Q&A: Article 20 pharmacovigilance procedures

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This page lists questions that stakeholders, in particular marketing authorisation holders (MAHs), may have on an Article 20 procedure resulting from the evaluation of data from pharmacovigilance activities.

It provides an overview of the European Medicines Agency’s (the Agency) practical and operational aspects with regards to the handling of Article 20 pharmacovigilance procedures. Revised topics are marked 'New' or 'Rev.' on publication.

A PDF version of these questions and answers is available:

These questions and answers are for guidance only, without prejudice to legal and regulatory interpretation that might be provided in future updates of the rules governing medicinal products in the European Union, volume 2, notice to applicants.

Table of contents


Initiation of an Article 20 pharmacovigilance procedure

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1. What is the legal basis of an Article 20 pharmacovigilance procedure?

An Article 20 pharmacovigilance procedure follows the provisions of Article 20 of Regulation (EC) 726/2004.

It applies when the procedure is initiated as a result of the evaluation of data relating to pharmacovigilance of medicinal product(s) authorised via the centralised procedure only.

References:

2. In which situations can an Article 20 pharmacovigilance procedure be initiated?

An Article 20 pharmacovigilance procedure should be initiated in case a Member State (MS) or the European Commission (EC) considers that at least one of the measures envisaged under title IX (Pharmacovigilance) of Directive 2001/83/EC must be applied for centrally authorised medicinal products.

References:

3. Who can initiate an Article 20 pharmacovigilance procedure?

An Article 20 pharmacovigilance procedure can only be initiated by the European Commission (EC). A marketing authorisation holder cannot trigger this procedure.

The EC refers the safety matter to the Agency, by circulating a notification to the Agency and to all Member States, requesting an opinion by the Committee for Medicinal Products for Human Use (CHMP) to be adopted on the basis of a recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC).

The notification will identify the safety concern including a detailed explanation of the issue raised and the regulatory action which is being considered.

The notification will be publicly available at the start of the procedure (please refer to Question 6).

4. Can a Member State take regulatory action on a centrally authorised medicinal product?

A Member State (MS) may on its own initiative or at the European Commission’s (EC) request, where urgent action is essential to protect public health, suspend the use of a centrally authorised medicinal product in its territory until a definitive decision is adopted.

When it does so on its own initiative, the MS should inform the EC and the Agency of the reasons for its action at the latest on the next working day following the suspension.

The Agency will inform all other MSs without delay, and the EC will immediately initiate an Article 20 pharmacovigilance procedure, if not already on going.

5. Which medicinal products can be involved in an Article 20 pharmacovigilance procedure?

An Article 20 pharmacovigilance procedure is initiated where only centrally authorised medicinal products (CAPs) are concerned by the safety issue.

The procedure may concern a specific medicinal product, all medicinal products containing the same active substance (range of medicinal products) or all medicinal products belonging to the same therapeutic class (several active substances concerned). If the safety concern referred relates to a range of products or therapeutic class involving not only CAPs but also nationally authorised medicinal products (including products authorised via the mutual recognition and decentralised procedures), then an Article 31 pharmacovigilance referral1 or an Article 107i procedure2, as appropriate will be initiated including all products affected.


1Please refer to the Questions & answers on Article 31 Pharmacovigilance referrals

2Please refer to Questions & answers on urgent union procedures

6. When and how will an Article 20 pharmacovigilance procedure be announced?

A brief summary of the safety issue will be discussed at the upcoming Pharmacovigilance Risk Assessment Committee (PRAC) plenary meeting and will be included in the agenda published at the beginning of the PRAC meeting.

The start of the procedure will be announced as part of the PRAC meeting highlights, which will be published on the next working day following the PRAC meeting during which the matter is considered.

In certain cases, depending on the urgency of the matter the announcement may take place earlier.

The announcement will specify the safety issue under consideration, the products concerned and will include the publication of the following documents on the Agency’s website on the specific procedure webpage:

  • notification triggering the procedure;
  • list(s) of questions and timetable adopted by the PRAC;
  • summary of the start of the procedure and
  • press release, if applicable.

The announcement on the Agency’s website will also be linked to the European public assessment report (EPAR) of the centrally authorised medicinal product(s) concerned by the Article 20 pharmacovigilance procedure.

7. How will marketing authorisation holders be informed about the start of the Article 20 pharmacovigilance procedure?

The public announcement on the Agency’s website will include all information related to the start of procedure.

In addition, all qualified persons for pharmacovigilance (QPPV) of the medicinal product(s) concerned by the Article 20 pharmacovigilance procedure will be notified electronically (via email/Eudralink) by the Agency. The notification to the QPPV of the procedure initiation will include:

  • the name and contact details of the Agency’s dedicated Procedure Manager who will be the contact point during the procedure. The EMA Product Lead for the centrally authorised product will remain assigned to this product and should always be put in copy in all correspondence regarding the Article 20 pharmacovigilance procedure;
  • the pathway to the Agency’s web page where the relevant documentation is available

The Agency may release updated information on the website during the procedure and therefore marketing authorisation holder(s) should continuously check the Agency’s website for any relevant updates (please refer to Question 27, Question 33, and Question 36).

8. Should marketing authorisation holders identify a contact person to communicate with the Agency during the Article 20 pharmacovigilance procedure?

The marketing authorisation holders (MAHs) will not need to designate a specific contact person for the Article 20 pharmacovigilance procedure. The qualified person for pharmacovigilance (QPPV) will, by default, be the contact person and will receive all correspondence from the Agency regarding this procedure.

The QPPV may if they wish to, designate a different contact person for the Article 20 pharmacovigilance procedure. In this case it must inform the procedure manager identified in the notification sent at the time of the procedure initiation.

All documentation concerning the Article 20 pharmacovigilance procedure will be sent to the contact person only.

Receipt of any documents by the contact person will be considered to constitute effective receipt by the marketing authorisation holder (MAH) inter alia for the purposes of calculating the procedural timelines.

9. Can marketing authorisation holders group with other marketing authorisation holders involved in the procedure?

The marketing authorisation holder(s) (MAHs) can form a group for the purpose of the procedure in order to provide a single consolidated response and/or oral clarifications to the questions raised by the Pharmacovigilance Risk Assessment Committee (PRAC) during the procedure. In this case the cover letter accompanying the single consolidated response and/or request for oral explanation should clearly identify the parties responsible for the submission/request.

10. Do marketing authorisation holders have to pay a fee?

The Agency will levy a fee for the assessment of a pharmacovigilance procedure under Article 20 of Regulation (EC) 726/2004.

The total chargeable units in the procedure will be identified from the Article 57 database. The share payable by each marketing authorisation holder (MAH) will be calculated by the Agency. In this respect, an advice note will be sent at the start of procedure, to the relevant qualified person(s) for pharmacovigilance (QPPV) in order to ensure the accurate identification of the chargeable units for the products involved in the procedure. At the start of the procedure, the invoice will be sent to each MAH with the relevant chargeable units calculation. The fee will be due to the Agency within 30 calendar days from the date of the invoice.

For MAHs already qualified as a micro-, small or medium-sized enterprise (SME) by the Agency, or those that will send a SME declaration in advance of the start date, or at least after 30 days of the invoice date, the fee will be reduced (small- or medium-sized enterprise) or waived (micro-sized enterprise).

The Agency will also publish further guidance on how the fees will be calculated and collected.

References:

11. Who can submit data to be considered for this procedure?

The marketing authorisation holder(s) (MAHs) concerned by an Article 20 pharmacovigilance procedure will be requested to submit information relevant for the assessment of the safety concern.

This is an opportunity given to the MAHs to present written or oral explanations to the Pharmacovigilance Risk Assessment Committee (PRAC) within the time limit as specified in the procedure timetable, and before a recommendation is issued by the PRAC.

The announcement of the start of the procedure will include detailed information on how and when to submit data (please refer to Question 15 and Question 17).

Regardless of whether or not the MAHs present written or oral explanations to the PRAC, a recommendation will be issued by the PRAC in any case, applicable to all marketing authorisation(s) concerned by the procedure.

12. How will data be gathered during the procedure?

The safety concern triggering the Article 20 pharmacovigilance procedure will be substantiated by additional data that could be requested by the Pharmacovigilance Risk Assessment Committee (PRAC) in the format of a list(s) of questions/list of outstanding issues, comments on the scientific background supporting the triggering of the procedure or by using data sources available to the Agency and/or to the national competent authorities (NCAs) of the Member States.

The additional data may be gathered from several different sources (i.e. from concerned marketing authorisation holders (MAHs), healthcare professionals, patients’ organisations, eudravigilance data, data available to the NCAs, etc).

The need for specific data to be collected is identified by the PRAC at the start of the procedure.

The data to be considered for the assessment will have to be submitted within the specified deadline as published in the announcement of the start of the procedure (please refer to Question 6).

Notwithstanding the above, the PRAC may in some specific cases also collect additional data through a further list of outstanding issues, public hearing and/or in an oral explanation in accordance with an extended timetable, which will be made publicly available (please refer to Question 19 and Question 21).

13. Who will perform the assessment?

The assessment of data within the Article 20 pharmacovigilance procedure is led by the Pharmacovigilance Risk Assessment Committee (PRAC). At the start of the procedure, the PRAC appoints a PRAC rapporteur and PRAC co-rapporteur(s) who will perform the assessment of all data collected within the agreed timelines.

The assessment will result in the PRAC issuing a recommendation on the safety issue reviewed, which will be forwarded to the Committee for Medicinal Products for Human Use (CHMP) (please refer to Question 2).

Even though the assessment of the Article 20 pharmacovigilance procedure will be performed by the PRAC, there will be a close collaboration between the PRAC rapporteur and the CHMP rapporteur.

14. How are the PRAC rapporteur and PRAC co-rapporteur appointed?

The Pharmacovigilance Risk Assessment Committee (PRAC) (co-) rapporteurs for an Article 20 pharmacovigilance procedure should be appointed by the PRAC from amongst its members or alternates (hereafter referred to as PRAC members). The priority is given to the PRAC (co-) rapporteur already nominated for the CAP(s).

If more than one CAP is involved, the PRAC referral (co-) rapporteur shall be appointed from amongst the PRAC (co-) rapporteurs for the CAPs involved in the referral. In case the referral procedure is not product specific, the PRAC Chairman may advise to open rapporteurship to all PRAC members. In case of an Article 20 procedure concerning several active substances belonging to the same therapeutic class, or where several issues are to be assessed, a lead rapporteur and several co-rapporteurs could be appointed.

The PRAC will endeavour to apply the criteria of best available expertise to be taken into account for the appointment of the PRAC (co-) rapporteurs for each procedure.

References:

During the assessment

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15. How shall I present my responses?

The announcement of the start of the procedure will specify the modalities for submission of data relevant to the procedure (e.g. response to the Pharmacovigilance Risk Assessment Committee (PRAC) list of questions, comments to the scientific background supporting the triggering of the procedure).

Marketing authorisation holder(s) (MAHs) of products concerned by the procedure should submit their responses as follows:

  • The data should be presented in electronic format according to the electronic Common Technical Document (eCTD) format and accompanied by a signed cover letter and a written summary of each question.
  • The cover letter must make clear reference to the procedure number and the Agency’s Procedure Manager who should always be put in copy.
  • The written summary answering each question should follow the numbering as per the published PRAC list of questions and PRAC list of outstanding issues (if applicable). Please note that supportive data to the responses submitted (e.g. study reports, literature data, risk management plan) are expected to be provided together with a summary of those data as per the modular structure of the eCTD format.

Published data can be presented as supportive documentation in response to a specific question if no other data is available.

In case some questions (e.g. on a specific pharmaceutical form) are not applicable/relevant to all product(s) concerned by the procedure, or to the product(s) of the represented group, the response should be “not applicable” with a short explanation.

It should be noted that the responsibility for the quality of the submitted documentation lies with the MAHs and is crucial to the overall assessment. All submissions are expected to be submitted in English and electronically only (please refer to Question 17).

Submission of responses should also follow the Dossier Requirements for Centrally Authorised Products (please refer to Question 17).

In case MAHs formed a group (please refer to Question 9), the cover letter accompanying the single consolidated response and/or request for oral explanation should clearly identify the parties responsible for the submission/request.

16. When do I have to submit revised product information?

In case the answers to the Pharmacovigilance Risk Assessment Committee (PRAC) require changes to the product information, the marketing authorisation holders (MAHs) must submit the revised product information annexes as part of the responses. Only the English language version (highlighted version) of a relevant example of the full set of product information annexes (i.e. Annex I, II, IIIA and IIIB) is required during the assessment.

17. How and to whom shall I submit my responses?

Within the given timeline as specified in the announcement of the procedure, the responses from marketing authorisation holder(s) (MAH) should be submitted as specified in Dossier Requirements for Centrally Authorised Products.

As of 1 March 2014, the use of the eSubmission Gateway and/or the Web Client became mandatory for all electronic Common Technical Document (eCTD) submissions through the centralised procedure. After this date, the Agency no longer accepts submissions on CD or DVD. This applies to all types of procedures.

Detailed information on the required naming conventions and file formats can be found in EMA eSubmission Gateway: Questions and answers relating to practical and technical aspects of the implementation and in the eSubmission Gateway Web Client - Guidance for Applicants. For more information please refer to eSubmission website. Submissions that are sent using the eSubmission Gateway and web client will receive an automated acknowledgement.

For the number of copies and for a full overview of dossier requirements for the Agency, (co)- rapporteurs and Committee Members/Alternates and national competent authorities (NCAs) of
(co)-rapporteur, including delivery addresses, please refer to Dossier Requirements for Centrally Authorised Products.

18. How will my data be assessed?

Submissions from marketing authorisation holder(s) (MAHs) are provided directly to the Pharmacovigilance Risk Assessment Committee (PRAC) (co)-rapporteurs to be considered for the assessment.

All information gathered will be assessed within an agreed timeframe as published in the announcement of the Article 20 pharmacovigilance procedure. The assessment report(s) prepared by the PRAC (co-)rapporteur will reflect all data reviewed and considered for the assessment.

The PRAC (co)-rapporteur assessment report(s) will be circulated to the PRAC members for comments. These will also be shared with the Committee for Medicinal Products for Human Use (CHMP) (co-)rapporteur(s) for comments.

19. What is the timetable for the assessment by the PRAC?

Please note that the timelines below are provided for guidance purposes only and they refer to active days, which correspond to the time the Pharmacovigilance Risk Assessment Committee (PRAC) takes to assess the data provided.

The timelines following a 60 day assessment period are as follows:

Article 20 pharmacovigilance procedure – Timetable for the assessment

Day

Notification of an article 20 pharmacovigilance procedure to the PRAC/Agency secretariat;

Day 0

 

Discussion at the first meeting of the PRAC following receipt of the notification:

  • Discussion of the question(s) referred and whether a public hearing, oral explanation(s) should be held,
  • Appointment of PRAC (co-) rapporteurs and
  • Adoption of the PRAC list of questions (LoQ) to be addressed by the marketing authorisation holder(s) (MAHs) and timetable;

Day 1

Preparation and submission of written explanations by the MAH(s) in response to the PRAC list of questions;

Clock Stop

Re-start of the procedure following submission of the responses in accordance with published submission dates;

Clock re-start

 

Circulation of the PRAC (co)-rapporteurs assessment report(s) on the MAH(s)’ written responses;

Day 20

Comments in writing from PRAC members, Committee for Medicinal Products for Human Use (CHMP) concerned Rapporteur(s) on the PRAC (co)-rapporteurs assessment report(s);

Day 25

Discussion at the PRAC meeting:

  • Adoption of the PRAC recommendation or adoption of PRAC list of outstanding issues (LoOI) to be answered in writing and/or in public hearing/non-public hearing, oral explanation and timetable for the rest of the procedure;

Day 30

Preparation and submission of written and/or oral explanations and/or public hearing/non-public hearing;

Clock Stop

Re-start of the procedure following submission of written explanations (in accordance with the published submission dates) or at the time of oral explanations and/or public hearing/non-public hearing;

Clock re-start

Day 31

Discussion at the PRAC meeting:

  • Adoption of the PRAC recommendation

Day 60

 

The dates to be followed in accordance with the adopted timetable by the PRAC for each month.

The usual timetable for the assessment by the PRAC is 60 days to issue a recommendation after the deadline for the submission of all data as published at time of announcement. However, in case of a justified urgency the PRAC may agree on a shorter timetable.

The PRAC may extend the usual 60 days (in which case there will be a clock-stop) to allow for the assessment of further data provided as answers to the PRAC list of outstanding issues, oral explanation, public (and non-public) hearing or in case the PRAC requires input from a scientific advisory group (SAG) or from an ad-hoc expert group to support the PRAC recommendation.

As a general rule, a clock-stop of up to one month will apply. For an extension of a clock-stop longer than the one adopted by the PRAC, the MAH should send a justified request to the Agency for agreement by the PRAC. The PRAC will consider the request during their next plenary meeting, and if agreed, an extended timetable may be adopted. All MAHs involved in the procedure will be informed of the PRAC outcome.

The PRAC assessment of responses to the list of outstanding issues will take up to 30 or 60 days depending on the complexity and amount of data provided by the MAH(s).

20. Will I receive the PRAC (co-) rapporteur assessment report(s)?

All marketing authorisation holder(s) with products included in the scope of the Article 20 pharmacovigilance procedure will be provided with the Pharmacovigilance Risk Assessment Committee (PRAC) (co-)rapporteur’s assessment report(s) electronically via email/Eudralink.

21. Will I have the possibility to present my views in front of the PRAC and how is this organised?

The Pharmacovigilance Risk Assessment Committee (PRAC) may decide whether there are issues that need to be addressed orally by the marketing authorisation holder(s) (MAHs). In such a case, the MAH(s) will be duly informed in advance of the issues to be addressed during an oral explanation.

The MAH(s) may also make a request to the PRAC to attend an oral explanation. In such a case, the MAH(s) should send a written request to the PRAC stating the reason(s) and specifying the issue(s) to be addressed during the oral explanation. The PRAC will take due account of the request and will decide whether the oral explanation will be held.

Oral explanation(s) should take place during the assessment phase and after the receipt of the PRAC (co)-rapporteur’s assessment report(s). Further detailed information on organisational aspects of the oral explanation.

Exceptionally, an oral explanation may be held in front of the CHMP following the PRAC recommendation (please refer to Question 32).

The MAH(s) can provide the oral explanation on their own behalf or on behalf of the group of MAHs whom they represent.

Where the urgency of the matter permits, the PRAC may hold public hearings, on justified grounds, particularly with regard to the extent and seriousness of the safety concern.

When the PRAC is of the opinion that a public hearing should be convened, the hearing shall be held in accordance with the modalities and rules specified by the Agency and will be announced on the Agency’s website. The announcement will also specify the modalities of the participation.

Where a MAH or another person intending to submit information has confidential data relevant to the subject matter of the procedure, he may request permission to present that data to the PRAC in a non-public hearing.

A non-public hearing can only be held whenever a public hearing has been decided and agreed upon by the PRAC. When the MAH or another person requests a non-public hearing, this should be duly justified on the grounds of confidentiality of the data to be presented.

22. What should I do if my product is transferred to another marketing authorisation holder?

If during the procedure, the marketing authorisation (MA) for an approved centrally authorised product is transferred, the former marketing authorisation holder (MAH) should inform the Agency and the appropriate procedure should be followed (please refer to Transfer of marketing authorisation: questions and answers).

23. What should I do if the name of my product changes or, if the name and/or address of the MAH changes or, if my product is withdrawn?

If during the procedure, the name of the medicinal product changes, or the name and/or address of a marketing authorisation holder (MAH) changes or if the marketing authorisation of a centrally authorised product is withdrawn, the MAH should inform the procedure manager of the Article 20 pharmacovigilance procedure. The appropriate procedures should be followed (please refer to and Withdrawn-product notification: questions and answers).

Pharmacovigilance Risk Assessment Committee (PRAC) Recommendation

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24. When will the PRAC recommendation be issued?

The Pharmacovigilance Risk Assessment Committee (PRAC) will issue a recommendation on the safety concern referred under Article 20 in accordance with the timetable adopted at the start date of the procedure. The PRAC may extend the initial timetable to take into account the views of the marketing authorisation holder(s), or in case a public (and non-public) hearing is held or an ad-hoc expert/scientific advisory group (SAG) meeting is needed.

The PRAC recommendation will usually be adopted on the last day of the PRAC's plenary meeting.

25. What could be the outcome of the PRAC recommendation?

The Pharmacovigilance Risk Assessment Committee (PRAC) recommendation on the safety matter referred under Article 20 may be that:

  1. the marketing authorisation (MA) should be maintained or varied subject to certain conditions;
  2. the MA(s) should be suspended or revoked;

Where the recommendation is for the MA(s) to be varied, including changes or addition of information in the summary of product characteristics (SmPC) or the labelling or package leaflet (PL) , the recommendation will include the suggested wording of such changes or added information, and state where in the SmPC, labelling or PL such wording should be placed.

Where the PRAC recommends that the MA(s) should be subject to certain conditions, these can include, but are not limited to, requesting the marketing authorisation holder(s) to conduct a post-authorisation safety study and/or to implement additional risk minimisation measures.

The PRAC recommendation can be adopted either by consensus or by majority vote. In the event of adoption by majority, the divergent positions of the concerned PRAC members and the grounds on which they are based will be appended to the recommendation issued by the PRAC.

References:

26. How is the PRAC recommendation structured?

The Pharmacovigilance Risk Assessment Committee (PRAC) recommendation will include:

  • a cover page in which the recommendation adopted is outlined together with the voting outcome of the PRAC;
  • a listing of all products concerned, i.e. the respective Annex A for each product will be attached;
  • the scientific grounds and explanation for the PRAC recommendation;
  • the wording (in English only) to be included in the relevant sections of the summary of product characteristics and/or the labelling and/or package leaflet, if applicable;
  • the conditions or restrictions imposed on the marketing authorisation holders or Member States for the safe and effective use of the medicinal product, if applicable;
  • the PRAC member(s)’s divergent views, in case the recommendation is adopted by majority;
  • Direct Healthcare Professional Communication (DHPC) and communication plan as agreed by PRAC (if applicable)

the PRAC assessment report on the evaluation performed and the conclusion of the PRAC that led to the adoption of the recommendation(s) based on all data gathered.

27. When is the PRAC recommendation published?

A brief outcome of the Pharmacovigilance Risk Assessment Committee (PRAC) recommendation will be included in the PRAC meeting highlights that are released on the next working day following the PRAC plenary meeting together with a summary of the PRAC recommendation and a press release, as applicable.

The PRAC recommendation including the PRAC assessment report in English only, will be published on the Agency’s website (on the specific procedure webpage) together with the final outcome of the Committee for Medicinal Products for Human Use (CHMP), within two weeks following the CHMP plenary meeting during which the CHMP opinion was adopted.

28. Will I receive the PRAC recommendation?

The marketing authorisation holder(s) (MAHs) of products concerned and identified at the start of the procedure, will receive the Pharmacovigilance Risk Assessment Committee (PRAC) recommendation electronically via email/Eudralink during the week following the PRAC meeting when the recommendation was adopted.

The PRAC assessment report will be publicly available on the Agency’s website on the specific procedure webpage, the week following the Committee for Medicinal Products for Human Use (CHMP) plenary meeting during which the opinion was adopted (please see Article 20 pharmacovigilance procedures' webpage).

29. What happens after the PRAC recommendation?

The Pharmacovigilance Risk Assessment Committee (PRAC) recommendation is sent during the week following its adoption to the Committee for Medicinal Products for Human Use (CHMP), for adoption of an opinion.

The CHMP will consider the PRAC recommendation at their following plenary meeting and will agree on the timeframe needed to issue anopinion. This timeframe should not exceed 30 days after receipt of the PRAC recommendation (please refer to Question 31).

Committee for Medicinal Products for Human Use (CHMP) opinion

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30. When will the CHMP issue an opinion?

Following the receipt of the Pharmacovigilance Risk Assessment Committee (PRAC) recommendation, the Committee for Medicinal Products for Human Use (CHMP) will consider the PRAC recommendation at their plenary meeting. As a general rule, the aim will be to adopt the CHMP opinion at their next plenary meeting following the receipt of the PRAC recommendation.

However in some cases, the CHMP may agree on the need to further consider the PRAC recommendation. In such cases, the CHMP opinion is expected to be adopted within a maximum of 30 days after receipt of the PRAC recommendation.

This decision will be reflected in the CHMP meeting highlights published on the next working day following the plenary meetings.

31. What is the basis of the CHMP opinion?

The Committee for Medicinal Products for Human Use (CHMP) will consider the Pharmacovigilance Risk Assessment Committee (PRAC) recommendation on an Article 20 pharmacovigilance procedure and assessment report and will adopt by consensus or by majority vote, a CHMP opinion on the maintenance, variation, suspension or revocation of the marketing authorisations (MAs) concerned (please refer to Question 26).

Exceptionally, an oral explanation may be held in front of the CHMP should issues need to be addressed orally by the marketing authorisation holders (MAHs). The CHMP decides whether the oral explanation will be held.

Where the CHMP opinion differs from the recommendation of the PRAC, the CHMP will attach to its opinion an explanation of the scientific grounds for the differences.

32. How is the CHMP opinion structured?

The Committee for Medicinal Products for Human Use (CHMP) opinion will include:

  • a cover page in which the CHMP opinion is outlined together with the voting outcome;
  • the Pharmacovigilance Risk Assessment Committee (PRAC) recommendation and its assessment report;
  • the scientific grounds and explanation for the opinion including a detailed explanation for any differences with the PRAC recommendation;
  • the CHMP member(s)’s divergent views, in case of adoption by majority instead of consensus;
  • the listing of all products concerned i.e. their respective Annex A;
  • the revised product information with agreed wording included in the relevant sections of the summary of product characteristics and/or the labelling and/or package leaflet, if applicable;
  • the conditions or restrictions imposed to the marketing authorisation holders or Member States for the safe and effective use of the medicinal product, if applicable;
  • Direct Healthcare Professional Communication (DHPC) and communication plan as agreed by PRAC (as relevant).
33. When will the CHMP opinion be published?

A brief outcome of the Committee for Medicinal Products for Human Use (CHMP) opinion will be included in the meeting highlights that are released on the next working day following the plenary meeting, together with an EMA public health communication and a press release.

The CHMP opinion with the final assessment with all its annexes in all EU languages will be published on the Agency’s website (on the specific procedure webpage) within the first four weeks following the European Commission Decision.

34. Will I receive the CHMP opinion?

The marketing authorisation holder(s) of products concerned and identified at the start of the procedure will receive the Committee for Medicinal Products for Human Use (CHMP) opinion during the week following the CHMP plenary meeting when the opinion was adopted.

35. When do I have to submit translations?

The marketing authorisation holder(s) ofcentrally authorised products involved in the procedurewill have to provide the full product information in all EU languages by Day +5 (i.e. 5 days after adoption of the opinion) to the Member States’ contact points for linguistic check and copied to the Agency.

Further detailed information on the translation process of Committee for Medicinal Products for Human Use (CHMP) opinion.

36. What happens after the CHMP opinion?

After the Committee for Medicinal Products for Human Use (CHMP) opinion, the Agency together with the concerned marketing authorisation holder(s) (MAHs) and national competent authorities in the Member States will finalise the translations and will send these to the European Commission (EC).

The EC will then start the decision-making process leading to the adoption of a binding decision addressed to the MAHs.

Detailed information on the decision-making process.

The MAHs need to submit within 5 days following the EC decision, an eCTD closing sequence of the final documents.

37. Will there be any publication in relation to the Article 20 pharmacovigilance procedure after the Commission Decision?

Following the European Commission (EC) decision on the Committee for Medicinal Products for Human Use (CHMP) opinion, the Agency’s webpage of the specific procedure will be updated with the CHMP Opinion with the final assessment with all its annexes in all EU languages. The date of the EC decision will be reflected (please refer to Question 33). This page will also be linked to the European public assessment report (EPAR) of the centrally authorised medicinal product(s) concerned by the Article 20 pharmacovigilance procedure.

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