Following brexit, the MHRA has published several guidelines concerning the end of transitionperiod and how pharmaceutical companies and Marketing Authorisation Holders have to approach from 1 January 2021.

In the following news announced by MHRA on UK's official website (link below), you can read about how and when to register updated packing and information leaflets (PIL) when new national marketing authorisations (MA) have been issued. The topic will cover:

• Actions to be taken following MA approval – local UK PV contact mandatory but EUQPPV acceptable with UK PSMF registration
• Multi-language packs in compliance with UK requirements
• National MAs granted after a mutual recognition (MRP) or decentralised procedure (DCP)
• Submission of new applications, corresponding fees and best practice guidance

Link: Registering new packaging information for medicines from 1 January 2021

If you are looking for further guidance and consultancy on the matter, you can contact us via info@pharmazet.com

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