Northern Ireland continues to follow EU guidance and therefore be part of EU procedures (centrally authorised medicines, MR/DC procedures). The UK could only be a CMS during the transition period and can no longer be part of EU procedures from 1st Jan 2021 (where UK is GB and NI). Although the MHRA will be taking all decisions and performing all functions as the UK regulator, as previously done by the EMA or EU Competent Authorities at EU-level, it will not have any decision-making ability with respect to Marketing Authorisation Applications or existing authorisations made by EU procedures, where marketed in Northern Ireland. Medicinal products in GB will follow GB law, which in the main is a direct transposition of EU law, implemented through SI 2012 No. 1916, The Human Medicines Regulations (HMR) 2012, as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019.
The direct transposition is of course good news, however there are some particular exceptions for new ‘generic’ marketing authorisations in terms of comparator and reference products.
Centrally Authorised Products (CAPs) and Products authorised under EU Decentralised or Mutual Recognition Procedures
Existing centrally authorised Marketing Authorisations were automatically converted into UK national MAs (these “converted EU MAs” are effective in GB only) on 1st January 2021 (known as “grandfathering”) and allocated UK Product Licence (PL) number(s). This protects the supply into GB of important medicines, previously authorised by EMA. The MA holder did have the option to opt out of this automatic conversion, but this needed to be done by 21st January 2021. There were no fees associated with the conversion process.
Existing centrally authorised EU MAs remain valid for the purposes of marketing in NI as a result of the Northern Ireland Protocol. The MHRA does not issue a separate MA for NI.
Existing products authorised under EU Decentralised or MR Procedures, where NI is specifically included will be authorised for use in NI, in which case a UK MA will be issued by MHRA in respect of NI. Where the product is authorised in GB as part of a DC/MP procedures, this will retain it’s existing national UK MA numbers and are now handled as nationally approved products, from 1st January 2021.
In order to effectively manage lifecycle changes of the converted EU MAs for GB, the MHRA requires the submission of a single eCTD initiating sequence representing the currently authorised and approved position, which must be provided by 31st Dec 2021 (see the following guidance). This is understood to be a potentially significant and important task for the Industry, not least because it will generally not be be possible for MA holders to renew and/or submit variations in respect of such converted MAs until this sequence is provided.
The current legal requirement for suppliers of pharmaceutical products, holding marketing authorisations, is to establish a legal entity in the EU. Following the end of the transition period, marketing authorisation holders for GB-licensed products must establish a legal presence in GB. On conversion of the EU MA, holders must establish a GB legal presence within 24 months of date of 1st Jan 2021.
