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Act No. 132 on Medicines etc.

Pays/Territoire
Norvège
Type du document
Législation
Date
1992 (2018)
Source
FAO, FAOLEX
Sujet
Bétail, Général
Mot clé
Législation de base Santé publique Mise en application Infractions/sanctions Santé des animaux Protection des animaux Médicaments Aliments pour animaux
Aire géographique
Europe, Europe et Asie Centrale, Atlantique Nord, Mer du Nord, Atlantique du Nord-Est, Europe du Nord
Résumé

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.

Texte intégral
Norvégien
Site web
www.lovdata.no

Références - Législation

Implementé par

Regulation No. 1573 on veterinary drugs.

Législation | Norvège | 2022 (2022)

Mot clé: Santé des animaux, Médicaments, Transformation/manutention, Commerce intérieur, Autorisation/permis, Collecte de données/déclarations, Infractions/sanctions, Royalties/redevances

Source: FAO, FAOLEX

Amendé par

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

Législation | Norvège | 2022

Mot clé: Santé des animaux, Médicaments

Source: FAO, FAOLEX