Details
- Status
- Closed
- Opening date
- Deadline
- Department
- Directorate-General for Health and Food Safety
Target audience
Public health community
Why we are consulting
Period of consultation
From 7 December 2011 to 23 March 2012.
Contributions to and results of the consultation
TEVA, the Freie und Hansestadt Hamburg, and the Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten asked not to publish their responses.
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 Ingredients Committee
- ASMI - Australian Self-Medication Industry : [1] - [2]
- Bogin - Bond van de Generieke Geneesmiddelenindustrie Nederland
- BPI - German Pharmaceutical Industries Association : [1] - [2]
- Brazil - Brazilian Government
- EDQM - European Directorate for the Quality of Medicines & HealthCare
- EFCG - European Fine Chemicals Group
- EFPIA - European Federation of Pharmaceutical Industries and Associations : [1] - [2] - [3]
- EGA - European Generic medicines Association
- EIPG - European Industrial Pharmacists' Group
- EUCOPE - European Confederation of Pharmaceutical Entrepreneurs
- IPFA - International Plasma Fractionation Association
- Japan - Mission of Japan to the European Union
- Republic of Latvia
- Lonza Group Ltd.
- H. Lundbeck
- MHRA - Medicines and Healthcare products Regulatory Agency : [1] - [2]
- Ministry of Health, Welfare and Sport (the Netherlands)
- PHARMIG - The association of the Austrian pharmaceutical industry
- PIC/S - Pharmaceutical Inspection Co-operation Scheme
The consultation document
The consultation document can be downloaded here.
Objective of the consultation
Directive 2011/62/EU introduces EU-wide rules for the importation of active substances: According to Article 46b(2) of Directive 2001/83/EC, active substances shall only be imported if, inter alia, the active substances are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing the exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the Union. The requirement of a written confirmation is waived for third countries listed by the Commission in accordance with Article 111b of Directive 2001/83/EC. Article 111b(2) of Directive 2001/83/EC provides that the Commission adopts an implementing measure to apply these requirements. This concept paper is being rolled out for public consultation with a view to preparing this implementing act.
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.