Cabinet of Ministers Regulations No. 37 in Riga on 11 January 2011 (pr. 3. § 36) amendments to the Cabinet of Ministers of 15 May 2007 the provisions of no. 319 "regulations on the manufacture of veterinary medicinal products and control the order in which the veterinary medicinal product, the manufacturer shall issue a certificate of good manufacturing practice for veterinary medicinal products, and the production of officers qualifications and professional experience requirements" Issued in accordance with article 5 of the law on Pharmacy 3 and 13 and article 52 to make Cabinet 15 May 2007 No. 319 "provisions of the rules on veterinary medicine production and control , the order in which the veterinary medicinal product, the manufacturer shall issue a certificate of good manufacturing practice for veterinary medicinal products, and the production of officers qualifications and professional experience requirements "(Latvian journal, 2007, 79 no; 2008, nr. 183; 2009, 113 no) the following amendments: 1. Replace the text, the words" production "(fold) with the words" special permit (license) "(fold).
2. Express (4) and (5) the following: "4. the manufacturer of the veterinary medicinal product or the manufacturer of the medicinal product, which also produce the veterinary medicinal products (hereinafter referred to as the manufacturer of a veterinary medicinal product), has received a food and veterinary service (hereinafter service) issued a special permit (license) for the manufacture of veterinary medicinal products, or 51.2 of the pharmaceutical law, in the case referred to in article by the national agency of medicinal products (hereinafter referred to as the Agency) issued a special permit (license) for the manufacture of the medicinal product with the scope of" production "of the veterinary medicinal product. Special permit (license) is also required for export (the export of veterinary medicinal products of the European economic area) for the manufacture of veterinary medicinal products.
5. The rules referred to in paragraph 4, the special permit (license) require both full and partial production activities, as well as different types of packing, packaging and product design activities. "
3. To supplement the provisions under point 5.1 by the following: "5.1 the manufacturer of veterinary medicinal products, veterinary medicinal products good manufacturing practices certificate issued by the Department or the pharmaceutical law-in the case referred to in article 51.2-Agency."
4. Replace the words "in paragraph 6.3 of the National Medicines Agency" with the words and figures "or-pharmaceutical law case referred to in article 51.2-agency".
5. To replace the words "in paragraph 6.4. Health inspections, inspectors and State agency officials" with the words and figures "and-pharmaceutical law case referred to in article 51.2-agency officials".
6. Amend paragraph 6.5., the words "as well as the State Agency's website on the internet (URwww.zva.gov.lv)".
7. Replace the words "in paragraph 6.7. Health inspections, inspectors and State agency officials" with the words "staff officers".
8. Replace the words "in paragraph 6.8.2. Medicine State agency officials" with the words and figures "and-pharmaceutical law case referred to in article 51.2-agency officials".
9. Replace paragraph 13, the words "National Agency for medicinal products" with the word "service".
10. Replace the words "in paragraph 16.5 medicine State Agency" with the words and figures "service or pharmaceutical law case referred to in article 51.2-agency".
11. Express 18.6. and 11.6. the following: section 18.6. inform "(paper or electronic) or – the pharmaceutical Act, in the case referred to in article 51.2 – Agency for veterinary medicinal products manufactured and their raw material sample retention site and provides the opportunity to visit the place of storage;
11.6. If the veterinary medicinal product produces an individual order, small quantities of veterinary medicinal products and raw materials or storage properties it is cumbersome, in agreement with the authorities or pharmaceutical law – 51.2 in the case referred to in article with the Agency for veterinary medicinal products and raw materials for storage or sampling can identify other conditions. "
12. Replace the words "in paragraph 20.3 of the National Medicines Agency" with the words and figures "and-pharmaceutical law case referred to in article 51.2-agency".
13. Express 21 as follows: "21. the manufacturer of the veterinary medicinal product before the contract with the laboratory for quality control of veterinary medicinal products shall ensure that the service or pharmaceutical law case referred to in article 51.2, officials of the Agency inspection laboratory and gives its opinion on the compliance of laboratories of good manufacturing practice requirements."
14. Replace paragraph 22, the words "the State Agency of medicines and health inspection" by the word "service".
15. Express 24 as follows: "24." then, when provided with a special permit (license) for the manufacture of veterinary medicinal products, the service monitors the manufacture of veterinary medicinal products and control compliance with the requirements of this Regulation: 24.1. at least every three years, made repeated good manufacturing practice inspections (inspections). Service with the manufacturer of a veterinary medicinal product shall agree on a trial period and not later than 10 working days before the inspection, notify in writing;
24.2. If necessary, unannounced inspections. In this case, the samples tested in the laboratory, which has the power to control the courtroom. "
16. To supplement the rules with 24.1 points as follows: "the law of article 24.1 Pharmaceutical 51.2 in the case referred to in the Agency monitored the production of veterinary medicinal products and quality control compliance with the requirements of this Regulation: 24.1 1. at least once every three years, made repeated good manufacturing practice inspections (inspections). The Agency and the manufacturer agree on a trial period and not later than 10 working days before the inspection, notify in writing;
15.0 2. If necessary, unannounced inspections. In this case, the sample shall be tested in a laboratory of the Agency, or other laboratory, which has the power to control the courtroom. "
17. Replace the introductory paragraph of paragraph 25, the words "the State Agency of medicines has the right" with the words "Service is entitled".
18. Replace the words "in paragraph 25.1. Medicine State Agency" with the word "service".
19. Make 26 the following: 26.24, 24.1 these terms and 25. the checks referred to in point according to the competence of the agency or service carried out by competent authorized officials are trained to take good manufacturing practice compliance controls and which is entitled: 26.1. to inspect manufacturers and laboratories to the holder (owner) take control of veterinary medicinal products. The expenses of the inspection shall be borne by the person to be tested in accordance with the laws of the State of the service monitoring and control activities and provided paid service fee, or, Pharmacy Law, in the case referred to in article 51.2-public agency paid the price list;
26.2. sampling, also to perform independent analysis of veterinary medicinal products in a laboratory, which has the power to take control of veterinary medicinal products. With the testing of veterinary medicinal product related costs shall be borne by the person to be tested in accordance with the laws of the State of the service monitoring and control activities and provided paid service fee, or, Pharmacy Law, in the case referred to in article 51.2-public agency paid the price list;
16.3. to examine documents relating to the object, subject to the limits on the powers relating to production methods. "
20. Replace paragraph 27, the words "State Agency" of the medicinal product with the words and figures "service or pharmaceutical law case referred to in article 51.2-agency".
21. Make 28 the following: "28. Service or agency within 10 working days after each of those rules 24, 24.1, 25 and 27 of the checks referred to in paragraph prepares the good manufacturing practices inspection report (annex 1). The report shall state whether a manufacturer of veterinary medicinal products shall respect the principles and guidelines of good manufacturing practice. Check the manufacturer of the veterinary medicinal product or veterinary drug registration certificate holder (owner) sends one message instance, and the other copy shall, if necessary, shall forward to the authority that requested the check. "
22. Replace paragraphs 29 and 30, the words "State Agency" of the medicinal product with the words and figures "service or pharmaceutical law case referred to in article 51.2-agency".
23. the introductory part of paragraph 31, the express, 31.1 and 31.2 of this.: "31. the pharmaceutical Act or, in the case referred to in article 51.2-Agency: 31.1. issued by the manufacturer of the veterinary medicinal product good manufacturing practice compliance certificate (annex 2), after the manufacturer of a veterinary medicinal product is paid for the issue of certificates in accordance with the laws of the State of the service monitoring and control activities and provided paid service fee, or, Pharmacy Law, in the case referred to in article 51.2-provided public agency paid the price list;
31.2. If adopted this rule 29.3. referred to in the decision, according to competency in accordance with the laws and regulations on special permit (license) for pharmaceutical or veterinārfarmaceitisk transaction and the issuing, suspension or cancellation of the decision on the agenda of the special permission (license) manufacture of the veterinary medicinal product suspension to good manufacturing practice referred to in the report of the control issue; ".

24. Replace paragraph 32, the words "national agencies" of the medicinal product with the words and figures "service or pharmaceutical law case referred to in article 51.2-agency".
25. replace paragraph 33, the words "the State Agency of medicines" by the words "and the Agency".
26. Replace paragraph 34 the words "State Agency" of the medicinal product with the words and figures "service or pharmaceutical law case referred to in article 51.2-agency".
27. To replace 35 and 36, the words "State Agency" of the medicinal product with the words and figures "service or pharmaceutical law case referred to in article 51.2-agency".
28. Delete paragraph 37 and 38.
29. Replace paragraph 39, the words "National Agency for medicinal products" with the word "service".
30. Make annex 1 as follows: "annex 1 Cabinet 15 May 2007 No. 319 of the rules of good manufacturing practice inspection report (form of the European Commission) report No 1.
2. Product (s) name and pharmaceutical form (s) specifies the checks requested by the European Medicines Agency (EMA). You only need a specific product tests 3. Tests (inspection) in place of the object name and full address, including the exact location of the locale.
Eudr GMP reference number.
Check the site identification (data universal numbering system (DUNS) number or global positioning system (GPS) coordinates) 4. manufacturing operations carried out the production of the finished product is not sterile sterile biological active substances, excipients, or veterinary medicinal products sterilization the primary packaging secondary packaging quality control testing the serial storage certification Import and distribution of the active substance manufacturing other _____ _____ _____ _____ _____ _____ _____ 5. Examination date date (s), month, year 6, the Inspector (s) and expert (s) Tracker (s) name (s) of the expert (the evaluator (s)) name (if necessary) the competent control body name 7. Reference veterinary medicinal products, the number of the certificate of registration and (or) special permit (license) for the manufacture of veterinary medicinal products.
The European Medicines Agency reference number (s) (if inspection is an inspection of the EMI) 8. Introduction a brief company description and if the examination is underway in the country, which are not members of the European economic area, indicate whether the competent authority of the country in which the examination is aware of and verify or the competent authority concerned has participated in the examination of the previous date of inspection the Inspector (s) who participated in the exporting country previous inspection (name first name, last name) the significant changes that have occurred since the previous inspection 9. brief report on inspection activities performed: 9.1. inspection check the brief description (product and process verification or (and) the general good manufacturing practices inspection (if you check a specific dosage form, it indicates)). Check the reason (for example, a new application for the registration of veterinary medicinal products, current inspection, product defect investigation) 9.2. verify (s) area (s) of each check zone 10. Unverified transactions if needed, identify areas or activities that a particular test was not tested during the inspection he found 11 personnel the personnel having Specified (name, title). List adds the message attachment 12. the Inspector (s) observations and found shortcomings in the relevant chapter titles in accordance with the instructions of the European Commission for medicinal products and investigational medicinal product good manufacturing practice, which European Union pharmaceutical regulation document item volume IV.
Here you can explain classification.
The content can be reduced if the controlling persons recognised as acceptable by the competent authority of production 13. Chapter titles (you can implement new chapter titles) overview of previous inspection findings and the adjustment operations quality management personnel, premises and equipment, documentation, production quality control and analysis of the Līgumražošan (quality control) records of complaints and product recall self-control 14. Distribution and transportation (shipping) 15. issues relating to the application for the registration of veterinary medicinal products evaluation example , before the registration of veterinary medicinal products other identified 16 specific questions such as the significant expected changes, for which the manufacturer declares 17. Shop floor the shop floor description describes the assessment, if any. Plant description data 18. Various news (retrieved samples) 19. annexes attached the list of annexes 20. Deficiencies (critical, essential and others) indicate any deficiencies and provide the reference to the European Union's drug regulatory document item volume VI part "medicines and investigational medicinal product good manufacturing practices guidelines".
Indicate any deficiencies detected immediately, even if adjustments were made in the transaction.
If the deficiencies concern the registration of veterinary medicinal products, the evaluation of the application clearly indicates.
Ask the manufacturer to notify the competent authority for the period in which to make certain adjustments to the activities and progress 21. Inspector's comments on the manufacturer's explanation and action in relation to its examination of whether the number is sufficient explanation 22. Inspector's comments on the questions the evaluation report Recommendation 23. for further action (if any) to the institution at which the request is made to the inspection, or the national competent control authority in which the company inspected 24. Summary and conclusions in the Inspector (s) indicate if the company tested areas in accordance with the European Union's good manufacturing practice regulations (they are defined in the Cabinet of Ministers of the Republic of Latvia of 15 May 2007 the provisions of no. 319 "regulations on the manufacture of veterinary medicinal products and control the order in which the veterinary medicinal product, the manufacturer shall issue a certificate of good manufacturing practice for veterinary medicinal products, and the production of officers qualifications and professional experience requirements") and or test the product manufacturer or importer may issue a certificate of good manufacturing practice (may apply in a situation of non-compliance, but corrective action plan has been approved and the Inspector has reason to believe that the corrective action plan will be implemented and public health is not compromised) 25. Verification shall be carried out: 25.1. first name, last name, signature and date of reports inspectors and observers participating in the inspection (inspection) 25.2 25.3. authority signature 26. date 27. Send a message if the test requested by the European Medicines Agency, the message must be sent to the note.
The drawbacks: 1 the critical shortcomings – lack) of veterinary medicinal products manufactured or are at high risk to produce veterinary medicinal products that are harmful to human or animal health or veterinary drug residues, leaving harmful organisms from animals from which the foodstuffs of animal origin;
2) serious shortcomings (not critical flaws) has flaws, which meets at least one of the following conditions: (a) a veterinary medicinal product produced) or likely to produce veterinary medicinal products that do not comply with the veterinary medicinal product concerned specified in the registration certificate;
(b)) are the deviations from good manufacturing practice requirements that can affect the quality of veterinary medicinal products to be produced;
(c)) are the deviations from the conditions of the special permission (license) manufacture of the veterinary medicinal product, which may affect the quality of veterinary medicinal products to be produced;
(d)) is not made to the special permission (license) manufacture of veterinary medicinal products the latter series release or (European Union) the qualified person shall not carry out their duties;
e) various other shortages, which during a specific defect is irrelevant, but together they become significant. It explained and stated in the report;
3 other disadvantages-lack) that is not classified as critical or important, but which indicate deviations from the principles of good manufacturing practice, as well as other deficiencies, if they are assessed as minor, or there is insufficient information to classify them as significant or critical. "
31. Make annex 2 as follows: "annex 2 Cabinet 15 May 2007 No. 319 of the rules, the Prime Minister v. Minister of Agriculture Dąbrowski – traffic Minister u. Augul States