Import a human medicine
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
Import a licensed medicine
If you want to import a licensed medicine you바카라 사이트檒l need to apply for one or more licences:
- Wholesale distribution licence (WDA(H))
- Manufacturer바카라 사이트檚 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 迟丑别听Home Office.
Apply for a wholesaler licence (WDA(H))
You바카라 사이트檒l 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 a聽Responsible Person for Import.
Apply for a wholesaler licence
Apply for a manufacturer licence
You바카라 사이트檒l 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 you바카라 사이트檒l 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 an聽MA听濒颈肠别苍肠别 before you can sell a human medicine. There are many types of聽MA听濒颈肠别苍肠别 so the process you need to follow depends on 迟丑别听type of聽MA听濒颈肠别苍肠别聽you 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:
- 迟丑别听MA
- good manufacturing practice
Site inspections
MHRA聽will inspect the manufacturing site you use to produce or import the medicine when you바카라 사이트檙e applying for an聽MA.
There is a list of GMP-compliant manufacturers available on 迟丑别听MHRA-GMDP or for certificates issued prior to 1st January 2021 on 迟丑别听.
There is a list of GMP-compliant manufacturers available on聽.
Import an unlicensed medicine
If you want to import an unlicensed medicine into the UK you will need:
- a Manufacturer바카라 사이트檚 바카라 사이트淪pecials바카라 사이트� Licence (MSL)聽if you바카라 사이트檙e 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 Dealer바카라 사이트檚 Licence (WDA (H))聽if you바카라 사이트檙e 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 an聽MA聽for the UK or a country on an approved country for import list.
Contact
Please refer to Contact the MHRA
Updates to this page
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Updated to reflect current guidance on the importation of medicines. Details on the importation of unlicensed medicines were moved to a new, dedicated page.
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Added information applying for a wholesaler licence or a manufacturer licence, the process for importing an unlicensed medicine and importing a special. This follows the end of the transition period.
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New information around Northern Ireland has been added
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First published.