Guidance

List of approved countries for clinical trials and investigational medicinal products

Updated 22 December 2021

The Medicines for Human Use (Clinical Trials) Regulations 2004 will refer 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 Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, which inserted these requirements into the Clinical Trials regulations came into force on 1 January 2021.

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.

1. 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:

1.1 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.

1.2 The European Economic Area (EEA)

EU countries, plus Iceland, Liechtenstein and Norway.

2. 2. Approved countries where a clinical trial sponsor, or their legal representative, may be established

Regulation 3(11)(a) of the Medicines for Human Use (Clinical Trials) Regulations 2004 will refer to a list of countries where a sponsor of a clinical trial, or their legal representative, may be established.

These countries are:

2.1 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.

2.2 The European Economic Area (EEA)

EU countries, plus Iceland, Liechtenstein and Norway.

3. 3. Approved countries for Qualified Person (QP) certification of investigational medicinal products (IMPs)

Regulations 43(2A) and 43A and 43A of the Medicines for Human Use (Clinical Trials) Regulations 2004 will refer to a list of countries approved for batch control (QP certification) and import of IMPs into Great Britain (GB) from outside the UK.

If you are a QP named on a UK manufacturing and import authorisation for IMPs (MIA(IMP)) you are not required to recertify an IMP on importation to Great Britain from outside 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 also not required to recertify comparator products that are imported into GB from outside the UK which have a marketing authorisation granted by a country on the approved country for import list or Northern Ireland. There must be evidence to show that products with a marketing authorisation in an approved country for import list has been QP certified in a country on that list.

There is no requirement to confirm QP certification in respect of products obtained from a Northern Ireland wholesaler or manufacturer.

Comparator products should be obtained via the relevant regulatory route for that product. Guidance on importation of such products has also been published.

Guidance on implementing an oversight process by the UK MIA(IMP) holder responsible for import to Great Britain is also published.

The following countries are approved for batch control (QP certification) and import of IMPs to Great Britain from outside the UK.

3.1 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.

3.2 The European Economic Area (EEA)

EU countries, plus Iceland, Liechtenstein and Norway.