With March 2019 fast approaching, there have been more Brexit-related developments in the Life Sciences sector which we wanted to highlight to you.
UK Parliament’s briefing paper on Brexit and medicines regulation
The briefing paper, which was released on 20 November and is available here, includes a summary of the current legislative framework for medicines and medical devices, the impact of the EMA relocation, and options for future regulation of medicines and medical devices post-Brexit.
European Medicines Agency guidance
Following the Q&A guidance prepared by the EMA in May this year (see our previous article here), on 24 November the EMA published a new guidance document called “Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure” which contains more detail on post Brexit procedures.
The EMA has also said that they are preparing a series of further Brexit-related guidance notes which they will publish on their website; they have suggested that users regularly check the “EMA’s dedicated webpage on the consequences of Brexit”.
MARQUES position paper
MARQUES, the European association representing the interests of brand owners, has set out a position paper on Brexit, identifying the key issues for brand owners ahead of the UK leaving the EU. It includes a 12-point plan which sets out how MARQUES considers harmonised rights should be dealt with during and after Brexit.