The UK MHRA has updated is guidance on variations to Marketing Authorisations (MAs) from 1 January 2021.
The original guidance was published on 27 October 2020. In the latest update, further information is provided on variations for products that were approved under mutual recognition (MR) or decentralised (DC) procedures.
- For approved products, MA holders will have the option to maintain the authorisation within the MR or DC procedure in Northern Ireland (NI), while maintaining a UK wide authorisation (Northern Ireland and Great Britain). Guidance on the handling of DC and MR procedures approved or pending on 1 January 2021 was published recently.
- Under the NI Protocol, Medicinal Products authorised via the MR/DC procedure from 1 January 2021, where NI is specifically included as a CMS may be authorised for use in NI only, where a UK MA in respect of Northern Ireland (PL(NI)) will be issued by the MHRA, or as a UK wide MA (PL) with Northern Ireland as a CMS, and GB aligned with the decisions taken by the RMS , but not part of the DCP/MRP.
- Any variations to these MAs will be managed as part of the specific MR/DC procedure, according to the relevant procedures laid down in the Variations Regulation (EC/1234/2008 as amended), where worksharing will also be possible.
How will variations be processed where a UK wide MA is involved?
- Where a UK wide MA is involved, since the MR/DC variation decision applies UK wide, it can be implemented unless the MHRA notifies the MAH within 30 days of the RMS decision that it cannot be accepted in GB. In this case a separate MA for GB will need to be issued.
- Where a PL(NI) is issued, if the same product is separately authorised in GB, a separate variation application will need to be submitted to vary that authorisation under domestic legislation. Type IA notifications can only be processed on the basis of what is actually submitted to the MHRA for GB.
- However, for Type IB and Type II variations, if such a variation is submitted for the corresponding GB authorisation, after approval of the identical changes by the RMS, and evidence of this is included with the submission, this will be taken into consideration according to the reliance route for variations.
- A lower fee will be charged and there will be no fee if the GB authorisation was granted under the unfettered access route, based on a purely national NI authorisation. Further guidance will be issued in due course.
How will variations be processed where a PL (NI) is issued and the same product is separately authorised in Great Britain?
- Where a PL(NI) is issued, if the same product is separately authorised in Great Britain, a separate variation application will need to be submitted to vary that authorisation under domestic legislation. Type IA notifications can only be processed on the basis of what is actually submitted to the MHRA for GB.
- However, for Type IB and Type II variations, if such a variation is submitted for the corresponding GB authorisation, after approval of the identical changes by the RMS, and evidence of this is included with the submission, this will be taken into consideration according to the reliance route for variations.
- A lower fee will be charged and there will be no fee if the GB authorisation was granted under the unfettered access route, based on a purely national NI authorisation. Further guidance will be issued in due course.
Source: MHRA website