Commission Directive (EU) 2017/1572

of 15 September 2017

supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use1, and in particular the first paragraph of Article 47 thereof,

Whereas:

(1)
Commission Directive 2003/94/EC2 applies to both medicinal products for human use and investigational medicinal products for human use.
(2)
In accordance with Article 63(1) of Regulation (EU) No 536/2014 of the European Parliament and of the Council3 the Commission is empowered to adopt a delegated act laying down principles of good manufacturing practice for investigational medicinal products for human use. It is therefore necessary to adapt the provisions of Directive 2003/94/EC by deleting the references to investigational medicinal products for human use.
(3)

The definition of a pharmaceutical quality system and some terminology should be updated to reflect the international developments or the actual usage of that terminology of inspectors and manufacturers.

(4)

All medicinal products for human use manufactured or imported into the Union, including medicinal products intended for export, should be manufactured in accordance with the principles and guidelines of good manufacturing practice. However, for the manufacturer to be able to comply with those principles and guidelines, cooperation between the manufacturer and the marketing authorisation holder, when they are different legal entities, is necessary. The obligations of the manufacturer and marketing authorisation holder vis-à-vis each other should be defined in a technical agreement between them.

(5)

The manufacturer of medicinal products has to ensure that they are fit for their intended use, comply with the requirements of the marketing authorisation and do not place patients at risk due to inadequate quality. To achieve this quality objective reliably the manufacturer must implement a comprehensively designed and correctly implemented pharmaceutical quality system incorporating good manufacturing practice and quality risk management.

(6)

In order to ensure conformity with the principles and guidelines of good manufacturing practice, it is necessary to lay down detailed provisions on inspections by the competent authorities and on certain obligations of manufacturer.

(7)

It is necessary to ensure that all medicinal products available on the EU territory comply with the same quality standards, therefore medicinal products imported into the Union should be manufactured in accordance with standards which are at least equivalent to the good manufacturing practice standards laid down in the Union.

(8)
In order to ensure the consistent application of the principles of good manufacturing practice, manufacturers of medicinal products for human use and inspectors should consider the guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC. However, for advanced therapy medicinal products, the guideline referred in Article 5 of Regulation (EC) No 1394/20074 should be applied. Principles and guidelines of good manufacturing practice for medicinal products for human use should be set out in relation to quality management, personnel, premises and equipment, documentation, production, quality control, outsourced operations, complaints, product recall, and self-inspections. As regards the advanced therapy medicinal products those principles and guidelines should be adapted to the specific characteristic of those products in accordance with the risk-based approach.
(9)

Since many of the provisions of Directive 2003/94/EC need to be adjusted, for the sake of clarity, that Directive should be repealed.

(10)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Medicinal Products for Human Use,

HAS ADOPTED THIS DIRECTIVE: