Medicinal products for human use
Public consultation on phasing-in requirements on a black symbol identifying medicinal products subject to additional monitoring
Period of consultation
From 21 November 2012 to 10 January 2013.
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:
- AEFI - Spanish Association of Pharmacists in industry
- AESGP - Association of the European Self-Medication Industry
- BPI - German Pharmaceutical Industry Association
- EFPIA - European Federation of Pharmaceutical Industries and Associations
- EGA - European Generic Medicines Association
- EIPG - European association for industrial pharmacists
- EUCOPE - European Confederation of Pharmaceutical Entrepreneurs
- PPTA - Plasma Protein Therapeutics Association
- Spirig Pharma AG
- Thalassaemia International Federation - LC
All citizens and organisations (public and private) are welcome to contribute to this consultation.
Objective of the consultation
Under the new pharmacovigilance provisions some medicinal products for human use are authorised subject to additional monitoring for reasons of their specific safety profile. Those products have to bear a black symbol which shall be selected by the Commission by July 2013 at the latest. In the context of selecting the symbol the Commission is currently considering the need for phasing-in arrangements for the inclusion of the symbol in the summary of product characteristics and the package leaflet of all products concerned.
This concept paper is being rolled out for public consultation with a view of receiving feedback from stakeholders on this issue.
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.