The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) has developed a Q&A document to help both marketing authorisation holders and competent authorities to understand the transition from Directive 2001/82/EC to the new Regulation (EU) 2019/6. While the European Commission's notice only deals with the validity period of the marketing authorisation and renewal applications still to be submitted, the CMDv's Q&A document additionally addresses questions on the new QRD templates and the transition from periodic safety update reports (PSURs) to signal management.

Renewals

While veterinary medicinal products authorised under Regulation (EU) 2019/6 after 28 January 2022 will have an unlimited validity, authorisations with a date of authorisation before 28 January 2022 will have to be renewed after five years according to Directive 2001/82/EC. For the transfer to an authorisation with unlimited validity under the new law, it depends on the type of procedure and the member state in which the authorisation was granted whether and how the authorisation holder must take action. In Germany, nationally authorised veterinary medicinal products (including those authorised in MR and DC procedures) for which no renewal application is needed anymore, are automatically transferred to a marketing authorisation of unlimited duration. Marketing authorisation holders do not have to take any action. For information how to procede for centrally authorised products, please contact the EMA and for marketing authorisations in other member states, please contact the competent authority of the member state where the Veterinary Medicinal Product is authorised. The RMS will not be coordinating the transfer to a marketing authorisation of unlimited duration.

For marketing authorisations whose validity expires on or after 28 January 2022 but whose latest submission date for the renewal application is before 28 January 2022, such an application must still be submitted in due time - at least six months before the expiry date - in accordance with Article 151(1) and (2) of Regulation (EU) 2019/6. These applications are still processed according to Directive 2001/82/EC.

Update of QRD templates

Articles 10 to 16 of Regulation (EU) 2019/6 outline new requirements for SPC, label and package leaflet. Therefore the QRD templates have been revised. Marketing authorisation holders have until 29 January 2027 to make the necessary adjustments. EMA and CMDv agreed that a Variation Requiring Assessment (VRA) is an appropriate process to adapt the SPC, label and package leaflet.

PSURs

No PSURs need to be submitted after 27 January 2022. The last Data Lock Point (DLP) for which a PSUR still needs to be submitted is 28 November 2021.

From 28 January 2022, all adverse drug reactions (ADRs), including those previously classified as non-serious, must be entered electronically into EVVET and ongoing signal management must be carried out, the outcome of which must be submitted annually to EVVET in accordance with Article 81 of Regulation (EU) 2019/6.

Due to this regulation, there is a period between the last submitted PSUR and 28 January 2022 during which non-serious ADRs are not reported via either route. Marketing authorisation holders are requested (on a voluntary basis) to report electronically to EVVET all non-serious ADRs occurring since the last PSUR and up to 28 January 2022. Alternatively, if electronic reporting is not possible, a line listing of the affected cases can be submitted to EVVET. The data submitted in this way will be analysed according to the signal management guideline that is currently being prepared.

Year of issue 2021
Date 22.07.2021

to the top