The UK Medicine and Healthcare Agency MHRA has just published a Guidance called “Importing Medicines on an approved country for import list from 1 January 2021“. It is pretty much in line with a document which was withdrawn in March and gives advice on what to do from 1 January 2021.
Important to notice is that there will be an “approved country for import list” and that wholesale dealers’ licences will remain in force. This licence will permit the importation of medicinal products from countries on this list (initially, this will be countries in the European Economic Area (EEA)).
If a company intends to continue to import medicinal products from a country on the list it should notify MHRA in writing of the intention to do so within 6 months. Within 2 years, a Responsible Person (import) (RPi) should be nominated and named on the wholesale dealer’s licence. The respective activities need to be covered by the wholesale dealer’s licence.
However, if the imported medicine is not licensed in the UK or a listed country, an “ordinary Responsible Person” will be needed – and not a RPi. And in the case of importing human medicines from a country on the list for export as an introduced medicine, activities will depend on the license (UK or not).
If a UK company imports a UK or Great Britain (England, Wales and Scotland) authorised medicine from a country on the list, a wholesale dealer’s licence will be needed that authorises import. The same will be needed for medicine for use as a special medicinal product in Great Britain.
If a medicine is imported from a country on the list for supply to the Great Britain Parallel Import market a respective wholesale dealer’s licence will be needed authorising the import. And the imported medicine must have the appropriate marketing authorisation in a country on the list for the designed Great Britain Product Licence Parallel Import (PLPI).
Sourcing form Northern Ireland
If a company sources a medicine without an authorisation in UK or Great Britain from Northern Ireland for supply to the Great Britain market a wholesale dealer’s licence will be needed. The current notification of intent to import an unlicensed medicine remains the same. The company in Great Britain will need an “ordinary Responsible Person” and not a RPi.
This will be the same for medicine with a marketing authorisation from Northern Ireland for supply to the Great Britain Parallel Import market or for export to a third country.
The Role of the Qualified Person
Another Guidance called “Acting as a Responsible Person (import) from 1 January 2021” states that the RPi “should ensure that written evidence is available to demonstrate that each batch of product has been QP certified as required in Article 51 of Directive 2001/83/EC.”
“Batch certification by a QP may be confirmed using evidence such as:
- Batch certificate confirming QP certification in accordance with Article 51 of Directive 2001/83/EC)
- A copy of the ‘control report’ (Appendix II to EU Good Manufacturing Practice Annex 16)
- Statement of certification (ad-hoc, confirming certification in accordance with Article 51 of Directive 2001/83/EC)
- Reference to company internal systems (e.g. global Enterprise Resource Planning system) that shows batch certification
- Confirmation that the final manufacturing step (other than batch certification) of an authorised medicine has been performed by a Manufacturing and Import Authorisation holder in a listed country. A copy of the Marketing Authorisation and technical agreement with the manufacturer should be available to place reliance on this supply chain control
- For medicines authorised in a listed country, batch certification may be verified by confirming that the medicine has been purchased from an authorised wholesaler after it has been ‘placed on the market’ in the listed country.”