Commission Implementing Decision (EU) 2020/569 of 16 April 2020 establishing a co... (32020D0569)
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Commission Implementing Decision (EU) 2020/569 of 16 April 2020 establishing a common format and information content for the submission of the information to be reported by Member States pursuant to Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes and repealing Commission Implementing Decision 2012/707/EU (notified under document C(2020) 2179) (Text with EEA relevance)
- COMMISSION IMPLEMENTING DECISION (EU) 2020/569
- of 16 April 2020
- establishing a common format and information content for the submission of the information to be reported by Member States pursuant to Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes and repealing Commission Implementing Decision 2012/707/EU
- (notified under document C(2020) 2179)
- (Text with EEA relevance)
- Article 1
- Article 2
- Article 3
- Article 4
- Article 5
- Article 6
- ANNEX I
- PART A
- Template for the submission of non-technical project summaries referred to in article 43(1) of directive 2010/63/EU
- PART B
- Template for the submission of an update to the non-technical project summary referred to in article 43(2) of directive 2010/63/EU
- ANNEX II
- INFORMATION REFERRED TO IN ARTICLE 54(1) OF DIRECTIVE 2010/63/EU
- A. NATIONAL MEASURES ON THE IMPLEMENTATION OF DIRECTIVE 2010/63/EU
- B. STRUCTURES AND FRAMEWORK
- 1.
- Competent authorities (Article 59 of Directive 2010/63/EU)
- 2.
- National committee (Article 49 of Directive 2010/63/EU)
- 3.
- Education and training of personnel (Article 23 of Directive 2010/63/EU)
- 4.
- Project evaluation and authorisation (Articles 38 and 40 of Directive 2010/63/EU)
- C. OPERATION
- 1.
- Projects
- 1.1.
- Granting of project authorisation (Articles 40 and 41 of Directive 2010/63/EU)
- 1.2.
- Retrospective assessment, non-technical project summaries (Article 38(2)(f), Articles 39 and 43 of Directive 2010/63/EU)
- 2.
- Animals bred for use in procedures (Articles 10, 28 and 30 of Directive 2010/63/EU)
- 3.
- Exemptions
- 4.
- Animal welfare body (Articles 26 and 27 of Directive 2010/63/EU)
- D. PRINCIPLES OF REPLACEMENT, REDUCTION AND REFINEMENT
- 1.
- Principle of replacement, reduction and refinement (Articles 4 and 13 and Annex VI of Directive 2010/63/EU)
- 2.
- Avoidance of duplication (Article 46 of Directive 2010/63/EU)
- 3.
- Tissue sampling of genetically altered animals (Articles 4, 30 and 38 of Directive 2010/63/EU)
- E. ENFORCEMENT
- 1.
- Authorisation of breeders, suppliers and users (Articles 20 and 21 of Directive 2010/63/EU)
- 2.
- Inspections (Article 34 of Directive 2010/63/EU)
- 3.
- Withdrawals of project authorisation (Article 44 of Directive 2010/63/EU)
- 4.
- Penalties (Article 60 of Directive 2010/63/EU)
- ANNEX III
- PART A
- Flowchart of statistical data input categories under article 54(2) of directive 2010/63/EU
- PART B
- Information referred to in article 54(2) of directive 2010/63/EU
- A. GENERAL PROVISIONS
- B. DATA INPUT CATEGORIES
- 1.
- Type of animal
- 2.
- Reuse
- 3.
- Species other than non-human primate – Place of birth
- 4.
- Non-human primate (NHP) – Place of birth
- 5.
- Non-human primate – Colony type
- 6.
- Non-human primate – Generation
- 7.
- Genetic status
- 8.
- Creation of a new genetically altered line
- 9.
- Severity
- 10.
- Purposes
- 11.
- Basic research studies
- 13.
- Regulatory use and Routine production
- 14.
- Quality control (including batch safety and potency testing)
- 15.
- Toxicity and other safety testing by test type
- 16.
- Acute toxicity testing methods
- 17.
- Repeated dose toxicity
- 18.
- Ecotoxicity
- 19.
- Type of legislation
- 20.
- Origin of legislation
- 21.
- Routine production by product type
- C. MEMBER STATE NARRATIVE
- ANNEX IV
- TEMPLATE FOR THE SUBMISSION OF THE INFORMATION REFERRED TO IN ARTICLE 54(3) OF DIRECTIVE 2010/63/EU
- ANNEX V
- CORRELATION TABLE
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