Pharmanager Development, provider of services and tools to guarantee the conformity and effectiveness of your products

Claims

Since the enforcement of Regulation (EU) No 432/2012, only validated nutritional and health claims can be used in the European market. This regulation requires manufacturers to ensure that their nutritional claims comply with the law when displayed on packaging, advertisements, and other communication materials.

We assist you in verifying your nutritional claims to ensure their compliance with the authorized list of nutritional claims. Our expertise also covers scientific evaluation, clinical study management, and the preparation of robust dossiers to secure the approval of your health claims by the competent authorities.

 

What are the regulations for claims?

1924/2006/EC

This regulation governs the use of nutritional and health claims, requiring them to be clear, scientifically proven, and non-misleading for consumers.

432/2012 /EU

This regulation establishes the list of authorized nutritional claims at the European level. It mandates that claims must be verified against predefined criteria before being used in marketing communications.

353/2008/EC

This regulation specifies the requirements for submitting claim authorization dossiers, including comprehensive scientific and technical data.

Verification of nutritional and health claims

 

We analyze the compliance of your claims with European regulations and compare them with the authorized claims list.

Health communication audits

We review your communication materials (packaging, advertisements, websites) to ensure that your claims meet regulatory standards.

Scientific dossier preparation

We conduct bibliographic research, analyze clinical trials, and prepare comprehensive dossiers for claim submission to regulatory authorities..

Clinical studies and risk analysis/span>

We help you set up clinical studies, establish prerequisites, and identify regulatory risks to optimize your product positioning..

Pharmanager Development supports you in :

Pharmanager Development assists you at every stage of the process to ensure the compliance of your nutritional and health claims. We help you verify the validity of your claims according to current regulatory requirements and prepare the necessary regulatory dossiers for submission to the competent authorities. Additionally, we manage the scientific and clinical studies required to validate your claims, ensuring that your products meet safety and efficacy standards. Our expertise enables you to navigate the regulatory landscape with confidence and ensure the compliance of your product communications in the market.

Un conseil, une question dans ce contexte de réglementation en évolution et de plus en plus exigeant ? Besoin d’un accompagnement expert ?