Decree No 344 / 2008 Coll.
Ordonnance on the use, prescription and supply of medicinal products in the provision of veterinary care
Valid
Order
Effective from 15.09.2008
344
DECLARATION
of 4 September 2008
on the use, prescription and supply of medicinal products in the provision of veterinary care
The Ministry of Agriculture provides, pursuant to § 114 (4) of Act No. 378 / 2007 Coll., on medicinal products and on amendments to certain related laws ("the Act '):
Preliminary provisions
This decree incorporates the relevant provisions of the European Communities (1) and regulates the rules for 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, the formalities for the notification of the handling of substances or preparations, including the conditions for keeping and maintaining records of such activities, and the rules for exemptions from the marketing authorisation for veterinary medicinal products authorised in another Member State.
Use of veterinary medicinal products in animals producing animal products intended for human consumption
(1) Before using, prescribing or dispensing a medicinal product, the treating veterinarian shall satisfy himself that the conditions for safe and effective use of the medicinal product are met, with particular regard to the risk arising from the use of the medicinal product for the treated animal or animals, humans and the environment, the risk arising from the transfer of residues of the medicinal product to food and the risk and development of resistance to the active substance or substances contained in the medicinal product.
(2) A breeder who, as an entrepreneur (2), maintains livestock producing animal products intended for human consumption shall inform the treating veterinarian of the facts which may adversely affect the safe and effective use of the medicinal product. Where the breeder submits the medicinal product to animals in accordance with Article 9 (12) of the Act, he shall ensure that the conditions for safe and effective use of the medicinal product in accordance with paragraph 1 are met mutatis mutandis. Medicinal products subject to medical prescription are used by the breeder in accordance with the instructions of the treating veterinarian.
(3) A medicinal product containing antibiotics or chemotherapeutic agents whose marketing authorisation has provided for an indication restriction for its use may be used only if no other appropriate medicinal product is available for that purpose and where susceptibility to the active substance contained in the medicinal product has been established.
(4) If an adverse reaction is suspected in an animal to which such a product has been administered in relation to the use of the medicinal product, or if residues of the medicinal product are transferred to raw materials or foodstuffs of animal origin or damage to the environment as a result of the use of the medicinal product, the breeder shall notify the veterinary surgeon immediately.
In the absence of a veterinary medicinal product authorised under Article 25 of the Act for the indication and for the species and category of animals, including a medicated premixture administered in the form of medicated feed (hereinafter referred to as the authorised veterinary medicinal product), for the treatment of animals producing animal products intended for human consumption, it may be prescribed, issued or used, in particular to prevent the suffering of treated animals, in a holding where a particular case occurs, exceptionally,
(a) a veterinary medicinal product authorised for another species or category of animal or for another indication in the same animal species;
(b) a registered medicinal product for human use, or a veterinary medicinal product authorised in another Member State, pursuant to § 9 (1) (e) and § 48 of the Act, for the same or other animal species producing animal products intended for human consumption, unless the veterinary medicinal product referred to in (a) is available;
(c) in bulk or individually in a pharmacy prepared by a medicinal product, if no medicinal product is available as referred to in (b); or
(d) a veterinary autogenic vaccine, as provided for in Article 2 (2) (f) of the Act, or a medicinal product for which a derogation has been provided for under Article 9 (2) (a) and Article 46 of the Act is provided for, if no medicinal product is available under point (c).
Use of medicinal products for veterinary care in animals not producing animal products intended for human consumption
Where the veterinary medicinal product concerned is not available for the purpose of veterinary care, it may be prescribed, issued or used for the treatment of animals which do not produce animal products intended for human consumption, including animals belonging to the family of equidae, which are declared in accordance with the relevant provisions of the European Community3) for slaughter for human nutrition purposes, in particular to prevent the suffering of the animals treated, exceptionally:
(a) a veterinary medicinal product authorised for another species or category of animal or for another indication in the same animal species;
(b) in the absence of a veterinary medicinal product as referred to in (a), a authorised medicinal product for human use, or a veterinary medicinal product authorised in another Member State pursuant to Articles 9 (1) (e) and 48 of the Act,
(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 referred to in Article 2 (2) (f) of the Act or the medicinal product for which a derogation has been provided for in Articles 9 (2) (a) and 46 of the Act.
Use of medicinal products by veterinary surgeons who are resident or established in a Member State other than the Czech Republic and who are entitled to provide veterinary care in the Czech Republic
A veterinarian who is resident or established in a Member State other than the Czech Republic and who is entitled to provide veterinary care in the territory of the Czech Republic (hereinafter referred to as "visiting veterinarian") may, when providing veterinary care, use a veterinary medicinal product other than the relevant authorised veterinary medicinal product if the medicinal product fulfils the following conditions:
(a) has a valid marketing authorisation granted by the competent authority of the Member State in which the visiting veterinarian is resident or established;
(b) it is not an immunological medicinal product;
(c) is transported by a visiting veterinarian in the original internal and, if any, external packaging;
(d) has the same qualitative and quantitative composition, if applicable, as a medicinal product authorised in the Czech Republic; and
(e) a withdrawal period is provided for him, which is at least as long as for a similar medicinal product authorised in the Czech Republic.
(1) A breeder to whom medicinal products have been distributed under Section 77 (1) (c) (8) of the Act may use those medicinal products provided that he has adequate storage facilities and facilities. These premises and facilities
(a) they are protected against access by unauthorised persons;
(b) have sufficient capacity and are designed, arranged and equipped to allow the storage of medicinal products in accordance with the decision to register them, or in accordance with the instructions of the veterinarian or pharmacy, and exclude the risk of damage, contamination or confusion;
(c) are continuously monitored while the medicinal products are stored, and the conditions under which the medicinal products are stored are recorded regularly and at least once a day,
(d) are protected against pests and are subject to regular sanitation, including pest control measures.
(2) Unusable medicinal products shall be removed by the breeder without delay in accordance with the requirements laid down in Section 88 of the Act.
(3) Where a medicinal product stored by a breeder is ordered to be withdrawn, the breeder shall ensure that the medicinal product is withdrawn from circulation and is treated in accordance with the requirements communicated to the breeder by the marketing authorisation holder or the relevant operator which provided the medicinal product to the breeder.
Records of the use of medicinal products in the breeder
(1) The records kept by a breeder who, as an entrepreneur, (2) maintains livestock producing animal products intended for human consumption, on the use of a medicinal product which is subject to medical prescription, contain:
(a) the name of the medicinal product used and, where appropriate, the lot, if indicated on the medicinal product,
(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) the reason for the use of the medicinal product or the medical diagnosis;
(f) the dose or quantity of the medicinal product used, if any,
(g) the withdrawal period provided for in Article 3 (2) of the Act;
(h) identification of the farm (4) where the medicinal product has been used.
(2) Where the medicinal product is used by the breeder in accordance with Section 9 (12) of the Act, the breeder shall ensure that the record of the use of the medicinal product referred to in paragraph 1 is made. Where a medicinal product is used by a veterinarian, the veterinarian shall ensure that the record of the use of the medicinal product referred to in paragraph 1 is made.
(3) In order to keep records of the use of medicinal products containing hormonal substances and beta agonists, the provisions of the Decree prohibiting the administration of certain substances to animals whose products are intended for human nutrition 8) shall apply.
(4) In experiments on animals authorised under other legislation5), where they are carried out on animals producing animal products intended for human nutrition, the head of the experiment shall keep the records referred to in paragraph 1 (6).
(5) The records kept with the breeder referred to in paragraph 1 shall be clear, clear and legible. The records must be kept in accordance with Paragraph 9 (11) of the Act in such a way that they are protected against deterioration, damage or loss.
Records of the use of medicinal products by the veterinarian
(1) The records kept by the veterinarian on each medicinal product used by him, the dispensation of which is subject to medical prescription, contain:
(a) the name of the medicinal product used and, where appropriate, the lot, if indicated on the medicinal product,
(b) the date of use of the medicinal product;
(c) the lot or quantity of the medicinal product used,
(d) the reason for the use of the medicinal product or a medical diagnosis, if the use of the medicinal product in whose marketing authorisation the use of the medicinal product has been subject to an indication restriction restricting the use of the medicinal product to cases where no other appropriate medicinal product is available for that purpose and where the susceptibility to the active substance contained in the medicinal product has been appropriately established or the medicinal product which contains the active substance
1. a substance listed in Annex IV to the directly applicable ES7 Regulation), or
2. a substance for which there is a restriction on the use or putting into circulation under another legislation8),
(e) the type of animal for which the medicinal product has been used,
(f) the number of animals for which the medicinal product has been used,
(g) the name and, where applicable, the name, surname and place of permanent residence of the animal breeder, if any, if it is a natural person, or a business name or business name and registered office, if it is a legal person.
(2) The veterinarian who uses the following information in the case of livestock producing animal products intended for human consumption other than the relevant registered veterinary medicinal product in addition to the records referred to in paragraph 1 shall:
(a) the date of the examination of the animals;
(b) duration of treatment,
(c) reason for use of the medicinal product or medical diagnosis,
(d) the withdrawal period provided for in Article 3 (2) of the Act.
(3) The records referred to in paragraphs 1 and 2 shall be kept by the veterinarian in such a way that they are clear, clear and legible. The records must be kept in accordance with Paragraph 9 (11) of the Act in such a way that they are protected against deterioration, damage or loss.
(4) Where a veterinarian carries out a professional veterinary activity as an employee of a natural or legal person authorised to carry out a professional veterinary activity, he shall keep the records referred to in paragraphs 1 and 2.
Records of prescription and dispensation of medicinal products for veterinary care
(1) The records kept by the veterinarian in the provision of veterinary care for each dispensing or prescription of a medicinal product subject to medical prescription 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 type and number of animals for which the medicinal product is intended and, if it is livestock producing animal products intended for human consumption, the type, number, category and destination of the animals for which the medicinal product is intended,
(e) the name and, where applicable, the name, surname and place of permanent residence of the animal breeder, if any, if it is a natural person, or a business name or business name and 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 producing animal products intended for human consumption.
(2) Records kept by a breeder who, as an entrepreneur, (2) maintains farm animals producing animal products intended for human consumption of any medicinal product which has been issued or distributed to him pursuant to § 77 (1) (c) (8) of the Act and whose dispensation is subject to medical prescription, contain:
(a) the name of the medicinal product,
(b) the date on which the medicinal product was issued or distributed;
(c) the quantity or number of doses of the medicinal product issued or distributed and the reason for the issue or distribution of the medicinal product;
(d) the name of the person who issued or distributed the medicinal product to the breeder;
(e) the species, category, number and destination of the animals for which the medicinal product has been issued or distributed.
(3) The records referred to in paragraphs 1 and 2 shall be kept by the veterinarian and the breeder in such a way that they are clear, clear and legible. The records must be kept in accordance with Paragraph 9 (11) of the Act in such a way that they are protected against deterioration, damage or loss.
(4) Where a veterinarian carries out a professional veterinary activity as an employee of a natural or legal person authorised to carry out a professional veterinary activity, he shall keep the records referred to in paragraph 1.
Notices on the treatment of substances having anabolic, antiinfectious, antiparasitic, anti-inflammatory, hormonal, or addictive substances or precursors, and records of such activities
(1) The notification of the implementation of the activities under Paragraph 78 (2) of the Act contains:
(a) the name and, where appropriate, the name, surname and place of 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 78 (1) of the Act;
(c) telephone connection or e-mail address,
(d) the designation of the substance or substances to which they are treated, indicating the normal name as provided for in Article 4 (1) of the Act;
(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 kept and kept by natural or legal persons on all commercial activities under Paragraph 78 (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 and, where applicable, the name, surname, place of permanent residence and the 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 must be kept in accordance with Paragraph 9 (11) of the Act in such a way that they are protected against deterioration, damage or loss.
Data contained in the application for import of a veterinary medicinal product authorised in another Member State
(1) The application for import of a veterinary medicinal product authorised in another Member State submitted by the treating veterinarian contains:
(a) the name and, where appropriate, the name, surname and place of business, or place of practice of the veterinarian; where the veterinarian carries out a professional veterinary activity as an employee of a natural or legal person authorised to carry out a professional veterinary activity, the name or, where applicable, the name, surname and place of business of that person, if any, or the name and address of the natural person,
(b) particulars of the veterinary medicinal product
1. the name under which the veterinary medicinal product is authorised in the Member State from which it is to be imported;
2. a composition indicating all the active substances contained in the veterinary medicinal product and, where appropriate, the excipients which may have a particular effect on the therapeutic effect of the veterinary medicinal product,
3rd Force,
4. Pharmaceutical Form,
5. type and size of inner packaging,
6.
7. the indication for which the veterinary medicinal product is authorised in another Member State; and
8. The Member State in which the veterinary medicinal product is authorised,
(c) details of how the veterinary medicinal product is put into circulation
1. the Member State from which the veterinary medicinal product is to be imported;
2. the person who ensures the import of the veterinary medicinal product;
3. the estimated date of import; and
4. the expected timing of use of the veterinary medicinal product,
(d) an indication of the quantity of veterinary medicinal product to be imported from another Member State; where imports are to be secured within a longer timetable, information on the quantities imported at specified intervals;
(e) indication of how the veterinary medicinal product is used
1. the species of animal in which the veterinary medicinal product is to be used,
2. the reason for use, specifying the therapeutic or preventive indication, the medical diagnosis or the disease to be diagnosed with the veterinary medicinal product,
3. where another appropriate registered veterinary medicinal product is available in the Czech Republic for an indication for which an exemption from the marketing authorisation for a veterinary medicinal product is submitted, the justification why such veterinary medicinal product cannot be used in a particular case,
4. in the event that the veterinary medicinal product is to be used within a longer period of time, a justification for the need for the proposed use of the veterinary medicinal product, and
5. where veterinary medicinal products are to be used in animals producing animal products intended for human consumption, the address and registration number of the holding on which the veterinary medicinal product is to be used and the withdrawal period to be observed after the administration of the veterinary medicinal product shall be indicated,
(f) other data which may be relevant for the assessment of the application, such as data on adverse effects of the veterinary medicinal product, references to the use of the proposed treatment procedure published in the scientific literature;
(g) a statement that the veterinarian will report to the Institute for State Control of Veterinary Bioprafts and Medicines in accordance with the law any suspected occurrence of serious adverse reactions, unexpected adverse reactions and adverse reactions that have occurred in humans in connection with the use of the veterinary medicinal product; and
(h) the date and signature of the veterinarian.
(2) The Annex to the application shall consist of a copy of the package leaflet as approved in the Member State where the veterinary medicinal product is authorised and a copy of the certificate of compliance with the conditions for carrying out the veterinary medicinal and preventive activity issued by the Chamber of Veterinary Physicians under another legislation9).
(3) An application may also be made for more than one veterinary medicinal product. In such cases, the particulars referred to in points (b), (c), (d), (e) and (f) of paragraph 1 shall be indicated separately for each veterinary medicinal product for which an exemption from the marketing authorisation is requested by the competent veterinarian.
Model of order for imports of a veterinary medicinal product authorised in another Member State
(1) The model of the order for the import of the veterinary medicinal product under Section 48 (2) of the Act is set out in the Annex to this Decree.
(2) In the case referred to in Section 48 (4) of the Act, the words "Exemption from the registration of a veterinary medicinal product - case of direct threat to the health or life of an animal 'shall be indicated in the order.
Data on imports of a veterinary medicinal product authorised in another Member State
(1) According to Section 48 (6) of the Act, the treating veterinarian shall keep the following documents on imports of veterinary medicinal products authorised in another Member State:
(a) a copy of the application pursuant to Article 11;
(b) a copy of the order referred to in Article 12, where the person authorised to distribute the veterinary medicinal product has requested the distribution of the veterinary medicinal product; and
(c) details of the purchase of the veterinary medicinal product in another Member State, unless it requests the distribution of the veterinary medicinal product by a person authorised to distribute the veterinary medicinal product; such data shall include:
1. the name of the veterinary medicinal product,
2. date of purchase of the veterinary medicinal product,
3. the quantity of veterinary medicinal product purchased; and
4. identification of the person from whom the veterinary medicinal product has been purchased, including details of telephone connection or e-mail address.
(2) Where a veterinarian carries out a professional veterinary activity as an employee of a natural or legal person authorised to carry out a professional veterinary activity, he shall keep the records referred to in paragraph 1.
(3) The distributor shall keep records of the distribution of the veterinary medicinal product distributed under § 48 of the Act from another Member State under § 77 (1) (e) of the Act and a copy of the order under § 12.
Repeal
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, shall be deleted.
Efficacy
This Decree shall take effect on 15 September 2008.
Minister:
Mgr. Gandalovich v. r.
Annex to Decree No 344 / 2008 Coll.
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. Directive 2004 / 28 / EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001 / 82 / EC on the Community code relating to veterinary medicinal products.
2) Act No. 513 / 1991 Coll., Commercial Code, as amended.
(3) Commission Decision 93 / 623 / EEC of 20 October 1993 laying down the identification document (movement certificate) accompanying registered equidae. Commission Decision 2000 / 68 / EC of 22 December 1999 amending Commission Decision 93 / 623 / EEC and establishing the identification of equidae for breeding and production.
4) 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. Act No. 154 / 2000 Coll., on the breeding, breeding and registration of livestock and amending certain related laws (Breeding Act).
5) Act No. 246 / 1992 Coll., on the protection of animals against abuse, as amended.
6) Article 18a of Act No. 246 / 1992 Coll., as amended by Act No. 243 / 1997 Coll., the Constitutional Court found under Act No. 30 / 1998 Coll., Act No. 77 / 2004 Coll., Act No. 413 / 2005 Coll. and Act No. 77 / 2006 Coll.
7) Council Regulation (EEC) No 2377 / 90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin.
8) Decree No 291 / 2003 Coll., on the prohibition of the administration of certain substances to animals whose products are intended for human consumption and on the monitoring (monitoring) of the presence of unauthorised substances, residues and contaminants for which animal products could be harmful to human health, animals and their products, as amended.
9) Act No. 381 / 1991 Coll., on the Chamber of Veterinary Physicians of the Czech Republic, as amended by Act No. 318 / 2004 Coll.
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Regulation Information
| Citation | Decree No 344 / 2008 Coll., on the use, prescription and supply of medicinal products for veterinary care |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 12.09.2008 |
|---|---|
| Effective from | 15.09.2008 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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