Decree of the Ministry of Agriculture and Nutrition of the Czech Socialist Republic No. 86 / 1989 Coll.
Decree of the Ministry of Agriculture and Nutrition of the Czech Socialist Republic on authorising the verification, production, import and entry into circulation, use and control of veterinary medicinal products and preparations
Valid
Effective from 01.09.1989
86
DECLARATION
Ministry of Agriculture and Nutrition of the Czech Socialist Republic
of 7 July 1989
authorising the verification, production, import and putting into circulation, use and control of veterinary medicinal products
The Ministry of Agriculture and Nutrition of the Czech Socialist Republic, in agreement with the Ministry of Health and Social Affairs of the Czech Socialist Republic, provides pursuant to § 18 paragraph 5 of Act No. 87 / 1987 Coll., on Veterinary Care:
Preliminary provisions
Veterinary medicinal products and preparations (hereinafter referred to as "preparations') under this Decree are mass-produced or individually prepared
(a) products intended for the prevention, diagnosis and treatment of animal diseases or affecting their physiological functions, including medicated feed and feed products and products containing specifically active substances, used in feedingstuffs and beverages;
(b) disinfectant, disinfectant and exterminator products coming into contact with animals and their environment, foodstuffs and raw materials of animal origin (hereinafter referred to as animal products) and feedingstuffs,
(c) medicinal cosmetic products for animals.
(1) Without the consent or authorisation of the competent authorities (1), products may not be verified, manufactured, imported and put into circulation.
(2) The authorisation of the State Veterinary Administration of the Slovak Socialist Republic, issued within its scope, is also valid in the Czech Socialist Republic.
Verification of products
(1) The application for approval or authorisation of the verification of a new preparation in animal husbandry is submitted by an organisation or, where appropriate, by a citizen proposing the use of this preparation to the State Veterinary Administration of the Czech Socialist Republic (hereinafter referred to as the State Veterinary Administration). The application shall contain:
(a) the brief characteristics of the preparation, its composition and determination;
(b) the results of own experiments, including monitoring the occurrence of residues and environmental effects;
(c) the proposed method of manufacture, quality evaluation and preliminary instructions for its use;
(d) the approved methodology for verifying the efficacy and safety of the product (Article 16 (1) (b));
(e) a proposal to identify the breeder to be verified.
(2) The applicant shall add to the application:
(a) the consent of the breeder to whom the product is intended to be verified;
(b) the opinion of the district or municipal veterinary authority responsible for the place where the product is to be verified.
(3) In agreement or authorisation, the State Veterinary Administration may specify further conditions of verification, including the date of its termination.
(1) The results of the verifications shall be submitted by the applicant to the State Veterinary Administration; At the same time, it shall request its approval to initiate verification production.
(2) The State Veterinary Administration will decide whether verification production of the product can be initiated. In a positive case, it shall determine the duration of the production and its volume and, where appropriate, the conditions of use of the preparation.
Manufacture and putting into circulation of preparations
(1) At the end of the verification production period, the manufacturer shall submit its results to the State Veterinary Administration together with an application for the approval or authorisation of the manufacture of the product and its putting into circulation.
(2) The State Veterinary Administration will decide on the application on the basis of the results of the verification production, the knowledge of the use of the product and the opinion of the authority of the highest professional control.
(3) Any change in the technology of manufacture, composition or designation of the preparation, including changes resulting from the introduction of an invention or improvement proposal, requires new consent or authorisation.
(1) The manufacture and putting into circulation of products may be authorised only if the organisation has established hygienic, operational, technical, organisational and cadre conditions for the manufacture of products in accordance with the principles of good manufacturing practice in the interests of the standard quality and the required effectiveness and safety of the products corresponding to the current knowledge of science and technology and veterinary care requirements.
(2) An organisation whose main economic activity is not the manufacture of preparations needs the approval of the State Veterinary Administration to produce the products referred to in Article 1 (1) (a).
(3) The principles of good manufacturing practice include in particular:
(a) compliance with the conditions under which manufacture of the product has been authorised and, in particular, with quality indicators resulting from generally binding legislation or technical standards and specified technological and working procedures,
(b) care for the hygiene of production, in particular regular cleaning, cleaning, disinfection, disinfecting and exerting, and compliance with the principles of personal hygiene by workers involved in the manufacture and handling of products;
(c) protection of raw materials and finished products from pollution and confusion;
(d) the correct indication of the shelf life and, where appropriate, the exspiration of the preparations and the time limits for which the use of the products adversely affects the health of animal products ("withdrawal periods");
(e) storage and transport of products under such conditions as to preserve their quality, efficiency and safety;
(f) the use of packaging and packaging materials which protect products from pollution or other deterioration and which cannot adversely affect their quality, efficiency and safety. The packaging of preparations must bear the particulars and markings required by the Czechoslovak Pharmacopoeia 2) and technical standards as well as the withdrawal periods,
(g) continuous care of the qualifications of and dissemination of personnel involved in the manufacture and handling of products.
(4) The manufacturer is obliged to specify in the instructions for use of the products the method of disposal of packaging and non-usable products, if required by the protection of human and animal health and environmental protection.
(1) The State Veterinary Administration may revoke the authorisation to manufacture and put into circulation the product,
(a) if the manufacturer of the authorised product so requests,
(b) if serious adverse reactions or other properties of the product are found that do not comply with the authorisation granted,
(c) if it is found that the authorisation resulting from the authorisation has been misused.
(2) For the reasons referred to in paragraph 1, the State Veterinary Administration may initiate the withdrawal of the registration of the preparation. (3)
The costs of authorising the manufacture and putting into circulation of the product shall be borne by the applicant by a lump sum of 2 000 Kčs and shall include the costs of drawing up expert Opponent Opponents and routine laboratory inspections (including the use of equipment and materials in its implementation).
Imports of products
(1) The provisions on the authorisation of the verification and manufacture of products and their putting into circulation, with the exception of the provisions on the certification production, shall also apply to the authorisation of imports of products.
(2) The importer is required to submit samples of the product to the competent authority for verification.
(3) Imports of products containing live embryos (strains of bacteria, viruses, phages, mould and parasites) may be authorised 4) only provided that the consignment:
(a) have been inspected before dispatch by and ready for transport by a State or State authorised by a veterinarian;
(b) it is transported in packages excluding the spread of human or animal diseases;
(c) it is accompanied by a health certificate highlighting that the consignment is authorised to be opened only by the consignee.
(4) Imports of products outside the framework of foreign trade (non-commercial imports) are only possible if they are mass-produced products in the original packaging, on the basis of the agreement of the competent district or municipal veterinary administration, or, where appropriate, if they are products containing live embryos, on the basis of the agreement of the State Veterinary Administration. For the import of travel products by foreigners for the needs of their animals during their stay in the Czechoslovak Socialist Republic, or by Czechoslovak natural and legal persons who have obtained them and started to use them abroad, there is no need for the consent of the competent veterinary authority; However, products may only be imported in such quantities.
Use of products
(1) Only preparations may be used for veterinary professional purposes
(a) approved under special regulations or authorised by the State Veterinary Administration in agreement with the Ministry of Health and Social Affairs of the Czech Socialist Republic;
(b) prepared in accordance with the veterinary prescription at a pharmacy or other designated establishment.
(2) The veterinary prescription of the organisation of the national veterinary service or, where appropriate, of the farm veterinary service, 5) must include:
(a) the name and stamp of the organisation of the national veterinary service or, where appropriate, of the organisation in which the farm veterinary service was established;
(b) the name and address, or the name and address of the breeder, and the type of animal;
(c) the product code, including the instructions for its use, and, where appropriate, the indication that the product is to be issued in accordance with the Regulation repeatedly;
(d) the date of completion of the Regulation;
(e) the name and signature of the veterinarian and, where appropriate, his name in block letters.
(3) Products subject to veterinary prescription may also be issued to an order from a breeding organisation certified by the competent veterinarian, provided that the order contains the particulars referred to in paragraph 2.
(4) When prescribing medicinal products containing narcotic or psychotropic substances, antibiotics and antimicrobial chemotherapeutic agents, hormones and substances having a hormonal effect, veterinary surgeons shall proceed according to specific regulations. 6)
(1) Products shall be prescribed and used in accordance with the principles of effective pharmacotherapy and protection of animal products against foreign substances.
(2) After expiry date or expiry date, products may not be used without verification of their quality, efficacy and safety.
(1) Only veterinary surgeons and other authorised veterinary staff may apply injectors.
(2) Mass administration of products the use of which, according to manufacturer or experience, is associated with an increased risk of adverse reactions in animals is permitted only under the supervision of the competent veterinarian.
(3) If not for the cases referred to in paragraphs 1 and 2, the competent veterinarian shall instruct the breeder:
(a) the method of administration, including measures to protect the health of persons handling the product,
(b) the dosage, timing and withdrawal period of the product;
(c) the possible adverse effects of non-compliance with the lesson.
(1) The competent authority of the veterinary administration shall determine the quantities in which the breeding organisation may store individual products.
(2) Breeding organisations shall:
(a) comply with the instructions of the competent authority of the veterinary administration concerning the use and storage of preparations and the withdrawal period;
(b) establish separate storage facilities for the products under seal and maintain them in a state consistent with the proper storage requirements of the products;
(c) to issue products subject to veterinary prescription from storage only with the agreement of the competent veterinarian;
(d) keep records of the purchase, disposal and use of products;
(e) inform without delay the competent authority of the veterinary administration of the serious adverse effects of the product used or any other defects thereof.
Control of products
Control tasks on the verification, production, import, putting into circulation and use of products shall be performed by:
(a) manufacturers of products,
(b) veterinary authorities in the framework of veterinary supervision, 7)
c) Institute for State Control of Veterinary Bioprafts and Medicines in cooperation with the State Institute for Drug Control.
(1) The manufacturer of the product must carry out:
(a) entry quality control of raw materials, interoperational control and exit control of quality, efficiency and safety of finished products;
(b) checking compliance with the principles of good manufacturing practice applied in the production of this type;
(c) checking the packaging and labelling of products.
(2) The products stored must be checked in particular for compliance with storage conditions and shelf life and, where appropriate, exspiration.
Institute for State Control of Veterinary Bioprafts and Medicines
(1) The Institute for State Control of Veterinary Bioprafts and Medicines as the body of senior professional control
(a) be made binding on proposals for technical documentation of products;
(b) approve proposals for methodologies for verifying the effectiveness, safety and stability of products;
(c) submit its opinions to the State Veterinary Administration on the results of the verification and verification of product production and on the examination of applications for consent or authorisation to manufacture and put into circulation of products;
(d) verify withdrawal periods before the products are put into circulation;
(e) carry out an evaluation of the quality, efficiency and safety of products manufactured, imported and exported;
(f) verify the quality, efficacy and safety of the products after the expiry date and, where appropriate, the expiry date and the conditions for their further use;
(g) where serious adverse reactions or other deficiencies are identified in terms of the quality, efficacy and safety of the product, the veterinary authority proposes to suspend the placing into circulation and use of the product until the necessary examinations and tests have been completed or, where appropriate, to withdraw the authorisation to manufacture and put it into circulation, or to initiate the withdrawal of the marketing authorisation;
(h) monitor the undesirable effects of the products, examine their causes and assess the justification for complaints concerning their quality, efficacy and safety;
(i) examine, at the request of the authorities and organisations, samples of preparations as well as samples of animal products, feed and water for residues of preparations;
(j) monitor compliance with the principles of good manufacturing practice applied in the manufacture of preparations.
(2) The Institute for State Control of Veterinary Bioprafts and Medicines also
(a) methodically directs:
1. verification of the products and evaluation of their results;
2. the detection of the content of specific active substances in the products referred to in Article 1 (1) (a);
3. control activities of manufacturers,
(b) ensure and manage product standards.
Efficacy
This Decree shall take effect on 1 September 1989.
Minister:
Ing. Vanek CSc. v. r.
1) § 10 (i) of Act No. 108 / 1987 Coll., on the competence of veterinary care bodies of the Czech Socialist Republic.
2) Decree No. 10 / 1987 Coll., on the binding of Czechoslovak Pharmacopoeia - fourth edition in the Czech Socialist Republic.
3) Article 6 of Decree No 43 / 1987 Coll., on the registration of mass-produced medicinal products and the reimbursement of the costs associated with it.
4) Article 16 (1) of Act No. 87 / 1987 Coll., on Veterinary Care. § 1 (1) of Decree No. 118 / 1987 Coll., on the Veterinary Protection of State Territory.
5) Paragraph 5 (3) of Decree No. 113 / 1987 Coll., on the Business Veterinary Service.
6) Decree of the Government of the Czech Republic No. 192 / 1988 Coll., on poisons and certain other harmful health substances.
7) § 22 of Act No. 87 / 1987 Coll. § 9 (1) (a) and § 10 (c) of Act No. 108 / 1987 Coll.
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Regulation Information
| Citation | Decree of the Ministry of Agriculture and Nutrition of the Czech Socialist Republic No. 86 / 1989 Coll., on authorising the verification, production, import and putting into circulation, use and control of veterinary medicinal products |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 31.07.1989 |
|---|---|
| Effective from | 01.09.1989 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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