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

  • Email
  • Help

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

Back to top

1. What is the legal basis of an urgent Union procedure?

An urgent Union procedure follows the provisions under Article 107i of Directive 2001/83/EC amended by Directive 2010/84/EU as regards pharmacovigilance.

Reference

  • Directive 2001/83/EC (consolidated version including Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010)
2. In which situations can an urgent Union procedure be initiated?

An urgent Union procedure can be initiated when, as a result of the evaluation of data resulting from pharmacovigilance activities, a Member State or the European Commission considers that urgent action is necessary in 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 safety  concerns, it has interrupted the placing on the market of a medicinal product or has taken action to have a marketing authorisation withdrawn, or that it intends to do so;
  • it considers that a new contraindication, a reduction in the recommended dose, or a restriction to the indications is necessary.
3. Who can initiate an urgent Union procedure?

This procedure can only be initiated by competent authorities in the Member States or by the European Commission. A marketing-authorisation holder cannot trigger such a 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 publicly available at the start of the procedure (please refer to question 8).

4. 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 in its territory until a definitive decision is adopted.

In this case, it should inform 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 trigger the urgent Union procedure (please refer to question 2).

5. 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 European Union will be included in an urgent Union procedure. This means all products concerned by the safety issue, regardless of whether the marketing authorisation was granted nationally (including via the mutual-recognition or decentralised procedure) or via the centralised procedure.

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

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

6. How are the products to be part of an urgent Union procedure identified?

The competent authority of the Member States (MSs) within the European Economic Area will identify the authorised products that 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 publicly available on the Agency’s website on the specific procedure's web page.

If, after consultation with the MSs, it is concluded that the safety issue triggering the urgent Union procedure also concerns other products (e.g. a range of products or a therapeutic class) in addition to 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 European Union, or subject to future authorisations by MSs, upon conclusion of the procedure, the concerned MSs should take due consideration of the scientific conclusions with regards to the products not initially included in the procedure but which are also affected.

7. 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 liaises with the competent authority of the Member States (MSs) within the European Economic Area enquiring about the existence of authorised products 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 products authorised in only one MS, no procedure will be initiated and the safety issue will be handled by the MS concerned.

8. 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) 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 Friday after 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 products concerned and the right and modalities for marketing-authorisation holders, healthcare professionals and the general public to submit information relevant to the procedure to the Agency (please refer to questions 14, 18 and 20).

The following documents are published at the time of announcement of the start of the procedure on the Agency’s website:

  • a notification triggering the procedure together with the scientific background;
  • a draft list of concerned medicinal products or active substances and MAHs;
  • lists of questions and timetables adopted by the Pharmacovigilance Risk Assessment Committee (PRAC);
  • a question-and-answer document;
  • a press release in relation to the urgent Union procedure, if applicable.
9. How will marketing-authorisation holders be informed about the start of the urgent Union procedure?

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 products concerned by the urgent Union procedure identified in the published list will be notified in writing by the Agency. Such a letter notifying the MAHs of the procedure's initiation will include:

  • the contact details of the Agency’s product team leader (PTL) from the Community Procedures Section who will be the primary contact point during the 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. Therefore, MAHs and other interested parties should continuously check the Agency’s website for any relevant updates (please refer to questions 30, 36 and 39).

10. 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, marketing-authorisation holders (MAHs) should inform the Agency of a designated contact person for the specific procedure.

The designated contact person will be receiving all the 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 e-mail 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.

11. 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 or company affiliation) in order to provide a single consolidated response or oral clarifications to the questions raised by the Pharmacovigilance Risk Assessment Committee (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.

If an MAH wishes to be represented by another party, all documentation concerning the referral will be sent to the group representative or contact person only. Receipt of any documents by the group representative or 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 validity of the letter of representation (e.g. change of the contact person) as soon as possible and provide relevant additional or revised letter of representation.

The letter 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).

12. 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 product's European public assessment report (EPAR).

The letter notifying of the start of the urgent Union procedure will include the contact details of the Agency’s product team leader from the Community Procedures Section, who will be the primary contact point during this procedure only. The PTL for the product 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-centrally authorised products involved in the procedure, 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 or company affiliation). This would allow the submission of a single consolidated response or oral clarifications to the questions raised by the Pharmacovigilance Risk Assessment Committee (PRAC) during the procedure (please refer to question 11).

13. Do I have to pay a fee?

Currently, there are no fees to be payable for the assessment of an urgent Union procedure.

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

Marketing-authorisation holders (MAHs), healthcare 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 Pharmacovigilance Risk Assessment Committee (PRAC) will, in any case, issue a recommendation applicable to all marketing authorisations concerned by the procedure, independently of whether or not data have been submitted.

The announcement of the start of the procedure will include detailed information on how and when to submit data (refer to questions 18 and 19).

15. How will data be gathered during the procedure?

The safety issue under urgent consideration by the Pharmacovigilance Risk Assessment Committee (PRAC) will be substantiated by additional data that could be requested as lists of questions, comments on the scientific background supporting the triggering of the procedure or the use data sources available to the Agency and national competent authorities of the Member States.

The additional data may be gathered from several different sources (i.e. from marketing-authorisation holders concerned, healthcare professionals, patient organisations, the public, EudraVigilance or national competent authorities). 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 (refer to question 8). The time limit for submission of data will not exceed 20 days.

Notwithstanding the above, the PRAC may also collect additional data in some specific cases through a public hearing or in an oral explanation (refer to question 23).

16. 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 Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), as applicable (refer to question 32).

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.

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

To be completed upon finalisation of the Pharmacovigilance Risk Assessment Committee (PRAC) rules of procedure.

During the assessment

Back to top

18. How should 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 Pharmacovigilance Risk Assessment Committee (PRAC) list of questions, comments on 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, patient organisations and the 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 according to the Common Technical Document (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. the Agency’s product team leader (PTL) from the Community Procedures Section 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 and risk-management plans) are expected to be provided together with a summary of those data as per module structure of the CTD format.
  • Published data can be presented as supportive documentation in response to a specific question if no other data are available.

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 in English and electronically only (refer to question 19).  Submission of responses concerning the urgent Union procedure with regards to centrally authorised products (CAP) will follow the requirements for post-authorisation procedures for CAPs (e.g. submission via electronic CTD).

In case some questions (e.g. on a specific pharmaceutical form) are not applicable or relevant to all products concerned by the procedure or to the products of the represented group, the response should be 'not applicable'. A short explanation as to why it is not applicable should be given.

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

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

The announcement of the urgent Union procedure has a dedicated section for submission of data by stakeholders who are not MAHs concerned by the procedure. All submissions from non-MAHs should be sent electronically only, via the dedicated e-mail 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 the published PRAC list of questions numbering).

It is of the utmost importance that data are 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.

19. To whom should I submit my answers?

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

  • the Agency:  One electronic copy of the complete application or submission on DVD or CD-ROM plus one original, signed cover letter (copying the product team leader from the Community Procedures Section with no additional copy needed);
  • Pharmacovigilance Risk Assessment Committee (PRAC) rapporteur and co-rapporteur(s): One electronic copy of the complete application or submission on DVD or CD-ROM;
  • Other PRAC members: One electronic copy of the complete application or submission on DVD or CD-ROM.

Dossier delivery

Addresses for PRAC members are available under PRAC members.

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

This is located at the rear of the Agency's premises and is open from 6.00am to 6.00pm, 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 e-mail address and in line with the requirements as described in question 18.

20. How will my data be assessed?

Submissions from marketing-authorisation holders (MAHs) concerned by the procedure should be provided in Common Technical Document (CTD) format directly to the Pharmacovigilance Risk Assessment Committee (PRAC) (co-)rapporteur to be considered for the assessment.

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

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

All information gathered will be assessed within an agreed timeframe as published in the announcement of the urgent Union procedure. The assessment reports 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 reports and to the PRAC assessment report and therefore published for transparency purposes and public awareness.

The PRAC (co-)rapporteur's assessment reports will be circulated to the PRAC members for comments. These will also be shared with the Committee for Medicinal Products for Human Use (CHMP) rapporteurs (if centrally authorised products are included in the scope of the procedure) or with the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) member with a leading role as appointed by the CMDh at the initiation of the procedure (if any of the products concerned are authorised nationally including through the mutual-recognition or decentralised procedures) for comments. This aims to ensure a close collaboration during the assessment.

21. 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 Pharmacovigilance Risk Assessment Committee (PRAC) may agree on a shorter deadline.

The timelines for a 60-day assessment period are listed below:

Timetable for the assessmentDay1
Assessment starts in the next PRAC meeting2 following submission of all data (as per published deadline)Day 1
PRAC (co-)rapporteur circulates assessment reports on the data collectedDay 20
Written comments PRAC members, Committee for Medicinal Products for Human Use (CHMP) rapporteurs concerned (if centrally authorised products are involved) and Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) members with leading role (if applicable)Day 35
PRAC (co-)rapporteur circulates updated assessment reports based on 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

1 The 60 days for assessment should be considered as the period of three consecutive PRAC plenary meetings.
2 Corresponds to the second 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 timetable: safety referral (Article 107i, urgent Union procedure).

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 explanations by the marketing-authorisation holders concerned, public (and non-public) hearings or case where the PRAC requires input from a scientific advisory group (SAG) or an ad-hoc expert meeting to support its recommendation.

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

22. 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 reports.

As a general rule, other stakeholders will not be provided with the Pharmacovigilance Risk Assessment Committee (PRAC) (co-)rapporteur’s assessment reports. In any case, the PRAC recommendation and assessment report will be published on the Agency's website together with the final outcome of the Committee for Medicinal Products for Human Use (CHMP) or the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) (refer to question 30).

23. Will I have the possibility to present my views in front of the PRAC? How is this organised?

Where the urgency of the matter permits, the Pharmacovigilance Risk Assessment Committee (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 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/she 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 that the PRAC holds an oral explanation. In such cases, the MAHs should send a written request to the PRAC stating the reasons and specifying the issues 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).

Detailed information on organisational aspects of oral explanations is available:

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

If the marketing authorisation (MA) for a nationally approved product (including one approved via the mutual-recognition or decentralised procedure) 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 inform the former MAH that they will no longer be contacted regarding that specific product. The Agency will request that the new MAH submits, if appropriate, an updated letter of representation or information on the new contact person for the procedure.

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

If the name of a nationally approved product (including one approved via the mutual-recognition or decentralised procedure) 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 of the name of the nationally approved product, the Agency will inform the MAH that the change in the name of the product has been noted.

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

If the name or address of the marketing authorisation holder (MAH) of a nationally approved product (including one approved via the mutual-recognition or decentralised procedure) 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

Back to top

27. 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 (refer to question 21). The PRAC recommendation will usually be issued on the last day of the PRAC 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).

28. What could the PRAC recommendation ve?

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

  1. no further evaluation or action is required at European 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 d, 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 the 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 majority. 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 to the recommendation issued by the PRAC.

29. 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;
  • the PRAC assessment report on the critical evaluation performed and the conclusion of the Committee that led to the adoption of the recommendations based on all data gathered;
  • the scientific grounds and explanation for the PRAC recommendation;
  • the wording 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 marketing-authorisation holders (MAHs) or Member States for the safe and effective use of the medicinal product, if applicable;
  • the PRAC members’ divergent views, if the recommendation is adopted by majority;
  • a listing of all products concerned including a dedicated list for all identified products approved nationally including via the mutual-recognition or decentralised procedure and their respective MAHs. If centrally authorised products are involved their respective annexes A will be attached.
30. 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 the Friday of the PRAC’s plenary meeting week together with an updated question-and-answer document and a press release, as applicable.

The full scientific PRAC recommendations including the PRAC assessment report and its annexes, in English only, will be published on the Agency’s website (on the specific procedure web page) together with the final outcome of the Committee for Medicinal Products for Human Use (CHMP) or the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) once the CHMP or CMDh meeting has finished.

31. Will I receive the PRAC recommendation?

The PRAC recommendation will be publicly available on the Agency’s website on the specific procedure web page at the time of the final outcome of the Committee for Medicinal Products for Human Use (CHMP) or the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) (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-mail.

32. 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 or CMDh will consider the PRAC recommendation at its next plenary meeting and will agree on the timeframe needed to issue an opinion, position or agreement. This timeframe should not exceed 30 days after receipt of the PRAC recommendation (refer to question 33).

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 official European Union languages (refer to question 37).

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

Back to top

33. When will the CHMP issue an opinion or the CMDh reach a position or agreement?

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

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

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

34. What is the basis of the CHMP opinion or CMDh position or agreement?

The CHMP or CMDh should rely on the PRAC recommendation when considering the adoption of an opinion, position or agreement on an urgent Union procedure.

The CHMP or 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 authorisations concerned (refer to question 28).

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

35. How is the CHMP opinion or CMDh position or agreement structured?

The CHMP opinion or CMDh position or agreement will include:

  • a cover page in which the adopted CHMP opinion or CMDh position or agreement is outlined, together with the voting outcome;
  • the PRAC recommendation and its assessment report;
  • the scientific grounds and explanation for the opinion, position or agreement  including a detailed explanation for any differences from the PRAC recommendation;
  • the CHMP or CMDh members’ divergent views, in case of adoption by majority and not by consensus;
  • the listing of all products concerned including a dedicated list for all identified products approved nationally (including those approved via the mutual-recognition or decentralised procedure) and their respective marketing-authorisation holders (MAHs). In case centrally authorised products are involved their respective annexes A will be attached;
  • the wording (only in English) to be included in the relevant sections of the summary of product characteristics, labelling or package leaflet, if applicable (only for products approved nationally including via the mutual-recognition or decentralised procedure);
  • the revised product information with agreed wording included in the relevant sections of the summary of product characteristics, labelling or package leaflet, if applicable (only for centrally authorised products);
  • the conditions or restrictions imposed on the MAHs or Member States for the safe and effective use of the medicinal product, if applicable.
36. When will the CHMP opinion or CMDh position or agreement be published?

A brief outcome of the CHMP opinion or CMDh position or agreement will be included in the meeting highlights that are released on Friday of the CHMP or CMDh plenary meeting week, together with an updated question-and-answer document and a press release, as applicable.

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

37. When do I have to submit translations?

Marketing-authorisation holders (MAHs) of products approved nationally (including via the mutual-recognition or decentralised procedure) will have to provide translations in all European Union (EU) languages (including Icelandic and Norwegian, if applicable) of the following annexes to the CHMP opinion or CMDh position or agreement:

  • list of products approved nationally (including via the mutual-recognition or decentralised procedure) concerned by the procedure;
  • wording to be included in the relevant sections of the summary of product characteristics, labelling 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 or position) and copied to the Agency.

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 Agency.

Further detailed information on the translation process is available:

38. What happens after the CHMP opinion or CMDh position or agreement?

In cases where the CHMP opinion or CMDh position is adopted 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 send them 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 whether it concerns centrally authorised products or nationally approved products (including those authorised via the mutual-recognition or decentralised procedures), respectively.

In cases where the CMDh agrees, 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.

39. 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 a CHMP opinion or CMDh position, the Agency’s web page on the specific procedure will reflect the date of the EC decision or the CMDh agreement, as applicable.

How useful is this page?

Average rating:

 Based on 10 ratings

Add your rating:

See all ratings
3 ratings
0 ratings
1 ratings
3 ratings
3 ratings