List of approved countries for authorised human medicines on exit day

Published 11 March 2019

1. List of exit day approved countries

If the UK leaves the EU without a deal, the Human Medicines Regulations 2012 will refer to lists of approved countries for:

Importation of medicines under a wholesale dealer’s licence (“approved country for import list”)
Batch testing of medicines (“approved country for batch testing list”)
Manufacturing of active substances with regulatory standards equivalent to the UK (“approved country for active substances list”)

On exit day, the UK will accept batch testing (quality control testing), certification by a Qualified Person and Active Substance manufacture from countries specified in these lists, subject to any relevant conditions or restrictions that existed in arrangements with the EU immediately before exit day. They will be reviewed at least every three years (but no earlier than two years after exit day in the case of EEA States on those lists).

2. Approved country for import list

Regulation 18A of the Human Medicines Regulations 2012 will allow importation of human medicines under a UK wholesale dealer’s licence from the following countries, provided that the UK wholesale dealer confirms that each batch has been certified by a Qualified Person (QP) in a listed country. Further guidance is available on importation of medicines for a listed country and the steps required to verify QP certification.

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. List of countries approved for Batch testing

Batch testing (quality control testing) of human medicines will be accepted from the following countries under paragraph 14(1)(b) of Schedule 7 of the Human Medicines Regulations 2012:

3.1 EU countries

3.2 The European Economic Area (EEA)

EU countries, plus Iceland, Liechtenstein and Norway.

3.3 Non-EEA countries with existing EU Mutual Recognition Agreements (MRA)

Australia, Canada, Israel, Japan, New Zealand, Switzerland and the United States of America.

There will be the same restrictions on the acceptance of batch testing from non-EEA countries as were in place immediately before exit day. The products not included in the scope of these agreements are:

Australia * Advanced Therapy Medicinal Products

Canada * Medicinal products derived from human blood or blood plasma * Advanced Therapy Medicinal Products

Israel * Medicinal gases * Homeopathic products * Medicinal products derived from human blood or blood plasma * Advanced Therapy Medicinal Products

Japan * Medicinal gases * Medicinal products derived from human blood or blood plasma * Advanced Therapy Medicinal Products

New Zealand * Advanced Therapy Medicinal Products

United States of America * No batch testing is accepted. The EU-USA MRA that does not include batch testing in scope until the USA assessment of EU Member State equivalence has been completed. This remains under review.

4. List of countries with equivalent regulatory standards for the manufacture of active substances

Regulation 450 of the amended Human Medicines Regulations 2012 will require the competent authority of the exporting country of the active substance manufacturer to issue a written confirmation of good manufacturing practice and regulatory oversight equivalent to that of the UK.

This is not required if the active substance manufacturer is in an approved country.

These approved countries are: