title: [The use of nanotechnology in medicinal products in the light of European Union law].
abstract: The purpose of EU regulations in relation to nanotechnology, according to the European Commission's Communication "Regulatory aspects of nanomaterials", is to allow the public to use innovative applications of nanotechnology while ensuring a high level of safety, health care and environmental protection. This article characterizes and comments on EU legislation in respect of medicinal products containing nanomaterials. Medicinal products manufactured using nanotechnology are subject to the optional centralized authorization procedure by the European Commission authorizations for the placing on the market throughout the EU; advanced therapy medicinal products containing nanomaterials are covered by the mandatory centralized procedure. Evaluation of medicines in centralized authorization mode for the marketing of medicinal products, including those containing nanomaterials, is carried out by the Committee on Medicinal Products for Human Use (CHMP) subject to the European Medicines Agency (EMA).
authors.forename: Margin
authors.initials: M
authors.lastname: Jurewicz
mesh_terms: D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D005062:European Union; D006801:Humans; D036103:Nanotechnology / Q000331:legislation & jurisprudence*; D011358:Product Surveillance, Postmarketing