title: [Importance of the Therapeutic Products Act for the ENT practitioner].
abstract: The Therapeutic Products Act controls therapeutic products and their fields of application, and classifies them legally. The present regulations on therapeutic products are based on a fundamental concept comprising basic demands, harmonized standards, agreement of the product attributes with the basic demands, and assessment of conformity. Therapeutic products (among which in vitro diagnostics are counted) must comply with definite regulations and are separated from medicines by their mode of action. In addition, therapeutic products must be subject to critical testing. The establishment, management, and use of therapeutic products are, with few exceptions, governed by the Regulations for the Use of Therapeutic Products. To avoid possible risks involved in the application of therapeutic products, a well-functioning system of registration is required, controlled by the Regulations on Therapeutic Products Safety.
authors.affiliation: Landesärztekammer Hessen, Frankfurt. roland.kaiser@laekh.de
authors.forename: R
authors.initials: R
authors.lastname: Kaiser
authors.forename: G
authors.initials: G
authors.lastname: Ininger
authors.forename: E
authors.initials: E
authors.lastname: Stosslein
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D004868:Equipment Failure; D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000009:adverse effects / Q000592:standards*; D005858:Germany; D017408:Guidelines as Topic / Q000592:standards; D006801:Humans; D010036:Otolaryngology / Q000331:legislation & jurisprudence* / Q000592:standards; D011358:Product Surveillance, Postmarketing / Q000592:standards