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: CMDvnoSpam@noSpamema.europanoSpam.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

5BPG for DCP20/09/202129/10/2021
6BPG for MRP20/09/202129/10/2021
7BPG for SRP20/09/202129/10/2021
8Recommendation on duplicate applications in MRP/DCP20/09/202129/10/2021
9BPG for Informed consent for MRP, SRP and DCP20/09/202129/10/2021
10BPG for Contact with representative organisations20/09/2021

29/10/2021

11BPG for variations not requiring assessment11/10/202111/11/2021
12BPG for variations requiring assessment11/10/202111/11/2021
13BPG for worksharing11/10/202111/11/2021
14BPG for changing the reference member state15/11/202115/12/2021
15BPG for handling marketing authorisations for veterinary medicinal products intended for limited markets (national, mutual recognition and decentralised procedures)15/11/202115/12/2021
16BPG for validation of applications15/11/202115/12/2021
17BPG for handling applications for marketing authorisations for veterinary medicinal products in exceptional circumstances (national, mutual recognition and decentralised procedures)13/12/202120/01/2022
18BPG for the CMDv tasks related to Pharmacovigilance14/12/202120/01/2022
19BPG for the processing of SPC, Labelling and Package leaflet and the preparation of Multilingual/-country Packaging provided in support of MRP/DCP/SRP and Variations17/12/202128/01/2022
20BPG for parallel trade in veterinary medicinal products28/03/202228/04/2022
21BPG for the submission of high quality national translations for veterinary medicines28/03/202228/04/2022
22BPG for classification of a product or group of products29/03/202228/04/2022

Ongoing public consultations

Currently no ongoing public consultation

Closed public consultations

(Please find below the versions published before the introduction of comments received during public consultation.)

Best Practice Guide for classification of a product or group of products

Best Practice Guide for parallel trade in veterinary medicinal products

Best Practice Guide for the submission of high quality national translations for veterinary medicines

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)

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 parallel trade in veterinary medicinal products

Overview of comments - Best practice guide for Informed consent for MRP, SRP and DCP

Overview of comments - 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

Overview of comments - Best Practice Guide for validation of applications

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

Overview of comments - Best practice guide for the CMDv tasks related to pharmacovigilance

Overview of comments - Best Practice Guide for MRP

Overview of comments - Best Practice Guide for SRP

Overview of comments - Best Practice Guide for Contact with representative organisations

Overview of comments - Best Practice Guide for DCP

Overview of comments - Guidance for duplicate applications in MRP/DCP

Overview of comments - Best Practice Guide for changing the reference member state

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

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