Procedure introduced to transfer marketing authorisation certificates for a medicine within the EAEU

During the events of Spring 2022, there were some significant legislative changes which have not been widely reported, but are of interest to businesses active in the EAEU.

One of these changes is the introduction of a procedure for transferring a marketing authorisation certificate for a medicine (the “Marketing Authorisation”) from one company to another. Relevant changes were introduced by EEC Council Decision No. 36* to the Rules for Registration and Examination of Medicines for Medical Use approved by EEC Council Decision No. 78*.

The lack of a regulated procedure for transferring Marketing Authorisations had been a recurring issue of Eurasian and Russian regulation. This complicated a variety of business processes: from intragroup reorganisation to the sale of a product line.

This gap in the law has now been filled. To transfer a Marketing Authorisation, documents have to be provided to the relevant authorised bodies to justify the transfer of the Marketing Authorisation and the new holder’s ability to fulfil the acquired regulatory responsibilities. In addition, some technical information must be provided, including a revised pharmacovigilance system specification, updated information for some sections of the dossier and a regulatory document pertaining to quality.

At the same time, changes in connection with the transfer of a Marketing Authorisation can be made simultaneously with the procedure of bringing the registration dossier in line with the requirements of the EAEU.

The new Marketing Authorisation transfer procedure makes the Eurasian Economic Union’s regulatory space more open for transactions with pharmaceutical assets. It also eases the reorganisation of Eurasian businesses, something which has recently become of interest to many foreign companies.

* In Russian

Co-authored by Ivan Zaraiskiy, Associate, and Maria Volkodaeva, Paralegal in Life Sciences & Healthcare.