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List of approved countries from “01 January 2021” Attaching an updated word file

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

Source: MHRA guideline on from 1 January 2021, the UK will accept certification by a Qualified Person and Active Substance manufacture from countries specified in these lists. Lists will initially include EEA countries and other countries with whom regulatory equivalence has been confirmed. The UK will also accept batch testing done in EEA countries for a period of 2 years after the end of the transition period, until 1 January 2023.

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