The procedures detailed under the Chapter IIa of Variations Regulation (EC) No 1234/2008 will be incorporated into UK law from 11pm on 31 December 2020. The current 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 1 January 2021.
Medicinal Products authorised via the centralised route will be directly authorised for use in Northern Ireland. A separate MA will not need to be issued by the MHRA for NI. If the same product is separately authorised in Great Britain a separate variation application will need to be submitted to vary that authorisation.
Pending variations (no decision) would be finalised. Purely national Marketing Authorisations (not part of any work-sharing procedure). The applicant should notify the licensing authority in writing that they no longer want the application to proceed. A partial fee refund may be applicable in line with the current MHRA fees regulations.
All new variations submitted from 1 January 2021 will be processed as purely national variations. New variations submitted as a result of Northern Ireland's involvement in European procedures will be managed in line with the base procedures. There will be no provision for work-sharing.
This includes the submission of a copy of the relevant Manufacturing Authorisation or as appropriate a valid good manufacturing practice (GMP) certificate issued by the UK. A change in importer/batch release site and/or quality control site should be submitted under the relevant change code under B.II.b.2 and be suitably supported.
Change of MAH from a company outside the UK to one established in the UK cannot be done as a variation. From 1 January 2021 the MAH will have 24 months to comply with rules on establishment in the UK. In the interim, the MHRA will require a contact in the UK.
MHRA will no longer have access to the Article 57 database. Any change to the QPPV or location of the PSMF should be submitted under change code C.I.8.a (Type IA IN) The QPPV for UK authorised products must be established in the EU or UK on day one.
From 1 January 2021, holders of a UK marketing authorisation who sponsor a paediatric study must submit the results of this study to the MHRA. In cases where an initial appraisal indicates that an assessment is required, the MAH will be asked to submit the paediatric data as a Type II complex variation to MHRA.
This guidance will apply from 1 January 2021 in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019. This guidance will also apply to the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019.