Batch testing (quality control testing) of human medicines will be accepted from the following countries. 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.
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
- The European Economic Area (EEA)
- EU countries, plus Iceland, Liechtenstein and Norway.
- 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.
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
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
The European Economic Area (EEA)
EU countries, plus Iceland, Liechtenstein and Norway.
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:
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
The European Economic Area (EEA)
- EU countries, plus Iceland, Liechtenstein and Norway.
Non-EEA countries
- Australia
- Brazil
- Israel
- Japan
- Republic of Korea
- Switzerland
- United States of America