Published Results: Art54AnnexI

1 Please indicate the Member State for which you submit Article 54(1) implementation report([ID11])

2 Is the implementation of Directive 2010/63/EU a responsibility of one or more ministry/ministries?([ID57])

2.bis Please provide the name of the ministry([ID59])

2.tris Please provide the name of the ministries involved and briefly describe the distribution of responsibilites([ID59])

A - 1 Describe main changes made to national legislative measures regarding the implementation of Directive 2010/63/EU([ID1])

B - 1.1 Provide information on the framework for competent authorities([ID5])

B - 1.2 There is only one public competent authority for the Member State, or for each region (where regional structure) who is tasked with all five tasks requiring competent authority (I.e., the same competent authority (national/regional) performs all tasks: authorisation of establishments, inspections, project evaluation, project authorisation and retrospective assessment of projects).([ID252])

B - 1.2.bis If your MS has a regional structure, how many regional authorities are there?([ID245])

B - 1.3.bis *) Please explain if "other" than national/regional authority and/or "non-public authority" was selected.([ID167])

B - 2.1 Provide information on the structure of your National Committee([ID63])

B - 2.2 Provide information on the operation of your National Committee in relation to its task to advise competent authorities, including on how it aims to address coherent approach to project evaluation and review strategies at national level as provided in Recital 48([ID64])

B - 2.3 Provide information on the operation of your National Committee in relation to its task to advise animal welfare bodies([ID64])

B - 2.4 Provide information on the operation of your National Committee in relation to its task to share best practice([ID64])

B - 2.5 Has the EU Guidance on Animal Welfare Bodies and National Committees been made available to the members of National Committee and establishment Animal Welfare Bodies ?([ID206])

B - 2.6 Has additional official guidance for Animal Welfare Bodies and National Committee been developed to facilitate implementation?([ID206])

B - 2.6.bis If you consider this guidance helpful for other Member States to facilitate the implementation of the Directive, please provide web-address for the guidance, where available.([ID239])

B - 3.1 Provide information on the minimum requirements for education and training for functions in Article 23(2)([ID63])

B - 3.2 Provide information on the requirements for obtaining, maintaining and demonstrating requisite competence for functions in Article 23(2)([ID63])

B - 3.3 Are there any additional education and training requirements for staff coming from another Member State?([ID65])

B - 3.3.bis Provide information on additional education and training requirements for staff coming from another Member State([ID70])

B - 3.4 Has the EU Guidance on Education and Training Framework been made available to those responsible for education, training and competence in establishments?([ID206])

B - 3.6 Has additional official guidance on education, training and competence been developed to facilitate implementation?([ID206])

B - 3.6.bis If you consider this guidance helpful for other Member States to facilitate the implementation of the Directive, please provide web-address for the guidance, where available.([ID239])

B - 4.1 Have the processes of project evaluation and authorisation been published as a means to implement the requirement of Article 38(4)?([ID71])

B - 4.1.bis Please provide the web-address where these processes can be found([ID78])

B - 4.1.tris Please explain how the obligation for the project evaluation process to be transparent has been achieved?([ID78])

B - 4.2 Explain the key steps of the project evaluation and authorisation processes including those for multiple generic projects and simplified administrative procedures in a MS where these are allowed.([ID63])

B - 4.2.bis Where allowed, please explain what type of projects are accepted under simplified administrative procedure?([ID43])

B - 4.3 What is the maximum length (in years) for a project authorisation implementing the requirement under Article 40(3)?([ID46])

B - 4.4 Explain how the requirement for expertise for project evaluation in Article 38(3) is considered([ID96])

B - 4.5 Please explain if and how the opinion of independent parties are integrated as provided in Article 38(4)([ID102])

B - 4.6 The decision within the project evaluation process is reached by([ID65])

B - 4.6.bis If by "vote" or "other", please explain in more detail how the decision is reached?([ID258])

B - 4.7 When project evaluation is tasked to a non-public authority and/or within an establishment, please describe how the impartiality of the process is achieved, in line with Article 38(4)([ID103])

B - 4.8 Two key elements which impact on the project evaluation and authorisation processes are the definition of "a project" and the interpretation of "a complete and correct application". If possible, please provide a short description of the types of "projects" authorised in your MS - e.g., are projects limited to single procedures of short duration or are more complex multi-species, multi-procedure projects of up to 5 years also authorised; how is a "complete and correct application" determined, and communicated to applicant; how are the interactions between applicant and competent authority accounted for in the authorisation deadlines as required in Article 41.([ID218])

B - 4.9 - Are the processes for amendments to projects the same as for the initial project evaluation and authorisation (including the deadlines in Article 41)? If not, please describe the main differences. What changes to a project will require a request for an amendment?([ID214])

B - 4.10 Has the EU Guidance on Project Evaluation and Retrospective Assessment been made available to all project evaluators?([ID206])

B - 4.11 Has additional official guidance on Project Evaluation and Retrospective Assessment been developed to facilitate implementation?([ID206])

B - 4.11.bis If you consider this guidance helpful for other Member States to facilitate the implementation of the Directive, please provide web-address for the guidance, where available.([ID78])

C - 1.i.1.bis Provide information of circumstances where the deadline of 40 days has been extended as provided in Article 41(2)([ID95])

C - 1.ii.1 Provide information on the operation of non-technical project summaries; and on how it is assured that the requirements under Article 43(1) are met.([ID99])

C - 1.ii.1.bis Based on the information on the operation the non-technical summaries during the first five years, what is the average time (in months) from authorisation to publication?([ID45])

C - 1.ii.2 Do the non-technical project summaries indicate projects chosen for retrospective assessment (Article 43(2))([ID104])

C - 1.ii.3 Please provide the web-address where non-technical project summaries are published([ID109])

C - 1.ii.5 Provide reasons for other projects (beyond those compulsory) being submitted for retrospective assessment broken down by each reporting year Mandatory question - please include data in the Excel or complete the requested information below([ID138])

C - 2.ii Do you have any authorised users, breeders or suppliers of non-human primates (NHP) in your Member State?([ID118])

C - 2.ii.bis Provide information on the sourcing of NHP and how the requirements of Article 10 are being met([ID80])

C - 2.ii.tris Provide information on strategies in place to increase the proportion of animals of F2 (or higher) in line with Article 28([ID80])

C - 3.1 Provide cumulative information covering years 2013-2017 on circumstances under which exemptions were granted to the requirement to use animals (listed in Annex I) purpose bred for scientific use; and/or to the use of marmosets that are not of F2/F2+ generation (Article 10(3)) Mandatory question - please include data in the Excel or complete the requested information below([ID123])

C - 3.2 Provide cumulative information covering years 2013-2017 on circumstances (such as work on animals in the wild, work on animals in a commercial farm) under which exemptions were granted to the requirement to carry out a project in user's establishment (Article 12(1)) Mandatory question - please include data in the Excel or complete the requested information below([ID123])

C - 3.3 Provide cumulative information covering years 2013-2017 on the exceptional circumstances under which exemptions were granted for the reuse of an animal after a procedure in which the actual suffering was assessed as severe (Article 16(2)) Mandatory question - please include data in the Excel or complete the requested information below([ID123])

C - 3.4 Provide cumulative information covering years 2013-2017 on circumstances (reasons) under which exemptions (such as for single housing, restriction of food/water, restriction on enclosure sizes) were granted to the care and accommodation requirements (Article 33(3)) Mandatory question - please include data in the Excel or complete the requested information below([ID123])

C - 4.1 Provide general information on the structure and functioning of animal welfare bodies([ID119])

C - 4.2 In describing the structure of animal welfare bodies, does your MS require other persons to be permanent members beyond those listed in Article 26(2)?([ID130])

C - 4.2.bis Please provide a description of the other persons required to be members of animal welfare bodies([ID129])

C - 4.3 Does your MS allow achieving the tasks in Article 27(1) by other means than through establishment of an animal welfare body?([ID120])

C - 4.3.bis Please describe what other means are used to achieve the tasks in Article 27(1)([ID129])

C - 4.4 If possible, based on experience obtained through inspections and through the work of the National Committee that shares best practice and interacts with animal welfare bodies, what aspects of the work of animal welfare bodies function well - please provide examples if possible.([ID135])

C - 4.5 If possible, based on experience obtained through inspections and through the work of the National Committee that shares best practice and interacts with animal welfare bodies, what aspects of the work of animal welfare bodies could be improved - please provide examples if possible.([ID135])

D - 1.1 Provide information on general measures taken to ensure that the principle of Replacement, Reduction and Refinement is satisfactorily addressed within authorised projects([ID125])

D - 1.2 Provide information on general measures taken to ensure that the principle of Replacement, Reduction and Refinement is satisfactorily addressed during housing and care including in breeding and supplying establishments([ID125])

D - 1.3 Has the EU Guidance on Severity Assessment Framework been made available to establishments, project evaluators and inspectors?([ID206])

D - 1.4 Has additional official guidance on Replacement, Refinement and Reduction been developed to facilitate implementation?([ID206])

D - 1.4.bis If you consider this guidance helpful for other Member States to facilitate the implementation of the Directive, please provide web-address for the guidance, where available.([ID78])

D - 2 Provide general description of measures taken to ensure that there is no duplication of procedures([ID125])

D - 3.1 Are genetically altered animals/animal lines (non-harmful and/or harmful phenotype) being created, bred and/or used in your MS?([ID143])

D - 3.3 Provide information on efforts being made to refine tissue sampling techniques for genotyping.([ID137])

D - 3.4 Please indicate the criteria for sampling to obtain representative information above (for example as a proportion of all establishments breeding GA animals and the period during which the sample was taken).([ID140])

D - 3.5 Has the Working Document on Genetically Altered animals been made available to establishments housing or using genetically altered animals?([ID206])

D - 3.6 Has additional official guidance on genetically altered animals been developed to facilitate implementation?([ID206])

D - 3.6.bis If you consider this guidance helpful for other Member States to facilitate the implementation of the Directive, please provide web-address for the guidance, where available.([ID78])

E - 1.3 Provide cumulative information covering years 2013-2017 on the suspensions or withdrawals of authorisation of breeders, suppliers and users, and reasons thereof Mandatory question - please include data in the Excel or complete the requested information below([ID123])

E - 2.1 Is the endorsed EU Inspection Risk Analysis Criteria used as the basis for risk assessment ?([ID183])

E - 2.1.bis Please provide the criteria used for risk analysis in your MS (including web-address where the criteria can be found)([ID197])

E - 2.2 Are all new establishments inspected before an authorisation is granted?([ID189])

E - 2.2.bis Provide description on how the compliance with the provisions of the Directive is ensured as required in the second paragraph of Article 20(1)([ID194])

E - 2.4 Provide qualitative operational information on inspections carried out under Article 34([ID163])

E - 2.5 What information is made publicly available on inspection / enforcement? Please provide a web-address where any published material on inspections / enforcement may be found.([ID52])

E - 3 Provide cumulative information covering years 2013-2017 on the withdrawals of project authorisation, and reasons thereof Mandatory question - please include data in the Excel or complete the requested information below([ID123])

E - 4.1 Provide a general description of the main rules and steps governing penalties in your MS that will put into context the cumulative information provided below in section 4.2-4.4. Please note that administrative procedures may vary significantly between countries.([ID123])

E - 4.2 Provide cumulative information covering years 2013-2017 on the nature of infringements Mandatory question - please include data in the Excel or complete the requested information below([ID123])

E - 4.3 Provide cumulative information covering years 2013-2017 on the nature of administrative actions as a result of infringements Mandatory question - please include data in the Excel or complete the requested information below([ID123])

E - 4.4 Provide cumulative information covering years 2013-2017 on the nature of legal actions as a result of infringements Mandatory question - please include data in the Excel or complete the requested information below([ID123])

E - 5 Has the EU Guidance on Inspections and Enforcement been made available to all inspectors?([ID206])

E - 6 Has additional official guidance on Inspections and Enforcement been developed to facilitate implementation?([ID206])

E - 6.bis If you consider this guidance helpful for other Member States to facilitate the implementation of the Directive, please provide web-address for the guidance, where available.([ID78])

F -1 Please provide here views on problematic areas for implementation of the Directive in your Member State([ID207])

F - 2 Please provide here views on well-functioning elements of the Directive in your Member State([ID207])

F - 3 Please provide here views on issues that would benefit from collaborative efforts to improve implementation of the Directive([ID207])

F - 4 Please provide here any other additional comments concerning the implementation of the Directive([ID207])