Q&A: Referral procedures regarding veterinary medicinal products

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This page addresses a number of questions that applicants or marketing-authorisation holders may have on Committee for Medicinal Products for Veterinary Use (CVMP) referral procedures. It provides an overview of the Agency’s position on issues typically addressed in discussions or correspondence with applicants and marketing-authorisation holders during referral procedures.

In order to obtain information on a topic, please click on the question. If a question is not addressed in this document, applicants and marketing-authorisation holders are strongly encouraged to contact the Agency for further information.

This information has been produced for guidance only and should be read in conjunction with the notice to applicants and regulatory guidelines for medicinal products for veterinary use, volume 6A, chapter 3.

Applicants and marketing-authorisation holders must in all cases comply with the requirements of the European Union (EU) pharmaceutical legislation on medicinal products for veterinary use. Provisions that extend to Iceland and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.

As of 1 January 2017 it will be mandatory for applicants to use the eSubmission Gateway / Web Client for all veterinary procedural submissions to the Agency. For more information, including links to guidance on registration with the system, see:

A compiled PDF version has been prepared for printing purposes only:

Table of contents


Start of referral

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1. What is the legal basis for my referral procedure?

Referral procedures may be initiated on the basis of one of the following Articles of EU pharmaceutical legislation:

  • Article 33(4) of Directive 2001/82/EC, as amended (referral following disagreement at the coordination group on a mutual recognition and decentralised procedure)
  • Article 34 of Directive 2001/82/EC, as amended (divergent decision by competent authorities referral)
  • Article 35 of Directive 2001/82/EC, as amended (referral of issues raised with regard to a product or a class of products which is of Community interest)
  • Article 40 of Directive 2001/82/EC, as amended (follow-up referral)
  • Article 13 of Regulation (EC) No 1234/2008  (referral following disagreement at the Coordination Group on a variation application)

References:

2. In which situations can a referral be initiated?

When a Member State, applicant, marketing authorisation holder or the European Commission decides to initiate a referral, a notification is sent to the CVMP or Agency secretariat, clearly identifying its legal basis, the product(s) concerned and a detailed explanation of the issue(s) referred.

Referral under Article 33(4) of Directive 2001/82/EC(mutual recognition procedure and decentralised procedure referral)

If the Member States involved in a mutual recognition procedure or decentralised procedure (MRP/DCP) fail to reach an agreement during the procedure in the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDv) referred to in Article 33(1) to (3) of Directive 2001/82/EC, a referral according to paragraph 4 of the same article, is initiated.

The referral is be triggered by the reference Member State in the MRP/DCP, on grounds of a potential serious risk to human or animal health or to the environment, where no agreement was reached during the CMDv procedure on the assessment report, the summary of product characteristics, the labelling or the package leaflet, prepared by the reference Member State.

Referral under Article 34 of Directive 2001/82/EC (divergent decision referral)

A referral procedure under Article 34 of Directive 2001/82/EC may be initiated when divergent decisions have been adopted by Member States concerning the authorisation, suspension or withdrawal of a particular veterinary medicinal product, for example where such a veterinary medicinal product has been nationally authorised in two or more Member States and the authorisations diverge (e.g. different indications, contraindications, posology or withdrawal periods). The referral may be initiated by the European Commission, a Member State, or a marketing-authorisation holder.

Referral under Article 35 of Directive 2001/82/EC (Community interest referral)

A referral procedure under Article 35 of Directive 2001/82/EC may be initiated in specific cases where the interests of the Community are involved. The expression ‘Community interest’ has a broad meaning but it refers particularly to the interests of human or animal health or of the environment in the Community, for example following concerns related to the quality, safety or efficacy of a veterinary medicinal product or new pharmacovigilance information.

Article 35(1) referral relates to a veterinary medicinal product while Article 35(2) referral refers to a class or range of veterinary medicinal products. Both may be initiated by the European Commission, a Member State, or an applicant or a marketing authorisation holder1.

Referral under Article 40 of Directive 2001/82/EC (follow-up referral)

This referral may be initiated by Member States in the frame of a follow-up procedure for veterinary medicinal product which has been granted a marketing authorisation via the mutual recognition or decentralised procedure or which has been subject to complete harmonisation in the frame of a referral procedure.

An Article 40 referral may be initiated to resolve any post-harmonisation divergences that may arise between Member States. It may be initiated by a Member State when it is considered that a variation, suspension or withdrawal of a harmonised marketing authorisation is necessary for the protection of human or animal health or the environment.

Referral under Article 13 of Commission Regulation (EC) No 1234/2008 (referral following disagreement at the Coordination Group on variation application)

A referral procedure under Article 13 of the Commission Regulation may be initiated by a Member State if it is not possible to recognise a decision in accordance with Article 10(4) of the Commission Regulation or to approve an opinion in accordance with point (b) of Article 20(8) of the Commission Regulation on grounds of a potential serious risk to human or animal health or to the environment. In that case Article 33(3), (4) and (5) of Directive 2001/82/EC applies.

References:

1The applicant or marketing-authorisation holder should include only their own products in a request for a Community referral under Article 35 of Directive 2001/82/EC but may, as part of the procedure, provide evidence that it is in the Community interest to extend the procedure to products other than its own. The European Commission or Member State may decide on the provided information to extend the scope of the procedure to all veterinary medicinal products containing the same active substance or to all veterinary medicinal products belonging to a specific therapeutic class.

3. Who can initiate a referral procedure?

Depending on the type of procedure, a referral can be initiated by an applicant, a marketing authorisation holder, a Member State or the European Commission:

  • Referral procedures under Article 33(4) of Directive 2001/82/EC are initiated by the reference Member State following a mutual recognition procedure or decentralised procedure (MRP/DCP), where no agreement was reached during the Coordination Group procedure referred to in paragraph 1 of the same article, provided that the Member State(s) that disagree submit a detailed statement of the reasons for disagreement.
  • Referral procedures under Article 34 of Directive 2001/82/EC can be initiated by any Member State, the European Commission or the marketing authorisation holder of a particular veterinary medicinal product.
  • Referral procedures under Article 35 of Directive 2001/82/EC can be initiated by any Member State, the European Commission, or the applicant or marketing-authorisation holder.
  • Referral procedures under Article 40 of Directive 2001/82/EC can be initiated by any Member State.
  • Referral procedures under Article 13 of Commission Regulation (EC) No 1234/2008 can be initiated by the reference Member State in case no agreement was reached during the Coordination Group procedure referred to in paragraph 1 of the same article, provided that the Member States that disagree submit a detailed statement of the reasons for disagreement. In that case, Article 33(3), (4) and (5) of Directive 2001/82/EC apply.

If the referrer is an applicant or marketing-authorisation holder, a pre-referral meeting with the Agency is recommended in advance of making a submission. Pre-referral meetings between the applicant or marketing-authorisation holder and the Agency are also possible in cases where the referrer is a Member State or the European Commission.

References:

4. Which products can be included in a referral procedure?

For a referral procedure under Article 33(4) of Directive 2001/82/EC, only the specific veterinary medicinal product for which a marketing authorisation was applied within a mutual recognition or decentralised procedure can be included.

For a referral procedure under Article 34 of Directive 2001/82/EC, only a particular veterinary medicinal product for which divergent decisions have been adopted in Member States concerning its authorisation, suspension or withdrawal can be included. As a result, neither generic nor competitor products can be included in an Article 34 referral procedure. Article 34 may apply to both purely national marketing authorisations and to authorisations issued following a mutual recognition or decentralised procedure.

For a referral procedure under Article 35 of Directive 2001/82/EC, both applications and veterinary medicinal products authorised in some or all EU Member States (following a national, mutual recognition or decentralised procedure) can be included. Depending on the scope, the referral can relate to a specific veterinary medicinal product only (Article 35(1) of Directive 2001/82/EC), to all veterinary medicinal products containing the same active substance or to all veterinary medicinal products belonging to a specific therapeutic class (including different active substances) (Article 35(2) of Directive 2001/82/EC).

For a referral procedure under Article 40 of Directive 2001/82/EC, a veterinary medicinal product which has been granted a marketing authorisation via the mutual recognition or decentralised procedures or which has been the subject of harmonisation as a result of a referral procedure can be included.

For a referral procedure under Article 13 of Commission Regulation (EC) No 1234/2008 only the specific veterinary medicinal product for which a variation application is applied can be included.

Veterinary medicinal products authorised through the centralised procedure cannot be included in referral procedures. However, a procedure under Article 45 of Regulation (EC) No 726/2004, applicable to centrally authorised products, could be initiated by the European Commission and Member States in parallel for products of the same active substance or therapeutic class.

References:

5. How will I be informed about the start of the referral procedure?

In case of a referral procedure under Articles 33(4), 34 and 35 of Directive 2001/82/EC and Article 13 of Regulation (EC) No 1234/2008, the triggering party will put the applicant or marketing-authorisation holder in copy in the notification form sent to the Agency.

For all referrals, immediately after the CVMP meeting in which the referral procedure is started, the Agency will send an official letter to all applicants and marketing-authorisation holders concerned informing them of the start of the procedure.

Applicants and marketing-authorisation holders cannot choose to be included in a referral procedure or not when a referral is initiated by a Member State or the European Commission. Whether their product is included in a referral procedure or not depends on the subject matter and scope of the specific referral initiated and the information provided by the relevant Member States. This is not applicable for referrals initiated by an applicant or marketing-authorisation holder.

The start-of-procedure letter will include the information below (as applicable).

  • Identification of rapporteur/co-rapporteur (see question 9);
  • Deadline for provision of answers to the CVMP list of questions, number of copies to be provided and general format to be followed for the responses (see questions 8 and 11);
  • Fees to be paid, if any (see question 6);
  • Information on the possibility for applicants and marketing-authorisation holders to group together (see question 7);
  • Request for nomination of a contact person and letter of representation (see question 7).

For a referral initiated by applicants or marketing-authorisation holders, some of this information might usefully be addressed in a pre-submission meeting.

The following documents are annexed to the start-of-procedure letter:

  • The official referral notification from the triggering party to the CVMP (not applicable for referrals under Article 34 of Directive 2001/82/EC initiated by marketing-authorisation holders);
  • The CVMP list of questions (not applicable for referrals under Article 34 of Directive 2001/82/EC initiated by marketing-authorisation holders);
  • The timetable for the procedure (see question 8);
  • A list of marketing-authorisation holders and veterinary medicinal products involved in the referral. Where applicable, the applicants and veterinary medicinal products with pending marketing authorisations are not included in this list due to confidentiality reasons. The list of applicants and veterinary medicinal products with pending marketing authorisations is sent separately from the list of marketing authorisation holders. The applicants and marketing-authorisation holders are requested to check the accuracy of the information provided by the Member States. This information includes contact details of the applicants and marketing-authorisation holders (address, telephone and fax) and information on the veterinary medicinal products (invented name, strength, pharmaceutical form and route of administration). This is not applicable for referrals under Article 34 of Directive 2001/82/EC initiated by the marketing authorisation holders;
  • Template for letter of representation (see question 7).
6. Do I have to pay a fee for a referral procedure?

A fee is payable only for a referral procedure under Article 34(1) or 35 of Directive 2001/82/EC initiated by an applicant or marketing authorisation holder.

The fee is independent of the number of applications or marketing authorisations held by a specific applicant or marketing-authorisation holder and is independent of the number of pharmaceutical forms, dosages or presentations.

When more than one applicant or marketing-authorisation holder is involved, they can either group themselves or participate individually. For applicants or marketing-authorisation holders who are grouping, irrespective of the group or company affiliation, one fee, if applicable, should be paid per group. In such cases, a group representative needs to be designated and a letter of representation needs to be submitted by each of the other members of the group to the Agency.

The Agency will issue an invoice and fees will be payable in Euros within 45 calendar days of the date of the start of the procedure. The invoice is sent to the billing address indicated by the applicant or marketing-authorisation holder, and will contain clear details of the product and procedures involved, the bank account where the fee should be paid and the due date for payment.

References:

7. Can I be represented by another party in the referral procedure?

As a general rule, an applicant or marketing-authorisation holder can be represented by another party provided that the applicant or marketing authorisation holder submits a letter of representation.

Applicants and marketing-authorisation holders can also group themselves for the purpose of the procedure, irrespective of group or company affiliation, in order to provide a single consolidated answer or oral clarifications to the questions raised by the CVMP. In such cases, the Agency requests that a group representative be designated. Each member of the group (including the legal entity representing the companies who choose to group) must submit a letter of representation to the Agency.

If the applicant or marketing-authorisation holder wishes to be represented by another party, the letter of representation will have the consequence that within the framework of the referral procedure, all documentation concerning the referral 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 applicant or marketing-authorisation holder inter alia for the purposes of calculating the procedural timelines. The contact person will be responsible for forwarding any documents to the individual members of the group.

It is the responsibility of the applicants and marketing-authorisation holders to notify the Agency of any changes that might affect the letter of representation (e.g. a change in the group) as soon as possible and provide relevant additional or revised letters of representation where needed.

8. What is the timetable for the referral procedure?

It should be emphasised that the interim timelines provided below are given as a rough guidance for the key steps in the referral procedure. The CVMP can adopt a different timetable in order to reflect the peculiarities of a referral or to accommodate the interest of the company when needed. The Agency and the CVMP, however, endeavour to not exceed the overall timeframe provided in the legislation.

Referrals under Articles 33(4), 34, 35 and 40 of Directive 2001/82/EC and Article 13 of Regulation (EC) No 1234/2008 initiated by a Member State or the European Commission

Day 0Notification of a referral to the CVMP and Agency secretariat
Day 1

First CVMP meeting following notification of referral. The CVMP discusses the questions referred during the plenary meeting. A rapporteur and a co-rapporteur are appointed.

Adoption of CVMP list of questions to be addressed by the applicants and marketing-authorisation holders and timetable.

Clock stopFor the applicants and marketing-authorisation holders to prepare the responses to the CVMP list of questions.
Day 2
(clock re-start)
Following submission of responses and, if applicable, including the proposed English summary of product characteristics (SmPC), labelling and package leaflet.
Day 20The (co-)rapporteur circulates the assessment report on the applicant's or marketing authorisation holder’s written responses and, if applicable, with the draft SmPC, labelling and package leaflet annexed to the opinion2.
Day 25Co-rapporteur’s critique3 and comments from CVMP members on the assessment report and proposed SmPC, labelling and package leaflet (if applicable).
Day 30

Discussion at the CVMP:

  • Discussion of assessment report, co-rapporteur’s critique2 and comments received from CVMP members;
  • Decision on need for oral explanations;
  • Adoption of CVMP list of outstanding issues to be answered in writing and in an oral explanation, if needed.
Clock stopIf necessary, for the preparation and submission of written explanations and preparation of oral explanations.
Day 31
(clock re-start)
If necessary, during the CVMP meeting following the submission of written explanations (in accordance with the recommended submission date) and at the time of oral explanations.
Day 45

The (co-)rapporteur circulates revised assessment report:

  • Following CVMP discussion on the draft rapporteur’s assessment report, co- rapporteur’s critique2 and comments received from CVMP members, or
  • Following the applicant’s or marketing authorisation holder’s response to the CVMP list of outstanding issues.
Day 60 Adoption of the CVMP opinion with its annexes, as per Article 36 of Directive 2001/82/EC.

Referrals under Article 34 and 35 of Directive 2001/82/EC initiated by an applicant/marketing authorisation holder

Day 0

Notification of a referral to the CVMP and Agency secretariat.

The Agency liaises with the applicant or marketing-authorisation holder to ensure that the relevant documentation is submitted to the Agency and CVMP.

Day 1First CVMP meeting following notification of referral, provided that relevant documentation has been submitted by the applicant or marketing-authorisation holder in advance of the start of the procedure. The CVMP discusses the questions referred during the plenary meeting. The rapporteur and co-rapporteur are appointed and the timetable is adopted. No CVMP list of questions is adopted.
Day 20The rapporteur circulates assessment report on the applicant/marketing authorisation holder’s submission and, if applicable, comments on the proposed SmPC, labelling and package leaflet.
Day 25Co-rapporteur’s critique and comments from CVMP members on the rapporteur’s assessment report and proposed product information (if applicable).
Day 30

Discussion at the CVMP:

  • Discussion of assessment report, co-rapporteur’s critique and comments received from CVMP members;
  • Decision on need for oral explanations;
  • Adoption of CVMP list of outstanding issues to be answered in writing and in an oral explanation, if needed.
Clock stopIf necessary, for the preparation and submission of written explanations and preparation of oral explanations.
Day 31
(clock re-start)
If necessary, during the CVMP meeting following the submission of written explanations (in accordance with the recommended submission date) or at the time of oral explanations.
Day 45

The rapporteur circulates the revised assessment report:

  • Following CVMP discussion on the draft rapporteur’s assessment report, co-rapporteur’s critique2 and comments from CVMP members, or
  • Following the applicant’s or marketing authorisation holder’s response to the CVMP list of questions.
Day 60Adoption of the CVMP opinion with its annexes, as per Article 36 of Directive 2001/82/EC.

2 In case of Article 33(4) referrals the co-rapporteur also circulates a separate assessment report at day 20.
3 Not applicable to Article 33(4) referrals.

The timelines in the tables above refer to active days, i.e. they correspond to the actual time in calendar days that the CVMP takes to assess the data provided. The clock stop is the time given to applicants and marketing-authorisation holders to prepare the responses to the list of questions and list of outstanding issues, or to prepare for the oral explanation.

Following the assessment of answers to the CVMP list of questions, if the CVMP considers there to be issues that need further clarification, the CVMP can adopt a CVMP list of outstanding issues to be addressed in writing or in an oral explanation.

For referrals under Articles 34 and 35 of Directive 2001/82/EC, the timetable may be extended allowing a total of 150 active days (60 days with a possibility of extension for a further period of up to 90 days). For referrals under Article 33(4) an opinion must be reached by day 60.

In general, the time given to the applicants and marketing-authorisation holders to answer the CVMP list of questions/list of outstanding issues should not exceed 3 months. The period for answering the list of outstanding issues should not exceed 2 months.

However, the applicants and marketing-authorisation holders may make a request to the CVMP for an extension to answer the list of questions or the list of outstanding issues. The request must be duly justified. When several applicants or marketing-authorisation holders are involved in a referral procedure, and where a request from one or more marketing authorisation holders to extend the timeframe to answer the CVMP list of questions/list of outstanding issues is accepted by the Committee, the timetable for the whole procedure and for all applicants and marketing-authorisation holders is extended. The other applicants and marketing-authorisation holders involved in the procedure will be informed accordingly. In general, the CVMP can grant a maximum of 3 months' extension of the clock stop for responding to the list of questions or 2 months to respond to outstanding issues.

The CVMP can decide to have very short timetables depending on the nature of the issue raised in the referral, or the need to have an outcome as early as possible (Article 36(1) of Directive 2001/82/EC). Without prejudice to the relevant legal provision, the timetable is in any case at the discretion of the CVMP.

For referrals under Article 34 or 35 of Directive 2001/82/EC that are initiated by an applicant or marketing-authorisation holder, the procedure starts with an evaluation performed by the rapporteur and co-rapporteur and there is no a list of questions as a starting point. The marketing-authorisation holder will provide the full dossier prior to day 1 (i.e. with the notification). Issues identified further to the evaluation of the referral dossier will be part of the list of questions at day 30.

9. How are the rapporteur and co-rapporteur appointed for the procedure?

A rapporteur and a co-rapporteur are appointed from amongst the members of the CVMP (including co-opted CVMP members) or CVMP alternate members. In case of a class referral or a referral concerning several issues to be assessed, the CVMP may consider it appropriate to have more than one co-rapporteur.

Reference:

During the referral procedure

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10. Do I have to submit answers to the CVMP list of questions or to the list of outstanding issues?

There is no legal obligation to submit written answers or to present oral explanations to the CVMP.

The CVMP will, in any case, adopt an opinion addressed to all applicants and marketing-authorisation holders included in the referral, independently of whether or not the applicants and marketing authorisation holders provided comments in the context of the opportunity to present written or oral explanations under Article 36(3) of Directive 2001/82/EC.

Reference:

11. How shall I present the documentation to the CVMP?

Referrals under Articles 33(4), 34, 35 and 40 of Directive 2001/82/ECand Article 13 of Regulation (EC) No 1234/2008 initiated by a Member State or the European Commission

The procedure starts with the adoption of a list of questions to be answered by the applicants or marketing-authorisation holders in a specific timeframe. The answers should be numbered according to the numbering on the CVMP list of questions or list of outstanding issues. The answers should be presented in two parts as described below:

Section I

Section I should contain an introduction, a written summary answering each question, a conclusion and a proposed summary of product characteristics, labelling and package leaflet (if requested).

In case of grouping, it is understood that the answers are provided by the designated contact person on behalf of the applicants and marketing-authorisation holders, as identified in the letter of representation received at the start of the procedure.

The applicants and marketing-authorisation holders are requested to provide a table listing all the studies referred to in the answers. For published studies, reference to the publication should be made. For each unpublished study, a clear statement should be provided indicating whether a detailed description of the study and its results cannot be released to the public in accordance with the relevant principles of law governing transparency and the protection of commercially confidential information. Applicants and marketing-authorisation holders should be aware that a brief summary of each study may nevertheless be included in the overall summary of the assessment, which will be published. The assessment of the responses provided by applicants and marketing-authorisation holders who have grouped themselves will be shared with the companies in the group.  

In case of referrals involving many products, some questions (e.g. on a specific pharmaceutical form) may not be applicable or relevant to some products or to the products of the group that someone represents. In such cases, the response provided should be “not applicable” and a short explanation should be provided.

Section II

Section II should contain the supportive documentation (e.g. protocols, study reports and literature) organised by quality, safety, residue, pre-clinical and clinical data and post-marketing experience as applicable.

Published data can be submitted in support of your own data or if you do not possess your own data (for instance data resulting from clinical trials) submitted in response to a specific question.

Referrals under Article 34 and 35 of Directive 2001/82/EC initiated by the applicant/marketing authorisation holder

In these referrals the evaluation starts with the data submitted by the applicant or marketing-authorisation holder.

For an Article 34 referral, the marketing authorisation holder should submit the relevant available evidence to support the harmonisation or identified divergences to the Agency and CVMP members prior to the start of the procedure.

For an Article 35 referral, the applicant or marketing-authorisation holder should submit all available evidence to support the matter referred at the start of the procedure. It is left to the applicant’s or marketing-authorisation holder’s discretion to decide the relevant documentation necessary to evaluate the matter referred. In any case it should be accompanied by an expert report.

References:

12. To whom shall I submit my answers?

The responses to the CVMP’s list of questions or list of outstanding issues should be sent to the rapporteur, the co-rapporteur, all remaining members of the CVMP (including co-opted members) and to the Agency by the deadline given in the cover letter to the list of questions or list of outstanding issues.

The responses should be submitted in the following number of copies and accompanied by signed cover letter:

To the rapporteur/co-rapporteur(s):

One paper copy, one CD-R/DVD-R or by e-mail.

To the remaining CVMP members:

A copy of the responses should also be sent to the remaining CVMP members according to their individual dossier requirements as indicated in this document:

For electronic submission, applicants and marketing-authorisation holders should make clear in the cover letter that full paper copies of all answers (including annexes and appendices) will be available within 48 hours upon request.

Please note that the data provided on CD-R/DVD-R should contain exactly the same documents as the paper copy and must be in a Microsoft Word format or other searchable electronic format and should not require installation of specific encrypting software.

To the Agency:           

One paper copy, one CD-R/DVD-R or by e-mail 

Please note that e-mail submission of responses to the Agency should be sent to vet.applications@ema.europa.eu.

Paper submissions or CD-R/DVD-R should be sent to:

Veterinary Applications
Veterinary Medicines Sector
European Medicines Agency
7 Westferry Circus, Canary Wharf
London E14 4HB
United Kingdom

References:

13. Will I have the possibility to present my views at an oral explanation?

In accordance with Article 36(3) of Directive 2001/82/EC, before issuing its opinion, the CVMP will provide the applicant or marketing-authorisation holder with an opportunity to present written or oral explanations.

The Committee will normally request an oral explanation if it considers there to be outstanding issues that need to be addressed orally by the applicants or marketing-authorisation holders.

The applicants or marketing-authorisation holders will normally be informed one month in advance of the date of the oral explanation and of which issues will need to be addressed.

Even if the CVMP has not indicated that an oral explanation is necessary, applicants and marketing-authorisation holders may, upon request, be given the opportunity to provide an oral explanation to the CVMP. This request should be sent to the Agency with the submission of the response to the list of questions or list of outstanding issues. Alternatively the request for an oral explanation can be submitted at the latest by the start of the CVMP meeting prior to the one at which the CVMP opinion on the referral is due.

Reference:

14. How is an oral explanation for a referral organised?

See guidance to applicants / marketing authorisation holders on oral explanations at CVMP.

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

If the application or marketing authorisation for a veterinary medicinal product is withdrawn or transferred during the referral procedure, the former applicant or marketing-authorisation holder 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 withdrawal of the application or marketing authorisation, the Agency will inform the former applicant or marketing-authorisation holder that the specific product will no longer be included in the ongoing referral. As a consequence, the applicant or marketing-authorisation holder will not be contacted further during the procedure regarding that specific product.

Following confirmation by the national competent authority of the transfer of an application or marketing authorisation for a product, the Agency will inform the new applicant or marketing-authorisation holder that they are included in the referral and will inform the former applicant or marketing-authorisation holder that they will no longer be contacted regarding that specific product. The Agency will ask the new applicant or marketing-authorisation holder to submit, if appropriate, an updated letter of representation and information on the new contact person for the referral (see question 11).

By withdrawing an application or marketing authorisation, the referral cannot be avoided. Once the referral is initiated, the referral can only be stopped if applicants or marketing authorisation holders withdraw the applications and marketing authorisations concerned in all EU and EEA Member States.

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

If the name of a veterinary medicinal product changes during the referral procedure, the applicant or marketing-authorisation holder should inform the Agency. The Agency will then liaise with the national competent authority of the Member State concerned to confirm this information.

Following confirmation by the national competent authority of the change of the name of the product, the Agency will inform the applicant or marketing-authorisation holder that the change in the name of the product has been noted.

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

If the name or address of an applicant or marketing-authorisation holder changes during the referral procedure, the applicant or marketing-authorisation holder should inform the Agency. The Agency will then liaise with the national competent authority of the Member State concerned to confirm this information.

Following confirmation by the national competent authority of the change of name or address, the Agency will inform the applicant or marketing-authorisation holder that the change has been noted.

18. How does the referral affect ongoing national and mutual-recognition procedures for products included in the referral?

Questions regarding how a referral affects national and mutual-recognition procedures need to be directed to the national competent authority or reference Member State.

During a referral procedure and until the Commission Decision on the referral is issued, the responsibility for granting or amending a marketing authorisation or taking any other regulatory action lies with each Member State.

The CVMP opinion

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19. What will the opinion of CVMP be?

The CVMP opinion on a referral procedure may recommend:

  • the granting of a marketing authorisation;
  • the refusal of the granting of a marketing authorisation;
  • variation to the terms of the marketing authorisation;
  • the suspension of a marketing authorisation;
  • the withdrawal of a marketing authorisation.

 

20. What is the basis of the CVMP opinion?

In order for the CVMP to make recommendations, the CVMP considers all available data in relation to the matters referred to. The CVMP can take into account, where relevant, quality, safety, residue, pre-clinical and clinical data (including data from clinical trials and pharmacovigilance data) and published literature. This data can be provided by the applicants/marketing authorisation holders and/or by the national competent authorities of Member States or the Agency. In certain cases, the CVMP can also consult experts in specific fields (e.g. through CVMP ad-hoc expert groups or scientific advisory groups).

21. How is the CVMP opinion structured?

The CVMP opinion on a referral procedure includes the following:

  • Opinion page – Stating the legal basis for the referral, the scope and the CVMP recommendation;
  • Annex I – List of names of the veterinary medicinal products and applicants and marketing-authorisation holders concerned by the referral procedure including product information (e.g. strength, pharmaceutical form, animal species, recommended dose, route of administration and withdrawal period, if relevant). This list will be sorted by Member State, including Norway and Iceland;
  • Annex II – Scientific conclusions and grounds for the granting, or refusal of the granting, of a marketing authorisation, a variation to the terms of the marketing authorisation, the suspension or the withdrawal of a marketing authorisation. Annex II will include a summary of the data made available and conclusions on quality, safety and/or efficacy (where relevant) and the grounds for the recommendation given by CVMP;
  • Annex III – English summary of product characteristics (SmPC), labelling and package leaflet (if applicable). If the CVMP recommends granting a marketing authorisation or varying the terms of the marketing authorisation, a harmonised SmPC, labelling and package leaflet should be annexed to the CVMP opinion. Such product information will be applicable to all products concerned by the referral. The product information should be in accordance with the guideline on SmPCs and Quality Review of Documents (QRD) templates. In those cases where certain sections of the product information cannot be harmonised (mainly the pharmaceutical particulars) the following sentence is included: “To be completed nationally”;
  • Annex IV – Conditions of the marketing authorisations (if applicable).

The Annexes to the CVMP opinion will be included in the Commission decision.

In addition to the Annexes, the CVMP opinion also includes appendices (e.g. the official referral notification to the CVMP, the CVMP assessment report and the divergent positions, if applicable), which will not be part of the Commission decision.

References:

22. When do I have to submit translations?

Only the English language version of the summary of product characteristics (SmPC), labelling or package leaflet needs to be provided at submission1.

Translations of the adopted annex I (list of products) and annex III (SmPC, labelling and package leaflet text) in all other EU languages (including Icelandic and Norwegian) are to be provided electronically (in one Eudralink package) to the Member State contact points for translations by day +5 (5 days after adoption of the CVMP opinion) and copied to the Agency (vet.translations@ema.europa.eu).

The following checks will apply:

Check byWhenWhoScope
Member StateDays +5 to +19Member StatesDetailed review of all translations
Product Information QualityDays +22 to +27AgencyReview of implementation of Member States’ comments


Comments will be sent directly by the Member States to the marketing authorisation holder at the latest by day +19, with a copy to the Agency (vet.translations@ema.europa.eu).

The marketing-authorisation holder will send the final translations with tracked changes, incorporating the Member States’ comments, electronically to the Agency (vet.translations@ema.europa.eu) by day +22.

The Agency will check if all Member States’ comments have been implemented before sending the final translations to the European Commission. In order to facilitate and accelerate the check of the implementation of the Member States’ comments, the marketing authorisation holder should indicate in QRD Form 2 for each language whether all comments have been implemented or not. In the latter case, a justification should be provided for the appropriate languages stating why certain comments are not reflected in the final texts. Such justifications or alternative proposals should be discussed and agreed with the relevant Member States before submitting final translations to the Agency.

Poor quality translations, poor implementation of Member States’ comments or absence of a completed QRD Form 2 may lead to a delay in transmission to the European Commission.

Following receipt of the final translations of the product information (annex III), list of products (annex I), scientific conclusions (annex II) and conditions (annex IV) from the Agency, the Commission will start the 22-day Standing Committee consultation, addressing only legal and public health matters, which means in principle no further linguistic revie).
 

1 For referrals according to Article 35(2) of Directive 2001/82/EC this may be limited to specific parts of the product information only.

23. What happens after the CVMP opinion?

Once the CVMP opinion is adopted, the Agency sends the CVMP opinion and the CVMP assessment report to all applicants and marketing-authorisation holders concerned by the referral procedure. If the applicants or marketing-authorisation holders do not agree with the CVMP opinion they have the possibility to request a re-examination.

Re-examination procedure

Within 15 days of the receipt of the CVMP opinion the applicants, marketing-authorisation holders or representatives of the group may notify the Agency of their intention for a re-examination. In such cases, the detailed grounds for re-examination should be sent to the Agency within 60 days of receipt of the opinion. New rapporteurs will be appointed and within 60 days of receipt of the grounds for re-examination the CVMP considers the grounds and adopts a final opinion.

Final opinion

Within 15 days of its adoption, the Agency forwards the final opinion of the CVMP to the Member States, the European Commission and applicants and marketing-authorisation holders. The Annexes to the opinion, including the product information are sent in all official languages of the EU.

Decision making procedure

After submission of the final opinion (including translations of the annexes) to the European Commission, the European Commission starts the Community decision-making procedure. Within 15 days of the receipt of the opinion, the Commission prepares a draft decision. The draft decision is forwarded to the Member States (in their own language) and to the applicants and marketing-authorisation holders. The Standing Committee on Medicinal Products for Veterinary Use is then consulted and allowed at least 22 days to send any written observations to the European Commission. Member States may forward written comments during the written procedure i.e.

  • Member States may ask in writing, duly stating the reasons, for the draft decision to be considered at a Standing Committee meeting. In this case, the Commission closes the written procedure with no result, and calls a Committee meeting as soon as possible. Where the opinion of the Standing Committee is in disagreement with the CVMP Opinion, the procedure will be suspended and referred back to the Agency and CVMP for further consideration;
  • If in the opinion of the European Commission the written observations of a Member State raise important new questions of a scientific or technical nature that have not been addressed in the opinion of the CVMP, the procedure will be suspended and referred back to the Agency and CVMP for further consideration.

Otherwise, the European Commission will take a final decision within 15 calendar days after the end of the Standing Committee phase.

Once the Commission Decision is adopted, it is addressed to the Member States and communicated to the applicants and marketing-authorisation holders for information. The Member States are required to grant, revoke, suspend or withdraw the marketing authorisations or vary the terms of the marketing authorisations as necessary to comply with the Commission Decision within 30 days of its notification. As the Commission Decision is addressed to all Member States, the decision is also transmitted to the Member States not involved in the referral procedure for information.

The national competent authorities are responsible for the implementation of the Commission Decision and future procedures affecting the products involved in the referral.

References:

24. Will there be any publication in relation to the referral?

The start of the referral will be reported in the CVMP press release which is published on the Agency's website. The grounds for initiating the referral will be briefly mentioned as well as the veterinary medicinal products or active substances concerned by the referral.

At the adoption of the CVMP opinion, the referral will be reported in the CVMP press release and CVMP monthly report, which are published on the Agency's website. The active substances concerned, the background and the outcome of the referral will be briefly mentioned. If the Agency considers that a specific public statement is necessary, it might be published at the opinion stage.

Once the European Commission has issued and published the Commission Decision on the referral, the Agency publishes a document giving the background information on the referral, the scientific conclusions reached, the list of products included in the referral, the product information and any conditions to the marketing authorisations as adopted by the CVMP.

References:

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