Act No. 14 on veterinary medicinal products.
Country
Type of law
Legislation
Abstract
The present Act lays down rules to ensure the quality and safety of veterinary medicinal products, whilst ensuring a high degree of animal welfare and safety. Furthermore, the aim of the Act is to ensure the safety and wholesomeness of foods from animal products in Iceland and to strengthen the fight against the resistance of infectious agents. The Act does not apply to compound feedingstuffs or to clinical trials on animals carried out for purposes other than the issue or maintenance of a marketing authorization. Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products is made mandatory in Iceland.
The Act contains 77 articles divided into the following Chapters: I. Objectives, legalization and scope; II. Glossary; III. Management and role of the Icelandic Medicines Agency; IV. Marketing authorization for veterinary medicinal products; V. Rules of procedure regarding marketing authorizations; VI. Databases and data collection; VII. Pharmacovigilance; VIII. Homeopathic medicines; IX. Manufacturing, importing and exporting; X. Wholesale etc.; XI. Use of medicines for animals; XII. Monitoring and control audits; XIII. Fees; XIV. Coercive measures and restrictions; XV. Penalties; XVI. Regulatory authority; XVII. Implementation and entry into force. The Icelandic Medicines Agency shall be the competent authority responsible for the implementation of this Act. Only veterinary medicinal products for which the Icelandic Medicines Agency has granted a marketing authorization may be marketed in Iceland.
The Act contains 77 articles divided into the following Chapters: I. Objectives, legalization and scope; II. Glossary; III. Management and role of the Icelandic Medicines Agency; IV. Marketing authorization for veterinary medicinal products; V. Rules of procedure regarding marketing authorizations; VI. Databases and data collection; VII. Pharmacovigilance; VIII. Homeopathic medicines; IX. Manufacturing, importing and exporting; X. Wholesale etc.; XI. Use of medicines for animals; XII. Monitoring and control audits; XIII. Fees; XIV. Coercive measures and restrictions; XV. Penalties; XVI. Regulatory authority; XVII. Implementation and entry into force. The Icelandic Medicines Agency shall be the competent authority responsible for the implementation of this Act. Only veterinary medicinal products for which the Icelandic Medicines Agency has granted a marketing authorization may be marketed in Iceland.
Attached files
Web site
Date of text
Repealed
No
Source language
English
Legislation Amendment
No
Original title
L g um d ralyf.