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.
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)
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
BPG for selection of product for SPC harmonisation
BPG for SPC harmonisation of the reference product
BPG for SPC harmonisation of generics/hybrids
BPG for the re-examination procedure
|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|
|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|
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.)
Overview of comments
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 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 handling marketing authorisations for veterinary medicinal products intended for limited markets (national, mutual recognition and decentralised procedures)