Import Licensed Human Medicine – Prior to importation of a licensed medicine applications for the relevant Licence(s) must be completed and submitted which may include one or more of the following:
- Wholesaler Distribution Authorisation(WDA(H)), also known as Wholesale Dealer Licence
- Manufacturer Licence
- Marketing Authorisation (MA)
The UK regulator for medicines, medical devices and blood components for transfusion in the UK, Medicines and Healthcare products Regulatory Agency (MHRA), is responsible for the issuing of wholesale and manufacturer licences. If the medicine intended for import contains a controlled substance the Home Office will also need to be contacted.
If intending to Import Licensed Human Medicine from a country on the approved country for import list or if based in Northern Ireland, a country in the European Economic Area (EEA), and intending to supply to another country, including the UK, you will need to apply for a WDA(H).
A WDA(H) will also be necessary if intending to import medicine from a country other than an approved country for import and export to a country other than an approved country for import, or if in Northern Ireland, an EEA country, and exporting to a non-EEA country. A Responsible Person for Import (RPi) may be required if your company is based in Great Britain.
If importing medicine from a country other than an approved country for import for use in the UK or supplying it to a country on an approved country for import list you will require a Manufacturer Licence. A manufacturer licence will also be necessary if in Northern Ireland and import medicine from outside the EEA for use in the UK, or to supply it to an EEA country.
An MA licence is required to be able to sell medicine. There are several types of MA licence and thus the process to follow depends on the MA licence required. Before release of a medicine to the market, a Qualified Person (QP) named in the manufacturer/importer licence, must certify that the medicine has been manufactured and tested in accordance with the MA and good manufacturing practice standards.
Apply for a wholesaler licence
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences
Good Manufacturing Practice
https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice
Apply for a manufacturer licence
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences
MA Licence Type