Medicinal products for human use

Public consultation on the concept paper concerning the Delegated act on the principles and guidelines of good manufacturing practice for active substances in medicinal products for human use

 
 

Period of consultation

From 20 January 2012 to 20 April 2012.

Contributions to and results of the consultation

The following respondent requested its response not to be published: TEVA.

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

The consultation document

The consultation document can be downloaded here.

Objective of the consultation

Directive 2011/62/EU places an obligation on Member States to take appropriate measures to ensure that manufacturers of active substances on their territory comply with good manufacturing practice ('GMP') for active substances. It also places an obligation on the Commission to adopt, by means of delegated acts, the principles and guidelines of good manufacturing practice for active substances. This concept paper is being released for public consultation with a view to preparing the delegated act on principles and guidelines of good manufacturing practice for active substances in medicinal products for human use.

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.

Additional information: