Mutual recognition agreements

This content applies to human and veterinary medicines.

The European Union (EU) has signed mutual recognition agreements (MRAs) with third-country authorities concerning the conformity assessment of regulated products. Such agreements contain a sectoral annex on the mutual recognition of good manufacturing practice (GMP) inspections and batch certification of human and veterinary medicines.

MRAs allow EU authorities and their counterparts to:

  • rely on each other's GMP inspection system;
  • share information on inspections and quality defects;
  • waive batch testing of products on import into their territories;

Each agreement has a different scope.

MRAs are trade agreements that aim to facilitate market access and encourage greater international harmonisation of compliance standards while protecting consumer safety.

These agreements benefit regulatory authorities by reducing duplication of inspections on each other territory, allowing for greater focus on sites that could have a higher risk and broadening the inspection coverage of the global supply chain.

They also facilitate trade in pharmaceuticals because they reduce costs for manufacturers by reducing the number of inspections taking place at facilities and waiving re-testing of their products upon importation.

EMA role

The European Commission is responsible to negotiate MRAs with partner countries on behalf of the EU. The European Commission may consult EMA on regulatory and scientific questions as part of this process.

EMA is involved in operational activities once the MRAs are in place, including:

  • facilitating cooperation on inspections, including joint inspections and exchange of information on inspections;
  • facilitating exchange of information and being the relevant contact point between the EU GMP inspectorates and partner authorities;
  • operating the EudraGMDP database and connecting partners countries to it;
  • responding to queries on the implementation of the MRA;
  • involving partners countries in relevant EMA working groups, such as the GMP/Good-distribution-practice Inspectors Working Group;
  • coordinating MRA maintenance activities.

Partner countries

The EU has MRAs with:

Overview of specific MRAs

AUSTRALIA

Status

In operation since:

  • 1 January 1999 for human medicines;
  • 1 June 2001 for veterinary medicines.
Products covered
  • human chemical pharmaceuticals;
  • medicinal gases;
  • human biologicals, including vaccines, immunologicals and biotherapeutics;
  • human radiopharmaceuticals;
  • stable medicinal products derived from human blood or human plasma;
  • homeopathic medicines, if classified as medicinal product;
  • vitamins, minerals and herbal medicines if clasified as medicinal products;
  • products intended for use in clinical trials, investigational medicinal products (IMPs), except those used in phase I clinical trials;
  • intermediate products and bulk pharmaceuticals;
  • active pharmaceutical ingredients, only for human medicinal products;
  • veterinary chemical pharmaceuticals;
  • premixes for preparation of veterinary medicated feedstuff;
  • veterinary immunologicals, including vaccines, immunologicals and biotherapeutics.
Products excluded
Territorial applicabilityProducts manufactured in the territories of the EU and Australia.
Exchange of information

Exchange of certificates of GMP compliance for manufacturers and batch certificates.

A two-way alert system is in operation.

Agreement
Related contentPartners and networks: Asutralia

CANADA

StatusIn operation since 1 February 2003
Products covered
  • human chemical pharmaceuticals;
  • medicinal gases;
  • human biologicals, including vaccines, immunologicals and biotherapeutics;
  • human radiopharmaceuticals, vitamins, minerals and herbal medicines classified as natural health products (NHP) if manufacturing sites hold an establishment licence in addition to the site licence required under the Natural Health Products Regulations;
  • products intended for use in clinical trials, investigational medicinal products (IMP) limited to manufacturers holding a manufacturing authorisation / establishment licence;
  • intermediate products and bulk pharmaceuticals;
  • veterinary chemic pharmaceuticals;
  • premixes and preparation of veterinary medicated feedstuff;
Products excluded
Territorial applicabilityProducts manufactured in the territories of the EU and Canada.
Agreement
Related contentPartners and networks: Canada

ISRAEL

Status

In operation since 19 January 2013

(after Israel had implemented the relevant EU legislation and aligned its GMP standards, inspection procedures and forms to those used in the EU)

Products covered
  • human chemical pharmaceuticals;
  • human radiopharmaceuticals;
  • vitamins, minerals and herbal medicines if classified as medicinal products;
  • intermediate products and bulk pharmaceuticals;
  • active pharmaceutical ingredients;
  • excipients;
  • veterinary chemic pharmaceuticals;
  • premixes and preparation of veterinary medicated feedstuff;
  • veterinary biologicals except immunologicals.

Israel and the EU recognise official batch releases carried out by each other's authorities.

Products excluded
Territorial applicabilityProducts manufactured in the territories of the EU and Israel and manufacturers in third countries inspected by the regulatory authority of either party if the product also undergoes re-control in one of the parties.
Exchange of information

Exchange of certificates of GMP compliance for manufacturers and batch certificates.

A two-way alert system is in operation.

Agreement
More information
Related contentPartners and networks: Israel

JAPAN

Status

In operation since 29 May 2004 with limited scope

Updated in July 2018 to to include sterile and biological products and active pharmaceutical ingredients. This scope extension is effective as of 17 July 2018.

Products covered

human medicines only, including:

  • chemical pharmaceuticals;
  • homeopathic medicinal products if classified as medicinal products and subject to GMP requirements in Japan;
  • vitamins, minerals and herbal medicines if classified as medicines in the both parties;
  • biological pharmaceuticals, including immunologicals and vaccines, that are:
    • produced by cell culture utilising natural or recombinant microorganisms or established cell lines;
    • derived from non-transgenic plants and non-transgenic animals;
  • active pharmaceutical ingredients of any medicine covered in the agreement;
  • sterile medicines that belong to any of the above categories;
Products excluded
Territorial applicabilityProducts manufactured in the territories of the EU and Japan.
Exchange of information

Exchange of certificates of GMP compliance for manufacturers through the EudraGMDP database and batch certificates.

A two-way alert system is in operation.

Agreement
Related contentPartners and networks: Japan

NEW ZEALAND

Status

In operation since:

  • 1 January 1999 for human medicines;
  • 1 June 2001 for veterinary medicines.
Products covered
  • human chemical pharmaceuticals;
  • medicinal gases;
  • human biologicals, including vaccines, immunologicals and biotherapeutics;
  • human radiopharmaceuticals;
  • stable medicinal products derived from human blood or human plasma;
  • homeopathic medicines, if classified as medicinal product;
  • vitamins, minerals and herbal medicines if classified as medicinal products;
  • products intended for use in clinical trials, investigational medicinal products (IMPs);
  • intermediate products and bulk pharmaceuticals;
  • veterinary chemical pharmaceuticals;
  • premixes for preparation of veterinary medicated feedstuff;
  • veterinary immunologicals, including vaccines, immunologicals and biotherapeutics.
Products excluded
Territorial applicabilityProducts manufactured in the territories of the EU and New Zealand, except Tokelau
Exchange of information

Exchange of certificates of GMP compliance for manufacturers and batch certificates.

A two-way alert system is in operation.

Agreement
Related contentPartners and networks: New Zealand

SWITZERLAND

StatusIn operational since 1 June 2002
Products covered
  • human chemical pharmaceuticals;
  • medicinal gases;
  • human biologicals, including vaccines, immunologicals and biotherapeutics;
  • human radiopharmaceuticals;
  • stable medicinal products derived from human blood or human plasma;
  • advanced therapy medicinal products;
  • homeopathic medicines, if classified as medicinal product;
  • vitamins, minerals and herbal medicines if classified as medicinal products;
  • products intended for use in clinical trials (investigational medicinal products - IMPs);
  • active pharmaceutical ingredients;
  • intermediate products and bulk pharmaceuticals;
  • veterinary chemical pharmaceuticals;
  • premixes for preparation of veterinary medicated feedstuff;
  • veterinary immunologicals, including vaccines, immunologicals and biotherapeutics.

Switzerland and the EU recognise official batch releases carried out by each other's authorities.

Territorial applicabilityProducts manufactured in the territories of the EU and Switzerland and manufacturers in third countries inspected by the regulatory authority of either party if the product also undergoes re-control in one of the parties.
Exchange of information

Exchange of information on manufacturing/import authorisations and GMP compliance and non-compliance including through the EudraGMDP database.

A two-way alert system is in operation.

Agreement
More information
Related contentPartners and networks: Switzerland

UNITED STATES

StatusEntered into force on 1 November 2017 but will be in transition phase until July 2019.
Transition phase

The authorities will assess each other's pharmaceutical legislation, guidance documents and regulatory systems as part of the agreement. As the US Food and Drug Administration (FDA) will assess each EU Member State authority individually, a transition phase will be in place until July 2019.

In June 2017, the European Commission confirmed that the US FDA has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU.

Update: In September 2018, the FDA confirmed the capability of Portugal. This follows confirmation of the capability of:

  • Ireland and Lithuania in June 2018;
  • the Czech Republic, Greece, Hungary, and Romania in March 2018;
  • Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom in November 2017.

This means that the FDA can now rely on a total of 15 Member States to replace their own inspections.

Imported products still need to be batch tested until the FDA recognises all EU Member States' authorities for human pharmaceuticals.

Products covered
  • human chemical pharmaceuticals;
  • medicinal gases;
  • human biologicals, including immunologicals and biotherapeutics;
  • human radiopharmaceuticals;
  • homeopathic medicines if classified as medicinal products;
  • vitamins, minerals and herbal medicines if classified as medicinal products;
  • active pharmaceutical ingredients;
  • intermediate products and bulk pharmaceuticals.
Products excluded
Decision expected on expansion of operational scope
  • veterinary medicines: by 15 July 2019;
  • vaccines for human use and plasma-derived medicines: by 15 July 2022;
  • products intended for use in clinical trials (investigational medicinal products): at a later stage. These products will be only covered if they are inspected by the FDA.
Agreement
Territorial applicabilityProducts manufactured in the territories of the EU and United States and manufacturers in third countries inspected by the regulatory authority of either party ('voluntary acceptance').
Exchange of information

Exchange of official GMPs documents.

A two-way alert system is in operation.

More information

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