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01/03/2022

Post MA

Once the marketing authorisation has been granted, the holder must update the manufacturing methods and control techniques mentioned in the pharmaceutical dossier in the light of technical and scientific progress. This is done through the submission of applications for variations to MAs, renewal...

Variations

Variations may be made to the MA granted to a marketing authorisation holder for a proprietary medicinal product. These are changes to the information of the dossier submitted in the initial application of the MA. 

With the entry into force of Regulation 2019/6, type IA, IB and II variations are deleted. Now two types of variation: with or without evaluation exist. Variations without evaluation become simple declarations: the list of variations that do not require an evaluation shall be determined by delegated act. This list contains the conditions to be fulfilled and the documentation to be provided, as well as a code for each variation.
Regulation 1234/2008 and the 2003 Guideline Classification will now only apply to medicinal products for human use.
The list of variations without evaluation is set out in Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations that do not require an assessment, in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council. 
CMDv completed the list and classification of variations requiring an assessment with a guideline: Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations. 

For variations without evaluation (Article 61), the Regulation provides that registrants will enter them directly into the medicinal products database within 30 days of their implementation. The competent authorities may then accept or reject the variation in the database and update their MA where necessary. The SPC, labelling and package leaflet shall be provided by the MA holder at the beginning of the procedure and stored in the database at the end of the procedure.

Grouping/supergrouping is not possible for variations without evaluation. 

MA variations requiring scientific evaluation correspond to all variations that are not listed in the EC Delegated Act. There will be no list of these variations, therefore no codification, documentation or conditions to be complied with. 

It will always be possible to group variations between them. It will therefore be possible to submit an application for several variations relating to the same marketing authorisation or for one variation relating to more than one MA. On the other hand, the Regulation does not state whether it is possible to group several variations for several MAs.

As regards worksharing (allocation of tasks — Article 65), the EC may, if it so wishes, lay down the detailed rules for this procedure by means of an implementing act. 
The BPG of the CMDv is considered sufficient to describe this procedure.

The schedule of variations with evaluation is 60 days (can be extended to 90 days). It shall be suspended in the event of a request for additions. In case of disagreement, the procedure described in Article 54 applies (Re-examination).The applicant has the possibility, as in the case of a decentralised procedure, to request a re-examination of the RMS report.

At the end of the procedure, MS have 30 days to notify their decision after the receipt of the translations by the MA holder. The database produced must also be updated accordingly by the MS.
The holder may implement the variation only once the decision has been notified. The competent authority must set a deadline for the implementation of this variation.

The guidelines of the Coordinating Group on Mutual and Decentralised Recognition Procedures — Veterinary (CMDv) on MA variations can be found on this page: CMDv- Variations.

To apply for authorisation for a veterinary medicinal product

Worksharing procedure

As regards worksharing (allocation of tasks — Article 65), the EC may, if it so wishes, lay down the detailed rules for this procedure by means of an implementing act. 

The BPG of the CMDv is considered sufficient to describe this procedure.

This note also details the steps to be followed before submitting a worksharing request to CMDv. It should be noted that now the first step is to be carried out with the RMS in order to determine the classification of the variations, the schedule, the RMS informs the CMDv and the CMS of the worksharing procedure. 


Documents relating to this procedure are available on the CMDv website


To apply for authorisation for a veterinary medicinal product