Transferring a veterinary marketing authorisation
A transfer application follows a 30-day procedure following receipt of the application. There are no set submission dates. In order to choose the best submission date, especially in case of any other ongoing/expected procedures, the Transferor should contact the Agency via Service Now by selecting Veterinary Regulatory > Pre-Submission-Vets at least 1 month before submission of the application. In case the application is correct and complete, the Agency aims to finalise the procedure by Day 10. In case of an incorrect or incomplete application the applicant will be notified and required to provide the amended and/or additional documentation via the eSubmission Gateway/Web Client within 10 calendar days from the date of the EMA notification. The EMA will not be able to issue a favourable opinion on the transfer in case the documentation is incomplete. Upon receipt of the applicant’s responses, the Agency aims to finalise the procedure by Day 20.
In any case finalisation of the opinion should be within 30 days upon receipt of the transfer application.
The transfer opinion will be sent to the Transferor, Transferee, the European Commission and the competent authorities of Iceland and Norway. Subsequently, the European Commission will issue a decision on the transfer of the MA. The transfer of the MA is authorised from the date of the notification of the Commission decision on the transfer.
However, the Agency by mutual agreement with the Transferor and the Transferee can set an implementation date for the transfer. This implementation date should be understood as the date on which the Transferee takes over all responsibilities. This date is stated on the opinion adopted by the Agency and also on the European Commission decision. (See also “How to choose the implementation date?”).
Reference
- Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorisation for a medicinal product falling within the scope of Council Regulation (EC) No 2309/93
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
