Mutual recognition agreements (MRA)

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.

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

Status

In operation since 1 February 2003.

In 2017, the MRA was suspended and incorporated into the Comprehensive Economic and Trade Agreement (CETA) between the EU and Canada, which applies provisionally as of September 2017. The suspended MRA will be terminated when CETA fully enters into force, pending ratification by EU Member States. 

The first Joint Sectoral Group on Pharmaceuticals under CETA met in November 2018 and agreed a number of Administrative Arrangements. More information is available from the European Commission.  

Products covered
  • human pharmaceuticals including prescription and non-prescription medicinal products or drugs and medicinal gases
  • human biologicals including immunologicals and biotherapeutics
  • human radiopharmaceuticals
  • veterinary pharmaceuticals, including prescription and non-prescription medicinal products or drugs, and pre-mixes for the preparation of veterinary medicated feeds
  • intermediate products and bulk pharmaceuticals
  • products intended for use in clinical trials or investigational medicinal products; manufactured by the manufacturers holding a manufacturing authorisation or establishment licence
  • vitamins, minerals and herbal remedies, homeopathic medicinal products (known in Canada as natural health products) manufactured by manufacturers holding a manufacturing authorisation or establishment licence in the case of Canada
Products excluded
Territorial applicability

Products manufactured in the territories of the EU and Canada (inspections of manufacturers in third countries by a regulatory authority of either party may be accepted on a voluntary basis; this provision is not currently in operation).

Agreement
Related contentPartners and networks: Canada

Israel

Status

The MRA with Israel is an agreement on conformity assessment and acceptance of industrial products (ACAA). This is a specific type of MRA based on the alignment of the legislative system and infrastructure of the country concerned with those of the EU.

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 and biological pharmaceuticals
  • human immunologicals
  • radiopharmaceuticals
  • vitamins, minerals and herbal medicines if classified as medicinal products
  • intermediate products and bulk pharmaceuticals
  • active pharmaceutical ingredients
  • excipients
  • veterinary chemical 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 applicability

Products 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.

For more information, see:

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.

For more information, see:

Agreement
More information
Related contentPartners and networks: Switzerland

United States

Status

Entered into force on 1 November 2017.

Fully operational for human medicines as of 11 July 2019, following a transition phase.

Transitory provisions apply for veterinary medicines, vaccines for human use and plasma-derived medicines.

Transition phase

During a transition phase, the authorities assess each other's pharmaceutical legislation, guidance documents and regulatory systems as part of the agreement.

Human medicines

Update: The transition phase for human medicines covered by the agreement ended on 11 July 2019:

  • the US Food and Drug Administration (FDA) completed its assessment of all 28 EU GMP inspectorates for human medicines, confiriming that they have the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the US;
  • the European Commission confirmed in June 2017 that the US FDA has the capability, capacity and procedures in place to carry out GMP inspections for human medicines at a level equivalent to the EU. 

As of 11 July 2019, qualified persons in the EU Member States do not need to batch test human medicines covered by the MRA, provided that they have verified that these controls have been carried out in the United States for products manufactured in and imported from the United States.

Veterinary medicines

The assessment of the GMP inspectorates for veterinary medicines for the veterinary scope is ongoing.

Products covered
  • Marketed finished pharmaceuticals for human use in various pharmaceutical dosage forms such as tablets, capsules, ointments, and injectables, including:
    • medical gases;
    • radiopharmaceuticals or radioactive biological products;
    • herbal (botanical) products if classified as medicinal products;
    • homeopathic products.
  • marketed biological products:
    • therapeutic biotechnology-derived biological products;
    • allergenic products
  •  intermediates;
  •  active pharmaceutical ingredients or bulk drug substance.
Products excluded
Decision expected on expansion of operational scope
Agreement
Territorial applicability

Products manufactured in the territories of the EU and United States.

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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