Masterstudiengang "Drug Regulatory Affairs"


Regulatory Requirements for Biocidal Products in Comparison to Medicinal Products within the EU ***

Dr. Sabine Frenzen (Abschlußjahr: 2010)

Language: English

In 1993, the European Commission published a proposal to establish a single European market for biocides by introducing a harmonised authorisation system based on assessment of risks to humans and the environment, together with a consideration of efficacy. This became the "Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market" commonly known as the "Biocidal Products Directive" (BPD). The BPD entered into force on 14 May 2000.

Medicinal Products have been first defined in the first pharmaceutical EU-Directive 65/65/EEC. In December 2001 this Directive has been repealed and replaced by "Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use" (Directive 2001/82/EC for veterinary medicinal products respectively).

These Directives mentioned above have in common that the European Market and the conditions for the entry into the market for substances within the scope of this legislation should be harmonised. Additionally, through the instrument of an authorisation procedure of designated Competent Authorities, products should be made safer for consumers and the environment.

But it has become evident that the scope of the Biocidal Directive has not been well defined. So for some product types such as the disinfectants used on human or animal skin there are discussions ongoing whether they should be classified as biocidal products or as medicinal products with the consequence that they must comply to different legislation and that they must fulfil different requirements.

For industry it is essential to be aware of these different requirements. When a new product should be developed it will save resources if the application dossier which must be submitted to the Competent Authority has the right focus with regard to the intended use.

The differences of the legislation become important when a product should be marketed where the classification is not clear - for example if the intended use is disinfection.

For these products it is outlined in borderline documents that the classification will be done due to claims: Medicinal products are all products with an intended medicinal use and with a therapeutic/ demonstrated claim (medicinal products by presentation or by function). Biocidal products are products used on humans/ animals without a therapeutic claim.

This masterthesis shows in more detail that the decision must be made case by case due to presentation and requested claims because each Competent Authority in each Member State might decide in another way about the question what a distinct claim is: medicinal or not.

Pages: 64, Annexes: 4 pages