IPA 2009 CROATIA Project Fiche HR

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1 IPA 2009 CROATIA Project Fiche HR Basic information 1.1 CRIS Number:IPA/2009/ Title: Preparations for ectd and implementation of digital archival information system 1.3 ELARG Statistical code: Free movement of goods 1.4 Location: Republic of Croatia, Agency for Medical Products and Medical Devices Implementing arrangements: 1.5 Implementing Agency: Central finance and contracting agency (CFCA) The Programme Authorising Officer (PAO) for the project is: Marija Tufekčić, Director Ulica grada Vukovara 284/II, HR Zagreb, Republic of Croatia Phone: , fax: marija.tufekcic@mfin.hr 1.6 Beneficiary (including details of SPO): Beneficiary: Croatian Agency for Medicinal Products and Medical Devices Mr. Siniša Tomić, Director Ksaverska cesta 4, HR Zagreb, Republic of Croatia Phone: , fax: sinisa.tomic@almp.hr On a daily basis, the technical counterpart for the project is: Mr. Arian Rajh, Associate for Documentation Management Ksaverska cesta 4, HR Zagreb, Republic of Croatia Phone: , fax: arian.rajh@almp.hr Senior Programming Officer: Mr. Ante-Zvonimir Golem, State Secretary Ministry of Health and Social Welfare Ksaver 200 a, HR Zagreb, Republic of Croatia Phone: , fax: antezvonimir-golem@mzss.hr ectd electronic Common Technical Document, standard for electronic resources for medicine regulations (

2 Financing: 1.7 Overall cost (VAT excluded) 1 : EUR EU contribution: EUR Final date for contracting: 2 years following the date of conclusion of the Financing Agreement 1.10 Final date for execution of contracts: 2 years following the end date for contracting 1.11 Final date for disbursements: 3 years following the end date for contracting 2. Overall Objective and Project Purpose 2.1 Overall Objective: Croatian participation in European medicines network based on sharing current common standards. 2.2 Project purpose: Implementation of current European-based digital resources for regulation of medicines by all procedure types Link with AP / NPAA / EP / SAA The project is in line with the Stabilization and Association Agreement because it contributes to establishing a free trade area and thus helping international co-operation and forwarding the process of association (SAA, 2001/0149 (AVC), p. 3). The project is in accordance with Accession partnership (2008/119/EC) since it enhances administration reform in the field of regulation of medicines. Project will enable the beneficiary to work compatible to regulatory practice of Member States medicines agencies and European Medicines Agency (EMEA) by providing the system that enables work with ectd resources. ectd is becoming a recognised European electronic format for regulation of pharmaceuticals (Accession Partnership Ability to assume the obligations of membership, Chapter 1 Free movement of goods, article 5). The project is in cohesion with the National programme for the integration of the Republic of Croatia into the European Union 2008 (NPIEU). The usage of ectd is becoming a common European practice in regulation of medicinal products. Key priority for Croatia is development of a modern legislation, NPIEU, p ). ectd relevant provisions should be included in national legislation. The project will ensure necessary software for the digital archival information system which is a practical prerequisite for using ectds. It also foresees adoption of subordinate legislation as a legal perquisite for using 1 The total cost of the project should be net of VAT and/or other taxes. Should this not be the case, the amount of VAT and the reasons why it should be considered eligible should be clearly indicated (see Section 7.6). 2 Registration procedure types include European procedures and a national procedure. European procedures are: centralised procedure, decentralised procedure and mutual recognition procedure, as well as NCADREAC procedure (New Collaboration Agreement between Drug Regulatory Authorities in Central and Eastern European Countries). 2

3 ectds. Amendment on the Ordinance on medicinal products registration shall be produced on the basis of Croatian Medicinal Products Act and adjusted to common European practice. This Ordinance and the digital archival information system shall enable further strengthening of administrative capacities as a mid-term priority. The project is in line with the Croatia Progress Reports. The Croatia Progress Report 2007 refers to the transposition of Community acquis on medicines and to the development of the new Law on medicinal products. It is also stated in the Croatia Progress Report 2007 that alignment to the acquis in that specific area needs to be further developed and confirmed (Ability to assume obligations from membership, Chapter 1 Free movement of goods, Croatia Progress Report 2007, p. 25). This project will intensely contribute to the alignment thus ensuring that the Croatian Agency for Medicinal Products and Medical Devices as regulator of medicines embraces the new European-based standard. Croatia Progress Report 2008 states that regulation activities still represent a challenge and that it is essential to develop instruments similar to the European instruments before Croatia becomes a Member State. (Ability to assume obligations from membership, Chapter 1 Free movement of goods, Croatia Progress Report 2008, p ). The project will help in process of alignment with the relevant acquis and development of instruments that are as close as possible to those of the EU. The proposed project is in an accordance with European Partnership supporting alignment with Community acquis and enhancing Beneficiary s operational capabilities (EP, COM(2004) 275, p. 5). The project directly addresses the requirement stated in the Strategy for implementation of the acquis communautaire in the field of free movement of goods (November 2007), concerning adjustment of medicines documentation used in Croatia and medicines documentation that is going to be used in European Member States from 2009 onwards (p. 42). The project also supports the principle of mutual recognition of products produced in the European Union among all Member States hence it provides infrastructure for working with the ectd common resources. This principle is essential to mutual recognition procedure, which is one of European procedures in the regulation of medicines (p. 9). Overall objective of the strategy is to ensure quality of products originating from Croatia and products originating from the EU on Croatian market (p. 10). The European-based ectd standard is an instrument used for quality control of medicines. 2.4 Link with MIPD The project contributes to institution building based on the ability to assume obligations from membership in the chapter dealing with free movement of goods (Multi-Annual Indicative Planning Document (MIPD) p. 2, p. 17). 2.5 Link with National Development Plan (where applicable) Not applicable. 2.6 Link with national/sectoral investment plans (where applicable) Not applicable. 3

4 3. Description of project 3.1 Background and justification: Croatian Agency for Medicinal Products and Medical Devices (the Beneficiary) is the government agency responsible for approbation of safe and efficient medicines and medical devices. Services provided by the Beneficiary comprise approvals of medicines and medical devices, wholesale and retail licences, clinical trials, pharmacoeconomy, pharmacovigilance, good manufacturing practice, emergency withdrawals from the market and educational activities for health personnel. The Beneficiary is financed by the fees provided by its activities, under the article 120 of the Law on Medicinal Products. The Beneficiary is the only institution in Croatia with afore-mentioned authorities. The Beneficiary aims to be fully operational and ready for the new European-based ectd records as resources for the regulation of medicines in a manner to fulfil its future membership obligation by ensuring free trade of goods policy in the medicines control sector. Free trade of goods policy will be ensured when Beneficiary starts to fully co-operate with Member States agencies and European Medicines Agency (EMEA). The ability to use and share digital ectd resources will become a prerequisite for such co-operation. It will make possible for the Beneficiary to participate in EU regulatory network. The proposed project aims to prepare the Beneficiary to start approving medicines from European Union by European registration procedures that encompass the usage of ectd standard. For EMEA and Member States agencies this project encourages expansion of European regulatory network by embracing well-prepared Croatian Agency for Medicinal Products and Medical Devices. Approbation of medicines is based on assessment of medicines records. At the moment CTD 3 and EU dossier 4 records are used as resource of that process in Croatian Agency for Medicinal Products and Medical Devices. From 2009 onward EMEA is shifting towards digital NeeS and ectd resources. Member States medicines agencies are following that policy based on the agreement of Heads of Medicines Agencies (Reykjavík meeting in February 2005). 5 It is essential for the Beneficiary to start using digital ectd resources and to digitise and microfilm previously submitted paper resources because industry representatives refer to them while submitting new applications. Working with interconnected ectd resources and digitised resources will be enabled by establishing digital archival information system, allowing the Beneficiary to improve its service for the pharmaceutical industry and to gain productivity. The Beneficiary will increase efficiency because employees could work with ectd resources at the same time, producing more assessments and preparing more approvals. This will minimise delays in approval processes. It is necessary to digitise 6 paper resources and incorporate them into digital archival information system. That will centralise storage of interconnected ectd resources and digitised resources, improving their management and disaster recovery possibilities. Working with digital NeeS and ectd resources and introducing digital archival information system are demanding operations. In order to manage them properly it is necessary 3 The Common Technical Document (CTD) is earlier standard used for submitting pharmaceutical resources during registration process and it will be replaced by the ectd standard from 2009 onwards. 4 EU dossier is outdated standard used for submitting pharmaceutical resources. It consists of part I (administrative), part II (pharmaceutical and biological information), part III (non-clinical) and part IV (clinical). 5 Summary Report of HMA meeting, Reykjavík, 28th February 2002, 6 Process of converting physical paper documents into digital documents. 4

5 to conduct business process analysis and redesign in Croatian Agency for Medicinal Products and Medical Devices. 3.2 Assessment of project impact, catalytic effect, sustainability and cross border impact (where applicable): The project will have two main impacts. The first one is full participation in the European regulatory network due to the capability to share same resources with the Member States agencies and to participate in European registration procedures. This way the proposed project will ensure free trade of goods for medicines in Croatia. European pharmaceutical companies will operate in the same regulatory environment as in EU. The second impact will be ability of the Beneficiary to become a referent agency for European procedures. This is important for Croatian pharmaceutical companies because placing their products on the EU market will be facilitated. Being able to process electronic submissions based on ectd standard, the Beneficiary will motivate regional industry to follow current shift toward electronic submissions. The project will also raise awareness in Croatia about the importance of digital archival information systems as instruments for preservation of evidential value and authenticity of documentary resources. Principle of additionality is ensured. EU funding will not replace other funding neither from the Beneficiary itself nor from other donors, and the EU funded intervention/project will result in benefits that would not otherwise occur. Transition of regulatory work from paper documentation to NeeS and ectd resources is a very demanding process for medical agencies because it requires extensive organisational and technological changes. It is apparent that agencies are engaged with regulatory work and they usually do not have enough IT experts and other competent experts, therefore they are able to implement only partial solutions. Experience of the Beneficiary and other medical agencies have shown that partial solutions are just provisory and they are not sufficient enough to ensure ectd shift in its entire complexity. Because of that the Beneficiary plans to carry out transition to ectd European-based standard by means of a large-scale IPA project instead of implementing in-house provisory and partial solutions. In addition to that, the Beneficiary will upgrade necessary IT infrastructure in close consultations with the contractor and upgrade and purchase additional support databases, ectd processing software and storage and archival hardware, on top of the national contribution in the project as specified in Annex 6. Sustainability is ensured. The future upgrading of IT infrastructure for the document and records management software will be ensured by the Beneficiary. The Beneficiary will maintain developed software for document and record management provided within the project after project completion. National co-financing and contribution will be timely ensured in Beneficiary s budget. The digital archival information system will be monitored and maintained constantly after the completion of the project. Immediate results and wider benefits produced by the project will be monitored, utilized and improved continuously. The proposed project shall have significant influence on Croatian pharmaceutical companies and European pharmaceutical Marketing Authorisation Holders in Croatia because they shall have the possibility to submit medicines documentation as ectd records. This possibility shall advance their regulatory procedures significantly and harmonise it with regulatory affairs in Member States in nearest future. It shall encourage other medicines agencies in the region to shift to ectd or to improve their ectd-based regulatory process and therefore it may have positive cross border impact. 5

6 3.3 Results and measurable indicators: Result 1: Digital archival information system for ectd and NeeS digital resources is set up. Measurable indicators: - Total number of ectd and NeeS submissions for European and national procedures successfully uploaded in digital archival information system 1 year after project implementation. Source of verification: Project Reports, Report from software for monitoring regulation of medicines with tracking function for procedure types and resource standards/ formats - Total number of analysed processes, designed prototypes, tested prototypes and redesigned processes in Croatian Agency for Medicinal Products and Medical Devices by the end of the project. Sources of verification: Project Reports, Proposal for process redesign, Strategic plan. - Submitted User manual for using document and records management software after customisation of the developed software. Source of verification: Project Reports. - Staff trained to work successfully with ectd resources 11 months after project beginning. Sources of verification: Project Reports. Staff trained to manage business processes after customisation of the developed software. Sources of verification: Project Reports. Staff trained to use document and records management software successfully after customisation of the developed software. Sources of verification: Project Reports. EU dossier, CTD, NeeS and ectd are standards/formats for medicines resources. EU dossier and CTD standards are outdated. ectd and NeeS records are currently used in EU. NeeS is temporary format that facilitates the shift between paper CTDs and advanced electronic ectds. ectd or electronic Common Technical Document 7 is a European-based standard for medicines documentation as a resource in procedures of pharmaceutical regulation. NeeS or Non-eCTD electronic Submissions 8 is a presently used transitional format for medicines documentation, but the number of NeeS records in the EU is significant and therefore NeeS must also be included into the digital archival information system of the Beneficiary. Result 2: Important digitised resources (CTD, EU dossier) previously and presently used in Croatian Agency for Medicinal Products and Medical Devices for 7 The electronic Common Technical Document (ectd) standard, The ectd consists of module 1 (administrative resources), module 2 (summaries of all submitted resources), module 3 (quality documents), module 4 (non-clinical resources) and module 5 (clinical resources). Specifications: specification for module 1 M2-5 specification for modules Non-eCTD electronic Submissions (NeeS) guidance: 6

7 regulation of medicines in all types of procedures are maintained, preserved and interconnected. Measurable indicators: - Total number of submissions with number of folders and files for digitised resources that are delivered and ready to be uploaded into the digital archival information system by the end of the project. Source of verification: Final Report. - Total number of physically destroyed paper CTD and EU dossier records by the Contractor after digitisation, microfilming and approval provided by the Croatian National Archive. Sources of verifications: List of records designated for disposition and weeding, Final Report, Request for disposition submitted by the Beneficiary to the Croatian National Archive, Croatian National Archive s decision on disposition of records. Maintenance of business-critical but format-outdated paper resources should be done by digitising them; once digitised they should be interconnected. Additional preservation should be done by microfilming. This result should be indicated and confirmed by Contractor in Final report. That report should include total number of submissions (number of digitised resources per medicines), number of folders included in each submission and number of files in each submission. Outdated resources that need to be digitised are CTD and EU dossier records. Most of the files except special files such as index files should be preserved as PDF files. It is very important to preserve CTD and EU dossier records because their evidential value is essential in the protection of consumers rights. Second reason for the preservation of these outdated resources is the necessity to interconnect them together and to connect them with digital ectd and NeeS resources. When pharmaceutical Marketing Authorisation Holder submits an application for approval to the Beneficiary in a number of cases older CTD or EU dossier resources are frequently quoted. Lack of storage capacity and inefficacy of working process based on the paper resources are additional reasons to digitise paper CTD and EU dossier resources. Croatian legislative concerning evidential value of records also requires microfilming. 3.4 Activities: Activities for Result 1: 1.1 Analysis and redesign of business processes Analysis and redesign of business processes involve optimisation of core, support and management processes, aiming to make the Beneficiary s processes and organisation more efficient. Once business processes are analysed, it is possible to adjust them according to the requirements for ectd shift and Beneficiary s operational needs. It is necessary to analyse business processes, to use that feedback for defining initial documents and records workflows and to customise document and records management software at later stage. Redesign will start after first results of the analysis. This redesign includes reengineering of business processes and designing of new business processes prototypes, evaluation and testing of these prototypes and making proposal for their implementation in Croatian Agency for Medicinal Products and Medical Devices. First it should be necessary to analyse and redesign Beneficiary s core 7

8 processes (i.e. registration, renewal and variation of medicines) and to design the process of digitalisation and upload of digitised resources. Core business processes (registration, renewal and variation of medicines) must be analysed and designed first in order to define initial workflows for working with ectd resources and to start using ectds 10 to 11 months after beginning of the project. Digitalisation process will be done in the facilities of Contractor (Contract no 1. for activities and ). Upload of digitised resources will be done in Croatian Agency for Medicinal Products and Medical Devices by Contractor responsible for development of document and records management software (Contract no.2). Digitised resources will be upload into the digital archival information system that will be sampled from software for document and records management developed by the Contractor and storage and archival hardware purchased separately by the Beneficiary. The process of digitalisation and upload of digitised resources should be designed in order to ensure authenticity of records that will be digitised and uploaded through this project and in future. 1.2 Defining workflows for documents and records Workflows should interconnect business processes with documents and it should serve as input for development of document and management software (activity 1.3). It should address requirements for all documentation in Croatian Agency for Medicinal Products and Medical Devices (including CTD, EU dossier, NeeS and ectd resources) using the input from redesigned business processes. Complete and final workflows should be defined after redesign of all business processes. 1.3 Development of software for document and records management with business process module, interconnection solution for digitised and digital records and solution for migration of large volume of records on demand Development and customisation of software for document and records management is linked to the feedback from business process analysis and redesign and defined workflows (activities 1.1 and 1.2). Customised management software will manage optimised business processes (from activity 1.1), digitised (CTD, EU dossier) and digital (ectd, NeeS) medical resources and all Beneficiary s digital records. The digital archival information system consists of software for document and records management and hardware. Customised software for document and records management will help establishing digital archival information system when the software will be assembled with the storage and archival hardware. Storage and archival hardware will be purchased additionally on top of the national contribution as it is indicated in the Annex 6. Digitised resources provided by the activity 2.2 should be uploaded by the management software contractor into the digital archival information system once the management software is fully customised (1 Q 2013). For details on software functionalities see Annex Preparation of User manual for using the document and records management software User manual should provide information for Beneficiary for working with ectd and NeeS records, managing business processes and using document and records management functionalities in general. 8

9 1.5 Carrying out training sessions for using the document and records management software, using business process management module and working with ectd resources: (A) training assessors to start working electronically with ectd resources (2 days/25 attendees), (B) training employees to start using digital archival information system (4 days/4 groups of 30 attendees) and (C) training 4 employees for working with business process module. Activities for Result 2: 2.1 Preparing CTD and EU dossier resources for digitisation and microfilming Guidance for preparing embedded metadata and indexing of digitised records, Guidance for preparing metadata for import into the Archival book and Guidance for structuring EU dossier records for digitisation should be provided by Contractor in close collaboration with the Beneficiary. All guidance should be produced in the first month of the project duration. Resources that should be digitised are core business process resources (CTD and EU dossiers). Before digitalization it is necessary to prepare paper resources for scanning. The organisation of CTD and EU dossier digitised resources should follow granularity similar to the one indicated in specifications for the ectd resources so all records can be maintained equally by the software for document and records management. Prepared resources should also be used for the microfilming activity. 2.2 Digitisation of CTD and EU dossier resources Digitisation is process of converting physical paper documents into digital records in order to integrate them into digital archival information system. Pharmaceutical Marketing Authorisation Holders often refer to older records in a new application for registration process, so digitised and digital resources should be well organised and interlinked before ingestion into digital archival information system. Digitisation is also necessary for the preservation of valuable paper resources used in Beneficiary s core business processes. Digitisation activity should fasten retrieval of resources. Indexing as part of digitisation process must be done according to the guidance developed by the activity Microfilming of CTD and EU dossier resources Microfilming is process of converting physical paper documents in microfilm images. Croatian archival laws and ordinances and Beneficiary s Ordinance on archive and registration office records allow digitally-born records to be considered as authentic, but this can not apply for records that were previously on paper and were digitised at later stage. However, authenticity and evidential value of digitised records can be supported by microfilming. Preserving medicines records and their evidential value is necessary for promoting public safety issues. 2.4 Disposition and weeding out paper CTD and EU dossier resources which are digitised and microfilmed according to the retention schedule 9

10 Disposition and weeding is process in which paper records are destroyed physically after authorisation. Ordinance on archive and registration office records authorises the Beneficiary to destroy paper resources after they once have been digitised and microfilmed. It is predicted that this activity occurs in last six months of the project. Disposition and weeding activity saves physical storage capacities for archiving and saves costs. It starts with identifying records for destruction according to the retention schedule from the Ordinance on archive and registration office records. Contractor should submit a list of records designated for disposition and weeding after digitisation and microfilming activities are conducted, and testing of quality of digital and microfilmed outputs is performed. This list should be confirmed by the Beneficiary and sent as request for disposition to the Croatian National Archive. After the Archive s decision, records should be destroyed in the manner that prevents their recreation from the scraps. Contractor shall submit proof of disposition and the Beneficiary shall forward it to the Croatian National Archive. Because of a large amount of paper records that should be destroyed, the Contractor is allowed to submit several lists and to perform disposition and weeding activity in more than one occasion. 2.5 Presentation of results of the project This visibility event includes publishing information on Beneficiary s website and a mini-conference for attendees from the medicines/health sector. The project predicts two contracts. Contract no. 1 is fee-based service contract and it covers activities 1.1, 1.2, Overall value of Contract no. 1 is estimated for EUR (IPA EUR national EUR ) Contract no. 2 is global price service contract and it covers activities Overall value of Contract no. 2 is estimated for EUR (IPA EUR national EUR EUR). For details about Contract no. 2 see Annex Conditionality and sequencing: Preparations for the project: Before the project starts it is necessary to establish a project implementation unit (PIU). By the end of 2009 amendment of the Ordinance on medicinal products registration should be in force as a legal pre-condition of the project. That involves co-operation between Beneficiary and Ministry of Health and Social Welfare. The amendment should lay down the legal possibility for pharmaceutical industry in Croatia to submit digital medical resources. During implementation of the project the Beneficiary will translate and publish up-to-date NeeS ectd European guidance (this is indicated in the framework matrix as assumption). During the project it will be necessary for team leaders of both service contracts to collaborate closely and to harmonise projects activities. Both teams shall be asked to actively participate during regular monthly meetings organised by the Beneficiary. If needed, this cooperation will be fostered as required.. Project activities: It is necessary to start analysing and redesigning business processes (activity 1.1) at the beginning of the project in order to get feedback for defining workflows (activity 1.2). Core business processes (i.e. registrations, renewals and variations of medicines) and related support and executive processes should be analysed first. Initial workflows should be outcome of 10

11 analysis of core and related support business processes. Development of the software for document and records management (activity 1.3) should start max. 6 months after the beginning of the project (beginning of activity 1.1). Outputs of activities 1.1 and 1.2. should be used for the customisation of the document and records management software. Such timeline will ensure that assessors can start working with ectd resources 10 to 11 months after beginning of the project. Final versions of workflows (activity 1.2) should be defined after redesign of business processes. The Beneficiary will upgrade and purchase necessary IT infrastructure, hardware and software. These will be done on top of the national contribution as specified in Annex 6. These items are indicated in the logical framework matrix as assumptions. The Beneficiary will upgrade and purchase these items in close consultations with the contractor for document and records management software because of technological compatibility related issues. Preparations of User manual (activity 1.4) should contribute to the efficient usage of that system. Trainings should be conducted after core and support business processes are implemented into digital archival information system and after customisation of this system is completed (please refer to Activities for Result 1, activity 1.5). It is necessary to start digitisation and microfilming activities at the beginning of the project because of large amount of paper records that needs to be digitised. Contractor for digitising and microfilming must produce preparatory guidance 1 month after start of the project (please refer to Activities for Result 2, activity 2.1). Digitisation and microfilming (activities ) should take place after producing guidance and preparation of paper records. Deposition and weeding out paper CTD and EU dossier resources, which are digitised and microfilmed, is going to be possible after finishing the upload procedure of the digitised resources in the software for document and records management. Presentation of the project will be done at the end of all project activities (mini conference). Project activities sequencing 3.6 Linked activities IPA 2007 TWL Strengthening the expert capacity in the Croatian Agency for Medicinal Products and Medical Devices. This twinning-light project aims to make working methods in Croatian Agency for Medicinal Products and Medical Devices more adjustable to European standards. IPA 2007 TWL and this project do not overlap since the first one is more extensive, it is not linked to format of resources 11

12 for registration procedures and it does not prepare the Beneficiary for working with ectds. However, twinner s recommendations and outputs from IPA 2007 TWL project can be used in IPA 2009 TAIB project as added value for business process analysis and redesign. In the proposed IPA 2009 TAIB project it is foreseen to use objectively verifiable indicator of IPA 2007 TWL activity 4.1 as an additional input for business process analysis and redesign. The new version of Standard Operating Procedures related to registration procedure from IPA 2007 TWL activity 4.1 should be consulted during activity 1.1 of this project. It is also believed that twinning activity 1.2 Conducting training for marketing authorisations will contribute to adaptation of the staff to redesigned business processing. Outputs of IPA 2007 TWL project activity 1.2 shall support the transition to ectd in Croatian Agency for Medicinal Products and Medical Devices because this activity deals with types of registration procedures that are common in Member States and that are using ectds as resources. Implementation of IPA 2007 TWL and IPA 2009 TAIB projects can fundamentally improve organisation and business in the Croatian Agency for Medicinal Products and Medical Devices and consequently support the transformation of the Beneficiary into reliable partner in European medicines network. European Medicines Agency (EMEA) co-operates with the Beneficiary through Participation of Croatia and Turkey in EMEA activities in 2006 and 2007 (Multibeneficiary programme ) and IPA Transition Assistance Programme (Transition IPA Programme ). Employees from the Croatian Agency for Medicinal Products and Medical Devices participate as observers in various working groups and committees EudraCT, TIGes, EudraGMP, EudraNet, EudraPHARM, 10 Good Clinical Practice Inspector, The Committee on Herbal Medicinal Products (HMPC) and Quality Working Party. Participation in these working groups and committees supports Beneficiary s preparations for future accession. The proposed national scientific project Digital Archive Creation Model DarcModel (proposed by the Faculty of Humanities and Social Sciences, University of Zagreb, submitted to Ministry of Science, Education and Sport in July 2008). The national scientific project is supposed to start in 2009, aiming to produce common recommendations on the model of digital archive, digitisation procedures, and long-term preservation issues. In preparation phase of DarcModel project a preliminary research was conducted. That research included pilot testing of the readability of records that are stored on optical carriers in Croatian Agency for Medicinal Products and Medical Devices. In the first phase of DarcModel project available literature, recommendations, guidelines, standards and examples 9 The Transition IPA Programme was launched within the framework of the Instrument for Pre-Accession Assistance (IPA) the European Commission's framework programme for providing assistance to candidate countries and potential candidate countries. This programme aims to build relationships between EMEA and the Candidate Countries. Full project description can be found on the internet site 10 EudraCT is is the European Clinical Trials Database of all clinical trials commencing in the European Union from 1 May 2004 onwards. TIGes stands for Telematic Implementation Group on electronic Submission. TIGes work with implementation of ectd and NeeS. EudraGMP is the European database of certificates of good manufacturing practice. EudraNet as IT platform facilitates the exchange of information between regulatory agencies during evaluation of applications. EudraPHARM is the database of medicinal products authorised in the European Union. 12

13 of digital archives from other projects and practices will be analysed. Result of the first phase will be an insight into numerous relevant resources. The next phase aims to determine accurate conditions of long-term preservation and to recommend specific method of preservation. It is planned to have first results of DarcModel project before the start of IPA TAIB 2009 project and this results could be used as scientific contribution. However, the afore-mentioned contribution is not prerequisite for IPA TAIB 2009 project. If the national scientific project will be approved by Ministry of Science, the financed activities in scientific project will not in any way overlap with the activities in IPA TAIB 2009 project. Also, rejection of the national scientific project would not affect or postpone the realization of IPA TAIB 2009 project in any way. 3.7 Lessons learned Throughout the Croatian participation in Telematic Implementation Group on electronic Submission (TIGes) established under Multi-beneficiary programme and Transition IPA Programme 2008, employees from Croatian Agency for Medicinal Products and Medical Devices had the opportunity to get acquainted with recent activities involving transition to ectd in Member States agencies. Active participation in TIGes helped Beneficiary s staff to understand the complexity of setting up an infrastructure for ectd resources. Most important for medical agencies is to ensure matching legal and practical prerequisites for electronic submission, to start receiving electronic submissions and thereby lead ectd process forward. National medical agencies should provide information by translating and publishing European ectd and NeeS guidance for the local industry. They should help preparing local industry representatives to start submitting ectd resources. From multi-beneficiary and transition programme it has been learned that the best way to implement practical prerequisites for ectd is to do it through carefully planned project that would be in line with actions taken by EMEA, Member States agencies and European industry associations European pharmaceutical industry association like European Generic medicine Association (EGA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) are also members of various telematic implementation groups (joint sessions) and also participate in ectd preparations. 13

14 4. Indicative Budget (amounts in EUR) SOURCES OF FUNDING ACTIVITIES IB (1) INV (1) TOTAL EXP.RE EUR (a)=(b)+(e) TOTAL PUBLIC EXP.RE EUR (b)=(c)+(d) IPA COMMUNITY CONTRIBUTION EUR (c) % (2) Total EUR (d)=(x)+(y)+(z ) NATIONAL PUBLIC CONTRIBUTION % (2) Central EUR (x) Regional/ Local EUR (y) IFIs EUR (z) PRIVATE CONTRIBUTION EUR (e) % (3) Contract no. 1 X Contract no. 2 X , , TOTAL IB , , TOTAL PROJECT , , NOTE: DO NOT MIX IB AND INV IN THE SAME ACTIVITY ROW. USE SEPARATE ROW Amounts net of VAT (1) In the Activity row use "X" to identify whether IB or INV (2) Expressed in % of the Public Expenditure (column (b)) (3) Expressed in % of the Total Expenditure (column (a)) 14

15 5. Indicative Implementation Schedule (periods broken down per quarter) Contracts Start of Tendering Signature of contract Project Completion Contract no. 1 2 Q Q Q 2013 Contract no. 2 3 Q Q Q 2013 Contract no. 1 should in principle be ready for tendering in the 1 st Quarter following the signature of the FA. Contract no. 2 should not be contracted in case that contract no. 1 is not signed since contracts are interconnected. These dates are provisional dates. Actual dates for tendering, contracting and project completion depend upon the date of signing of the Financing Agreement. Project activities timeline * The Beneficiary will start using ectd resources 10 to 11 months after project beginning (4 Q 2011). The Contractor of Contract no.2 should upload all the digitised resources into the developed digital archival information system in 1 Q Cross cutting issues (where applicable) 6.1 Equal Opportunity The principle of equal opportunities between women and men should be taken into account when evaluating the quality of all projects proposed under the two components and during all phases of their implementation. Specific attention will be paid to the gender dimension when determining the benefit of training activities. While implementing the project activities and, to the extent applicable, the Beneficiary will try to assure that gender disaggregated data will be made available to carry out an analysis of the social and economic impact of the actions undertaken. 6.2 Environment 15

16 The Beneficiariy shall ensure that, during the implementation of project actions, due consideration is given to the Government s development policy relating to environmental management and that such policy is embodied, within all strategic policy documents they may draft and all training activities they may carry out. Working electronically raises ecological awareness and produce less paper. ANNEXES 6.3 Minorities Not applicable. 1- Log frame in Standard Format 2- Amounts contracted and Disbursed per Quarter over the full duration of Programme 3- Description of Institutional Framework 4 - Reference to laws, regulations and strategic documents: Reference list of relevant laws and regulations Reference to AP /NPAA / EP / SAA Reference to MIPD Reference to National Development Plan Reference to national/sector investment plans 5- Details per EU funded contract (*) where applicable: For TA contracts: account of tasks expected from the contractor For twinning covenants: account of tasks expected from the team leader, resident twinning advisor and short-term experts For grants schemes: account of components of the schemes For investment contracts: reference list of feasibility study as well as technical specifications and cost price schedule + section to be filled in on investment criteria (**) For works contracts: reference list of feasibility study for the constructing works part of the contract as well as the section on investment criteria (**); account of services to be carried out for the service part of the contract (*) non standard aspects (in case of derogation to PRAG) also to be specified (**) section on investment criteria (applicable to all infrastructure contracts and constructing works): Rate of return Co-financing Compliance with state aids provisions Ownership of assets (current and after project completion) 6 - Contribution on top of the national contribution to the project 16

17 ANNEX 1: Logical framework matrix in standard format Preparations for ectd and implementation of digital archival information system Agency for Medical Products and Medical Devices Programme name and number IPA 2009 Contracting period expires Two years following the date of conclusion of the Financing Agreement Total budget: EUR Disbursement period expires Three years following the end date for contracting IPA budget: EUR Overall objective Objectively verifiable indicators Sources of Verification Croatian participation in European medicines network based on sharing current common standards Increased number of medicines regulated by European procedures as electronic applications, electronic variations and electronic renewals in Croatian Agency by 25%. This number should be taken 1 year after project completion and compared with the same number taken 1 year after Amendment on the Ordinance on medicinal products entered into force. European Medicines Agency (EMEA) Telematic implementation group on electronic submission (TIGes) ectd Implementation Survey Report and Survey Graphs Reports from software for monitoring regulation of medicines with tracking function for procedure types and resource standards/ formats Project purpose Objectively verifiable indicators Sources of Verification Assumptions Implementation of ectd and NeeS European-based digital resources for Total number of medicines regulated by processing ectd and NeeS Reports from software for monitoring regulation of medicines with tracking EU Member States will implement ectd from the 17

18 regulation of medicines by all procedure types resources 1 year after project completion. function for procedure types and resource standards/ formats end of 2009 onwards on the basis of Heads of medicines agencies meeting agreement (Reykjavík, February 2005) Results Objectively verifiable indicators Sources of Verification Assumptions Result 1 Digital archival information system for ectd and NeeS digital resources is set up Result 2 Important digitised resources (CTD, EU dossier ) previously and presently Result 1 - Total number of ectd and NeeS submissions for European and national procedures successfully uploaded in digital archival information system 1 year after project implementation. - Total number of analysed processes, designed prototypes, tested prototypes and redesigned processes in Croatian Agency for Medicinal Products and Medical Devices by the end of the project. - Submitted User manual for using document and records management software after customisation of the developed software. - Staff trained to work successfully with ectd resources 11 months after project beginning. - Staff trained to manage business processes after customisation of the Result 1 - Project reports (information on successful uploading of ectd and NeeS applications and information on successful completion of the project activities) - Proposal for processes redesign - Strategic plan - Agency s decision on redesigning processes - User manual for using documents and records management software - Report from software for monitoring regulation of medicines with tracking function for procedure types and resource standards/ formats Further participation in EMEA activities Croatian pharmaceutical companies progressively implement document and records management software and ectd as a standard Staff involved in ectd process remain in the Agency 18

19 used in Croatian Agency for Medicinal Products and Medical Devices for regulation of medicines in all types of procedure are maintained, preserved and interconnected. developed software. - Staff trained to use document and records management software successfully after customisation of the developed software. Result 2 - Total number of submissions with number of folders and files for digitised resources that are delivered and ready to be uploaded into the digital archival information system by the end of the project. - Total number of physically destroyed paper CTD and EU dossier records by the Contractor after digitisation, microfilming and approvals provided by the Croatian National Archive. Result 2 - Final report - List of records designated for disposition and weeding - Request for disposition submitted by the Agency to the Croatian National Archive - Croatian National Archive s decision on disposition of records Activities Means Costs Assumptions 1.1 Analysis and redesign of business processes 1.2 Defining workflows for document and records 1.3 Development of software for document and records management with business process module,, interconnection solution for digitised and digital records and solution for migration of large volume of records on demand 1.4. Preparation of User manual for Contract no. 1 SR fee-based (activities 1.1, 1.2, ) Contract no. 2 SR global price (activities ) Contract no. 1: EUR Contract no. 2: EUR PIU established Translation and issuing up-to-date common European guidance for NeeS and ectd Purchase of ectd processing software for all types of medicines registration procedures Development of software for monitoring regulation 19

20 using the software 1.5 Carrying out training sessions for using the document and records management software, using business process management module and working with ectd resources 2.1 Preparing CTD and EU dossier resources for digitisation and microfilming 2.2 Digitisation of CTD and EU dossier resources 2.3 Microfilming of CTD and EU dossier resources 2.4 Disposition and weeding out paper CTD and EU dossier resources which are digitized and microfilmed according to the retention schedule 2.5Presentation of results of the project of medicines with tracking function for procedure types and resource standards/ formats Purchase of registration office s software Necessary IT infrastructure upgraded Storage and archival hardware upgraded and purchased Purchase of microfilm reader-and-printer device Effective collaboration of Contractors with Beneficiary and CFCA Pre conditions Amendments to the Ordinance on medicinal products registration concerning digital ectd resources in force by the end of

21 ANNEX 2: amounts (in ) Contracted and disbursed by quarter for the project Contracted 4 TH Q ST Q ND Q RD Q TH Q ST Q ND Q RD Q TH Q ST Q ND Q 2013 Contract no Contract no Cumulated Disbursed 4 TH Q ST Q ND Q RD Q TH Q ST Q ND Q RD Q TH Q ST Q ND Q 2013 Contract no Contract no Cumulated The disbursement schedule for service contracts (fee-based) is: advance payment within 45 days from contract signature. Advance payment is 40% for contracts of 12 months or less, and 30% if contract duration is between months; then 6 monthly interim payments, Final Payment minimum 10%. 21

22 ANNEX 3: Description of Institutional Framework Medicinal products and medical devices regulation in Croatia is under competence of the Agency for Medicinal Products and Medical Devices (the Beneficiary). The Beneficiary regulates pharmaceuticals by assessing submitted documentary resources and by testing quality, efficacy and safety of pharmaceuticals. Medical devices are approved also through assessments of their associated documentary resources. The Beneficiary is supervising pharmacovigilance activities for pharmaceuticals and for medical devices. Other responsibilities include permitting wholesale and retail licences, approving clinical trials, gathering and processing pharmacoeconomy statistics, monitoring good manufacturing practice, ordering emergency withdrawals from the market and providing education for health personnel. These activities are within Beneficiary s competence under the Law on medicinal products and subsequent ordinances. The work on legislative proposals is within competence of the Ministry of Health and Social Welfare, although the Beneficiary s legal department always participates in constructing the legal framework. The Beneficiary publishes Croatian Pharmacopoeia in co-operation with the Croatian Pharmaceutical Society. Employees from Croatian Agency for Medicinal Products and Medical Devices also participate in production of the European Pharmacopoeia. 12 The Agency for Medicinal Products and Medical Devices - current organisation: ANNEX 4: Reference to laws, regulations and strategic documents Reference list of relevant laws and regulations Law on medicinal products (Official Gazette 71/07, Ordinance on medicinal products registration (Official Gazette 113/08, Ordinance on archive and registration office records (Agency for Medicinal Products and Medical Devices) Law on electronic signature (Official Gazette 10/2002, 80/2008, 12 The European Pharmacopoeia is EDQM publication and a single reference work for the quality control of medicines in Europe. EDQM is the European Directorate for the Quality of Medicines & HealthCare (