List of approved countries
Updated 22 December 2021
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This publication is available at https://www.gov.uk/government/publications/list-of-approved-countries-for-authorised-human-medicines/list-of-approved-countries
1. List of approved countries
The Human Medicines Regulations 2012 refers 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”)
The UK will accept certification by a Qualified Person and Active Substance manufacture from countries specified in these lists. These lists will initially include EEA countries and other countries with whom regulatory equivalence has been confirmed. The lists will be reviewed at least every 3 years.
The UK’s acceptance of batch testing done in EEA countries will be reviewed before 31 December 2022. A two-year notice period will be given in the case of changes.
2. Approved country for import list
Regulation 18A of the Human Medicines Regulations 2012 will allow importation of human medicines into Great Britain 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
- 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 Non-EEA countries with existing Mutual Recognition Agreements (MRA)
- Australia
- Canada
- Israel
- Japan
- New Zealand
- Switzerland
- 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 1 January 2021. 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
- Vaccines
- Advanced Therapy Medicinal Products
- Medicinal products derived from human blood or blood plasma
3.2 EU countries
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czech Republic
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Latvia
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
3.3 The European Economic Area (EEA)
EU countries, plus Iceland, Liechtenstein and Norway.
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:
4.1 EU countries
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czech Republic
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Latvia
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
4.2 The European Economic Area (EEA)
EU countries, plus Iceland, Liechtenstein and Norway.
4.3 Non-EEA countries
- Australia
- Brazil
- Israel
- Japan
- Republic of Korea
- Switzerland
- United States of America