This content is exclusively provided by FAO / FAOLEX

Regulation No. 1573 on veterinary drugs.

Country
Type of law
Regulation
Date of original text
Date of latest amendment
Source

Abstract
The present Regulation, adopted by the Ministry of Health and Care Services, the Ministry of Agriculture and Food, and the Ministry of Trade, Industry and Fisheries, lays down rules and supplements EU legislation on veterinary drugs. It contains the following chapters: I. Implementation of (EEA/EU) Regulations; II. Supplementary national provisions concerning authorities; III. Supplementary national provisions on the clinical testing of veterinary drugs; IV. Exemptions from the requirement for marketing authorization; V. Supplementary national provisions on language and labelling; VI. Supplementary national provisions on prescription status; VII. Supplementary national provisions on homeopathic drugs; VIII. Supplementary national provisions on drug manufacturing; IX. Supplementary national provisions on wholesale distribution of veterinary drugs; X. Animal healthcare personnel's reporting of side effects; XI. Miscellaneous provisions; XII. Fees and charges; XIII. Entry into force.
The rules regulates the authorization requirement for clinical trials of veterinary drugs; the information to be provided with veterinary drugs; veterinary drugs subject to prescription requirements; the authorization requirement for wholesale distribution; immunological drugs; etc. The Norwegian Food Safety Authority shall be the competent authority under Regulation (EU) 2019/6 on provisions on veterinary medicinal products. The Norwegian Medicines Agency is the competent authority under Article 28(1) of the Medicines Act.
Notes
Updated version as last amended by Regulation No. 357 of 20 March 2023.
Repealed
No
Source language

English

Legislation Amendment
No
Original title
FOR-2022-09-08-1573: Forskrift om legemidler til dyr.