Since 25th May 2012, Commission Regulation (EU) No 432/2012 establishes a list of health claims. Manufacturers must ensure that all of their health messages (packaging, advertising, websites, etc.) comply with it. Since 14th December 2012, only generic claims authorised by this regulation and those pending a decision by the European Commission may be used for marketing in the European market.
Pharmanager Development support you in :
- Suggesting authorized generic claims.
- Realizing claim audits (evaluation of the regulatory compliance of your communication, proposals / recommendations).
- Realizing claim application files :
- Exhaustive bibliographic research and analysis of the state of the art.
- Evaluation of the quality of your clinical trials.
- Choice of the claim formulation.
- Setting up a clinical study if necessary :
- Setting up the prerequisites.
- Assistance with the CRO (partnership with Biofortis).
- Constitution and follow-up of the file with the authorities during the evaluation process.
Thanks to our team’s expertise and the tools we use, we are able to give reliable, fast and effective advice (our database lists all claims, including more than 4,000 entries or approximately 10,000 ingredient/claim pairs).
Strategies for adapting to claims regulation