EMA Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use
EMA and the European Commission have published a notice to marketing authorisation holders of centrally authorised medicines intended to remind them of their legal obligations in preparation for Brexit.
3rd May 2017
Marketing authorisation holders of centrally authorised medicinal products for human and veterinary use are reminded of certain legal repercussions, which need to be considered.
Marketing authorisation holders will need to act sufficiently in advance to avoid any impact on the continuous supply of medicines for human and veterinary use within the European Union.
In particular, the Commission and the European Medicines Agency expect marketing authorisation holders to prepare and proactively screen authorisations they hold for the need for any changes. The necessary transfer or variation requests will need to be submitted in due time considering the procedural timelines foreseen in the regulatory framework.
For detailed information please refer to the notice published by EMA here.