The European Medicines Agency (EMA) has released a simplified process for transferring marketing authorisations in response to Brexit. The process applies to companies that would like to move marketing authorisations between organisations registered under the same EudraVigilance (EV) headquarter profile.
The old guidance from the EMA on transferring product registrations went by the assumption that the former marketing authorisation holder (MAH) and the new MAH were different entities. The original MAH invalidated the authorised medicinal product (AMP) and the new MAH then reinstated the AMP. The process placed several responsibilities on each MAH, whilst ensuring both parties had agreed to the transfer. According to the new guidance, MAHs must still follow this process when transferring AMPs to other companies.
However, regarding Brexit, the assumption that AMP transfers will involve two distinct entities is no longer valid. MAHs are currently moving AMPs from affiliates based in the United Kingdom to affiliates that are based in one of the other 27 member states, to ensure they are compliant with the regulations when Brexit occurs in March 2019. The precautionary steps that are incorporated in the normal transfer process are of less value to these companies.
Therefore, the EMA has released a simplified process for internal transfers, which eliminates several of the steps involved in transfers between companies. Following the new process, MAHs change the authorisation status, enter the new and old EV Codes and then submit the information to transfer an AMP to an affiliate.
The time saved by the new process may be limited as updating details in EudraVigilance is just one part of moving a marketing authorisation to another member state, but small time savings may add up due the industry moving thousands of authorisations.
The new process is detailed in updates to the EMA’s guidance on the electronic submission of information and a document that provides answers to questions that were submitted by the industry. Updates to the guidance include new information related to AMP transfers. Furthermore, the guidance states that the Qualified Person Responsible for Pharmacovigilance must be registered at the affiliate that is receiving the AMP.
To read the EMA guidance on electronic submission of information on medicinal products for human use by MAHs to the EMA, please click here.
To read the question and answers document from the EMA on electronic submission of article 57(2) data, please click here.