CMDv Q&A (Question and answers)

Questions on regulatory matters may be asked to CMDv, via this hyperlink

CMDh list of Questions and Answers related to the submission of variations according to Commission Regulation (EC) 1234/2008 (December 2009) - click link

General questions

Where can guidance and recommendations in relation to the implementation of the new legislation be found?

For general regulatory guidance on the interpretation and implementation of the new pharmaceutical legislation, please refer to the Notice to Applicants, where updated guidance will be published by the European Commission.
http://pharmacos.eudra.org/F2/eudralex/vol-6/home.htm
Mutual recognition procedures (MRP) for new applications, multiple applications, extensions and repeat use applications submitted before the date of entry into force of the new legislation, but with day 90 after 30 October 2005

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If a MRP starts before the date of entry into force of the new legislation, but day 90 is after 30 October 2005, and a Member State cannot approve the assessment report or the SPC on the grounds of potential serious risk to human or animal health or the environment, will it still be possible to withdraw the application from the disagreeing Member States or will the points of disagreement be referred to the coordination group for the 60 days procedure?

For MRP started before the date of entry into force of the new legislation but with day 90 after 30 October 2005, applicants can still withdraw the application from the disagreeing Member State(s) to avoid a referral to the coordination group, provided the withdrawal is done before 30 October 2005. After 30 October 2005 the point(s) of disagreement will be referred to the coordination 2 VMRF/456/05
group for the 60 days procedure, regardless of whether the application has or not been withdrawn from the disagreeing Member State(s).

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If a CVMP referral procedure is triggered after 30 October 2005 for MRP started before the date of entry into force of the new legislation, will the Member States that have approved the assessment report and the draft SPC of the reference Member State be able to authorise the medicinal product without waiting for the outcome of the procedure, in accordance with Article 33(6) of Directive 2001/82/EC, as amended?

Yes. The Member States that have approved the assessment report and the draft summary of product characteristics of the reference Member State may, at the request of the applicant, authorise the medicinal product without waiting for the outcome of the CVMP referral procedure. However, the authorisation granted shall be without prejudice to the outcome of the referral procedure.

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Will MRPs started before the date of entry into force of the new legislation, but with day 90 after 30 October 2005, result in harmonised labelling and PL?

Applicants are reminded that the new legislation is effective from the date of entry into force. The harmonisation of the PL and labelling will apply to all applications for marketing authorisation authorised after 30 October 2005 via the mutual recognition or decentralised procedures. Applicants should provide justification for any plans for future harmonisation based on the status and timing of the pending application at 30 October. Applicants are advised to discuss how to follow the new legislation with the RMS.

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What should be the procedure to harmonise the labelling and PL of a MR medicinal product where the repeat-use procedure is to be used after 30 October 2005?

The recommendation of the VMRFG is that the harmonisation of the labelling and PL of a veterinary medicinal product should be achieved using a Type II variation before the start of the repeat-use MRP. For repeat use procedures started before 30 October 2005, applicants should provide justification for any plans for future harmonisation based on the status and timing of the pending application at 30 October. Applicants are advised to discuss how to follow the new legislation with the RMS.

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Will there be any transitional period for the harmonisation of the labelling and PL of medicinal products authorised via MRP before 30 October 2005?

The recommendation of the VMRFG is for Marketing Authorisation Holders to harmonise the labelling and PL of existing medicinal products as early as possible (e.g. on the occasion of a major variation or renewal procedure) and to contact the RMS in this regard.

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What should be the procedure for the harmonisation of the labelling PL for renewals finalised after 30 October 2005?

Applicants are reminded that the new legislation is effective from the date of entry into force. The harmonisation of the PL and labelling will apply for products renewed after 30 October 2005 via 3 VMRF/456/05 the mutual recognition procedure, even if the procedure is started before this date. However, if for renewal procedures started before 30 October 2005 and finalised after this date it is not feasible to obtain harmonised labelling at the end of the procedure, MAHs may provide justification for any plans for future harmonisation based on the status and timing of the pending renewal at 30 October. .

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In accordance with Article 25(4) of Directive 2001/82/EC, as amended, the competent authority shall make publicly accessible without delay the assessment report (AR), together with the reasons for its opinion, after deletion of any information of a commercially confidential nature. Will the assessment report for all MRPs with day 90 after 30 October 2005 be publicly available? If so, where will assessment reports be published?

The VMRFG has agreed to make publicly available the AR for veterinary medicinal products submitted via the mutual recognition or decentralised procedure, with day 90 after 30 October 2005. The public AR in English will be available on request from the RMS. Public ARs will also be published on the HEVRA website (www.hevra.org) as soon as the site is able to accommodate them. The publication of ARs in the national languages is the decision and responsibility of national competent authorities.

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In accordance with Article 28(2) of Directive 2001/82/EC, as amended, marketing authorisation holders will have to submit the renewal application at least six months before the marketing authorisation ceases to be valid. Will this requirement be only applicable after the date of entry into force of the new legislation and therefore only for marketing authorisations with a renewal date as of 1 May 2006?

Yes. The six-month period for the submission of the renewal application is only applicable for marketing authorisations with a renewal date after 1 May 2006. For marketing authorisations with a renewal date before 1 May 2006, the renewal application should be submitted at least 3 months before the renewal date

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