Decree No. 348 / 2022 Coll.
Decree amending Decree No. 25 / 2020 Coll., on the Prescription of Medicinal Products for Veterinary Care
Valid
Order
Effective from 01.12.2022
Text versions:
01.12.2022
23.11.2022
348
DECLARATION
of 15 November 2022
amending Decree No. 25 / 2020 Coll., on the Prescription of Medicinal Products for Veterinary Care
According to Article 114 (3) of Act No. 378 / 2007 Coll., on medicinal products and on the amendment of certain related laws (Act on Medicines), as amended by Act No. 70 / 2013 Coll. and Act No. 262 / 2019 Coll., ("the Act ') for the implementation of § 71 (2), § 74 (1) and § 80a (3) of the Act and under § 44c (4) of Act No. 167 / 1998 Coll., on addictive substances, as amended by Act No. 273 / 2013 Coll. and Act No. 366 / 2021 Coll., (" the Law on addictive substances') for the implementation of § 13 (11 (e) and (f) of the Law on addictive substances:
Decree No. 25 / 2020 Coll., on the Prescription of Medicinal Products for Veterinary Care, is amended as follows:
1. in Article 1 (a), the words "the requirements of the recipe and the requisition" shall be replaced by the words "the scope of the information given on the recipe and the requisition."
2. in Paragraph 1 (b):
"(b) data on a recipe with a blue stripe displayed in paper form, its period of validity, restrictions on the type and quantity of medicinal products for the treatment of animals prescribed therein and the rules for its use;"
3. in Article 1, the following point (c) is inserted after point (b):
"(c) data on applications with a blue stripe displayed in paper form, its period of validity, restrictions on the type and quantity of medicinal products for the treatment of animals that may be prescribed on it and the rules for its use;"
Points (c) and (d) shall be renumbered points (d) and (e).
4. The following heading is inserted before the designation of Section 2:
"Prescription of medicinal products that do not contain highly addictive substances'.
5. The heading of Section 2 reads:
"Scope of the data on the recipe and the requisition '.
6. Paragraph 2 (1) shall be added at the end of the text in point (b) "; if this is necessary for the unambiguous identification of the treated animal or group of animals, the additional information necessary for such unambiguous identification shall be given '.
7. In Article 2 (1) (d) (1), the words "the package size and" shall be inserted after the word "preparations."
8. in Paragraph 2 (1), the following points (f) to (i) are inserted after point (e):
"(f) the word" Cascade, "where the prescription of a medicinal product is to be applied in accordance with Article 112, 113 or 114 of the Regulation on veterinary medicinal products and following those Articles in accordance with the Law on medicinal products,
(g) the word "Prophylaxis," if it is a case of prescription for an antimicrobial medicinal product to be used for prophylactic purposes,
(h) the wording "Metaphylaxis," if applicable, for the prescription of an antimicrobial medicinal product to be used for the purposes of metaphylaxis,
(i) the duration of the withdrawal period, if it is a case of prescription of the medicinal product to be used in an animal producing animal products intended for human consumption, by:
1. the word "OL - PI," if the withdrawal period laid down in accordance with the terms of its marketing authorisation is to be respected after the administration of the authorised veterinary medicinal product,
2. the word expression "OL," supplemented by the number of days or hours, for the relevant animal products expressed as "meat," "milk," "eggs" or "honey," if the conditions of point 1 are not fulfilled, or if the withdrawal period after the administration of the registered veterinary medicinal product must be extended,
3. the words "OL as instructed by the veterinarian," where it is not possible to make a clear decision on the duration of the withdrawal period at the time of issue of the recipe and the withdrawal period is determined subsequently by the veterinarian and is recorded in a dossier under the legislation governing the prescription of medicinal products for the provision of medical services (11); This form of expression may not be used where the breeder of an animal producing animal products intended for human consumption does not keep records of the use of the medicinal product in accordance with other legislation13),
13) Decree No 344 / 2008 Coll., on the use, prescription and supply of medicinal products for veterinary care, as amended by Decree No 139 / 2011 Coll. '.
Points (f) to (j) shall be renumbered (j) to (n).
9. in § 2 (1) (k):
"(k) an imprint of the stamp containing the identification details of the prescribing veterinarian, the name and, where appropriate, the names and surnames, the place of business and, where appropriate, the place of practice, the identification number, if any, and the telephone number; where the prescribing veterinarian carries out professional veterinary activities (5) as an employee of a natural or legal person authorised to carry out professional veterinary activities, the name, where appropriate, the name and surname of the prescribing veterinarian, the name and, where appropriate, the surname, the place of business, the place of practice and, where applicable, the place of practice of his employer, if any, the natural person, or the name, address and identification number of his employer, if applicable, ';
10. in Article 2 (1) (l), the words "prescribing private veterinarian under another legislation (6)" shall be deleted;
footnote 6 is deleted.
11. in Article 2 (2) (a):
"(a) the identification of the person authorised to carry out the professional veterinary activities, the name or, where applicable, the name, surname, place of business, place of practice, identification number, if any, and the number of the prescribing veterinarian; where the veterinarian carries out professional veterinary activities (5) as an employee of a natural or legal person authorised to carry out professional veterinary activities (5), the name and, where appropriate, the name, surname, place of regular veterinary care and the identification number of his employer, if any, or the name, registered office and identification number of his employer, if applicable, of the legal person; ';
12. in Article 2 (2) (c) (1), the words "the package size and" shall be inserted after the word "preparations," and the words "if the package size is not indicated, the minimum package size for the medicinal product concerned shall be deemed to be prescribed."
13. in Article 2 (2) (e):
"(e) an imprint of the stamp containing the identification details of the prescribing veterinarian, the name and, where appropriate, the names and surnames, the place of business, where appropriate the place of practice, the identification number, if any, and the telephone number; where the prescribing veterinarian carries out professional veterinary activities (5) as an employee of a natural or legal person authorised to carry out professional veterinary activities, the name, where appropriate, the name and surname of the prescribing veterinarian, the name and, where appropriate, the surname, the place of business, the place of practice and, where applicable, the place of practice of his employer, if any, the natural person, or the name, address and identification number of his employer, if applicable, ';
14. in Article 2 (2) (f), the words "if the prescribing veterinarian is a private veterinarian" and the words "the private veterinarian who has issued the application" shall be deleted;
15. in Article 2 (7), "(g)" is replaced by "(k)";
16. in Article 4 (1) (a), the words "antibiotics and antimicrobial chemotherapeutic agents" are replaced by the words "antimicrobials."
17. in Article 4 (1), at the end of point (b), the dot is replaced by a semicolon and the words "for a prescription containing a medicinal product containing an addictive substance under the legislation governing the treatment of addictive substances (8), or the scheduled category 1 substance under the directly applicable European Union drug precursor regulation (9) may be extended by the prescribing veterinarian to a maximum of 30 days."
18. In Article 4, the words "unless otherwise specified by the prescribing veterinarian, at the end of the text of paragraph 2, the prescribing veterinarian may extend the validity of the recipe to a maximum of 1 year from the day following its issue 'shall be added.
19. Paragraph 4 (4) reads as follows:
"(4) The medicinal product application shall be valid for 60 days from the day following that on which it is issued."
20. Paragraph 5 (2) is deleted.
Paragraphs 3 to 6 shall become paragraphs 2 to 5.
21. Paragraph 5 (2) reads:
"(2) In accordance with the procedure laid down in Article 2 (4), a medicinal product containing an addictive substance may not be prescribed under the legislation governing the treatment of addiction8) or category 1 scheduled substance under the directly applicable European Union drug precursors regulation 9). '.
22. in Article 5 (3), the word "registered" shall be inserted after the word "neither."
23. in Article 6 (2) (a), "antibiotics or chemotherapeutic agents" is replaced by "antimicrobials."
24. The following heading is inserted above the designation of Section 7:
"Prescription of medicinal products containing highly addictive substances."
25. Article 7, including the title, reads:
Prescription with blue stripe
Medicinal products that can only be issued with a blue stripe or a blue stripe recipe under the addictive law are prescribed
(a) a blue-striped recipe under Section 80a (1) (b) of the Act, with the first sheet and 2 prescription entries being completed; the first sheet and the first copy are intended for delivery of the prescribed medicinal product at the pharmacy, the second copy is left in the block of recipes used,
(b) a blue stripe request under Paragraph 80a (1) (d) of the Act, with the first sheet of the request being completed at the time of the prescription, and 3 copies; the first sheet of the application form and 2 signatures are intended for dispensing the prescribed medicinal product at the pharmacy, the third sheet is left in the block of the requested goods. '
26. The following Sections 7a to 7d are inserted after Section 7, including the headings:
Data on the medical prescription with blue stripe
(1) The blue-striped recipe shall contain the data referred to in Article 2 (1).
(2) The blue stripe request shall show the data referred to in Article 2 (2).
Restrictions on the type and quantity of medicinal products for the treatment of animals that may be prescribed to a prescription with a blue stripe
(1) Only medicinal products for which the law on addictive substances provides can be prescribed for a blue stripe recipe or blue stripe requisition.
(2) No more than 1 type of medicinal product may be prescribed for a blue-striped recipe.
(3) A maximum of 5 types of medicinal products may be prescribed for a blue stripe.
Duration of the Blue Stripe prescription
The blue-striped recipe and the blue-striped voucher shall be valid for 14 calendar days starting on the day following the day of issue, unless otherwise specified by the veterinarian, but not more than 30 days.
Rules on the use of the Blue Stripe medical prescription
(1) For the production and distribution of medical prescription forms with a blue stripe and for the procedure in the event of their loss or theft, the conditions laid down in Section 22 of the legislation governing the prescription of medicinal products for the provision of medical services (11) shall apply mutatis mutandis, and authorised persons shall also be authorised to provide veterinary care under Section 6 (1) (d) of the Act.
(2) For the treatment of blue stripe recipes and blue stripe vouchers by authorised persons referred to in paragraph 1, the conditions laid down in Article 23 of the legislation governing the prescription of medicinal products when providing medical services (11) shall apply mutatis mutandis.
(3) For blue-striped recipes and blue-striped vouchers, the models laid down by the legislation regulating the prescription of medicinal products when providing medical services (11) shall be used. ';
27. in Article 8 (1) to (3):
"(1) Medicated feedingstuffs shall be prescribed to a prescription containing the particulars set out in Annex V to the Regulation on medicated feedingstuffs (hereinafter referred to as the Annex),
(a) the details of the veterinarian referred to in point 1 of the Annex shall be understood as:
1. the name, names, and surnames, place of business, place of practice, identification number, if any, and telephone number; where the prescribing veterinarian carries out professional veterinary activities (5) as an employee of a natural or legal person authorised to carry out professional veterinary activities, the name and, where applicable, the name and surname of the prescribing veterinarian, the name and, where appropriate, the surname, and surname, place of business and, where applicable, the place of practice of his employer, if any, the natural person, or the name, seat and identification number of his employer, if applicable, the legal person,
2. registration number of the Chamber of Veterinary Physicians,
(b) the unique number of the Regulation referred to in point 2 of the Annex means the identification number of the person authorised to carry out the professional veterinary activities followed by the registration number of the Chamber of Veterinary Doctors prescribing the veterinarian, followed by the calendar year in which the Regulation was issued and the serial number of the Regulation in the relevant calendar year;
(c) the particulars of the breeder referred to in point 3 of the Annex shall be understood as:
1. if it is a natural person, name or surname, surname, address of the place of permanent residence or place of residence in the Czech Republic, if it is a foreigner, and telephone number, if the breeder agrees to mention it,
2. if the legal person, name or business name, registered office and telephone number are concerned, if the breeder agrees to mention it,
3. if the breeder for whom a registration obligation is laid down under another legislation (1), the number of the holding where the animals for which the medicated feed is intended are kept,
(d) for the purposes of point 7 of the Annex, the following shall apply:
1. the provisions of Paragraph 2 (1) (f) in the case of the prescription of a veterinary medicinal product pursuant to Article 112, 113 or 114 of the Regulation on veterinary medicinal products, mutatis mutandis;
2. Paragraph 2 (1) (h) in the case of the prescription of a veterinary medicinal product pursuant to Article 107 (4) of the Regulation on veterinary medicinal products, mutatis mutandis,
(e) for the purposes of point 12 of the Annex, Article 2 (1) (i) (1) or (2) shall apply mutatis mutandis.
(2) The provisions of Article 16 (8) of the Regulation on medicated feed shall apply to the validity of the Regulation on medicated feed.
(3) The prescription for medicated feed shall be drawn up by the veterinarian in 4 copies, of which 1 copy shall be retained, 1 copy transmitted to the breeder referred to in the prescription for medicated feed and 2 copies shall be transmitted to the manufacturer of the medicated feed. In the case where the medicated feed was not produced before the issue of the prescription for medicated feed pursuant to Article 8 of the medicated feed Regulation, the manufacturer shall ensure that the manufacture and subsequent delivery of medicated feed is carried out without undue delay upon receipt of the current prescription for medicated feed. ';
28. In the first sentence of Article 8 (4), "2 'is replaced by" 1'; the word "distributor 'is replaced by" supplier'; in the second sentence, "distribution 'is replaced by" supply'; and the word "distributor 'is replaced by" supplier'.
29. Paragraph 8 (5) reads:
"(5) The supplier of the medicated feed, or the manufacturer who also ensures the delivery of the medicated feed, shall complete the particulars referred to in point 15 of the Annex to the Regulation in the form of a signature in accordance with point 16 of the Annex for the supply of the medicated feed. ';
30. In the first sentence of Paragraph 8 (6) of the first part of the sentence in front of the semicolon, the words "3 to 5 'are replaced by the words" 3 and 4' and the words "2 'in the second sentence are replaced by" 3'.
31. in Article 8 (7), the word "distribution" shall be replaced by "delivery," the words "provided by a distributor" shall be replaced by "provided by another supplier" and the words "secured by a distributor" shall be replaced by "provided by that supplier."
33.In Paragraph 9 (1) (a):
"(a) identification of the breeder in accordance with Article 2 (1) (a),"
34. in Article 9 (1), points (b) and (c) are deleted;
Points (d) to (m) shall be renumbered (b) to (k).
35. in Article 9 (1), the following point (h) is inserted after point (g):
"(h) the contact details of the Regional Veterinary Administration responsible for receiving the notification pursuant to Article 71 (6) of the Act,"
Points (h) to (k) shall be renumbered as points (i) to (l).
36. in Paragraph 9 (1) (j):
"(j) the stamp containing the particulars of the prescribing veterinarian referred to in Article 2 (1) (k),"
37. in Paragraph 9 (1), the following point (k) is inserted after point (j):
"(k) the registration number of the Chamber of Veterinary Physicians,"
Points (k) and (l) shall be renumbered as points (l) and (m).
This Decree shall take effect on 1 December 2022.
Minister:
Ing. Nekula v. r.
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Regulation Information
| Citation | Decree No. 348 / 2022 Coll., amending Decree No. 25 / 2020 Coll., on the Prescription of Medicinal Products for Veterinary Care |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 23.11.2022 |
|---|---|
| Effective from | 01.12.2022 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Agriculture
The regulation text is for informational purposes only.
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