Decree No. 325 / 2003 Coll.
Ordinance laying down rules on the use of medicinal products in the provision of veterinary care, including the related prescription and supply of medicinal products and the requirements for keeping records of such activities, and the particulars of the notification of the handling of substances or products, including the conditions for keeping and storing records of such activities
Valid
Order
Effective from 30.09.2003
Text versions:
30.09.2003
325
DECLARATION
of 10 September 2003
laying down rules on the use of medicinal products in the provision of veterinary care, including the related prescription and supply of medicinal products and the requirements for keeping records of such activities, and on the details of the notification of the handling of substances or preparations, including the conditions for keeping and keeping records of such activities
The Ministry of Agriculture provides pursuant to Article 75 (4) of Act No. 79 / 1997 Coll., on medicinal products and on amendments and additions to certain related laws, as amended by Act No. 129 / 2003 Coll., hereinafter referred to as "the Act ', and in accordance with the law of the European Communities: 1)
RULES FOR THE USE OF MEDICINAL PRODUCTS FOR THE PROVISION OF VETERINARY HEALTH, INCLUDING RELATED PRESENTATION AND SUPPLY OF MEDICINAL PRODUCTS AND REQUIREMENTS FOR RECORDING OF SUCH ACTIVITIES
Use of medicinal products in the provision of veterinary care
(K § 5b (1) to (5) of the Act)
(1) Where a veterinary medicinal product authorised under Article 23 of the Act is not available for the purpose of providing veterinary care for that indication and for that species and category of animal, including a medicated premixture administered in the form of medicated feed (hereinafter referred to as the "authorised veterinary medicinal product '), it shall be prescribed, issued or used exceptionally.
(a) a veterinary medicinal product authorised for another species or category of animal or for another indication;
(b) unless the veterinary medicinal product referred to in (a) is available, the authorised medicinal product for human use;
(c) if neither the medicinal product referred to in (b) is available, in bulk or individually in a pharmacy prepared the medicinal product; or
(d) if the medicinal product referred to in (c) is not available, the veterinary autogenic vaccine (2) or the medicinal product for which the State Veterinary Administration has authorised an exemption (3).
(2) A veterinary medicinal product other than the relevant authorised veterinary medicinal product may be used in particular to prevent the suffering of treated animals, either in one animal or in a small number of livestock kept in one herd or in pet animals (4) in one breeder.
(3) In less numerous or exotic animal species from which animal products intended for human consumption are not obtained, a veterinary medicinal product other than the relevant authorised veterinary medicinal product may be used whenever necessary taking into account the availability of medicinal products for the indication.
(4) Medicated feed shall only be used in the provision of veterinary care in accordance with the conditions laid down in the veterinary prescription for medicated feed issued in accordance with the requirements laid down by law. 5)
(5) The medicinal product shall be used by the veterinarian or, under his direct responsibility, by the person designated by that veterinarian when providing the veterinary care referred to in paragraph 1.
Keeping records of the prescription, issuing and use of medicinal products in the provision of veterinary care
(K § 5b (6) of the Act)
Keeping records of the use of medicinal products by breeders
(1) Records kept by breeders who, as entrepreneurs, (6) keep farm animals from which animal products intended for human consumption are obtained include:
(a) the name of the medicinal product used,
(b) the date of use of the medicinal product;
(c) the species and category of animal for which the medicinal product has been used,
(d) the number and identification of the animals for which the medicinal product has been used,
(e) reason for the use of the medicinal product,
(f) the dose (s) of the medicinal product used in the animals,
(g) established withdrawal period, 7)
(h) identification of the holding, (8) where the medicinal product has been used.
(2) In experiments on animals authorised by specific legislation, (9) when carried out on animals from which products for human consumption are obtained, the records referred to in paragraph 1 shall be kept by the person responsible for the experiment. 10)
(3) The records referred to in paragraph 1 shall be made by the breeder of each use of the medicinal product in such a way as to be clear, unambiguous and legible. The records shall be stored in such a way that they are protected against deterioration, damage or loss.
Keeping records of the use of medicinal products by veterinary surgeons
(1) The records kept by the veterinarian on each medicinal product used by him in animals contain:
(a) the name of the medicinal product used,
(b) the date of use of the medicinal product;
(c) the dose (s) of the medicinal product used,
(d) the type of animal for which the medicinal product has been used,
(e) the number of animals for which the medicinal product has been used,
(f) the name, surname and permanent residence of the keeper of the animal, if it is a natural person, or a business name or registered office, if it is a legal person.
(2) In the case of livestock from which animal products intended for human consumption are obtained, the veterinarian shall record the veterinary medicinal product concerned in a dossier kept and kept by the breeder in accordance with Section 2, (11) in addition to the particulars referred to in paragraph 1.
(a) the animal category for which the medicinal product has been used,
(b) the identification of the animals in which the medicinal product has been used,
(c) a medical diagnosis or reason for use of the medicinal product,
(d) a specified withdrawal period. 7)
(3) In the case of livestock from which animal products intended for human consumption other than the veterinary medicinal product is obtained, the veterinarian shall record in his dossier and in the documentation kept and kept by the breeder in accordance with Article 2 (11), in addition to the particulars referred to in paragraph 1.
(a) the date of the examination of the animals;
(b) the animal category for which the medicinal product has been used,
(c) the identification of the animals in which the medicinal product has been used,
(d) the medical diagnosis or reason for use of the medicinal product,
(e) a specified withdrawal period, 7)
(f) identification of the holding, (8) where the medicinal product has been used,
(g) duration of treatment.
(4) The records referred to in paragraphs 1, 2 and 3 shall be made by the veterinarian in such a way that they are clear, clear and legible. The records shall be stored in such a way that they are protected against deterioration, damage or loss.
Records of prescription and dispensation of medicinal products for veterinary care
(1) The records kept by the veterinarian on each dispensation or prescription of the medicinal product in the provision of veterinary care include:
(a) the name of the medicinal product issued or prescribed;
(b) the date of issue or prescription of the medicinal product,
(c) the quantity of medicinal product delivered or prescribed,
(d) the species and number of animals for which the medicinal product is intended and, if it is livestock from which animal products intended for human consumption are obtained, the species, number, category and identification of the animals for which the medicinal product is intended,
(e) the name and surname and permanent residence of the animal breeder, if it is a natural person, or a business name or registered office, if it is a legal person;
(f) a medical diagnosis or reason for dispensing or prescribing a medicinal product, if it is animals from which products intended for human consumption are obtained.
(2) A breeder who, as an entrepreneur, (6) maintains livestock from which animal products for human consumption are obtained shall keep records of the medicinal product which has been given or prescribed to him, including in particular:
(a) the name of the medicinal product which has been given or prescribed to it,
(b) the date of issue or prescription of the medicinal product,
(c) the quantity (number of doses) of the prescribed or issued medicinal product,
(d) the designation of the person who prescribed or issued the medicinal product,
(e) the species, category, number and identification of the animals for which the medicinal product has been issued or prescribed.
(3) The records referred to in paragraphs 1 and 2 shall be made by the veterinarian and the breeder in such a way that they are clear, clear and legible. The records shall be stored in such a way that they are protected against deterioration, damage or loss.
The Commission shall be empowered to adopt delegated acts in accordance with Article 21 concerning:
(K § 42c (3) and (4) of the Act)
(1) The notification pursuant to § 42c (3) of the Act contains:
(a) the name, surname and permanent residence of the natural person, or the business name and registered office of the legal person;
(b) the designation and address of all places of business where the treatment of substances is carried out under Section 42c (1) of the Act;
(c) telephone or fax connections,
(d) the designation of the substance or substances to which it is treated, indicating the international non-proprietary name (INN), if any; if this name is unknown, another professional name or description shall be given;
(e) the purpose for which they treat the substance or substances.
(2) Any changes to the data referred to in paragraph 1 shall be notified without delay to the Institute for State Control of Veterinary Bioprafts and Medicines.
(3) Records of any transactions which are held and held by natural or legal persons pursuant to Paragraph 42c (4) of the Act include:
(a) the method of handling the substance (s);
(b) the date on which the transaction took place;
(c) the quantity and labelling of the substance or substances which have been the subject of the relevant transaction;
(d) the name, surname, permanent residence and identification number of the natural person who is the supplier or customer; in the case of a customer or supplier who is a legal person, his business name or name and registered office and identification number,
(e) the method of modification of the substance or substances.
(4) The records referred to in paragraph 3, including electronic, photographic or other systems, shall be made so as to be clear, unambiguous and legible. The records shall be stored in such a way that they are protected against deterioration, damage or loss.
EFFECTIVE
This decree shall take effect on the day of its publication.
Minister:
Ing. Palas v. r.
1) 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.
2) Sections 2 (9) and 41h of the Act.
3) Article 31 of the Act.
4) § 3 (e) of Act No. 246 / 1992 Coll., on the Protection of Animals against Abuse, as amended.
5) § 41k of the Act.
6) § 2 paragraphs 1 and 2 of Act No. 513 / 1991 Coll., Commercial Code.
7) Paragraph 2 (21) of the Law.
8) Paragraph 3 (1) (b) of Act No. 166 / 1999 Coll., on Veterinary Care and on the Amendment of Certain Related Acts (Veterinary Act), as amended by Act No. 131 / 2003 Coll.
9) Act No. 246 / 1992 Coll., as amended by Act No. 162 / 1993 Coll., Act No. 193 / 1994 Coll., Act No. 243 / 1997 Coll. and the Constitutional Court found under No. 30 / 1998 Coll.
10) Article 12 of Decree No. 311 / 1997 Coll., on the rearing and use of experimental animals.
11) § 61 (e) of Act No. 166 / 1999 Coll., as amended by Act No. 131 / 2003 Coll.
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Regulation Information
| Citation | Decree No 325 / 2003 Coll., laying down rules on the use of medicinal products in the provision of veterinary care, including the related prescription and supply of medicinal products and the requirements for keeping records of such activities, and the details of the notification of the handling of substances or products, including the conditions for keeping and storing records of such activities |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 30.09.2003 |
|---|---|
| Effective from | 30.09.2003 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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