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Public Health

Public consultation on the Commission Delegated Act on principles and guidelines on good manufacturing practice for Investigational Medicinal Products and on inspection p

Period of consultation

From 28 August 2015 to 24 November 2015.

Contributions to and results of the consultation

A summary of the responses is available here.

Below are the public responses to the above-mentioned public consultation.

Objective of the consultation

Article 63(1) requires the European Commission to:

  • adopt delegated acts to specify the principles and guidelines on good manufacturing practice and detailed arrangement for inspection for ensuring the quality of investigational medicinal products; and
  • adopt and publish detailed guidelines in line with those principles of good manufacturing practice for investigational medicinal products.

Two public consultations are carried out to seek the views of stakeholders on and inform the development of such delegated acts and guidelines.

The consultation document

The consultation document can be downloaded here.

Protection of personal data

The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.

Specific privacy statement

Please consult the Privacy Statement to be downloaded here.

Additional information: