Public consultation on Good Manufacturing Practice for Medicinal Products for Human Use

Public health community

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:

• AESGP - Association of the European Self-Medication Industry
• EFPIA - European Federation of Pharmaceutical Industries and Associations
• Dutch Health Care Inspectorate
• Medicines Healthcare products Regulatory Agency (UK)

Objective of the consultation

With this public consultation, the Directorate General for Health and Food Safety seeks the view of stakeholders regarding principles and guidelines of good manufacturing practice for medicinal products for human use.The contributions received will inform the development of an Implementing Act laying down principles and guidelines of good manufacturing practice for medicinal products for human use that the Commission shall adopt pursuant to the first paragraph of Article 47 of Directive 2001/83/EC.

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:

• Quality of medicines and Good Manufacturing Practices (GMP)
• Quality of medicines and Good Manufacturing Practices (GMP) - Major developments