CREATING EUDRAVIGILANCE PRODUCT REPORT MESSAGES: PRODUCT REPORT STEP-BY-STEP GUIDE

Transcription

1 CREATING EUDRAVIGILANCE PRODUCT REPORT MESSAGES: PRODUCT REPORT STEP-BY-STEP GUIDE The WEB Trader allows the users to create and send EudraVigilance Product Report Messages (EVPRMs) containing Product Reports for authorised products. PLEASE NOTE THAT, WHENEVER A SAFETY REPORT IS SENT FOR WHICH THE PRODUCT INFORMATION IS NOT IN THE EUDRAVIGILANCE MEDICINAL PRODUCT DICTIONARY, THE PRODUCT DATA SHOULD BE SENT AT THE SAME TIME VIA EVWEB OR VIA THE SIMPLE DB (ACCESS DATABASE). THE SAFETY REPORT WILL SUBSEQUENTLY BE LINKED TO THE PRODUCT DATA SUBMITTED This step-by-step guide explains how to enter information on authorised products into the EudraVigilance Medicinal Product Dictionary (EVMPD). 1. Create a EudraVigilance Product Report Message (EVPRM) 2 2. Validate, Send and Save a EudraVigilance Product Report Message Field description 21 1

2 1. Create a EudraVigilance Product Report Message (EVPRM) The information in the fictitious Summary of Product Characteristics below will be used to complete the Product Report for an authorised medicinal product. EXAMPLE SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Antiflam 1.5 mg/ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 1.5 mg antiflamine 3. PHARMACEUTICAL FORM Oral solution 4. PHARMACOLOGICAL PROPERTIES 4.1 Pharmacodynamic properties Pharmacotherapeutic group: (group) ATCVet code : QM01A 4.2 Pharmacokinetic properties 5. CLINICAL PARTICULARS 5.1 Target species Dogs 5.2 Indications for use 5.3 Contraindications 5.4 Undesirable effects 5.5 Special precautions for use 5.6 Use during pregnancy and lactation 5.7 Interaction with other medicinal products and other forms of interaction 5.8 Posology and method of administration Dogs: Oral administration 5.9 Overdose 5.10 Special warnings for each target species 2

3 5.11 Withdrawal period 5.12 Special precautions to be taken by the person administering the medicinal product to animals 6. PHARMACEUTICAL PARTICULARS 6.1 Major incompatibilities 6.2 Shelf life 6.3 Special precautions for storage 6.4 Nature and contents of container A plastic white bottle with a screw cap containing 50 ml or 100 ml oral solution and a polypropylene measuring syringe. 6.5 Special precautions for the disposal of unused medicinal product or waste materials, if any 7. NAME OR CORPORATE NAME AND ADDRESS OR REGISTERED PLACE OF BUSINESS OF THE MARKETING AUTHORISATION HOLDER Nobel Company Horseshoes Industrial Estate Endlock Middlesex EN2 0A) United Kingdom 01/02/2000 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION MARKETING AUTHORISATION NUMBER EU/2/00/098/001 EU/2/00/098/002 15/04/2002 DATE OF REVISION OF THE TEXT 3

4 The EudraVigilance Screen Dynamic button set Tree-view area Active area General tips: Please note that the product information is entered PER PRESENTATION, therefore if the product has 3 presentations, you have to enter the information for the 3 presentations separately, as three separate products (there is a handy Duplicate product tool though!). Remember to always press enter to open a field to allow data entry; once you have typed the information, or chosen an entry from a lookup table, you must then press enter again in order to record that information in the field and move to the next one. The sections that need completing appear in red. Some of the sections are repeatable, like Products, Pharmaceutical products, and Route of administration. In these repeatable sections, to enter the first item you click on the relevant section on the Tree view area, and you create your entry by clicking in the tick box saying New that appears in the Active area Once you have filled your first entry, to enter the second item, you must click again on the original section on the tree view area (in this example it would be Pharmaceutical Product ), and you would then be able to create a second entry 4

5 If you wish to delete an entry on a repeatable section, select the relevant section on the tree view area, then untick the entry you wish to delete from the list that appears in the Active area, and press the Clear button on the toolbar; this will remove the entry. How to enter a Product in EVWEB: Open the Send Products section by clicking on the appropriate button on the main menu. Then you need to give the message a number, by entering it on the EVPR Message field in the active area (right-hand side). To enter the information, select the field using your mouse, then press the Enter key on your keyboard. (There are no conventions established for the message number field, you may choose whatever number you wish for your own reference). Type your chosen message number or text, and then press the Enter key again to display it. 5

6 Click on the little square with the plus sign on the left side of EVPR Message to display the different sections of the EudraVigilance Product Report Message (EVPRM). Click on Products, then select New by ticking the small square box, press Enter Select Authorised Product. The area on the right-hand side displays the fields that need to be completed that section. It also indicates which fields are mandatory. 6

7 The Operation Type field is automatically generated and it displays Insert. This information cannot be modified. Select MAH and press Enter. A query area is displayed at the bottom of the active area. Type the name of the Marketing Authorisation Holder (Nobel Company in this example) in the Organisation Name field, press Enter. 7

8 If the MAH has been already entered in the system, it will show up in the look-up table. Select it and press Enter. In this example, the query did not return any results, since the MAH Nobel Company is not yet in EudraVigilance. To enter a new MAH, select the Organisations section on the tree view area (left hand side of the screen), tick New, and Enter The screen displays a form were you can enter the information for the MAH. 8

9 Once you have finishing entering the information for the MAH, return to the Authorised Product section by clicking on Authorised Product. Click on the MAH field so it turns blue, then click L (Local look-up) on the toolbar on the top of the screen. The name of the MAH you have entered on the MAH section will appear in a Look-up box. Select the name of the MAH, and press enter. Select Info Date field and press Enter. A pop-up window with a calendar will appear. Choose the date by clicking on the little arrows at the left and right side of the year and the month. 9

10 The Info Date field has been completed. Select Local Code, press Enter. This is the code attributed to this product in your company or Authority s database. Type in the information and press Enter again. Select the appropriate Authorisation procedure from the pop-up window, press enter. Select Authorisation Country Code and press Enter. A look-up table is displayed. Choose the country, and Enter. 10

11 The information entered on the next three fields will depend on the type of authorisation the product received. Choose the Authorisation number field, and Enter. Complete the field with the information from the Summary of Product Characteristics. Fill in this field with the authorisation number EU/2/00/098/001 as it appears in the Summary of Product Characteristics. As Antiflam was a centrally authorised product, complete the EU number field. Next, go to Full presentation name. Enter the full name, as it appears on the Summary of Product Characteristics, on the box, and click on the green tick button to enter. 11

12 Continue completing the information in the Product Short Name, Product Generic Name, Product Company Name, Product Strength Name and Product Form Name fields, if this information is part of the Full Presentation Name. Click on Package Description, press Enter. Fill in the information available from the SPC, then click on the green tick sign to enter. Now you can proceed to the next section, Pharmaceutical Product(s). Select it, and press enter. You will get the following screen: 12

13 Tick the box New Pharmaceutical Form, press Enter. From the look-up table, choose the relevant information, and press Enter. Select Drug route on the left-hand side of the screen. The right-hand side of the screen displays the following section, New drug route. This section is repeatable, to allow data entry for medicinal products that have several routes of administration. Click on New drug route, press Enter. 13

14 Select Species, press Enter. A look-up table will appear. Choose the appropriate species, press Enter Choose the required Route of administration from the look-up table, press Enter. Then select Tissue, press Enter. Select the tissue specified on the SPC from the list that appears on the screen. In this case as it is a dog, we choose Not specified. 14

15 We do not need to enter a Withdrawal period for this species either. In the cases where this entry is necessary, enter the appropriate period in this field, then choose the unit from the look up on the next field ( Withdrawal period unit ). Now click on the Drug ingredient (s) section on the left-hand side of the screen. Select New drug ingredient, press Enter. (This is also a repeatable section; it allows you to input all the ingredients for the product.) Select Substance, Enter. Type the substance name on the name field, press Enter. If the substance already exists in the dictionary, it will be displayed below. Select it and press Enter. In this example, the substance does not appear in the list; therefore it has to be added to the dictionary. To add it, go to the Substances section, click New substances, press Enter. 15

16 A new menu appears on the right-hand side of the screen. Fill out the information as appropriate: Once the information has been entered, go back to the Drug ingredient (s) section by clicking on the Drug ingredient field on the left-hand side of the screen. Select Substance in the active area and then click on the button L (Local Data Lookup) from the dynamic button set. 16

17 Continue entering the information. Click on Role of the ingredient, press Enter. Choose the relevant information on the pop-up window, then Enter. To enter the information on the Type of Concentration field, select the field, press Enter. A pop-up window is displayed. Choose the appropriate type of concentration. To continue entering the product information, click on Concentration unit code, then press enter. On the pop-up window displayed, choose the relevant unit, then Enter. 17

18 Then type the numerical value for the concentration on the Concentration field. In this example, the SPC for this product shows only one ingredient. If, however, the product had several ingredients, you would have to repeat the above procedure for all the ingredients shown on the SPC. Now go to the Drug ATC (s) section, by clicking on the field shown on the left-hand side of the screen, press Enter. Select New drug ATC by ticking the box. Select the relevant species to the ATC code. Select the field, then press enter. A look-up will appear. Select the appropriate species, and enter. 18

19 To finalise the entry of the product, complete the field ATC Code with the ATC as it appears in the Summary of Product Characteristics (QM0 1A). Press Enter, type the ACT code on the Name field, select it on the look-up table, and Enter. Now that all the available information on the Medicinal Product has been entered, the information has to be validated, saved and sent. As mentioned at the start of this tutorial, the products are entered per Presentation. If a product has multiple presentations, once you have entered the first one, you can copy it by using the Duplicate function, and then change the information on the relevant fields. To duplicate a product, click on the name of the product you have just entered, then press the Duplicate button on the toolbar: The product will be copied below, and you will be able to go through the information and make the necessary amendments for the different presentations. 19

20 2. Validate, Send and Save a EudraVigilance Product Report Message Before sending the Product Message, you should validate the information by clicking on the Validate button from the toolbar. In this example, all the information necessary has been entered correctly, therefore the validation is OK. And since the validation is OK you can send the message by clicking on the Send button. The message can now be saved on XML or RTF format. 20

21 Message on XML format: And this is the message on RTF format: 21

22 3. FIELD DESCRIPTION This document contains a brief description of the mandatory fields in the Send Products section in the EVWEB. The information provided with the Send Products function of EVWEB should reflect the information as approved in the latest version of the Summary of Product Characteristics (SPC). MESSAGE SECTION Message Number Number you wish to assign to the EudraVigilance Product Report Message (EVPRM) you are creating. PRODUCTS SECTION MAH Name of the Marketing Authorisation Holder (MAH). The information to be inserted in this field is available in a look-up table. If the MAH name you are looking for is not yet part of the look-up table, you can add it by providing the information in the MAHs section. Info Date Information on the most recent update of the Summary of Product Characteristics (SPC). The format is a date value: DD/MM/YYYY. In most SPCs the date value is presented as MM/YYYY (e.g. Jul/2001). In this case, you should enter the first day of the month as a standard. So, for example, for Jul/2001 you would enter 01/07/2001. For those products that might not have a SPC, the info date could correspond to the international birth date of the medicinal product. Local Code This field is to be completed with a number that uniquely identifies a medicinal product in your database. This number is not generated by the EMEA. The Local Code will be considered for future updates of the product via the XML electronic exchange of information. Authorisation Procedure This field provides the following information. EU centralised procedure list A EU centralised procedure list B EU mutual recognition procedure EU national procedure Non-EU procedure One of the proposed procedures has to be selected in accordance with the procedure for granting the authorisation to the medicinal product. The following definitions should be applied: EU centralised procedure list A EU centralised procedure list B Council Regulation (EEC) No 2309/93, as amended creates a centralised Community procedure for the authorisation of medicinal products, for which there is a single application, a single evaluation and a single authorisation allowing direct access to the single market of the Community. The types of product, which fall within the scope of Council Regulation (EEC) No 2309/93, as amended, are set out in the Annex to that Regulation. For medicinal products falling within the scope of Part A of the Annex, applicants are obliged to use the centralised procedure and send their 22

23 application to the EMEA. For those falling within the scope of Part B of the Annex, applicants may, at their discretion, also use the centralised procedure. EU mutual recognition procedure This procedure is based on the mutual recognition by concerned Member States of a national marketing authorisation granted by the reference Member State. The concerned Member State refers to the reference Member State that issued the national marketing authorisation on which the mutual recognition procedure is based. At the end of the mutual recognition procedure, a national marketing authorisation will be issued in the concerned Member States. The harmonisation is maintained through mutual recognition procedure for variations, line extensions and renewals. EU national procedure Independent national procedures will continue, but are strictly limited from 1 January 1998 to the initial phase of mutual recognition (granting of the marketing authorisation by the reference Member State) and to medicinal products, which are not to be authorised in more than one Member State. Non-EU procedure This refers to marketing authorisation procedures outside the Community. Authorisation Country Code Country where the medicinal product has been authorised. This field provides a look-up table with the name of the countries in alphabetical order, accordingly to ISO Authorisation Number Authorisation number of the medicinal product as granted by the National Competent Authority. Since some National Competent Authorities also apply national numbers to medicinal products authorised through EU procedures (Centralised Procedure or Mutual Recognition Procedure), take into account the possible different scenarios as described below in order to complete this field. Centrally authorised medicinal product (List A and B) National number is assigned to the centrally authorised medicinal product. The Authorisation Number field is to be completed with the national number while the EU Number field is to be completed with the EU authorisation number. National number is NOT assigned to the centrally authorised medicinal product. Both the Authorisation Number field and the EU Number field are to be completed with the EU authorisation number. MRP authorised medicinal product National number is assigned to the MRP authorised medicinal product. The Authorisation Number field is to be completed with the national number while the MRP Number field is to be completed with the MRP authorisation number. National number is NOT assigned to the MRP authorised medicinal product. Both the Authorisation Number field and the MRP Number field are to be completed with the MRP authorisation number. EU national authorised medicinal product The Authorisation Number field is to be completed with the authorisation number granted to the medicinal product by the National Competent Authority. Non EU national authorised medicinal product The Authorisation Number field is to be completed with the authorisation number granted to the medicinal product by the non EU National Competent Authority. MRP Number It is a mandatory field when the EU mutual recognition procedure is selected. 23

24 This field is to be completed with the authorisation number assigned to the medicinal product authorised through the Mutual Recognition procedure. EU Number It is a mandatory field when the EU centralised procedure (List A and B) is selected. This field is to be completed with the European authorisation number assigned to the medicinal product authorised through the centralised procedure. Full Presentation Name Name of the medicinal product as it has been authorised by the Regulatory Authority and as stated in the Summary of Product Characteristics. The Full Presentation Name is defined as the given name to a medicinal product, which may be either an invented, common or scientific name, together with a trademark or the name of the manufacturer followed by both the strength and the pharmaceutical form (even if there is only one strength/pharmaceutical form) as authorised by the Regulatory Authority and as stated in the Summary of Product Characteristics. For centrally authorised medicinal products you have to complete the Full Presentation Name field with the information regarding the name of the medicinal product as approved in the SPC for each country for all the Member States (i.e. you have to refer to the information in the approved SPC in the local language for each Member State). Product Short Name Product Short (Trade) Name is defined as the given name to a medicinal product, which may be either an invented, common or scientific name without a trademark or the name of the manufacturer. Common name means the INN (International Non-Proprietary Name) recommended by the World Health Organization (WHO) or if one does not exist, the usual common name. The Product Short (Trade) Name field is to be completed with the invented, common or scientific name of the product without the trademark or the name of the manufacturer. Pharmaceutical Form Information on the pharmaceutical form of the medicinal product as specified in the SPC. The pharmaceutical form should be described by the European Pharmacopoeia standard term. If an appropriate term does not exist, the National Competent Authority should be asked to request a new Standard Term from the European Department for Quality of Medicines (EDQM) of the Council of Europe. The information to complete this field is provided in a look-up table (European Pharmacopoeia Standard Terms) from where the pharmaceutical form has to be selected. 24

25 DRUG ROUTE (S) SECTION This section allows the specification of the approved route(s) of administration for the medicinal product. You have to specify at least one administration route for each medicinal product. This is a repeatable section: you can specify more than one route of administration for a medicinal product. Administration Route Code This field is to be completed with the information on the route of administration of the medicinal product as specified in the SPC. The information to be inserted in this field is provided in a look-up table (European Pharmacopoeia Standard Terms) from where the route of administration is to be selected. Species Target species as specified on the SPC. DRUG INGREDIENT (S) SECTION This section allows you to enter the composition of the medicinal product. The information in this section should be provided as it has been authorised in the SPC. You have to specify at least one active ingredient for each medicinal product. This is a repeatable section: you can enter more than one ingredient. Substance This field allows for the standardised provision of information on active ingredients and excipients, as they have been approved in the SPC. The list of the substances in this field displays a look-up table, based on International Non-Proprietary Nomenclature (INN) and European Pharmacopoeia terminology. Excipients should be referred to by their recommended INN term accompanied by the salt or hydrate form or by their European Pharmacopoeia name. If an excipient has neither an INN nor European Pharmacopoeia name, it should be described by its common name. The ingredients in excipient mixtures should be listed individually. In cases where the applicant does not know the full composition of a flavour or fragrance, they may be declared in general terms (e.g. orange flavour, citrus perfume), however any of the components that are known, or which have a recognised action or effect must be included. Chemically modified excipients should be declared in such way as to avoid confusion with the unmodified excipients e.g. pregelatinised starch. You can select an ingredient in the list, which constitutes the data in standard terminology. If the substance is not part of the look-up table, you can add the substance by providing the information in the SUBSTANCE chapter. Role of the Ingredient This field describes the function of the ingredient. You can select one of the following options: 1) Active ingredient 2) Excipient When specifying an active ingredient the following fields will be mandatory: Type of Concentration, Concentration Unit Code and Concentration / Concentration2. When specifying an excipient the following fields are not mandatory: Type of Concentration, Concentration Unit Code and Concentration / Concentration2. Type of Concentration This is a mandatory field for active ingredients and non-mandatory field for excipients. Select one of the items from the list of options: Equal: Not less than: if the concentration is given as an unique value; if the concentration is expressed as minimum value; 25

26 Range: Up to: if the concentration is expressed as a range. If you select range, both the Concentration field and Concentration2 field need to be completed. if the concentration is expressed as a maximum value. Concentration Unit Code This is a mandatory field for active ingredients and non-mandatory field for excipients. Select one of the standard concentration units from the list. Concentration Enter the concentration in which the ingredient is present in the medicinal product. When entering numerical values to indicate decimal fractions a full stop must be used. Concentration2 This field is mandatory when range is selected in the Concentration type field. When range is selected, both Concentration and Concentration2 are to be completed in order to enter both the minimum and the maximum value. DRUG ATC (S) SECTION This is a repeatable section: you can enter more than one ATC Code. ATC Code This field is to be completed with the ATC Code for which the medicinal product has been authorised. SUBSTANCES SECTION This section allows the provision of information regarding substances. In the following circumstances, you should provide information on a substance completing the fields in the this section: When an ingredient s name is not part of the look-up table, you have to create a Substance Report. In this case you should add a term using one of the sources in the following order of preference: 1- INN 2- European Pharmacopoeia 3- National Pharmacopoeias 4- Other official sources 5- Other sources (The specific name of the bibliographical source will have to be provided). Source This refers to the bibliographical source from which the term has been taken. No entries can be inserted without the bibliographical source. Select one of the values from the look-up table. If the source is not part of the look-up table, you can add the source by providing the information in the SOURCE chapter. Substance Name This field is to be completed with the name of the substance. MAHs This section allows the provision of information on Marketing Authorisation Holders (MAHs). Please note that you cannot provide information concerning other MAHs. Therefore, you are only allowed to specify MAHs that belong to your organisation hierarchy (e.g. you as the headquarter and your affiliates MAH Name This field is to be completed with the name of the MAH. 26