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Act No. 132 on Medicines etc.

Country/Territory
Norway
Document type
Legislation
Date
1992 (2018)
Source
FAO, FAOLEX
Subject
Livestock, General
Keyword
Basic legislation Public health Enforcement/compliance Offences/penalties Animal health Animal welfare Drugs Animal feed/feedstuffs
Geographical area
Europe, Europe and Central Asia, North Atlantic, North Sea, North-East Atlantic, Northern Europe
Abstract

The present Act lays down general principles and obligations concerning the use of medicines for humans and animals. It contains the following chapters: (I) Scope of the Act. Definitions; (II) Clinical trial of drugs; (III) Requirements for drugs. Standards; (IV) Special pharmaceutical preparations; (V) Manufacture and import of medicines; (VI) Wholesale, distribution and retail sales of pharmaceuticals; (VII) Medicine advertising etc.; (VIII) Narcotics; (VIII a) Substances that may be used in the illicit manufacture of drugs; (IX) Miscellaneous provisions; (X) Penalties, confiscation and enforcement; (XI) Entry into force. Amendments to other acts. The Act gives relevant authorities the power to adopt implementing regulations within the framework established by the Act. Among other things, its rules require marketing authorization for the following types of medicines: (i) Medicines for human and animal use, manufactured industrially or by the use of an industrial process, and (ii) Premixes for medicated feed. The manufacture, packaging, repackaging, labeling, re-labeling and release of medicines, as well as the necessary controls in connection with these activities, is subject to prior authorization by the Ministry of Health and Care Services. The same authorization requirement applies to the wholesale of medicines. Veterinarians are allowed to sell drugs when access to a pharmacy is difficult, as long as they have been acquired from a pharmacy in a ready-made condition.

Full text
Norwegian
Website
www.lovdata.no

References - Legislation

Implemented by

Regulation No. 1573 on veterinary drugs.

Legislation | Norway | 2022 (2022)

Keyword: Animal health, Drugs, Processing/handling, Internal trade, Authorization/permit, Data collection/reporting, Offences/penalties, Royalties/fees

Source: FAO, FAOLEX

Amended by

Act No. 54 amending the medicines act (veterinary medicinal products).

Legislation | Norway | 2022

Keyword: Animal health, Drugs

Source: FAO, FAOLEX