On 19/July/2021 the CMDv released document EMA/CMDv/181154/2021 entitled “Transitional arrangements for the entry into application of Regulation (EU) 2019/6 for veterinary medicinal products registered under national, mutual recognition and decentralised procedures”. CMDv has prepared this document to assist Marketing Authorisation Holders (MAHs) as well as National Competent Authorities (NCAs) in the management of the transition from Directive 2001/82/EU to Regulation (EU) 2019/6. The CMDv provides this guidance mainly for the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP).

The release of the CMDv document follows publication 2021/C 274/02 from the European Commission “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”, which clarifies some practical steps, mainly for the centralised procedure with some aspects also applying to the national procedure.

What do these documents contain?

Both documents are addressing MAs for Veterinary Medicinal Products (VMPs) that require renewals, either under the current Directive 2001/82/EU or under the new Regulation (EU) 2019/6 and their Marketing Authorisation (MA) validity.

What is the main difference of these documents with regards to MA validity?

With regards to MA validity, the main difference between Directive 2001/82/EU and Regulation (EU) 2019/6 is the timeframe for MA validity. Directive 2001/82/EU limits the validity of MA for Veterinary Medicinal Products initially to five years, MA regulated under Regulation (EU) 2019/6 will have an unlimited validity (exceptions apply). Both documents clarify the provisions already contained in the applicable legislations. A new one-step process for acquiring an MA for VMPs for an unlimited duration will replace the previous two-step process.

Sample clarifications

For the Centralised Procedure (CP), MAHs with MA for VMP that expiry on or after 28/January/2022 will receive a letter from the EMA concerning the expiry date. With a positive reply from the MAH, the EMA will initiate steps to ensure unlimited validity of the MA. In the case of no (or a negative) reply, the MA will expire.

For the CP, MA submitted before 28/January/2022 but yet undecided will be dealt with under Directive 2001/82/EC.

What happens to MAs with validity after 28/January/2022 but with MA granted before 28/January/2022? As renewals should be submitted at least six months before the MA ceases, MAs will be handled according to Directive 2001/82/EC. In the case of the validity of the MA ending after 28/January/2022 with a submission date also falling after this date, no renewal application is required. The validity for the MA will be amended by the NCA.

In summary

With the New Veterinary Regulations now only months away, MAHs have to decide on when best to submit VMP renewals to make the most of the unlimited validity of MA under Regulation (EU) 2019/6. Replacing the two-step process under Directive 2001/82/EU with a one-step process under Regulation (EU) 2019/6 is certainly an improvement, but rules will apply. However, this is one final step to get to an unlimited validity of the Veterinary Medicinal Product more quickly….

Published by Olaf Schoepke

Passionate about sharing ideas with regulatory professionals in the human and veterinary medicinal product space.

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