Finished medicinal products
A finished medicinal product , an Austrian medicinal specialty, is a medicinal product that is manufactured in advance and placed on the market in a pack intended for delivery to the consumer.
For a finished medicinal product to be placed on the market, authorization from the competent supervisory authority is required. For this approval, proof of the efficacy and safety as well as the pharmaceutical quality of the drug must be provided.
In the EU, the European Commission is the supervisory authority for a finished medicinal product authorized via a central procedure after it has been examined by the European Medicines Agency .
Germany
The term finished medicinal product comes from the Medicines Act (AMG) and is defined there (AMG § 4 Other Definitions). Defects produced in pharmacies are also finished medicinal products, in contrast to the formulations also produced in pharmacies (see also: In-house production of medicinal products ).
The approval authorities are the Federal Institute for Drugs and Medical Devices , the Paul Ehrlich Institute and the Federal Office for Consumer Protection and Food Safety . Due to the federal structure of Germany, various state authorities are responsible for drug monitoring (see also: Central Office of the States for Health Protection for Drugs and Medical Devices ).
For a number of officially standardized standard formulations with specified indications, so-called standard approvals, greatly reduced requirements apply in the approval process. Certain homeopathic medicinal products and some medicinal products produced in pharmacies (formulations and defects as well as standard approvals) are exempt from the authorization requirement . A finished medicinal product must be labeled in accordance with the requirements of the Medicines Act. Instructions for use ( package insert ) intended for the consumer must also be enclosed. The manufacturer must also provide specialist information for members of the medical professions .