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 assists you with :
- Suggestions of authorised generic claims.
- Claim audits (assessing how well your marketing, proposals and recommendations comply with regulations).
- The stages prior to providing scientific substantiation for a health claim (articles 13-5 and 14), by:
- Performing a thorough literature search and an analysis of the state of the art
- Assessing the quality of your clinical trials
- Choosing the wording ofyour claim
- Organising a clinical study, if necessary, including:
- – Establishing the prerequisites
- – Assisting with CRO dealings (partnership with Biofortis)
- Putting together your application and following up with the authorities during the assessment 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