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
14 BPG for changing the reference member state 15/11/2021 15/12/2021
15 BPG for handling marketing authorisations for veterinary medicinal products intended for limited markets (national, mutual recognition and decentralised procedures) 15/11/2021 15/12/2021
16 BPG for validation of applications 15/11/2021 15/12/2021
17 BPG for handling applications for marketing authorisations for veterinary medicinal products in exceptional circumstances (national, mutual recognition and decentralised procedures) 13/12/2021 20/01/2022
18 BPG for the CMDv tasks related to Pharmacovigilance 14/12/2021 20/01/2022
19 BPG for the processing of SPC, Labelling and Package leaflet and the preparation of Multilingual/-country Packaging provided in support of MRP/DCP/SRP and Variations 17/12/2021 28/01/2022

Ongoing public consultations

Best Practice Guide for the processing of SPC, Labelling and Package leaflet and the preparation of Multilingual/-country Packaging provided in support of MRP/DCP/SRP and Variations

Best Practice Guide for the CMDv tasks related to Pharmacovigilance

Best Practice Guide for handling applications for marketing authorisations for veterinary medicinal products in exceptional circumstances (national, mutual recognition and decentralised procedures)

Closed public consultations

Best Practice Guide for changing the reference member state

Best Practice Guide for handling marketing authorisations for veterinary medicinal products intended for limited markets (national, mutual recognition and decentralised procedures)

Best Practice Guide for validation of applications

Best Practice Guide for variations not requiring assessment

Best Practice Guide for variations requiring assessment

Best Practice Guide for worksharing

Best Practice Guide for DCP

Best Practice Guide for MRP

Best Practice Guide for SRP

Recommendation on duplicate applications in MRP/DCP

Best Practice Guide for Informed consent for MRP, SRP and DCP

Best Practice Guide for Contact with representative organisations

Best Practice Guide for the selection of the products for the SPC harmonisation

Best Practice Guide for the harmonisation procedure of the SPC of the reference products

Best Practice Guide for the harmonisation procedure of the SPC of generic/hybrid veterinary medicinal products

Best Practice Guide for Re-examination of RMS assessment report procedure

Overview of comments

Overview of comments - Best Practice Guide for Re-examination of RMS assessment report procedure

Overview of comments - Best Practice Guide for variations not requiring assessment

Overview of comments - Best Practice Guide for variations requiring assessment

Overview of comments - Best Practice Guide for worksharing

Overview of comments - Best Practice Guide for the selection of the products for the SPC harmonisation

Overview of comments - Best Practice Guide for the harmonisation procedure of the SPC of the reference products

Overview of comments - Best Practice Guide for the harmonisation procedure of the SPC of generic/hybrid veterinary medicinal products