The Coordination Group for Mutual Recognition and Decentralized Procedure-human (CMDh) has updated the "Practical guidance on the implementation of the Protocol on Ireland/Northern Ireland for medicinal products for human use approved via MRP/DCP".
The new guidance is based on the Commission Notice on the application of the EU’s pharmaceutical laws for markets that have historically been dependent on medicines supply from parts of the United Kingdom other than Northern Ireland.
In practical terms, the new guidance gives clarification on how medicinal products in Northern Ireland must be placed on the market with the withdrawal of the United Kingdom from the European Union.
The following questions & answers have been updated:
30. Can I still place my product on the market when the MAH, batch release site, batch control site, local representative, QPPV or PSMF will still be located in the UK after the end of transition period?
For MR/DCP procedures that include Member States Ireland, Cyprus, Malta or Northern Ireland (UK/NI), the facilities for batch control, batch release, MAH location, local representative and for Northern Ireland the function of QPPC or the PSMF may continue to be located in the United Kingdom under the conditions set out in the Commission Notice once the authorities in Ireland, Cyprus, Malta and Northern Ireland have approved it for supply in their market.
31. What will happen to my ongoing DCP marketing authorization application when the applicant, future MAH, batch release site, batch control site, local representative, QPPV or PSMF will still be located in UK after the end of transition period?
It has been included here that the Commission Notice includes the possibility for authorities in Ireland, Cyprus, Malta, Northern Ireland to accept a marketing authorization holder who is based in the UK and for Northern Ireland marketing authorizations the QPPV and PSMF may be located in the UK .
35. What will be the effect of UK`s withdrawal on authorizations granted in accordance with Article 126 (a) of Directive 2001/83/EC on the basis of Marketing Authorizations issued by the UK?
Until December 31, 2022, or until the legislative changes come into force if they are before December 31, 2022, the authorities of Cyprus and Malta may continue to apply the authorizations under Article 126 (a) of Directive 2001/83/EC hold, extend or authorize based on authorizations granted in the United Kingdom. This is done in accordance with Commission Notice 2021/C 524/02.
37. For existing authorizations, if I still have UK sites mentioned in the dossier after the end of the transition period in addition to use EU sites, e.g., alternative batch release or batch control sites, should I remove these?
Manufacturing sites located in Great Britain (UK/GB) may continue to be permitted under the conditions set out in Commission Notice 2021/C524/02 if approved by the authorities in Ireland, Cyprus, Malta or Northern Ireland for their markets by 31 December 2021. December 2022 or by the date until the legislative changes come into force (possibly before December 31, 2022).
38. What will happen if I submit a marketing authorization application after the end of the transition period with the applicant, future MAH, batch release site, batch control site, local representative, QPPV and/or PSMF located in the UK?
The Commission Notice gives the ability for authorities in Ireland, Cyprus, Malta and Northern Ireland to accept a Marketing Authorization Holder located in the UK. For Northern Ireland registrations, the QPPV and PSMF may be located in the UK.
- From the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP by the CMDh (page 5-19)