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 has also been updated 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)

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 is applicable since 28^th January 2022.

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

The table below lists the documents for which a public consultation was performed. Comments provided by stakeholders were evaluated by CMDv and were taken into consideration if appropriate. Please find respective information below the table.

N°	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
20	BPG for parallel trade in veterinary medicinal products	28/03/2022	28/04/2022
21	BPG for the submission of high quality national translations for veterinary medicines	28/03/2022	28/04/2022
22	BPG for classification of a product or group of products	29/03/2022	28/04/2022