The secondary legislation revokes the Variations Regulation (EC) No 1234/2008, as amended, which was immediately binding in the EU and applied immediately before exit day and incorporates in the Human Medicines Regulations 2012 (“HMRs”) the elements of that Regulation that remain applicable in a no-deal Brexit.
The procedures detailed under Chapter IIa of that Regulation, which specifically applied to variations to purely national Marketing Authorisations, will continue to apply to both pending and new variations to UK Marketing Authorisations, all of which will be purely national, after exit day and can be found in new regulation 65C and Schedule 10A to the HMRs.
In addition, unless specifically highlighted under section 3, the current variations classification guidelines, which explains the type of variation (Type IA, Type IAIN, Type IB, Type II or Extension) to submit and, where relevant, the conditions to be met and any required supporting documentation, will continue to apply.
Any extension application should be submitted in accordance with the procedures for new Marketing Authorisations. The variations classification guidelines will continue to apply until the MHRA issues any revised guidance in the future.
The UK will recognise any Article 5 recommendation published by the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) before exit day. Any specific request from a Marketing Authorisation Holder (MAH), concerning the classification of a variation, which is still pending (no recommendation) on exit date or is submitted after exit day will need to be submitted directly to the MHRA, who will issue its own recommendation…