title: Quality of alcohol-based hand disinfectants and their regulatory status. Development and marketing authorisation.
abstract: A 2005 survey showed that there are at least four legal product classifications for hand disinfectants in the European Union: medicinal products, biocidal products, cosmetics and medical devices. An internationally harmonized classification does not exist. The regulatory status of those products is defined at national level. In order to assure compliance with the regulations these four classifications provide different levels of official surveillance varying from product-specific marketing authorisations and production site audits to the obligation to just work in accordance with certain general guidelines. Biocidal product regulations cover eco-toxicological and toxicological aspects, but do not very much address to the customers' quality and efficacy expectations. In contrast, the medicinal product legislation is the most ambitious one claiming quality, safety, efficacy, and an independent benefit risk-assessment by an authority. In respect of ambition, the two remaining product categories--cosmetics and medical devices--rank between the both classifications mentioned above. For medical devices, it is the responsibility of the manufacturer to make sure the products meet defined essential requirements regarding quality, safety and performance and to have an appropriate quality assurance system implemented under third party control. For cosmetics there are some legal restrictions, but within these it is the sole responsibility of the manufacturer to ensure that the products are safe and fulfil their claims. This paper describes one way out of this increasingly complex situation, the definition of a single quality standard meeting the users' expectations as well as all legal requirements regardless of the specific sales country. This international quality standard for products would take priority over any individual national standard, to the benefit of users.
authors.affiliation: BODE Chemie GmbH & Co. KG, Regulatory Affairs/Documentation, Hamburg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Stengele
mesh_terms: D000891:Anti-Infective Agents, Local / Q000592:standards*; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods*; D005062:European Union; D006235:Hand Disinfection / Q000592:standards*; D006801:Humans
chemical_list: D000891:Anti-Infective Agents, Local