Strategy

Cosmetics are regulated differently around the globe. While some countries require dossiers for registration, others only require a notification or a simple declaration [e.g. Special use (SUC) and Non special use (non-SUC) Cosmetics, functional cosmetics, general cosmetics, natural cosmetics, grade I and II cosmetics, OTC monograph, quasidrugs]. Due to the continuously evolving nature of the regulatory environment, it is becoming more challenging for professionals to fine tune best fast moving consumer goods (FMCG) strategy.

How can we help?

EUDRAC can retrieve the latest regulatory requirements to establish the correct strategy to market a product / a brand in a specific market

• EUDRAC helps manufacturers, distributors and marketers of cosmetics
• EUDRAC can support cosmetics strategy ‘à la carte’ or as end to end project
• Consultants at EUDRAC have the ability to think outside the box, challenge the team and bring strong global regulatory arguments to ensure the best outcome for the business.

EU 1223/2009

European regulation 1223/2009 came into force in July 11, 2013 with the intent to ensure a high level of protection of human health and establishing standards for cosmetics in the EU market.

How can we help?

EUDRAC can manage clients’ portfolios to meet the regulation

• Towards a well-established matrix of delegations, EUDRAC can offer Responsible Person’s full services and be partner of choice to commercialise cosmetics within the European Union
• EUDRAC manages the writing of the Product Information File with the support of external registered (ERT) Toxicologists
• EUDRAC can collect the regulatory documentation from suppliers and other important requirements to ensure compliance

International

Cosmetic definition varies country to country and products are regulated according to local legislation. Harmonisation across countries is in its early stages.

How can we help?

EUDRAC brings strong expertise in the international management of cosmetic products

• EUDRAC helps EU manufacturers to export their cosmetic products in several countries around the globe including but not limited to USA, Mexico, Brazil, China, South Korea, Middle-East
• Our team is highly knowledgeable when it comes to OTC monograph management in the USA
• EUDRAC helps manufacturers when it comes to site inspection

Safety and Cosmetovigilance

Beyond the effectiveness of cosmetic products, safety is the other pillar of their global development

How can we help?

• EUDRAC helps manufacturers to design clinical programme that meets their product’s claims and safety objectives
• EUDRAC helps manufacturers to review and assess claims and safety from literature search or clinical studies
• EUDRAC can support cosmetovigilance services, e.g. regular cosmetovigilance intelligence reviews and training for our clients; specific support for audits and inspections can be provided.