Medicinal products for human use
Public consultation on the concept paper concerning the delegated act on the criteria to be considered and the verifications to be made when assessing the potential falsified character of medicinal products
A concept paper has been submitted for public consultation concerning the delegated act on the criteria to be considered and the verifications to be made when assessing the potential falsified character of medicinal products introduced in the Union but not intended to be placed on the market.
Period of consultation
From 6 September 2012 to 10 December 2012.
Contributions to and results of the consultation
Below are the public responses to the above-mentioned public consultation:
- AEFI - The Spanish Association of Pharmacists in Industry
- Austrian Federal Office for Safety in Health Care
- BPI - German Pharmaceutical Industry Association
- The Norwegian Medicines Agency
- EAEPC - European Association of Euro Pharmaceutical Companies
- EFPIA - European Federation of Pharmaceutical Industries and Associations
- EGA - European Generic Medicines Association
- EUCOPE - European Confederation of Pharmaceutical Entrepreneurs
- Irish Medicines Board and Irish Customs Administration
- CPSU, MHEC (Malta)
- AEMPS (Spain)
- MHRA (UK)
- SGAE (France)
- Roy Vancauwenberghe
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.