The Rules 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 Producti...

Original Language Title: Noteikumi par veterināro zāļu ražošanu un kontroli, kārtību, kādā veterināro zāļu ražotājam izsniedz labas ražošanas prakses sertifikātu, un par veterināro zāļu ražošanu atbildīgās amatpersonas kvalifikācijas un profesionālās pieredzes prasībām

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Read the untranslated law here: https://www.vestnesis.lv/ta/id/157312

Cabinet of Ministers Regulations No. 319, Riga, 15 May 2007 (pr. No 29 40. §) rules on the manufacture of veterinary medicinal products and control the order in which the veterinary medicinal product, the production company to issue the 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 52 of article i. General questions 1. determines the production of veterinary drugs and control procedures, procedures for the production of veterinary medicinal products, the trader is served good manufacturing practice certificate and for the manufacture of veterinary medicinal products, officers qualifications and professional experience requirements.
2. The terms used in the following terms: 2.1 validation – documented implementation program that allows you to say with great conviction that the process, method or system that is used in the production of medicines or controlled, constant work, delivering results that meet the criteria set out above;
2.2. qualifying – the operation demonstrated and documented that the manufacture of veterinary medicinal products used in the equipment is properly installed, work correctly and ensure that the intended results. Qualification is, however, certain components of the validation of the qualification stage did not mean the process validation;
2.3. active substance-a substance or mixture of substances intended for use in the manufacture of the veterinary medicinal product, and which in this case becomes the active ingredients of the medicinal product concerned;
2.4. manufacture of the active substance, the active substance of complete or partial manufacture or import (import) and various types of weighing, packaging and design activities to the inclusion of the substance concerned in the composition of the veterinary medicinal product, including repackaging and relabelling, carried out by the distributor of raw materials.
3. the rules apply to: 3.1. veterinary medicinal products to be placed on the market in a Member State of the European Union or the European Free Trade Association (EFTA) countries which have signed the agreement on the European economic area (hereinafter referred to as Member States), if the medicinal product is manufactured industrially or associated with their preparation for industrial medicine preparation process;
3.2. medicated feed premix (veterinary medicinal products intended for animal feed for the production of therapeutic);
3.3. homeopathic veterinary medicinal products;
3.4. active substances which are used as raw materials in the manufacture of veterinary medicinal products;
3.5. substances which may be used as veterinary medicinal products that have anabolic, and pretbakteriāl, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties.
4. The veterinary medicinal product produces economic operators (hereinafter referred to as the manufacturer of the veterinary medicinal product), and the activities of pharmaceutical veterinārfarmaceitisk regulatory laws in the order received a special permit (license) for the manufacture of veterinary medicinal products (hereinafter referred to as the production document). Production document will also need a veterinary medicinal product for export.
5. The production document need both complete and partial production proc sa, as well as various types of weighing, packaging and product design activities.
6. the manufacturer of the veterinary medicinal product has the following responsibilities: 6.1 to employ the personnel carrying out veterinary medicine production and control according to the requirements of this regulation;
6.2. to deal with veterinary medicinal products for which a veterinary medicinal product issued registration certificate, in accordance with the requirements laid down in the regulations on the registration of veterinary medicinal products, use and dissemination;
6.3. immediately (no later than five working days) in written or electronic form to notify the State Agency of medicines, if you replace the pharmaceutical law referred to in article 52 Executive (hereinafter referred to as the qualified person);
6.4. to provide national pharmaceutical inspection inspectors and State agency officials any time to get into the production of veterinary drugs and control rooms;
6.5. to respect these rules for veterinary medicinal products referred to in the principles and guidelines of good manufacturing practice, their interpretation in the light of the pharmaceutical law referred to in article 51.1 of the European Commission's Handbook on good manufacturing practice principles and guidelines (hereinafter referred to as the guidelines of the European Commission), and the use of raw materials only active substances, which are produced according to the instructions of the European Commission (the European Commission has published the European Union regulatory framework for medicinal products document item volume 4. , as well as the State Agency's website on the internet (URwww.zva.gov.lv));
6.6. to register the company's database of veterinary medicinal products (also supplied by the manufacturer of the veterinary medicinal product samples) by destination state legislation. For each transaction in veterinary medicinal products (including for free samples of the veterinary medicinal product delivery) specifies the following information: 6.6.1. delivery date;
6.6.2. name of the veterinary medicinal product;
6.6.3. the volume of supply;
6.6.4. the beneficiary's name and address;
6.6.5. serial number;
6.7. This provision of the information referred to in point 6.6 of the store for at least three years and, upon request, to provide national pharmaceutical inspection inspectors and State agency officials. Information relating to narcotic and psychotropic substances, keep 10 years;
6.8. to encourage qualified persons obligations, transfer of necessary equipment at its disposal to ensure the following requirements are met: 6.8.1. each series of veterinary medicinal products manufactured and controlled according to the requirements of this regulation and in accordance with the conditions of registration of veterinary medicinal products;
6.8.2. each produced a series of veterinary medicinal products the final certification, making exact records log or other dedicated document and with a signature certifying that the series was produced and controlled according to the provisions in point 6.8.1. those requirements. Log or relevant documents stored in merchants for at least five years after the last entry and shall produce, on request, the State Agency of medicines. 
II. Qualified personal qualifications and professional experience requirements 7. manufacturer of the veterinary medicinal product shall have permanently and continuously at his disposal an at least one qualified person whose qualifications and professional experience corresponds to the provision in paragraph 8.
8. The qualified person shall meet the following requirements: 8.1 it is the diploma, certificate or other evidence of formal qualifications of higher education institutions (universities) learning or study programme the study programme of learning what the laws in Latvia in accordance with the procedure laid down is recognised as equivalent by the University studies program, which includes at least four years of theoretical and practical study in one of the following sectors of Science: 8.1.1. pharmacy;
8.1.2. medicine;
8.1.3. veterinary medicine;
8.1.4. chemistry;
8.1.5. the pharmaceutical chemistry and technology;
8.1.6. Biology;
8.2. the provisions referred to in point 8.1 courses have acquired in the theoretical knowledge and practical skills in the following subjects (courses): 8.2.1. physics;
8.2.2. General Chemistry;
8.2.3. inorganic chemistry;
8.2.4. organic chemistry;
8.2.5. analytical chemistry;
8.2.6. the pharmaceutical Chemistry (summary analysis);
8.2.7. General and medical biochemistry;
8.2.8. Physiology;
8.2.9. microbiology;
8.2.10. Pharmacology;
8.2.11. pharmaceutical technology;
8.2.12. toxicology;
8.2.13. pharmacognosy (plant and animal composition of the active substance and exposure research);
8.3. the minimum duration of the University studies (University) may be three years and six months, followed by theoretical and practical training, the duration of which is at least a year and for at least six months in a general type of pharmacy, and the end of the exam have been completed under the University (University) tuition programme;
8.4. it has acquired practical experience over at least two years, in one or more enterprises, which have high-quality production of document analysis and quantitative analysis of active substances and of the company are carried out tests and checks the quality of veterinary medicinal products. Practice time can be shortened by one year, if the duration of the University course was five years, and for one year and six months, if the University (University) tuition programme duration was six and more.
9. If Latvia two colleges (universities) are two study programmes or two courses that are recognised as equivalent, and one course duration is four years and the other over three years, the diploma, certificate or other evidence of education or formal qualification issued in the three-year study programme, considered to be the appropriate rules referred to in point 8.1 conditions for the duration of the study.
10. If a qualified person's education does not match this rule 8.1. criteria referred to in the post, the applicant submitted additional papers on theoretical and practical learning. Study on the amount of this provision at the bottom paragraph 8.2. subjects (courses) must be such as to enable the person concerned to carry out the provisions mentioned in paragraph 6.8 below. 
III. Health principles and the guidelines of good manufacturing practice for medicinal products

11. In this chapter, veterinary medicinal products referred to in the principles and guidelines of good manufacturing practice for veterinary medicinal products, the manufacturer interpreted according to the instructions of the European Commission.
12. the manufacturer of a veterinary medicinal product: 12.1. ensure the manufacture of veterinary medicinal products in accordance with the requirements of this chapter and the conditions of production of the document;
12.2. the system creates and maintains the quality of veterinary medicinal products (hereinafter referred to as the quality system). The system covers all organisational measures to ensure that medicinal products produced comply with the intended use, quality. The system meets the following requirements: 12.2.1. production and control activities are accurately identified and meet the conditions of good manufacturing practice;
12.2.2. is clearly defined management responsibilities;
12.2.3. is carried out all the necessary inspections and all the intermediate inspection and validation of the process;
12.2.4. finished products processed and inspected in accordance with established procedure;
12.2.5. medication stored, distributed and handled so as to maintain the quality of the product throughout the storage period;
12.2.6. According to develop self-control system or the quality control procedures regularly evaluate the quality system effectiveness and applicability.
13. the manufacturer of the veterinary medicinal product, all veterinary medicinal products registered in the manufacturing operations carried out in accordance with the registration of veterinary medicinal products, the information provided in the application. The manufacturer of the veterinary medicinal product review production methods and submitted to the State Agency of medicines of the application for the necessary changes to the registration documentation, if production methods intended to change.
14. the manufacturer of the veterinary medicinal product shall ensure that the following requirements are met: 14.1. production and control in each location are employed whose qualifications and practical experience ensures the compliance of veterinary medicinal products intended for use in quality;
14.2. the personnel management and supervisory responsibilities are definitely working in Kumu description milk. Personnel responsible for the application of good manufacturing practice and functional, is the qualified person, the head of the production department and the quality control Department. The company determines the subordination structure diagram. The company's organisation chart and job descriptions shall be approved in accordance with the veterinary medicinal product, the manufacturer's internal procedures;
14.3. the provisions referred to in paragraph 14.2. personnel assigned to specific powers of its duties;
14.4. the staff ensure the initial and continuing training, in which the staff learns of a veterinary medicinal product quality assurance and good manufacturing practice principles theory and application;
14.5. have been developed and are being followed activities to appropriate hygiene programmes. Hygiene programmes set out the requirements for staff health, personal hygiene and clothing.
15. Premises and equipment shall meet the following requirements: 15.1. premises and manufacturing equipment shall be so designed, constructed, placed, adjusted and maintained according to the production of the document referred to in the application;
15.2. premises and manufacturing equipment shall be located, constructed and used so as to produce the veterinary medicinal product or the raw materials are not damaged or contaminated. An advisory provides cleaning, operation and maintenance, to avoid veterinary medicinal products and raw materials, pollution, cross-pollution playlists (pollution of raw materials or medicinal products with other products or raw materials) and any adverse effect on the quality of the product;
15.3. premises and equipment intended for use in veterinary medicinal products, quality assurance in the critical stages of the manufacture of veterinary medicinal products, are appropriately qualified and validated.
16. The veterinary medicinal product, the manufacturer shall establish and maintain a documentation system that meets the following requirements: 16.1. documentation includes: 16.1.1. specifications;
16.1.2. manufacturing formula.
16.1.3. handling and packing instructions;
16.1.4. procedure descriptions and records of certain production operations;
16.1.5. instructions on precautionary measures;
16.2. the documentation is regularly updated;
16.3. Description of procedures are available, as well as specific documents that reflect the series production process and quality control process (hereinafter referred to as the serial number). This documentation provides the traceability of each product series production history, the changes made in the course of product development, distribution, and other important factors that affect the quality of the finished product (hereinafter referred to as the series documentation);
16.4. the series documentation for at least a year after the series of product expiration date, or five years after this provision 6.8.2. veterinary medicinal products referred to in the certification of service, if the limit is exceeded during respective medicine series expiration date;
16.5. If the documentation used for the series of electronic, photographic or other data processing systems, a manufacturer of veterinary medicinal products must first validate the systems, to provide data storage capability to the storage. The relevant data stored in the system is readily available and understandable, and, on request, provide the State Agency of medicines. Electronically stored data protection system by backing them or prepare backup copies, moving to other storage systems, or keeping records of inspections, to prevent data loss or damage.
17. the process of manufacture of the veterinary medicinal product shall meet the following requirements: 17.1. production activities are carried out in accordance with the established instructions and procedures and in accordance with good manufacturing practice requirements;
17.2. production control is available to provide needed resources, his production process deviations and product defects shall be documented, investigated and remedied;
17.3. performing technical and organisational measures to prevent the veterinary medicinal products and raw materials between pollution and contamination;
17.4. is validated each new production process or significant changes in the production process. The critical stage of the manufacturing process shall be regularly validate again.
18. Veterinary medicinal products quality control shall meet the following requirements: 18.1. veterinary medicinal products, the manufacturer shall establish a quality control Department and ensures its functioning. The Department is headed by a responsible officer of that job description is adequate for certain qualifications and is independent of production;
18.2. the quality control Department shall have at its disposal one or more quality control laboratories, verifying and testing the raw materials, packaging materials, intermediate products and finished products. The quality of veterinary medicinal products, you can also control the laboratories with which the contract was concluded under paragraph 19 of these rules;
18.3. the Department of quality control of the finished product during the final inspection before placing the veterinary medicinal product on the market or distribution, in addition to analytical results evaluate other relevant information, such as a description of the conditions of production, the production process, the results of the checks carried out in the production documentation, and packaging of the final product conformity with specifications;
18.4. each series of finished product samples are stored for at least a year after the series of product expiration date;
18.5. veterinary medicinal products, starting materials used in the manufacture of samples, other than solvents, gases and water, stored for at least two years after the release of the final product. The retention period can be shortened if the substances specified in the specification of the stability period is shorter;
18.6. inform (on paper or electronically) to the National Agency for medicinal products for veterinary medicinal products manufactured and their raw material sample retention site and provides the Agency's officials a chance to visit the place of storage;
11.6. If the veterinary medicinal product produces an individual order, or in small quantities of veterinary medicinal products and raw materials storage, because of their characteristics, are cumbersome, in agreement with the National Agency for medicinal products for veterinary medicinal products and raw materials for storage or sampling can identify other conditions.
19. If any industry or activity or quality control carried out by another person (hereinafter referred to as the contractor), the manufacturer of the veterinary medicinal product and the contractor enters into a contract for the performance of the work in question. The contract accurately determined the duties and responsibilities of the parties, in particular the duty of the contractor to comply with the principles and guidelines of good manufacturing practice, as well as the manner in which the qualified person responsible for the certification of each series, to meet their obligations.
20. Contractor: 20.1. the veterinary medicinal product without the manufacturer's written consent may not be with the third party to conclude a subcontract for the performance of their work on contracted with a manufacturer of veterinary medicinal products;
20.2. to contract out production of the veterinary medicinal product or part of a production operation, if the production document is received;
20.3. comply with the principles of good manufacturing practice and shall submit to the State Agency of medicines.
21. the manufacturer of the medicinal product before the contract with the laboratory of veterinary medicine production quality controls ensure that medicine State agency official inspection laboratory and gives its opinion on the compliance of laboratories of good manufacturing practice requirements.

22. Veterinary medicinal products, the manufacturer shall implement a system for recording and reviewing complaints, while providing a system for recalling promptly and at any time the veterinary medicinal products in the distribution network of the chain. Every complaint about the quality of veterinary medicinal products defects shall be recorded and investigated. The manufacturer of a veterinary medicinal product within 24 hours of the finding, inform the State Agency of medicines and the national pharmaceutical inspection for any defects or complaints, which may be the basis for the withdrawal of the veterinary medicinal product from the market or distribution restrictions as well as beneficiary countries. The distribution of veterinary medicinal products shall be limited or withdrawn from the market in medicinal products in accordance with legislation on the labelling of the veterinary medicinal product, distribution, and control.
23. the manufacturer of a veterinary medicinal product shall ensure repeat self-control with a predefined regularity, to monitor implementation of good manufacturing practice and implementation and to propose the necessary improvement measures. Information about each of the self-control and any subsequent corrective action documented and preserved for at least five years. 
IV. Good manufacturing practice certificate procedure and control 24. Once issued with a special permit (license) for the manufacture of veterinary medicinal products, the State Agency of medicines shall monitor 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). The State Agency of medicines with a manufacturer of veterinary medicinal products shall agree on a trial period and not later than 10 working days before the start of the test shall notify in writing;
24.2. If necessary, unannounced inspections. In this case, the samples tested by the State Agency of medicines or the laboratory, which has the power to control the courtroom.
25. the State Agency of medicines has the right to carry out unannounced checks on active producers of substances and veterinary medicinal products registration certificate holder (holder) premises in the following cases: 25.1. State Agency of medicines has a reasonable suspicion that an active substance are complied with the principles and the guidelines of good manufacturing practice;
25.2. is received in another Member State, the European Commission or the European Medicines Agency request to make such verification;
25.3. the manufacturer of the veterinary medicinal product is asked to perform such a check.
26. This provision in paragraph 24 and 25 of the said inspections shall be carried out by the national agency of medicinal products authorised by the competent authorities, which are trained to take good manufacturing practice compliance controls and which is entitled: 26.1. inspections of the manufacturer of the veterinary medicinal product and production laboratories of the holder (owner) take control of veterinary medicinal products. The expenses of the inspection shall be borne by the person to be tested according to the State Agency of medicines to the public provided by the paid service price list;
26.2. sampling, also to perform independent analysis of veterinary medicinal products by the national agency of medicinal products in a laboratory or another laboratory, which has the power to take control of veterinary medicinal products. With the testing of medicinal products associated costs shall be borne by the person to be tested according to the State Agency of medicines to the public provided by the paid service price list;
16.3. to examine documents relating to the object, subject to the limits on the powers relating to production methods.
27. the State Agency of medicines in addition to checks of immunological veterinary medicinal products used in the manufacturing process of the producer are validated and ensure the homogeneity of the series.
28. the National Agency for medicinal products within 10 working days after each of those rules 24, 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. The State Agency of medicines inspected manufacturer or veterinary medicinal products, veterinary medicinal products, the registration certificate holder (owner) sends one copy of the message. The second specimen, if necessary, forwarded to the Government and the pharmaceutical inspection body that requested the check.
29. the State Agency of medicines on the basis of this provision in paragraph 28 of that report, in the month following the completion of the inspection shall take a decision: 29.1. for good manufacturing practice compliance certificate, if the test found compliance with the principles and guidelines of good manufacturing practice;
29.2. for good manufacturing practice compliance temporary suspension of issue of the certificate, stating the reasons and the time frame in which to take the necessary measures. The question of the time limit, taking into account that the final good manufacturing practices certificate issued shall not exceed 90 days after this rule 24, 25 and 27 of the checks referred to in paragraph completion;
29.3. the refusal to issue a good manufacturing practice certificate of compliance. The decision on the refusal to issue a good manufacturing practice certificate of compliance within five working days of written notice to the manufacturer of the veterinary medicinal product.
30. the State Agency of medicines of the decision on the refusal to issue a certificate of good manufacturing practice shall be adopted, if according to the report, found that: 30.1. production of the veterinary medicinal product does not meet these rules laid down the principles and guidelines of good manufacturing practice;
30.2. the veterinary pharmaceutical company is not qualified;
30.3. the duties carried out by the qualified person person whose qualifications or professional experience does not meet the requirements of this regulation.
31. the State Agency of medicines: 31.1. issued by the manufacturer of the veterinary medicinal product good manufacturing practice compliance certificate (annex 2). The certificate shall be issued after the manufacturer of the veterinary medicinal product is paid for the issue of certificates in accordance with the State Agency of medicines to the public provided by the paid service price list;
31.2. If adopted this rule 29.3 bottom point. that decision, inform the Commission of the pharmaceutical licensing activities. Commission regulations on special permit (license), the activity in issue veterinārfarmaceitisk, suspension and cancellation procedures shall take a decision on the special permission (license) for the manufacture of the medicinal product suspension to control report that issue;
31.3. an electronic document in the form sent to the European Medicines Agency this rule 19.3. the certificate referred to in paragraph for inclusion in the European Union database, what the task of the Member States of the European Union managed by the European Medicines Agency;
19.5. this rule 29.3. referred to information on the refusal to issue a 19.3. these provisions referred to in the certificate electronically to the European Medicines Agency for inclusion in the database of the European Union.
32. the manufacturer of the veterinary medicinal product upon request, providing the National Agency for medicinal products authorised officers information about the controls carried out in the veterinary medicinal products or their ingredients and intermediate products of the manufacturing process under the registration of veterinary medicinal products.
33. the National Agency for medicinal products authorised officials, checking the manufacturer of the veterinary medicinal product, having regard to the European Commission for the compilation of Community inspection and information exchange procedures. To interpret the raw material of the veterinary medicinal product and the principles and guidelines of good manufacturing practice, take into account the instructions of the European Commission. 
V. monitoring and control 34. These rules certain veterinary medicinal products for production monitoring and control requirements ensure the State Agency of medicines.
35. the State Agency of medicines shall examine whether the skilled person's qualifications comply with the requirements laid down in these rules, and shall be entitled to propose the manufacturer of the veterinary medicinal product on time suspended or be removed from Office by a qualified person if it does not comply with the provisions referred to in paragraph 6.8.
36. the State Agency of medicines shall, upon request, provide to the competent authorities of the other Member States information on good manufacturing practices inspection report, prepared in accordance with paragraph 28 of these terms.
37. the State Agency of medicines has the right to send the rule referred to in paragraph 28 of the good manufacturing practices inspection report of national pharmaceutical inspection for a decision on the suspension of the manufacture of veterinary medicinal products if the test found that: 37.1. the manufacturer of the veterinary medicinal product does not support the requirements of the rules;
37.2. veterinary medicinal products considered hazardous for use for the following reasons: 37.2.1. the composition of the veterinary medicinal product, quantitative and qualitative indicators have been changed and do not meet the registration of veterinary medicinal products referred to in the documentation;
37.2.2. period to which the product is released from the body, above the laws on minimum safety requirements and maximum allowable drug residues in food of animal origin defined allowable margins;
37.2.3. products of animal origin for human health has been found dangerous levels;
37.3. not ready to control the veterinary medicinal product or the manufacture of the veterinary medicinal product control intermediate (intermediate production intended for the document);
37.4. document the veterinary medicinal product is not a therapeutic effect as regards the species of animal for which the medicinal product is intended;
37.5. veterinary medicinal products used in the manufacture of veterinary medicinal products, production facilities, equipment and installations, which are not mentioned in document production or which have not been verified by the State Agency of medicines;

23.4. the qualified person does not make that provision referred to in paragraph 6.8;
37.7. the veterinary medicinal product is prohibited in accordance with the movement of veterinary medicinal products regulatory laws;
23.5. are used in the manufacture of the active substance or veterinary medicines that do not match the movement of veterinary medicinal products regulatory laws and requirements.
38. at paragraph 37 of these rules of receipt of the information referred to in national pharmaceutical inspection shall take a decision on one of the veterinary medicinal product or all types of suspension of production of medicinal products in accordance with the law on companies, institutions and organisations of the suspension of the order ".
39. by another Member State, the European Commission or the European Medicines Agency at the request of the State Agency of medicines shall authorise the officials that rule 24, 25 and 27 of the said checks at the manufacturer of the veterinary medicinal product, which is located in third countries.
40. the State Agency of medicines, pharmaceutical inspectorate and the State food and veterinary service under the competency provides operational exchange of information, to facilitate the implementation of the requirements of these regulations, as well as provide law enforcement institutions and the Ministry of information on the Health conditions of the diversion of the veterinary medicinal product in the illicit circulation. 
VI. final question 41. Be declared unenforceable in the Cabinet of 12 august 2003 Regulation No 445 "production and veterinary medicinal product control rules" (Latvian journal, 2003, 114 no; 2006, 68 no). 
Informative reference to European Union directives, the regulations include provisions resulting from: 1) of the European Commission on 23 July 1991 Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products;
2) of the European Parliament and of the Council of 6 November 2001 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products;
3) of the European Parliament and of the Council of 31 March 2004, Directive 2004/28/EC amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.
Prime Minister a. Halloween Minister of Agriculture m. Roze Editorial Note: rules shall enter into force on 18 May 2007.
   
1. the annex to Cabinet 15 May 2007 No. 319 of the rules of good manufacturing practice inspection report the European Union model form 1.
Report No.
2. inspection (inspection) in place of the object name and the full address 3.
Manufacturing operations that they perform in the production of active substances in the production of the final intermediate or bulk products import package (only) testing laboratory in the series and serial output for storage and distribution of investigational medicinal products other ____ ____ ____ ____ ____ ____ ____ ____ ____ 4.
Date of inspection date, month, year 5.
The Inspector the Inspector name Experts (evaluators) name the competent control body name 6.
Veterinary medicinal products, the references of the registration certificate number and (or) special permit (license) for the manufacture of veterinary medicinal products number of the European Medicines Agency (EMEA) reference number (s) (if inspection is an inspection by the EMEA) 7.
Introduction of company and business brief description 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 previous tests at the date the Inspector (s) who participated in the exporting country previous inspection (name) significant changes that have occurred since the previous inspection 8.
Brief report on inspection activities carried 8.1.
Inspection area test Short 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) 8.2.
Check (s) area (s) of each check zone 9.
Untested actions if needed, identify areas or activities in a given test was not tested 10.
At the time of inspection personnel come across indicates the personnel come across (name, title). List adds the message to annex 11.
The Inspector (s) observations and deficiencies the chapter titles of the European Commission's guidance on medicinal products and investigational medicinal product good manufacturing practice, which European Union regulatory framework for medicinal products volume 4 (Guide to good manufacturing practice, essential requirements for the fields to be checked).
Here you can explain classification.
The content can be reduced if the controlling persons recognised as acceptable by the competent authority, of the 12 plants.
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 13.
Distribution and transportation (shipping) 14.
Questions relating to the registration of the application, assessment, such as checking before registration 15.
Others identified specific questions such as the significant expected changes, for which the Company Announces 16.
Shop floor the shop floor description describes the assessment, if any. Plant description data 17.
Various news (samples taken) 18.
Attached to the list of annexes annex 19.
Disadvantages (critical, essential and others) indicate any deficiencies and provide the reference to the European Commission's guidance on medicinal products and investigational medicinal products good manufacturing practices and other relevant recommendations of the European Union.
Indicate any deficiencies detected even if the adjustment were carried out immediately.
If the deficiencies concern the registration application, the assessment clearly indicates.
Ask the company to inform the competent authority for the period in which to make certain adjustments to the activities and progress of 20.
Recommendations to the institution at which the inspection carried out at the request of the State or the competent control body, in which the company inspected 21.
Summary and conclusions the Inspector (s) indicates that a company operating in the areas inspected under European Union rules of good manufacturing practice, if necessary, that the appropriate corrective action taken, as well as other conditions, to alert the authority that requested the inspection. You can refer to the conclusions, which, according to national procedures, as reflected in other documents, such as the inspection report in the covering letter 22.
Check out: 22.1.
name checking (inspection) report signed and dated by inspectors and observers who attended the examination (inspection) 22.2.
signature 22.3.
authority 23.
Date 24.
Report notes.
1. the critical weaknesses – weaknesses that produced the product or there is a high risk of producing products that are harmful to human or animal health, or product that leaves the harmful residues of animal organisms, from which the foodstuffs of animal origin.
2. The serious shortcomings (not critical flaws) are: 2.1 which produced a product or may produce a product that does not comply with the product information specified in the registration certificate;
2.2. which points to significant deviations from the European Union good manufacturing practice requirements;
2.3. which points to significant deviations from the conditions of the special permission (license) manufacture of veterinary medicinal products (European Union);
2.4. to indicate that without special permission (license) manufacture of veterinary medicinal products the latter series release or (European Union) the qualified person shall not carry out their duties;
2.5. the combination of various other defects, in which each individual is essential to lack, but together they become significant. It explained and stated in the report.
3. other weaknesses – weaknesses which are not classified as critical or important, but which indicate deviations from the principles of good manufacturing practice. Also other deficiencies, if they are assessed as minor, or there is insufficient information to classify them as important or critical. 
Minister of agriculture m. Roze annex 2 Cabinet 15 May 2007 No. 319 of the rules of good manufacturing practice certificate of conformity (European Commission model form) of the Republic of Latvia the State Agency of medicines ____ ____ ____ ____ ____ ____ ____ ____ (address, registration number, telephone number, fax number, e-mail address) in the REPUBLIC OF Latvia, the State AGENCY OF medicines _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ (address, registration number, phone, fax number, e-mail) certificate No ___/___/___ certificate Of.                           
 
The manufacturer of the medicinal product good manufacturing practices GMP compliance certificate OF SERTIFIKĀTS1 compliance OF A MANUFACTURER part 1 part 1 Issued after official verification (inspection) in accordance with the provisions of Directive 2001/82/EC article 80 paragraph 5 following an inspection of the Issued in accordanc with art. 80 (5) of Directive 2001/82/EC or/or

issued in accordance with the mutual recognition agreements between the European Union and European economic area countries and the (mutual recognition agreement partners) Issued under the provision of the Mutual Recognition Agreement between the European Community and [MR Partner] medicine State Agency declares: the State Agency of medicines of the confirm the following: medicines manufacturer/the manufacturer ____ ____ ____ ____ ____ ____ ____ ____ _____ production site address/site address ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ is officially tested the national monitoring and control of compliance with the framework of the special permission (license) manufacture of veterinary medicinal products no ____ ____ ____ ____ ____ ___, in accordance with the provisions of Directive 2001/82/EC, 44. the article, carried by 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 production company to issue the certificate of good manufacturing practice for veterinary medicinal products, and the production of officers qualifications and professional experience requirements" Has been inspected under the national inspection programme in connection with the manufacturing authorisation. ____ ____ ____ ____ _____ in accordanc with art. 44 of Directive 2001/82/EC transposed in the following national legislation: regulations of the Cabinet of Minister of 15 May 2007 No. 319 "regulations on the manufacture and Control of Veterinary Medicinal product, the procedure for the Granting of the certificate of GMP compliance and requirements for Qualified Persons for the manufacture of Veterinary Medical products" or/or manufacturer that is located outside the European economic area has been officially tested and comply with the registration certificate specified in accordance with the European Parliament and of the Council of 31 March 2004, Regulation (EC) No 726/2004 laying down the procedures for the authorisation and supervision of medicinal products for human and veterinary use Community procedures and establishing a European Medicines Agency, article 8, paragraph 2 (article 19 (3)) or Directive 2001/82/EC article 80 (4), in the Cabinet of Ministers of the Republic of Latvia of 15 May 2007 No. 319 "the provisions of the rules on veterinary medicine production and control , the order in which the veterinary medicinal product, the production company to issue the certificate of good manufacturing practice for veterinary medicinal products, and the production of officers qualifications and professional experience requirements "Has been inspected in connection with marketing authorisation (s) listing manufacturers located outside of the European Economic area in accordanc with art. 8 (2)/19 (3) of Regulation (EC) 726/2004 or in the 80 (4) of Directive 2001/82/EC transposed in national legislation the following : regulations of the Cabinet of Minister of 15 May 2007 No. 319 "regulations on the manufacture and Control of Veterinary Medicinal product, the procedure for the Granting of the certificate of GMP compliance and requirements for Qualified Persons for the manufacture of Veterinary Medical products" and/or/and/or is the producer of the active substance, which has been officially inspected in accordance with Directive 2001/82/EC article 80 (1) of the 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 production company to issue the certificate of good manufacturing practice for veterinary medicinal products, and the production of officers qualifications and professional experience requirements" Is an active substance manufacturer that has been inspected in accordanc with art. 80 (1) of Directive 2001/82/EC transposed in national legislation the following : regulations of the Cabinet of Minister of 15 May 2007 No. 319 "regulations on the manufacture and Control of Veterinary Medicinal product, the procedure for the Granting of the certificate of GMP compliance and requirements for Qualified Persons for the manufacture of Veterinary Medical products" or/or other (specify) */Other (Please specify) __ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ___ manufacturer's official tests, the last of which was performed … …/… …/… … (date), found that the producer meets the prasībām1 of good manufacturing practice laid down in the European Union and the European economic area agreement of mutual recognition, and (the mutual recognition agreement partners)/labas production practices and guidelines laid down in Directive 91/412/EEC (2)/active substance principiem2 good manufacturing practices specified in Directive 2001/82/EC in article 51.
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on .../… …/… … [date], it is considered that it would with the Good Manufacturing compl practice referred to in the requirements1) agreement of Mutual Recognition between the European Community and [MR partner]/The principles and guidelines of Good Manufacturing practice, put down in Directive 91/412/EEC2/the principles of GMP for active substances2 referred to in Directive 2001/82/Article51 ECU.
 
This certificate reflects the status of the place of production of the said official checks (inspections), and this may not reflect the compliance status if, after official checks and issuing this certificate is more than three years.
 
This certificate will reflect the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflec the compliance status if more than three years have elapsed since the date of that inspection, after which time the issuing authority should be consulted.
 
The authenticity of the certificate can certify the State Agency of medicines.
The authenticity of this certificate may be verified with the issuing authority.
The notes.
1Sertifikāt the need for Directive 2001/82/EC article 80, paragraph 5. You also need a certificate for introduction into the Member States of the European Union from third countries.
The certificate referred to in paragraph 80 (5) of Directive 2001/82/EC, as amended, shall also be required for imports coming from third countries into a Member State.
2Atbils the World Health Organization (who) good manufacturing practice recommendations.
These requirements fulfil the GMP recommendations of the who.
 
 Part 2 part 2 medicinal products for veterinary use Veterinary Medicinal products 1. Manufacturing operations MANUFACTURING operations * licensed *-production activities include the full and partial production (including various cutting, packing and design processes), serial output and certification, determine the form of authorised storage and distribution manufacturing operations include total and partial manufacturing (including the various processes of dividing up, packaging or presentation), batch release and certification, storage and distribution of specified forms unless you informed "to the contrary – quality control (test) and (or) serial output and certification activities without production activities refers to the products concerned – quality control testing and/or release and batch certification activities without manufacturing operations should be specified under the relevant items-if the company involved in the manufacture of medicinal products, which must comply with specific conditions, such as radiopharmaceuticals, medications containing penicillin, sulphonamides, citotoksīn, cephalosporin, substances with a hormonal effect or other potentially dangerous active substances, it is appropriate to the nature and form of the medicinal product, if the company is engaged in the manufacture of products with special requirements e.g. radiopharmaceutical or products containing peanut, sulphonamid, cytotoxic, cephalosporin, substances with hormonal activity or others or potentially hazardous active ingredients this should be stated under the relevant product type and "form 1.1.
The pharmaceutical form sterile products Sterile 1.1.1.
aseptically obtain (pharmaceutical form) prepared aseptically 1.1.1.1.
large volume of liquid packaging large volume liquid in 1.1.1.2.
the lyophilisat of the lyophilisate 1.1.1.3.
soft dosage forms of semi-solid in 1.1.1.4.
small volume of liquid in small volume liquid packaging in 1.1.1.5.
solid dosage forms, and implants are solid and implant 1.1.1.6.
 
other products obtained aseptically others aseptically prepared products (free text) 1.1.2.
sterilized in the final product (pharmaceutical form) terminally sterilised (list of forms ") 1.1.2.1.
large volume of liquid packaging large volume liquid to 1.1.2.2.
soft dosage forms of semi-solid in 1.1.2.3.
small volume of liquid in a small volume of liquid packaging 1.1.2.4.
solid dosage forms, and implants are solid and implant 1.1.2.5.
 
other product forms of sterile (free text) other terminally sterilised prepared products (free text) 1.1.3.
only series certification batch certification only 1.2.
Non sterile pharmaceutical form (pharmaceutical form) Non-sterile products (list of forms ") for the 1.2.1.
hard capsules capsules, hard shell 1.2.2.
soft capsule capsules, soft shell 1.2.3.
chewing chewing gum of the pharmaceutical form 1.2.4.
impregnated impregnated Matrix-Matrix 1.2.5.
liquids should use liquid for external use 1.2.6.
liquid for oral use liquid for internal use 1.2.7.
medical gas medicinal gas-1.2.8.
other solid dosage forms of other solid forms "1.2.9.
aerosol preparations (under pressure) for pressurised preparation 1.2.10.
radionuclide generator radionuclid generator is in 1.2.11.
soft dosage forms of semi-solid to 1.2.12.

rectal in suppositor to 1.2.13.
tablets tablets 1.2.14.
transdermal patches are transdermal patches 1.2.15.
intrarumināl device intraruminal devices 1.2.16.
Veterinary veterinary premix 1.2.17 of premixtures.
other non-sterile dosage forms (free text) other non-sterile in medicinal products (free text) 1.2.18.
only series certification batch certification only 1.3.
Biological medicinal products Biological medicinal products 1.3.1.
of blood and plasma derived medicinal products blood products 1.3.2.
immunological preparations, immunological products 1.3.3.
cell therapy medicinal products in cell therapy products 1.3.4.
gene therapy gene therapy medicinal products 1.3.5.
biotechnology biotechnology products preparations 1.3.6.
from human or animal materials distributed to human or animal extracted products preparations of 1.3.7.
other biological medicinal products (free text) other biological medicinal products (free text) 1.3.8.
only series certification batch certification only 1.3.8.1.
of blood and plasma derived medicinal products blood products 1.3.8.2.
immunologicals 1.3.8.3 immunological products.
cell therapy medicinal products in cell therapy products 1.3.8.4.
gene therapy gene therapy medicinal products 1.3.8.5.
biotechnology biotechnology products 1.3.8.6 preparations.
from human or animal materials distributed to human or animal extracted products products 1.3.8.7.
other biological medicinal products (free text) other biological medicinal products (free text) 1.4.
Other products or production activities (other similar production activities or types of medicinal products which are not listed above, such as sterilization of the active substances, biologically active raw material production, medical gas, herbal medicine or homeopathic medicine, full or partial production) Other products or manufacturing activities (any other relevant manufacturing activities/product type that is not covered above e.g. sterilisation of active substances, manufacture of biological starting materials, active , herbal or homoeopathic medicinal gas, products, bulk or partial manufacturing etc.)
1.4.1. the manufacture of production section 1.4.1.1.
herbal medicine herbal products 1.4.1.2.
homeopathic medicinal products 1.4.1.3 homeopathics.
biologically active raw material biological starting materials, active 1.4.1.4.
other (free text) other (free text) 1.4.2.
active substance/excipient/sterilization of the final sterilisation of active substance/excipient/finished products 1.4.2.1.
filter filtration 1.4.2.2.
sterilization with hot dry air dry heat 1.4.2.3.
sterilization with steam to heat 1.4.2.4 mois.
chemical chemical 1.4.2.5.
irradiation with gamma rays the gamma irradiation 1.4.2.6.
irradiation with electron beam in electron beam 1.4.3.
other (free text) other (free text) 1.5.
Only packaging Packaging only 1.5.1.
the primary packaging (a list that contains the type of the medicinal or pharmaceutical form) primary packing (list of product types/forms ") 1.5.1.1.
hard capsules capsules, hard shell 1.5.1.2.
soft capsule capsules, soft shell 1.5.1.3.
chewing chewing gum of the pharmaceutical form 1.5.1.4.
impregnated impregnated Matrix-Matrix 1.5.1.5.
liquids should use liquid for external use 1.5.1.6.
liquid for oral use liquid for internal use 1.5.1.7.
medical gases for medicinal gas 1.5.1.8.
other solid dosage forms of other solid forms 1.5.1.9 ".
aerosol preparations (under pressure) for pressurised 1.5.1.10 preparation.
radionuclide generators generator of radionuclid 1.5.1.11.
soft dosage forms of semi-solid in 1.5.1.12.
rectal suppositor to 1.5.1.13 in.
tablets tablets 1.5.1.14.
transdermal patches are transdermal patches 1.5.1.15.
intrarumināl device 1.5.1.16 intraruminal devices.
Veterinary veterinary premix 1.5.1.17 of premixtures.
other non-sterile dosage forms (free text) other non-sterile in medicinal products (free text) 1.5.2.
secondary packaging secondary packing a 1.6.
Quality control testing Quality Control testing 1.6.1.
microbiological: sterility sterility microbiological: 1.6.2.
microbiological: not sterile dosage forms: non-sterility of microbiological purity 1.6.3.
chemical or physical chemical/Physical 1.6.4.
organic biological MEDICINAL PRODUCTS, the importation of 2 (IMPORT) the IMPORTATION OF MEDICINAL products-import (import) without production activities – importation activities without manufacturing activity – import (import), which includes storage and distribution, importation activities include storage and distribution is informed to the contrary unless 2.1.
(Imported) imported medicine quality control testing Quality control testing of imported medicinal products 2.1.1.
microbiological: sterile microbiological: sterility 2.1.2.
microbiological: not sterile dosage forms: non-sterility of microbiological purity 2.1.3.
chemical or physical chemical/Physical 2.1.4.
organic biological 2.2.
The imported medicine series (imported) certification certification of imported medicinal products Batch 2.2.1.
the pharmaceutical form sterile products sterile 2.2.1.1.
aseptically obtain a pharmaceutical form of aseptically prepared 2.2.1.2.
finished products terminally sterilized sterilized 2.2.2.
non-sterile dosage forms of non-sterile products 2.2.3.
biological veterinary medicinal product of biological products 2.2.3.1.
of blood and plasma derived medicinal products blood products 2.2.3.2.
immunologicals 2.2.3.3 immunological products.
cell therapy medicinal products in cell therapy products 2.2.3.4.
gene therapy gene therapy medicinal products 2.2.3.5.
biotechnology biotechnology products 2.2.3.6 preparations.
from human or animal materials distributed to human or animal extracted products products 2.2.3.7.
other biological veterinary medicinal product (free text) other biological medicinal products (free text) 2.2.4.
other import (import) (other similar import (import) the activities which are not mentioned above, for example, radiopharmaceutical, medical gas, herbal medicinal products or the introduction of homeopathic medicinal products (import)) others importation activities (any other relevant importation activity that is not covered above e.g. importation of radiopharmaceutical medicinal, herbal or homoeopathic gas; products etc.)
2.2.4.1. for radiopharmaceuticals/radionuclide generators/Radionuclid generator for radiopharmaceutical 2.2.4.2.
medical gases for medicinal gas 2.2.4.3 it.
herbal medicine herbal products 2.2.4.4.
homeopathic medicine 2.2.4.5 homoeopathic products.
biologically active start biological starting materials of active materials 2.2.4.6.
other (free text) other (free text) active substances. Verified (inspected) substances * manufacture of active substance. Names of substances subject to inspection * ___ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ _____ Any limitations or explanations relating to this certificate areas Any restriction or clarifying remarks related to the scope of this certificate * ____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ ... .../… …/… …
(date/date)
The State Agency of medicines authorised officials name and signature ** name and signature of the authorised person of the Competent Authority of United Kingdom * _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ (name, title, institution, telephone and fax number/name, title, national authority, phone fax number &) Z.v. Stamp notes.
1. Delete the inappropriate.
Delete that which does not apply.
2. Sign, date, and contact information is on each page of the certificate.
Signature, date and contact details should appear on each page of the certificate.
 
Minister of agriculture m. rose