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4. Regulatory strategy and impact on product development
Identifying and analyzing regulatory difficulties and risks upstream of product development is essential. The result is the regulatory strategy for bringing the product to market, a strategy which, right from the design phase, makes it possible to identify possible claims and requirements, having an impact on product development. Determining regulatory status is crucial, as it determines :
possible claims, and the level of evidence provided to support them;
product composition ;
regulatory and administrative constraints with which the company must comply (file, notification, compulsory information, etc.);
the tests to be implemented.
4.1 Impact...
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Regulatory strategy and impact on product development
Conclusion
Bibliography
Websites
National Agency for the Safety of Medicines and Health Products http://ansm.sante.fr/
BAILLY (M.), Dental products back on the market http://www.lsa-conso.fr
French Union for Oral Health http://www.ufsbd.fr/
...Events
Perfumes and Cosmetics Congress – Regulatory issues, held every year in Paris http://www.congres-parfumscosmetiques.com/fr/
Cosmetagora tradeshow, held every year in Paris http://www.cosmetagora.fr/
Salon Beyond Beauty,...
Standards and norms
- Oral medicine – Toothpastes – Requirements, test methods and marking - ISO/DIS 11609 -
Regulations
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 Nov. 2009 on cosmetic products, OJ L 342, 22 Dec. 2009, p. 59-209.
Commission Regulation (EU) No. 655/2013 of July 10, 2013 laying down common criteria that cosmetic claims must meet in order to be used, OJ L 190, July 11, 2013, pp. 31-34.
Patents
Stripe toothpaste, color-stable, WO 1998020849 A1.
Toothpaste made from coloured silica, WO 2005046631 A1.
Directory
Manufacturers – Suppliers – Distributors (non-exhaustive list)
Directory of cosmetics professionals http://www.cosmetic-valley.com/annuaire/
Organizations – Federations – Associations (non-exhaustive list)
Cosmetic Valley, the world's leading perfumery and cosmetics network
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