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The Distribution Of Veterinary Medicinal Products And Control Rules

Original Language Title: Veterināro zāļu izplatīšanas un kontroles noteikumi

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Cabinet of Ministers Regulations No. 326 in 2016 (May 31. No 26 15) the veterinary medicinal product, distribution, and control rules Issued in accordance with article 5 of the law on Pharmacy and 3 General questions 1. determines: 1.1. requirements and distribution of veterinary medicinal products control; 1.2. veterinary pharmacies and veterinary lieltirgotav the rules of procedure. 2. the rules shall not apply to: 2.1 the medicated feed animal; 2.2. in the case of veterinary medicinal products containing radioactive isotopes; 2.3. animal feed additives, 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 is published on tīmekļvietn the European Commission authorised additives in feedingstuffs in the register; 2.4. the biocides; 2.5. veterinary medicinal products intended for research in the development of the veterinary medicinal product; 2.6. the animal care products. 3. the meaning of these provisions: the manufacturer-merchant who has received special permission (license) (hereinafter licence) the manufacture of veterinary medicinal products for the manufacture of medicinal products or, if specified in the licence area of activity is the manufacture of veterinary medicinal products; 3.2. the importer-merchant who has received the license for the manufacture of veterinary medicinal products if the scope specified in the licence is the importing of veterinary medicinal products, or license the production of medicinal products, if specified in the licence is the importing of veterinary medicinal products; 3.3. imports-imports of veterinary medicinal products in the European Union customs territory from a State that is not a Member State of the European Union or the European economic area (hereinafter third country); 3.4. lieltirgotav-merchant who has received a license to open a health lieltirgotav (operation) or license a medicine to open lieltirgotav (transaction) with special operating conditions "distribution of veterinary medicinal products"; 3.5. pharmacy-merchant who has received a license to open a general or type of pharmacies opening (transaction) with special activities set out in the annex to the terms "distribution of veterinary medicinal products"; 3.6. veterinary pharmacy – merchant who has received a license to open a veterinary pharmacy (operation); 3.7. the beneficiary – livestock owner or holder (hereinafter referred to as the owner) or educational and scientific institution, which does not deal with veterinary practice, but having the right to acquire the veterinary medicinal product in its lieltirgotav activity, if that person food and veterinary service according to the rules laid down in Chapter 3 of the requirements has allowed to purchase veterinary medicinal products; 3.8. responsible practicing veterinarian-veterinary practice authority or veterinary services that don't work in veterinary practice body if it has registered its activities according to the requirements of the legislation on veterinary practice and the veterinary authorities and the service provider have concluded a contract with the consignee for the authorisation of veterinary services; 3.9. the recipient list, the food and veterinary service created the list of people who are eligible to purchase veterinary drug lieltirgotav their activity without the right to distribute them; 3.10. veterinary narcotic drugs and psychotropic medication-veterinary medicinal products containing substances which, in accordance with the laws of Latvia controlled the national drugs, psychotropic substances and precursors included in list II and III; 3.11 fake veterinary medicinal products, veterinary medicinal products, which is a false identity, packaging, label, name, or composition for any ingredients or strength, or fake origin – the manufacturer, the country of manufacture, country of origin, the holder of the registration certificate or the holder and a document concerning the distribution path. 4. the illicit manufacture of narcotic drugs and psychotropic Veterinary Medicine distribution, in addition to the requirements laid down in these provisions comply with the requirements laid down in the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" and on the basis of this Act, regulations issued. 5. Veterinary medicinal products distributed: 5.1 manufacturer and importer. Veterinary narcotic drugs and psychotropic medicines distributed only a manufacturer with a licence for the manufacture of medicinal products authorised in the specified production or import operation with veterinary drugs and psychotropic drugs or who have received a licence for the illicit manufacture of narcotic drugs and psychotropic manufacture of veterinary medicinal products or import; 5.2. lieltirgotav. Veterinary narcotic drugs and psychotropic drugs distributed in the lieltirgotav, which has received the license for the illicit manufacture of narcotic drugs and psychotropic veterinary wholesale distribution of medicinal products or medicinal license to open lieltirgotav (performance), which indicates that the activity is permitted by a veterinary drugs and psychotropic drugs; 5.3. the Pharmacy and veterinary pharmacy (except veterinary narcotic drugs and psychotropic drugs); 5.4. veterinary practice authority that is registered by the food and veterinary service of the object in the registry, the practice. Veterinary narcotic drugs and psychotropic drugs distributed in the veterinary practice the authority of the food and veterinary service, consistent with the laws of the order in which the person engaged in veterinary practice, carried out transactions with the narcotic and psychotropic drugs, have included it in the veterinary practice in the list of institutions that are operating with narcotic and psychotropic drugs. 6. a Person in another Member State of the European Union or the European economic area (hereinafter referred to as Member States) has received a licence to wholesale distribution of veterinary medicinal products: 6.1 before Latvia started to distribute veterinary drug, food and veterinary service provides the following information: 6.1.1. license owner's name, address and legal status, the date of award and the licence number, as well as the competent authority of the Member State which has granted a license; 6.1.2. branch or representative office of the merchant name, registered and operating address, registration number of the commercial register, phone number, e-mail address, and information about other forms of communication; 6.1.3. the distribution of veterinary medicinal products in the company officers first name, last name, phone number, and electronic mail address; 6.1.4. name of the veterinary medicinal product, the manufacturer and the number of the registration certificate; 6.1.5. date when the scheduled to launch the distribution of veterinary medicinal products in Latvia; 6.2. stopping the distribution of veterinary medicinal products in Latvia, 10 working days notify the food and veterinary service; 6.3. the veterinary medicinal product is distributed in Latvia according to the requirements of this regulation and in accordance with the laws and regulations on the collection of information and statistics of the order the movement of veterinary medicinal products in food and veterinary service provides information on distributed on veterinary medicinal products. 7. food and veterinary service after this rule 6.1. receipt of the information referred to: 7.1 request from this rule 6.1.1. referred to the competent authorities information about the licence holder, if necessary; 7.2. ensure that rule 6.1.1, 6.1.2 and 6.1.3.. referred to public availability of information from the food and veterinary service tīmekļvietn; 7.3. After these rules referred to in point 6.2 receipt of relevant information changes.
2. wholesale distribution of veterinary medicinal products in the wholesale trade of veterinary medicinal products 8 includes all the veterinary medicinal product with the purchase, sale, import and export-related activities or other dealings with them, except for the following: 8.1. distribution by the manufacturer of the veterinary medicinal product and the importer; 8.2. the distribution by that rule 5.3 and 5.4 of the person referred to. 9. Lieltirgotav is entitled: 9.1. purchase of veterinary medicinal products, if they distribute the veterinary medicinal product, the manufacturer, the importer or lieltirgotav; 9.2. distribute medicinal products for veterinary use (excluding medical premix): 9.2.1. lieltirgotav; 9.2.2. veterinary drugstores and pharmacies; 9.2.3. the veterinary practice in the institutions established by the food and veterinary service of the object in the registry. Veterinary narcotic drugs and psychotropic medicines permitted to distribute veterinary practices in institutions that are included in the food and veterinary service of the veterinary practice established in the list of institutions that are operating with narcotic and psychotropic drugs; 9.3. distribute Medicated pre-mixes: 9.3.1. lieltirgotav; 9.3.2. veterinary drugstores and pharmacies; 9.3.3. animal feed business establishments that manufacture medicated feed and are included in the food and veterinary service of the feed company list as a medicated feedingstuffs manufacturers who produce medicated feed for further distribution; 9.4. in accordance with article 48 of the law on Pharmacy was the first part to distribute veterinary medicinal products this provision 14. authorisations referred to in paragraph 1.
10. the Lieltirgotav shall comply with the following requirements: 10.1 ensure room that meets this provision in Chapter 7; 10.2. the storage of veterinary medicinal products and activities with the veterinary medicinal products concerned personnel have the skills and experience that guarantees the veterinary medicinal product or material quality of their storage and handling; 10.3. the competent authority is fixed: the veterinarian or pharmacist with at least one year work experience in medicine, storage and distribution or sales of the medicinal product or procurement operations, and it 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, registration number and (or) product number; 10.4.3. veterinary medicinal products, the manufacturer of the veterinary medicinal product, the 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 or the recipient's name and address; 10.4.6. name, address, and on the movement of veterinary medicinal products, the practitioner responsible for the veterinarian's name and certificate number, in the case of veterinary medicinal products the rules referred to in point 14 permission to the recipient. 10.5. ensure that veterinary medicine distribution process does not change the description of a veterinary medicinal product for veterinary medicinal products referred to in the qualitative and quantitative characteristics; 10.6. these provisions stored 20. requests referred to in paragraph 1 for the purchase of the veterinary medicinal product; 10.7. providing food and veterinary service information about distributed veterinary medicinal product in accordance with the laws and regulations on the collection of information and statistics on the movement of veterinary medicinal products. 11. Lieltirgotav for veterinary medicinal products supplied for veterinary medicine in the delivery document shall contain at least the following information: 11.1. the veterinary medicinal product concerned: 11.1.1 name; 11.1.2. the quantity of secondary packaging and secondary packaging; 11.1.3. manufacturer assigned serial number and expiration date; 11.2. beneficiaries of the veterinary medicinal product, which is taxable at the same time, name, or first name and last name; 11.3. the veterinary medicinal product, the delivery address, which corresponds to the information to the food and veterinary service of the company in the register or the register of persons who purchase veterinary drug lieltirgotav their activity without the right to distribute them further; 11.4. other information according to laws and regulations on accounting and organization. 12. Lieltirgotav in his tīmekļvietn indicates: 12.1. up to date information on veterinary medicinal products-izplatāmaj name, registration number, the registration certificate holder, pharmaceutical form, package sizes, ensuring that the information on the veterinary medicinal product is provided under the legislation on advertising of veterinary medicinal products; 12.2. the last update date. 13. Lieltirgotav: 13.1. This provision of the information referred to in paragraph 10 of the document referred to in paragraph 11 and paragraph 20 of veterinary medicinal products referred to in the request shall be not less than three years and presented the food and veterinary service inspectors at their request; 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. ensure the food and veterinary service inspectors to visit the facilities and lieltirgotav presented by the movement of medicinal products related documents; 13.4. ensure food and veterinary service approach in this 12.1. the provisions referred to in the information, and information about the address of tīmekļvietn, as well as one working day after any modifications made in the tīmekļvietn inform the food and veterinary service; 13.5. prepare emergency plans to ensure the withdrawal of the veterinary medicinal product, provided that: 13.5.1. food and veterinary service has adopted a decision on the withdrawal of the veterinary medicinal product concerned; 13.5.2. withdrawal 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).
3. distribution of the veterinary medicinal product to persons not engaged in veterinary practice, but is entitled to purchase veterinary drug lieltirgotav their activity without the right to distribute its next 14. Authorisation for the acquisition of veterinary medicinal products, the rules referred to in paragraph 9.4 of the livestock owner or institution of education and Science: 14.1. conclude a contract for the provision of services to the veterinary veterinary practice authority or veterinary services (which do not work in veterinary practice) who have registered their activity according to the requirements of the legislation on veterinary practice and the veterinary authorities of service providers; 14.2. ensure that practicing veterinarian responsible fulfil the requirements laid down in the legislation for scientific purposes the protection of animals used, if that rule 14.1 of the contract referred to in closed educational and scientific institution; 14.3. submitted to the food and veterinary service of the application. The application shall state: 14.3.1. the animal owner or educational and scientific institution name or first and last name, address, telephone number, electronic mail address or fax number and the actual site address, if different from the registered office; 14.3.2. holding and flock registration number, if the application is submitted by the owner of the animal; 14.3.3. the registration number of the food and veterinary service trial breeders, suppliers or users of the register and the species of animals, if the application shall be submitted to the Ministry of education and science; 14.3.4. veterinary practice name, address, and so practicing veterinarian's name and certificate number of the veterinary practice that constantly perform actions on veterinary medicinal products, where this provision 14.1. contract referred to veterinary practices; 14.3.5. veterinary service provider name and the veterinary practice certificate number if this rule 14.1. the contract referred to the veterinary services that don't work in veterinary practice; 14.3.6. the rules referred to in paragraph 14.1. contract period; 14.3.7. grounds for the acquisition of veterinary medicinal products, by practicing whereof the responsible official veterinarian the signature and the imprint of the stamp of the veterinary practice; 14.4. bear with the actual site inspection expenses in accordance with the laws and regulations establishing procedures for food and veterinary service of the country carried out surveillance and control activities and paid services. 15. This provision in the agreement referred to in paragraph 14.1 of the veterinary practice authority it separately practicing veterinarian's name and certificate number of the veterinary practice that permits the receiving company or institution of education and science constantly take action to veterinary medicinal products.
16. food and veterinary service: 16.1 10 working days after this rule 14.3. submission receipt referred to evaluate and, if necessary, check the permissions specified in the application to the applicant's actual site; 16.2. register the applicant permission permissions list if the following conditions are met: 16.2.1. storage, livestock and animals are registered and labeled according to the requirements of the law on the animal, herd and the recording of holdings and identification of animals, if the claim is true; 16.2.2. the applicant deals with the keeping of farm animals for the production of animal products or other agricultural purposes and the number of animals in a herd of cattle is not less than 150 units in accordance with the provisions of annex 1, where the applicant is the owner of the animal; 16.2.3. the applicant engaged in trial for animal production or used in accordance with the laws and regulations for scientific purposes the protection of animals used, if it is an educational and scientific institution; 16.2.4. the applicant has concluded that rule 14.1 of the contract referred to in (a); 16.2.5. practicing veterinarian responsible complies with this rule and 14.2. in paragraph 14.1 above requirements; 16.2.6. food and veterinary service in the last 12 months of the applicant's authorization and practicing veterinarian responsible in action is not established by the movement of veterinary medicinal products and medicinal products, maximum residue levels for regulatory infringements of the laws that may pose risk to human or animal health; 16.3. refusing registration lists if the applicant for the authorization and practicing veterinarian responsible has not fulfilled the provisions of 16.2.3 16.2.1, 16.2.4 16.2.2, 16.2.5.,., or 16.2.6. the requirements referred to in subparagraph; 16.4. specify the list, if you have received this rule 12.2. information referred to in paragraph (a); 16.5. check permissions on the recipient's compliance with this provision, as well as in paragraph 16.2.19, 20 and 21 of these requirements. 16.6. the decision to exclude permissions permissions the recipients from the list of beneficiaries in such cases: 16.6.1. check reveals the movement of veterinary medicinal products regulatory infringements of the laws that may pose risk to human or animal health; 16.6.2. food of animal origin produced by the beneficiary of the authorisation of veterinary medicinal products, residues in quantities exceeding maximum residue levels or substances which are banned from use in food-producing animals of veterinary medicinal products in accordance with the movement of the regulatory requirements and the laws the Commission 22 December 2009 Regulation (EU) No 37/2009 on pharmacologically active substances and their classification of the maximum permissible content (hereinafter Regulation No 37/2010); 16.6.3. productive knowledge that belongs to the beneficiary of the authorisation, substances which are banned from use in food-producing animals of veterinary medicinal products in accordance with the movement of the regulatory requirements and the laws and Regulation No. 37/2010; 16.6.4. don't force 14.1. these provisions referred to in the contract, or a practicing veterinarian responsible does not match this rule 14.1 and 14.2. the requirements referred to in subparagraph; 16.6.5. number of animals in the herd for more than six months do not correspond to the provisions referred to in paragraph 16.2.2. requirements; 16.6.6. the beneficiary is excluded from the trial of breeders, suppliers or users of the registry; 16.6.7. permission is received the recipient's application for exclusion from the list of beneficiaries of the authorisation; 10.4. provides permission to the list of recipients of the public availability of food and veterinary service and one tīmekļvietn working days following this rule 16.2, 16.4., or 16.6. event referred to update the information in the list; 16.8. the data about the recipient of the permit shall keep not less than five years after the permission requested removal from the list.
17. food and veterinary service in the list of the beneficiary of the authorisation shall include the following information: 17.1. the registration number of the recipient in the list; 17.2. the date the authorisation of the recipient in the list; 17.3. the beneficiary's name and the address of the site; 17.4. veterinary practice name and practicing veterinarian's name and certificate number of the veterinary practice, where this provision 14.1. referred to in the contract has been concluded with a veterinary practice; 17.5. the veterinary service provider name, and veterinary practice certificate number, if this provision 14.1. referred to in the contract has been concluded with the veterinary service provider that does not work in veterinary practice;
10.9. the rules referred to in paragraph 14.1. the period of validity of the contract; 17.7. the species of animals in the herd.
18. the authorisation holder, which is excluded from the permissions list and wish to be included, the food and veterinary service shall submit the rule 14.3. of the applications referred to in point: 18.1. not earlier than one year after the date of the finding of the infringement, if has been excluded from the list in accordance with this provision, 16.6.2 16.6.1. or section 16.6.3.; 18.2. after remove the grounds for exclusion, if the decision on the authorisation requested exclusion from the list adopted in accordance with the provisions of 16.6.6 16.6.4., or section 16.6.5... "
19. This provision of the authorization referred to in paragraph 14 of the recipient's responsibilities: 19.1. to promote responsible veterinarian practicing in action, placing at their disposal the necessary space and does not hinder practicing veterinarian in charge of the duties of the Permanent; 19.2. ensure that veterinary medicinal product to animals, only practicing veterinarian responsible by or under direct supervision; 19.3. the movement of veterinary medicinal products within the company to ensure, in accordance with the laws and regulations on the procedures for persons engaged in veterinary practice, acquired, stored and used in medicine; 19.4. to ensure the quality of veterinary medicinal products and veterinary medicinal products used for the destruction of primary packaging according to the legislation on waste management; 19.5. The food and veterinary service, on request, be produced to the Inspector of the veterinary medicinal product storage facilities and medicine circulation of documentation; 12.2. within five working days after the event to inform the food and veterinary service about: name of consignee 19.6.1. permission or change of address; 19.6.2. herd or shed, changing the registration number; 19.6.3. practicing veterinarian in charge; 19.6.4. cessation of economic activities, livestock exclusion from the State agencies "agricultural data centre" registry or other circumstances, if the acquisition of the veterinary medicinal product authorisation for the operation of the beneficiary no longer necessary; 19.7. If you end this rule 14.1. referred to in the contract or economic activity or the acquisition of a veterinary medicinal product authorised for the operation of the recipient does not need a further five working days to provide: 19.7.1. the veterinary medicinal product, inventory counting, comparing the received and spent by the veterinary medicinal product actually remaining quantity of medicinal products; 19.7.2. submission of information to the food and veterinary service on the remaining stocks of medicines and on the planned actions with them; 19.7.3.19.6.4. these provisions in the case referred to in subparagraph remaining stockpiles of medicines in accordance with legislation on waste management. On hazardous waste considered as veterinary medicinal products for accounting, identification, storage, packing, labelling and transport records in accordance with regulations on hazardous waste tracking, identification, storage, packaging, labelling and transport records; 19.8. the rules referred to in paragraph 20 of the request, submit one copy to lieltirgotav and the second copy to keep with them to receive veterinary medicinal products supporting documents received, on the basis of that request. 20. a practicing veterinarian responsible, when the request for the purchase of veterinary medicinal lieltirgotav: 20.1. request include: name of the recipient. the 20.1.1, the actual site address, telephone number, electronic mail address; 20.1.2. practicing veterinarian in charge name and certificate number of the veterinary practice; 20.1.3. the registration number of the recipient in the list; 20.1.4. drug name, form, strength and quantity; 20.1.5. veterinary practice certificate stamp if the request is not made in electronic form of the document, date, as well as the responsible official veterinarian signature of medical practitioner; 20.2. takes into account that the request is valid for 14 days; 20.3. prepare two copies, unless the request is not filed in electronic form of a document pursuant to the regulations on electronic document design. 21. a practicing veterinarian responsible: 21.1. spent and accounted for the veterinary medicinal product is authorised consignee undertaking or establishment in accordance with the movement of veterinary medicinal products regulatory legislation requirements; 21.2. entering the veterinary medicinal product to animals or allow another person to do so by monitoring the entry of animals of veterinary medicinal products, as well as monitor the health of the animals during the use of the medicinal product; 21.3. in five working days, inform the food and veterinary service about: these rules 21.3.1.14.1. termination of the contract referred to in subparagraph a; 21.3.2. Amendments 14.1. these provisions in the agreement referred to in the notification of the change of the official veterinarian practicing, which permits the company to constantly carry out transactions with the veterinary medicinal product, where the contract is concluded with a veterinary practice authority services applied more than one practicing veterinarian.
4. the manufacturer of the veterinary medicinal product and the importing of veterinary medicinal product distribution implemented 22. Veterinary medicinal products, the manufacturer and the importer is entitled to distribute the produced or imported veterinary medicinal products. 23. The veterinary medicinal product, the manufacturer and the importer: 23.1. designate the Executive who recorded in detail the common veterinary drug and the quantity of the samples. The records shall contain at least the following information: 23.1.1. delivery date of the veterinary medicinal product; 23.1.2. name of the veterinary medicinal product; 23.1.3. the delivered quantity of veterinary medicinal products; 23.1.4. veterinary medicinal products, the recipient's name and actual address; 23.1.5. the veterinary medicinal product, manufacturer's serial number; 23.2. the provisions referred to in 23.1. stores information in not less than three years. The records shall be presented on request to the food and veterinary service inspectors; 23.3. ensure that the distribution of the veterinary medicinal product does not change during the veterinary medicinal product, the description of that veterinary medicinal product, qualitative and quantitative characteristics; 14.5. not less than annually make the veterinary medicinal product, item count versus common produced or received and the quantity of the veterinary medicinal product with the actual quantities of veterinary medicinal products in the warehouse; 14.6. provide food and veterinary service information on veterinary medicinal products distributed under the laws and regulations on the collection of information and statistics of the order of movement of veterinary medicinal products.
5. requirements for retail distribution of veterinary medicinal products in 5.1. requirements for veterinary drugstores and pharmacies 24. a Person who has received a license to open a veterinary pharmacy (operation) or to open a drugstore (transaction) with special operating conditions, "the distribution of veterinary medicinal products ': 24.1. designated as the movement of veterinary medicinal products, which the officials responsible are veterinarian or pharmacist, and suitably qualified person replace the movement of veterinary medicinal products of the officials responsible for its prolonged absence; 24.2. ensure that the movement of veterinary medicinal products officer job duties throughout the pharmacy work; 15.1. you can even function on the movement of veterinary medicinal products the responsible duties, if the veterinarian or pharmacist; 15.2. the veterinary medicinal product is stored, distributed and produced in the areas specified in the licence; 15.2. ensure that company for the movement of veterinary medicinal products officer develops and articulates the self-control system of distribution of veterinary medicinal products; 24.6. ensure that veterinary medicine distribution process does not change the description of a veterinary medicinal product for veterinary medicinal products referred to in the qualitative and quantitative characteristics. 25. The rules referred to in paragraph 24.1. Executive ensure that: 25.1. veterinary medicinal products storage and distribution according to the requirements of this regulation; 25.2. the distribution of veterinary medicinal products which satisfy the movement of veterinary medicinal products regulatory legislation requirements; 25.3. received and veterinary medicinal products issued records requirements of these provisions; 25.4. reporting on the use of the veterinary medicinal product-related adverse reactions, in accordance with the legislation on veterinary pharmacovigilance of the medicinal products; 25.5. the reporting of the veterinary medicinal product with quality defects and counterfeit veterinary medicinal products, as well as the withdrawal of the veterinary medicinal product according to the requirements of this regulation.
26. Veterinary pharmacy or a pharmacy on every transaction carried out with medicinal products that are authorised to issue against veterinary prescription or allowed to issue only a practicing veterinarian, is recorded and stored the following: 26.1. obtaining of the veterinary medicinal product or the date of issue; 26.2. name of the veterinary medicinal product; 26.3. the manufacturer of a veterinary medicinal product for veterinary medicinal products that are assigned a serial number;
26.4. the received or issued quantities of veterinary medicinal products; 26.5. the veterinary medicinal product, supplier's name and address; 16.5. the veterinary medicinal product, name of consignee name and address; 16.6. the veterinarian's name and address, who issued the recipe, and the recipe first, if this requirement is applicable; 26.8. veterinary practice institution practicing veterinarian and drawn with the signature and stamp of the veterinary practice certificate fingerprint request, if approved by the veterinary medicine veterinary practice issued by the authority. 27. The veterinary pharmacy or pharmacy can open the secondary packaging of the veterinary medicinal product, without damaging the primary packaging. In this case, the veterinary medicinal products issued pursuant to the demand quantity, each separately the quantities of veterinary medicinal products issued by adding both the written information that indicates the validity period and serial numbers, and the use of medicinal products a copy of the instruction manual, which comply with the legislation on the labelling of the veterinary medicinal product. 28. The veterinary pharmacy or pharmacy: 28.1.26. these provisions and the information referred to in paragraph 36, and the veterinary medicinal product in question and the issue of supporting documents of the supply of goods, which also contains this provision, 26 and 36 referred to in the news, keep not less than five years. Information and reception of the veterinary medicinal product and the issue of supporting documents for the supply of goods referred to in paragraph 24 of the rules of the competent authority, on request, produce food and veterinary service inspectors; 28.2. no less than annually make the veterinary medicinal product, inventory counting, comparing the issued quantity of veterinary medicinal products, with the actual quantities of medicinal products in the warehouse; 28.3. provides the space and the documentation available to the food and veterinary service inspectors; 28.4. ensure that veterinary medicinal product issued by a person who meets the qualifications of the pharmaceutical law 40 the second paragraph of article 1 or 2 set out in paragraph requirements; 28.5. veterinary medicinal products which are authorised to issue against the animal's owner, (holder) only be issued against the practicing veterinarian prescription prescription designed in accordance with the legislation on veterinary prescription design and storage requirements, procedures and medical premix against practicing veterinarian prescription prescription issue only food and veterinary services for animals in therapeutic for manufacturers of compound feedingstuffs who manufacture of medicated feed his farm for animal nutrition. 29. the Person who issues the veterinary medicinal product, provide advice to the owner of the animal (holder) for the use of veterinary medicinal products. Veterinary pharmacy or pharmacy located in a visible place in the Latvian society Veterinarian issued a copy of the certificate or the distribution of veterinary medicinal products in veterinary practice, a copy of the certificate.
30. the veterinary pharmacy is allowed to purchase medicinal plants from natural persons, if the officer has indicated in writing to the medicinal plant harvesting and preparation of the drog and storage location and circumstances. Veterinary pharmacy information on medicinal plants bought the place of origin and who have been supplied with medicinal plants, keep not less than three years.
5.2. requirements for veterinary pharmacy made the distribution of veterinary medicinal products in 31 veterinary pharmacy distributed the pharmacy made the veterinary medicinal product, where: 31.1. license for opening of veterinary pharmacy (operation) is indicated in the annex to the special operating conditions "for the manufacture of veterinary medicinal products"; 31.2. the veterinary medicinal product is manufactured and quality controlled by a person who meets the pharmaceutical Act, article 35 of the fifth part listed in paragraph 4; 31.3. veterinary medicinal products are manufactured and quality controlled 33.1.1. these provisions the referred instructions, subject to the pharmaceutical form manufacturing technology, the compatibility of the substance and physical-chemical properties; 19.5. the veterinary medicinal product is made in one of the following ways: 31.4.1. According to medical prescription prescription of a veterinarian (the magistral formula), and are intended for a particular animal or group of animals; 31.4.2. in accordance with the prescriptions of a pharmacopoeia (the officinal formula); 31.5. veterinary medicinal products manufactured quality and efficiency meets the intended purpose of the use of the medicinal product and relevant technical standards or the standards of pharmacopoeia monographs; 19.6. the manufacture of veterinary medicinal products intended for the active substances and excipients are acquired from persons who are authorised to distribute such substances and provide the substance and quality of the supporting documents. 32. the veterinary medicinal product is manufactured in the permitted to distribute, if their label, the manufacturer has specified the following information at least: 32.1. the exact description of the veterinary medicinal product, indicating the ingredients, shape, strength, quantity, packaging; 32.2. the veterinary pharmacy name, address and phone number are made of the veterinary medicinal product; 32.3. the use of veterinary medicinal products for conditions such as dose, route of administration, frequency of use; 32.4. the target species and, where appropriate, animal age, weight and other information about the proper use of the veterinary medicinal product; 32.5. the date of manufacture of the veterinary medicinal product; 32.6. the period of validity of the veterinary medicinal product. 33. a Person who has received a license to open a veterinary pharmacy (transaction) with special activities set out in the annex to the terms "manufacture of the veterinary medicinal product": 33.1. ensure that the company is development and actualized 33.1.1. veterinary medicinal products: fabrication and quality control manual, which comply with the pharmacopoeia monographs or technical regulatory requirements. The leaflet includes information about manufacturing procedures and tests that assess the quality of veterinary medicinal products manufactured by a veterinary medicinal product organoleptic, physical, qualitative and quantitative; 33.1.2. self-control system for the manufacture of the veterinary medicinal product and quality control; 33.2. confirm this rule 33.1. documents referred to; 33.3. report to the food and veterinary service of the use of veterinary medicinal products manufactured in the induced adverse effects; 20.8. report on the distribution of veterinary medicinal products manufactured according to the regulations on the collection of information and statistics of the order the movement of veterinary medicinal products. 34. The veterinary pharmacy is allowed to produce the veterinary medicinal products and to distribute them, if the Latvian register of veterinary medicinal products not included or not in Latvia is distributed veterinary drugs with the same active substance or combination thereof, strength, shape and usage. 35. The veterinary pharmacy that is entitled to produce the veterinary medicinal products, veterinary medicinal products made issued by the owner of the animal to the veterinarian's prescription of a medical practitioner or veterinary prescription practice authority against the institution practicing veterinarian prescription request. The recipe and the request of the manufacturer, it is permissible to specify the assigned name of the veterinary medicinal product. 36. If the veterinary pharmacy distributes veterinary medicinal products manufactured: 36.1. This provision referred to in paragraph 24 of the responsible officer provides the following information: 36.1.1. veterinary medicinal products manufactured to the exact description, including the pharmaceutical form of the medicinal product composed of active substances and excipients name, strength and quantity; 36.1.2. the name, address and qualifications, which manufactures veterinary medicinal products; 36.1.3. veterinary medicinal products date of manufacture and expiry date; 36.1.4. manufactured date of issue of the veterinary medicinal product; 36.1.5. veterinary medicinal products have received the name and address of the person or name, if the veterinary medicinal product is issued to the owner of the animal; 36.1.6. name and registration number of the food and veterinary service of the exposed object in the registry if the veterinary medicinal product issued by veterinary practice; 36.1.7. its animal species, age and identification number, which the medicinal product is intended, if possible; 36.1.8. veterinary medicinal products manufactured quality control and results to date, if stores information in paper form, with the signature of the person who approved the quality control; 36.2. stores: 36.2.1. practicing veterinarian's prescription for the first copy, in the case of veterinary medicinal products shall be issued to the owner of the animal; 36.2.2. veterinary practice institution practicing the veterinarian's prescription and with the signature and stamp of the veterinary practice to confirm the request if the veterinary medicinal product issued by veterinary practice; 36.2.3. veterinary medicinal products used in the manufacture of the active substance and other supporting documentation to the origin.
5.3. requirements for non-prescription distribution of veterinary medicinal products through the Web via 37. Veterinary pharmacies or pharmacies with Web can be distributed through the non-prescription of veterinary medicinal products if they: 37.1. has received a license to open a veterinary pharmacy (operation), in addition to the distribution of veterinary medicinal products specified in the special conditions for non-prescription veterinary medicine distribution to Web, or license, or a general open-type pharmacies opening (operation), in addition to special operating conditions on the distribution of veterinary medicinal products specified in the special conditions for non-prescription veterinary medicine distribution to the Web; 37.2. persons wishing to purchase veterinary medicinal products through the website, are provided the opportunity to communicate with the veterinary pharmacies or pharmacies and get free information and advice on such products one day; 37.3. ensure purchased and issued records of veterinary medicinal products in electronic form, retaining the information on each transaction, or a correction, and the date of the transaction, with the ability to filter and select the records; 37.4. has created any time of the day or a public tīmekļvietn, which contains information in accordance with the legislation on distance contracts and regulations concerning advertising of veterinary medicinal products, as well as information in accordance with paragraph 38 of these rules. 38. This rule 37.4. referred to in subparagraph tīmekļvietn: 38.1. contains at least the following information: 38.1.1. veterinary pharmacies or pharmacies provide services report, with explanations about the possibility to receive the service. This condition applies to non-prescription veterinary medicine distribution to the Web; 38.1.2. electronic mail address; 38.1.3. veterinary drugstore or pharmacy name, address, business hours, phone and fax number, license number and the name of the holder, as well as address; 38.1.4. first and last name of the person who gives advice on veterinary medicinal products, and the Veterinarian Association of Latvia issued the certificate of a veterinary medicinal product for distribution or veterinary practice certificate number, as well as consulting phone number; 38.1.5. graphical elements-additional license graphic representation; 38.1.6. the link to the food and veterinary service or national agency tīmekļvietn, which contains information on veterinary pharmacies or drugstore issued license and special operating conditions; the last tīmekļvietn the Insert 38.1.7. information renewal date; 38.2. ensure option letter or the pharmacy pharmacy to send electronically. 39. Veterinary pharmacies or pharmacies that distribute non-prescription veterinary medications through the Web, the following requirements shall be met: 24.3. for movement of veterinary medicinal products has been developed by the responsible person and the holder of the licence is approved by the order in which non-prescription veterinary medicines are distributed with the Web; 24.4. information on non-prescription medicinal products are separated from the information on other products or clearly indicate that the product is non-prescription veterinary medicinal products; 39.3. regularly update the information provided in tīmekļvietn; 24.5. the movement of veterinary medicinal products designated officer within three working days after the change of the domain name and e-mail address shall inform the food and veterinary service; 24.5. The food and veterinary service inspectors are able to visit the pharmacy or veterinary pharmacy facilities and on-demand access with the movement of veterinary medicinal products related documents and veterinary use electronic records.
6. Veterinary medicinal products and substances with anabolic, antimicrobial, anti-parasitic, anti-inflammatory, hormonal or psychotropic effects distribution requirements 40. Veterinary medicinal products, the manufacturer, importer and lieltirgotav, which distributes the active substances which can produce the veterinary medicinal products with anabolic, antimicrobial, anti-parasitic, anti-inflammatory, hormonal or psychotropic effects, determines the Executive for this active substance records and storage. Officer creates a record of all the transactions with the relevant substances and which shall be kept for at least three years after the last entry. The data in the register shall contain at least the following information on the active substance: 24.9. name; 40.2. the received or issued quantity of active substances; 40.3. expiry date and manufacturer's serial number; 25.1. the receipt and the date of issue; 25.2. the supplier's or the consignee's name and address.
41. Productive livestock owners that food-producing animal or group of animals used in veterinary medicinal products containing substances with anabolic, antimicrobial, anti-parasitic, anti-inflammatory, hormonal or psychotropic effects, not less than five years after the medicines (even if treated animals during this time have already been slaughtered) Save: 25.5. purchase of the veterinary medicinal product concerned documents that specify the drug buyer's name or business name, name of the veterinary medicinal product serial number and quantity; 41.2. the registry or tracking log on the administration of the veterinary medicinal product concerned. 42. This rule 41.2. the register referred to in subparagraph or accounting log shall contain at least the following information: 42.1. entering the veterinary medicinal product; 26.2. name of the veterinary medicinal product; 26.3. the veterinary medicinal product; 26.3. the veterinary medicinal product, the supplier's name or name and last name; 26.4. the veterinary medicinal product, the supplier's address; 26.5. identification number of the animal for which the veterinary medicinal product;
26.5. a practicing veterinarian's instructions about the restrictions the use of animal products, derived from animals to which the veterinary medicinal products are entered. 43. in paragraph 40 of these provisions and 41.2. the register referred to in point or accounting magazines on request presented to the food and veterinary service inspectors.
7. storage of the veterinary medicinal product and delivery requirements 44. Veterinary medicinal products manufacturer and importer for distribution for veterinary medicinal products kept in facilities where they can be stored separately from packaging materials, raw materials, intermediate products or ready-made veterinary medicinal products which have been revoked, been returned, rejected or subject to quarantine. 45. The veterinary medicinal product, the manufacturer and the importer separated from other rooms or room parts in the quarantine area. It marked "quarantine area" and ensure that no unauthorised person enters. The quarantine area in veterinary medicinal products, the distribution of which is suspended until final clarification of the circumstances of the case are suspected movement of veterinary medicinal products regulatory legislation. 46. The veterinary medicinal product, which is expired, cancelled, returned or rejected veterinary medicine veterinary medicine manufacturer and importer stores especially provided for this purpose in a separate room or enclosed spaces. 47. Lieltirgotav: 29.3. at least the following premises or enclosed space: 47.1.1. the adoption of the veterinary medicinal product; 47.1.2. storage of the veterinary medicinal product; 47.1.3. dispensing veterinary medicinal products; the 47.1.4. intended for destruction, recalled, returned or rejected, or a veterinary medicinal product for veterinary medicinal products which are subject to quarantine. Quarantine in the grass by a of the other and ensure compliance with the quarantine area this provision in paragraph 45 above; 47.2. a separate room for staff; 47.3. the sanitary knot. 48. the veterinary medicinal product Lieltirgotav storage space provided by: 29.9. easy to clean and disinfect equipment; 48.2. storage of veterinary medicinal products individually, taking into account a group of veterinary medicines and the series; 48.3. based on this rule 65. Permissions referred to in paragraph 1, a veterinary medicinal product imported into storage this provision 47.1.2. referred to in subparagraph a room or room part separately from other medicinal products, their location is the "country of the veterinary medicinal product is not registered"; 30.1. to avoid damage to the packaging of the veterinary medicinal product and avoid cross contamination of the veterinary medicinal product; 30.1. temperature and humidity control. Temperature and humidity measurements are recorded not less frequently than once a day.
49. The veterinary medicinal product, the manufacturer, importer and lieltirgotav stored in the veterinary medicinal product is placed on pallets or shelves, made of material which is easy to clean and disinfect. 50. This rule 44, paragraph 47, and the rooms are easy to clean, dry, ventilated and lit accordingly. They ensure the labelling of the veterinary medicinal product and in the instructions for use: 50.1. the specified storage conditions – proper humidity and lighting; 50.2. the specified temperature: 50.2.1. at room temperature (15 – 25 ° c); 50.2.2. cool site (8-15 ° c); 50.2.3. cold (2-8 ° c). 51. If the veterinary medicinal product, the storage required for a specific temperature, lieltirgotav storage room or equipment is equipment that records the deviation from the prescribed temperature. 52. The veterinary pharmacy or pharmacy in at least the following interrelated enclosed rooms or parts of rooms: 52.1. the veterinary medicinal product; 52.2. 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; 52.3. personnel; 52.4. sanitary node; 52.5. If the veterinary medicinal product on pharmacies making: 52.5.1. According to the work to be carried out is in the room or cordoned off part of non-sterile dosage forms, sterile dosage forms production, as well as the manufacture of veterinary medicinal products, the provision of the necessary utility room; 52.5.2. manufacture of the veterinary medicinal product is appropriate for the room furnished and equipped, in order to ensure the quality of veterinary medicinal products manufactured; 52.5.3. manufacture of veterinary medicinal products on the premises according to the work to be carried out: 52.5.3.1 is furnished and equipped. jobs in liquid, soft and hard form for the manufacture of medicinal products, veterinary medicinal products and purified water for analysis, as well as the packaging of the veterinary medicinal product and labelling; 52.5.3.2. is especially equipped for the jobs with analytical devices to be used in the work, hardware and equipment to produce the veterinary medicinal product quality control. 53. in paragraph 52 of these rules in the same rooms or room parts are prohibited from the market and treat the animals, as well as to engage in activities that are not related to the pharmaceutical law set out in article 33.1 veterinary pharmacy functions.
54. in paragraph 52 of these rules in the same rooms or parts of rooms provide: 54.1. placing veterinary medicinal products on the shelves or pallets; 54.2. the labelling of the veterinary medicinal product in storage conditions according to the temperature, humidity and lighting; 54.3. easy cleaning of the space conditions, easy to clean and disinfect equipment, as well as purity; 54.4. the storage of certain veterinary medicinal products, having regard to the Group of veterinary medicinal products and series; 54.5. to avoid damage to the packaging of the veterinary medicinal product and avoid cross pollution of veterinary medicinal products. 55. Fake veterinary medicinal products which have been detected in the distribution network, stored separately from other products. Its clearly marked with special indication "not for sale". The day when discovered counterfeit medicinal products for veterinary use shall immediately notify the holder of the registration certificate and the food and veterinary service. After being informed by the food and veterinary service act under this provision in Chapter 12.
56. the distribution of medicinal products for veterinary use, including transport, veterinary medicinal products, the manufacturer, importer, lieltirgotav, veterinary pharmacy and pharmacy provides: 56.1. the labelling of the veterinary medicinal product in specified circumstances, appropriate lighting and humidity; 56.2. the labelling of the veterinary medicinal product contains temperature: 56.2.1. at room temperature (15 – 25 ° c); 56.2.2. cool site (8-15 ° c); 56.2.3. cold (2-8 ° c); 56.3. equipment that keeps the temperatures provided for veterinary medicinal products during transport, if necessary; 56.4. 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; 56.5. 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, if this requirement is applicable.
57. The destruction of the veterinary medicinal product is intended to be disposed of according to the laws and regulations on waste management, before its listing. Records indicate the name of the veterinary medicinal product, serial number, quantity, and type of packaging. Distribution of invalid on hazardous waste considered as veterinary medicinal products for accounting, identification, storage, packing, labelling and transport records in accordance with regulations on hazardous waste tracking, identification, storage, packaging, labelling and shipping of inventory.
8. Remaining stocks of veterinary medicinal products in the distribution of 58. If the owner of the registration certificate shall be made changes to the registration of veterinary medicinal products according to the procedure laid down in the regulations on the registration of veterinary medicinal products, within 12 months from the date of the decision of approval of the change of registration of veterinary medicinal products, the owner of the registration certificate or its authorized representative is entitled to distribute stock to existing veterinary medicinal products which are not implemented on the approved changes to the registration documentation, except that rule 59. in the case referred to in paragraph. This condition shall apply to veterinary medicinal products, wholesale trade. 59. food and veterinary service, deciding on the approval of the change in the registration dossier, you can adopt the following decision: 59.1. set another deadline for the remaining inventory of veterinary medicinal products for distribution, the distribution of permits issued, the remaining stock of the veterinary medicinal product if the change is due to the limitations of animal and human health, for example, changing the classification of the veterinary medicinal product (annex 2); 59.2. prohibit the remaining inventory of the distribution of the veterinary medicinal product if the change is related to the express limitations of animal and human health protection and safe use of the product, such as changes in therapeutic indications, contraindications, dosages in target species due to get new information about the safe use of the medicinal product. The decision taken by the food and veterinary service and the public in its tīmekļvietn shall notify the holder of the registration certificate or the authorized representative the day of adoption of the decision. 60. following these rules referred to in paragraph 58 of the expiry of the 12 months or that rule 59.1. the expiry of the period referred to in subparagraph remaining inventory of medicines that are approved without changes, may distribute only the veterinary pharmacies, pharmacy and veterinary practices authorities to the remaining stocks of medicines, but not longer than the specified drug expiration date.
61. If the veterinary medicinal product is not re-registered pursuant to the regulations on the registration of veterinary medicinal products or food and veterinary service of renewal is refused, suspended or cancel the registration or the registration date of expiry of the licence or the regulations referred to in paragraph 65.1. validity, the food and veterinary service, based on the registration certificate of the veterinary medicinal product or the owner or his authorised representative, that rule 65.1. the permit holder referred to in the application is entitled to determine the remaining inventory of the distribution of medicinal products, the period of authorisation of the distribution of the remaining inventory of the veterinary medicinal product marketing (annex 2).
62. the holder of the registration certificate or its authorized representative or 65.1. these provisions permit holder referred to in accordance with the laws and regulations establishing procedures for food and veterinary service of the country carried out surveillance and control activities and fees, shall bear the costs related to the evaluation of the application for authorisation to release the remaining inventory of veterinary medicinal products for sale.
63. food and veterinary department in inserted in your tīmekļvietn information on licences issued the remaining inventory of veterinary medicinal products for sale, including: 39.2. the permit holder's name and address; 39.3. veterinary medicinal products given in: 63.2.1. name, strength, pharmaceutical form; 63.2.2. the registration number of the Latvian register of the veterinary medicinal product or this rule 65.1. the number of the licence referred to in (a); 63.2.3. the manufacturer's serial number, the number of secondary packaging and expiry date; 63.3. remaining stocks of veterinary medicinal products in the distribution deadline.
64. by the food and veterinary service of the veterinary medicinal product, request the registration certificate holder, manufacturer, importer, lieltirgotav, veterinary pharmacy, pharmacy and veterinary practice authority shall give notice of the remaining stocks of the veterinary medicinal product, which is not implemented the registration documentation of approved changes. This also applies to parallel imports and parallel distributed on veterinary medicinal products. The notification shall specify the following: 64.1. name of the veterinary medicinal product, registration number and (or) product number; 64.2. the veterinary medicinal product, the strength and the pharmaceutical form; 64.3. the remainder of the veterinary medicinal product serial number, number of packages and the expiration date.
9. The State does not register the distribution of veterinary medicinal products not registered in the country of 9.1 veterinary medicine distribution requirements 65. in accordance with article 12 of the law of Pharmacy was the first part of paragraph 7 of point "a" in Latvia can be import and distribute veterinary medicinal products which are not included in the Latvian register of veterinary medicinal products in food and veterinary service issued by one of the following permissions: 65.1. veterinary medicinal products (other than immunological veterinary medicinal products) import and distribution of veterinary practice authorisation (hereinafter referred to as the distribution of veterinary medicinal products authorised for the provision of veterinary practices); 65.2. veterinary medicinal products (other than immunological veterinary medicinal products) import and use authorization in exceptional cases (hereinafter referred to as the authorisation of veterinary medicinal products); 65.3. the immunological veterinary medicinal product (hereinafter referred to as the vaccine) importation and usage permission exceptional cases (hereinafter referred to as the consent to use of the vaccine).
66. The food and veterinary service will establish and maintain the necessary veterinary active substance, veterinary medicinal products containing it and indicating the target species list (hereinafter referred to as the list of active substances), taking into account the Veterinarian Association of Latvia. 67. the veterinarian Association prepares a proposal for the veterinary practice active substances required by the target species of the veterinary medicinal product and the indication, taking into account the following criteria: 67.1. veterinary medicinal products containing the same active substance or combination of substances, strength, shape and usage are not included in the Latvian register of veterinary medicinal products; 67.2. veterinary medicinal products containing active substances, it is necessary: to prevent 67.2.1. suffering and ensure specific diseases, in particular rare diseases in the country, treatment or prevention; 67.2.2. specific target species, in particular sheep, goats, horses, bees, aquaculture, wildlife and exotic animals; 67.2.3. a small, but permanent; 67.3. the active substance satisfies the maximum residue levels of regulatory laws; 41.9. in the case of veterinary medicinal products intended for equidae, have been compliance with the substance of the active substances referred to in the Commission's 13 December 2006 Regulation (EC) no 1950/2006 of the European Parliament and of the Council Directive 2001/82/EC on the Community code relating to veterinary medicinal products, establish a list of substances which are essential for the treatment of equidae and for which additional clinical benefit If the active substance is required for the treatment of equidae. 68. the veterinarian Association of 67. these provisions referred to in paragraph 1, the proposal shall be submitted to the food and veterinary service, specifying at least the following: 68.1. the active substance or combination of substances, strength, form, route of administration and the desired size of the packaging; 68.2. indications – disease and symptoms that need treatment or prevention of active substances in veterinary medicinal products; 68.3. target species or target species; 68.4. If possible, the active substance of necessity rationale: 68.4.1. estimated number of animals number of flocks or aquaculture (tonnes, ponds), which require active substances in veterinary medicinal products; 68.4.2. information on the incidence of the disease and current state; 68.4.3. estimated the required quantity of active substance per year, if possible; 68.4.4. other information on animal health or welfare grounds. 69. The food and veterinary service shall evaluate these rules referred to in paragraph 68 of the Latvian society Veterinarian and active substance of proposals: 69.1. active substances included in the list if it meets this rule 67. criteria referred to in paragraph 1; EB 69.2. refused to include the active substance in the list: 69.2.1. veterinary medicinal products are included in the register of veterinary medicinal products containing the same active substance or combination thereof with the same pharmaceutical form, strength and route of administration; 69.2.2. the active substance shall be prohibited from using certain target species in accordance with the requirements of the laws or the food and veterinary service following restrictions specified on the basis of the animal health and welfare, public health or environmental reasons; 69.2.3. There are other circumstances based on animal health and welfare, public health or environmental reasons. 70. The food and veterinary service does the following: 70.1. ensure the active substances of the public availability in your tīmekļvietn by using the following information: 70.1.1. active substance or substances in combination, the strength, the pharmaceutical form, route of administration and, if required, it is recommended that the size of the packaging; 70.1.2. target species; 70.1.3. indications for use; 70.2. the active substance shall be deleted from the list of active substances in the following cases: 70.2.1. veterinary medicinal products are included in the register of the veterinary medicinal product with the same active substance, target species and indications; 70.2.2. active substance included in the list of active street is prohibited for use in animals the European Union directly applicable law, national laws and regulations or the food and veterinary service of the decision, taking into account the risks to animal health and welfare, public health or the environment; 70.3. the updating of the information published in the list of active substances within 10 working days of the new active substance inclusion list or within three working days after the removal of the active substance.
9.2. requirements the country unregistered distribution of veterinary medicinal products for veterinary practice provision 71. distribution of the veterinary medicinal product authorisation for the provision of veterinary practice you can get food and veterinary service of the object in the registry include the lieltirgotav of the veterinary medicinal product in Latvia: 71.1. veterinary medicinal products the active substance, the target species of the veterinary medicinal product and the indication is included in the list of active substances; 71.2. the veterinary medicinal product is registered in another Member State; 71.3. the lack of veterinary medicines can cause hazard to animal health and welfare, public health or the environment. 72. in order to obtain the distribution authorization of veterinary medicinal products, veterinary practice (annex 3), the veterinary medicinal products lieltirgotav: 72.1. intention to import and distribute the veterinary medicinal product in Latvia shall notify in writing the veterinary medicinal products concerned on the registration certificate to the owner or his authorised representative; 72.2. submitted to the food and veterinary service of the application (annex 4).
73. The food and veterinary service shall evaluate this rule 72.2. the application referred to and adopted decisions on: 73.1. distribution of the veterinary medicinal product authorisation for the provision of veterinary practice, in the case of veterinary medicinal products complies with this provision in paragraph 71 above; 73.2. refusal to issue a permit to the distribution of veterinary medicinal products, veterinary practices, if: 73.2.1. constituting of veterinary medicinal products the active substance or combination of active substances, indications for use, and the target is not in the list of active substances; 73.2.2. a register of veterinary medicinal products are included in the same veterinary medicinal product or veterinary drug with the same active substance or combination of active substances, strength, use, indications, route of administration and target species (hereinafter referred to as the equivalent of veterinary medicinal products); 73.2.3. the application and the attached documents not submitted in accordance with the movement of veterinary medicinal products regulatory legislation and by the food and veterinary service request permission to the applicant has not made the necessary adjustment or application contains news is misleading; 73.2.4. the Member State of importation for veterinary medicinal products, the registration certificate has been suspended or withdrawn; 73.2.5. the manufacturer of the veterinary medicinal product, the transaction is reversed or the manufacture of the veterinary medicinal product concerned stopped animal health and welfare, public health or environmental reasons; 73.2.6. the application of veterinary medicinal products attached to the description, instructions for use, the label does not match the description of the State approved, instruction for use, marking as specified in the application of the veterinary medicinal product, the registration certificate of the issuing country (e.g., different target species, indications for use, dosage, route of Administration); 73.2.7. There are others with animal health and welfare, public health or the protection of the environment, sound reasons. 74. the distribution of veterinary medicinal products authorised for the provision of veterinary practices recipient: 74.1. the import of the veterinary medicinal product launch and distribution in Latvia within three months after receipt of the authorization; 74.2. veterinary medicinal products are imported only from the countries specified in the authorization and manufacturer; 46.2. any packaging of the veterinary medicinal product by the food and veterinary service coordinated the use of veterinary medicinal products in the national language of instruction according to the laws and regulations on the labelling of the veterinary medicinal product; 74.4. within five working days of receipt of the information in writing to the food and veterinary service: 74.4.1. the veterinary medicinal product registration certificate suspension or revocation of the country in which it was issued, as well as the suspension or cancellation reasons; 74.4.2. about the changes in the conditions of registration of veterinary medicinal products in the country issuing the registration certificate are approved in accordance with the requirements of Commission 24 November 2008. Regulation (EC) No 1234/2008 concerning the examination of variations of a marketing authorisation for medicinal products for human use and veterinary medicinal products for conditions; 74.4.3. the intention to stop imports of veterinary medicinal products, stating the date on which the suspend imports of veterinary medicinal products; 46.3. veterinary medicinal products provides storage, transport and records in accordance with requirements of this regulation; 74.6. veterinary medicinal products distributed veterinary practices; 74.7 at information gathering. provides and reporting to the food and veterinary service of the use of the veterinary medicinal product-related adverse reactions, in accordance with the legislation on veterinary of pharmacovigilance; 46.5. information about imported and distributed veterinary medicinal products given in accordance with the laws and regulations on the collection and statistical information making arrangements for the movement of veterinary medicinal products; 74.9. ensure the withdrawal of the veterinary medicinal product on the market, this provision in Chapter 12 cases and order; 74.10. ensure invalid destruction of the veterinary medicinal product in accordance with the laws and regulations on waste management; 74.11. five working days prior to the distribution of veterinary medicinal products authorised for the provision of veterinary practices the expiry shall inform the food and veterinary service of the country of the veterinary medicinal product imported items that are not common, showing the primary packaging of the veterinary medicinal product, the number of secondary packaging, secondary packaging, number of serial number and expiration date, if applicable. 75. The food and veterinary service of the decision: stop 75.1. the distribution of veterinary medicinal products authorised for the provision of veterinary practice where: 75.1.1. the Member State which issued the registration certificate of the veterinary medicinal product, its operation is suspended; 75.1.2. manufacture of the veterinary medicinal product concerned is stopped on animal health and welfare, public health or environmental reasons; 75.1.3. the beneficiary of the authorisation provided the food and veterinary service has submitted an application for its suspension of the veterinārfarmaceitisk for a period that is shorter than the period of validity of the authorisation; 75.2. restore the distribution of veterinary medicinal products authorised for the provision of veterinary practice, if: 75.2.1. the beneficiary of the authorisation provided the food and veterinary service has submitted an application for renewal of authorisation, adding one of the following attestations: 75.2.1.1. State that stopped the veterinary medicinal products concerned the operation of the registration certificate, it is renewed; 75.2.1.2. manufacture of the veterinary medicinal product concerned has been restored; 75.2.1.3. veterinārfarmaceitisk activity is renewed. 76. a food and veterinary service shall take the decision to withdraw the authorisation of veterinary medicinal products in the distribution for the provision of veterinary practice, if these permissions: 76.1. beneficiary has ceased veterinārfarmaceitisk activities or has ceased to import and distribute the mentioned in the authorisation of veterinary medicinal products; 76.2. the beneficiary of the authorisation submits a request for the withdrawal of the authorisation; 76.3. the permit specified in veterinary medicinal products, active substances included in the target species and the indications for use are deleted from the list of active substances; 76.4. the Member State which issued the certificate of registration of veterinary medicinal products, a certificate of registration is cancelled the animal health and welfare, public health or environmental reasons or is prohibited the manufacture of the veterinary medicinal product concerned; 76.5. veterinary medicinal products are included in the register of the same or equivalent to veterinary medicinal products; 47.6. within three months after receipt of the authorization of the veterinary medicinal product is not launched import and distribution; 47.7., has established that the beneficiary of the authorisation provided in breach of this provision in paragraph 65 of the veterinary medicine distribution requirements; 76.8. is another with animal health and welfare, public health or the protection of the environment, reasonable grounds. 77. a food and veterinary service, deciding to revoke the authorisation of veterinary medicinal products in the distribution for the provision of veterinary practice, decide how to handle the remaining country but not the imported, distributed the stock of the veterinary medicinal product.
78.76. These provisions in the case referred to in paragraph distribution authorization of veterinary medicinal products in veterinary practice requires the recipient within five working days following cancellation, in writing, by the food and veterinary service of the following information about the country, but not distributed in respect of veterinary medicinal products: 78.1. primary packaging size, indicating volume or weight unit; 78.2. quantity of veterinary medicinal products, stating the number of primary packaging secondary packaging, secondary packaging; 78.3. serial number; 78.4. validity period. 79. If the distribution of veterinary medicinal products authorised for the provision of veterinary practice cancelled for reasons which do not pose a threat to the animal health and welfare, public health or the environment, the food and veterinary service permission to distribute the country imported stocks of veterinary medicinal products in accordance with the provisions of paragraph 60. 80. a food and veterinary service within five working days after this provision referred to 74.11. informed decision to allow to distribute the remaining supplies of veterinary medicinal products in accordance with the provisions of paragraph 61 of the conditions or prohibition to distribute them, taking into account the risks to animal health and welfare, public health or the environment. 81. the distribution of veterinary medicinal products authorised for the provision of veterinary practice the recipient provides the remaining destruction of veterinary medicinal products in accordance with legislation on waste management, where the food and veterinary service shall take a decision to prohibit the spread of this provision in or 74.11, paragraph 77 remaining inventory of veterinary medicinal products.
9.3. in the country do not register the distribution of veterinary medicinal products in exceptional cases 82. consent to use of the veterinary medicinal product may require a food and veterinary service of the object included in the registry lieltirgotav for veterinary medicinal products, veterinary medicinal products, the importer or the veterinary practice authority in the following cases: 82.1. veterinary medicinal products are included in the Latvian register of veterinary medicinal products, but is not distributed in Latvia; 82.2. the veterinary medicinal product is not included in the Latvian register of veterinary medicines, but are registered in another country, and the veterinary medicinal products the active substance, the target species and indications for use: 82.2.1. active substances have been included in the list, and the veterinary medicinal product is not issued to the distribution of veterinary medicinal products authorised veterinary practices; 82.2.2. not included in the list of active substances; 82.3. veterinary medicinal products needed: 82.3.1. a particular animal or group of animals or treatment or prevention of disease, in particular veterinary practice; 82.3.2. specific herd treatment or prevention, if the owner of the animals that have received this rule 9.4. authorization referred to, has been submitted to the responsible official veterinarian practicing request. 83. for medicinal products for veterinary use (annex 5), lieltirgotav, veterinary medicinal products, veterinary medicinal products, the importer or the veterinary practice the authority shall provide the food and veterinary service of the application (annex 6). 84. The use of veterinary medicinal products: 84.1 receiving authorisation. information about imported or imported veterinary medicinal products given in accordance with the laws and regulations on the collection and statistical information making arrangements for the movement of veterinary medicinal products, where the received lieltirgotav of the veterinary medicinal product or the importer; 52.3. information about the imported veterinary medicinal products within five working days after the event, notify the food and veterinary service to the specified e-mail address or by telephone, mentioning the date of entry and quantity of veterinary medicinal products, as well as specifying the primary packaging size, volume or weight of the packing units, the number of primary and serial number, if the permit received veterinary practices; 84.3. about the use of veterinary medicinal products-induced side effects inform food and veterinary services in accordance with the laws and regulations on the use of veterinary medicines side effects monitoring arrangements; 84.4. the veterinary medicinal product is stored, transported and reference lists from distribution in accordance with the requirements of this regulation, given that the authorisation of that veterinary medicinal product: 84.4.1. only in supplying veterinary practice where the use of veterinary medicinal products has received the authorization of the veterinary medicinal product or the importer lieltirgotav; 84.4.2. used only in his veterinary practice, if the use of the veterinary medicinal product has received the permission of the veterinary practice; 84.5. within five working days of receipt of the information in writing to the food and veterinary service, if the received information that the veterinary medicinal product concerned is withdrawn registration certificate manufacturing and distribution or is prohibited in the country of importation of the veterinary medicinal product; 84.6. veterinary medicinal products imported from the country and purchased from the person specified in the application for authorisation of the use of veterinary medicines; 84.7. information on prices for imported veterinary medicinal products provided by the food and veterinary service request, if the authorization has received veterinary practices; 84.8. no veterinary medicinal product issued is destroyed according to the legislation on waste management, except for this provision, paragraph 99.
9.4. in the country unregistered vaccines for distribution in exceptional cases 85. Vaccine usage rights (annex 7) may require a food and veterinary service of the object in the registry include the lieltirgotav of the veterinary medicinal product, the importer or the veterinary practice authority in the following cases: 85.1. vaccine is included in the Latvian register of veterinary medicinal products, but is not distributed in Latvia; 85.2. the vaccine is not included in the Latvian register of veterinary medicines, but is registered in another country; 85.3. vaccine required: 85.3.1. particular animal or group of animals infectious disease treatment or prevention of specific veterinary practice; 85.3.2. specific herd animal infectious disease treatment or prevention, if the animal owner has entered into a contract with a veterinary practice authority for veterinary services and the medical institution concerned veterinarian this vaccine has requested a systematic vaccination.
86. If the vaccine needs of the livestock herd scheduled vaccinations for infectious disease containment or preventive measures, an animal owner provides: 53.5. herd vaccination plan (hereinafter referred to as the livestock vaccination plan). Herd vaccination plan shall specify the name of the proposed vaccines and the vaccination target, justified the need for the vaccine and the frequency of use and, if possible, include the evaluation of the effectiveness of the vaccination; 86.2. laws and biosecurity measures for animal holding the biosecurity measures. 87.86. These provisions referred to in paragraph 1, the vaccination of livestock the plan: 87.1. has developed the responsible veterinarian practicing veterinary practice or institution who is under contract with the owner of the animals of veterinary services; 87.2. the signature and the imprint of the stamp of the veterinary practice has been approved by the practicing veterinarian and approved with the signature of the owner of the animal; is the food agreement 101.8. and veterinary service. Herd vaccination plan for the harmonization of food and veterinary service shall submit together with this provision the application referred to in paragraph 88. 88. in order to receive permission to use of the vaccine, lieltirgotav, veterinary medicines or veterinary practice, the importer shall provide the food and veterinary service of the application (annex 8). 89. the use of a vaccine recipient of authorization, the following requirements shall be met: 89.1. information about imported and distributed vaccines, given in accordance with the laws and regulations on the collection and statistical information making arrangements for the movement of veterinary medicinal products, if the authorisation is received lieltirgotav of the veterinary medicinal product or the importer; 89.2. information on imported vaccines, within five working days after their introduction into the food and veterinary service to the specified e-mail address or by telephone, stating the date of entry, the name and quantity of the vaccine, as well as specifying the number of doses in the package number of packages and the serial number, if the permit is received by the veterinary practice; 89.3. within five working days of receipt of the information in writing to the food and veterinary service: 89.3.1. about the changes in the instructions for use of the vaccine, the label and description, approved in the State issuing the registration certificate of the vaccine; 89.3.2. for cancellation of the registration certificate of the vaccine or the suspension of production in the country that has issued the certificate of registration and the reasons for the suspension; 89.4. report to the food and veterinary service of the vaccine-related side effects of use in accordance with the legislation on veterinary of pharmacovigilance; 89.5. vaccines stored, recorded, and withdrawn from distribution in accordance with the requirements of this regulation, given that the vaccines referred to: 89.5.1. permission to use the vaccine only be issued to the people below, if the authorisation is received lieltirgotav of the veterinary medicinal product or the importer; 89.5.2. used only in his veterinary practice, if the vaccine has received permission to use veterinary practices; 55.7. vaccines coming from the country and purchased from the person who is specified in the application for authorisation of the use of vaccines; 55.7. information about the price of the imported vaccine provided by the food and veterinary service request, if the authorization has received veterinary practices; 89.8. vaccine withdrawn from distribution in accordance with Chapter 12 of these rules; 55.9. invalid vaccines and vaccines issued not be disposed of in accordance with the laws and regulations on the management of hazardous waste, except where the authorization of the use of the vaccine in accordance with the provisions of paragraph 99 is not issued for changes to the vaccines. Vaccine intended for destruction of records, identification, storage, packing, labelling and transport records in accordance with regulations on hazardous waste tracking, identification, storage, packaging, labelling and shipping of inventory. 90. the livestock owners whose animals intended for the use of vaccine in the vaccine specified in the authorization, the following requirements shall be met: 90.1. ensure that the vaccine is applied only to animals belonging to him; 90.2. the use of vaccine for at least five years, the following information: name of vaccine 90.2.1. 90.2.2. the vaccine expiration date and serial number; 90.2.3. the vaccine manufacturer's name and address; 90.2.4. official veterinarian practicing it name, and veterinary practice certificate number, which is requested and entered the vaccine in animals; 90.2.5. date when the vaccine entered animals, species, age, number, identification number (if available) and other information, in order to ensure the traceability of animal vaccine and traceability that entered the vaccine; 90.3. the official veterinarian practicing in action transferred the necessary space and provides clinical and laboratory examination for the necessary conditions. 91. A practicing veterinarian who has requested and enter a livestock vaccine specified in the authorization of the use of the vaccine, the following requirements shall be met: 91.1. animal owner has entered into a contract for the provision of services and the veterinary knowledge of herd health status, if a vaccine intended for food-producing animals; the vaccine uses only 91.2. of the herd animals specified in the permit for the use of the vaccine, if vaccine for livestock at the scheduled vaccination; 91.3. ensure the use of vaccine safety monitoring to detect potential risks to animal or human health or the environment; 91.4. lists and at least five years, the following information: name of vaccine 91.4.1. 91.4.2. the animal owner's name and address; 91.4.3. date when the vaccine entered animals, animal species, age and number; 91.4.4. clinical examination and laboratory test results, if such examinations have been carried out, ensuring the use of the vaccine safety monitoring; 91.4.5. use of vaccine side effects; 56.9. upon request, provide food and veterinary service information on vaccine safety monitoring of the use of the results and other vaccine-related information.
9.5. The food and veterinary service, monitoring the country distribution of veterinary medicinal products registered exceptionally 92. food and veterinary service shall evaluate this rule 83. and application referred to in paragraph 88 and accompanying documents, and shall take a decision: 57.2. about the use of veterinary medicinal products in use, licence or permit of the vaccine if the veterinary medicinal product complies with this provision or paragraph 85 82. these requirements and the application and attached documents meet the requirements of these regulations; 92.2. refusal to issue a permit for the use of veterinary medicines or vaccines for permission to use the following where: 92.2.1. register of veterinary medicinal products are included and are available at the same or equivalent to the veterinary medicinal product, where the application of that veterinary medicinal product planned to be imported from another Member State; 92.2.2. Member States are recorded and are available for the same veterinary medicinal product if the application in veterinary drug scheduled to be imported from a third country;
92.2.3. the application and the attached documents not submitted in accordance with the requirements of these regulations and the food and veterinary service has not been submitted within the time limit set in the required additional information or submit news is misleading; 92.2.4. with food and veterinary service is not consistent livestock vaccination plan, if the vaccine is for livestock herd systematic vaccination; 92.2.5. the State planned to import veterinary medicinal product, its operation, or of the registration certificate manufacturing and distribution has been suspended or withdrawn; 92.2.6. the manufacturer of the veterinary medicinal product or the distributor from which you purchased for veterinary medicinal products, is not entitled to produce or distribute the veterinary medicinal product concerned; 92.2.7. the application of veterinary medicinal products attached to the description, instructions or label does not meet the approved of the State Veterinary Medicine description, instructions and marking as specified in the application of the veterinary medicinal product, country of registration, such as different species, indications, dose; 92.2.8. intended for food-producing animals of veterinary medicinal products in the composition of active substances not specified the maximum amount of residue or veterinary medicinal product contains prohibited substances in the European Union; 92.2.9. food and veterinary service has banned the use of the vaccine in animals or the use of such products is prohibited by laws and regulations; 92.2.10. There are others with animal health and welfare, public health or the protection of the environment, sound reasons.
93. a food and veterinary service shall take a decision on the authorisation of the use of veterinary medicines or vaccines for the withdrawal of the authorisation of the use in the following cases: 93.1. veterinary medicinal products are included in the registry or placed on the market for the same or equivalent to veterinary medicinal products; 93.2. country from which imported veterinary medicinal products, veterinary medicinal products, the operation of the certificate of registration is cancelled the animal health and welfare, public health or environmental reasons or is prohibited in the manufacture of veterinary medicinal products and distribution; 93.3. intended for food-producing animals of veterinary medicinal products the active substance is determined for the European Union prohibited substances; 93.4. food and veterinary service prohibits the use of vaccines or vaccine use this is prohibited in accordance with the regulations; 93.5. the recipient stops veterinārfarmaceitisk or veterinary activities; the application was received 93.6. revoke that authorization; 93.7. the recipient is in breach of these provisions in paragraph 65 of the veterinary medicine distribution requirements; 58.3. There are others with animal health and welfare, public health or the protection of the environment, sound reasons.
9.6. The food and veterinary service of the decision on the country registered the distribution of veterinary medicinal products 94. food and veterinary service: 94.1. takes decision about: 94.1.1. the use of veterinary medicinal products-licences within 10 working days of the requirements of this regulation according to the application and all necessary information; 94.1.2. the distribution of veterinary medicinal products for the issue or renewal of the authorisation of the administrative procedure law; 94.1.3. use of vaccines permits: If the vaccine is intended 94.1.3.1. systematic vaccination – administrative procedure law; 94.1.3.2. If the vaccine is not designed for systematic vaccination, within 10 working days of the requirements of this regulation according to the application and all necessary information; 94.2. issue: 94.2.1. the distribution of veterinary medicinal products authorised for the provision of veterinary practice for a period not exceeding one year; 94.2.2. the use of the veterinary medicinal product authorisation for a period not exceeding three months; 94.2.3. permission to use the vaccine: 94.2.3.1. If it is not provided for the systematic vaccination, for a period not exceeding three months; 94.2.3.2. If it is intended for scheduled vaccinations — for a period not exceeding one year, taking into account livestock vaccination plan set out in the vaccination schedule. 95. a food and veterinary service for distribution of the veterinary medicinal product issued authorization to provide veterinary practices within five working days after the issue of the permit in its tīmekļvietn the following public information: 95.1. name of the veterinary medicinal product, the active substance, form, strength, route of administration, the target species and indications for use; 95.2. registration certificate of the veterinary medicinal product and the owner's name and the Member State; 95.3. veterinary medicinal products, the manufacturer's name and the country of manufacture; 95.4. the distribution of the veterinary medicinal product authorisation: 95.4.1. number and the recipient's name, address, and kontaktinformāciju; 95.4.2. the period of validity; 95.4.3. on the movement of veterinary medicinal products the responsible first name, last name, phone number, and e-mail address. 96. a food and veterinary service of the veterinary medicinal product issued authorization or permission for the use of the vaccine within five working days after the issue of the permit in its tīmekļvietn the following public information: 96.1. veterinary medicinal products, including vaccines, the registration number and the name of the owner of the certificate of registration and the country; 96.2. veterinary medicines and vaccine manufacturer's name and the country of manufacture; 96.3. veterinary medicines and vaccines name, pharmaceutical form, strength or number of doses in the package, if applicable; 59.9. consent to use of the veterinary medicinal product or the vaccine. usage permissions: 96.4.1 number and the recipient's name or business name; 96.4.2. the period of validity. 97. The food and veterinary service: 60.3. within five working days after the receipt of new information supports this provision and paragraph 95.96. updating of the information referred to in; 97.2. This provision, the information referred to in paragraph 96 of the stores publicly available not less than one year after the expiry date of the authorisation. 98. This provision permits referred to in paragraph 65 of the recipient the veterinary medicinal product is authorised to be imported into the country until the expiry date of the authorisation.
9.7. the changes in the country are not registered in the distribution of veterinary medicinal products 99. food and veterinary service may make changes to the use of veterinary medicinal products in the authorisation or permission to use the vaccine if the relevant permissions received the recipient's application for changes. 100. where the authorization of the use of veterinary medicines or vaccines for use in veterinary practice referred to in the authorisation authority has waived the relevant veterinary medicinal products which are imported into the country, but has not been granted the appropriate permissions, the recipient of food and veterinary service shall submit an application, including: 100.1. the authorization number, date of issue and expiry date; 100.2. the beneficiary's name and address; 100.3. the authorization referred to in the name of the person and the name and address, which refused to receive veterinary medicinal products; 100.4. veterinary practice authority wishing to receive veterinary medicinal product concerned, indicating the full name and address; 100.5. name of the veterinary medicinal product and the quantity intended to issue the rule in subparagraph above 100.4. veterinary practice; 100.6. the justification of changes that added to the veterinary practice in the request of the authority of the veterinary medicinal product concerned. 101. The food and veterinary service evaluated within 10 working days of this provision, the information referred to in paragraph 100 and decide on changes in the use of veterinary medicinal products in the authorisation or permission to use the vaccine in a person who is entitled to receive veterinary medicinal products, or on refusal to make changes to animal health and welfare, public health or environmental reasons. 102. The provisions referred to in paragraph 65 of the authorisation the applicant this provision 71.83.88, or an application referred to in paragraph may not add the appropriate assurances on compliance with the information given in the application of legislative requirements, if an application is submitted after these rules repeatedly referred to in paragraph 94 of the expiry date of the authorisation and the relevant details of the veterinary medicinal product and of the applicant for the permit have not changed. 103. the applicant, in submitting that the application referred to in paragraph 65 of the authorization, or changes, in accordance with the laws and regulations establishing procedures for food and veterinary service of the country carried out surveillance and control activities and fees shall be borne by the application and document evaluation and authorisation or changes related to the food and veterinary service.
9.8. the autogenous vaccines Inactivated distribution requirements. 104 to get food and veterinary service permission to the autogenous vaccines inactivated and use (annex 9), a practicing veterinarian and veterinary services to food submitted the application and accompanying documents pursuant to this provision 10. specimen in the annex. 105. Veterinary practice authority or that rule 14.1. referred to practicing responsible veterinarian requires that the authorization referred to in paragraph 104 only if not available in Latvia 105.1. registered veterinary immunological products, which gives a positive therapeutic effect for certain specific animal disease treatment or prevention; 105.2. autogenous vaccine inactivated (autogenous vaccine) is based on the clinical diagnosis and laboratory findings; 105.3. autogenous vaccines intended for the manufacture of the micro-organism cultures, isolated from the infected herd animals, and it is intended for use only in the infection control and prevention at the same spot on the herd; autogenous vaccine contains 105.4. micro-cultural or extracts that are inactivated and non-toxic; 105.5. autogenous vaccines produce company that received: 105.5.1. food and veterinary service of issuing the certificate of good manufacturing practice, if the manufacturer is located in Latvia; 105.5.2. other competent authorities of the Member State issuing the certificate of good manufacturing practice, if the manufacturer is located in another Member State. 106. the authority or Veterinary practice practicing responsible veterinarian, who determined the need for this particular animal animals belonging to the owner to use the autogenous vaccines: 106.1. has entered into with the owner of the animals contract for veterinary services and knowledge of herd health status; 106.2. autogenous vaccines use only those animals that are specified in this rule referred to in paragraph 104 of the food and veterinary service of the authorisation; 106.3 autogenous vaccines before the herd of animals make use of Autogenous vaccine effectiveness and safety tests of the target species of animal group. 106.4. ensure the use of Autogenous vaccine safety monitoring to detect potential risks to animal or human health or the environment; 106.5. upon request, provide food and veterinary service of the autogenous vaccine information for safe use of the results of the monitoring, the manufacturer's quality certificate issued in the series and another with autogenous vaccine-related information; 106.6. autogenous vaccines provide storage in accordance with the manufacturer's instructions; 106.7. the following information on the use of Autogenous vaccines: 106.7.1. the name given by the manufacturer of the vaccine; 106.7.2. the vaccine expiration date and serial number; 106.7.3. the manufacturer of the vaccine name, address and telephone number; 106.7.4. date when the vaccine entered animals, animal species, age and number; 106.7.5. the animal owner's name and address; 106.7.6. use of vaccine side effects, as well as clinical examinations and laboratory test results, making use of the vaccine safety monitoring; 106.8. one working days referred to in the authorisation are autogenous vaccines shall inform the food and veterinary service on the date of entry of the vaccines, the vaccines imported volume and the number of animal species and to vaccinate. 107. the owner of the Animal, which animal the autogenous vaccine, the following requirements shall be met: 107.1. the vaccine will enter the autogenous only animals belonging to him that are specified in this provision in paragraph 104, the permit and it is not distributed to other persons; about autogenous vaccines 107.2. importation and use of at least five years, the following information: 107.2.1 of the vaccine manufacturer's assigned. name; 107.2.2. the vaccine expiration date and serial number; 107.2.3. the manufacturer of the vaccine name, address and telephone number; 107.2.4. the official veterinarian practitioner name and certificate number of the veterinary practice, who enters the vaccine in animals; 107.2.5. date when the vaccine entered animals, species, age, number, identification number (if available) and other information, in order to ensure the traceability of the animals that enter the vaccine and autogenous the autogenous vaccine; 107.3. promote this provision in paragraph 106 of the practicing veterinarian action by passing the required space and providing clinical and laboratory examination for the necessary conditions. 108. the Autogenous vaccine manufacturer: 108.1. autogenous vaccine in the primary markets shall specify at least the following information: 108.1.1. the name given to the autogenous vaccines, such as in autogenous vaccine inactivated, micro-organisms and the target species. The autogenous vaccine prohibited to grant trade name; 108.1.2. package size, specifying the quantity or weight of the volume, and the number of doses; 108.1.3. name and address of the manufacturer; 108.1.4. the owner's name and address, which the vaccine for animals to enter; 108.1.5. the autogenous vaccine expiration date and serial number; 108.2. autogenous vaccines in the instructions for use shall contain at least the following information: 108.2.1 the name given to the autogenous vaccine; 108.2.2. the manufacturer's name, address and telephone number; autogenous vaccine 108.2.3. components, specifying the isolated microorganisms, preservatives and other AIDS; 108.2.4. package size, specifying the quantity or weight of the volume, and the number of doses; 108.2.5. the route of administration, dose and frequency; 108.2.6. expiration date and serial number; 108.2.7. storage conditions and special precautions; 108.2.8. the official veterinarian practitioner name and certificate number of the veterinary practice, who have requested vaccine and animal owner (holder's) name and address; 108.2.9. the indication "for use in animals. Clinically healthy (non point) vaccination against infectious diseases, which suggests (point to a particular strain of micro-organisms). Do not vaccinate 21 days before slaughter of animals (or indicates a longer withdrawal period, if any, subject to certain vaccine adjuvant added to the withdrawal period). Use only if not available on the register of the veterinary medicinal product. Vaccine for animals may enter only practicing veterinarian or veterinarian practicing under direct supervision ". 109. The food and veterinary service shall evaluate these rules referred to in paragraph 104 of the applications and accompanying documents, and shall adopt one of the following decisions: 109.1. authorise the autogenous vaccine inactivated and use, if the applicant complies with this provision and paragraph 108 104. those requirements and the information provided is complete and true; 109.2. to refuse authorisation of Autogenous vaccines inactivated, and for use in the following cases: 109.2.1. are available according to the established veterinary immunological products in Latvia or in other Member States; 109.2.2. information and documentation submitted is incomplete, autogenous vaccines is not justified and the applicant has provided false information; 109.2.3. the autogenous vaccine production takes place in the company, which does not meet the good manufacturing practice requirements and is not licensed to manufacture the veterinary medicinal product concerned; 109.2.4. the autogenous vaccines use could pose a risk to animal or human health or the environment; 109.2.5. the use of Autogenous vaccines can make it infectious disease diagnosis, control and eradication, eradication and control of which is in accordance with the infectious animal disease control programme of the country. 110. a food and veterinary service permission to inactivated vaccines, and autogenous use granted for not more than one year. 111. The food and veterinary service may cancel the permission of Autogenous vaccines inactivated and use if: 111.1. in Latvia or in any other Member State are recorded in immunological veterinary medicinal products for the treatment of the animals concerned; 111.2. practicing veterinarian or animal owner is in breach of these conditions in the permit, including the permit that the permit that the vaccine is distributed in autogenous to another person; 111.3. There is no guarantee of sterility or autogenous vaccines, inactivation, it creates an infectious disease spreading and risk to animal or human health or the environment; autogenous vaccines 111.4. use monitoring results show that the use of the risk-benefit assessment is favourable; 111.5. animal food products derived from vaccinated animals have found substances that may pose a risk to animal and human health.
10. Veterinary Medicine distribution monitoring and control 112. food and veterinary service monitors and controls the distribution of veterinary medicinal products in compliance with the requirements of this regulation.
113. A wide range of diseases or epizootic disease threat to the food and veterinary service may temporarily authorise the distribution and use of unregistered immunological veterinary medicinal product, where appropriate in Latvia the veterinary medicinal product is not registered, are not available or are available in small quantities. 114. The food and veterinary service is entitled to authorize and use this rule 113 referred to 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 required the use of immunological veterinary medicinal products.
115. where the animal is exported to a third country, the food and veterinary service is entitled to authorize the treatment of the animals in question apply to 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.
116. If food and veterinary service, finds that this provision in paragraph 5 that the person who distributes the veterinary medicinal product in the Republic of Latvia in accordance with article 25.1 of the pharmaceutical law, does not comply with those in the licence conditions and the movement of veterinary medicinal products regulatory legislation, the food and veterinary service shall inform the issuer of the relevant licence to the competent authority of the Member State of the alleged infringements.
117. The food and veterinary service movement of veterinary medicinal products regulations govern the cases prohibits the distribution of veterinary medicinal products: 117.1. 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; 117.2. veterinary medicinal products not intended therapeutic effect on the target species; 117.3. the veterinary medicinal product, qualitative and quantitative composition of veterinary medicinal products does not match the certificate of registration indicated in the documentation; 117.4. 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; 117.5. manufacture of veterinary medicinal products or import does not match the 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 food and veterinary service of the pharmaceutical law, or, in the case referred to in article 51.2-State Agency of medicines of the veterinary medicinal product in production licence; 117.6. veterinary medicinal products, labelling or the package leaflet do not comply with the requirements of this regulation; 117.7. information submitted for the registration certificate are true; 117.8. veterinary medicinal products are not added to the contrast medium, if necessary add a contrast medium in accordance with the requirements specified in the registration certificate;
117.9. the veterinary medicinal product is prohibited in accordance with the movement of veterinary medicinal products regulatory laws and requirements. 118. The food and veterinary service has the right to impose a prohibition to deliver or withdraw from a trade only contested series of veterinary medicinal products.
119. The food and veterinary service is entitled to prohibit the importation of immunological veterinary medicinal products, and distribution throughout the territory of Latvia or its part if: the use of the product referred to 119.1. makes: 119.1.1. the diagnosis of the disease, infection control and eradication, eradication and control of which is in accordance with the national infectious disease eradication programme; 119.1.2. opinion on the contamination in live animals; 119.1.3. opinion on pollution in food of animal origin or other products derived from vaccinated animals; 119.2. throughout the territory of Latvia or its part is not present in the disease to which the immunological veterinary medicinal product causes immunity; 119.3. it other movement of veterinary medicinal products regulatory laws. 120. a food and veterinary service shall inform: 120.1. the European Commission when the territory of Latvia has banned some of the immunological veterinary medicinal product importation, distribution or production; 120.2. the health inspection of the alleged infringements of the illicit manufacture of narcotic drugs and psychotropic drug circulation within three working days after the finding of fact. 121. a food and veterinary service comply with the European Parliament and of the Council of 31 March 2004, Regulation (EC) No 726/2004 laying down the procedures for the authorisation and supervision of medicinal products for human and veterinary use Community procedures and establishing a European Medicines Agency (hereinafter Regulation No 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. 122. The food and veterinary service may request information from veterinary medicinal products, the competent authorities of the home Member State, if the chain found high-quality veterinary medicine. 123. If food and veterinary service, based on risk to human or animal health, challenging another decision of the competent authority of the Member State, it shall inform the relevant competent authority of their objections or requests additional information. The food and veterinary service shall also inform the European Commission and the European Medicines Agency, if there are significant differences of opinion between the food and veterinary service and other competent authority of the Member State. 124. the distribution of veterinary medicinal products, suspension or withdrawal, arguing such action, the registration of veterinary medicinal products, the licence holder shall report to the food and Veterinary Office and the Member States, which are distributed to those veterinary medicinal products.
11. The immunological veterinary medicinal product quality control requirements 125. food and veterinary service requires the immunological veterinary medicinal product to the holder of the certificate of registration before the start of distribution of veterinary medicinal products to submit bulk samples of this product series for testing by an official medicines control laboratory, if it is justified by reasons of animal health and welfare, public health or the protection of the environment. 126. After the food and veterinary service of the immunological veterinary medicinal product at the request of the owner of the registration certificate, the food and veterinary service of the submitted samples with the serial output of 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 food and veterinary service organizes the sampling. The food and veterinary service is entitled to recognise other Member States the official medicines control laboratory testing results. In the case of veterinary medicinal products manufactured in Latvia, the food and veterinary service, based on a series production Protocol and study results, declares their conformity with the approved specifications.
127. The food and veterinary service of the intention to implement the provisions referred to in paragraph 126 of review inform the European quality Directorate and the other Member States which are established in the veterinary medicinal product concerned.
128. If the competent institution of another Member State shall inform the food and veterinary service of the intention to carry out the provisions mentioned in paragraph 126, the food and veterinary service that checking is not performed.
129. following these rules referred to in paragraph 126 of the serial output of the medicinal product certificate examination on the quality of veterinary medicinal products in the laboratory responsible for the control, using the samples placed at its disposal, repeats all veterinary medicinal products by the producer of the serial output checks appropriate to the registration of veterinary medicinal products. 130. The number of inspections, which repeats for control of veterinary medicinal products in a laboratory authorized to cut only with the consent of all the Member States in which the medicinal product in question have been registered, and, if necessary, the European Directorate for the quality of medicines. 131. Imunoloģiskaj veterinary medicinal products registered in the centralised procedure of registration in accordance with Regulation No 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. 132. The food and veterinary service recognizes the results of the checks carried out, if the other Member State in accordance with this provision, paragraph 128.
133. This rule checks referred to in paragraph 126 of the food and veterinary service of the administrative procedure conducted in accordance with the procedure prescribed by law, but no later than 60 days after receipt of samples. If the inspection requires a longer time, the food and veterinary service shall inform the European Commission of time and justifies it.
134. The food and veterinary service 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 and the owner of the registration certificate of the immunological veterinary medicinal product manufacturer.
135. If the immunological veterinary medicinal product does not meet a series of veterinary medicinal products, the manufacturer's serial output supplied certificate or registration of veterinary medicinal products, the food and veterinary service according to the requirements of these regulations, shall decide on the distribution of the immunological veterinary medicinal product authorisation or refusal to issue a permit and the decision taken shall inform the Member States in which the medicinal product concerned is logged.
12. withdrawal of a veterinary medicinal product order 136. Veterinary medicinal products is prohibited, as well as withdrawals are from the market, if the medicinal product is covered by one or more of the following conditions: 136.1. veterinary medicinal products used in accordance with the instructions and in accordance with the terms of the registration dossier, endanger animal or human health; 136.2. veterinary medicinal products have no therapeutic effectiveness; 136.3. veterinary medicinal benefits and risk balance is not favourable for the authorized conditions of use; veterinary medicine 136.4. qualitative and quantitative composition is not as described in the registration dossier; 136.5. 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, to grant a licence for the manufacture of veterinary medicinal products; 136.6. period during which the medication withdrawal exceeds the withdrawal period laid down in the legislation on maximum residue levels of the medicinal products in foodstuffs of animal origin.
137. the revocation is an action series, applied to the 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. 138. The veterinary medicinal product, the manufacturer shall inform the food and veterinary service: 138.1. on 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 it is related to the effects of the veterinary medicinal product or animal or human health; 138.2. 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 11) and specify the country to which the veterinary medicinal product with a defect.
139. If there is a suspicion the quality of veterinary medicinal products or about this rule referred to in paragraph 55 counterfeit medications or have received a message that the quality of the veterinary medicinal product does not meet the relevant registration conditions referred to in the documentation, the importer, lieltirgotav, pharmacy or veterinary pharmacy, veterinary practice, the authority shall notify the food and veterinary service. If the food and veterinary service has not received notification of the manufacturer of the veterinary medicinal product on quality defects or the withdrawal of the veterinary medicinal product, the importer shall submit such statement or lieltirgotav of the food and veterinary service. 140. 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 marketing authorisation holder, the manufacturer of veterinary medicinal products, the importer, lieltirgotav, veterinary pharmacy, pharmacy or veterinary practice authority by telephone, by fax, electronically or by 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: 140.1. name of the veterinary medicinal product, strength, form, serial number, registration number, the Latvian register of veterinary medicinal products covered by the notification of the suspension of distribution of medicinal products for veterinary use and withdrawal from the market;
140.2. the distribution of suspension and revocation reason of veterinary medicinal products; 140.3. the quality defects the degree (first, second, or third) and description; 140.4. the degree of urgency of the recall; 140.5. details of all customers or only the customer information on the withdrawal of veterinary medicinal products which have received irrevocable series of veterinary medicinal products; 140.6. information about the withdrawal of the veterinary medicinal product from a retail network, or an entire market, if one is set; 140.7. the further disposal of the medicinal product; 140.8. the order in which the veterinary medicinal product is returned to the back of the veterinary medicinal product supplier or registration certificate of the veterinary medicinal product owner; 140.9. veterinary medicinal products collection and destruction; 140.10. procedures will be covered. 141. 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: 141.1. the date and time of receipt of the notification of the suspension of distribution of veterinary medicinal products and veterinary medicinal products withdrawn from the market, as well as a receipt of the form, for example, by telephone, by fax, by electronic means; 141.2. notifier's name or the person (name, title, telephone number, fax number and electronic mail address), which issued a statement on the suspension of distribution of veterinary medicinal products and veterinary medicinal products withdrawn from the market; 141.3. name of the veterinary medicinal product, strength, form, serial number, registration number, the Latvian register of veterinary medicinal products, quality defects the degree (first, second, or third) and a description of the quality defects subject to the notification of the suspension of distribution of veterinary medicinal products and veterinary medicinal products withdrawn from the market; 141.4. distribution of veterinary medicinal products and veterinary medicinal products, suspension of the withdrawal from the market, the person responsible for the name and job title; 141.5. distribution of veterinary medicinal products and veterinary medicinal products, suspension, revocation of market launch date and time. 142.139. These provisions of the person referred to in paragraph 1 within 10 days after completion of the withdrawal of the veterinary medicinal product on the market, the food and veterinary service, submitted a report on the withdrawal of the veterinary medicinal product (annex 12).
143. If food and veterinary service of the veterinary medicinal product has established quality defects or counterfeit medicinal products for veterinary use, food and veterinary service and the rules referred to in paragraph 139 of the person on the distribution of veterinary medicinal products, suspension and revocation of inform by telephone and in writing, for example, by fax, by electronic means: 143.1. four hours after the fact, when the capture of the veterinary medicinal product have found first degree quality defect, (11.) or have found counterfeit medicines; 143.2. within 24 hours after the fact, when the capture of the veterinary medicinal product has found the second stage quality defect (annex 11;) 143.3.48 hours after the fact, when the capture of the veterinary medicinal product is found in the third level of quality defect (annex 11).
144. If the quality defect found in veterinary medicinal products which are exported to a third country, veterinary medicinal products, the manufacturer and exporter of veterinary medicinal products within four hours after the fact of detection of the defect of the product shall notify the veterinary medicinal product to the recipient in the third country, and the food and veterinary service.
145. The veterinary medicinal product, the manufacturer, the importer or lieltirgotav shall submit a food and veterinary service statement: 145.1. According to this provision the model in annex 13 on continuous telephone 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; 145.2. about changes to this provision the information referred to in subparagraph 145.1. – three days after committing it. 146. in practice, Veterinary Authority veterinary pharmacy and pharmacy shall submit a food and veterinary service information about continuous telephone number or other means of communication, through which you can communicate with the persons responsible for the withdrawal of the veterinary medicinal product, and within three days after the change takes place, inform the food and veterinary service about changes.
13. The food and veterinary service's responsibilities in the withdrawal of the veterinary medicinal product and the procedure laid down in this chapter 147. rapid reaction procedure does not apply to emergency response procedures related to the use of veterinary medicinal products on pharmacovigilance. 148. The food and veterinary service at 138. these provisions and referred to in paragraph 139 of the notice and the notice (hereinafter referred to as the notice) to assess the receipt and make sure that the information provided therein shall not apply to the use of the veterinary medicinal product-related side effects. If the quality of the veterinary medicinal product defect may pose risk to human or animal health or the environment, assess the possible risks, as well as the nature and extent of this risk and current and specifies the following information: 148.1. risks to animal or human health or the environment, if the potential quality defects actually exist. If the veterinary medicinal product with a quality defect or prolonged medicinal use are cumulative or immediate effect, assess the risk of human 148.1.1.: health of the medicinal product in question is used for the treatment of animals; 148.1.2. 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; 148.2. possibility that the fault really exists and appears on the veterinary medicinal product by the manufacturer; 148.3. 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); or possible risks 148.4. animal and human health or to the environment is to implement emergency measures, be informed of the emergency situation of the person concerned at any time of day or the withdrawal of a veterinary medicinal product the person responsible for the work; 148.5. veterinary medicinal products manufacturer's information on: 148.5.1. other quality defects in these products related messages; 148.5.2. series, for example, distributed some veterinary practices the authorities distributed wholesale; 148.5.3. date of commencement of the veterinary medicinal product with a quality defect or a series of these medicinal products in the distribution, and the distribution date of last times; 148.5.4. the remaining amount of the item of the veterinary medicinal product to the manufacturer of the veterinary medicinal product; 148.5.5. the possibility that other this product series can have the same defect, and this series of distribution of medicinal products; 148.6. background, if these medications are not available, alternative medicine availability and impact on animal health supplies rupture; 148.7. further activities to be implemented or and needs assessment for the same medicinal product in other series or other veterinary medicinal products and whether this research is continued; 148.8. prohibition to exercise the remaining inventory of the veterinary medicinal product on time or in full; 148.9. good manufacturing practice inspections need manufacturing site of the veterinary medicinal product, to prevent similar situations from happening again; 148.10. or a statement distributed to all or certain veterinary professionals involved in the care or notice of revocation and distributable media, and whether the information to be disclosed by the competent authorities, press tīmekļvietn or similar way.
149. the procedure (hereinafter referred to as the emergency response) include the urgent dispatch of the notice that is specific to veterinary medicinal products or their serial recall. 150. 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 food and veterinary service and: 150.1. The Member States of the European Union and European economic area countries competent authorities; 150.2. the competent authority of the candidate country of the European Union, which has signed a cooperation agreement with the Agency for medicinal products; Pharmaceutical inspection cooperation 150.3. systems of the Secretariat; 150.4. European Directorate for the quality of medicines; 150.5. 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.
151. quick response to the food and veterinary service provides any time of the day.
152. in order to ensure the effectiveness of the emergency response, food and veterinary service rapid response system sends only the emergency information if the risk to animal and human health does not allow 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.
153. a food and veterinary service: 153.1. ensure that: the first degree 153.1.1. defects (annex 11, paragraph 1) is sent in a response statement to all Member States and the institutions referred to in paragraph 150 of these provisions, regardless of whether the revocation of the veterinary medicinal product series has left to the country concerned; 153.1.2. on the secondary fault (annex 11, paragraph 2) is sent in a response message only to those Member States and the institutions referred to in paragraph 150 of these regulations and for which it is known or there is reason to believe that there has been a common irrevocable series of veterinary medicinal products. If the parallel imports of the medicinal product concerned have tracked the rapid notification is sent to the competent authorities of all Member States; 153.2. the communication on third-degree defects (annex 11, paragraph 3) not send; 153.3. 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 150.5. authorities, if the further distribution of the medicinal products in question representing a threat to animal or human health.
154. The food and veterinary service response notification of quality defects/withdrawal of veterinary medicinal products (hereinafter referred to as rapid communication) (annex 14) 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: 154.1. four hours after the fact about the capture of the first fault. Also applies to data transmission in the rapid alert system. If necessary, in addition to also inform on the phone number in the interaction outside of work time; 154.2. within 12 hours after the fact about the capture of the second defect. The rapid alert system for food and veterinary service of the notice shall be sent within 24 hours after notification in Latvia; 154.3.48 hours after the fact about the capture of the third degree of fault. Statement on third-degree defects food and veterinary service provides rapid response system. 155. The food and veterinary service: 155.1. develop such internal regulations: 155.1.1. arrangements for receiving response message; 155.1.2. procedures evaluated rapid communication; 155.1.3. 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; 155.1.4. procedure for the submission of information on quality defects that are not urgent, and on further action to be taken (annex 15); 155.2. order of the officer 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; 155.3. provide the necessary information and support for veterinary medicinal products, the manufacturer of a veterinary medicinal product recall process and supervise the withdrawal process of veterinary medicinal effectiveness; 155.4. information on the withdrawal of a veterinary medicinal product shall immediately notify this rule 150. persons referred to in paragraph 1, if the quality defect poses a serious risk to public and animal health; 155.5. 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; 155.6. information on quality defects of the veterinary medicinal product that is not urgent, these rules provide appropriate annex 14.
156. a food and veterinary service on a case-by-case basis and assess the seriousness 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.
157. If the veterinary medicinal product with a quality defect, including parallel imported and distributed parallel to veterinary medicinal products, originally found in Latvia, the food and veterinary service: the research of quality fault 157.1. and the order of the response message, if the veterinary medicinal product is registered in the national registration procedure; 157.2. quality fault manages research and order of the response message, if the veterinary medicinal product is recorded in the centralised registration procedure or in the case of veterinary medicinal products is a registered national or centralised, mutual recognition or decentralised registration procedure. Notice of withdrawal of the veterinary medicinal product concerned authorities provide proposals for recommended actions. 158. a food and veterinary service 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.
159. 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. 160. 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 notice 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. 161. 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 150 above countries and institutions. 162. The food and veterinary service shall establish and maintain a system to enable 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.
163. The food and veterinary service provides and controls the decision on the suspension of distribution of veterinary medicinal products and the withdrawal of the veterinary medicinal product, as well as the further actions to be taken.
164. The food and veterinary service in its tīmekļvietn the following information concerning the veterinary medicinal products withdrawn: 164.1. name of the veterinary medicinal product, strength, shape, serial number, manufacturer name, and country of manufacture, but veterinary medicinal products registered, registration number; the reason for the withdrawal and 164.2. the veterinary medicinal product, the description of the fault.
165. If the veterinary medicinal product withdrawn from circulation removes the registration certificate 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. 166. in the case of a veterinary medicinal product quality finds and removes from circulation a person who is not the holder of the registration certificate, 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. 167. the distribution for veterinary medicinal products shall be destroyed pursuant to the laws and regulations on waste management. Distribution of invalid on hazardous waste considered as veterinary medicinal products for accounting, identification, storage, packing, labelling and transport records in accordance with regulations on hazardous waste tracking, identification, storage, packaging, labelling and shipping of inventory. 168. the distribution of the veterinary medicinal product or the withdrawal of veterinary medicinal products in the case of a veterinary medicinal product shall be returned back to the supplier of the veterinary medicinal product or veterinary drug registration certificate holder (holder), the delivery document is being prepared under the laws and regulations governing accounting and organization.
14. concluding issues. 169 to declare unenforceable in the Cabinet of 19 June 2007 Regulation No 407 "the labelling of the veterinary medicinal product, distribution, and control rules" (Latvian journal, 2007, no. 100; 2009, 195. No; No 2 2011). 170. before the entry into force of these rules for livestock owners (holders) that does not deal with veterinary practices and veterinary education and science institutions granted authorisation to purchase veterinary drug is effective until further changes to it. 171. before the entry into force of these rules in the country issued tracked distribution of veterinary medicinal products and permits the autogenous vaccines inactivated and use are valid until their expiry date. 172. the application for the authorization of that veterinary medicinal product, the purchase and distribution of these rules submitted by the date of entry into force, according to the requirements of the laws that were in force at the date of the application.
173. the rules shall enter into force on June 15, 2016.
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 Māris kučinskis Agriculture Minister John Dūklav annex 1 Cabinet of 31 May 2016. Regulations No 326 flock number of animals required to obtain permission for the purchase of a veterinary medicinal product no lieltirgotav p. k. Species, sex and age group conversion factor in conditional units of bovine animals the number of animals of the bovine 150 units 1. Cash cow, a suckler cow held 1.000 150 2. Baby up to 12 months. 0.400 375 3. From 12 to 24 months young. 0.700 214 4. The bull from 24 months. 1.000 150 5. Tele from 24 months. 0.800 188 6. Other cows (any age), including the European bison, wild cow (heck cattle) 0.800 188 7. Piglet 0.027 5556 8. Breeding boar or sow 0.500 300 9. Other pigs, it the number of wild boar 0.300 500 10. Goat (any age) 0.100 1500 11. Sheep (any age) 0.100 1500 12. Equidae, 0.800 188 13. Fox 0.056 2679 14. Nutria 0.059 2542 15. Mink 0.022 6818 16. Stag (deer) 0.606 248 17. Dambried a 0.437 343 18. DOE, American deer (white-tailed deer and the melnast) 0.114 1316 19. The laying hens 0.014 10714 20. Broiler farming Minister John 0.007 21429 Dūklav annex 2 Cabinet 31 May 2016 regulations no 326 permission to Release the remaining inventory of veterinary medicinal products in the Republic of Latvia food and veterinary service in Riga No. ____ _____ (date) 1. Name of the veterinary medicinal product, the strength, the pharmaceutical form registration number Latvian register of veterinary medicinal products or imports of veterinary medicinal products and distribution permissions to provide veterinary practices registration number 2. veterinary medicinal product remaining : 2.1 serial number, number of primary packaging secondary packaging, secondary packaging number 2.2. expiry date 3. Remaining stocks of veterinary medicinal products in the distribution deadline 4. manufacturer of the veterinary medicinal product, the State Veterinary Medicine 5. registration certificate holder (holder) 6. The holder of the authorisation of veterinary medicinal products: marketing authorisation holder (holder) parallel imports of the medicinal product importers and distribution permissions veterinary practice requires the owner of (indicate the name) 7. Decision on the authorization of veterinary medicinal products remaining in the inventory (the number , date) of the food and veterinary service officer (name, surname, signature) date _____ _____ z. v. 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 page of the attached form. 3. the document properties in the "signature", "date" and "Z" does not fill in the v. If an electronic document is drawn up according to the law on electronic document design.
Agriculture Minister John Dūklav in annex 3 of the Cabinet of 31 May 2016. Regulations No 326 import veterinary medicinal products and the distribution licence to provide veterinary practices in the Republic of Latvia food and veterinary service in Riga No. ____ _____ (date) based on the food and veterinary service decision No. ___ _____ ___ for issuing a permit for the import of veterinary medicinal products and the provision of veterinary practices in the Republic of Latvia (legal person of the name, address, registration number) are allowed to import veterinary medicinal products and distribution in the Republic of Latvia in accordance with the application No.   received (the registration number of the food and veterinary service) (date of registration in the food and veterinary service) the following veterinary medicinal products: registration certificate number, name (s) of the active substance (s), shape, strength and number of the holder of the registration certificate in the package (owner) of a Member State of the European Union or the European economic area country, which has granted a certificate of registration of veterinary medicinal products 1. manufacturer (name, address, country) 2. estimated quantities of veterinary medicinal products (packaging) 3. movement of veterinary medicinal products (designated officer name first name, last name, e-mail address, mobile phone number) 4. Permit valid until (day, month, year) 5. food and veterinary service official, responsible for taking the decision (name, surname, signature) z. v. Notes. 1. If the licence is presented, without the use of electronic media, the food and veterinary service officer sign each page. 2. the document properties in the "signature" and "Z" does not fill in the v. If an electronic document is drawn up according to the law on electronic document design.
Agriculture Minister John Dūklav in annex 4 of the Cabinet of 31 May 2016. Regulations No 326 application import veterinary medicinal products and the distribution of veterinary practice providing permission to receive no ____ _____ (date) I share details of permission applicants 1. Applicant 1.1. legal persons name, address, registration number 1.2 1.3. phone and fax number 1.4. e-mail address 1.5. about the movement of veterinary medicinal products Officer 1.5.1. name name of qualification and title 1.5.2 1.5.3. e-mail address 1.5.4. telephone and mobile phone number part II details concerning medicinal products 2. Veterinary medicinal product name 2.2 2.1. the active substance (s) (s) 2.3 pharmaceutical form 2.4 strength 2.5. route of Administration 2.6. packaging size 2.7. target (s) 2.8. therapeutic indication (s) (s) (3). the Member State of the European Union or the European economic area country, which has granted a certificate of registration issued by the competent authority 3.1 the registration certificate number 3.2. registration certificate holder (holder) (the name , address, contact info) or its authorized representative (name, address, contact info) 3.3 a person, which planned to buy veterinary medicines (if different from the manufacturer) (name, address, contact information) 4. manufacturer of the veterinary medicinal product name 4.2 4.1 registered office and business address, country 4.3. phone and fax number 4.4. e-mail address 5. Person to contact for submissions 5.1. name 5.2 5.3. phone number email address 6. the planned import quantity of veterinary medicinal products (the number of packages)   7. Tīmekļvietn address where available information on veterinary medicinal products part III annexed documents necessary to mark with an X, specify the number of pages attached 1. Description of the veterinary medicinal product in the country of origin and its English translation 2. packaging of the veterinary medicinal product or its mock-up with country of origin labelling and packaging with label or mock-up for Latvian market with the translation of the Latvian language (may be submitted in electronic form) 3. Instructions for use in the case of veterinary medicinal products in their country of origin and its translation into Latvian language (may be submitted in electronic form) 4. Document (copy), certifying that the veterinary medicinal product, the holder of the registration certificate or its authorized representative is informed of its intention to import and distribute veterinary medicinal product in Latvia 5. Document or a copy of the document certifying the payment of the expenditure relating to the evaluation of I, (name, officers, the applicant or his authorized representative) certify that the information given is true. Undertake the import and distribution of veterinary medicinal products in accordance with the movement of veterinary medicinal products regulatory laws and requirements.  Executive (authorised representative of the applicant) name, title signature date place date of receipt of the application to the food and veterinary service of the Z v. 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 page. 3. the document properties in the "signature" and "Z", and v. the date of receipt of the application to the food and veterinary service does not indicate if the electronic document is drawn up according to the law on electronic document design.
Agriculture Minister John Dūklav annex 5 cabinet 31 May 2016 regulations no 326 import veterinary medicinal product and authorisation in exceptional cases in the Republic of Latvia food and veterinary service in Riga No. ____ _____ (date) based on the food and veterinary service decision No. ____ __ _____ on the authorization of veterinary medicinal products, and for use in exceptional circumstances, the Republic of Latvia (lieltirgotav or importer's name, special permission (license) number/veterinary practice name , the registration number of the food and veterinary service of the object in the registry (the)) are allowed to import veterinary medicinal products and distribution in the Republic of Latvia in accordance with the application No.   received (the registration number of the food and veterinary service) (date of registration in the food and veterinary service) the following veterinary medicinal products: 1. the name 1.1. active substance (s) (s) 1.2. form strength route 1.4 1.3. package quantity (volume or weight unit of measure) 2. Registration certificate number 3. Registration certificate of the owner or his authorised representative (name, address, country) 4. Veterinary medicinal products, the manufacturer (name, address, country) the veterinary medicinal product is authorized to distribute veterinary practice authority (name, number of packages , address) permit valid until * (URdd.mm. yyyy.)
The food and veterinary service officer responsible for taking the decision (name, surname, signature) v Z. After the authorisation of veterinary medicinal products given in the quantity of the import (import) repeating the import of medicinal products obtain a new permit. The notes. 1. In the column or row that is not filled in, draw the line. 2. If the authorisation shall be drawn up without the use of electronic media, the officer signed each page. 3. the document properties in the "signature" and "Z" does not fill in the v. If an electronic document is drawn up according to the law on electronic document design. 4. Fill out if recipient is the authorisation of medicinal products for veterinary lieltirgotav veterinary medicinal product or the importer. 5. Veterinary medicinal products into the country from another EU Member State.
Agriculture Minister John Dūklav in annex 6 Cabinet 31 May 2016 regulations no 326 application of veterinary medicines and the use of import permits for exceptional cases no ____ _____ (date) Please, food and veterinary service of the country for authorisation of veterinary medicinal products not registered for import and use in exceptional cases in the Republic of Latvia on the specified in part II of this submission, the veterinary medicinal product.
(I) the particulars of the applicant 1. Applicant 1.1. name 1.2. activity (specify veterinārfarmaceitisk or veterinary activities) 1.3. address 1.4. phone and fax number (if any) 1.5. e-mail address 1.6. registration number (specify the appropriate) 1.6.1. special permission (license) lieltirgotav opening of the veterinary medicinal product (transaction) number, in the case of veterinary medicinal products intended for import or import 1.6.2. special permission (license) to import veterinary medicinal product number If the veterinary medicinal product to be imported veterinary practice 1.6.3. registration number of the authority of the food and veterinary service of the object in the registry, in the case of veterinary medicinal products intended for import 1.7. person to contact for submissions 1.7.1 1.7.2. name, telephone and fax numbers (if any) 1.7.3. e-mail address part II details concerning medicinal products 2. Veterinary medicinal product name 2.2 2.1. the active substance (s) (s) 2.3 pharmaceutical form , route 2.4 strength 2.5. packaging quantity (volume or mass, units) 2.6. country in which the veterinary medicinal product registered 2.7. registration number in the national register by the competent authority for veterinary medicinal products 3 registration certificate holder (holder) 3.1 3.2 3.3 name address telephone number   3.4. the e-mail address of the manufacturer of the veterinary medicinal product 4 4.1 4.2 name site address, phone number, e-mail address 4.3. If the veterinary medicinal product is planned to import veterinary medicinal products – good manufacturing practice certificate number and date of issue or the manufacture of veterinary medicinal products in compliance with good manufacturing practices or equivalent requirements name of identity document, the issuing State, the competent authority and issuing date of issue 5. Person, which planned to buy veterinary medicines (if different from the manufacturer) 5.1 5.2 title activity 5.3 site address telephone number 5.4 5.5. email address 6. the competent authorities of the tīmekļvietn address, which contains details of the registrant veterinary medicinal products 7. Practicing veterinarian who requested a veterinary medicinal product (where the applicant is a lieltirgotav of the veterinary medicinal product or the importer) 7.1 7.2 name of veterinary practice certificate number 7.3. veterinary practice name and address of the granting authority 8. the planned quantity of veterinary medicinal products part III annexed documents necessary to mark with an X, specify the number of pages attached 9. packaging of the veterinary medicinal product with a label in their country of origin and a translation in English instructions for use 10. veterinary medicinal products their country of origin and its English translation a practicing veterinarian discharged 11 demand the supply of veterinary medicinal products for the treatment of animals required or prevention course for up to three months. The request contains information about: 11.1. the necessary medicines, their quantity; 11.2. target species; 11.3. the diagnosis, the estimated number of animals (if possible) a practicing veterinarian approved 12. Rationale: why not use 12.1. veterinary drugs with similar effects, which are available in Latvia (if any); 12.2. the need for veterinary medicinal products supporting the examination results, for example, antimicrobial sensitivity of the means test results (if any) 13. If the veterinary medicinal product is imported, the permissions of the applicant's statement that the equivalent of the veterinary medicinal product is not available in the European Union 14. If the veterinary medicinal product is purchased from an importer, the competent authorities of the Member State issuing the registration number of the document and the date of issue, certifying that the importer is entitled to import veterinary medicinal products 15. proof of consideration of documents associated with the payment of expenditure, I, (name, officers, the applicant or his authorized representative) certify that the information given by me is true and the veterinary medicinal product will be used in accordance with the movement of veterinary medicinal products regulatory laws and requirements.  Executive (authorised representative of the applicant) name, title signature date place date of receipt of the application to the food and veterinary service of the Z v. 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 page. 3. the document properties in the "signature" and "Z" does not fill in the v. If an electronic document is drawn up according to the law on electronic document design.
Agriculture Minister John Dūklav annex 7 in the Cabinet of 31 May 2016. the Regulation No. 326 of the immunological veterinary medicinal product authorised for import and use in exceptional cases in the Republic of Latvia food and veterinary service in Riga No. ____ _____ (date) based on the food and veterinary service decision No. ____ __ _____ on the authorisation of the immunological veterinary medicinal product, and for use in exceptional cases in the Republic of Latvia, (lieltirgotav of the veterinary medicinal product or the importer's name, special permission (license) number/veterinary practice name , the registration number of the food and veterinary service of the object in the registry (the)) are allowed to import the immunological veterinary medicinal product and distribution in the Republic of Latvia in accordance with the application No.   received (the registration number of the food and veterinary service) (date of registration in the food and veterinary service) the following immunological veterinary medicinal products: 1. the name of the form, strength of the 1.1 1.2. active substance (s) (s) use 1.3 1.4. quantity of package 2 dose. the number of the registration certificate 3. Registration certificate of the owner or his authorised representative (name, address, country) 4. Immunological veterinary medicinal products, the manufacturer (name, address, country) 5. Immunological veterinary medicinal products authorized to distribute veterinary practice authority (name, number of packages , address) 6. Immunological veterinary medicinal products intended for pet owners of * 6.1 (first name and last name, address, registration number of the herd) 6.2 (species) permit valid until *** (URdd.mm. yyyy.)  
The food and veterinary service officer responsible for taking the decision (name, surname, signature) v Z. After the authorisation of veterinary medicinal products given in the quantity of the import (import) repeating the import of medicinal products obtain a new permit. The notes. 1. If the licence is presented, without the use of electronic media, the officer signed each page. 2. the document properties in the "signature" and "Z" does not fill in the v. If an electronic document is drawn up according to the law on electronic document design. 3. Fill out the beneficiary is lieltirgotav of the veterinary medicinal product or the importer of the veterinary medicinal product. 4. Fill in if a vaccine for the vaccination of the livestock at the scheduled. 5. Veterinary medicinal products the importation or imports of the country.
Minister of agriculture John Dūklav
  8. the annex to Cabinet of 31 May 2016. Regulations No 326 application of the immunological veterinary medicinal product importation and usage permission exceptional cases receive no ____ _____ (date) Please, food and veterinary service to issue the permit of the immunological veterinary medicinal product, and for use in exceptional cases in the Republic of Latvia for the application specified in part II of the immunological veterinary medicinal product.
(I) the particulars of the applicant 1. Applicant 1.1. name 1.2. mode of action (indicate economic activity) address 1.4 1.3. phone and fax number (if any) 1.5. electronic mail 1.6. registration number (indicate applicable) 1.6.1. special permission (license) lieltirgotav opening of the veterinary medicinal product (transaction) number if the veterinary medicinal product is intended to be imported from a Member State of the European Union or third country 1.6.2. special permission (license) to import veterinary medicinal product number If the veterinary medicinal product is intended to be imported from a third country veterinary practice 1.6.3. registration number of the authority of the food and veterinary service of the exposed object in the registry if the veterinary medicinal product is intended to be imported from a Member State of the European Union 1.7. person to contact for submissions 1.7.1 1.7.2. name, telephone and fax numbers (if any) 1.7.3. e-mail address of news on imunoloģiskaj part II veterinary medicinal products 2. Immunological veterinary medicinal product name 2.2 2.1. the active substance (s) (s) 2.3 form , route of administration, the number of doses 2.4 package 2.5. country where immunological veterinary medicinal products registered 2.6. registration number in the national register by the competent authority, the competent authorities in the 2.7. tīmekļvietn address, which contains details of registered immunological veterinary medicinal products 3. Immunological veterinary medicinal products for the holder of the registration certificate 3.1 3.2 3.3 name address telephone number 3.4. e-mail address 4. Immunological veterinary medicinal products, the manufacturer name 4.1 4.2 4.3 operational site address telephone number 4.4. e-mail address 4.5. veterinary medicinal products good manufacturing practices certificate number and date of issue, or other national competent authority issued certificate concerning the manufacture of veterinary medicinal products in compliance with good manufacturing practices or equivalent requirements indicate the issuing State, the competent authority and the date of issue, if the immunological veterinary medicinal products imported from a third country Person, 5 of which are intended to buy the immunological veterinary medicinal product (if different from the manufacturer) 5.1 5.2 title activity 5.3 site address telephone number 5.4 5.5. email address 6. Practicing veterinarian that requested the immunological veterinary medicinal product (where the applicant is a lieltirgotav of the veterinary medicinal product or the importer) name 6.1 6.2. veterinary practice certificate number 6.3. veterinary practices in the name of the owner of the Animal, 7 which animals for veterinary medicinal products 7.1. name 7.2. address 7.3 flock registration number, the number of animal species and 8. the planned quantity of the immunological veterinary medicinal product (packaging) was added to the part III documents necessary to mark with an X , specify the number of pages attached 9. Description of the immunological veterinary medicinal product in the country of origin and its translation in English 10. Immunological veterinary medicinal product packaging with label or mock-up in the country of origin and a translation in the English language 11. Immunological veterinary medicinal products, instructions for use in their country of origin and its translation into English and Latvian language 12. Practicing vets demand out of the immunological veterinary medicinal product delivery. The request contains information about: 12.1. the necessary medicines, their quantity; 12.2. target species; 12.3. the diagnosis, the planned number of animals (if possible); 12.4. the livestock owner (name and address) Practicing veterinarian approved 13. Rationale: 13.1. Why are not to be used for immunological veterinary medicinal products with a similar immunological effects, which are available in Latvia (if any); 13.2. the results of the laboratory examinations, if the vaccine is required for the control of infectious diseases of farm animals in the herd, or any other information justifying the need for vaccines (if the vaccine is not designed for systematic vaccination) 14. Livestock vaccination plan or a copy, if vaccine for the vaccination of the scheduled 15. If the immunological veterinary medicinal product import, permits the applicant's statement that the equivalent of the veterinary medicinal product is not available in the European Union 16. Good manufacturing practice certificate or equivalent certificate number, the issuing country and the authority and the date of issue, if the immunological veterinary medicinal product imported by 17. If the immunological veterinary medicinal product purchased from an importer, the competent authorities of the Member State concerned, the document issued by the registration number of the issuing country and the authority and the date of issue, certifying that the importer is entitled to import veterinary medicinal products 18. proof of consideration of documents associated with the payment of expenditure, I, (name, officers, the applicant or his authorized representative) certify that the information given is true and the immunological veterinary medicinal product will be used in accordance with the movement of veterinary medicinal products regulatory laws and requirements.  Executive (authorised representative of the applicant) name, title signature date place date of receipt of the application to the food and veterinary service of the Z v. Notes. 1. In the column or row that do not fill in, draw the line. 2. If the form is sent without the use of electronic media, the applicant shall sign each page of the attached form. 3. the document properties in the "signature" and "Z" does not fill in the v. If an electronic document is drawn up according to the law on electronic document design.
Agriculture Minister John Dūklav 9. attachment Cabinet 31 May 2016 regulations no 326 permission of Autogenous vaccines inactivated for import and use in the Republic of Latvia, the food and veterinary service in Riga No. ____ _____ (date) based on the food and veterinary service decision No. ___ _____ ___ for permission to import the autogenous vaccines inactivated and the use, grant permission for the practicing veterinarian (name, surname, veterinary practice certificate number, address/veterinary practice name , address if applicable) Application No.   received (the registration number of the food and veterinary service) (date of registration in the food and veterinary service) on the autogenous vaccines inactivated the following: 1. The vaccine manufacturer's name 2. The vaccine manufacturer's name and address 3. Vaccine composition 4. Packaging size 5. Vaccine for animals (species, age) 6. Dose, route of administration, the vaccination scheme 7. Withdrawal period 8. The owner of the animal, where the animal vaccine for (first name and last name or the name, address, telephone number, Flock registration number of the holding and the State agencies "agricultural data centre" in the registry) 9. Special precautions 10. Permit valid until (date, month, year) of the decision of the food and veterinary service officer (name, surname, signature) z. v. Notes. 1. If the licence is presented on several pages, the officer signing every page except if the electronic document was made according to the regulations on electronic document design. 2. the document properties in the "signature" and "Z" does not fill in the v. If the electronic document was made according to the regulations on electronic document design.
Agriculture Minister John Dūklav 10. attachment Cabinet 31 May 2016 regulations no 326 application, authorisation of Autogenous vaccines inactivated, and use no ____ _____ (date) Please, food and veterinary service to issue the permit of Autogenous vaccines inactivated, and use of the application specified in part I of the veterinary medicinal product.
Part I-administrative information 1. News about practicing veterinarian, which requested the autogenous vaccines inactivated 1.1 name 1.2. veterinary practice certificate number 1.3. phone number 1.4. e-mail address address of workplace 1.5 1.6. veterinary practice name (if applicable) 2. the owner of the animals, which animal vaccine 2.1. name or first and last name, actions, veids1 2.2. herd and the registration number of the holding of State agencies "agricultural data centre" register 2.3. legal address and place of business address 2.4. phone and fax number (if is) 2.5. email address 3. details of the autogenous vaccines inactivated 3.1. manufacturer's name (for example, inactivated vaccine and the micro-organism in autogenous name) and description of the micro-organism non 3.2 3.3. adjuvants, including solvents, preservatives, inactivation features 3.4 vaccine package description 3.5 inactivation method of sterilization method 3.6 3.7 gave, gave detection methodology, drug conditions (type, frequency, duration) 3.8 withdrawal period 3.9. quantity of vaccine produced in the primary packaging (indicates the units of weight or volume and dose) 3.10. storage conditions , the storage space (address) 3.11. expiry date 3.12. Special precautions, if any 4. News about the vaccine manufacturer name 4.2 4.1 registered office and business address 4.3. special permission (license) manufacture of veterinary medicinal products number 4.4. phone and fax number (if applicable) 4.5 e-mail address 5. News about the vaccine's manufacturer, responsible for the serial output (if different from the manufacturer of the vaccine) 5.1 5.2. name, registered office and business address 5.3. special permission (license) manufacture of veterinary medicinal products number 5.4. phone and fax number (if applicable) 5.5. e-mail address for serial release 5.6. responsible person name 5.6.1 5.6.2 5.6.3. phone number email address 6. Person to contact about the application 6.1 6.2 name, last name, phone and fax number (if applicable) 3.9. e-mail address part II 7 animals. Animals, from which the microorganisms isolates or antigens 7.1 species, variety (if possible) 7.2. the number, age, identification number2 7.3. other information on the traceability of the animals (if any) 8. Animals for autogenous vaccines inactivated species, breed 8.1 8.2 8.3. number, age identification number2 5.2. obtain the foodstuffs of animal origin Yes No 8.5. other information on the traceability of the animals (if any) is added to the part III documents necessary to mark with an X, specify the number of pages attached 9. Practicing veterinarian prescription request 10. Practicing veterinarian trained and with the signature and stamp of the veterinary practice approved of inactivated informācija3 autogenous vaccines need that: 10.1. specified animal or group of animals and its symptoms and diagnosis of the disease, which is based on animal studies, clinical and laboratory findings, as well as previous animal prevention or treatment, if any; 10.2. the detailed reasons why the immunological veterinary medicinal products, which is equivalent to the therapeutic effect and which are available do not work for a given animal or group of animals; 10.3. the laboratory is attached to the message (test report) on the results of the laboratory examinations (copy); 10.4. estimated vaccination has been added Schedule 11. special permission (license) for the production of a copy of the veterinary medicinal product and the certificate of good manufacturing practice, if a copy of the vaccine manufacturer its activities carried out in another Member State of the European Union 12. brief description of the manufacturing method 13. Primary packaging labeling and instructions for use model (model) 14. Document confirming with the attached document handling costs provisions I,, (a practicing veterinarian name, title) certify that the information given is true.
Signature Z. v.
Date of receipt of the application to the food and veterinary dienestā5 notes. 1. Indicate the type of economic activity. 2. the identification number indicates, if the vaccine is intended for a specific animal, which assign an identification number. 3. Submit a copy of the electronic document was made according to the regulations on electronic document design. 4. the document properties in the "signature" and "Z." does not specify v, if the electronic document was made according to the regulations on electronic document design. 5. food and veterinary service tag is required if the electronic document was made according to the regulations on electronic document design.
Agriculture Minister John Dūklav 11. Annex a Cabinet of 31 May 2016. the Regulation No. 326 of the veterinary medicinal product quality defects 1. defects in the first class represents a possible threat to animal or human health or is likely to constitute a serious danger 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 can result in a serious risk to animal or human health; 1.3. sterile injectable solution or Ophthalmology veterinary medicinal products used in microbial contamination; 1.4. chemical contamination, which poses a serious risk to animal or human health; 1.5. some products are contaminated more than one packing; 1.6. active substance wrong multicomponent medicinal products which constitute a serious risk to animal or human health. 2. The secondary defects can cause disease in animals or improper treatment, but they are not classified as first degree defects. Response notification sent to all contacts response notification list, if you have difficulties to find out which is common in veterinary medicine. If the distribution of veterinary medicinal products is known, the message is sent only to the appropriate contacts. Second quality defects, such as the following: 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 specification (for example, does not meet the persistence, fill, weight); 2.7. unreliable sealing system which poses a serious threat 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 withdrawal may be determined for any other reason. If the food and veterinary service considers it necessary, may apply to the emergency response procedures, for example, in the following cases: 3.1 an incomplete package (for example, the label contains an incorrect serial number or wrong drug expiration date if it is not listed 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)). Agriculture Minister John Dūklav 12. attachment Cabinet 31 May 2016 regulations no 326 report on withdrawal of veterinary medicinal products (I). the report provider name 2 1. License number 3. address 4. food and veterinary service of the database registration number (fill in food and veterinary service after receipt of the report) (II). information on medicinal products withdrawn 5. Quick response notification of quality defects/withdrawal of the veterinary medicinal product, the reference number 6. Emergency response notification sender name and properties 7. Name of the veterinary medicinal product , the strength, the pharmaceutical form, the sequence number of the vendor from which 8 received veterinary medicines (name, address) of the supplier, the quantity of veterinary medicinal product No. p. k. The requested name of the veterinary medicinal product in a common quantity of veterinary medicinal products return date Atpakaļatdot the quantity of veterinary medicinal products For veterinary use of the withdrawal from the market, the responsible person (position, name, surname, signature) date note. Document properties in the "signature" and "date" does not fill in, if an electronic document is drawn up according to the law on electronic document design.
Agriculture Minister John Dūklav 13. attachment Cabinet 31 May 2016 regulations no 326 notice of continuous phone number (and other means of communication), you may contact the 24-hour time, and persons responsible for veterinary medicinal products revocation information provider corresponding to mark with an X to indicate the document number, registration certificate of the veterinary medicinal product holder (holder) registration certificate No.   The manufacturer of the veterinary medicinal product, the special permission (license).   Wholesaler of veterinary medicinal products special permission (license).   Importing of veterinary medicinal products special permission (license).  
Information providers data name address phone number fax number e-mail address 2. information on the persons who are entitled to receive the information about the withdrawal of the veterinary medicinal product, to provide information and to ensure the withdrawal of the veterinary medicinal product 2.1. person in charge of the withdrawal of the veterinary medicinal product name title address phone number of jobs where a person daily available fax number e-mail address 2.2. additional contact name title business address telephone number that person available 24 hours fax number email address 3. Mandate by order No.     (merchant/institution name)   (date) the designated responsible person (person in charge in the absence of the-the additional contact) time of day is authorized to receive information from the food and veterinary service and is responsible for stopping the distribution of veterinary medicinal products and veterinary medicinal products from the market for the withdrawal, as well as the laws and regulations in specific information on withdrawal of provision of veterinary medicinal products in food and veterinary service. About changes in the information specified undertake to notify the food and Veterinary Office within three days. The document is drawn up in duplicate.
Date (name, surname, signature) v Z.
 
Fill out the food and veterinary service officer database registration No.      ---Food and veterinary service officer (position name, signature) date notes. 1. the requirements referred to in paragraph 3, to submit certain documents number of copies is not applicable, if the documents are submitted in the form of an electronic document. 2. the document properties in the "signature", "date" and "Z" does not fill in the v. If an electronic document is drawn up according to the law on electronic document design. 3. food and veterinary service mark is not required when an electronic document is drawn up according to the law on electronic document design.
Agriculture Minister John Dūklav 14. Annex a Cabinet of 31 May 2016. Regulations No 326 rapid notification of quality defects/Rapid Alert Notification of the withdrawal of a Quality defect/Recall important – send the immediately important – DELIVER IMMEDIATELY reference number (reference number), the sender's name and properties (add letter-head of the sender) With 1 (see attached list if there is more than one recipient) it (see list attached if more than one) 2. the degree of fault of the medicinal product, the reference medicinal product which (the desired circle) product recall class of defect (circle one) 3 III. Fraud/counterfeiting (specify) (specify) Falsification/Fraud 4. Veterinary drug product registration certificate number 5 for use in humans/animals (delete if need) Marketing authorisation number For use in humans/animals (delete as required) 6. Brand/Trademark Brand/trade name 7. international non-proprietary name (INN) or generic name or the generic name INN 8. Pharmaceutical form (quantity) "form (quantity) 9. Strength Strength 10. batch number Batch number (and bulk, if different) 11. Expiry date Expiry date 12. packaging size and description Pack size and description 13. Manufacturing date date manufactured 14. The holder of the registration certificate (the owner) the Marketing authorization holder 15.1 manufacturer ** Manufacturers contact contact person phone telephone 16. Firm that reference (if different) Recalling firm (if different) contact person contact person phone telephone 15.2. If the defect is attributable to the place of production, the place in which the fault finding, if different from that specified in paragraph 15.1. Where the defect is attributed to a manufacturing site, the site where defect occurred (if different from 15.1) contact person contact person phone telephone 17. Revocation number (if available) Recall number assigned (if available) 18. Fault description/reason for cancellation details of defect/Reason for recall information on the distribution of 19. including exports (customer type, such as a hospital) Information on distribution including exports (type of customers, e.g. hospital) * 20. activities implemented by the issuing competent authority of the Action taken by the issuing authority 21. proposal for action Proposed action 22 of how (the issuing competent authority) From (issuing Authority) 23. contact person contact person phone telephone 24. signature signature date date 25 time time 26. ** information not required if notified outside the European Union. * Information not required, when notified from outside the European Union. ** Directive 2001/83/EC or in article 40 of Directive 2001/82/EC in article 44 that 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 in 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. This is intended only for persons that is addressed, and may contain limited access and confidential information that is protected by law. If you are not the addressee or person who is authorized to receive the distribution, you are that is not allowed in any review, disclosure, copying, distribution or other action based on this statement. If you have received this document in error, please immediately notify us by phone and pass it to the sender. Thank you! This is intended only for the use of the party to whom it is addressed and may contain information that is privileged, confidential, and protected from disclosure under applicable law. If you are not the persons addresse, or (a) authorized to deliver the document to the addresse, you are hereby notified that any review, dissemination, copying, disclosure, or other action based on the content of this communication is not authorized. If you have received this document in error, please notify us by telephone immediately and return it to us at the above address by mail. Thank you!
The notes. 1. In the column or row that is not filled in, draw the line. 2. If the notification is presented on several pages, the officer signing every page, if the electronic document has not been drawn up according to the law on electronic document design. 3. If an order for further quick response series 18 "emergency response following the initial quick response; reference number "(" Rapid alert following the original rapid alert # URref.no # "(fill in the food and veterinary service). 4. the notification reference number, consisting of the country code (in which the finding for 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). Fill out the food and veterinary service. 5. If the notification is provided to veterinary medicinal products, the heading shows "rapid communication on counterfeit medicines". 6. Communication 15.1 and 15.2 points in the special permission (license) manufacture of veterinary medicinal products and special permissions (licenses), which in the name of the qualified person released series, if they are different individuals. 7. the document properties in the "signature", "date" and "time" will not be completed where the electronic document is drawn up according to the law on electronic document design.
Agriculture Minister John Dūklav 15. attachment Cabinet 31 May 2016 regulations no 326 information on quality defects that are not urgent and Non-urgent follow-up Information for Quality Defect adds the sender's name and properties Add letter head of sender 1. who (see attached list if there is more than one recipient) it (see list attached, if more than one) 2. revocation specified number (Recall number assigned) 2a. The national reference number (if it is specified) National reference number (where applicable) 4. Veterinary drug product registration certificate number 5. Marketing authorization number 6. Brand/Trademark Brand/trade name 7. international non-proprietary name (INN) or generic name or the generic name INN 8. Pharmaceutical form (quantity) "form 9. Strength Strength 10. batch number Batch number (and bulk, if different) 14. The holder of the registration certificate (owner) Marketing authorization holder (owner) 15. Manufacturer1 Manufacturer1 16. Contact person contact 17. Object name subject title Add basic information to Add bulk message here 18. From how (the issuing competent authority) From (issuing Authority) 19. contact person contact person 20. signature signature date date 21.22. Time to time notes. 1. 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 in 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.
2. the document properties in the "signature", "date" and "time" will not be completed where the electronic document is drawn up according to the law on electronic document design.
Minister of agriculture John Dūklav