Legal requirements to access international markets for cosmetic and pharmaceutical ingredients

Cosmetic and pharmaceutical ingredients imported into international markets must comply with all of the applicable requirements related to ingredients approval. For example, through  submission   of   a   new   drug   application, proper  labeling,  establishment  of registration and drug listing and manufacturing in accordance with current Good Manufacturing  Practices.

Market approval

• In the USA the New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the Food and Drug Administration approve a new pharmaceutical for sale and marketing. You can read more about NDA procedure on the FDA guidance website.
• In order to protect public health within the European Union (EU), imports of medicinal products are subject to the importing and marketing authorization. You can read more about rules which govern authorization of medicinal products to be sold on the European market on the website of the European Commission.
• Also you can consult Active Pharmaceutical Ingredient Sourcing Database or European cosmetic ingredient database to check if your ingredient is registered worldwide.
• Sometimes it may be unclear whether a particular product is a cosmetic product under cosmetics legislation or whether it falls under other sectorial legislation. In the case of these “borderline products”, the decision on a product’s classification must be taken on a case-by-case basis. You can read guidelines and manuals for ‘borderline’ products on the webpage of European Commission.