Cabinet of Ministers Regulations No. 445 in 2003 (12 august. Nr. 44, 5. §) production and veterinary medicinal product control rules Issued in accordance with article 5 of the law on Pharmacy (3) i. General questions 1. veterinary medicinal products shall be established, including medicated premix (a mixture of a veterinary medicinal product intended for medicated feedingstuffs) and the manufacture of homeopathic medicinal products for veterinary use and control arrangements.
2. the rules do not apply to the medicated feedingstuffs and medicinal composition which contains radioactive isotopes.
3. The veterinary medicinal product may be produced by the company (the company) (hereinafter referred to as a manufacturer of veterinary medicinal products) regulations prescribed have received a special permit (license) for the manufacture of veterinary medicinal products.
4. special permission (license) is also required in the following cases: 4.1 health pharmacy drugs manufactured in series (one tank finished medicinal products with the same weight, fast, packaged and labelled in a prepared grass);
4.2. veterinary medicinal products prepared in a pharmacy in series fast, packed or repacked;
4.3. the veterinary medicinal product lieltirgotav repacked finished product.
5. special permission (license) is required for veterinary pharmacy that: 5.1 on a veterinarian's prescription or written request made and fast (or change the packaging or design) the veterinary medicinal product is intended for the individual patient;
5.2. the medicinal product is manufactured in accordance with the pharmacopoeia monograph and distributed to retail, except for the provision in paragraph 4.
6. the manufacturer of a veterinary medicinal product for which a special permit (license), allowed: 6.1 to produce, making all or part of the production process, the special permission (license) veterinary medicinal products and pharmaceutical forms;
6.2. the use of the special permission (license) the specified premises;
6.3. to distribute veterinary medicinal products produced in accordance with the law on Pharmaceutical and other legal requirements;
6.4. repackage (repackaged) and package the drugs or make other changes to the package (for example, to change the design).
7. the manufacturer of a veterinary medicinal product: 7.1 designate at least one factory, for the production of the responsible person. The person in charge ensures: 7.1.1. each series of veterinary medicinal products, the production and inspection under legislative requirements;
7.1.2. the imported from third countries used in the manufacture of the veterinary medicinal product testing (tests) to prove that the imported medicinal product complies with food and veterinary service submitted in the registration dossier for this;
7.1.3 all from third countries imported veterinary medicine active substance in qualitative and quantitative;
7.1.4. Add the documentation for imports from third countries used in the manufacture of veterinary medicinal products, to demonstrate that the manufacturer of the veterinary medicinal product is legislation according to the quality assurance system (good manufacturing practice);
7.1.5. quality supporting document (certificate of quality control results compliance with the technical regulations, the documentation requirements) for each veterinary medicinal products produced in series. The quality of the copy of the identity document of the manufacturer of the veterinary medicinal product in the stores no less than five years;
7.2. designate at least one site for quality control of a responsible person;
7.3. ensure that rule 7.1. and 7.2. persons referred to in subparagraph obligations.
8. the manufacturer of a veterinary medicinal product: 8.1. submit to the food and veterinary service of the written report: 8.1.1. of planned changes in the production or manufacture of the veterinary medicinal product in or on a change of form;
8.1.2. for amendments to the list of persons responsible in the 15 days after the manufacturer of a veterinary medicinal product and the person in charge of the termination;
8.1.3. for amendments to documents on the basis of which it is issued a special permit (license);
8.2. immediately notify the food and veterinary service, if the person is replaced due to unforeseen circumstances;
8.3. manufacture and control of veterinary medicinal products in accordance with these rules and regulations of the testing of medicinal products;
8.4. the veterinary medicinal product creates and maintains accounting databases: 8.4.1. operation after each production database made such precise entries: 8.4.1.1. detailed information about purchased veterinary medicinal products and forms, as well as for the active substances intended for use in manufacturing;
8.4.1.2. detailed information about veterinary medicinal products manufactured and their shapes;
8.4.2. amend the records, if used in the manufacture of hormonal or psychotropic substances or active substances that have anabolic, anti-parasitic, anti-inflammatory and antimicrobial activity;
8.5. keep records of veterinary medicine and the veterinary medicine samples not less than five years after the last entry of the veterinary medicinal product by the accounting database.
 
II. Requirements for the qualifications of the persons responsible 9. person responsible meet the following qualification criteria: 9.1 a diploma or certificate of high school courses or recognised in Latvia in the acquisition of one of the following: 9.1.1 the pharmaceutical industry;
9.1.2. medicine;
9.1.3. veterinary medicine;
9.1.4. chemistry;
9.1.5. industrial pharmaceutical technology or biology;
9.2. the rules referred to in paragraph 9.1 programmes are acquired in the theoretical knowledge and practical skills in the following subjects (courses): 9.2.1. applied physics;
9.2.2. General Chemistry, inorganic chemistry, organic chemistry, analytical chemistry and pharmaceutical Chemistry (summary analysis);
9.2.3. the General and applied Biochemistry (medical);
9.2.4. Physiology;
9.2.5. microbiology;
9.2.6. Pharmacology;
9.2.7. pharmaceutical technology;
9.2.8. toxicology;
9.2.9. pharmacognosy;
9.3. the programmes acquired four years of theoretical and practical studies. The minimum duration of study can be three years and six months, at least after they followed years of theoretical and practical studies, which for at least six months in a general type of pharmacy or veterinary pharmacy, and finally are settled according to the examination requirements laid down in the University;
9.4. the responsible person shall have relevant work experience: 9.4.1. no less than a year, if the duration of study is at least five years;
9.4.2. not less than six months if the duration of study is at least six years.

10. If the person responsible does not meet the education provisions 9.1. criteria referred to in (a), an applicant for the position in addition to the documents submitted for this rule 9.2. referred to theoretical and practical learning.
 
III. the quality of veterinary medicinal products in the production establishment 11. Veterinary medicinal products is the responsibility of the manufacturers to establish and maintain a quality assurance system, involving the management of the company (the company) and all persons involved in the production process.
12. the quality assurance system complies with the following requirements: 12.1. premises and manufacturing equipment shall be designed, constructed, adapted and maintained its place, to be able to carry out high-quality production process;
12.2. premises and equipment design and construction, as well as the manufacturing process steps is to: 12.2.1. prevent pollution of veterinary medicinal products, their mutual contamination and quality of produce adverse factors on medicinal substances and ready-made products (packaging material, raw material and finished product contamination with other materials or substances);
12.2.2. provide equipment and facilities for cleaning and disinfecting easy.
12.3. each production and control station employed personnel have appropriate qualifications;
12.4. the production company's structure, administrative staff and responsibilities determined by the authority and approved by the head of the production company;
12.5. the staff determines the duties and responsibilities of the position description;
12.6. the company (business) management controls, or shall be respected, in accordance with the laws and regulations in specific hygiene requirements relating to the health status of staff, personal hygiene and clothing;
12.7. the staff are provided initial training and qualifications (theoretical and practical training), including the principles of quality assurance.
13. to ensure that the manufacture of veterinary medicinal products and quality control (sampling, testing, documentation and other associated work organisation procedures that ensure the quality of raw materials and materials in compliance with the marketing of medicinal products), a manufacturer of veterinary medicinal products: 13.1. production operations carried out by the enterprise (the company) driving instructions and approved production operations (operations that directly or indirectly related to the manufacture of medicinal products), in order to ensure the purity of the substances of the medicinal product (not to mix among themselves and not to contaminate the environment);
13.2. at least once a year, perform internal audits. The audit examined the operation of the quality system and in any non-compliance with the Protocol. Records shall be kept for at least three years and presented by the food and veterinary service officer so requests;
13.3. the approved (or validate, demonstrate quality system compliance with legislation requirements or test at the final stage of development to ensure that the designed system functions according to these requirements): 13.3.1. any new production processes or changes in the production process;
13.3.2. the critical stage of the manufacturing process (manufacturing process, which is a medicine contamination risk) according to scientific and technical progress;
13.3.3. conformity, quality and safety of medicinal products (products come into specific viruses, and it in no way is not infected) if the veterinary medicinal product is produced, containing animal blood and plasma.
14. the manufacturer of the veterinary medicinal product have the right to conclude with natural or legal persons contract for certain veterinary medicinal products for the production and quality control. The contract accurately determined the duties and responsibilities of the parties. The contractor of the veterinary medicinal product without the manufacturer's written consent should not ask the relevant works to a third party.
15. the manufacturer of a veterinary medicinal product for at least 15 days before the commencement of the production control production company, submit a copy of the contract concluded by the food and veterinary service.
16. quality control of veterinary medicinal products include: 16.1. quality of packaging materials, raw materials and intermediate products;
16.2. the inspection of the finished product prior to distribution (for the control of veterinary medicinal products the final phase); check constitutes a basis for the evaluation of the quality of the finished product.
17. Veterinary medicinal products quality control studies carried out national veterinary diagnostic Center, as well as other accredited laboratories and institutions law in a fixed order is entitled to check medications.
18. the manufacturer of a veterinary medicinal product: 18.1. stored in each series of samples of the veterinary medicinal product for at least a year after their expiry date;
18.2. stored samples of the raw material for at least two years after their expiration date.
19. the manufacturer of the veterinary medicinal product shall maintain documentation that includes: 19.1. information on the quality certificate of the veterinary medicinal product;
19.2. the production formula.
19.3. the instructions;
19.4. the production and operation of control descriptions (updated);
19.5. the protocols which gathered all the information on each series of veterinary medicines production history, distribution, and conditions that can affect the quality of veterinary medicinal products.
20. production and control operations are stored together with the document for each of the veterinary medicinal product concerned. If the series of the veterinary medicinal product has expired, the documents shall be kept for a period of five years from the serial quality to the date of issue of the certificate.
21. the manufacturer of a veterinary medicinal product shall ensure safe storage of documentation. The documentation presented by the food and veterinary service of the Inspector's request.
22. the manufacturer of a veterinary medicinal product: 22.1. every two years, or by the food and veterinary service of the request, provide the details (description) for the plant, the production process and the establishment of a system of self-control;
22.2. create complaint registration and examination system, as well as inform the food and veterinary service for each of the medicinal products or form found defects. The food and veterinary service shall decide on the revocation of the veterinary medicinal product concerned, withdrawal or suspension of the distribution;
22.3. ensure the withdrawal of the veterinary medicinal product and withdrawal;
22.4. the presentation of the food and veterinary service of the Inspector of the veterinary medicinal product component or finished product control data.
 
IV. A notice of the registration of veterinary medicinal products status

23. at the manufacturer or exporter of veterinary medicinal products (importer) at the request of the competent institution by the State food and veterinary service shall issue a registration certificate of the veterinary medicinal product or a copy of the notice of registration of veterinary medicinal products (hereinafter referred to as the certificate), if the product in question is registered by the food and veterinary service.
24. food and veterinary service of the proof presented in Latvian and in English and shall be issued within 30 days of receipt of the application.
25. Exportable certification of veterinary medicinal products in food and veterinary service of the veterinary medicinal product description add a summary.
 
V. 26. Food control and veterinary service: 26.1. control this enforcement;
26.2. the diet in the case of veterinary medicinal products manufacturer and Distributor, which is authorised to carry out transactions with: 26.2.1. veterinary medicinal products containing hormonal or psychotropic substances;
26.2.2. active substances that have anabolic, anti-parasitic, anti-inflammatory or antimicrobial activity.
27. food and veterinary service officer: 27.1. inspection of the licensed manufacturer of the veterinary medicinal product and the control laboratories; the Inspector may require to make the control of medicaments and study their shapes, to take samples and conduct a detailed document and production methods;
27.2. inspect all manufacturers of veterinary medicinal products, which applied a special permit (license) or renewal;
27.3. at least once a year, inspect each of the manufacturing site of the veterinary medicinal product concerned, to check how is the quality and the production company or the veterinary medical product is manufactured according to and described in the food and veterinary service provided production methods.
28. After inspection the Inspector draws up legislation and of its contents shall inform the manufacturer of the veterinary medicinal product.
29. food and veterinary service shall act on veterinary medicinal products (one of a series of veterinary medicinal products) production suspension, withdrawal from the veterinary medicinal product or a special permit (license) the cancellation of the following cases: 29.1. the documents submitted to obtain special permission (license), that information is not true;
29.2. the manufacturer of the veterinary medicinal product is not made ready for veterinary medicinal products or their components control studies in accordance with these rules;
29.3. veterinary medicinal products considered hazardous for use for the following reasons: 29.3.1. the composition of the veterinary medicinal product, quantitative and qualitative indicators have been changed and do not meet the registration of veterinary medicinal products specified in the documents;
29.3.2. the period to which the product is released from the body, above the laws on minimum safety requirements and the maximum quantity of residues of medicinal products in foodstuffs of animal origin specified allowable margins;
29.3.3. products of animal origin for human health has been found dangerous levels;
29.4. not ready to control the veterinary medicinal product or the manufacture of the veterinary medicinal product control intermediate (if any is provided for registration documentation) or does not comply with other laws and regulations in the field of Pharmacy requirements;
29.5. the special permission (license) the veterinary medicinal product is not a therapeutic effect as regards the species of animal for which they are intended;
18.4. the manufacturer of the veterinary medicinal product produces a veterinary drug or dosage forms which are not specified in the special permit (licence) and registration documents;
18.5. a person who has received a special permit (licence), used in the manufacture of veterinary medicinal products, premises, equipment and installations, which are not mentioned in the application for a special permit (license) and which have not been inspecting food and veterinary service;
29.8. on-site veterinary medicinal products during the manufacturing process is not responsible;
29.9. examination found that the manufacturer of the veterinary medicinal product has not provided information on the amendment of the documents, on the basis of which a special permit (license);
29.10. veterinary medicinal products is prohibited in accordance with the legislation.
30. food and veterinary service shall decide on the suspension of the manufacture of veterinary medicinal products in the following cases: 30.1. no decision is taken on a special permit (license) issued to the manufacturer of a veterinary medicinal product or not extended special permission (license);
30.2. are used in the manufacture of the active substance or medicinal products which do not comply with the requirements provided for in the legislation on medicinal products limited usage in animal nutrition.
31. on the basis of the food and veterinary service, drawn up by inspectors of the food and veterinary service shall take a decision on production of the veterinary medicinal product, or suspension or removal of distribution and ten days of the decision and the reasons for the manufacturer of the veterinary medicinal product, as well as inform the manufacturer of the veterinary medicinal product on his right.
32. Submissions and complaints relating to acts drawn up by inspectors examine the food and veterinary service. The food and veterinary service of the decision may be appealed to the law.
 
VI. final question 33. This provision 9.2, 9.3 and 9.4., 10., paragraph 12.1, 12.2 and 13.3 shall enter into force by 1 May 2004.
 
Informative reference to European Union Directive provisions included in the law arising from Directive 2001/82/EC.
Prime Minister e. Repše Minister of Agriculture m. Roze Editorial Note: rules shall enter into force on 16 august 2003.