Import a licensed medicine
If you want to import a licensed medicine youll need to apply for one or more licences:
- wholesale (also known as a wholesale dealer licence or wholesaler distribution authorisation)
- marketing authorisation (MA)
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for issuing wholesale and manufacturer licences. MHRA aim to process all applications within 90 working days.
If the human medicine you want to import contains a controlled substance (having or using it is controlled by law) you must contact the Home Office.
Apply for a wholesaler licence
Youll need to apply for a wholesaler licence if you import medicine from:
- a country in the European Economic Area (EEA) and then supply it to another country, including the UK
- a non-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 Responsible Person for Import.
Apply for a manufacturer licence
Youll need to apply for a manufacturer licence if you import medicine from outside the EEA or use in the UK or to supply it to an EEA country.
Apply for a marketing authorisation (MA) licence
You need to have an MA licence before you can sell a human medicine. There are many types of MA licence so the process you need to follow depends on the type of MA licence 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:
MHRA will inspect the manufacturing site you use to produce or import the medicine when youre applying for an MA.
There is a list of GMP-compliant manufacturers available on the EUs EudraGMDP website.
Import an unlicensed medicine
You can import an unlicensed medicine if:
- you import it from a non-EEA country to export it back to a country outside the EEA (called an introduced product);
- licensed medicines do not work for the special clinical needs of a patient (called a special product)
- there are no licensed medicines available for the clinical needs of a patient (also called a special product)
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 non-EEA country to supply medicinal products by wholesale distribution.
You can only export an introduced product to a person authorised in the non-EEA country to receive medicinal products for wholesale distribution or supply to the public.
An introduced medicinal product will not have an MA for the UK or a country on an approved country for import list.
Import a special
Youll need to apply for a:
Youll also need to make a notification of intent to import an unlicensed medicine 28 days before you import it.
Make a notification of intent to import an unlicensed medicine
You must send a completed notification of intent form to MHRA.
Each entry must have the unique reference number you have given it and each unlicensed human medicine must be given a product code. This should define:
- generic name (of drug substance(s))
- brand name, strength, pharmaceutical form and pack size (for a single pack, as number of items in pack)
- manufacturer name and address
- exporting country
The code must be less than 16 characters in length, including spaces and contain only letters and numbers.
Send completed notifications to: email@example.com.
MHRA may object to the import if:
- there are concerns about the products safety or quality
- there is an equivalent licensed product available that will meet the special clinical needs of the individual patient
- there isnt a special clinical need for a patient to have the product
You can import the product if MHRA does not object within 28 days of their acknowledgement letter.
Importers are responsible for ensuring that the products imported comply with the Transmissible Spongiform Encephalopathies (TSE) Regulations.
Importers should look at the guidance on the TSE requirements when importing an unlicensed medicine.
Make an urgent import notification
In cases of a clinical emergency (usually for life-threatening illnesses or where imminent serious injury is likely) MHRA is able to waive the need for the 28-day notice period and usually process the notification within one working day.
Commercial or other non-clinical reasons are not acceptable reasons for urgency.
During office hours you can talk to the import notifications supervisor by calling 020 3080 7002. If the line is busy, phone 020 3080 6000.
For exceptionally urgent cases that are out of office hours, contact the MHRA duty officer on 07795 641532.
Unlicensed Medicines the MHRA would normally object to import
There are some products that MHRA do not licence for import. Downloadfor updates on importing: