What is Act No 314 / 2022 Coll.?

Act No. 314 / 2022 Coll., amending Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Law on Medicines), as amended, and other Related Acts — Act amending Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Law on Medicines), as amended, and other Related Laws.

When it became Act No 314 / 2022 Coll. effectiveness?

Act No 314 / 2022 Coll. became effective 01.12.2022.

Is Act No 314 / 2022 Coll. still valid?

Yes, Act No 314 / 2022 Coll. is still valid and effective.

How many times was it Act No 314 / 2022 Coll. amended?

Act No 314 / 2022 Coll. has 3 time versions of the text.

Act No 314 / 2022 Coll.

Act amending Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Law on Medicines), as amended, and other Related Laws

Valid Law Effective from 01.12.2022

Text versions: 01.12.2022 31.10.2022

ČÁST PRVNÍ Čl. I „§ 9 „§ 9a § 9b „§ 16 „§ 29 „§ 30a § 30b § 30c „§ 43 „§ 45a „§ 48 „§ 48a „§ 53 § 60 „§ 60a „§ 61a „§ 66a § 68a § 68b § 68c § 73 § 74 „§ 94 „§ 94a „§ 95 „§ 96 „§ 97 „§ 101d § 102a § 102b § 102c § 102d § 102e „§ 112b Čl. II ČÁST DRUHÁ Čl. III „§ 5h „§ 5o ČÁST TŘETÍ Čl. IV Čl. V ČÁST ČTVRTÁ Čl. VI „§ 32c ČÁST PÁTÁ Čl. VII Čl. VIII ČÁST ŠESTÁ Čl. IX ČÁST SEDMÁ Čl. X ČÁST OSMÁ Čl. XI

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314

THE LAW

of 12 October 2022

amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended, and other Related Acts

Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

Amendment to the Drug Act

Čl. I

Act No. 378 / 2007 Coll., Act No. 141 / 2009 Coll., Act No. 281 / 2009 Coll., Act No. 291 / 2009 Coll., Act No. 75 / 2011 Coll., Act No. 375 / 2011 Coll., Act No. 50 / 2013 Coll., Act No. 70 / 2013 Coll., Act No. 250 / 2014 Coll., Act No. 251 / 2017 Coll., Act No. 36 / 2018 Coll., Act No. 44 / 2019 Coll., Act No. 65 / 2017 Coll., Act No. 66 / 2017 Coll., Act No. 183 / 2017 Coll.

1. In footnote 1, the sentences "Directive 2001 / 82 / EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, as amended by Directive 2004 / 28 / EC 'and" Council Directive 90 / 167 / EEC of 26 March 1990 laying down the conditions for the preparation, placing on the market and use of medicated feedingstuffs in the Community' are deleted.

2. At the end of footnote 2, the sentences are added to the separate rows

"Regulation (EU) 2019 / 6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001 / 82 / EC, as amended. Regulation (EU) 2019 / 4 of the European Parliament and of the Council of 11 December 2018 on the production, placing on the market and use of medicated feed, amending Regulation (EC) No 183 / 2005 of the European Parliament and of the Council and repealing Council Directive 90 / 167 / EEC. Commission Implementing Regulation (EU) 2021 / 16 of 8 January 2021 laying down the necessary measures and practical steps for the Union database on veterinary medicinal products (Union database on products). Commission Implementing Regulation (EU) No 221 / 17 of 8 January 2021 laying down a list of amendments which do not require an assessment pursuant to Regulation (EU) 2019 / 6 of the European Parliament and of the Council. Commission Implementing Regulation (EU) 2016 / 963 of 10 June 2021 laying down detailed rules for the application of Regulations (EU) 2016 / 429, (EU) 2016 / 1012 and (EU) 2019 / 6 of the European Parliament and of the Council as regards the identification and registration of equidae and laying down model identification documents for those animals. Commission Implementing Regulation (EU) 2016 / 1248 of 29 July 2016 on measures for the proper distribution of veterinary medicinal products in accordance with Regulation (EU) 2019 / 6 of the European Parliament and of the Council. Commission Implementing Regulation (EU) No 221 / 1280 of 2 August 2021 on measures for the good distribution practice of active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019 / 6 of the European Parliament and of the Council. Commission Implementing Regulation (EU) 2021 / 1281 of 2 August 2021 laying down rules for the application of Regulation (EU) 2019 / 6 of the European Parliament and of the Council as regards good pharmacovigilance practice and the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products. Commission Implementing Regulation (EU) 2021 / 1904 of 29 October 2021 adopting the design of a common logo for the retail sale of veterinary medicinal products at a distance. Commission Implementing Regulation (EU) No 2022 / 209 of 16 February 2022 establishing the format of the data to be collected and reported for the determination of the volume of sales and use of antimicrobial medicinal products in animals in accordance with Regulation (EU) 2019 / 6 of the European Parliament and of the Council. Commission Delegated Regulation (EU) 2016 / 577 of 29 January 2021 supplementing Regulation (EU) 2019 / 6 of the European Parliament and of the Council with regard to the content and format of the information necessary for the application of Articles 112 (4) and 115 (5) to be contained in the single lifetime identification document referred to in Article 8 (4) of that Regulation. Commission Delegated Regulation (EU) 2016 / 578 of 29 January 2021 supplementing Regulation (EU) 2019 / 6 of the European Parliament and of the Council with regard to requirements for the collection of data on sales volume and the use of antimicrobial medicinal products in animals. Commission Delegated Regulation (EU) 2021 / 805 of 8 March 2021 amending Annex II to Regulation (EU) 2019 / 6 of the European Parliament and of the Council. Commission Delegated Regulation (EU) 2021 / 1760 of 26 May 2021 supplementing Regulation (EU) 2019 / 6 of the European Parliament and of the Council by establishing criteria for the determination of antimicrobials to be reserved for the treatment of certain infections in humans. '

3. in Article 2 (2) (b), the words "; medicated feed shall be considered as veterinary medicinal products and shall not be considered as additives (3)," including footnote 3;

4. in Article 2 (2) (d):

"(d) veterinary immunological medicinal products,"

5. in Article 2 (2) (f), including footnote 122:

"(f) veterinary autogenic vaccines which mean inactivated immunological veterinary medicinal products made from pathogens or antigens derived from an animal or an animal in a single epidemiological unit (122) and which are used for the treatment of an animal or animal in the same epidemiological unit or in an epidemiological unit which has the same disease situation with that epidemiological unit;

(122) Regulation (EU) 2016 / 429 of the European Parliament and of the Council of 9 March 2016 on animal diseases and amending and repealing certain acts in the field of animal health ("animal health legal framework"), as amended. ';

6. in § 2 (2) (l), § 39 (7) and (8), § 81f (1) (b), § 82 (4), § 87 (1) of the introductory part of the provision, § 93d (3) and in § 100a the word "medicinal" shall be replaced by "medicinal human."

7. In Paragraph 2 (2) (m), the word "plant 'is replaced by the words" human plant'.

8. In § 2 (2) (n), § 3 (4) of the introductory part of the provision, § 4 (7), § 11 (p), § 23 (1) (d), § 24 (2) and (9), § 25 (2) (e), § 67 (5) (b), § 88 (2), § 100 (7), § 103 (2), § 104 (8) (b) and (c), and in § 108 (1) (b), the word "transfusion" shall be replaced by "human transfusion."

9. in Article 2 (2), the following point (o) is inserted after point (n):

"(o) veterinary transfusions of blood of animals and its constituents which have not undergone industrial processing;"

Points (o) to (q) shall be renumbered as points (p) to (r).

10. in Article 2 (2) (q) and (r), the word "humane" shall be inserted after the word "means."

11. in Paragraph 2, the dot is replaced by a comma at the end of paragraph 2 and the following point (s) is added:

"(s) biological veterinary medicinal products."

12. in Article 2, paragraphs 5 and 6 are deleted;

13. in Paragraph 3 (2):

"(2) For the purposes of this Act, a withdrawal period shall mean the period referred to in Article 4 (34) of Regulation (EU) 2019 / 6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001 / 82 / EC (" the Regulation on veterinary medicinal products'); This also applies to other medicinal products used in accordance with Articles 113 and 114 of this Regulation. ';

14. in Article 3 (3), the words "medicinal products for human use" shall be inserted after the words "medicinal products for human use"; the words "medicinal products for veterinary use" shall be inserted after the words "medicinal products for human use"; and the words "medicinal products" shall be inserted after the words "medicinal products";

15. in Article 3 (4) of the introductory part of the provision, the words "on its submission" shall be deleted, after the words "to appear after" shall be inserted the words "its use under the terms of its registration or outside the terms of its registration, usually after" and the word "destination" shall be replaced by the word "determination."

16. in Article 3 (4) (c), the words "are harmful and unintended and which appear in humans after exposure to the veterinary medicinal product" shall be deleted.

17 (3) (a) (3) (3) (a) (3) (3) (a) (3) (3) (a) (3) (3) (a) (3) (3) (3) (a) (3) (3) (a) (3) (3) (a) (3) (3) (3) (3) (3) (3) (5) (5) (1) (2) (2) (2) (5) (1) (1) (d) (1) (1) (1) (1) (1) (a) (1) (1) (1) (1) (1) (2) (1) (1) (2) (2) (1) (1) (2) (2) (2) (2) (2) (2) (2) (2) (2) (2) (3) (3) (3) (3) (3) (3) (3) (a) (a) (3) (3) (a) (a) (3 (3) (3) (3) (

18. in § 3 (5), § 3a (7) and (8), § 5 (6), § 13 (2) (d), § 24 (2) and (9), § 67 (1) and (3), § 67 (4) (f), § 67 (4) (g), (h) and (k), § 67 (4) of the final part of the provision, § 67 (5) (b) and (c), § 67 (7) (a) to (c), § 67 (10), § 104 (2), § 106 (2) and in § 108 (4 of the final part of the provision, the word "transfusion" shall be replaced by the words "human transfusion."

19. in Paragraph 3 (8), the word "or" shall be deleted at the end of point (a), the dot shall be replaced by "or" and the following point (c) shall be added:

"(c) the risk of developing resistance if it is a veterinary medicinal product."

20. in Article 3 (10) and Article 103 (6) (f) of the Introductory Part of the provision, the word "transfusion" shall be replaced by "human transfusion."

21. In Articles 4 (6) and (7), 5 (5) and (9), 11 (e) and (k), 13 (2) (a) (2), 24 (1) (a), 24 (1) (i) of the provisions, 24 (2), 24 (5) (a), (c) and (e), 67 (1) to (3), 67 (4) (c) and (f), 67 (4) (i) of the provisions, 6 and 7, 67 (10) and 11, 77 (1) (c) (11), and in Article 101 (5 (d), the word "transfusible" shall be replaced by "humane transfusible."

22. § 4 (6), § 5 (8) (a) (3), § 13 (3) (p), § 25 (4) of the introductory part of the provision, § 37 (2), § 39 (4) of the introductory part of the provision, § 39 (8), § 64, § 65 (6) (a), § 66 (1) (b), § 77c (1), § 81f (1) (a), § 84 (4) (a), § 87 (2), § 90 (1) (c), § 90 (2) (c), § 91 (1) (a), § 91 (1), § 91 (1) (e), § 93 (2), § 93a (1), § 87 (2), § 90 (2), § 90 (c), § 39 (1), § 103 (1) (1) (a), § 103 (1), § 103 (1), § 103), § 39), § 103 (1), § 103 (a), § 103 (1), § 103, § 103 (

23. in Article 5 (5), the words "and the distribution of veterinary transfusions and biological veterinary medicinal products" shall be inserted after the words "for further production by the establishments of the transfusion service."

24. in Article 5 (8) (b), the words "their supply to breeders for subsequent administration to animals or their direct administration to animals" shall be replaced by the words "their use to animals or groups of animals, or their use in animals or groups of animals, and the provision of medicinal products to breeders in the amount needed to complete the treatment or treatment."

25. in Article 5 (9), the words "the supply of veterinary transfusions" shall be inserted after the words "the distribution of human transfusions,"

26. in Paragraph 5 (10):

"(10) For the purposes of this Act, a veterinary special treatment programme shall mean the use of a veterinary medicinal product which is not authorised in the European Union or in a third country under the conditions laid down in this Act. ';

27. in Article 5 (14) of the introductory part of the provision, the word "humane" shall be deleted;

28. In Article 5, at the end of paragraph 16, the sentence "The definition of the production of the active substance, when it relates to its use in veterinary medicinal products, shall be added. ';

29. in Article 7 (1) (b):

"(b) comply with the instructions for the treatment of a medicinal product in accordance with the Summary of Product Characteristics, as far as the use of medicinal products for human use is concerned in accordance with § 8 (3) to (5) or in the provision of veterinary care under § 9 (1) (b) to (m)."

30. In the headings of Sections 8, 77d and 80, the words "medicinal 'are replaced by the words" medicinal human'.

31. in § 8 (8), § 84 (4) (d), § 90 (1) (a), § 93a (2) of the introductory part of the provision, § 93a (3), § 93c (4) and in § 93d (2), the word "medicinal products" shall be replaced by "medicinal products for human use."

32. Paragraph 9, including the title and footnotes Nos 14 and 123, reads as follows:

„§ 9

Use of medicinal products in the provision of veterinary care

(1) In the provision of veterinary care, only:

(a) a veterinary medicinal product authorised in accordance with Section 25;

(b) the veterinary autogenic vaccine;

(d) a medicinal product prepared in accordance with the Articles of the Czech Pharmacopoeia and in the manner laid down in the implementing legislation at the pharmacy or at the workplace of another health service provider authorised under § 79 (2) to prepare medicinal products;

(e) a veterinary medicinal product authorised in another Member State in accordance with European Union14), for which the conditions laid down in Section 48 have been fulfilled for the placing into circulation in the Czech Republic,

(f) a medicinal product for human use authorised in accordance with Section 25;

(g) the veterinary medicinal product used in the framework of a veterinary special treatment programme approved by the Institute for State Control of Veterinary Bioprafts and Medicines (hereinafter referred to as the Veterinary Institute) for one animal or for a group of animals pursuant to Article 48a, having regard to Article 112, 113 or 114 of the Regulation on veterinary medicinal products,

(h) a veterinary medicinal product for which a clinical trial has been approved by the Veterinary Institute in accordance with § 60 or 60a;

(i) a biological veterinary medicinal product containing autologous or allogeneic cells or tissues;

(j) veterinary radiopharmaceuticals,

(k) the veterinary transfusion preparation,

(l) a veterinary medicinal product for which the Central Veterinary Administration of the State Veterinary Administration ("the Central Veterinary Administration") has issued an exemption under Paragraph 46; or

(m) an unregistered immunological veterinary medicinal product decided to be used by the European Commission ("the Commission").

(2) The medicinal products referred to in paragraph 1 may be used in the provision of veterinary care only if they comply with the conditions laid down in Chapter VII, Section 3 of the Regulation on veterinary medicinal products, Commission implementing acts or Commission delegated acts issued pursuant to the Articles of this Section, this Act and the implementing legislation. The implementing act shall impose restrictions on the use of the medicinal products referred to in paragraph 1 and the conditions for their availability with regard to authorised veterinary medicinal products under the directly applicable European Union Regulation.

(3) A veterinary medicinal product put into circulation under Article 34 of the Regulation on veterinary medicinal products or under this law is subject to medical prescription, a veterinary medicinal product which is not bound by a prescription but which is to be used outside the conditions of its authorisation and a medicinal product for human use used in the provision of veterinary care may only be used:

(a) a veterinarian authorised to carry out a veterinary medical and preventive activity in accordance with the conditions laid down in the Chamber of Veterinary Physicians or a university veterinarian authorised to carry out a veterinary medicinal and preventive activity in accordance with § 58 (3) (a) of the Veterinary Act (the "veterinarian"); or

(b) the breeder of the animal, if he / she is responsible for administering the medicinal product for the animal he / she is kept in accordance with the instructions given by the veterinarian and, in the case of an animal producing animal products intended for human nutrition, also in accordance with the conditions laid down in veterinary law (10).

Where a veterinarian intends to use an unregistered veterinary medicinal product in an animal, a veterinary medicinal product to be used outside the conditions of its registration, or a medicinal product for human use, he shall inform the keeper of the animal of the possible adverse consequences associated with the use of such a product.

(4) The veterinary surgeon shall use the medicinal product referred to in paragraph 3, or shall lay down instructions for the administration of such medicinal product only after diagnosis or other conclusion authorising it to use the medicinal product, on the basis of:

(a) a properly carried out and documented examination of the animal or animals in breeding normally carrying out a therapeutic and preventive veterinary activity and an assessment of any other conditions which may affect the safety or efficacy of the medicinal product to be used;

(b) a detailed and documented set of information on the health status of the animal or group of animals in the holding for which the conditions referred to in point (a) are met, in case of preventive use of medicinal products or a long-term programme of treatment in the holding; or

(c) on the basis of an immediate assessment of the health status of the animal or other information to the extent necessary to decide on the use of the medicinal product in such a way as to minimise the risk of its adverse effects, if there is an exceptional case of danger to the health or life of the animal;

taking further account of the conditions laid down in the Regulation on veterinary medicinal products.

(5) Only a veterinarian who has carried out the operations referred to in paragraph 4 may use:

(a) a veterinary medicinal product for which the Veterinary Institute has restricted the range of persons authorised to use the veterinary medicinal product by decision pursuant to Paragraph 40 (4);

(b) a medicinal product for human use as referred to in paragraph 1 which is associated with a high risk to public health, animal health or the environment, including the risk of developing resistance to antimicrobials; the implementing legislation establishes a list of such medicinal products for human use or groups thereof,

(d) the biological veterinary medicinal product for cellular or tissue therapy referred to in Article 68c;

(e) veterinary radiopharmaceuticals,

(f) a veterinary medicinal product for which the Central Veterinary Administration has so decided pursuant to Article 46,

(g) the medicinal product for which the Veterinary Institute has so decided pursuant to § 48, and

(h) an immunological veterinary medicinal product for which such a restriction has been provided for in the framework of protective or protective measures laid down by veterinary authorities under another legislation (18).

(6) A medicinal product containing thyrostatic substances, hormonal substances or beta-agonists may only be used for the purpose of providing veterinary care if its use is not contrary to the conditions laid down in this Act and other legislation17). A veterinarian intending to use the medicinal product according to the first sentence in an animal producing animal products intended for human consumption shall inform the breeder in advance and obtain the consent of the breeder to administer such medicinal product. However, if it is required to protect the health or life of an animal, the veterinarian may use the medicinal product according to the first sentence without obtaining the consent of the breeder, but shall immediately inform the breeder in a conclusive manner.

(7) An immunological veterinary medicinal product may only be used for veterinary purposes if its use complies with this law and the measures laid down by veterinary authorities under another legislation18).

(8) Following the administration of a veterinary medicinal product to an animal producing animal products intended for human consumption in accordance with the conditions of its registration, the breeder of such an animal shall comply with the withdrawal period laid down in the conditions for registration of the veterinary medicinal product, unless the veterinarian who has carried out the operations referred to in paragraph 4 provides for a longer withdrawal period.

(9) Following the administration of a medicinal product to an animal producing animal products intended for human consumption under conditions other than those referred to in paragraph 8, a withdrawal period shall be set taking into account the conditions laid down in Article 115 of the Regulation on veterinary medicinal products by a veterinarian who has carried out the operations referred to in paragraph 4, and the breeder shall comply with at least the withdrawal period laid down in this Regulation.

(10) The veterinarian who has carried out the operations referred to in paragraph 4 shall record any use of the medicinal product in the provision of veterinary care in accordance with the requirements laid down in the implementing legislation. Records of the use of medicinal products shall be kept by the veterinarian who carried out the operations referred to in paragraph 4 for at least 5 years. The implementing act shall lay down the manner in which such records are kept and the content thereof. Records of the use of medicinal products shall be provided by the veterinarian who carried out the operations referred to in paragraph 4 in electronic form to the Veterinary Institute in accordance with the conditions laid down in Sections 102a to 102e.

(11) Breeders who:

(a) for the purpose of business, keeping an animal producing animal products intended for human consumption;

(b) keeping an animal producing animal products intended for human nutrition and selling them in small quantities in accordance with other legislation18);

(c) for the purpose of business, keeping an animal which does not produce animal products intended for human consumption; or

(d) is a breeder of a horse or other animal of the equine family;

it has an obligation to acquire medicinal products exclusively from operators under this Act and to keep records of the acquisition and use of medicinal products in accordance with Article 108 of the Regulation on veterinary medicinal products and the implementing legislation laying down the form of records, the extent and the method of storage. Breeders shall be obliged to keep records of the use of medicinal products for at least 5 years, even if the animals to which the medicinal products have been administered have been slaughtered or are no longer held by the breeder.

(12) The visiting veterinarian authorised to provide veterinary care in the territory of the Czech Republic under the Veterinary Chamber Act may administer medicinal products to animals to the extent provided for in Article 111 (1) (a) of the Regulation on veterinary medicinal products, with the exception of authorised immunological veterinary medicinal products other than those containing exclusively toxins and serum, subject to the conditions laid down in Article 111 (1) of the Regulation on veterinary medicinal products. The visiting veterinarian shall comply with the restrictions on the use of medicinal products provided for in this Act, in the case of the submission of a medicinal product to an animal producing animal products for human consumption, he shall be obliged to provide for a withdrawal period under this Act and to comply with the rules laid down by the Chamber of Veterinary Doctors in accordance with Article 111 (1) (c) of the Regulation on veterinary medicinal products. The visiting veterinarian must not issue a medicinal product to the breeder for the purpose of its subsequent administration to animals or otherwise equip it with such medicinal product and must only use authorised veterinary medicinal products. The visiting veterinarian shall keep the records referred to in paragraph 10 on the use of medicinal products and, if he fulfils the conditions for the electronic provision of data on the use of medicinal products under Sections 102a to 102e, he shall provide them to the Veterinary Institute in accordance with the conditions laid down in Sections 102a to 102e.

(13) For the use of authorised veterinary medicinal products, except veterinary immunological medicinal products, in the form of administration in feed on a given farm (20), only those technological equipment which is part of that holding and for which the Regional Veterinary Administration has laid down animal health conditions and measures in accordance with other legislation18) may be used; Where such animal health conditions and measures have not been laid down for the relevant technological establishment, the breeder may not use such equipment for the purpose of medication until the relevant county veterinary authority has established the animal health conditions and measures which it requests to establish these conditions and measures. The Regional Veterinary Administration shall lay down such conditions in the light of the conditions laid down by the Commission in accordance with Article 106 (6) of the Regulation on veterinary medicinal products. The Regional Veterinary Administration does not provide such conditions in the case of the production of medicated feedingstuffs on a holding subject to authorisation under another legislation68).

(14) The veterinarian shall be responsible, irrespective of his fault, for any damage caused by the use of an unauthorised medicinal product, with the exception of the use of the veterinary medicinal product under the conditions laid down for its clinical trial, the use of the authorised medicinal product outside the conditions of its registration or the use of the medicinal product for human use.

(15) Unless the experimental project approved under another legislation (123) sets out the conditions for the use of medicinal products, only the veterinarian who carried out the operations referred to in paragraph 4 may use the medicinal products when carrying out the experiments at the premises of the user of the experimental animals, in accordance with the conditions laid down in this law and other legislation123).

(16) Treatment of veterinary medicinal products other than in accordance with this Act is prohibited.

14) Directive 2001 / 82 / EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, as amended.

123) Act No. 246 / 1992 Coll., as amended. '

33. The following Sections 9a and 9b are inserted after Section 9, including the headings:

„§ 9a

Conditions for the use of antimicrobial medicinal products in the provision of veterinary care

(1) Unless otherwise provided, the restrictions on the use of antimicrobial medicinal products in the provision of veterinary care provided for in Article 107 of the Regulation on veterinary medicinal products shall apply also to medicinal products authorised under this law and to medicinal products not subject to registration.

(2) A breeder who, as an entrepreneur, maintains an animal producing animal products intended for human consumption is obliged to take systemic measures to limit the risk of developing and disseminating infectious disease agents in breeding, thereby reducing the need for the use of antimicrobial medicinal products in breeding and further allowing the conditions for the use of an antimicrobial medicinal product under this law. To this end, the breeder shall cooperate with the veterinarian who carried out the operations referred to in Section 9 (4).

(3) In the case of an antimicrobial medicinal product, the conditions of its use shall include those laid down in Article 9 (4); and

(a) a justification for its use with regard to the presence of the infectious agent and its sensitivity to the antimicrobial medicinal product used, based on a history, epidemiological data, the outcome of a clinical examination, the use of rapid diagnostic methods or laboratory testing results;

(b) the ability of the medicinal product to reach effective drug concentration at the site of infection at the specified dosage;

(c) in the case of group use of the medicinal product, the ability to ensure adequate dosing throughout the treated group of animals;

(d) the effect of administration of the medicinal product on the presence and spread of resistance in and in animals, food and the environment; and

(e) the need to administer the medicinal product as prophylaxis or metaphylaxis under the Regulation on veterinary medicinal products.

(4) In the provision of veterinary care, the following additional conditions shall be fulfilled for the use of an antimicrobial veterinary medicinal product for which, in accordance with Article 40 (6), the indication restriction, the medicinal product for human use and the non-registered veterinary medicinal product referred to in Article 9 (1) (c), which comply with the conditions laid down in the implementing legislation:

(a) the medicinal product does not apply in cases of prophylaxis provided for in the implementing legislation;

(b) in the case of an animal, on a holding or on an epidemiological unit, an infectious agent has been established by laboratory in accordance with Regulation (EU) 2016 / 429 of the European Parliament and of the Council of 9 March 2016 on epizootic diseases and amending and repealing certain animal health acts ("animal health legal framework") and this information is still valid at the time of use of the medicinal product under the conditions laid down in the implementing legislation;

(c) for the agent referred to in point (b), sensitivity to the medicinal product has been confirmed in the laboratory, whereby the State Veterinary Administration may, under another legislation18) designate laboratories authorised to carry out sensitivity testing;

(d) with regard to the specified agent referred to in (b) and its sensitivity, no other appropriate antimicrobial agent is available for treatment, the use of which represents a lower risk for the occurrence and spread of resistance in animals, food, human or environment; and

(e) the veterinarian shall evaluate and record the effectiveness of the treatment and, in case of insufficient efficacy, shall send the Pharmacovigilance Report to the Veterinary Institute in accordance with § 94.

(5) The implementing legislation lays down detailed conditions for the use of antimicrobial medicinal products, when it comes to prophylaxis and metaphylaxis.

§ 9b

Specific conditions for the use of medicinal products

(1) The State Veterinary Administration shall be authorised, in the performance of its duties under the Veterinary Act, to use medicinal products, by way of derogation from the conditions laid down in Section 9 or 9a, where justified by the nature or circumstances of their use. Where the use referred to in the first sentence concerns animals producing foodstuffs intended for human consumption intended for circulation, the State Veterinary Administration shall comply with the restrictions on the safety of foodstuffs following the use of medicinal products provided for in the Regulation on veterinary medicinal products and this Act. The State Veterinary Administration shall keep records of the use of medicinal products and shall keep such records for at least 5 years.

(2) The Ministry of Defence, the Ministry of Interior, the Ministry of Justice, the Ministry of Finance and, where appropriate, the organizational bodies of the State established by them, the armed forces of the Czech Republic and the Police of the Czech Republic are authorised to use medicinal products, by way of derogation from the conditions laid down in § 9 or 9a, if justified by the nature or circumstances of their use. Where the use concerns animals producing foodstuffs intended for human consumption for putting into circulation, the second sentence of paragraph 1 shall apply mutatis mutandis. Where the use referred to in the first sentence concerns immunological veterinary medicinal products, the competent Ministry shall discuss the use of such medicinal products with the Ministry of Agriculture. The competent authorities of the State shall keep records of the use of medicinal products and shall keep such records for at least 5 years.

(3) The officers of the municipal police, who have successfully completed an expert course for catching and treating animals without master, stray and abandoned animals, including at animal shelters, are entitled to use veterinary medicinal products in the course of the performance of their duties, solely for the purpose of catching the animal itself, in accordance with the conditions laid down in Section 9 and in accordance with the instructions of the veterinarian who carried out the operations referred to in Section 9 (4). The municipal police shall keep records of the use of the medicinal product in accordance with the requirements laid down in Article 9 (11). ';

34. in Article 10 (2) (c):

"(c) Veterinary Institute,"

35. in Article 11 (h), the words "if they require the provision of general measures and if the conditions for its issue are met, they shall be followed in accordance with (g) or (q)," shall be deleted.

36. In Article 11, at the end of point (r), the dot is replaced by a comma and the following point (s) is added:

"(s) may, following the prior approval of the Government, ensure the availability of medicinal products of public health significance by buying or distributing them, unless otherwise possible."

37. The heading of Section 12 reads:

"Ministry of Interior, Ministry of Justice, Ministry of Defence and Ministry of Finance."

38. In Article 12, the current text becomes paragraph 1 and the following paragraphs 2 and 3 are added:

"(2) The Ministry of the Interior, the Ministry of Justice, the Ministry of Defence and the Ministry of Finance carry out the tasks of the State administration provided for by this Act on the section of the inspection pursuant to § 101 and the imposition of penalties under § 103 to 109 in the field of veterinary care in the field of the bodies of the State established by them. In the case of the armed forces of the Czech Republic, the tasks referred to in the first sentence shall be performed by the Ministry of Defence. In the case of the services of the Police of the Czech Republic, tasks according to the first sentence are performed by the Ministry of the Interior.

(3) For the purpose of the provision of veterinary care, the Ministry of Defence, the Ministry of Interior, the Ministry of Justice, the Ministry of Finance and, where appropriate, the organizational bodies of the State, the armed forces of the Czech Republic and the Police of the Czech Republic in the event of emergency situations, are entitled to proceed with the provision of medicines by way of derogation from this Act. "

39. in Paragraph 13 (2) (f), the words "and excipients" shall be deleted;

40. in Paragraph 13 (2) (m), the word "medicinal products" shall be replaced by "authorised medicinal products" and the words "such medicinal products" shall be replaced by "such medicinal products."

41. in Paragraph 13 (3) (s), the word "humane" shall be inserted after the word "offers."

42. In Section 14, the words "shall be added at the end of the text of point (a), shall ensure coordination with the competent authorities of the Member States and, on a proposal from the Veterinary Institute, shall give consent to the appointment of a representative of the Czech Republic pursuant to Article 140 and Article 145 of the Regulation on veterinary medicinal products'.

43.

"(c) publish the information referred to in Article 11 (f) in a way that allows remote access;"

44. In Article 14, at the end of point (d), the comma is replaced by a dot and point (e) is deleted.

45. in Article 15 (a), the words "Institute for State Control of Veterinary Bioprafts and Drugs" are replaced by the words "Veterinary Institute."

46. in Article 15 (b), the words "pursuant to Article 46" shall be inserted after the words "authorised."

47. Paragraph 16, including the title, reads:

„§ 16

Veterinary Institute

(1) The Veterinary Institute is a national administrative authority under the authority of the Central Veterinary Administration. The Director shall be head of the Veterinary Institute; its selection, appointment and appeal are governed by the Civil Service Act.

(2) Veterinary Institute for Veterinary Medicines

(a) issue:

1. authorisation to place veterinary medicinal products on the market, modification, extension, transfer, suspension and revocation, decision to authorise simultaneous importation, decision to forfeit the veterinary medicinal product, decision to prevent the veterinary medicinal product,

2. authorisation for the production of veterinary medicinal products, including veterinary autogenic vaccines, veterinary transfusion products or biological veterinary medicinal products for cellular or tissue therapy pursuant to § 68c, authorisation for the operation of the control laboratory and authorisation for distribution; decide to amend, suspend or revoke such authorisations;

3. the certificates referred to in Article 13 (2) (a) (3) mutatis mutandis;

4. an opinion on the use of an unauthorised medicinal product in the provision of veterinary care and on the use of an active substance or an additive for veterinary use not included in the list provided for in the implementing legislation;

5. the decision to authorise the supply of veterinary medicinal products authorised in another Member State under Paragraph 48;

6. the authorisation decision referred to in Article 37 (2) to place on the packaging particulars in excess of the Regulation on veterinary medicinal products,

(b) issue a decision approving a clinical trial of veterinary medicinal products and decide whether or not to terminate a clinical trial, approve non-interventional post-authorisation veterinary studies and decide whether or not to terminate them;

(c) in the event of a threat to the health or life of animals, to the health of persons or to the environment, in particular where an adverse effect of the veterinary medicinal product or a suspicion of its adverse effect is identified, or where a defect or suspicion of a defect in the quality of the medicinal product is detected, it shall, by analogy, issue a temporary measure in accordance with Article 13 (2) (c);

(d) in the event of a threat to the health or life of animals, to the health of persons or to the environment, decide on the measures provided for in Article 13 (2) (e) mutatis mutandis;

(e) carry out an inspection in the field of veterinary medicinal products in accordance with Article 13 (2) (f) and (g) mutatis mutandis;

(f) decide mutatis mutandis in cases of doubt under Article 13 (2) (h) unless the Commission has decided in accordance with Article 3 of the Regulation on veterinary medicinal products in the present case;

(g) in the field of veterinary medicinal products, discuss offences and implement infringement measures;

(h) decide on the possibility of placing on the packaging of the veterinary medicinal product data in a language other than the Czech language;

(i) issue measures of a general nature pursuant to Article 30a (1);

(j) deliver an opinion on the application for exemption from the marketing authorisation submitted pursuant to Paragraph 46;

(k) decide on the authorisation of a veterinary special treatment programme under § 48a;

(l) carry out control over the prescription of veterinary medicinal products for the purposes of the manufacture or placing on the market of medicated feedingstuffs and their subsequent use and control over the supply, use and sale of medicated feedingstuffs pursuant to Article 74;

(m) carry out the activities entrusted to the competent authority of a Member State or a Member State by the Regulation on veterinary medicinal products and its implementing and delegated acts, unless otherwise provided for in that law, or where their exercise is attributable to another administrative authority under any other legislation;

n) represents the Czech Republic, within its scope, in the working groups and committees of the European Union,

(o) ensure the exchange of information with the European Union institutions, including the exchange of information required by European Union regulations.

(3) The Veterinary Institute in the field of veterinary medicinal products

(a) carry out risk-benefit monitoring of veterinary medicinal products including monitoring of adverse effects, including lack of efficacy, use outside the scope of the marketing authorisation, risks arising from veterinary medicinal products for the environment and the adequacy of the withdrawal periods of veterinary medicinal products, in particular through the veterinary pharmacovigilance system and professional operations which support the functioning of the veterinary pharmacovigilance system; to that end, the Veterinary Institute shall further ensure the functioning of the pharmacovigilance database of veterinary medicinal products for the Czech Republic, participate in the administration and have access to the pharmacovigilance database of European Union veterinary medicinal products and shall exchange data with that pharmacovigilance database established under the Regulation on veterinary medicinal products,

(b) implement and maintain a fund of expert information on medicinal products, including data on the consumption and use of veterinary medicinal products, and may, to this end, participate in public research projects in the field of veterinary medicinal products, exclusively by ensuring the various professional activities which are requested; the identification of the research project, the description of the professional activities carried out by the Veterinary Institute and the outputs processed by the Veterinary Institute, shall be published in the Veterinary Institute information medium referred to in point (c);

(c) publish on its website and in the Bulletin of the Institute for State Control of Veterinary Bioprafts and Medicaments, which are the information means of the Veterinary Institute (hereinafter referred to as the Veterinary Institute information), the information referred to in Section 99, the information on the exceptions to the registration provided for in Sections 46 to 48 and other information provided for in this Act,

d) participates in the preparation of the European Pharmacopoeia 4) and participates in the preparation of the Czech Pharmacopoeia,

(e) issue a binding opinion pursuant to Article 13 (3) (e) by analogy;

(f) ensure cooperation in accordance with Article 13 (3) (f) by analogy; the representative shall appoint, after approval by the Ministry of Agriculture and appoint representatives for activities in the coordination group for the registration procedure by mutual recognition and for the decentralised procedure for the registration of veterinary medicinal products under the Regulation on veterinary medicinal products,

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Regulation Information

Citation	Act No. 314 / 2022 Coll., amending Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Law on Medicines), as amended, and other Related Acts
Regulation Type	Law
Author	-
Collection	Code of Laws

Date of Promulgation	31.10.2022
Effective from	01.12.2022
Effective until	-
Status	Valid

Legal Areas: Taxes Finance Information, Data, Data Labour law Administrative offences Administrative law State (official) control Health Agriculture Eligibility for the pursuit of certain professions (activities)

Parliamentary Paper: Paper No. 73

Public Contracts 1

Poskytování právní pomoci

Ústav pro státní kontrolu veterinárních bioprepará... Kovařík Jaromír, JUDr., advokát

762 300 CZK

12.04.2019

Source: Hlídač státu (CC BY 3.0 CZ)

The regulation text is for informational purposes only.