Decree No 158 / 2021 Coll.
Decree amending Decree No. 419 / 2012 Coll., on the Protection of Experimental Animals, as amended by Decree No. 299 / 2014 Coll.
Valid
Effective from 15.04.2021
Text versions:
15.04.2021
08.04.2021
158
DECLARATION
of 30 March 2021
amending Decree No 419 / 2012 Coll., on the protection of experimental animals, as amended by Decree No 299 / 2014 Coll.
The Ministry of Agriculture provides pursuant to Article 29 (1) of Act No. 246 / 1992 Coll., for the protection of animals against abuse, as amended by Act No. 162 / 1993 Coll., Act No. 77 / 2004 Coll., Act No. 312 / 2008 Coll., Act No. 291 / 2009 Coll., Act No. 359 / 2012 Coll. and Act No. 501 / 2020 Coll., to implement Section 15c (7) of the Act:
Decree No. 419 / 2012 Coll., on the protection of experimental animals, as amended by Decree No. 299 / 2014 Coll., is amended as follows:
1. in Paragraph 1, point (a) is deleted;
Points (b) to (j) shall be renumbered (a) to (i).
2. in Article 1, points (b) and (c) are deleted;
Points (d) to (i) shall be renumbered (b) to (g).
3. Article 2 shall be deleted, including the title.
4. Paragraph 3 (1), including footnotes 2 and 3, reads as follows:
"(1) The breeder of experimental animals, the supplier of experimental animals or the user of experimental animals who applies for the authorisation to breed experimental animals, the authorisation to supply experimental animals or the authorisation to use experimental animals (the applicant) shall submit to the assessors:
(a) a document authorising the use of a building for breeding or supplying experimental animals or for conducting experiments on experimental animals under a building law or a binding opinion of the relevant regional veterinary administration in the territorial, building and approval proceedings, if required by other legislation2); This does not apply if:
1. conduct experiments in the wild,
2. the agricultural research referred to in Annex 7 to this Decree, point 7, in which the objective of the experiment project requires experimental animals to be kept under similar conditions as commercial livestock;
(b) a written statement by the competent regional veterinary authority on the operation of the establishment which:
1. on the date on which the application for authorisation for the use of experimental animals, for breeding of experimental animals or for the supply of experimental animals shall not exceed two months;
2. shall apply to the establishments referred to in the application for authorisation to use experimental animals, to breed experimental animals or to supply experimental animals;
(c) the operating rules of the establishments, including the emergency arrangements of the premises of the experimental animal breeder, the supplier of the experimental animals or the user of the experimental animals;
(d) technological procedures; the breeder of experimental animals, the supplier of experimental animals or the user of experimental animals, who is obliged to process standard operational procedures under other legislation3), submit standard operational procedures;
(e) documentation of the nature of the objects, including:
1. addresses, exact location, name and, where appropriate, any other indication of the individual premises used for breeding or supplying experimental animals or where experiments are carried out on experimental animals, in particular the identification of individual rooms, stables and similar parts of establishments;
2. species of experimental animals intended for breeding, delivery or use, their maximum daily status in total and in individual rooms, stables or similar parts of the establishment and the weight categories of animals to which the maximum daily status applies;
3. an indication of whether individual rooms, stables or similar parts of equipment are intended for the alternating location of different species of animals which are not or may not be present at the same time; an indication of which animal species and the maximum daily condition they may be placed alternately in the premises if such use of the premises takes place;
4. the indication of the farming system used in the establishment, in particular whether it is an open, barrier or insulator system, or the use of animals in the wild;
5. a description of the technical equipment suitable for the species of experimental animals present therein and, if experiments are carried out in the establishment, also for conducting experiments, in particular their number, type and size;
6. a plan of plan of equipment in which individual rooms, stables and similar parts of equipment are marked,
(f) records of the professional competence to design experiments and experimental projects and of the competence to conduct experiments on experimental animals, the care of experimental animals and the killing of experimental animals pursuant to Article 15d (8) of the Act;
(g) proof of the provision of the person responsible for the care of experimental animals and his certificate of competence for the design of experiments and experimental projects;
(h) evidence of the establishment of a expert panel on the welfare of experimental animals;
(i) the list of members of the expert panel on the welfare of experimental animals, the proof of the provision of a member of that expert committee, the certificate of competence of the members of that expert panel for the design of experiments and experimental projects;
(j) proof of the provision
1. a designated veterinarian and a document proving that he has obtained appropriate veterinary higher education under the Higher Education Act or his certificate of professional competence to design experiments and experimental projects; or
2. an appropriately qualified expert responsible for providing advice on the welfare and handling of experimental animals and his certificate of competence for the design of experiments and experimental projects.
2) Act No. 166 / 1999 Coll., on veterinary care and amending certain related laws (Veterinary Act), as amended.
3) Decree No. 86 / 2008 Coll., laying down the principles of good laboratory practice in the field of pharmaceuticals. '
5. in Article 3 (2) (b) and (c):
"(b) records kept under Article 17g (1) of the Act,
(c) the information and documentation referred to in Article 17h (1) of the Act as regards the applicant who maintains, supplies or uses dogs, cats or non-human primates; ';
6. in Article 3 (2), the following point (d) is inserted after point (c):
"(d) the strategy for maintaining the health status of experimental animals as set out in Annex 8 to this Decree, point (a) (1),"
Points (d) to (i) shall be renumbered as points (e) to (j).
7. in Article 3 (2), the following point (h) is inserted after point (g):
"(h) experimental protocols, including inspection records, carried out by the person responsible for the care of experimental animals and by the expert committee for the welfare of experimental animals, in the case of users of experimental animals,";
Points (h) to (j) shall be renumbered (i) to (k).
8. in Article 3 (2) (i), the words "unless this dossier is part of the test report referred to in (h)" shall be inserted after the words "assessment to the assessor,";
9. In Article 3 (2) (j), the words "for the registration of animals' are deleted and the words" under Article 15g (5) of the Act 'are inserted after the words "experimental projects'.
10. in Article 3 (3) (d):
"(d) an assessment of the spatial capacity of the facilities and technical equipment of the premises in which experimental animals are kept, delivered and used, in particular:
1. the types of experimental animals intended for breeding, delivery or use, their maximum daily status in total and in individual rooms, stables or similar parts of establishments, and the weight category of animals to which the maximum daily status applies;
2. defects and deficiencies detected, ';
11. in Article 3 (3), the following points (e) to (h) are inserted after point (d), including footnote 4:
"(e) the farming system used in the establishment, in particular whether it is an open, barrier or isolation system, or the use of animals in the wild;
(f) an indication of whether the size of the premises has been assessed under this Regulation or under the Ordinance governing minimum standards for the protection of livestock (4), in the case of agricultural research under Annex 7 to this Regulation, point 7, in which the objective of the experiment project requires experimental animals to be kept under similar conditions as commercial animals;
(g) the opinion of the assessors on the application for exemption from the obligation to conduct experiments only in approved establishments of the experimental animal user pursuant to Article 15a (2) of the Act, if the applicant has submitted such an application;
(h) the opinion of the assessors on the application for exemption from the obligation to use experimental animals referred to in Article 17f (1) of the Act only if they have been kept for use in experiments, if the applicant has made such a request;
4) Decree No. 208 / 2004 Coll., on minimum standards for the protection of livestock, as amended. '
Points (e) to (h) shall be renumbered as points (i) to (l).
12. Sections 4 and 5 shall be deleted, including the headings.
13. Annexes 1 to 4 are deleted.
Transitional provisions
1. In administrative proceedings which began before the date of entry into force of this Decree, the breeder of experimental animals, the supplier of experimental animals or the user of experimental animals, who applies for authorisation to breed experimental animals, the authorisation to supply experimental animals or the authorisation to use experimental animals, shall submit data to the assessors in accordance with Decree No. 419 / 2012 Coll., as effective before the date of entry into force of that decree.
2. In administrative proceedings initiated before the date of entry into force of this Order, the assessors shall prepare a written opinion under Decree No. 419 / 2012 Coll., as effective before the date of entry into force of this Order.
Final provision
This Decree was notified in accordance with Directive (EU) 2015 / 1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical and information society services.
Efficacy
This Decision shall enter into force on 15 April 2021.
Minister:
Ing. Toman, CSc., v. r.
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Decree No 158 / 2021 Coll., amending Decree No 419 / 2012 Coll., on the protection of experimental animals, as amended by Decree No 299 / 2014 Coll. |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 08.04.2021 |
|---|---|
| Effective from | 15.04.2021 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
Comments 0