Masterstudiengang "Drug Regulatory Affairs"


Borderline Situations and other important Aspects for the Regulatory Work with Medicinal Products for Oral Care in Europe

Dr. Claus-Peter Danzer (Abschlußjahr: 2009)

Language: English

Oral care products play a role in all of our daily lives and serve cosmetic purposes such as to keep our teeth clean and white and our breath fresh, but also medicinal purposes like supporting the health and hence function of teeth and gingiva. Products comprise a wide range of toothpastes, mouthrinses, brush-on gels, and other product categories. Chemical compounds playing an important role as ingredients comprise fluoride as the pivotal molecule in caries prevention since many years, but also bleaching and anti-bacterial agents, molecules acting against sensitive teeth, and others. Dealing with regulatory affairs for oral care products in particular from the perspective of handling medicinal products is very complex due to the fact that in the European Union different legal bases regulate oral care products. Oral care products are in many cases products at the borderline of different classifications, the most important one between medicinal products and cosmetics, which is discussed here. A product can be regulated as a medicine according to Directive 2001/83/EC either due to its functionality in treating disease, or if it is presented as having properties as to treat disease. A cosmetic in contrast is defined by the way the target site of application of the product, and the fact that the product fulfils “exclusively or mainly” a cosmetic function as defined (i.e. cleaning, perfuming, changing appearance, correcting body odours, protecting, keeping in good condition). According to the principle of non-cumulation a product can only belong to one or the other category, and from 2001/83/EC Art. 2(2) it follows that if a product may be defined as a medicinal product and within the definition of a product covered by other community legislation the provisions of 2001/83/EC will apply. Various guidance documents from different European and national bodies exist to help with classification of a product. The final decision will be made by the member states concerned. Particular examples of demarcation decisions concerning oral care products are discussed. The United Kingdom is explained as a particular example here because of the extensive body of guidance provided by national authorities and the strict interpretation of many claims as medicinal, which sets the country and the requirements apart from others across Europe.

Working with medicinal products for oral care at the borderline to other regulations makes it necessary to be aware of particular applicable authorisation procedures, which exist in some countries. The “Visa de publicité” authorisation is given by the French Health Authority to approve claims and promotional material. Up to 57% of all applications concern oral care products and this authorisation plays therefore a major role in the field. In Spain, oral care products falling within the scope of 2001/83/EC in the EU are frequently still registered in the Dent-register. The Dent-registration can be considered a unique registration with more requirements than for a cosmetic product in Europe, but less requirements than for a medicinal product.

In the concluding section of this thesis aspects contributing to complexity and posing a challenge when working with medicinal products in the environment of an oral care company are discussed. Oral care companies are usually set up to produce and market cosmetics mainly. Therefore understanding for stricter pharmaceutical requirements needs to be created and maintained across the company in different departments from finance over marketing to production and quality control. Only then continuing compliance with the complex regulatory requirements of medicinal products can be guaranteed.

Pages: 40