YES Pharma Consultancy B.V. is specialized in questions coming up from the OTC market. We are experienced in the legislation of pharmaceuticals, medical devices, cosmetics and foods. We have participated in borderline discussions concerning the classification of OTC products, since it is not always obviously clear which legislation (pharmaceutical, medical device, cosmetic or food) applies to an OTC product.

We kindly refer you to the pages for pharmaceuticals and medical devices for more details about those products.

In the text below you find a short description for cosmetics and food supplements.

Cosmetics

Cosmetics are used to clean, perfume, change the appearance, protect or correct the body odours of skin, hair, nails, lips, teeth and mouth. Cosmetics in Europe must comply with the European Regulation 1223/2009. Manufacturers are obliged to have a Product Information File (PIF) available on demand and a cosmetic product must be notified in the CPNP database when placed on the market. Cosmetics can be recognized by the mentioning of a “Responsible Person” on the packaging material.

We perform safety evaluations on the ingredients of a potential cosmetic product and advise whether the product will comply with Regulation 1223/2009 or not. We prepare complete Product Information Files including i.e. a safety assessment report, description of the manufacturing method, clinical evidence for the to be used claims, and packaging texts conform Reg. 1223/2009.

Food supplements

For food and health improving products we prepare technical files and we advice in claims on the package according to the European health claims legislation.