Now that the Brexit transition has taken place you may be wondering what your options are for submitting new variations or how your pending variations will be processed. Here is a summary of how Marketing Authorisations (MAs) will be handled according to the process by which they were licenced.
How will Mutual Recognition/ Decentralised (MR/ DC) Procedure MAs be handled?
For approved products via MRP/ DCP, MAHs will have the option to maintain the authorisation within the MRP/ DCP in Northern Ireland, while maintaining a UK wide authorisation (Northern Ireland and Great Britain – England, Scotland and Wales).
Consequently variations to these MAs from 1 January 2021 may be submitted and managed as part of the relevant MR/ DC procedure under Chapter II of Regulation (EC) No 1234/2008 with Northern Ireland as CMS, where the outcomes will be implemented UK wide.
What will the Variations Procedure be?
Existing EU procedures* have been incorporated into UK law** and as such continue to apply to both pending and new variations to purely national UK MAs from 1 January 2021.
* detailed under Chapter IIa of Variations Regulation (EC) No 1234/2008, which specifically applied to variations to purely national MAs.
** new regulation 65C and Schedule 10A to the Human Medicines Regulations 2012 (“HMRs”).
How will Variations to UK MAs be handled?
MAs authorised in the UK by the MHRA before 1 January 2021:
-continue to have effect across the UK (Northern Ireland and Great Britain). This includes those which are currently and will continue to be part of any MR/ DC procedure.
For purely national MAs:
-any pending and new variations will be processed to conclusion after 1 January 2021 as national variations, where the relevant national procedures will be followed.
For MAs which were already authorised as part of MRPs/ DCPs before 1 January 2021:
-any pending and new variations will be processed to conclusion after 1 January 2021 as MR/ DC variations using the relevant MR/ DC procedures led by the RMS. This includes relevant worksharing variations.
What happens with licences under the Northern Ireland Protocol (NIP)?
Under the provisions of the NIP, medicinal products authorized for Northern Ireland continue to follow EU rules.
The requirements of unfettered access will be respected for those products where the MAH is established in Northern Ireland and the Great Britain MA has been obtained as a qualifying Northern Ireland Good*.
*The Definition of Qualifying Northern Ireland Goods (EU Exit) Regulations 2020.
How will variations to products authorised under EU DCP/ MRP be handled?
(See also previous information in this post for guidance on how MRP/ DCP MAs are handled.)
Under the NIP, Medicinal Products authorised via MRP/ DCP from 1 January 2021, where Northern Ireland is specifically included as a CMS may be authorised for use in Northern Ireland 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 Great Britain 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 MRP/ DCP, according to the relevant procedures laid down in the Variations Regulation (EC/1234/2008 as amended), where worksharing will also be possible.
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 Great Britain. In this case a separate MA for Great Britain will need to be issued.
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.
What is the situation for Type IA notifications?
Type IA notifications can only be processed on the basis of what is actually submitted to the MHRA for Great Britain.
What is the situation with Type IB and Type II variations?
However, for Type IB and Type II variations, if such a variation is submitted for the corresponding Great Britain 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.
How will pending (no decision on 1 January 2021) variations be finalised?
1. Purely national MAs (not part of any worksharing procedure)
These will be processed to conclusion under the transitional provisions, using the same purely national procedures that were in place prior to 1 January 2021.
2. UK MAs covered under “Variations to MAs granted in accordance with Chapter 4 of the 2001 Directive i.e. MR/ DC variations (Type IA, Type IB or Type II)”*
These will be processed to conclusion after 1 January 2021 as MR/DC variations using the relevant MRPs/ DCPs led by the RMS, where NI will be a CMS.
*Chapter II of Regulation (EC) No 1234/2008
3. Purely National MAs before 1 January 2021, but part of a worksharing procedure* (Type IB or Type II)
Any worksharing variation involving purely national MAs will be processed to conclusion after 1 January 2021 as part of the existing worksharing procedures led by the relevant Reference Authority.
*under Article 20 of Regulation (EC) No. 1234/2008
Pending variations (decision made)
In the event that the UK is not the RMS or Reference Authority for a variation procedure and a final decision has already been taken by the lead authority, but not finally processed in the UK before 1 January 2021, the MHRA will implement the agreed outcome of the procedure.
New variations
All new variations submitted will either be processed:
(a) as purely national variations, according to the same transposed procedures, as were in place prior to 1 January 2021 or
(b) those which were already part of MRPs/ DCPs prior to then, which will continue to be processed as MR/DC variations.
Northern Ireland Protocol (NIP)
New variations submitted for MAs issued as a result of Northern Ireland’s involvement in European procedures will be managed in line with the base procedures.
All other new variations will be processed as purely national variations, according to the same transposed procedures, as were in place prior to 1 January 2021.
Worksharing
Worksharing will only be possible for purely national MAs authorised for use only in Northern Ireland. However, provided the identical Type IB or Type II variation has already been approved for a related European MA and evidence of this is included with the submission, this will be taken into consideration during the assessment process according to the reliance route procedure.
Community Marketing Authorisations – Variations:
Under the NIP, Medicinal Products authorised via the centralised route will be directly authorised for use in Northern Ireland. Any variations to these MAs will be centrally managed by the EMA in accordance with relevant procedures. A separate MA will not need to be issued by the MHRA for Northern Ireland.
If the same product is separately authorised in Great Britain a separate variation application will need to be submitted to vary that MA. Type IA notifications can only be processed on the basis of what is actually submitted to the MHRA for Great Britain. However, for Type IB and Type II variations, if such a variation is submitted for the corresponding Great Britain authorisation, after approval of the identical changes by the EMA, and evidence of this is included with the submission, this will be taken into consideration according to the reliance route for variations.
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