, record your agreement in R4BP and by sending the agreement through ad hoc communication to the applicant and, if applicable, to the other cmss (see section on how to agree on the SPC). In case a given cms agrees on the SPC (and a positive assessment report), the cms completes the actions in the Evaluate & Decide page (Figure 20) and grants the authorisation within 30 days of reaching agreement in conformity with the agreed SPC and close the task by approving the application for the national authorisation (see section 3.12). Before closing the task, upload the agreed SPC in R4BP 3 (see section 3.8.2). Within 7 days after agreement, SPC should be translated by applicant in all applicable languages (as requested by the cms). The finalised respective language versions of the SPC must be uploaded by the cms when approving the authorisation. Make sure to assign the same expiry date as for the reference product. To find the expiry date of the reference product go to the related cases tab of your case s details page and copy the reference number of the reference product (see point 8 of Figure 7). Search for the reference authorisation using this number. b. If you consider that the BP assessed by the rms does not meet the conditions laid down in Article 19 of the BPR, send a detailed explanation of the points of disagreement and the reasons for your position to the rms, the other cmss, the applicant and, where applicable, the authorisation holder through ad hoc communication. This shall be referred to the Coordination Group without delay (see section 28). c. If you refuse to grant the authorisation of the BP or want to adjust the terms and conditions of the authorisation to be granted according to Article 37 of the BPR, communicate to the applicant a detailed statement of the grounds for seeking a derogation through ad hoc communication and seek to reach an agreement on the proposed derogations. You can also use the resubmit task and this will trigger the need for the applicant to upload an IUCLID file and an SPC file Supporting documents Template agreement/disagreement on SPC. NA-BBP, NA-BBS National authorisation of the same biocidal product 17.1 Introduction Please consult this chapter of the BPR Practical Guide for a description of the regulatory requirements and the related process.

71 How to run BPR processes with R4BP 3 in Member State competent authorities Release date: October Authorisations can be sought in a Member State where a national authorisation according to the BPD or the BPR has already been granted (authorised, NA-BBS) or an application for such an authorisation has been submitted (pending, NA-BBP). The new same biocidal product regulation (EU) 2016/1802, amending Implementing Regulation (EU) No 414/2013, introduces the possibility to apply for authorisations in a Member State whether an Union authorisation has already been granted (NA-BBS) or an application for an Union authorisation has been submitted (NA-BBP). The Competent Authority document (CA-March15-Doc.4.7) provides guidance on applications for a same biocidal product of an individual product of a biocidal product family. BRC > MAA > VAL > EVL 17.2 Workflow 17.3 Application requirements Please consult this Biocides Submission Manual for a description of the application requirements related to this process Steps to be followed by the MSCA NA-BBS National authorisation of same biocidal product (authorised) Step 1: Claim the MSCA accept task. Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant via the Case details Financial management sub-tab in R4BP 3 (see section 3.11). Step 3: Complete the actions in the MSCA accept page (Figure 17). Check whether the fee has been paid within 30 days (3a) or not (3b). a. If the fee has been paid accept and proceed with Step 4. The applicant will be notified accordingly. b. If the fee has not been paid, reject the application (see section 3.12). The applicant will be automatically notified (see section 3.12). Step 4: 18). Claim the Validate task and complete the actions in the Validation page (Figure Validate the application within 30 days of the acceptance date. Check whether all information described in Article 2 of Implementing Regulation (EU) No 414/2013, amended by Regulation No 2016/1802, has been submitted and the proposed differences concern only administrative changes (3a) or not (3b). a. Validate and proceed with Step 5, or b. Reject application (see section 3.12) Step 5: Claim the Evaluate & Decide task (Figure 20) and complete the actions. Within 60 days of validating the application, evaluate whether the biocidal product

72 is identical to the reference product, except for information on administrative changes according to Implementing Regulation (EU) No 354/2013. Close the task by approving or not approving the application for the product authorisation (see section 3.12). Upload the final SPC with your decision. Make sure to assign the same expiry date as for the reference product. To find the expiry date of the reference product go to the related cases tab of your case s details page and copy the reference number of the reference product (see point 8 of Figure 7). Search for the reference authorisation using this number. For the reference product a link is given to the same biocidal products under the related assets/cases as appropriate. 72 The final SPC must not include confidential information, as it will be publicly available. Figure 34: Tracking the reference case or asset of a same biocidal product National authorisation of same biocidal product (pending, NA-BBP) For national authorisation of the same biocidal product (pending), the applicant submits an application for product authorisation (the reference product) to the Member States, creating the reference case, and simultaneously asks for the authorisation of one or more same biocidal product(s). When the reference product is authorised the authorisation of the same biocidal product(s) can be granted. Since the process is not automated the MSCA needs to