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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”.

Country/Territory
Armenia
Document type
Regulation
Date
2004 (2012)
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Animal health Drugs Registration Business/industry/corporations Risk assessment/management
Geographical area
Asia, CIS (Commonwealth of Independent States), Europe, Europe and Central Asia, Landlocked Developing Nations, Western Asia
Entry into force notes
This Governmental Decree enters into force on 30 October 2004.
Abstract

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”.

Full text
Armenian
Website
www.arlis.am