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Act No. 132 on Medicines etc.

País/Territorio
Noruega
Tipo de documento
Legislación
Fecha
1992 (2018)
Fuente
FAO, FAOLEX
Materia
Ganado, General
Palabra clave
Legislación básica Salud pública Cumplimiento/aplicación Infracciones/sanciones Sanidad animal Protección de los animales Medicamentos Alimentos para animales/piensos
Área geográphica
Europa, Europa y Central Asia, Atlántico Norte, Mar del Norte, Atlántico Nordeste, Europa Septentrional
Resumen

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.

Texto completo
Noruego
Página web
www.lovdata.no

Referencias - Legislación

Implementado por

Regulation No. 1573 on veterinary drugs.

Legislación | Noruega | 2022 (2022)

Palabra clave: Sanidad animal, Medicamentos, Procesamiento/manipulación, Comercio interior, Autorización/permiso, Recopilación de datos/informes, Infracciones/sanciones, Derechos/cánones

Fuente: FAO, FAOLEX

Enmendado porr

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

Legislación | Noruega | 2022

Palabra clave: Sanidad animal, Medicamentos

Fuente: FAO, FAOLEX