Brexit has affected all sectors of the economy, and the pharmaceutical industry is no exception. This industry in the UK provides tens of thousands of jobs and billions in tax revenue and research investment.
If you own a business related to importing and exporting pharmaceutical products, you need to be up to date on the latest rules and regulations.
Importing pharmaceutical products to the UK
- Importing a licensed medicine
If you want to import a licensed medicine, you need to apply to The Medicines and Healthcare products Regulatory Agency (MHRA) for one or more licences:
- wholesale
- manufacturer
- marketing authorisation (MA)
- Applying for a wholesaler licence
From 1st January 2021, a wholesale dealer in Great Britain may only import medicines from the European Economic Area (EEA) if the Responsible Person makes certain checks for import.
- Applying for a manufacturer licence
You 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 land for import list.
- Applying for a marketing authorisation (MA) licence
You need to have an MA licence to sell medicine. There are many types of MA licences, so the process you need to follow depends on the type of MA licence you need.
A Qualified Person (QP) named in the manufacturer/importer licence must certify that it has been manufactured and tested according to:
Centrally Authorised Market Authorisations (CAP MAs) have been automatically converted into GB MAs (England, Wales & Scotland) since 1st January 2021. Existing CAPs will remain valid for marketing products in Northern Ireland.
- Importing 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),
- licensed medicines do not work for the particular clinical needs of a patient (called a unique product)
- there are no licensed medicines available for the clinical needs of a patient (also called a unique product)
Export of pharmaceutical products
- Medicines
To export medicines, you must:
- check you have a drug manufacturer, wholesale dealer and marketing licence – if you don’t, apply for the licence
- check if you need an export certificate – contact your importer or the authority in the destination country to find out
There are five types of certificates depending on the requirements of the importing country:
- Certificate of a pharmaceutical product (licensed) which specifies: the marketing authorisation holder, the active ingredients and excipients, the manufacturing, packaging and batch release sites, whether or not the product is on the market in the UK
- Certificate of a pharmaceutical product (unlicensed) which certifies that the drug has been manufactured in the UK and you have a manufacturer licence for the drug
- Certificate of manufacturing status which confirms that the named sites on a specified manufacturer licence meet good manufacturing practises requirements
- Certificate of licensing status – for importing agents who must screen bids made by an international tender for licensed or unlicensed products (excluding specials)
- Certificate for the importation of a pharmaceutical constituent – the specific active ingredient or excipient must be in either a current licensed human medicine or national or international pharmacopoeia (official standards for pharmaceutical substances and drugs)
- Controlled drugs
If your drug is on the list of common controlled drugs, you need a Home Office controlled drug licence to export it. In addition to any domestic licence, you need to possess the drug in the UK.
If your drug is not on the list, but you think it might have the properties of a controlled drug, check the relevant legislation to find it out.
Your licence is valid for up to 2 months (or until your import permit expires, if sooner).
Bottom line
The EU-UK Trade and Cooperation Agreement, signed on 30th December 2020, contains a wide range of provisions on the import and export of pharmaceutical products, including mutual recognition of Good Manufacturing Practice (GMP) inspections and certificates.
However, a lot of uncertainties and concerns remain. The only way to prevent possible surprises and damage to your business is to keep informed.
If you want to learn more about valuable topics, read our blog.
Sources:
https://www.gov.uk/guidance/export-drugs-and-medicines-special-rules#medicines
https://www.gov.uk/guidance/import-a-human-medicine
https://www.gmp-compliance.org/gmp-news/brexit-how-to-import-medicines-into-uk
BREXIT: Pharmaceutical Products and Import/Export – Key Changes