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Regulation No 20 of the Minister of Agriculture of validating the Requirements for reference laboratories and requirements for content of application for grant of authorization to operate as reference laboratory, list of documents to be annexed to application and procedure for processing applications.

Country/Territory
Estonia
Document type
Regulation
Date
2007 (2007)
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Animal health Animal welfare Animal feed/feedstuffs Pests/diseases Biosafety Authorization/permit
Geographical area
Europe, Europe and Central Asia, European Union Countries, Northern Europe
Entry into force notes
This Regulation enters into force on 1 April 2007.
Abstract

This Regulation establishes the bio-safety requirements for national reference laboratories provided by Article 33 of Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.04.2004, pp. 1–141) and the requirements for content of application for grant of authorisation to operate as a reference laboratory, the list of documents to be annexed to the application and the procedure for processing applications. An applicant for authorisation to operate as a reference laboratory (hereinafter authorisation) shall submit a written application to the Minister of Agriculture setting out the following information: (a) the name, personal identification code or registry code and telecommunication numbers of the applicant and the representative thereof; (b) the address of the applicant; (c) the scope of the applied authorisation and the list of used methods of analysis for the use of which the laboratory is accredited; and (d) the name and position of the person responsible for the organisation of the activities of the laboratory. The following documents shall be annexed to an application: (a) copies of the accreditation certificate issued by the accreditation institution and its appendix; (b)an action plan within the scope of the applied authorisation for compliance with the requirements provided for in Article 33.2 of Regulation (EC) No 882/2004 of the European Parliament and of the Council; and (c) in the case of application for grant of initial authorisation to operate as a reference laboratory, information regarding payment of the state fee shall be provided. Only laboratories complying with the bio-safety requirements established for reference laboratories in the relevant EU legislation for diagnosing an infectious animal disease may be authorised to operate as reference laboratories.

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