Implementation of the VMP Regulation

Q&A on transitional arrangements

CMDv has prepared a Q&A document in order to assist both MAHs and NCAs in the management of the transition between the requirements of Directive 2001/82/EC and Regulation (EU) 2019/6.
Several items are developed in this document as renewals, update of QRD templates and transition from PSUR to signal management.
This document will be updated as required with new developments for instance the transition from the DDPS to the PSMF.

Additional information:
EMA: Q&A on renewals (link)
EMA: publication of version 9 of the QRD templates (link)
EC: Commission Notice on marketing authorisations for veterinary medicinal products for which the expiry of the 5-year period of validity falls on or after the date of entry into application of Regulation (EU) 2019/6 2021/C 274/02 (link)

 

Call for contributions to the public consultation on the best practice guides of the CMDv updated or newly prepared due to the implementation of the Regulation 2019/6 (EC)

The Regulation 2019/6 (EC) was published in January 2019 (Official Journal 7.1.2019) and will be applicable from the 28th January 2022.

The CMDv is seeking feedback on its best practice guides newly prepared or updated due to the implementation of this Regulation.

The table below is the list of the documents for which comments will be welcomed as well as the dates of the end of the public consultations.

You are invited to consult regularly this page as more documents will be added to this list.

The CMDv strongly recommends that comments are made by e-mail to the CMDv secretariat at EMA at the following e-mail address: cmdv@ema.europa.eu

 

Name of the document

Date of release for public consultation

Deadline for comments

1

BPG for selection of product for SPC harmonisation

29/05/2021

29/06/2021

2

BPG for SPC harmonisation of the reference product

29/05/2021

29/06/2021

3

BPG for SPC harmonisation of generics/hybrids

29/05/2021

29/06/2021

4

BPG for the re-examination procedure

29/05/2021

29/06/2021

5 BPG for DCP 20/09/2021 29/10/2021
6 BPG for MRP 20/09/2021 29/10/2021
7 BPG for SRP 20/09/2021 29/10/2021
8 Recommendation on duplicate applications in MRP/DCP 20/09/2021 29/10/2021
9 BPG for Informed consent for MRP, SRP and DCP 20/09/2021 29/10/2021
10 BPG for Contact with representative organisations 20/09/2021

29/10/2021

11 BPG for variations not requiring assessment 11/10/2021 11/11/2021
12 BPG for variations requiring assessment 11/10/2021 11/11/2021
13 BPG for worksharing 11/10/2021 11/11/2021