This is a Quick Guide to Importing a human medicine to the UK.
Import a licensed medicine.
You'll need to apply for one or more licences if you want to import a licenced medicine:
Wholesale Licence (also known as a wholesale dealer licence or wholesaler distribution authorisation).
Manufacturer Licence.
Marketing Authorisation licence.
Wholesale and manufacturing licences are issued by the Medicines and Healthcare Products Regulatory Agency. The MHRA aims to complete all applications within 90 days.
Apply for a wholesaler licence.
If you plan to import medicine from the following countries, you'll need to apply for a wholesaler licence.
A country on an approved country for import list, or a country in the European Economic Area if you're in Northern Ireland, and then supplying it to another country, including the UK.
A country that isn't approved for import and exports it to a country that isn't approved for import, or if you're in Northern Ireland, an EEA country that exports to a non-EEA country.
The type of application determines the amount you pay, the number of sites, and the total amount of money you make selling licenced human medicines.
Once you are ready with your licences and other documentation, you can use Customs-Declarations dot UK's platform for filing your customs declaration swiftly and effortlessly.
Apply for a manufacturer licence.
If you want to import medicine from a country that isn't on the approved country for import list for use in the UK or supply it to a country on the approved country for import list, 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 to another EEA country, you'll need to apply for a manufacturing licence in Northern Ireland.
Apply for a marketing authorisation licence.
Before you may sell human medicine, you must first obtain an MA licence. Because there are many different sorts of MA licences, the procedure you must take is determined by the type of MA licence you require.
A Qualified Person listed in the manufacturer or importer licence, must certify that a drug has been prepared and tested according to good manufacturing practice before being supplied to the market.
Customs-Declarations dot UK, makes it easy for you to maintain and track your authorisations on a single platform and easily link those with your customs declaration.
Import an unlicensed medicine.
You can import an unlicensed medicine if you meet the following criteria:
You import it from a country that isn't approved for import and then export it to a country that isn't approved for import (called an introduced product).
You are in Northern Ireland, and you are importing it from a non-EEA country to export it to another non-EEA country (called an introduced product).
Licensed medicines do not work for a patient's unique clinical needs (called a special product).
No licenced medication are available to meet a patient's clinical demands (also called a special product).
Import an introduced product.
To import an introduced product into the UK, you must be a licenced wholesale dealer.
Only a person authorised to import or supply medicinal items through wholesale distribution in a country other than an approved country or in Northern Ireland in a non-EEA country may receive an introduced medicine.
Import a special product.
If you're importing medicine from a country that isn't on the list of recognised countries for import, or if you're in Northern Ireland from outside the EEA, you'll need to apply for a manufacturer 'specials' licence.
You will also need to make a notification of intent to import an unlicensed medicine 28 days before you do so.
