Medicines Healthcare Products Regulatory Agency
November 30
16:58
2022
Details
The European Commission Directive 2022/642 amends Directives 2001/20/EC and 2001/83/EC to enable derogations from certain obligations concerning medicinal products for human use made available in the UK in respect of NI. The Directive came into force on 20 April 2022, applying retroactively from 1 January 2022.
The derogations are (in summary):
- Marketing Authorisation Holder may be based in GB for Marketing Authorisations that apply in NI.
- Where there is an application for a Marketing Authorisation Application, or Authorisation already granted, in a EU Member State, a Marketing Authorisation Application can be made to the UK competent authority (UKCA) for that product and the UKCA can grant a national Marketing Authorisation.
- For authorisations that apply in NI, batch testing and release by Qualified Person may be based in GB, the Qualified Person may reside in GB and the Qualified Person for Pharmacovigilance (QPPV) may reside in GB.
- Products may be imported in NI without a Manufacturing and Import Authorisation (MIA), subject to an appropriate Wholesale Distribution Authorisation and quality control testing.
The Directive requires the competent authority of the United Kingdom to publish on their website a list of medicinal products making use of these derogations. This list will be updated every 6 months.