Details
- Status
- Closed
- Opening date
- Deadline
- Department
- Directorate-General for Health and Food Safety
Target audience
Public health community
Why we are consulting
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.
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The following respondent requested its response not to be published: TEVA.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:
- Agencia Española de Medicamentos y Productos Sanitarios
- AESGP - Association of the European Self-Medication Industry
- APIC - Active Pharmaceutical Ingedients Committee : [1] - [2]
- AssICC - Associazione Italiana Commercio Chimico
- Bayerisches Staatsministerium für Umwelt und Gesundheit
- Bayer
- Bogin (the Netherlands)
- BPTF - Bulk Pharmaceuticals Task Force (US)
- Brial Allergen
- Bundesministerium für Gesundheit (Germany)
- China State Food and Drug Administration
- Czech Republic
- DSM Nutritional Products Ltd. (Switzerland)
- EDQM - European Directorate for the Quality of Medicines & Healthcare
- EFCG - European Fine Chemicals Group : [1] - [2]
- EFPIA - European Federation of Pharmaceutical Industries and Associations : [1] - [2]
- EGA - European Generic medicines Association
- EGS - European Glaucoma Society
- EIGA - European Industrial Gases Association : [1] - [2]
- EIPG/GPIE - The European Industrial Pharmacists Group
- EUCOPE - European Confederation of Pharmaceutical Entrepreneurs
- France
- IPFA - International Plasma Fractionation Association
- Italy - Agenzia Italiana del Farmaco
- Ministry of Health, Welfare and Sport (the Netherlands)
- NVC Netherlands Packaging Centre
- PDA - Parenteral Drug Association Europe gGmbH
- PHARMIG - Association of the Austrian pharmaceutical industry
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.