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 you’ll 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
You’ll 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 Responsible Person for Import.
Apply for a manufacturer licence
You’ll 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 you’ll 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 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:
- the MA
- good manufacturing practice
MHRA will inspect the manufacturing site you use to produce or import the medicine when you’re applying for an MA.
There is a list of GMP-compliant manufacturers available on the MHRA-GMDP or for certificates issued prior to 1st January 2021 on the EUDRAGMDP website.
There is a list of GMP-compliant manufacturers available on MHRA-GMDP.
Import an unlicensed medicine
You can import an unlicensed medicine if:
- you import it from a country other than an approved country for import to export it back to a country other than an approved country for import (called an introduced product)
- you are in Northern Ireland and 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 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 MA for the UK or a country on an approved country for import list.
Import a special
You’ll need to apply for a:
- manufacturer ‘specials’ licence if you’re importing 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)
- wholesaler licence if you’re importing a medicine from a country on an approved country for import list
You’ll 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: firstname.lastname@example.org.
MHRA may object to the import if:
- there are concerns about the product’s safety or quality
- there is an equivalent licensed product available that will meet the special clinical needs of the individual patient
- there isn’t 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:
- single component measles, mumps and rubella vaccines
- subcutaneous immunotherapy (allergy desensitising products)
- sublingual immunotherapy (SLIT) products
- supplements from the USA
- talc preparations for pleurodesis
Supply of unlicensed medicines between Northern Ireland and Great Britain
Once imported into the United Kingdom or manufactured in the United Kingdom, unlicensed medicines may be supplied between Northern Ireland and Great Britain (England, Wales and Scotland) without making additional notifications to MHRA.
The supplier in either territory may supply the unlicensed human medicine to a person authorised to receive a medicine (such as a doctor or a hospital), or to a wholesaler in the receiving territory.
The supplier will need to confirm that there is a special clinical need for use of the medicine which is unlicensed in the receiving territory.
Fees are charged annually using a banding system based on the number of notifications you submit. Customers are provided with an estimate early in the financial year, followed by an invoice once all the information for the year is available.
A doctor may make the request to a licensed importer, or to a pharmacist who then places the order with the importer. If a doctor or pharmacist holds their own wholesaler or specials licence, they can make the order themselves.
Fees for safety and quality vetting of unlicensed imported medicines
|Number of notifications estimated for coming year||Additional sum to be paid with annual periodic fee for manufacturers licence holders and wholesale dealer licence holders £|
Combination medicines and products, which have two different medicines within one pack, are considered a single notification. Separate packs of different products would require separate notifications.
For help, email email@example.com or phone 020 3080 7002.