List of approved countries for clinical trials and investigational medicinal products if the UK leaves the EU without a deal
Updated 10 October 2019
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This publication is available at https://www.gov.uk/government/publications/guidance-on-importation-of-investigational-medicinal-products-from-approval-countries/list-of-approved-countries-for-clinical-trials-and-investigational-medicinal-products-if-the-uk-leaves-the-eu-without-a-deal
This guidance follows on from the further guidance note published on 3 January 2019.
The Medicines for Human Use (Clinical Trials) Regulations 2004 refers to lists of countries for the purposes of:
- defining a ‘marketing authorisation’
- approved countries where a clinical trial sponsor, or their legal representative, may be established
- recognising Qualified Person certification of investigational medicinal products.
The draft legislation that inserts these regulations in to the Clinical Trials regulations has not yet been approved by the Houses of Parliament.
This guidance provides the lists of countries and a summary of the circumstances under which the lists can be used.
These lists will be reviewed at least every three years, beginning from the day the UK leaves the EU.
1. Approved countries for definition of ‘marketing authorisation’
Regulation 2A of the Medicines for Human Use (Clinical Trials) Regulations 2004 will refer to a list of countries for the purpose of the definition of “marketing authorisation”. Where an investigational medicinal product has a marketing authorisation in a listed country and the product is to be used in accordance with the terms of that authorisation, the summary of product characteristics (SmPC), or equivalent document, relating to that product would be accepted as an alternative to the investigator’s brochure in a clinical trial application.
Products with marketing authorisations in the listed countries would also be exempted from the written authorisation procedure for clinical trials involving medicinal products with special characteristics. These countries are:
EU countries
Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.
The European Economic Area (EEA)
EU countries, plus Iceland, Liechtenstein and Norway.
2. Approved countries where a clinical trial sponsor, or their legal representative, may be established
Regulation 3(11)(a) of the Regulations will refer to a list of countries where a sponsor of a clinical trial, or their legal representative, may be established. These countries are:
EU countries
Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.
The European Economic Area (EEA)
EU countries, plus Iceland, Liechtenstein and Norway.
3. Approved countries for Qualified Person (QP) certification of investigational medicinal products (IMPs)
Regulations [43] and 43A of the Regulations will refer to a list of countries approved for batch control (QP certification) and import of IMPs to the UK.
If you are a QP named on a UK manufacturing and import authorisation (MIA(IMP)) you are not required to recertify an IMP on importation to the UK when there is evidence to show that it has been QP certified in a listed country. The listed country QP certification should refer to the relevant UK clinical trial.
You are not required to recertify comparator products which have a marketing authorisation granted by a country on the approved country for import list[^1], provided that there is evidence to show that it has been QP certified in a country on that list.
Guidance on implementing an oversight process by the UK MIA(IMP) holder responsible for import to the UK is also published.
The following countries are approved for batch control (QP certification) and import of IMPs to the UK.
EU countries
Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.
The European Economic Area (EEA)
EU countries, plus Iceland, Liechtenstein and Norway.
[^1] Approved country for import list as described in regulation 18A of the Human Medicines Regulations 2012. The countries included on this list is available in further guidance.