Questions and answers: Urgent Union procedure (Article 107i)

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This page lists questions that stakeholders, particularly marketing-authorisation holders (MAHs), may have on urgent Union procedures.

It provides an overview of the European Medicines Agency’s practical and operational aspects with regards to the handling of these 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.

These questions and answers should be read in conjunction with Directive 2001/83/EC, as amended by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010, without prejudice to the implementation of the changes resulting from Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance.

Table of contents


Initiation of the urgent Union procedure

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1. What is the legal basis of an urgent union procedure? Rev. Oct 2013

An urgent union procedure follows the provisions under article 107i of Directive 2001/83/EC.

Reference

2. In which situations is an urgent union procedure initiated? Rev. Oct 2013

An urgent union procedure is initiated when, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, a Member State or the Commission considers one (or more) of the following situations:

  • it considers suspending or revoking a marketing authorisation;
  • it considers prohibiting the supply of a medicinal product;
  • it considers refusing the renewal of a marketing authorisation;
  • it is informed by the marketing authorisation holder that, on the basis of safetyconcerns, he has interrupted the placing on the market of a medicinal product or has taken action to have a marketing authorisation withdrawn, or intends to take such action or has not applied for the renewal of a marketing authorisation;
3. In which other situations can an urgent union procedure be initiated? New Oct 2013

When, on the basis of concerns resulting from of the evaluation of data from pharmacovigilance activities, a Member State or the Commission considers that urgent action is necessary in case of a new contraindication, a reduction in the recommended dose or a restriction to the indications of a medicinal product.

4. Who can initiate an urgent union procedure?

This procedure can be initiated by competent authorities in the Member States or by the European Commission. A marketing authorisation holder cannot trigger this procedure.

The initiator of the procedure will circulate a notification to the Agency, all (other) Member States and the European Commission triggering the urgent union procedure. The notification will identify the safety concern and the regulatory action which is being considered.

The notification will be publically available at the start of the procedure (please refer to Question 9).

5. Can a Member State take regulatory action before triggering an urgent union procedure?

A Member State may, where urgent action is necessary to protect public health, suspend the marketing authorisation and prohibit the use of the medicinal product concerned on its territory until a definitive decision is adopted.

In this case, it informs the European Commission, the Agency and all other Member States, no later than the following working day, of the reasons for its action and simultaneously triggering the urgent union procedure (please refer to Question 2 and Question 3).

6. Which medicinal products can be involved in an urgent union procedure?

All products affected by the safety concern and with a valid marketing authorisation in the Union will be included in the urgent union procedure. This includes all products concerned by the safety issue, regardless if the marketing authorisation was granted nationally (including via the mutual recognition and decentralised procedures) or via the centralised procedure. However, in case the safety issue concerns only centrally authorised medicinal products, the procedure under article 20 of Regulation (EC) No 726/2004 is initiated.

The procedure can concern a specific medicinal product, all medicinal products containing the same active substance (range of medicinal products) or all medicinal products belonging to a therapeutic class (several active substances concerned).

The marketing authorisation holders cannot choose to include or not their products in an urgent union procedure. The inclusion of their products depends on the scope of the procedure.

7. How the product(s) are identified to be part of an urgent union procedure?

The competent authorities of the Member States (MSs) within the EEA will identify the authorised products which are concerned by the procedure and will inform the Agency accordingly. This will take place at the start of the procedure and a draft list of the products identified will be publically available on the Agency’s website on the specific procedure webpage (please refer to Question 9).

If after consultation with the MSs it is concluded that the safety issue triggering the urgent union procedure concerns also other product(s) (e.g. range of products, a therapeutic class) than the ones covered by the notification, the Agency can extend the scope of the procedure.

From a procedural view point, only those products identified at the start of the procedure will be covered by its scope. However, to the extent that other medicinal products affected by the scope and not identified at the start of the procedure may be authorised in the Union, or subject to future authorisations by the MSs, upon conclusion of the procedure, the concerned MSs should take due consideration of the scientific conclusions of the procedure and apply them to these products not initially included in the procedure.

8. What happens if the medicinal product involved is only approved in one Member State?

Upon receipt of the notification triggering the urgent union procedure, the Agency will liaise with the competent authority of the MSs within the EEA enquiring on the existence of authorised product(s) in their country, as identified in the notification.

If after consultation with the MSs, it is concluded that the safety issue triggering the urgent union procedure concerns product(s) authorised only in one MS, no procedure will be initiated and the safety issue will be handled by the MS concerned.

9. When and how will an urgent union procedure be announced?

A brief summary of the safety issue and the urgent action being considered will be included in the upcoming Pharmacovigilance Risk Assessment Committee (PRAC)’s plenary meeting agenda to be published on the Friday before the PRAC meeting.

The start of the procedure will be announced as part of the PRAC meeting highlights to be published on the Friday of 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 urgent consideration, the product(s) concerned and the right and modalities for the marketing authorisation holder(s), healthcare professionals and the general public to submit to the Agency information relevant to the procedure (please refer to Question 15, Question 19 and Question 21).

The following documents will be published at the time of announcement of the start of the procedure on the Agency’s website on the specific procedure webpage:

  • notification triggering the procedure together with the scientific background;
  • draft list of concerned medicinal products/active substances and MAHs;
  • list(s) of questions and timetable(s) adopted by the PRAC;
  • summary of the start of the procedure and
  • press release in relation to the urgent union procedure, if applicable;
10. How will marketing authorisation holders be informed about the start of the urgent union procedure? Rev. Feb 2014

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

In addition, all marketing authorisation holders (MAHs) of a product(s) concerned by the urgent union procedure identified in the published list will be notified in writing electronically (via e-mail/Eudralink) by the Agency. Therefore, MAHs need to ensure that the National Competent Authorities of the Member States where their products are authorised, are provided with the MAHs’ up to date contact details. The letter notifying the MAHs of the procedure initiation sent electronically (by e-mail/Eudralink) will include:

  • the contact details of the Agency’s Product Team Leader (PTL) from the referral procedures service that will be the primary contact point during the procedure and will include
  • the pathway to the Agency’s website web page where the relevant documentation is available.

The Agency may release updated information on the website during the procedure and therefore MAHs and other interested parties should continuously check the Agency’s website for any relevant updates (please refer to Question 31, Question 37and Question 40).

11. Should I identify a contact person to communicate with the Agency during the urgent union procedure?

To facilitate the exchange of information during the procedure, the marketing authorisation holders (MAHs) should inform the Agency of the designated contact person for the specific procedure.

The designated contact person will receive all correspondence from the Agency regarding the specific procedure. The contact details of the designated person should be clearly stated (name, address, phone, fax number and email address) in the letter of representation.

As a general rule, MAHs can be represented by another party provided that the MAH submits a letter of representation.

12. Can I group with other marketing authorisation holders (MAHs) involved in the procedure?

MAHs can form a group for the purpose of the procedure (irrespective of group/company affiliation) in order to provide a single consolidated response and/or oral clarifications to the questions raised by the PRAC during the procedure. In this case the group of MAHs must designate a contact group representative and each member of the group must submit a letter of representation to the Agency signed by a legal representative.

In case a MAH wishes to be represented by another party all documentation concerning the referral will be sent to the group representative/contact person only. Receipt of any documents by the group representative/contact person will be considered to constitute effective receipt by the MAH inter alia for the purposes of calculating the procedural timelines. The group representative will be responsible for forwarding any received documents to all the other individual members of the group.

It is the responsibility of the MAH to notify the Agency of any change that might affect the validity of the letter of representation (e.g. in case of a change of the contact person) as soon as possible and provide relevant additional or revised letter of representation.

The template letter(s) of representation to be used by MAHs in each of the above cases and additional information in case of representation by another party can also be found in the announcement of the specific procedure (see Article 107i procedures).

13. What happens if centrally authorised products are involved in the procedure??

If a centrally authorised product (CAP) is involved in an urgent union procedure the marketing authorisation holder (MAH) will be notified by the Agency of the start of the procedure as will all other concerned MAHs. The announcement on the Agency’s website will also be linked to the EPAR of the product.

The letter notifying the start of the urgent union procedure will include the contact details of the Agency’s Product Team Leader (PTL) from the referral procedures service that will be the primary contact point during this procedure only. The PTL for the CAP will remain the same for all other procedures and should always be put in copy in all correspondence regarding the urgent union procedure.

If you are also the MAH of non-CAPs involved in the procedure please also consider the possibility of designating one contact person for this procedure as well as grouping with other MAHs for the purpose of the procedure (irrespective of group/company affiliation). This would allow the submission of a single consolidated response and/or oral clarifications to the questions raised by the PRAC during the procedure (please refer to Question 12).

14. Do I have to pay a fee?

Currently, no fees are payable for the assessment of an urgent union procedure.

15. Can I submit data to be considered for this procedure?

The marketing authorisation holders (MAHs), health care professionals and the general public have the right to submit information relevant to the safety issue under review in the urgent union procedure.

This is an opportunity given by the provisions of the pharmacovigilance legislation for data to be submitted by all stakeholders and considered for the assessment of the safety issue. This is not a mandatory step of the procedure.

The PRAC will, in any case, issue a recommendation applicable to all marketing authorisations concerned by the procedure, independently of whether or not data has been submitted.

The announcement of the start of the procedure will include detailed information on how and when to submit data (please refer to Question 19 and Question 20).

16. How will data be gathered during the procedure?

The safety issue under urgent consideration by the PRAC will be substantiated by additional data that could be requested under the format of a list(s) of questions, comments to 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 State(s).

The additional data may be gathered from several different sources (i.e. from concerned marketing authorisation holders, healthcare professionals, patients’ organisations, the public, 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 and announced on the Agency’s website.

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 9). The time limit for submission of data will not exceed 20 days.

Notwithstanding the above, the PRAC may in some specific cases also collect additional data through a public hearing and/or in an oral explanation (please refer to Question 24).

17. Who will perform the assessment?

The assessment of data within an urgent union procedure is the responsibility of the Pharmacovigilance Risk Assessment Committee (PRAC). At the start of the procedure, the PRAC appoints a PRAC rapporteur and PRAC co-rapporteur who will take the lead in the assessment of all data collected within the agreed timelines.

The assessment will result with the PRAC issuing a recommendation on the safety issue reviewed, to be provided for adoption to the Committee for Medicinal Products for Human Use (CHMP) or to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), as applicable (please refer to Question 33).

Even though the assessment of the urgent union procedure will be performed by the PRAC, there will be a close collaboration between the PRAC (co-) rapporteurs and the CHMP rapporteur or with the CMDh member with a leading role during the assessment.

18. How are the PRAC rapporteur and PRAC co-rapporteur appointed? Rev. Oct 2013

The PRAC (co)-rapporteur for an urgent union procedure should be appointed by the PRAC from amongst its members or alternates (hereafter referred to as PRAC members). Alternates representing healthcare professionals and patient organisations cannot be appointed as PRAC (co)-rapporteur.

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 urgent union procedure.

During the assessment

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19. How shall I present my answers?

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 PRAC list of questions, comments to the scientific background supporting the triggering of the procedure).

Considering the urgency of the matter, all information available by stakeholders (e.g. marketing authorisation holders, healthcare professionals, patients’ organisations, general public) must be provided by the date published in the announcement.

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

The data should be presented in electronic format according to the CTD format and accompanied by a written summary of each question and a signed cover letter.

The cover letter must make clear reference to the procedure number and the Agency’s PTL from the referral procedures service should always be put in copy. The written summary answering each question should follow the numbering as per the published PRAC list of questions. 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 that data as per the module structure of the CTD format.

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

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 of the safety issue.

All submissions from MAHs are expected to be submitted in English and electronically only (please refer to Question 20).Submission of responses concerning the urgent union procedure with regards to CAPs should follow the requirements for post-authorisation procedures for CAPs (e.g. submission via e-CTD).

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 as to why it is “not applicable”.

In case MAHs formed a group, it is understood that the answers are provided by the designated group representative/contact person on behalf of the MAHs, as identified in the letter of representation.

Other stakeholders (e.g. healthcare professionals, patients’ organisations, general public), can submit data relevant to the assessment of the safety issue to the Agency by means of a dedicated email address available on the Agency’s website on the specific procedure webpage (please see Article 107i procedures).

The announcement of the urgent union procedure has a dedicated section for submission of data by stakeholders which are not MAHs concerned by the procedure. All submissions from non- MAHs should be sent electronically only, via the dedicated email address included in that section of the announcement.

All submissions have to be accompanied by a submission form (template available in the announcement) with all its mandatory fields duly completed. This is a requirement for data to be considered for assessment. The other requirement is the submission of all data within the deadline specified in the announcement.

All data submitted should be accompanied by an overall summary of its content and should make reference to the specific PRAC question being addressed (as per PRAC published list of questions numbering).

It is of the utmost importance that data is provided in due course to avoid undermining the safety review. In the same sense, due regard should be given to timelines constrains in the event of requirements for translations prior to assessment. Considering this aspect within the nature and timeframe of an urgent union procedure, data submission in English is therefore strongly advised.

20. To whom shall I submit my answers? Rev. Feb 2014

Within the given timeline as specified in the announcement of the procedure, the responses from marketing authorisation holders (MAHs) should be submitted to:

EMA: 1 electronic submission of the complete application in CTD format on DVD or CD-ROM + plus 1 original, signed cover letter

PRAC:

(Co)-Rapporteur: 1 electronic submission in CTD format on DVD or CD-ROM

Other members: 1 electronic submission in CTD format on DVD or CD-ROM

Dossier delivery

The responses to the Agency should be addressed and sent to the following address:

Product and Application Business Support (PA-BUS)
European Medicines Agency
Loading Bay
Ontario Way
Canary Wharf
LONDON E14 4HB
UNITED KINGDOM

(located at the rear of the EMA premises, 06:00-18:00, Monday to Friday)

Boxes containing dossiers should weigh less than 15 kg.

Within the given timeline as specified in the announcement of the procedure, the responses from other stakeholders should be submitted to the Agency electronically only, by means of the dedicated email address and in line with the requirements as described in Question 19).

21. How will my data be assessed?

Submissions from marketing authorisation holders (MAHs) concerned by the procedure are provided in CTD format and directly to the PRAC (co-) rapporteur to be considered for the assessment.

Data submitted from other stakeholders (e.g. healthcare professionals, patients’ organisations, general public), will be received and recorded by the Agency.

The Agency will prepare a list of all data received (i.e. from MAHs and other stakeholders). This listing together with the respective data from other stakeholders’ non-MAHs will be provided by the Agency to the PRAC (co-) rapporteur to be considered for the assessment.

All information gathered will be assessed within an agreed timeframe as published in the announcement of the urgent union procedure. The assessment report(s) prepared by the PRAC (co-) rapporteur will reflect all data submitted and considered for the review. The listing will be annexed to the PRAC (co-) rapporteur’s assessment report(s) and to the PRAC assessment report and therefore published for transparency purposes and public awareness.

The PRAC (co-)rapporteur assessment report(s) will be circulated to the PRAC members for comments. These will also be shared with the CHMP rapporteur(s) (in case at least one centrally authorised product is included in the scope of the procedure) or with the CMDh member with a leading role as appointed by the CMDh at the initiation of the procedure (in case the concerned products are only nationally authorised including via the mutual recognition and decentralised procedures) for comments. This aims to ensure a close collaboration during the assessment.

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

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

The timelines following a 60 days assessment period are:
 

Article 107 Urgent Union Procedure – Timetable for the assessmentDay1
Assessment starts on the next PRAC meeting2 following submission of all data (as per the published deadline)Day 1
PRAC (co-) rapporteur circulate the assessment report(s) on the data collectedDay 20
Comments in written by PRAC members, CHMP concerned Rapporteur(s) (if CAP(s) involved), CMD(h) member with leading role (if applicable)Day 35
PRAC (co-) Rapporteur circulate an updated assessment report(s) based on the comments received and reflecting any additional information received (if applicable)Day 45
PRAC Recommendation: Final discussion is held and the final recommendation is reachedDay 60

1The 60 days for assessment should be considered as the period of 3 consecutive PRAC plenary meeting.
2 Corresponds to the 2nd PRAC meeting following the receipt of the notification triggering the procedure.

The exact dates to be followed in accordance to the above timetable for each month can be found in the following link to timetable for safety referral- Article 107i.

Additional procedural steps within the same timeframe (i.e. maximum of 60 days) may be necessary before the PRAC issues a recommendation. This applies in case of oral explanation(s) by the concerned marketing authorisation holders, public (and non-public) hearing or in case the PRAC requires input from a scientific advisory group (SAG) or from an ad-hoc expert meeting to support the PRAC recommendation.

Please note that the above timelines are provided for guidance purposes only. The PRAC may agree on a shorter timetable due to the urgency of the issue.

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

All marketing authorisation holders (MAHs) with products included in the scope of the urgent union procedure will be provided with the PRAC (co-) rapporteur’s assessment report(s).

As a general rule other stakeholders will not be provided with the PRAC (co-) rapporteur’s assessment report. In any case, the PRAC recommendation and assessment report will be published on the Agency website together with the final outcome of the CHMP/CMDh, as applicable (please refer to Question 31).

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

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 shall be announced on the Agency’s website. The announcement shall also specify the modalities of the participation.

Where a marketing authorisation holder (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 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 data to be presented.

The PRAC, depending on the urgency of the matter, may also decide whether there are issues that need to be addressed orally by the MAHs. In such case, the MAHs will be duly informed in advance on the issues to be addressed during the oral explanation.

The MAHs may also request the PRAC to hold an oral explanation. In such case, the MAHs should send a written request to the PRAC stating the reasons and specifying the issue(s) to be addressed during the oral explanation. The PRAC will take due account of the request considering the urgency of the matter 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 can be found here.

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

If the marketing authorisation (MA) for a nationally (including mutual recognition and decentralised) approved product is withdrawn or transferred during the procedure, the former marketing authorisation holder (MAH) should inform the Agency. The Agency will then liaise with the national competent authority of the Member State (MS) concerned.

Following confirmation by the national competent authority of the withdrawal of the MA, the Agency will inform the former MAH that the specific product will no longer be included in the ongoing procedure so they will not be further contacted during the procedure regarding that specific product.

Following confirmation by the national competent authority of the transfer of a MA the Agency will inform the new MAH that they are included in the urgent union procedure and will request the submission of an updated letter of representation and/or information on the new contact person for the procedure.

26. What should I do if the name of my product changes?

If the name of a nationally (including mutual recognition and decentralised) approved product changes during the procedure, the marketing authorisation holder (MAH) should inform the Agency. The Agency will then liaise with the national competent authority of the Member State concerned. Following confirmation by the national competent authority of the change, the Agency will inform the MAH that the change has been noted.

27. What should I do if the name or address of the marketing authorisation holder changes?

If the name and/or address of a marketing authorisation holder (MAH) of a nationally (including mutual recognition and decentralised) approved product changes during the procedure the MAH should inform the Agency. The Agency will then liaise with the national competent authority of the Member State concerned. Following confirmation by the national competent authority of the change, the Agency will inform the MAH that the change has been noted.

Pharmacovigilance Risk Assessment Committee (PRAC) recommendations

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28. When will the PRAC recommendation be issued?

The PRAC has a maximum of 60 days to issue a recommendation after the deadline for submission of all data as published at time of announcement (please refer to Question 22). The PRAC recommendation will usually be issued on the last day of the PRAC's plenary meeting.

However, in case of justified urgency, the PRAC may issue a recommendation on a shorter timeframe and if needed by written procedure (i.e. outside a scheduled plenary meeting).

29. What could be the PRAC recommendation?

The PRAC recommendation shall include any or a combination of the following conclusions:

  1. no further evaluation or action is required at Union level;
  2. the marketing authorisation holder (MAH) should conduct further evaluation of data together with the follow-up of the results of that evaluation;
  3. the MAH should sponsor a post-authorisation safety study together with the follow up evaluation of the results of that study;
  4. the Member States or MAH should implement risk minimisation measures;
  5. the marketing authorisation should be suspended, revoked or not renewed;
  6. the marketing authorisation should be varied.

With regards to point (4.), the recommendation will specify the risk minimisation measures recommended and any conditions or restrictions to which the marketing authorisation should be made subject.
Where the recommendation is for the marketing authorisation to be varied, as referred to in point (f), including changes or addition of information in the summary of product characteristics or the labelling or package leaflet:

  • the recommendation will include the suggested wording of such changed or added information and state where in the summary of the product characteristics, labelling or package leaflet such wording should be placed.

The PRAC recommendation can be adopted 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 shall be appended in the recommendation issued by the PRAC.

30. How is the PRAC recommendation structured?

The 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 including a dedicated list for all identified products approved nationally (including via the mutual recognition/decentralised procedures) and their respective marketing authorisation holders (MAHs). In case centrally authorised products are involved their respective Annex A 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 or the labelling or package leaflet, if applicable;
  • the conditions or restrictions imposed on the MAHs or Member States for the safe and effective use of the medicinal product, if applicable;
  • the PRAC members’ divergent views, in case the recommendation is adopted by majority;
  • 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;
31. When is the PRAC recommendation published?

A brief outcome of the PRAC recommendation will be included in the PRAC meeting highlights that are released on Friday of the PRAC’s plenary meeting week together with a summary of the PRAC recommendation and a press release, as applicable.

The full scientific PRAC recommendation including the PRAC assessment report and its annexes, in English only, will be published on the Agency’s website (on the specific procedure webpage) together with the final outcome of the CHMP/CMDh as applicable, on the week following the CHMP/CMDh plenary meetings during which the opinion/position/agreement/was adopted.

32. Will I receive the PRAC recommendation?

The PRAC recommendation will be publicly available on the Agency’s website on the specific procedure webpage the week following the CHMP/CMDh plenary meetings during which the opinion/position/ agreement was adopted. (please see Article 107i procedures).

The marketing authorisation holders (MAHs) of products concerned and identified at the start of the procedure will receive the PRAC recommendation by post on the week following the PRAC meeting when the recommendation is adopted.

33. What happens after the PRAC recommendation?

The PRAC recommendation on an urgent union procedure is sent on the week following its adoption to:

  • the CHMP, if at least one centrally authorised product is included in the procedure, for adoption of an opinion;
  • the Coordination Group (CMDh), if only nationally (including via mutual recognition and decentralised authorised products) are included in the procedure, to reach a position/agreement;

The CHMP/CMDh will consider the PRAC recommendation at their following plenary meeting and will agree on the timeframe needed to issue an opinion/position/agreement. This timeframe should not exceed 30 days after receipt of the PRAC recommendation (please refer to Question 34).

In parallel, if you are a concerned marketing authorisation holder (MAH) you may be contacted by the Agency with a proposal for worksharing of the translation process in all EU official languages (please refer to Question 38).

Committee for Medicinal Products for Human Use (CHMP) opinion / Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) position or agreement

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34. When will the CHMP issue an opinion/CMDh reach a position/agreement?

Following the receipt of the PRAC recommendation, the CHMP/CMDh will, at their plenary meeting, consider the PRAC recommendation. As a general rule, the CHMP opinion/CMDh position/agreement will aim to be adopted in the same month of the PRAC recommendation.

However in some cases, the CHMP/CMDh may agree on the need to further consider the PRAC recommendation. In such cases, the CHMP opinion/CMDh position/agreement will be adopted within a maximum of 30 days after receipt of the PRAC recommendation. This decision will be reflected in the CHMP/CMDh meeting highlights published on Friday of the plenary meetings.

The overall process including timelines for adoption of an opinion/position/agreement is the following:

35. What is the basis of the CHMP opinion/CMDh position/agreement?

The CHMP/CMDh should rely on the PRAC recommendation when considering the adoption of an opinion (CHMP)/position/ agreement (CMDh) on an urgent union procedure.

The CHMP/CMDh will consider the PRAC assessment report and recommendation and adopt, by consensus or by majority vote, an opinion on the maintenance, variation, suspension, revocation or non-renewal of the marketing authorisation(s) concerned (please refer to Question 29).

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

36. How is the CHMP opinion/CMDh position/agreement structured?

The CHMP opinion/CMDh position/agreement will include:

  • a cover page in which the CHMP opinion/CMDh position/agreementadopted is outlined together with the voting outcome;
  • the PRAC recommendation and its assessment report;
  • the scientific grounds and explanation for the opinion/position/agreementincluding a detailed explanation for any differences with the PRAC recommendation;
  • the CHMP/CMDh members’ divergent views, in case of adoption by majority instead of consensus;
  • the listing of all products concerned including a dedicated list for all identified products approved nationally (including via the mutual recognition/decentralised procedures) and their respective MAHs. In case centrally authorised products are involved their respective Annex A will be attached;
  • 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 (only for products approved nationally including via the mutual recognition/decentralised procedures);
  • 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 (only for centrally authorised products);
  • the conditions or restrictions imposed to the marketing authorisation holders (MAHs) or Member States for the safe and effective use of the medicinal product, if applicable;
37. When will the CHMP opinion/CMDh position/agreement be published?

A brief outcome of the CHMP opinion, CMDh position/agreement, as applicable, will be included in the meeting highlights that are released on Friday of the CHMP’s and CMDh’s plenary meeting week together with an EMA public health communication and a press release.

The CHMP opinion/CMDh position/agreement with the final assessment conclusions and recommendations with all its annexes will be published on the Agency’s website (on the specific procedure webpage) the week following the plenary meetings during which the opinion/position/agreement was adopted.

38. When do I have to submit translations?

Marketing Authorisation Holders (MAHs) of products approved nationally (including via the mutual recognition or decentralised procedures) will have to provide translations in all EU languages (including Icelandic and Norwegian, if applicable) of the following annexes to the CHMP opinion/CMDh position/agreement:

  • list of products approved nationally (including via mutual recognition/decentralised procedures) concerned by the procedure;
  • wording to be included in the relevant sections of the summary of product characteristics and/or the labelling and/or package leaflet, if applicable;

Only one translation per EU language is required, therefore the MAHs actively involved in the procedure will be presented with a proposal for worksharing for the translation process.

The Agency will contact the MAHs as early as possible to ensure the smooth running of the worksharing process. The translations will have to be provided to the Member States contact points for linguistic check by Day +5 (i.e. 5 days after adoption of the opinion/position) and copied to the EMA.

Marketing Authorisation Holders (MAHs) of centrally authorised products involved in the procedurewill have to provide the full product information in all EU languages within the same timeframe (i.e. 5 days after adoption of the opinion) and to the Member States contact points for linguistic check and copied to the EMA.

Further detailed information on the translation process of CHMP opinion/CMDh position/agreement can be found here.

39. What happens after the CHMP opinion/CMDh position/agreement?

In case of CHMP opinion/ CMDh position by majority vote, the Agency together with the concerned marketing authorisation holders (MAHs) and national competent authorities (NCAs) in the Member States will finalise the translations and will send it to the European Commission.

The European Commission will then start the decision -making process leading to the adoption of a binding decision addressed either to MAHs or Member States, depending on whether the decision concerns centrally authorised products or nationally authorised products (including via the mutual recognition and decentralised procedures), respectively.

In case of CMDh agreement, the Agency together with the concerned MAHs and the NCAs in the Member States will finalise the translations. The agreement will be implemented by the Member States in accordance with the timetable determined in the agreement.

40. Will there be any publication in relation to the urgent union procedure after the Commission Decision and after consensus by CMDh?

Following the European Commission (EC) decision on the CHMP opinion/CMDh position, the Agency’s webpage of the specific procedure will be updated to reflect the date of the EC decision or the CMDh agreement, as applicable.