Act No. 132 on Medicines etc.

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 requirement for authorization 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. Article 2b makes Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products and repealing Directive 2001/82/EC applicable in Norway.