ABSTRACT
The European Economic Community (EEC) have Council Directive 76/768/ EEC up to the 27th Amending Directive 2003/15/EC and including the previous 26 amendments and this has to be translated into the language of each member state. In the United Kingdom, the law is Statutory Instrument 2004 No. 2152, The Cosmetic Products (Safety) Regulations 2004. In addition, products must not infringe the Medicines for Human Use (Marketing Authorizations, etc.) Regulations 1994, a very common infringement with today’s eagerness to have “alluring” pack copy. The regulations provide that, unless exempt, any “medicinal product” to which Chapters II to V of Directive 2001/83/EEC apply must not be placed on the U.K. market unless it has a marketing authorization (product license) granted by the European Commission or by the U.K. Licensing Authority. The Act similarly provides that, unless exempt, any other “medicinal product” must not be sold or supplied without a marketing authority. A marketing authorization or product license is only granted for a product that meets statutory standards of safety, quality, and efficacy.
