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Governmental Decree No. 1335-N “On state registration and the registration procedure of cure and diagnostics in the field of veterinary”.

Pays/Territoire
Arménie
Type du document
Règlement
Date
2004 (2012)
Source
FAO, FAOLEX
Sujet
Bétail
Mot clé
Santé des animaux Médicaments Enregistrement Commerce/industrie/sociétés Évaluation/gestion des risques
Aire géographique
Asie, CEI (Communauté des États indépendants), Europe, Europe et Asie Centrale, Nations en développement sans littoral, Asie Occidentale
Entry into force notes
This Governmental Decree enters into force on 30 October 2004.
Résumé

This Governmental Decree establishes the procedure for the use of vaccines, serum and diagnostic means used in veterinary medicine (Article 15 of the Law of the Republic of Armenia "On Drugs" and Article 6, Part 1, Article 20 of the Law of the Republic of Armenia "On Veterinary") referred to as veterinary medicines, the procedure for refusing registration and to invalidate registration. It authorizes manufacturing, import, distribution, trade and application only of veterinary medicines registered in the Republic of Armenia. State registration shall be performed separately for each manufacturer (business entity) of drugs and for each country manufacturing the same drugs. Registration authority guarantees confidentiality of received information. State registration of drugs shall be performed after testing thereof for compliance with quality, efficiency and safety standards on the basis of scientific substantiation by the results of testing. Registration shall be performed by the “Scientific center for assessment of safety of foodstuffs, risks and analysis”.

Texte intégral
Arménien
Site web
www.arlis.am