GovWire

Import a licensed medicine

If you want to import a licensed medicine youll need to apply for one or more licences:

• Wholesale distribution licence (WDA(H))
• Manufacturers licence
• Marketing authorisation, also known as product licence (MA)

If the human medicine you want to import contains a controlled substance (having or using it is controlled by law) you must contact theHome Office.

Apply for a wholesaler licence (WDA(H))

Youll need to apply for a wholesaler licence if you import medicine from:

• a country on an approved country for import list or if you are in Northern Ireland a country in the European Economic Area (EEA) and then supply it to another country, including the UK
• a country other than an approved country for import and export it to a country other than an approved country for import or if you are in Northern Ireland a EEA country and export it to a non-EEA country

How much you pay depends on the type of application, the number of sites, and your total turnover in licensed human medicines.

If your company is based in Great Britain, you may need aResponsible Person for Import.

Apply for a wholesaler licence

Apply for a manufacturer licence

Youll need to apply for a manufacturer licence if you import medicine from a country other than an approved country for import for use in the UK or to supply it to a country on an approved country for import list.

If you are in Northern Ireland youll need to apply for a manufacturer licence if you import medicine from outside the EEA for use in the UK or to supply it to an EEA country.

Apply for a manufacturer licence

Apply for a marketing authorisation (MA) licence

You need to have anMAlicence before you can sell a human medicine. There are many types ofMAlicence so the process you need to follow depends on thetype ofMAlicenceyou need.

Before a medicine can be released to the market, a Qualified Person (QP) named in the manufacturer/importer licence must certify that it has been manufactured and tested according to:

• theMA
• good manufacturing practice

Site inspections

MHRAwill inspect the manufacturing site you use to produce or import the medicine when youre applying for anMA.

There is a list of GMP-compliant manufacturers available on theMHRA-GMDP or for certificates issued prior to 1st January 2021 on theEUDRAGMDP website.

There is a list of GMP-compliant manufacturers available onMHRA-GMDP.

Apply for anMAlicence

Import an unlicensed medicine

If you want to import an unlicensed medicine into the UK you will need:

• a Manufacturers Specials Licence (MSL)if youre importing a medicine from a country other than an approved country for import or if you are in Northern Ireland from outside the EEA (you will need to supply supporting documents)
• a Wholesale Dealers Licence (WDA (H))if youre importing a medicine from a country on an approved country for import list

Before you import an unlicensed medicine you will need to notify the MHRA of your intent to import an unlicensed medicine before you import it. You can only proceed with the import if the MHRA does not object to it.

Additional information on the importation and supply of unlicensed medicines can be found on Supply unlicensed medicinal products (specials)

Import an introduced product

You must be a licensed wholesale dealer in the UK to import an introduced product.

You may only obtain an introduced medicine from a person authorised in the country other than an approved country for import or if you are in Northern Ireland in the non-EEA country to supply medicinal products by wholesale distribution.

You can only export an introduced product to a person authorised in the country other than an approved country for import or if you are in Northern Ireland the non-EEA country to receive medicinal products for wholesale distribution or supply to the public.

An introduced medicinal product will not have anMAfor the UK or a country on an approved country for import list.

Contact

Please refer to Contact the MHRA