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Medicinal Products Act (AMG).

Country/Territory
Germany
Document type
Legislation
Date
1976 (2023)
Source
FAO, FAOLEX
Long title
Act on the marketing of medicinal products.
Subject
Livestock, General
Keyword
Legal proceedings/administrative proceedings Authorization/permit Enforcement/compliance Processing/handling Hygiene/sanitary procedures Monitoring Offences/penalties Public health Institution Data collection/reporting Registration Internal trade Inspection Research Liability/compensation Drugs Animal health
Geographical area
Alps, Europe, Europe and Central Asia, European Union Countries, North Sea, North-East Atlantic, Western Europe
Entry into force notes
This Act comes into force on 01 January 1978.
Abstract

The purpose of this law is to ensure, in the interest of a proper supply of the population with medicinal products, the safety in the traffic of medicinal products, especially regarding the quality, effectiveness, and safety of medicinal products, in accordance with the following regulations. The text consists of 149 articles divided into 18 Parts as follows: Purpose of the act, definition of terms, scope (I); Requirements on medicinal products (II); Manufacture of medicinal products (III); Approval of the medicinal products(IV); Registration of medicinal products (V); Protection of human subjects in clinical trials (VI); Dispensing of medicinal products (VII); Safety and quality control (VIII); Observation, collection and evaluation of drugs risks (X); Monitoring (XI); Special provisions for the federal armed forces, federal police, public order police and civil protection (XII); Import and export (XIII); Information officer, pharmaceutical consultant (XIV); Designation of the competent higher federal authorities and other provisions (XV); Liability for damage caused by medicinal products (XVI); Penal provisions and provisions on administrative fines (XVII); Transitional and interim provisions (XVIII). Chapter (IX) with regard to special provisions for medicinal products intended for use in animals is repealed and deleted.

Full text
German
Website
www.bgbl.de

References - Legislation

Implemented by

Ordinance concerning pharmaceutical legislation on drug use in agricultural holdings.

Legislation | Germany | 2015

Keyword: Animal welfare, Drugs, Offences/penalties, Enforcement/compliance, Animal health

Source: FAO, FAOLEX