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Good Manufacturing and Distribution Practices

Good Manufacturing Practices (GMP)

The manufacture or import of medicinal products is subject to manufacturing or import authorisation. The authorisation holder must comply with the principles and guidelines of good manufacturing practice and use active substances (active pharmaceutical ingredients) which were manufactured in compliance with GMP.

The relevant legal requirements are outlined below.

For human medicinal products and investigational medicinal products:

For veterinary medicinal products:

Eudralex Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 2003/94/EC and 91/412/EEC, respectively. Further information can be found on the website of the EMA.

Mutual Recognition Agreements (MRAs) and related agreements on GMP with third countries

The EU has MRAs on GMP with Australia, Canada, Israel, Japan, New Zealand, Switzerland and the United States. All these agreements cover human/veterinary medicines; however the detailed product scope varies. For more details please see:

First recognitions of EU and US authorities for pharmaceutical Good Manufacturing Practices inspections of veterinary products

On 30 May 2023, another milestone was reached when the US Food and Drug Administration (FDA) confirmed that the national competent authorities of Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Luxembourg, Netherlands, Poland, Portugal, Slovenia and Spain have pharmaceutical Good Manufacturing Practices (GMP) inspection capability, capacity and procedures for veterinary products, equivalent to those of the US.

At the same time, the EU also recognised the US FDA as equivalent authority for veterinary products.

On 26 September 2023, the US FDA recognised the competent authority of Sweden. On 28 November 2023, the competent authority of Latvia was recognised. The competent authority of Lithuania was recognised on 18 July 2024. Germany’s competent authority received recognition on 7 August 2024. On 8 October 2024, Cyprus joined the list of recognised authorities. Czechia followed soon after, receiving recognition on 18 October 2024. A link to the up-to-date list of recognised authorities is available below. 

This means that the EU and the US FDA can now rely on the results of pharmaceutical GMP inspections conducted on the respective territories of the parties and no longer need to duplicate inspections of manufacturing sites for veterinary products.

The basis for these recognitions is the extension of the scope of the Sectoral Annex to the EU-US Mutual Recognition Agreement to veterinary products. This extension took effect on 11 May 2023 with the EU and US signing Joint Sectoral Committee Decision 2536/2023. The Sectoral Annex has been fully effective for human medicines since July 2019.

With the entry into force of the Sectoral Annex for veterinary products both transatlantic partners have further reduced barriers to trade. The recognition of the inspection capacity and comparable procedures makes it faster and less costly to bring medicines to the market to the benefit of human and animal health, reduces administrative burden and costs from duplicating inspections, frees up inspection capacity allowing to focus on manufacturers in other countries.

The Mutual Recognition Agreement is underpinned by robust evidence that the EU and the US have comparable procedures to carry out pharmaceutical GMP inspections for veterinary products and human medicines. The work relies on Joint Audit Programme audits in all EU Member States, and on close technical cooperation between the European Medicines Agency (EMA), the US FDA and the Commission.

The assessment of the EU competent authorities continues according to a schedule agreed with the US. The target date for completion of the assessment by the US FDA of all EU veterinary authorities’ inspection capacity was set for July 2024. Due to delays resulting mostly from the COVID-19 crisis, the target date was moved to 31 January 2025.

Batch testing waiving would only start to apply when all EU veterinary authorities have been recognised by the US. From that moment on, veterinary products imported from the US would no longer need to be re-tested for quality before being made available in the EU.

Finally, technical cooperation between the EU and the US continues with a focus on a possible decision to extend the scope of the Sectoral Annex to human vaccines, and possibly at a later stage to plasma-derived medicinal products. These topics are also on the agenda of the EU-US Trade and Technology Council meetings.

11 July 2019 - EU-US MRA fully implemented for inspections of manufacturing sites for human medicines in their respective territories

EU and Japan reinforce their collaboration on inspections of medicine manufacturers

On 18 July 2018, The EU and Japan agreed to broaden the range of medicines for which they recognise each other’s inspections of manufacturing sites.

The full scope of the MRA covers chemical pharmaceuticals, homeopathic medicinal products (as long as treated as medicinal products and subject to the GMP requirements in Japan), vitamins, minerals and herbal medicines (if considered as medicinal products in both parties); certain biological pharmaceuticals including immunologicals and vaccines, active pharmaceutical ingredients (APIs) for any of the above categories and sterile products belonging to any of the above categories.

The former mutual recognition agreement (MRA) was operational since 29 May 2004. It allowed regulators to rely on Good Manufacturing Practice (GMP) inspections in each other’s territories, to waive batch testing of medicines that enter Japan from EU countries and vice versa and to share information on inspections and quality defects.

Import of active substances

Directive 2011/62/EU amending Directive 2001/83/EC introduces EU-wide rules for the import of active substances (active pharmaceutical ingredients APIs). Article 46b(2) specifies that APIs can only be imported if, they are accompanied by written confirmation from the competent authority of the exporting third country confirming similar standards of GMP and control to those of the EU.

Good Distribution Practice (GDP)

The wholesale distribution of medicinal products and active substances is an important activity. The quality and the integrity of medicinal products can be affected by a lack of adequate control. To this end, the Commission published:

The measures on good distribution practice for veterinary medicinal products and for active substances used as starting materials in veterinary medicinal products are laid down in:

Further information can be found on the website of the EMA.