The Labelling Of The Veterinary Medicinal Product, Distribution, And Control Rules

Original Language Title: Veterināro zāļu marķēšanas, izplatīšanas un kontroles noteikumi

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Read the untranslated law here: https://www.vestnesis.lv/ta/id/159272

Cabinet of Ministers Regulations No. 407, Riga, 19 June 2007 (pr. No 36 39) the labelling of the veterinary medicinal product, distribution, and control rules Issued in accordance with article 5 of the law on Pharmacy 3 and paragraph 12, the first subparagraph of article 48 and the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" article 37 paragraph 1 and 2 of the i. General questions 1. determines: 1.1. procedures for the person who has the right to produce the veterinary medicinal products and veterinary medicinal products lieltirgotav distributed veterinary medicinal products (including drugs In addition, Latvia controlled drugs and psychotropic substances list II substances (narcotic drugs) and (iii) the list of substances (hereinafter referred to as psychotropic drugs));
1.2. the order in which the veterinary medicinal product is distributed by merchant, which shall have the right to engage in the retail supply of veterinary medicinal products;
1.3. the labelling of the veterinary medicinal product and the development of the instruction;
1.4. the veterinary medicinal product, import and export procedures.
2. the rules shall not apply to: 2.1 the medicated feed animal;
2.2. the inactivated immunological products, which are manufactured from pathogens and antigens obtained from a specific agricultural animals and SAIM used the same farm animal treatment;
2.3. the pharmacy medicinal products manufactured for a particular animal or group of animals, taking into account the information provided in the veterinary prescription (the magistral formula);
2.4. in accordance with the prescriptions of a pharmacopoeia (the officinal formula) pharmacy in manufactured products;
2.5. in the case of veterinary medicinal products containing radioactive isotopes;
2.6. additives in feedingstuffs, in accordance with the European Parliament and of the Council of 22 September 2003 Regulation (EC) no 1831/2003 on additives used in animal nutrition are published on the European Commission's website the register of authorised feed additives, where these additives are added to animal feed or animal feedingstuffs;
2.7. veterinary hygiene biocidal products intended for them;
2.8. veterinary medicinal products intended for research and tests of veterinary medicinal products development;
2.9. animal care products.
3. Veterinary medicinal products distributed: 3.1 the operator who received special permission (license) manufacture of veterinary medicinal products (hereinafter referred to as the manufacturer of a veterinary medicinal product). The manufacturer of the veterinary medicinal product by the pharmaceutical law of distributed only for the same veterinary medicinal product produced, indicated to the special permission (license) manufacture of veterinary medicinal products;
3.2. merchant who received special permission (license) manufacture of veterinary medicinal products if its annex States that the trader allowed to perform with the importing of veterinary medicinal products in related activities (hereinafter importer). The importing of veterinary medicinal products imported into the European Union customs territory from a third country (a country which is not a Member State of the European Union or the European Free Trade Association countries that signed the agreement on the European economic area) (hereinafter import);
3.3. merchant who received special permission (license) to open the health lieltirgotav (performance), or special permission (license) to open the lieltirgotav of medicinal products indicated in the annex to the special operating conditions, the distribution of veterinary medicinal products (hereinafter referred to as lieltirgotav);
3.4. merchants who have received permission (license) to veterinary pharmacies (open or general type of veterinary pharmacy and veterinary care closed or merchant pharmacy) to open (action) (hereinafter referred to as veterinary pharmacies) or to open a drugstore (transaction) with special activities in annex a – conditions of distribution of veterinary medicinal products (hereinafter referred to as the pharmacy);
3.5. the veterinary care he and the person that deals with veterinary practice (a practicing veterinarian or medical veterinārfeldšer (hereinafter referred to as a practicing veterinarian))-practice.
II. The veterinary medicinal product, wholesale distribution of veterinary medicinal products wholesale 4 includes all with the purchase of a veterinary medicinal product, sale, import or export (export of veterinary medicinal products from the customs territory of the European Union to third countries), the related transactions or other dealings with them, except for the following: 4.1 the supply by a manufacturer of veterinary medicinal products manufactured by himself;
4.2. the veterinary medicinal product, retail delivery, carried out by persons who have the right to make such deliveries.
5. the manufacturer of the veterinary medicinal product and importer: 5.1. designate the officials responsible for performing distributed veterinary medicines and their detailed records of samples. Records shall contain at least the following: 5.1.1 the delivery date of the veterinary medicinal product;
5.1.2. name of the veterinary medicinal product;
5.1.3. the delivered quantity of veterinary medicinal products;
5.1.4. the veterinary medicinal product, the name and address of the consignee;
5.1.5. the veterinary medicinal product, the manufacturer assigned serial number and expiration date;
5.2. the rules referred to in point 5.1 stores information in not less than three years. Information on drug production and distribution, 10 years. The records shall, on request, be produced to the national pharmaceutical inspection officer;
5.3. no less than annually make the medicine inventory counting, comparing the received and sent quantities of veterinary medicinal products, with the actual quantities of the medicinal product in the store.
6. importing of veterinary medicinal products, the following requirements are met: 6.1. importing of veterinary medicinal products, the manufacturer of which has been issued in the third country concerned permit the manufacture of veterinary medicinal products and in the manufacture of which comply with the good manufacturing practice guidelines that are equivalent to those laid down in the European Union or higher;
6.2. it constantly and continuously have at least one qualified person who, in the qualification and professional experience corresponds to the responsible of the qualification and professional experience criteria laid down in legislation on veterinary medicine production and control procedures for the manufacture of veterinary medicinal products shall be issued a certificate of good manufacturing practice for veterinary medicinal products, and the production of officers qualifications and professional experience requirements. On the change of qualified person immediately, but not later than within five days shall inform the State Agency of medicines;
6.3. the authorisation of medicinal products by the national agency officials any time to visit all the premises of the importing of veterinary medicinal products;

6.4. import veterinary medicinal product quality controls comply with the principles and guidelines of good manufacturing practice laid down in legislation on veterinary medicine production and control procedures for the manufacture of veterinary medicinal products shall be issued a certificate of good manufacturing practice for veterinary medicinal products, and the production of officers qualifications and professional experience requirements;
6.5. contributes to this rule 6.2. qualified person referred to in the performance of the obligation, the transfer of the necessary equipment and to ensure that the qualified person shall: 6.5.1. each series of veterinary medicinal products imported from a third country, even if these products have been manufactured in a Member State of the European Union or the European economic area (hereinafter referred to as Member States), remove and coming back, take the full qualitative analysis, a quantitative analysis of all active substances as well as the tests and verification necessary to ensure the quality of veterinary medicinal products in accordance with the registration of veterinary medicinal products. These checks are carried out on the veterinary medicinal product imported series that such checks have been carried out in another Member State and which have been delivered to them from another Member State together with the signed by the qualified person of the control message. Imported from a third country of the immunological veterinary medicinal product quality control by any official of the pharmaceutical quality control laboratory;
6.5.2. output series certification. Log or other document for the purpose of making exact records and certified with a signature that matches the product series that rule 6.4 6.5.1. the conditions referred to in point. By following the steps for importing of veterinary medicinal products, log or the relevant document and keep the company not less than five years from the date of the last entry, ensuring the availability of medicines journal government agency officials.
7. The qualified person may not make this rule 6.5.1. each referred to a series of control of medicinal products in the case of veterinary medicinal products imported from countries that have concluded with Member States good manufacturing practice compliance assessment of mutual recognition agreements. In this case, each series of veterinary medicinal products imported by the producer to add a series of veterinary medicinal product certificate that conforms to the European Commission for the compilation of Community inspection and information exchange procedures defined and published pattern.
8. The veterinary medicinal product, the importer is importing the narcotic drugs and psychotropic drugs that are specified in the application to get the special permission (license) manufacture of the veterinary medicinal product, provided that the special permissions (licenses) referred to in annex a, that authorised the import of the veterinary medicinal product, and if the State Agency of medicines shall issue the special permit (license), consistent with the laws of the special permission (license) pharmaceutical and veterinārfarmaceitisk to the operation of the service, suspension, cancellation, renewal and the agenda has included medicinal products database and to import medicinal products specific to the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order "order is issued by the State Agency of medicines from the permission.
9. Lieltirgotav, its affiliates and the importer is entitled: 9.1. purchase of veterinary medicinal products, if they distribute the person according to the pharmaceutical law have the right to distribute veterinary drug wholesale;
9.2. distribute veterinary drug wholesale: 9.2.1. merchants, which according to the pharmaceutical law to distribute veterinary drug wholesale;
9.2.2. veterinary drugstores and pharmacies;
9.2.3. veterinary care for economic operators and for practicing veterinarians. Lieltirgotav, its affiliates and the importer distributes the narcotic drugs and psychotropic drugs in veterinary care for economic operators and practiced these veterinarians if they have received a food and veterinary service's permission to buy the narcotic drugs and psychotropic medicines;
9.2.4. institutions, organizations and economic operators, for which the food and veterinary service according to the rules laid down in chapter III requirements is issued a permit to purchase veterinary medicines.
10. Lieltirgotav or its affiliates the following requirements are met: 10.1. premises that meet the rule requirements laid down in chapter VI;
10.2. the personnel who are involved in the storage of the medicinal product and the transaction with veterinary medicinal products is with the skills and experience that guarantees the veterinary medicinal product or the storage and movement of material, keeping the quality of veterinary medicinal products;
10.3. have certain Executive (veterinarian or pharmacist) with work experience for veterinary medicinal products, storage and distribution or sales of the medicinal product or in procurement operations, which provides: 10.3.1. veterinary medicinal products distributed storage and distribution according to the requirements of this regulation;
10.3.2. only the distribution of veterinary medicinal products which satisfy the movement of veterinary medicinal products regulations regulatory requirements;
10.4. received and issued detailed records for veterinary medicinal products, stating the following information: 10.4.1 the veterinary medicinal product, and the date of issue of the receipt;
10.4.2. name of the veterinary medicinal product, the registration number and (or) product number;
10.4.3. veterinary medicinal products, the manufacturer of a veterinary medicinal product granted a serial number and term of validity of these products;
10.4.4. the received or issued quantities of veterinary medicinal products;
10.4.5. the veterinary medicinal product, the supplier and the recipient's name and address.
11. Veterinary medicinal products, the manufacturer, importer and lieltirgotav, as well as its affiliates provide the following additional information: 11.1. an individual's name, address and certificate number veterinary practice, if the veterinary medicinal product issued by a practicing veterinarian;
11.2. company address on get veterinary medicinal products and the use of the responsible veterinarian practicing veterinary practice certificate number and issued a request for veterinary medicinal products, in the case of veterinary medicinal products shall be issued by the operator of veterinary care;

11.3. address, name, registration number and the date of the inclusion of food and veterinary service, about the movement of veterinary medicinal products by the veterinarian responsible veterinary practice certificate number and a request for veterinary medicinal products, in the case of veterinary medicinal products shall be issued by the institutions, bodies and the economic operators who receive 9.2.4. these provisions referred to in the authorization.
12. If the veterinary medicinal product, the manufacturer, the importer or the lieltirgotav, as well as its affiliates distribute the narcotic drugs and psychotropic drugs, the company is set for the illicit manufacture of narcotic drugs and psychotropic medicines accounting officer, which provides: 12.1. the illicit manufacture of narcotic drugs and psychotropic drug demand and the purchase or sale of formal design, tracking and storing separately from other requests and the veterinary medicinal product, the purchase or sale of the supporting documents;
12.2. the illicit manufacture of narcotic drugs and psychotropic medicine records according to the illicit manufacture of narcotic drugs and psychotropic drug circulation in the regulatory laws and requirements.
13. The importer and lieltirgotav or its affiliates: 13.1.10 and 11 of these regulations. information referred to in paragraph 1 and request veterinary medicinal products shall be stored for not less than three years. Information about drug distribution and records shall be kept for 10 years. This information shall, on request, be produced to the national pharmaceutical inspection officer. National pharmaceutical inspection immediately by telephone or electronically inform the food and veterinary service of the irregularities detected in the operation of lieltirgotav, if that infringement may be compromised due to human or animal health;
13.2. no less than annually make the veterinary medicinal product, inventory counting, comparing the sent and received quantities of veterinary medicinal products, with the actual quantities of medicinal products in the warehouse;
13.3 allows national pharmaceutical inspection inspectors to visit the lieltirgotav rooms at any time.
14. The importer and lieltirgotav, as well as its affiliates prepare emergency plans to ensure the withdrawal of the veterinary medicinal product, if: 14.1. requested the State Agency of medicines, pharmaceutical inspection or State food and veterinary service;
14.2. the withdrawal shall be carried out in cooperation with the manufacturer of a veterinary medicinal product or the certificate of registration of veterinary medicinal products (hereinafter referred to as the registration certificate) owner (holder).
15. The importer and lieltirgotav each quarter (up to 15 April, 15 July, 15 October 15 January) provides a national medicines agency review of the marketing of a veterinary medicinal product (including parallel and distributed parallel imported medicinal products). The report indicates the following: 15.1. name of the veterinary medicinal product, registration number and (or) product number;
15.2. the received quantities of veterinary medicinal products;
15.3. a common quantity of veterinary medicinal products.
16. the State Agency of medicines shall, upon request, provide food and veterinary service of the rules referred to in point 15 information on Latvia wholesale distributed on veterinary medicinal products.
III. Arrangements for the food and veterinary service institutions, organizations and economic operators authorised veterinary medicinal product is to buy 17. for this provision in paragraph 9.2.4. bottom of the permit, and the head of the institution or the livestock merchants who have no veterinary care merchant (hereinafter holding), submitted to the food and veterinary service of the application. The application specifies the following information: name, shed 17.1 and herd registration number the State agencies "agricultural data centre" in the register of farm animals;
17.2. address, phone number, e-mail address, fax number;
17.3. the movement of veterinary medicinal products in the responsible veterinarian holding position, name, surname and the veterinary practice certificate number;
17.4. place of inspection and the desired date;
17.5. the justification of the need to buy veterinary drug lieltirgotav.
18. The food and veterinary service creates a list of the holdings, which are allowed to purchase veterinary drug lieltirgotav (hereinafter list) indicating the movement of veterinary medicinal products in the veterinarian responsible for the holding of the request. The farm, ensure that the following requirements are met: 18.1. storage, livestock and animals are registered and labeled according to the laws and regulations on animal, herd and the registration of holdings and identification of animals;
18.2. the holding account of the movement of veterinary medicinal products regulations regulatory requirements;
18.3. the movement of veterinary medicinal products in the veterinarian responsible for the holding and holding activities in the last 12 months is not detected the movement of veterinary medicinal products regulatory laws;
18.4. the movement of veterinary medicinal products in the farm veterinarian responsible has entered into a contract of employment with the housekeeper and ensure constant veterinary supervision on the holding.
19. food and veterinary service list shall contain the following information: 19.1 the registration number of the holding;
19.2. the date when the list of holdings. The list shall include the holding of 12 months since the date of the food and veterinary service officer who prepared the list, received food and veterinary service officer proof of compliance with this provision holding 18;
19.3. the name and address of the holding;
19.4. the movement of veterinary medicinal products in the veterinarian responsible for the holding name and veterinary practice certificate number;
19.5. the authorised veterinary medicinal product on the basis of the movement of veterinary medicinal products prepared by the official veterinarian responsible for the holding and approved the list of veterinary medicinal products. The veterinarian for the holding of the veterinary medicinal product in the list, specify the name of the veterinary medicinal product and the registration number of the Latvian register of veterinary medicinal products.
20. The food and veterinary service: 20.1. assess the housekeeper in the application specified a rationale for the need to buy veterinary drug lieltirgotav and checks;
20.2. registered holding list if it complies with the provisions of paragraph 18 of these requirements.
20.3. the list electronically pharmaceutical inspection, the State food and veterinary service offices and lieltirgotav;

20.4. If changes, adding and correcting the information contained in the list of changes within three working days of informing this rule 20.3. institutions and referred to the merchant.
IV. distribution of veterinary medicinal products in the retail 21. Trader who received special permission (license) open or general type of veterinary pharmacy (operation) or to open a pharmacy opening (transaction) with special operating conditions, the distribution of veterinary medicinal products, in which – for a veterinary medicinal product storage and distribution Executive.
22. The provisions referred to in paragraph 21, the designated officer shall ensure that: 22.1. the veterinary medicinal product is to be stored and distributed according to the requirements of this regulation;
22.2. to distribute only those veterinary medicinal products which satisfy the movement of veterinary medicinal products regulatory laws and requirements.
23. Veterinary pharmacy or pharmacy in this rule referred to in paragraph 21 of the officer for each transaction conducted with medicinal products that are authorised to issue against veterinary prescription, register and store the following information: 23.1. date of issue of the veterinary medicinal product;
23.2. name of the veterinary medicinal product and the name of the manufacturer of the veterinary medicinal product;
23.3. the manufacturer of a veterinary medicinal product for veterinary medicinal products that are assigned a serial number;
23.4. the issued quantity of veterinary medicinal products;
14.6. the veterinary medicinal product, the name and address of the beneficiary;
14.7. the veterinarian's name and address, who issued the recipe, and the recipe the first copy.
24. The veterinary pharmacy: 24.1. This provision of the information referred to in paragraph 23, shall be kept for not less than five years. This provision of information referred to in paragraph 21, the designated officer shall, on request, be produced to the food and veterinary service officer;
24.2. no less than annually make medicinal item count versus the issued quantity of veterinary medicinal products, with the actual quantities of medicinal products in the warehouse;
24.3. ensure that veterinary pharmacy premises and documentation available to the veterinary service food inspectors.
25. The Pharmacy: 25.1. This provision of the information referred to in paragraph 23, shall be kept for not less than five years. Information on request this provision referred to in paragraph 21, the designated officer shall produce the food and veterinary service officer or national pharmaceutical inspection officer;
25.2. not less than annually make medicinal item count versus the issued quantity of veterinary medicinal products, with the actual quantities of medicinal products in the warehouse;
25.3. ensure that the pharmacy premises and documentation of the veterinary medicinal product should be available for public inspection of pharmacy inspectors. On irregularities detected in the operation of pharmacies the State Pharmacy Inspectorate shall immediately inform the food and veterinary service, if the breach was in danger to animal or human health.
26. The provisions referred to in paragraph 21 of the responsible officer of the appropriate veterinary medicinal products received prescriptions for medicinal products, fill out a form that is issued for the treatment of food-producing animals (annex 1), and each month until the tenth date written or electronically submitted to the food and veterinary service information issued the previous month prescription drugs.
27. The provisions of paragraph 26 of the condition does not apply to closed type, or veterinary care merchant pharmacies.
28. A practicing veterinarian be allowed to move to another Member State for veterinary medicinal products, in quantities not exceeding one day-use quantities of veterinary medicinal products, and to use it to animals (other than immunological veterinary medicinal products which are prohibited in the Member State of destination) if: 28.1. veterinary medicinal products according to the regulations on the procedure for the registration of veterinary medicinal products have been issued a registration certificate in the Member State in which the veterinary doctor has established his professional activity and has received a certificate in veterinary practices;
28.2. the veterinarian veterinary medicinal products carried in the manufacturer's original packaging;
28.3. veterinary medicinal products intended for Administration to food-producing animals, the qualitative and quantitative composition in active substances is equivalent to the composition of the veterinary medicinal product, which allowed for use in food-producing animals in the Member State of destination;
28.4. a veterinarian familiar with the right of the Member State of destination and of veterinary practices provide to meet the withdrawal period for veterinary medicinal products specified in the labelling of the veterinary medicinal product (the information specified on the primary or secondary packaging). If the Member State of destination equivalent veterinary medicinal products set a longer withdrawal period according to the Member State of destination principle of good veterinary practices, the official veterinarian.
29. A practicing veterinarian shall not be issued in the Member State of destination of the animals treated the owner or holder of the veterinary medicinal product, other than the minimum volume required for a particular course of treatment of the animal.
30. A practicing veterinarian 28 of these rules in the case referred to in paragraph in addition to the following information shall be recorded in the Member State of destination of the animals treated: 30.1. identification number, species and age;
30.2. defined diagnosis;
30.3. the use of veterinary medicinal products and dose;
18.9. the animal care duration;
5. the prescribed withdrawal period for veterinary medicinal products, if necessary.
31. This provision of the information referred to in paragraph 30 shall be kept for not less than three years and shall, on request, be produced to the food and veterinary service officer.
32. natural person crossing the Latvian border with animals may be imported and exported animals for veterinary medicinal products (except for narcotic drugs and psychotropic drugs) treatment not exceeding two months. The need for veterinary medicinal products of the veterinarian's prescription prescription prescription copy or other proof of this fact.
V. procedures for distributing veterinary medicinal products that have anabolic, antimicrobial, anti-parasitic, anti-inflammatory, hormonal or psychotropic action 33. State Agency of medicines shall establish and maintain a register of veterinary drug manufacturers, lieltirgotav and its affiliates, which produces and distributes active substances or veterinary medicinal products containing substances with anabolic, antimicrobial, anti-parasitic, anti-inflammatory, hormonal or psychotropic activity.

34. The veterinary medicinal product, the manufacturer, the importer, lieltirgotav and lieltirgotav branches, which distributes active substances or veterinary medicinal products containing substances with anabolic, antimicrobial, anti-parasitic, anti-inflammatory, hormonal or psychotropic activity, determined by the officials responsible for the veterinary medicinal product concerned accounts and storage. Officer creates a record of all the transactions with the relevant veterinary medicinal products and substances.
35. the registry shall be kept for at least five years after the last entry and shall produce, on request, the national pharmaceutical inspection officer.
36. Productive livestock owners or holders, food-producing animal or group of animals used in veterinary medicinal products containing substances with anabolic, antimicrobial, anti-parasitic, anti-inflammatory, hormonal or psychotropic action, not less than five years after the medicines (even if treated animals during that time have already been slaughtered) Save: 36.1. purchase of the veterinary medicinal product concerned documents that specify the drug buyer's name or business name;
36.2. the registry or tracking log on the administration of the veterinary medicinal product concerned.
37. This provision 36.2. register referred to in subparagraph or accounting log shall contain at least the following information: 37.1. entering the veterinary medicinal product;
37.2. name of the veterinary medicinal product;
37.3. quantity of veterinary medicinal products;
23.2. the veterinary medicinal product, the supplier's name (first name, last name) and address;
37.5. the identification number of the animal for which the veterinary medicinal product;
23.4. practicing veterinarian's instructions about the restrictions the use of animal products, derived from animals to which the veterinary medicinal products are entered.
38. This rule 36.2. register or referred to on-demand accounting journals show a food and veterinary service officer.
Vi. Procedures for distribution of veterinary medicinal products shall be stored and handled 39. Veterinary medicinal products, the manufacturer and the importer of the veterinary medicinal product is kept in areas where it can provide separate storage of packing materials, raw materials, intermediate products or ready-made veterinary medicinal products which have been withdrawn, rejected or been returned are subject to quarantine.
40. The rules referred to in paragraph 39 rooms are easy to clean, dry and ventilated. Indoor lighting and temperature is indicated on the labelling of the veterinary medicinal product. To this end, use the automatic action of temperature and humidity measuring device.
41. The veterinary medicinal product, the manufacturer and the importer of the quarantine zone (zone the storage of veterinary medicinal products, the distribution of which is suspended until final clarification of the circumstances, if there is suspicion of movement of veterinary medicinal products regulatory breaches the laws) is separated from the other rooms or room parts. It marked "quarantine area" and ensure that it does not penetrate the outsiders.
42., atpakaļatsūtīt or reject the storage of veterinary medicinal products, veterinary medicinal products, the manufacturer and the importer, shall provide the designated room or room part.
43. Veterinary drug store pallets or on shelves made of material which is easy to clean and disinfect.
44. Lieltirgotav and its branches are: 44.1. rooms or enclosed space: 44.1.1. adoption of the veterinary medicinal product;
44.1.2. storage of the veterinary medicinal product;
44.1.3. dispensing veterinary medicinal products;
44.1.4. destruction, for the recall, atpakaļatsūtīt, or rejected, or a veterinary medicinal product for veterinary medicinal products which are subject to quarantine. Subject to quarantine containment of other medications and ensures that the quarantine zone in compliance with the rules referred to in paragraph 41;
44.2. a separate room for staff;
44.3. the sanitary knot.
45. This provision is referred to in paragraph 44 rooms are easy to clean, dry, ventilated and lit accordingly.
46. Lieltirgotav and its branch of the veterinary medicinal product storage space provided by: 46.1. the labelling of the veterinary medicinal product and in the instructions for use for the specified storage conditions according to the temperature, humidity and lighting;
46.2. easy to clean and disinfect equipment;
46.3. the storage of certain veterinary medicinal products, having regard to the Group of veterinary medicinal products and series;
46.4. to avoid damage to the packaging of the veterinary medicinal product and avoid cross contamination of the veterinary medicinal product;
46.5. the temperature and humidity control. Temperature and humidity measurements recorded at least once a day;
29.0 positioning of the veterinary medicinal product. shelves or pallets made of material which is easy to clean and disinfect.
47. If the veterinary medicinal product, the storage required for a specific temperature, lieltirgotav and lieltirgotav branches of the storage room or equipment is equipment that captures any deviation from the intended temperature.
48. General or open type of veterinary pharmacy or pharmacy are interconnected rooms or space delimited parts: 29.9. veterinary medicinal product;
48.2. the storage of veterinary medicinal products. In this part of the room or destruction not provided for quality veterinary medicinal products provides a protected part of the room or container;
48.3. the staff;
30.1. the sanitary node.
49. The closed-end type, or veterinary care merchant pharmacy: 30.5. is delimited by space or part of the premises for the storage of the veterinary medicinal product;
30.6. the destruction of poor quality products are stored separately from the use and distribution of the medicinal products;
30.6. the veterinary medicinal product, provided the records according to the requirements of the law on procedures for veterinary care, and proprietorship of the persons engaged in veterinary practice, acquired, stored, and used.
50. This rule 48 and 49 above premises or parts of premises forbidden to market and treat the animals, as well as to engage in activities that are not related to the distribution of veterinary medicinal products.
51. This rule 48 and 49 above premises or parts of premises provide: 51.1. the placing of veterinary medicinal products on the shelves or pallets;
51.2. the labelling of the veterinary medicinal product in storage conditions according to the temperature, humidity and lighting;
51.3. easy cleaning of the space conditions, easy to clean and disinfect equipment;
51.4. the storage of certain veterinary medicinal products, having regard to the Group of veterinary medicinal products and series;

51.5. to avoid damage to the packaging of the veterinary medicinal product and avoid cross pollution of veterinary medicinal products.
52. Disseminating (including transport) and storage of veterinary medicinal products, veterinary medicinal products, the manufacturer, the importer, lieltirgotav, veterinary pharmacy and pharmacy provides: 52.1. the labelling of the veterinary medicinal product in accordance with the conditions of apg outbreaks, and humidity;
52.2. the labelling of the veterinary medicinal product specified temperature: 52.2.1. room temperature (15-25? (C));
52.2.2. cool site (8-15? (C));
52.2.3. cold (2-8? (C));
52.3. equipment that keeps the temperatures provided for veterinary medicinal products during transport, if necessary;
52.4. to avoid damage to the packaging of the veterinary medicinal product and avoid cross pollution of veterinary medicinal products, as well as to climatic or other factors will not affect the quality of veterinary medicinal products;
52.5. special permission (license) for the production of a copy of the veterinary medicinal product to veterinary medicine that Latvia imported from a third country, delivered in another Member State.
53. the premises in which the veterinary medicinal product, the manufacturer, the importer or the lieltirgotav stored in the narcotic drugs and psychotropic medicines, secured against unauthorised entry and shall be equipped with an alarm.
54. The veterinary medicinal product, the manufacturer, the importer and the drug lieltirgotav drugs store in a closet or in a metal safe deposit box fixed to the wall or floor, or safe, or in an array in a separate room. Space, a safe deposit box or metal cabinet shall be equipped with an alarm. Ensures the label and instructions for use under certain storage conditions and compliance with the illicit manufacture of narcotic drugs and psychotropic substances, regulations governing the circulation requirements.
55. The veterinary medicinal product, the manufacturer, importer and lieltirgotav psychotropic drugs stored in cupboards or lockers under this provision in paragraph 54 above requirements separate from other medicinal products, while respecting the labelling of the medicinal product and in the instructions for use and compliance with the requirements to the illicit manufacture of narcotic drugs and psychotropic substances, regulations governing the circulation requirements.
56. Veterinary medicinal products as regards their identity or origin is with the šēj intention of misleading previously marked, be deemed counterfeit medicines. Counterfeiting can apply to both the original medicinal products and generic medicines. Fake veterinary medicinal product may be made with the right ingredients or with the wrong ingredients, without active ingredients or with insufficient active ingredients in quantities or with the pakaļdarināt package. Fake veterinary medicinal product, which is found in the distribution network, stored separately from other products in order to prevent any confusion. They are clearly marked with special indication "not for sale" and immediately the fact of opening day, notify the owner of the registration certificate (holder) and the national pharmaceutical inspection, if fake veterinary medicinal products found at lieltirgotav, importer merchant company or pharmacy, and the food and veterinary service, if fake veterinary medicinal products detected in the veterinary pharmacy. The food and veterinary service shall inform the national pharmaceutical inspection of veterinary pharmacy in perceived counterfeit medicinal products. Following receipt of the national pharmaceutical inspection act according to this provision the requirements laid down in chapter XIV.
57. The destruction of the veterinary medicinal product is intended to destroy the movement of hazardous waste regulations regulatory order, before doing the tracking. Records indicate the following information on the destruction of the quality not provided for veterinary medicinal products: 57.1. name;
57.2. serial number;
57.3.;
57.4. type of packaging.
VII. Procedures for veterinary medicinal products, the manufacturer, the importer or the lieltirgotav destroyed the quality of the narcotic drugs and psychotropic medicines 58. Veterinary medicinal products, the manufacturer, the importer or the poor quality of lieltirgotav narcotic drugs and psychotropic medicines until their destruction in a separate space, separated space or package, eliminating the chance to mess with quality products. Poor quality of narcotic drugs and psychotropic drugs stored in accordance with this provision, 51, 52 and 53. the requirements laid down in paragraph 1.
59. the poor quality of the narcotic drugs and psychotropic medication that is not transferred back to the supplier, shall be disposed of in accordance with regulations on hazardous waste by a manufacturer of veterinary medicinal products, the importer or owner of the lieltirgotav order of the created Commission (three persons) or contracts in the presence of hazardous waste management to a person manage hazardous waste and has received appropriate permission. On the quality of medicinal products and the transfer of the substances present and the acceptance of the transfer Act. The Commission invites the national pharmaceutical inspection and national police representative.
60. This provision, paragraph 59, the Commission prepares legislation on quality in the illicit manufacture of narcotic drugs or psychotropic drug destruction or surrender and acceptance. The Act specifies the name of the medicinal product, the serial number, quantity, the destruction of reason, the members of the Commission of the names and posts. Act shall be drawn up in duplicate and signed by all the members of the Commission. One copy to be sent within three days of the national pharmaceutical inspection. Act shall be kept for a period of five years.
61. the illicit manufacture of narcotic drugs and psychotropic drug destruction officer shall record the mandatory register and indicate on the destruction of the Act or the transfer and adoption of Act number.
VIII. Restrictions on the distribution of veterinary medicinal products 62. Prescription veterinary drug and issued the statement processing or treatment of an animal for any less quantity. To protect human and animal health, on veterinary prescription shall be issued the following prescriptions of the veterinary medicinal product: 62.1. products subject to distribution (including delivery) or use restrictions laid down in the law on restrictions on the use of veterinary medicinal products;
62.2. veterinary medicinal products for food-producing animals, except in the case referred to in the regulations on the registration of veterinary medicinal products;
38.7. veterinary medicinal products which use the veterinarian observe extreme caution, since they can be dangerous: 62.3.1. target species (species of animal for which the veterinary medicinal product is intended);
62.3.2. person veterinary drug used in the treatment of animals;
62.3.3. environment;

62.3.4. persons who consume animal food products obtained from animals treated with the medicinal product concerned;
38.8. medicines used in animal pathological process and, if necessary to determine an accurate diagnosis or drug use may cause effects which impede or interfere with subsequent diagnostic or treatment;
62.5. Hall on a veterinarian's prescription pharmacy prepared in producing animal;
38.9. veterinary medicinal products which contain active substances for use in veterinary medicinal products approved in less than five years ago.
63. Immunological veterinary medicinal products and veterinary medicinal product in accordance with the movement of veterinary medicinal products regulations regulatory requirements may only enter animal veterinarian, issued: 39.2. practicing veterinarian;
39.3. veterinary care for the merchants or these rules referred to in paragraph 20 of the holding, which shall be for the movement of veterinary medicinal products issued from the veterinarian responsible for the request.
64. national pharmaceutical inspection by the food and veterinary service proposal is entitled to prohibit the manufacture of immunological veterinary medicinal products, imports and distribution (including delivery) across the territory of Latvia or its part if: 64.1. This makes the use of the medicinal product: 64.1.1 animal diseases. their diagnosis, control and eradication, eradication and control of which is in accordance with the national infectious disease eradication programme;
64.1.2. opinion on the contamination in live animals;
64.1.3. opinion on pollution in food of animal origin or other products derived from vaccinated animals;
64.2. throughout the territory of Latvia or its part is not present in the disease to which the immunological veterinary medicinal product causes immunity;
64.3. set other movement of veterinary medicinal products regulatory vajos in normat.
65. national pharmaceutical inspectorate shall inform the European Commission of the cases where the immunological veterinary medicinal product, distribution, import or manufacture in the territory of Latvia is prohibited.
IX. Veterinary medicinal products remaining item distribution conditions after change approval documentation for the registration of veterinary medicinal products in 66. If the veterinary medicinal product, the registration certificate holder (holder) makes changes to the registration of veterinary medicinal products according to the procedure laid down in the regulations on the registration of veterinary medicinal products, 12 months from the date of the decision for approval of changes in registration of veterinary medicinal products in the documentation, the registration certificate holder (holder) is entitled to distribute stock to existing veterinary medicinal products which are not implemented on the approved changes to the registration documentation. This condition applies to the pharmaceutical wholesale trade. After the end of the period of 12 months, the remaining stock of medicines that are approved changes, you can distribute a veterinary pharmacy, pharmacies, veterinary care, and proprietorship practising veterinarians to the remaining stocks of medicines, but not longer than the specified drug expiration date.
67. the State Agency of medicines, deciding on the approval of the change in the registration dossier, is entitled to take such a decision at: 67.1. set another deadline for the remaining inventory of veterinary medicinal products for distribution, the distribution of permits issued, the remaining inventory of the veterinary medicinal product marketing (annex 2). The decision taken by the National Agency for medicines electronically inform the food and veterinary service;
67.2. prohibit the remaining inventory of the distribution of the veterinary medicinal product if the change is related to urgent with animal and human health-related limitations and safe use of the product (for example, changes in the therapeutic indications, contraindications, dosages in target species due to get new information about the safe use of medicines), and if the changes are implemented in the registration dossier. The decision taken by the national agency of medicines shall notify the veterinary medicinal product, the registration certificate holder (holder), pharmaceutical inspection and State food and veterinary service at the date of adoption of the decision.
68. If the veterinary medicinal product in accordance with the procedures laid down in the regulations on the registration of veterinary medicinal products, is not re-registered or State Agency of medicines of the renewal is refused, or the registration is suspended or withdrawn, or the registration date of expiry of the licence, the State Agency of medicines of the veterinary medicinal product registration certificate holder (holder) is entitled to impose, at the request of the medicinal product concerned item distribution deadline, giving permission to release the remaining inventory of the veterinary medicinal product marketing (annex 2).
69. at the request of the State Agency of medicines of the veterinary medicinal product by the marketing authorisation holder (holder), a manufacturer, importer, lieltirgotav and pharmacy shall notify the State Agency of medicines and the national pharmaceutical inspection on the remaining inventory of veterinary medicinal products in which no changes have been made to the approved registration documentation (also applies to parallel and distributed parallel imported medicinal products). By the food and veterinary service of veterinary pharmacy request, veterinary care, and proprietorship practising veterinarians provide notice of the remaining inventory of veterinary medicinal products in which no changes have been made to the approved registration documentation tation!. The food and veterinary service of the information collected at the request of the State Agency of medicines or the national pharmaceutical inspection. The notification shall state the following information: 69.1. name of the veterinary medicinal product, the registration number and (or) product number;
EB 69.2. veterinary medicinal strength and pharmaceutical form;
69.3. veterinary medicinal products remaining serial number and quantity.
X. claim of veterinary medicinal products, labelling and package leaflet for information labelling in 70 to veterinary medicine and primary packaging secondary packaging, as well as the information in the operating instructions stated in accordance with the State language requirements set out in law. If the veterinary medicinal product imported in Latvia (except drugs imported and stored, to the other Member States or third countries), the information on the label in the national language is not specified, before the commencement of distribution of medicinal products, the packaging of the medicinal product in Latvia shall affix a sticker with the information provided on the label translations in the language of the country.

71. the label with the label in a translation of the information provided in the national language to be affixed to the packaging of the medicinal product and the operating instructions included in the secondary packaging or attached to the primary packaging before commencement of distribution of medicinal products in Latvia. These requirements ensure the registration certificate of the veterinary medicinal product holder (holder) or veterinary medicinal products, the manufacturer and the importer, imported in parallel or permit distribution of veterinary medicinal products. The attached information may not cover the specified on the packaging of the veterinary medicinal product name, validity period and serial manufacturing number. Adding information (including instructions for use into a secondary packaging or primary packaging fastening) must not affect the quality of the medicinal product concerned.
72. the State Agency of medicines shall approve the primary packaging of the veterinary medicinal product and a secondary packaging, if it complies with the requirements of this chapter. The veterinary medicinal product, the primary and secondary packaging labelling information is no different from the information in the summary of product characteristics and other accompanying documents attached to the registration certificate and prepared according to the regulations on the registration of veterinary medicinal products. Primary or secondary packaging labelling legible lettering: 72.1. name of the veterinary medicinal product followed by the strength and the pharmaceutical form. General name used if the veterinary medicinal product is composed of one active substance and its name is the name that has been assigned;
72.2. the veterinary medicinal product, qualitative and quantitative composition in active substances in one dose or veterinary medicinal products according to the use of veterinary medicinal products, veterinary medicinal products, volume or weight. Active substance names are specified using the generic name;
72.3. veterinary medicinal products manufacturer assigned serial number;
72.4. registration certificate number;
72.5. registration certificate holder (holder) and wrap in the bass owner (holder) representative (if any) name, domicile or registered place of business;
72.6 at. target species, the use of the veterinary medicinal product, method or route of Administration (if necessary). Free site provides one indication of therapeutic dose;
72.7. intended for food-producing animals of veterinary medicinal products for the withdrawal period for all included in the registration certificate for the animal species concerned and the food (meat and offal, eggs, milk, honey). The withdrawal period shall also specify the foodstuffs of animal origin, the withdrawal period is zero;
72.8. validity of the veterinary medicinal product with a clear deadline for the characters;
45.3. Special precautions for storage of the veterinary medicinal product, if any;
72.10. Special precautions for unused veterinary medicinal product or waste disposal of the veterinary medicinal product and the reference for the relevant waste collection systems;
72.11. (if any) on precautionary measures that you can use your medication or other animal, human and animal health or safety needs the information that has become known by the Vate farmakoloģ tests or clinical trials or after administration of veterinārmedic in the practice of electronic check;
72.12. "using animals";
72.13. "prescription of veterinary medicinal products", in the case of veterinary medicinal products is registered as a prescription medicine.
73. the pharmaceutical form and the contents by weight, by volume or dose Unit indicates the secondary packaging.
74. the national language of the labelling of the veterinary medicinal product provides the information set out in this provision, 72.7 72.8 72.6 at..,.,.,., 45.3 72.10 72.11., 72.12. and in paragraph 72.13..
75. This provision 72 ampoules. the information referred to in paragraph 1 points to the secondary packaging.
76. Ampoules to primary packaging shall bear the following information: 76.1. name of the veterinary medicinal product;
76.2. active substance;
76.3. route of administration;
76.4. veterinary medicinal products, the manufacturer of a veterinary medicinal product granted a serial number;
76.5. period of validity;
47.6. "Use of animals".
77. the national language of the ampoule label provides the information referred to in these provisions and in 76.3.76.6.
78. If the veterinary medicinal product is not a secondary packaging, message that matches this rule 72, 74, 75 and 76 above. information, point to primary packaging.
79. If the primary packaging (except ampoules) is one of the veterinary medicinal product and gave it is not possible to deploy this rule 72 and 74 above information, the information shall be shown on the secondary packaging.
80. the package leaflet shall be inserted in each packaging of veterinary medicinal products. If the instructions appearing on the information is already fully laid out on veterinary medicinal products, primary or secondary packaging, instructions for use, you can not put the packaging of the veterinary medicinal product concerned.
81. the package leaflet shall be drawn up in an official language and the language of the Member State (s) where the veterinary medicinal product is intended to be placed on the market. Instructions for use preparation used for the general public to understand the term. The person who submitted the application for the certificate of registration of veterinary medicinal products, instructions can be printed in multiple languages by providing instructions for use of the same in different languages.
82. If the veterinary medicinal product may enter only practicing veterinarian medicine governmental agency with respect to the specific instructions for use of the veterinary medicinal product or the packaging label is entitled from the obligation that certain particulars shall appear and that the language of the country in which the medicinal product is placed on the market.
83. the State Agency of medicines shall examine the Latvian language of instruction translated text with the summary of the information provided, as well as the requirements laid down in these provisions. Check the instructions for the grant identification number.
84. the information specified in the instruction corresponds to the information contained in the registration certificate of the veterinary medicinal product to the accompanying documentation and the approved summary of product characteristics pursuant to the regulations on the registration of veterinary medicinal products. The leaflet contains the following information: 84.1. mah (the holder), it's representative (if any) and the name of the manufacturer of the veterinary medicinal product, the name or business name and the address or registered place of business;

52.3. name of the veterinary medicinal product and the indication of the strength and the pharmaceutical form. General name used if the veterinary medicinal product contains only one active substance and if its name is the name that has been assigned. If one of the veterinary medicinal product with different names in some Member States are registered in the mutual recognition procedure or the decentralised procedure, add in each Member State, the registered name of the veterinary medicinal product concerned list;
84.3. therapeutic indications of the veterinary medicinal product;
84.4. contraindications and possible side effects, in so far as these particulars are necessary, the use of the veterinary medicinal product;
84.5. target species, dosage for each species, the method or type of use and, if necessary, instructions for the proper use of the veterinary medicinal product;
84.6. the withdrawal period for veterinary medicinal products (specify the veterinary medicinal products intended for food-producing animals). The withdrawal period for veterinary medicinal products shall be indicated even if this is nil;
84.7. instructions for the storage of the veterinary medicinal product, if any;
84.8. messages (if any) on precautionary measures followed, using medication or other animal, human and animal health or safety needs the information that has become known by the Vate farmakoloģ tests or clinical trials or after this medicine veterinary medical practice;
84.9. instructions for veterinary medicinal products, waste and unused veterinary medicinal product disposal (if any);
84.10. "prescription of veterinary medicinal products", if the veterinary medicinal product is authorized to be issued only on veterinary prescription prescription.
85. If the holder of the registration certificate (holders) do not comply with the requirements laid down in this chapter and does not comply with the State Agency of medicines requirements for necessary modifications or amendments on the labelling of the veterinary medicinal product or in the instructions, the State Agency of medicines has the right to suspend or revoke a certificate of registration.
86. Homeopathic veterinary medicinal product labelling indicates clearly the phrase "homeopathic veterinary medicinal product" and "consult a veterinarian if the homeopathic veterinary medicinal product-induced side effects".
87. Homeopathic veterinary medicinal products registered in the simplified registration procedure, labelling and package leaflet shall clearly indicate the words "homeopathic veterinary medicinal product without approved therapeutic indications".
88. The provisions referred to in paragraph 87 of homeopathic veterinary medicinal products on the label and in the instruction specifies the following information: 88.1. raw or scientific name and the degree of dilution, which is indicated using symbols of the pharmacopoeia. If the homeopathic veterinary medicinal product is composed of more than one raw material, raw material on the label in addition to the scientific name, you can specify the name assigned;
88.2. marketing authorisation holder (holder) and the manufacturer of the veterinary medicinal product (if different) name and business address;
88.3. method of application and, if necessary, the route of administration;
88.4. the exact expiration date of the veterinary medicinal product (month and year);
88.5. pharmaceutical form;
88.6. commercial ads sample content;
88.7. storage or instructions for use (if any);
88.8. target species;
88.9. homeopathic veterinary medicine information contained in annotations and warnings about the use of homeopathic veterinary medicinal products (if any is required);
88.10. veterinary medicinal products manufacturer of homeopathic veterinary medicinal products assigned serial number;
88.11. registration certificate number.
XI. Claim of the parallel importing of veterinary medicinal products in 89. Veterinary medicinal products which have been registered in the Member State of registration in the national procedure (including mutual recognition procedure) and imported by a person in another Member State, other than the manufacturer of a veterinary medicinal product, the registration certificate holder (holder) or his authorized representative (hereinafter referred to as the parallel importer), are parallel imported medicinal products for veterinary use.
90. Distributors of veterinary medicinal products which is not of the registration certificate holder (holder) or their representatives and which the veterinary medicinal product imported from another Member State Latvia, of its intention to import a veterinary medicinal product shall notify the holder of the registration certificate (the holder), the State Agency of medicines and the medicines the trademark holder. This condition does not apply to veterinary medicinal products registered in a centralized registration procedure of the European Parliament and of the Council of 31 March 2004 on the Regulation 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 (hereinafter referred to as the European Parliament and Council regulation 726/2004).
91. the parallel importing of veterinary medicinal products is allowed if the parallel importer has received the State Agency of medicines authorisation parallely the imported distribution of veterinary medicinal products in the Republic of Latvia in accordance with the requirements of this chapter and that authorisation is in force.
92. If the parallel imported medicinal products for veterinary use veterinary medicinal products repackaged, the trademark holder is entitled to require the parallel importer to supply a sample of the product have been repacked.
93. The veterinary medicinal product, the trademark owner may not use the trademark rights to prevent repackaging when: 93.1. the proprietor of the trade mark rights in relation to the marketing system which he has created an artificial market, promote the allocation between the Member States;
93.2. repackaging does not adversely affect the original product;
93.3. new packaging is specified, which product is repacked and produced by him;
93.4. the proprietor of the prior notification is received before the product is placed on the repacked.
94. the parallel importing of veterinary medicinal products is allowed if the veterinary medicinal product, the registration certificate holder (holder) has withdrawn the relevant veterinary medicinal products registered in Latvia for a registration certificate for economic reasons and the revocation of the registration certificate is not associated with the veterinary medicinal products concerned on the animal and human health, drug safety, efficiency and quality.
95. for these rules permit referred to in paragraph 91, the parallel importer of a drug shall be submitted to the National Agency for veterinary medicinal products imported in parallel distribution permit application (hereinafter referred to as the application) in accordance with the provisions of annex 3. The information provided in the application is accurate, truthful and not misleading.

96. the State Agency of medicines within seven working days of registration of the application to verify the information provided and shall inform the applicant in writing, if you need additional information or have submitted incomplete or incorrect information. After examination of the information from the national agency of medicinal products by the competent authorities of the Member State, which has registered and assessed the parallel imported medicinal products for veterinary use, requires the following data and documents about the parallel imported medicinal products: 96.1. the registration certificate number and date of expiration;
96.2. or parallel imported medicinal products are released for free circulation;
96.3. veterinary medicinal products registration certificate holder (holder), legal firms and activities site address (if different);
59.9. veterinary medicinal products manufacturer company, legal and business sites, as well as information on whether the special permit (license) for the manufacture of veterinary medicinal products is in force;
96.5. the veterinary medicinal product, qualitative and quantitative composition;
96.6. veterinary medicinal products shelf life and recommended storage conditions;
96.7. Description of the method of production (if there is a difference between the parallel imported medicinal products and companies in Latvia registered veterinary medicinal products).
97. the State Agency of medicines shall check the received data and documents, taking account of the information received in another Member State, and compares it with the relevant veterinary medicinal products registered in Latvia. Parallel imported medicinal products for veterinary use shall meet the following requirements: 60.3. they are registered and released for free circulation in the Member State from which the parallel imported medicinal products for veterinary use is delivered;
97.2. manufacturer (pārpakotāj) it is a special permit (license) for the manufacture of veterinary medicinal products, and the production complies with the good manufacturing practice requirements;
60.5. the package leaflet and labelling shall comply with the requirements of this regulation;
60.5. they are similar in Latvia registered veterinary medicinal products;
97.5. differences from the respective permitted in Latvia registered veterinary medicinal products meet the requirements of this chapter. The differences do not affect the parallel imported medicinal products for veterinary therapeutic importance, not the risk to animal and human health and: parallel imports 97.5.1. veterinary medicinal products registered in Latvia and the relevant veterinary medicinal product have the same active substances and therapeutic effect if the product is produced using the same production methods;
97.5.2. in parallel, a manufacturer of veterinary medicinal products imported in a certain method of use of the medicinal product and gave the match the Latvian veterinary medicinal products registered in the registration dossier for the use specified in the method and dosage;
97.5.3. the difference (if any) the colouring agents are small (another color code);
97.6. parallel to the labelling of the veterinary medicinal product imported: 97.6.1. is blocked (for example, with the label) therapeutic indications which have been approved by the other Member States, but not approved in Latvia registered medicinal products (if any);
97.6.2. is listed alongside the distribution of imported veterinary medicinal product authorisation holder and manufacturer;
If the parallel imported 97.7. veterinary medicinal products are repacked (pārmarķēt): 97.7.1. veterinary medicinal products is specified in the pārpakotāj (pārmarķētāj);
97.7.2. the composition of the veterinary medicinal product is not changed;
97.7.3. the products remain intact;
97.7.4. primary packaging does not open;
97.7.5. pārpakotaj medicinal products in production series number label is specified separately from the repackaging of a serial number, or with it;
97.8. instructions for use and the label shows the parallel distribution of veterinary medicinal products imported permissions to the business name and address of the owner.
98. the State Agency of medicines shall evaluate the parallel imported veterinary medicinal products for compliance with the requirements of this chapter and prepare the assessment report. The State Agency of medicines shall inform in writing the applicant if additional information is needed to assess whether the parallel imported medicinal products for veterinary use and the Latvian register of veterinary medicine include veterinary medicinal products are produced using the same production methods and formulas.
99. The medicine State agency within 30 days after receipt of the application, shall take a decision on the authorisation of veterinary medicinal products imported in parallel distribution in Latvia or the refusal to issue the permit parallel import distribution of veterinary medicinal products in Latvia. If a decision on issuing a permit, State Agency of medicines shall issue authorisations for parallel imported distribution of veterinary medicinal products in the Republic of Latvia (annex 4).
100. The medicine State agency within 30 days after receipt of the application, shall take a decision on the refusal to issue a permit parallel import distribution of veterinary medicinal products in Latvia: 100.1. the information provided does not meet the requirements of this chapter;
100.2. animal and human health (safety, efficiency and quality) in Latvia registered the distribution of veterinary medicinal products is prohibited or suspended or veterinary drug is withdrawn from the market in Latvia or another Member State.
101. The parallel importer: 101.1. maintain records showing the information on activities related to parallel importation of veterinary medicinal products imported. The register indicates the name of the veterinary medicinal product imported, produced, serial number, and the amount of the imported series;
101.2. Latvia shall inform the relevant veterinary medicinal product on the register for veterinary medicinal products of the registration certificate holder (holder) for parallel imports of veterinary medicinal products in the distribution started in Latvia;
101.3. two weeks after national pharmaceutical inspection or food and veterinary service of receipt of the request, provide information about transactions with parallel imported medicinal products;
101.4. two weeks details of the National Medicines Agency if has changed information specified in the application;
101.5. If the repacked (pārmarķēj) open packaging, for example, to change the secondary packaging or instructions for use, for every repackaging operation save one reference sample containing veterinary drug. Provides the ability to identify the errors in the repackaging of a responsible person (the original manufacturer or parallel importer, pārpakotāj) if these errors may affect the extent of withdrawal of the product;
If, in addition to 101.6. (pārmarķēj) the veterinary medicinal product is, without opening the packaging, save only the packing material.

102. The veterinary medicinal product, the registration certificate holder (holder) informs the parallel importer of a change in the registration of veterinary medicinal products in the documentation at the submission of changes to the registration of veterinary medicinal products in drug filing documentation national agency.
103. If the State Agency of medicines according to the European Commission of 3 June 2003, Regulation (EC) no 1084/2003 concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a Member State relating to medicinal products for human use and veterinary medicinal products, has approved changes in the registration dossier in Latvia registered veterinary medicinal products, in relation to whom made parallel imports, the State Agency of medicines: 103.1. writing to the parallel distribution of imported veterinary medicinal product authorisation holder or the applicant for the approved changes to the description of the veterinary medicinal product concerned on the , instructions for use, the labelling and classification of medicinal products;
103.2. parallel to the distribution of veterinary medicinal products imported permissions to the owner or applicant shall issue an amended and approved by the national agency a copy of the summary of product characteristics of the Latvia registered veterinary medicinal products.
104. If there have been changes to the registration of veterinary medicinal products, lieltirgotav, authorized to carry out parallel imports of veterinary medicinal products: 104.1. stop parallel imports of veterinary medicinal products if the changes occurred in the parallel imported medicinal products for veterinary use of the registration certificate, the issuing country and the State Agency of medicines shall be submitted on application for the approval of changes in parallel to the imported distribution authorization of veterinary medicinal products. The application shall be accompanied by information establishing the relevant changes. Parallel distribution of veterinary medicinal products imported to resume after receiving the State Agency of medicines of the decision on the approval of changes in parallel to the imported distribution authorization of veterinary medicinal products;
104.2. This provision after 103. data referred to in paragraph 1 shall be submitted to the State Agency of medicines application for approval of changes in parallel to the distribution of veterinary medicinal products imported in the authorisation. The application shall be accompanied by information establishing the relevant changes. Parallel distribution of veterinary medicinal products imported to resume after receiving the State Agency of medicines of the decision on the approval of changes in parallel to the imported distribution authorization of veterinary medicinal products;
104.3. ensure appropriate changes parallel imported medicinal products for veterinary use and marking in the instruction manual under the State Agency of medicines requirements and deadlines.
105. A change in the parallel import of veterinary medicinal products in the distribution of the property of the permit holder, the owner shall notify in writing the State Agency of medicines. The State Agency of medicines shall take a decision to grant a new veterinary medicinal product imported in parallel distribution authorisation administrative procedure law.
106. The applicant, in accordance with the State Agency of medicines of pricing public services shall bear the expenses related to the evaluation of the application of the parallel distribution of veterinary medicinal products distributed authorization. If the State Agency for medicinal products imported in parallel distribution of the veterinary medicinal product does not issue or revoke the authorisation, to the evaluation of medicinal products-related expenses paid shall not be refunded.
107. the State Agency of medicines shall take a decision on the parallel imports of veterinary medicinal products in the distribution of any withdrawal of permission if: parallel imported 107.1. the veterinary medicinal product, the producer country, the Member State from which the product is delivered, or Latvia, the veterinary medicinal products registered in the registration certificate has been cancelled for reasons related to the risk to human and animal health (safety, quality or effectiveness);
107.2. has changed information specified in the application, but the State Agency of medicines has not been informed about it;
107.3. parallel to the manufacture of veterinary medicinal products imported do not meet good manufacturing practice requirements;
107.4. Reregistration parallel imported distribution of veterinary medicinal products in Latvia has been rejected.
108. the State Agency of medicines shall take a decision on the parallel imported distribution of veterinary medicinal products if the suspensions: 108.1. parallel to the import country of the veterinary medicinal product, the supplier concerned or the veterinary medicinal products concerned in Latvia, the certificate of registration has been suspended for reasons that are related to the risk to human or animal health (safety, quality or effectiveness);
108.2. the permit holder parallel to the imported distribution of veterinary medicinal products in Latvia has not provided data and documents about the changes in the registration certificate or legal name change or not implemented in accordance with the procedure laid down in these provisions;
108.3. parallel to the production of imported veterinary medicinal product does not meet the good manufacturing practice requirements;
108.4. permit parallel import distribution of veterinary medicinal products in Latvia is not re-registered.
109. the State Agency of medicines of the decision taken by the (justified) in writing notify the veterinary medicine parallel distribution permit holder of the administrative procedure law.
110. the State Agency of medicines shall abolish decision on parallel distribution of veterinary medicinal products imported authorization suspension based on the appropriate application of the permit holder, if the reasons for which the permit was suspended.
111. the State Agency of medicines shall, upon request, provide information to the competent authority of another Member State of the parallel imported medicinal products.
XII. Claim of the parallel distribution of veterinary medicinal products, veterinary medicinal products, in parallel to 112. distribution of the European Parliament and of the Council regulation 726/2004 that the centralised registration procedure established in the supply of veterinary medicinal products from one Member State to another Member State, if the wholesaler of veterinary medicinal products, which is not the manufacturer of the medicinal product, the registration certificate holder (holder) or his authorized representative (there know how? parallel Distributor).
113. the parallel distributor about their intention to distribute centrally registered veterinary medicine Announces: 113.1. registration certificate of the veterinary medicinal product holder (holder) and the National Agency for medicines, but if the medication delivered to another Member State, the competent authority of the Member State concerned;

113.2. veterinary medicinal products, the trademark owner, before the product is put on sale have been repacked, and veterinary medicinal products by the trademark owner's request, supply to him a sample of the product have been repacked;
113.3. European Medicines Agency in accordance with the provisions of paragraph 116 and 117.
114. The veterinary medicinal product, the trademark owner may not use the trademark rights to prevent repackaging this rule 93 of the cases referred to in paragraph.
115. the parallel distribution of medicinal products for veterinary use is allowed where a centrally registered veterinary drug registration certificate holder (holder) has not initiated the distribution of medicinal products in Latvia.
116. the parallel distributor shall submit to the European Medicines Agency, notification of a centrally registered parallel distribution of medicinal products (hereinafter referred to as the notice) of the European Medicines Agency laid down that Latvian language published by the National Agency for Medicines home page on the internet.
117. where centrally registered veterinary medicinal products annexes of the registration certificate is amended or changed the data in parallel retailer in the information provided in the notification (for example, change the data on the pārpakotāj of the veterinary medicinal product or the parallel Distributor), parallel distributors shall provide notice of a change centrally to the parallel distribution of medicinal products registered in accordance with the European Medicines Agency, a specific sample that Latvian language published medicine State Agency website. This notice must be provided in such a case, where a change in the Member State in which the centrally registered veterinary medicinal products will be distributed.
118. the parallel distributor may only be introduced with the centrally registered packaging of the veterinary medicinal product-related changes: 118.1. provision of information on the label and in the instruction manual in the language of the country in which the veterinary medicinal product on the market, besides the information on the label and in the instructions for use is the same in all the languages used;
118.2. packaging size changes, provided that the packaging size corresponds to the centralised procedure for the registration of veterinary medicinal products registered in the registration dossier contains the package size.
XIII. Claim of the immunological veterinary medicinal product quality control 119. Immunological veterinary medicinal product registration certificate holder (holder) shall be submitted for verification before you distribute the bulk of this series of samples of medicinal products by an official medicines control laboratory.
120. the immunological veterinary medicinal product marketing authorisation holder (holder) shall submit to the State Agency of medicines of samples simultaneously with the serial output of the medicinal products a copy of the certificate signed by the qualified person in accordance with the legislation on veterinary medicine production and control procedures, except in the case of immunological veterinary medicinal products manufactured in another Member State and its national competent authority has examined a series of the medicinal product concerned and proven compliance with approved specifications. If necessary, the State Agency of medicines shall organise examination of samples. The State Agency of medicines has the right to recognise other Member States the official medicines control laboratory testing results. In the case of veterinary medicinal products manufactured in Latvia, the State Agency of medicines based on serial production Protocol and study results, declares their conformity with the approved specifications.
121. the State Agency of medicines of its intention to implement that rule 120 examination referred to in paragraph shall inform the European Directorate for the quality of medicines and other Member States in which the veterinary medicinal product is authorised.
122. If the competent institution of another Member State shall inform the State Agency of medicines of its intention to make that rule 120 examination referred to medicinal products, a government agency that checking is not performed.
123. following that rule 120 of the medicinal products referred to in paragraph series certificate examination of the output on the quality of veterinary medicinal products in a laboratory responsible for the control, using the laboratory samples placed at disposal, repeats all veterinary medicinal products by the producer of the serial output checks appropriate to the registration of veterinary medicinal products.
124. The number of inspections, which repeats for control of veterinary medicinal products in a laboratory authorized to cut only on the condition that it agrees with all the Member States in which the veterinary medicinal product registered, and, if necessary, the European Directorate for the quality of medicines.
125. Imunoloģiskaj veterinary medicinal products registered in the centralised registration procedure in accordance with European Parliament and Council regulation 726/2004, the number of checks, which is repeated on the control of veterinary medicinal products in a laboratory authorized to reduce only by agreement with the European Medicines Agency.
126. the State Agency of medicines shall recognise the results of the checks carried out, if the other Member State in accordance with this provision, paragraph 122.
127. That rule 120 examination referred to medicinal products by the National Agency shall take administrative procedure law, but no later than 60 days after receipt of samples. If the inspection requires a longer time, the State Agency of medicines shall inform the European Commission on time and justifies it.
128. the State Agency of medicines of the inspection findings within 60 days shall inform the European Directorate for the quality of medicines, Member States in which the veterinary medicinal product registered, of the immunological veterinary medicinal product registration certificate holder (holder) and the immunological veterinary medicinal product manufacturer.
129. If the medicine State Agency concluded that the series of the immunological veterinary medicinal product does not match the manufacturer of the veterinary medicinal product submitted to the serial output certificate or registration of veterinary medicinal products, it shall take a decision on the distribution of the immunological veterinary medicinal product authorisation according to the requirements of this regulation and shall inform the national pharmaceutical inspection, food and veterinary service and the Member States in which the veterinary medicinal product registered.
XIV. procedure for the withdrawal of the veterinary medicinal product in 130. Veterinary medicinal products, and prohibits the supply of veterinary medicinal products provides the withdrawal from the market, if the medicinal product is covered by one or more of the following conditions: 130.1. veterinary medicinal products endanger animal or human health, the use of the medicinal product in accordance with the instructions and in accordance with the conditions of registration;
130.2. the veterinary medicinal product is not a therapeutic effectiveness;
130.3. veterinary medicinal benefits and risk balance is not favourable to the authorised conditions of use;

130.4. the veterinary medicinal product, qualitative and quantitative composition is not as described in the registration dossier;
130.5. veterinary medicinal products has not been carried out or the quality control of raw materials and the manufacturing process at an intermediate state control or other condition is not fulfilled the special permission (license) manufacture of veterinary medicinal products.
131. The serial recall is an action that is carried out to remove a series of veterinary medicinal products in the distribution network and user. The series may be a partial withdrawal, if it applies to specific dealers or users.
132. The veterinary medicinal product, the registration certificate holder (holder) shall inform the State Agency of medicines and the national pharmaceutical inspection: 132.1. any action that it takes, to stop the distribution of the veterinary medicinal product or to withdraw the product from the market, and on the basis of the activity in question, if that activity is related to the effects of the veterinary medicinal product or animal or human health;
132.2. for each identified defect in the quality of veterinary medicinal products if the veterinary medicinal product or a part of the series does not satisfy the registration conditions referred to in the documentation and this drug threat to animal and human health. The quality of veterinary medicinal products evaluated according to the defects of quality defects in medicinal products in the European Community classification inspection and information exchange procedures (annex 5) and specify the country to which the veterinary medicinal product with a defect.
133. If the veterinary medicinal product quality or has received notification that the quality does not meet registration conditions referred to in the documentation, the importer or the lieltirgotav announces the country's pharmaceutical authorities. If the State Pharmacy Inspectorate of the veterinary medicinal product has not received marketing authorisation holder (holder) or national pharmaceutical inspection notification of quality defects or drug withdrawal, or the importer shall submit such report lieltirgotav national pharmaceutical inspection. The food and veterinary service of the national pharmaceutical inspection report shall be submitted, if the information on veterinary medicinal products received from veterinary pharmacies, veterinary care or practicing veterinarian traders or these rules 56. in the case referred to in paragraph.
134. Where a decision has been taken about the suspension of distribution of veterinary medicinal products and veterinary medicinal products withdrawn from the market of the veterinary medicinal product concerned the registration certificate holder (holder), a manufacturer of veterinary medicinal products, the importer, lieltirgotav, veterinary pharmacy, drugstore, veterinarian or veterinary medical care in a merchant by telephone, by fax, electronically or through other means of communication shall notify the decision adopted persons the medicines is prevalent. If the information is provided by telephone, notice shall also be in writing. The notification shall specify the: 134.1. medicinal products for veterinary use covered by the notification of the suspension of distribution of medicinal products for veterinary use and withdrawal from the market, the name, strength, shape, serial number, registration number, the Latvian register of veterinary medicinal products;
134.2. the distribution of suspension and revocation reason of veterinary medicinal products;
134.3. the quality defects the degree (first, second, or third) and description;
134.4. revocation to the degree of urgency;
details of all customers 134.5. or only the customer information on the withdrawal of veterinary medicinal products which have received irrevocable series of veterinary medicinal products;
134.6. information about the withdrawal of the veterinary medicinal product from a retail network or entire market (if one is specified);
134.7. further action with this treatment;
134.8. the order in which the veterinary medicinal product is returned back to the supplier of the veterinary medicinal product or a registration certificate of the veterinary medicinal product holder (holder);
134.9. veterinary medicinal products collection and destruction;
134.10. procedures will be covered.
135. A Person who provides the suspension of distribution of medicinal products and the withdrawal from the market of the medicinal product, the following information shall be recorded: 135.1. the announcement of the suspension of distribution of veterinary medicinal products and veterinary medicinal products, withdrawal from the market, the date, time, and type (for example, by telephone, by fax, by electronic means);
135.2. announcement of the suspension of distribution of veterinary medicinal products and veterinary medicinal products, withdrawal from the market, to ISP name, person's name, title, telephone number, fax number and electronic mail address;
135.3. medicinal products for veterinary use covered by the notification of the suspension of distribution of veterinary medicinal products and veterinary medicinal products, withdrawal from the market, the name, strength, shape, serial number, registration number, the Latvian register of veterinary medicinal products, the quality of the degree of fault (first, second, or third) and quality defects;
135.4. distribution of veterinary medicinal products and veterinary medicinal products, suspension of the withdrawal from the market, the responsible person (name and title);
135.5. distribution of veterinary medicinal products and veterinary medicinal products of the suspension of the withdrawal from the market launch (date, time).
136. The provision in paragraph 134 of the person not later than 10 days after the revocation of the veterinary medicinal product on the market shall submit complete national pharmaceutical inspection report on the withdrawal of the veterinary medicinal product (annex 6).
137. Where the national pharmaceutical inspection has found the quality defects of the veterinary medicinal product, the national pharmaceutical inspection and this provision a person referred to in paragraph 134 of the distribution of veterinary medicinal products, suspension and revocation of inform by telephone and in writing (by fax or electronically): 137.1. four hours after the fact, when the capture of the veterinary medicinal product have found first degree quality defect (annex 5) or fake medicines have been detected;
137.2. within 24 hours after the fact, when the capture of the veterinary medicinal product has found the second stage quality defect (annex 5);
137.3. the 48 hours after the fact, when the capture of the veterinary medicinal product is found in the third level of quality defect (annex 5).
138. If the quality defect found in exported medicinal products, veterinary medicinal products, the registration certificate holder (holder) and wholesaler of veterinary medicinal products within four hours after the fact and electronically capture shall be notified in writing of the defect of the product of the veterinary medicinal product to the recipient in the third country and the country's pharmaceutical authorities.
139. The veterinary medicinal product, the registration certificate holder (holder), a manufacturer of veterinary medicinal products, the importer shall submit to the State lieltirgotav or pharmaceutical inspection notification:

139.1. for continuous operation the phone number (or other means of communication), through which you can communicate any time of the day, and the persons responsible for the withdrawal of the veterinary medicinal product, according to the provisions of annex 7 of the specimen;
139.2. about changes to this provision the information referred to in subparagraph 139.1. – three days after committing it.
140. The food and veterinary service shall provide public notice of the pharmaceutical inspection of continuous phone number (or other means of communication), through which you can communicate any time of the day, and the food and veterinary service officials responsible for the withdrawal of the veterinary medicinal product from a retail distribution network. About changes in the information that the food and veterinary service national pharmaceutical inspection shall inform, within three days of being made.
141. Veterinary care, veterinary pharmacy merchant, pharmacy and practicing veterinarian shall provide the food and veterinary service information about continuous phone number (or other means of communication), through which you can communicate with the person responsible for the withdrawal of the veterinary medicinal product, and inform about the changes in the food and veterinary service three days after the change takes place.
XV. Obligations of the competent authority and the procedure for rapid reaction in This chapter 142. rapid reaction procedure does not apply to emergency response procedures related to the use of veterinary medicinal products on pharmacovigilance.
143. the national pharmaceutical inspection after 132. these provisions or the notification referred to in paragraph 133, or rapid notification (hereinafter referred to as the notice) the receipt shall submit it to the State Agency of medicines. The State Agency of medicines shall have jurisdiction to consider whether the statement specified quality defect is associated with many veterinary medicines side effects. State Pharmacy Inspectorate assesses the notification received and, if the defect in the quality of veterinary medicinal products may pose a risk to human and animal health, invited by the national agency of medicinal products and the food and veterinary service representatives to assess the information provided in the notification received on the quality of veterinary medicinal products, the risks of failure of animal and human health, and the nature of the risk, and current events. The assessment report shall indicate the following information: 143.1. risks to animal or human health, if possible quality defect exist. Evaluate the risk, if the veterinary medicinal product with a quality defect in long-term use (or medicine is cumulative action) or have an immediate effect. In this case, evaluate the risk of 143.1.1.: human health that the medicinal product in question is used for the treatment of animals;
143.1.2. risk to the health of people who use food products derived from animals treated with the medicinal product, as well as the risks of the veterinary medicinal product with a quality defect levels in food of animal origin;
143.2. probability chance that fault really exists and appears in the veterinary medicinal product by the manufacturer;
143.3. possibility that the use of immunological veterinary medicinal products may interfere with the implementation of a national programme of infectious animal disease diagnosis, control and eradication, if the vaccines fault is suspected (cross-contamination with the virus);
143.4. or possible threats to animal and human health is to conduct such emergency measures (informed about emergency rules 139 persons referred to at any time of day), or the withdrawal of a veterinary medicinal product the person responsible can be informed of the event during work;
143.5. veterinary medicinal products, the manufacturer information about: 143.5.1. other quality defects in these products related messages;
143.5.2. series distribution (for example, common known for practicing veterinarians, widespread wholesale);
143.5.3. date when launched with veterinary medicinal products quality defects or distribution of this product series, and the date of the last distribution;
143.5.4. the remaining amount of the item of the veterinary medicinal product to the manufacturer of the veterinary medicinal product;
143.5.5. the possibility that other this product series can have the same defect, and this series of distribution of medicinal products;
143.6. background, if these medications are not available, alternative medicine availability and impact on animal health supplies rupture;
or further to 143.7. activities and evaluation of the other, or to the same series of medicinal or other veterinary medicinal products, and continue the research question;
the prohibition to exercise the remaining 143.8. veterinary medicinal products inventory or complete;
143.9. inspection of good manufacturing practice for veterinary medicinal products, the need of the production company, the economic operator to prevent similar situations from happening again;
143.10. notice all or distributed or certain electronic check at the veterinārmedic care professionals concerned or a notice of revocation and distributable media, and whether the information to be disclosed by the competent authorities of the home page, press or similar way.
144. the quick response means to ensure urgent notification is sent to the other country's competent authority that recall the series of veterinary medicinal products has been determined.
145. the procedure (hereinafter referred to as the emergency response) is the transmission of information on the withdrawal of the veterinary medicinal product in the rapid alert system, if the medicinal product is a quality defect or found in counterfeit medicinal products for veterinary use and requires urgent action in order to protect animal and human health. Exchange of information takes place between the Government and the pharmaceutical inspection: 145.1. The Member States of the European Union and European economic area countries competent authorities;
145.2. the competent authority of the candidate country of the European Union, which has signed a cooperation agreement with the Agency for medicinal products;
145.3. The pharmaceutical inspection cooperation scheme of the Secretariat;
145.4. European Directorate for the quality of medicines;
145.5. the competent authority of a country with which the European Union has a network of good manufacturing practice for medicinal products conformity assessment agreements of mutual recognition.
146. quick response to national pharmaceutical inspection shall ensure at any time of day.

147. in order to ensure the effectiveness of the emergency response, national pharmaceutical inspection response system sends only the emergency information if the risk to animal and human health do not allow of any delay. The procedure can also be used to transmit warning information about the use of the veterinary medicinal product or the withdrawal of the veterinary medicinal product in relation to their safety, or for the actions to be taken in connection with the withdrawal of the veterinary medicinal product.
148. the national pharmaceutical inspection: 148.1. ensure that: 148.1.1. about the first defect (annex 5) is sent in a response statement to all Member States and the institutions referred to in this provision, 145.4 145.2.145.3.,., and 145.5. regardless of whether revocation of the veterinary medicinal product has exported to the country concerned;
148.1.2. on the secondary fault (annex 5) is sent in a response message only to those Member States and the institutions referred to in this provision, 145.4 145.2.145.3.,., and in and 145.5 known or has a reasonable suspicion that an irrevocable series of veterinary medicinal products in these countries is common. If the parallel imports of the medicinal product concerned have tracked the rapid notification is sent to the competent authorities of all the Member States;
148.2. notice of defects, third-degree (annex 5) not send;
148.3. send response notification of withdrawal of the veterinary medicinal product or the prohibition of the distribution of veterinary medicinal products, the production or importation of withdrawal of the licence and these regulations in all Member States referred to in subparagraph 145.5. authorities, if the further distribution of the medicinal products endanger animal or human health.
149. the national pharmaceutical inspection rapid notification of quality defects/withdrawal of veterinary medicinal products (hereinafter referred to as rapid communication) (annex 8) completed in English and distributed together with its attached list of veterinary medicinal products shall send by fax to the recipient or, if possible, by electronic means. Response message sent: 149.1. four hours after the fact about the capture of the first degree defects (also applies to data transmission in the rapid alert system). If necessary, in addition to also inform on the phone who stated on the vehicle outside working hours;
149.2. within 12 hours after the fact about the capture of the second defect. Quick response system in national pharmaceutical inspection notice shall be sent not later than 24 hours after notification in Latvia;
149.3.48 hours after the fact about the capture of the third degree of fault. Notice of third degree of national pharmaceutical inspection defect does not provide rapid response system.
150. national pharmaceutical inspection: 150.1. develop such internal regulations: 150.1.1. procedures for receiving response message;
150.1.2. procedures evaluated rapid communication;
150.1.3. the order in which inform about the rapid communication with fast response, sent to the persons that are included in the European Medicines Agency response list;
150.1.4. procedure for the submission of information on quality defects that are not urgent, and on further action to be taken (annex 9);
orders for official 150.2., which is responsible for the rapid dispatch of the notice. Information about the officials gave the European Medicines Agency, stating the officer's name, surname and contact types during and outside working hours, as well as inform you about changes to these data;
150.3. provide the necessary information and support for veterinary medicinal products, the registration certificate holder (holder) for veterinary medicinal products, in the process of withdrawal and supervise the withdrawal process of veterinary medicinal effectiveness;
150.4. information on the withdrawal of a veterinary medicinal product shall immediately notify this Rule 145. persons referred to in paragraph 1, if the quality defect poses a serious risk to public and animal health;
150.5. study of the veterinary medicinal product with a quality defect distribution conditions and monitored, to veterinary medicinal products, the manufacturer, the importer and the registration certificate of the veterinary medicinal product holder (holder) perform the necessary operations with the quality of veterinary medicinal products, the proliferation of the defect;
150.6. information on quality defects of the veterinary medicinal product that is not urgent, these rules provide appropriate annex 9.
151. national pharmaceutical inspection on a case-by-case basis and in cooperation with the State Agency of medicines and food and veterinary services evaluated the gravity of the fault, the damage caused by animal and human health and the environment and to distribute a series of veterinary medicinal product with a quality defect.
152. If the veterinary medicinal product with quality defects (also applies to parallel imported medicinal products and parallel to izplatāmaj veterinary medicinal products) originally found in Latvia, the national pharmaceutical inspection in cooperation with the State Agency of medicines and food and veterinary service: 152.1. research quality defect and issue order for emergency notification (in the case of veterinary medicinal products is registered in the national registration procedure);
wire quality 152.2 fault research and issued the order for the rapid notification (in the case of veterinary medicinal products is registered in the registration procedure or centralised in the case of veterinary medicinal products are registered and centralised, and national registration procedures). The notice shall provide a veterinary medicinal product, the institutions involved in the withdrawal proposals for recommended actions.
153. national pharmaceutical inspection may agree with the European Medicines Agency and the European Medicines Agency Committee for veterinary medicinal products, which is the Committee for medicinal products for veterinary medicinal products, the rapporteur on the action that the withdrawal of the veterinary medicinal product.
154. using quick response, describes the different types of packaging in which products can be packed, if such information is received from the European Medicines Agency.
155. in the case of Parallel distribution, in the case of veterinary medicinal products are repacked, but the fault is not associated with repacking, but the result of veterinary medicinal products in the production process, the notification shall include a description of the different types of packaging in which the product can be distributed from the European Medicines Agency, the information on the types of packaging.

156. using quick response, information about the possible proliferation of fake veterinary medicinal products, the distribution of veterinary medicinal products which are manufactured, fraudulent packed, distributed, or advertise, or distribution of veterinary medicinal products containing fake materials, send this provision in paragraph 145 above countries and institutions.
157. the national pharmaceutical inspection shall establish and maintain a system to ensure receiving notification when there is a suspicion of a product with a defect, as well as under the European Commission's overview of Community inspection and information exchange procedures creates, maintains and restores the revocation list for veterinary medicinal products.
158. the national pharmaceutical inspection decision on suspension of the distribution of veterinary medicinal products and the withdrawal of the veterinary medicinal product on the day of its adoption, notify the food and veterinary service, the Sanitary border inspection, the State Agency of medicines and the Health Ministry. National pharmaceutical inspection ensure and supervise the execution of the decision, as well as the further actions to be taken.
159. If the veterinary medicinal product withdrawn from the market of the veterinary medicinal product withdrawn registration certificate holder (holder) or the manufacturer of the veterinary medicinal product or the importer, he covered the losses incurred by people who buy and use these products, as well as the costs associated with this collection, delivery of medicines for disposal and destruction.
160. Where the quality of veterinary medicinal products and shall withdraw from circulation a person that is not a registration certificate of the veterinary medicinal product holder (holder), veterinary medicinal products, the manufacturer or importer, the loss incurred by the people who buy and use these products, as well as the costs associated with this collection, delivery of medicines for disposal and destruction shall be borne by the person whose fault the halls have become noisy.
161. the distribution for veterinary medicinal products shall be destroyed by the laws on the disposal of hazardous waste.
XVI. claim of unreported distribution of veterinary medicinal products Not registered 162. veterinary medicinal products distributed by the merchant to whom the State Agency of medicines has not registered the distribution of veterinary medicinal products.
163. no veterinary medicinal products registered in the validity of the discharge is entitled to check the food and veterinary service. Doubt and suspicion, the State Agency of medicines has the right to request the food and Veterinary Office to register a discharge of veterinary medicines correctness check.
164. A practicing veterinarian and veterinary care for the economic operator before the prescription of veterinary medicinal products registered to obtain information on the characteristics of these medicinal products, to be able to assess their therapeutic benefits and safety.
165. If a State Agency of medicines based on animal and public health, has received permission to distribute the application in a different Member State registered veterinary drug, the State Agency of medicines: 165.1. notify the veterinary medicinal product, the registration certificate holder (holder) in the Member State concerned on a proposal to give the medicinal product authorised for distribution in Latvia;
165.2. Requests the competent authority of the Member State concerned to submit an evaluation report on veterinary medicinal products and medicinal products a copy of the existing copy of the registration certificate.
166.165. These provisions in the case referred to in paragraph get unregistered distribution of veterinary medicinal products (annex 10), (11.) the State Agency of medicines has the right to make the issued the registration certificate holder (holder), the applicant of the registration (in the case of veterinary medicinal products is the registration process) or the veterinary authority.
167. the packaging of the veterinary medicinal product with a label and instructions for use in the national language according to the requirements of this Regulation shall be submitted to the State Agency of medicines shall not register the distribution of veterinary medicinal products by the licensee (holder) or registration of the applicant (if the product is in the registration process).
168. If you do not register the distribution authorization of the veterinary medicinal product has been issued on the basis of this provision, paragraph 165, unreported distribution of veterinary medicinal products by the licensee (holder): 168.1. provide veterinary of pharmacovigilance;
168.2. comply with laws and regulations concerning advertising of veterinary medicinal products.
169. the State Agency of medicines ensures national agency website on the internet information on veterinary medicinal products not registered, which issued a registered veterinary medicine distribution permit this provision 165. in the case referred to in paragraph 1, indicating the name of the medicinal product concerned, the strength and form of the veterinary medicinal product manufacturer and marketing authorisation holder (holder's) name or business name and address, as well as the nationality of the veterinary medicinal product or prescription non-prescription medicines.
170. the State Agency of medicines shall notify the European Commission of the non-registered veterinary medicinal products issued registered distribution of veterinary medicinal products authorized in Latvia in accordance with the provisions of paragraph 165, and of those not registered veterinary medicinal products whose distribution is no longer permitted in Latvia, specifying a distribution permit holder (holder's) name or business name and address.
171. the veterinary medicinal product is not registered to deliver and distribute can a person who is entitled to distribute veterinary medicinal product if the person received the distribution of veterinary medicinal products registered licence issued on the basis of this provision, paragraph 165. If you are not a registered veterinary medicinal products distributed by parallel importers, he followed the parallel importing of veterinary medicinal products for the requirements set forth in these rules.
172. Non-registered veterinary medicinal products authorized to distribute in other cases, if the person has the right to distribute medicinal products for veterinary use is received registered the distribution of veterinary medicinal products (annex 12). To get that permission, the State Agency of medicines shall submit the application (annex 13), to which is attached the veterinary care merchant request or a practicing veterinarian's prescription.
173. The Person who received this rule referred to in paragraph 172 of the veterinary medicinal product not registered distribution authorization in not registered veterinary medicinal products may be distributed only in veterinary care business operators or for practicing veterinarians.

174. By submitting the application does not register the distribution of veterinary medicinal products has been accompanied by a receipt for the assessment of the veterinary medicinal product in the payment of expenditure, in accordance with the State Agency of medicines of the public paid services price list.
175. the State Agency of medicines of the decision on the distribution of veterinary medicinal products registered in the authorisation process shall be adopted in accordance with the procedure prescribed by law.
176. the State Agency of medicines shall decide not to register the distribution of veterinary medicinal products if the cancellation of the permit: permit the 176.1. veterinary medicinal products registered in Latvia;
176.2. it is in possession of information about the potential risks to animal and human health in connection with the veterinary drug safety, quality and effectiveness;
176.3. the applicant has supplied inaccurate information concerning the veterinary medicinal products not registered.
XVII. distribution of the veterinary medicinal product control 177. national pharmaceutical Inspectorate monitors and controls the parallel imported and distributed in parallel the distribution of veterinary medicinal products.
178. the distribution of veterinary medicinal products in compliance with the movement of veterinary medicinal products regulatory laws under the competence of the State to monitor and control pharmaceutical inspectorate and the food and veterinary service.
179. A wide range of diseases or epizootic disease threat of national agency of medicinal products by the food and veterinary service proposal is entitled to temporarily allow the spread and use of unregistered immunological veterinary medicinal product if the Latvian register of veterinary medicinal products have not been registered for appropriate immunological veterinary medicinal products. The State Agency of medicines has the right to authorize import and use these drugs if you have received permission from the European Commission to use such products. To get European Commission permission for use of such products, by the food and veterinary service shall inform the European Commission of the detailed necessary logical imunol veterinary medicinal products for conditions of use.
180. If the animal is exported to a third country, the national agency of medicinal products by the food and veterinary service advice to this particular animal is entitled to allow the use of immunological veterinary medicinal products which have not been registered in Latvian register of veterinary medicines, but are permitted under the laws of the third country in question, if this medicine risk-benefit assessment of the conditions of use is allowed.
181. the State inspection of Pharmacy and the food and veterinary service under the competency of the medicines and the movement of veterinary medicinal products regulations governing cases prohibits the distribution of veterinary medicinal products: 181.1. veterinary medicinal products, the risk-benefit assessment of documentation registration certificate specified conditions of use, especially with regard to the benefits for animal health and welfare and benefits, safety and health of consumers in the case of a veterinary medicinal product intended for Administration to animals, the body's physiological function;
181.2. veterinary medicinal products not intended therapeutic effect on the target species;
181.3. the veterinary medicinal product, qualitative and quantitative composition of veterinary medicinal products does not match the certificate of registration indicated in the documentation;
181.4. registration certificate of the veterinary medicinal product documentation for the specified withdrawal period for veterinary medicinal products of the animal's body is not long enough to get from animals treated foodstuffs do not contain residues of veterinary medicinal products, which can be a health hazard to the consumer;
181.5. manufacture of the veterinary medicinal product does not meet the import or movement of veterinary medicinal products regulations regulatory requirements or quality control of veterinary medicinal products, the manufacturer or the trader's company in the manufacture of veterinary medicinal products do not correspond to the documents that the manufacturer of the veterinary medicinal product or the importer in the State Agency of medicines of the veterinary medicinal product in production licence;
181.6. labelling of the veterinary medicinal product or the package leaflet do not comply with the requirements of this regulation;
181.7. information submitted for the registration certificate is false;
181.8. veterinary medicinal products are not added to the contrast agent (if it needs must, in accordance with the requirements of the registration certificate).
182. national pharmaceutical inspection and food and veterinary service according to competency is entitled to determine the prohibition of supply or remove from trading only contested series of veterinary medicinal products.
183. the State Agency of medicines of the veterinary medicinal product under the control of the importer's compliance with these rules 6, 7 and 8 the requirements referred to in paragraph 1, taking into account the law on veterinary medicinal products, the production and inspection procedures.
184. The veterinary medicinal product, the manufacturer and the importer of a medicinal product during control state agency officials provide the following information and documents: 184.1. the veterinary medicinal product serial output control (made in a Member State), in accordance with the documentation for the registration of veterinary medicinal products;
184.2. imunoloģiskaj for veterinary medicinal products of all the qualified person approved series release certificate (control message).
185. the national pharmaceutical inspection, on the basis of the State Agency of medicines of the control message is entitled to stop a particular veterinary medicinal product or importing of veterinary medicinal products referred to in the application for a special permit (license) for the manufacture of veterinary medicinal products if the granting State Agency of medicines of the veterinary medicinal product control during the importer determined that: 185.1. veterinary medicinal products quality control and serial output does not satisfy this provision, paragraph 7 and 8 of the said requirements;
185.2. the qualified person does not perform this rules 6 and 7 of the obligations laid down in paragraph 1;
185.3. importing of veterinary medicinal products control does not show during that rule 184 the data referred to in paragraph and documents.
186. the State Agency of medicines of the implementation of European Parliament and Council regulation 726/2004 referred to in article 43 the competent supervisory authority in respect of veterinary medicinal products which are registered in a centralized registration procedure and imported.

187. a National Medicines Agency may require information from veterinary medicinal products, the competent authorities of the home Member State, if the chain found high-quality veterinary medicine. If the State Agency of medicines based on risk to human or animal health, disputes the competent authority of another Member State, it shall inform the competent authority of their objections or requests additional information. The State Agency of medicines shall also inform the European Commission and the European Medicines Agency, if there are significant differences of opinion between the State Agency of medicines and the other competent authority of the Member State.
188. the State Agency of medicines shall immediately inform the European Medicines Agency for such decisions (including their grounds): 188.1. special permit (license) issued this rule 3.1. and 3.2. bottom economic operators referred to in points;
refusal to issue special 188.2. permission (license) that rule 3.1. and 3.2. bottom economic operators referred to in points;
3.1. these provisions 188.3. and 3.2. bottom special permit referred to in paragraph (license) cancellation.
189. the distribution of veterinary medicinal products, suspension or withdrawal, arguing such action, the registration certificate of the veterinary medicinal product holder (holder) reported to the drug agency, the State food and veterinary service and the Member States, which distributes those veterinary medicinal products.
190. the State Agency of medicines shall inform the European Medicines Agency if: this provision 187 190.1. the operations referred to in paragraph related to the lack of efficacy of the veterinary medicinal product or the protection of public health, or in Latvia and other Member States produce and distribute of the immunological veterinary medicinal product quality and safety;
190.2. the 188 and 189 these provisions. the actions referred to in paragraph has informed international organisations operating in the veterinārfarmaceitisk area.
XVII. The illicit manufacture of narcotic drugs or psychotropic medicine shortage, the theft and loss of natural disasters due to 191. If found in the illicit manufacture of narcotic drugs or psychotropic drug shortage or surplus, theft or robbery took place or the damage occurred due to natural disasters, space and safety sealed and secured against unauthorised access. Veterinary medicinal products, the manufacturer, the importer or lieltirgotav (hereinafter referred to as the head of the company) or for the illicit manufacture of narcotic drugs and psychotropic substances and medicines accounting officer about what happened without delay to the national police and the country's pharmaceutical authorities.
192. following this rule 191, paragraph fact finding medicine manufacturer, importer company manager immediately with orders to establish a Commission, which invited inspection of national pharmaceutical representative. The Commission is made up of: 192.1. company Manager or his authorized officer;
192.2. the illicit manufacture of narcotic drugs and psychotropic substances and medicines accounting officer;
national pharmaceutical inspection 192.3. representative.
193.192. These provisions referred to in paragraph 1, the Commission shall draw up a law on the illicit manufacture of narcotic drugs or psychotropic drug shortage or surplus. The Act specifies the Act of dialing location, and the date, the name of the medicinal product, pharmaceutical form, strength of the medicinal product, the serial number of the production quantity, a drug company, the members of the Commission of the name and job title. Legislation signed by all the members of the Commission. Act shall be kept for a period of five years.
194. the illicit manufacture of narcotic drugs and psychotropic substances and drug records officer to the illicit manufacture of narcotic drugs or psychotropic drug shortage or surplus, theft or robbery, as well as damages due to natural disasters recorded a mandatory register and indicates that rule 193. the Act referred to in paragraph number.
XIX. concluding issues. Void 195 out of the Cabinet of Ministers of 25 March 2004, the provisions of no. 168 "labelling of the veterinary medicinal product, distribution, and control rules" (Latvian journal, 2004, 49, no. 144; 2006, 68 no).
196. This provision is referred to in paragraph 3, the special permission (license) manufacture of the veterinary medicinal product to distribute by wholesale the issuing of own produced products are eligible for economic operators, which to this date of entry into force of the provisions have been issued a special permit (license): 196.1. veterinary pharmaceutical company to open the (operation);
196.2. manufacture of veterinary medicinal products (repackaging and rewrapping) lieltirgotav.
197. Lieltirgotav, which on the date of entry into force of the provisions have been issued a special permit (license) lieltirgotav opening of the veterinary medicinal product is authorised to distribute wholesale imported veterinary medicinal products, to receive a special permit (license) for the manufacture of veterinary medicinal products by the operations specified in annex a, that authorised the import of veterinary medicinal products, but not longer than until 31 October 2007.
198. special permission (license) for the production of veterinary medicines and animal health to open lieltirgotav (performance), issued by the food and veterinary service, they are valid until the expiry date. These special permissions (licenses) Re-register under laws of special license pharmaceutical and veterinārfarmaceitisk the operation of the procedures for the issue and renewal requirements.
199. This rule 62.2. exception referred to in relation to prescription use in food-producing animals come into force by 1 October 2007. 
Informative reference to European Union directives, the regulations include provisions resulting from: 1) 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;
2) of the European Parliament and of the Council of 31 March 2004, Directive 2004/28/EC that the right Directive 2001/82/EC on the Community code relating to veterinary medicinal products.
Prime Minister a. Halloween Minister of Agriculture m. Roze Editorial Note: the entry into force of the provisions to the 23 June 2007.
 
1. the annex to Cabinet of 19 June 2007, regulations no 407 veterinary pharmacy medicines issued to treat food-producing animals farming Minister m. rose annex 2 Cabinet of 19 June 2007 regulations no 407 of Agriculture Minister m. rose annex 3 Cabinet of 19 June 2007, regulations no 407 application authorization parallel imported distribution of veterinary medicinal products in the Republic of Latvia Minister of Agriculture m. Roze annex 4 Cabinet-19 June 2007. Regulations No 407 of the Republic of Latvia National Agency for medicinal products authorised in parallel with the imported distribution of veterinary medicinal products In the Republic of Latvia Minister of Agriculture m. Roze annex 5 Cabinet of 19 June 2007 regulations no 407 of the veterinary medicinal product quality defects

1. First degree defects represent a potential threat to animal or human health or may cause serious risk to animal or human health. Notify these defects in any case using a rapid procedure. First quality defects, such as the following: 1.1 the wrong medications (described on the labelling of veterinary medicinal products and the content of the primary packaging is different products);
1.2. the right medicine, but no for this strength, which may cause serious risk to animal or human health;
1.3. sterile injectable solution or Ophthalmology veterinary medicinal products used in microbial contamination;
1.4. chemical pollution, causing a serious risk to animal or human health;
1.5. some products are contaminated more than one packing;
1.6. active substance wrong multi-component product, causing a serious risk to animal or human health.
2. The secondary defects can cause disease in animals or incorrect treatment but are not classified as first degree defects such as: 2.1. incorrect labelling of the veterinary medicinal product, such as incorrect or incomplete text or numbers;
2.2. incorrect or incomplete information in the instructions for use;
2.3. solution (which is not used in the injection) and sterile medicines (which is not used in ophthalmology) microbiological contamination that may pose a risk to animal or human health;
2.4. the veterinary medicinal product, chemical or physical pollution (pollution, significant cross-contamination of medicines, particles);
2.5. some products are contaminated in one packing;
2.6. non-compliance with the specifications (e.g., persistence, fill, weight);
2.7. unreliable sealing system, causing a serious risk to animal and human health (e.g., cytotoxic drugs).
3. Third degree defects may not pose a serious risk to human or animal health, but drug withdrawal can happen for another reason, such as: 3.1 an incomplete package (for example, in the labelling or the instructions for use contains the wrong serial number or wrong expiry date of the medicinal product, or its not specified at all);
3.2. the conclusion of the stub system;
3.3. the packing pollution (for example, microbiological contamination, dirt or detrital (non-living organic material)).
Minister of agriculture m. Roze annex 6 Cabinet of 19 June 2007 Regulation No. 407 of the report on the withdrawal of the veterinary medicinal product, the Minister of Agriculture m. Roze annex 7 Cabinet of 19 June 2007, regulations no 407 notice of continuous phone number (and other means of communication), you may contact the 24-hour period, and the persons responsible for the withdrawal of the veterinary medicinal product, the Minister of Agriculture m. Roze Annex 8 Cabinet of 19 June 2007 regulations no 407 response notification of quality defects/drug withdrawal
Rapid Alert Notifications of a Quality defect/Recall notes.
1. In the column or row that is not filled in, draw the line.
2. If the authorisation is presented to multiple pages, the officer signed each page.
3. If an order for a quick response the following sequence, indicated in paragraph 18 of the "emergency response following the initial rapid response # reference number (" Rapid Alert "following the original rapid alert # URref.no #" (fill in the State Pharmacy Inspectorate).
4. the notification reference number, which make up the country code (in which finding the first time) and the code for the competent authorities, as well as, where appropriate, the classification of the correspondence (for example, EN//II/04/07-point second-degree emergency response initiative from Latvia, 04-quick response, which established Latvia, 07-response correspondence) (refer to Chapter XV of the rules. Fill out the national pharmaceutical inspection).
5. If the notification is provided to veterinary medicinal products, the heading shows "rapid communication on counterfeit medicines".
6. the statement in paragraph 15 indicates a special permit (license) for the manufacture of veterinary medicinal products and special permit (license) holder, which in the name of the qualified person made the serial output, if they are different individuals.
Minister of agriculture m. Roze attachment 9. Cabinet of Ministers of 19 June 2007, regulations no 407 information on quality defects that are not urgent and Non-urgent follow-up Information for Quality Defect of note. Directive 2001/83/EC or in article 40 of Directive 2001/82/EC referred to in article 44, the holder of the licence and the holder of the licence, which in the name of the qualified person has released the series in accordance with the provisions of Directive 2001/83/EC or article 51 of Directive 2001/82/EC article 55, if they are different individuals.
 
the holder of an authorization referred to [under] article 40 of Directive 2001/83/EC or article 44 of Directive 2001/82/EC and the holder of the authorization on behalf of whom the qualified person has released the batch in accordanc with article 51 of Directive 2001/83/EC or article 55 of Directive 2001/82/EC if different.
 
Minister of agriculture m. Roze annex 10 of the Cabinet of Ministers of 19 June 2007, regulations no 407 of the Republic of Latvia the State Agency of medicines shall not register the distribution of veterinary medicinal products authorized the Minister of Agriculture m. Roze annex 11 of the Cabinet's June 19, 2007, regulations no 407 application of veterinary medicinal products not registered distribution authorization of the Minister of Agriculture m. Roze 12. attachment Cabinet of 19 June 2007, regulations no 407 of the Republic of Latvia the State Agency of medicines shall not register the distribution of veterinary medicinal products authorised for medicinal products granted an individual Minister of Agriculture m. rose 13. attachment Cabinet
June 19, 2007, regulations no 407 Submissions individually assigned does not register the distribution of the veterinary medicinal product authorisation notes.
1. In the column or row that is not filled in, draw the line.
2. If the form is sent without the use of electronic media, the applicant shall sign each form added to her page.
3. If the application is presented on several pages, the officer signed each page.
Minister of agriculture m. rose