Cabinet of Ministers Regulations No. 338 in 2016 (May 31. No 26 18) the amendments to the Cabinet of Ministers of 18 July 2006, regulations No. 600 "registration procedures for veterinary medicinal products" Issued in accordance with article 5 of the law on Pharmacy 3 and 6 point 1. make Cabinet 18 July 2006 regulations No. 600 "registration procedures for veterinary medicinal products" (Latvian journal, 2006, 127. No; 2007, 161. no; 2009, 155, 200. no; 2010, nr. 185.2011, 3, 75; No. 13; 5, 147, 209. No.) the following amendments: 1. replace the entire text: 1.1.1. the word "clinical" not (the fold) with the word "pre-clinical" (fold); 1.1.2. the words "holder (owner)" (fold) with the words "owner (holder)" (fold); 1.2. to supplement the rules by 2.10, 2.11, 2.12. and 2.13. subparagraph by the following: "2.10. field research – in relation to clinical trials conducted outside research laboratory; 2.11. sponsor: the natural or legal person who assumes responsibility for the clinical trial initiation, management and financing; 2.12. principal investigator-practicing veterinarian who, in accordance with the regulatory field of veterinary regulations has the right to independently deal with veterinary practices; 2.13. the research protocol-a document that describes the purpose of the clinical trial (s), design, methodology, statistical considerations and organisation of research procedures and criteria to a particular animal or group of animals for inclusion or non-inclusion in the study, as well as the study and publication of the results of the monitoring procedure. "; 1.3. make paragraph 4 by the following: "4. in the case of veterinary medicinal products in food and veterinary service issued a certificate of registration pursuant to this regulation, no need to add additional information about the strength, the pharmaceutical form, the route of administration, changed the design of the veterinary medicinal product or to carry out the registration extension (extension), the food and veterinary service shall decide on the registration of medicinal products, or on changes in the registration certificate. This decision to include the registration of veterinary medicinal products, and it is part of the registration certificate issued, in particular as regards this provision 22, 23 and 24 of those veterinary medicinal product. '; 1.4. to replace the words in paragraph 5.1 "premixtures" with the words "medical" premixtures; 1.5. make 8.3 point as follows: "8.3 As prescription medications classified such veterinary medicinal product: 8.3 1. medicinal products for veterinary use covered by the distribution (including delivery) or use restrictions laid down in the law on restrictions on the use of the medicinal product in animals and animal products and movement, if the animals used in medicine, and the law on animals and it contained certain substances and residues; 8.3 2. veterinary medicinal products for food-producing animals (excluding this provision in paragraph 8.2); 8.3 3. veterinary medicinal products which use the veterinarian observe extreme caution, since they can be dangerous: 8.3 3.1. target species (animal species for which the veterinary medicinal product is intended for); 8.3 3.2. person veterinary drug used in the treatment of animals; 8.3 3.3 environment; 8.3 4. veterinary medicinal products which are used in animal pathological process and, if necessary to determine an accurate diagnosis or if drug use may cause effects which impede further diagnosis or treatment, or is in conflict with it; 8.3 5. veterinary medicinal products containing an active substance that is for use in veterinary medicinal products approved for less than five years. "; 1.6. the deletion of 8.5 points; 1.7. to complement the chapter I with 8.11, 8.12, 8.14, 8.15 and 8.16 8.13, paragraph by the following: "8.11 food and veterinary service in accordance with the laws and regulations establishing procedures for food and veterinary service of State surveillance and control activities and fees, up to the current year's February 28, prepares and sends the registration certificate holder (holder) justification document post-marketing surveillance annual fees for veterinary medicinal products that veterinary medicinal products are included in the registry. 8.12 the registration certificate holder (holder) has the right to: 1. the benefit of 8.12 veterinary medicine post-registration annuities where the preceding calendar year in the veterinary medicinal products concerned common total turnover does not exceed eur 2000; 8.12 2. exemption from veterinary medicine post-registration annuity, if the preceding calendar year in the spread of the veterinary medicinal product concerned, the total turnover does not exceed eur 1000. 8.13 To registration certificate holder (holder) get this rule 8.12 above relief or exemption, it is up to the current year may 31, submitted to the food and veterinary service application (free form) for the relevant veterinary medicinal product, in Latvia the previous calendar year wholesale has the person to whom the registration certificate holder (holder) supplied by the veterinary medicinal product. The application specifies the following information: 1. name and 8.13 registration number; 8.13 2. total turnover (including this rule 8.13 2.1. and 2.2. referred to in 8.13), consisting of: 8.13 2.1. wholesale distributed in Latvia, the number of secondary packaging; 8.13 2.2. marketing authorisation holder (holder) the secondary packaging sales price. 8.14 if the marketing authorisation holder (holder) has not submitted all this provision of the information referred to in paragraph 8.13 or it is incomplete, the food and veterinary service requires the holder of the registration certificate (holder) within 10 working days from the date of receipt of the request to submit additional information. 8.15 the food and veterinary service of the administrative procedure law, but no later than 30 June of the current year: 8.15 1. evaluate this rule 8.13 application referred to in paragraph 1 and the information and makes a decision on relief of post-registration of veterinary medicinal products, the annual fee for the release of a veterinary medicinal product for post-registration annual fees or refusal to apply for relief or exemption; 8.15 2. prepares and sends the registration certificate of the veterinary medicinal product holder (holder) remedial justification document If the decision to grant the rule referred to in paragraph 8.12 relief or exemption. 8.16 the registration certificate holder (holder), in accordance with the arrangements to be made for a food and veterinary service of State surveillance and control activities and fees, no later than July 31 each year to pay this rule 8.11 points or 8.15 2. justification referred to in subparagraph the amount specified in the document. "; 1.8. to supplement paragraph 9 second sentence with the following: "submitting a registration application electronically, fill in the special online form European joint registration submission Portal CESP (available at https://cespportal.hma.eu tīmekļvietn) or the European Medicines Agency for secure file Exchange System Eudralink (available at http://eudralink.ema.europa.eu tīmekļvietn), using the respective tīmekļvietn in authentication features available."; 1.9. the express section 13.1. by the following: "13.1. the applicant's first name, last name or business name and the operator's actual or legal address. If the manufacturer and applicant are one and the same person, the applicant shall indicate the manufacturer of the veterinary medicinal product or manufacture of the veterinary medicinal product producer involved in the name and actual address; " 1.10. the express section 13.11. the following wording: "13.11. detailed use of veterinary medicines side effects monitoring description of the system and, if necessary, a detailed description of the risk control system, which the applicant intends to introduce. Descriptions prepared according to the pharmaceutical law referred to in article 25.2 of the European Commission recommendations, published in the European Community pharmaceutical legislative framework document item Volume IX of part B of the guidelines "guidelines on pharmacovigilance for veterinary medicinal products"; "; 1.11. to replace the words "in paragraph 13.13. labelling, distribution, and control rules" with the word "marking"; 1.12. subparagraph 13.14. to replace the words "sample prepared according to legislation on the labelling of the veterinary medicinal product, distribution, and control regulations" with the words "layout, drawn up in accordance with legislation on the labelling of the veterinary medicinal product,"; 1.13. replace paragraph 23, the words "Where a biological veterinary" with the words "If the immunological veterinary"; 1.14. Express 31 the following: "31. In the case of veterinary medicinal products containing several active substances (combined veterinary medicinal products), with each used separately registered in the composition of veterinary medicinal products, but so far no one used in veterinary medicinal products for therapeutic purposes, for the following active substances of the medicinal product shall be submitted to the new combination of pre-clinical or clinical research results, new safety test results and, if necessary, new test results for residues. '; 1.15. the deletion of paragraph 32, the words "(informed consent application)"; 1.16. supplement 33. point after the words "pharmaceutical form" with the words "(informed consent application)"; 1.17. replace paragraph 34, the word "test" with the word "research"; 1.18. Express 35. paragraph by the following: "35. The veterinary medicinal product, the following information to be included in the description (in the order listed): 21.8. name of the veterinary medicinal product, plus an indication of the strength and the pharmaceutical form; 35.2. active substance and excipients in the qualitative and quantitative composition in terms of what is important to know the correct use of the medicinal product (used widely or chemical names used); 35.3. pharmaceutical form; 35.4. clinical information: 35.4.1. target species; 35.4.2. indications for use, specifying the target species; 35.4.3. contraindications; 35.4.4. Special warnings for each target species, 35.4.5. precautions the use of the medicinal product, including special precautions the person administering the medicinal product to animals; 35.4.6. adverse reactions (frequency and hazards); 35.4.7. the use of veterinary medicinal products during pregnancy, lactation or lay eggs; 35.4.8. the veterinary medicinal product, interaction with other medicinal products and other forms of interaction, 35.4.9. dose and route of administration; 35.4.10. overdose (symptoms, emergency action, antidote, if necessary); 35.4.11. limitation period (s) in the use of animal products, including products for which the withdrawal period is defined is zero; 22.1. pharmacological or immunological characteristics: 35.5.1. pharmacodynamic properties; 35.5.2. pharmacokinetic particulars; 35.6. the pharmaceutical information: 35.6.1. list of excipients; 35.6.2. significant drug incompatibility; 35.6.3. period of validity of the medicinal product and a statement of validity for the medicinal product after dilution or primary packaging is opened; 35.6.4. special storage conditions; 35.6.5. primary packaging method and content; 35.6.6. special instructions unused veterinary medicinal product or waste materials, if any; 22.2. the registration certificate holder (holder's) name and address; 22.2. the registration certificate (s) number (s); 22.3. registration or re-registration date; 35.10. date when the revised text for the description of the medicinal product. '; 1.19. Express and 23.5. subparagraph 37.7. following: 37.7. "animal tests be carried out in conformity with the laws and regulations in the field of animal protection requirements; 23.5. the documentation indicates the environmental risk assessment, which is presented in 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 and the European Commission's guidelines. Veterinary medicinal products containing genetically modified organisms or the composition of those environmental risk assessment in addition to the design comply with the requirements laid down in the legislation on genetically modified organisms deliberate release. "; 1.20. replace paragraph 39.1. the word "and" by "or"; 1.21. make 42, second sentence: "this provision shall not apply to 52, 53, 54 and 55. the requirements referred to in paragraph, does not approve, as well as the summary of product characteristics shall not apply the medicine therapeutic effect supporting documentation requirements."; 1.22. replacing 43.7. in subparagraph the words "samples or their advertising with the word" sample "mock-ups"; 1.23. replace 43.9 in the word "time" with the word "period"; 1.24. to replace the words in paragraph 47 and the number "that this provision shall apply the requirements referred to in chapter V" with the words "that it and the number of the registration application must be submitted under this rules the requirements contained in chapter V "; 1.25. Express 30.6. subparagraph by the following: "can send finished 30.6. the veterinary medicinal product, its starting materials and, if need be, its intermediate products or other constituent laboratory of medicinal products in a laboratory investigation, entitled control medicines, to verify that the submitted documents for registration of medicinal products medicinal products specified by the manufacturer control techniques are sufficient for the quality control of veterinary medicinal products. The applicant pay for laboratory examination in accordance with the actual cost of a laboratory; " 1.26. the express section 30.7. the following wording: "49. may require the applicant to the food and veterinary service provide the necessary quantities of the substances needed to verify the analytical methods for the detection of residues of veterinary medicinal products, the applicant pointed out registration documents. The applicant pay for laboratory examination in accordance with the actual cost of a laboratory; " 1.27. replace 60.2 in the word "trade" with the word "market"; 1.28. the express in paragraph 62 the introductory paragraph as follows: "62. After receipt of the registration certificate holder (holder) informs the food and veterinary service according to its tīmekļvietn in the specified form of:"; 1.29. replace 69.1 in Word 4. "owner" with the words "owner (holder)"; 1.30. Replace subparagraph 71.2.5., the words "the labelling of the veterinary medicinal product, distribution, and control regulations" with the words "legislation on the labelling of the veterinary medicinal product,"; 1.31. replace paragraph 72, the words "authorisation holder" with the words "licence holder (holder)"; 1.32. replace the words "in 74.2 is in registration process" with the words "not registered"; 1. make the following paragraph 78: "78. If the food and veterinary service filed an application for the registration of veterinary medicinal products in accordance with the provisions of paragraph 73 of the decision adopted in accordance with the approved assessment report, summary of product characteristics, labelling and package leaflet to the administrative procedure law, but not later than 30 days after this provision 77.2. agreements referred to registration. "; 1.34. replace paragraph 80, the words "the labelling, distribution, and control regulations" with the words "distribution and control"; 1.35. to replace in paragraph 85 of the word "Committee" with the words "the Commission"; 1.36. replace the introductory paragraph of paragraph 88 of the word "natural" with the word "environment"; 1.37.91. point be expressed as follows: "91. Authorisation of veterinary medicinal products in the clinical trial, the sponsor or its authorized representative to the food and veterinary service of the application of the veterinary medicinal product, clinical trial (clinical trial application) according to annex 7 of these rules."; 1.38. supplement with 91.1, 91.2, 91.3, 91.4, 56.9, 91.8, 91.6, 91.7, 91.9, 91.10, 91.11 and follows 91.12 points: 91.1 if the sponsor or "authorized representative has not submitted all of the clinical trial submission documents referred or they are incomplete, the food and veterinary department require it within 10 working days from the date of receipt of the request to submit additional information. 91.2 food and veterinary service of the administrative procedure law shall assess the clinical trial application and accompanying documents, and shall take a decision on the issue of the clinical trial authorization or refusal to issue the permit. The decision taken by the food and veterinary service within three working days, send to the sponsor or its authorized representative. Clinical trial authorization the food and veterinary service issued an electronic document by sending it to the clinical trial application-specified e-mail address. Clinical trial authorisation document shall be issued in the form of paper, if you have the appropriate reference in the application of clinical trials. 91.3 food and veterinary service shall decide on the refusal to issue a permit for the clinical trial, if: 1 91.3. sponsor or its authorized representative is not submitted by the specified period 91. these rules and documents referred to in paragraph 91.1; 91.3 2. clinical trial in the submissions and the documents submitted indicate information about the clinical trial does not meet animal protection, environmental protection or public health conditions; 91.3 3. veterinary medicinal benefits and risk assessment is unfavourable; 4. sponsor 91.3 is not declared or registered office is not located in any of the countries of the European economic area; 5. receipt of sponsor 91.3 or the authorized representative of the clinical trial application cancellation on the basis of the veterinary medicinal product registration certificate holder (holder) or veterinary medicinal products of the manufacturer or of his authorised representative objections; 91.3 6. principal investigator does not meet the requirements of this regulation. 91.4 Multi-centre clinical trials in accordance with the uniform number of the researchers responsible for more locations. Clinical research sites can be located both in one or more Member States and in one or more Member States and one or more third countries. 56.9 food and veterinary service shall decide on the multicenter clinical trial in the territory of Latvia. Decision on multicenter clinical trial in another Member State or third country adopt a national competent authority. 91.6 Sponsor or its authorized representative, submit a clinical trial application to the food and veterinary service, for the planned clinical trials of the veterinary medicinal product, inform the marketing authorisation holder (holder) or – if the veterinary medicinal product is not registered, the manufacturer of the veterinary medicinal product, or its authorised representative. 57.0 If the veterinary medicinal product, the mAh (the holder) or veterinary medicinal products, the manufacturer or his authorized representative objects to the clinical trial, the sponsor or its authorized representative to the food and veterinary service reference in the submitted clinical trial application by adding information about the objections received. 91.8 amendments to clinical trial authorization, the sponsor or its authorized representative to the food and veterinary service application (free form), in support of the amendment. 91.9 food and veterinary service of the administrative procedure law shall assess the application for amendment of the authorisation of clinical trials and its accompanying grounds and take a decision to amend or not to amend clinical trials permission. The decision taken by the food and veterinary service within three working days, send to the sponsor or its authorized representative. New clinical trial authorisation of food and veterinary service issued an electronic document, by sending them to this provision in the application referred to in paragraph 91.8 the specified e-mail address. Clinical trial authorisation shall be issued in the form of a paper document, if you have the appropriate reference in the application. 91.10 Sponsor or its authorized representative: 91.10 1. immediately notify the food and veterinary service, if the suspect used in clinical trial adverse reactions to the veterinary medicinal product or contrary to their effects during the clinical trial or if unexpected have emerged following the side effects or symptoms of exposure and endangering the health of animal life or the environment. food and veterinary service, assessment of risk-benefit ratio within 10 working days, decide on the continuation of clinical trials or termination and three working days of the decision taken by the sponsor or send an authorized representative. Sponsor or its authorized representative for the decision to suspend the clinical trials; 91.10 2. immediately notify the food and veterinary service of the Center for the study of the closure or a change researchers in charge; 91.10 3.  15 days inform the food and veterinary service, if was necessary to stop before clinical trials clinical trials approved by the end of the period of the action, indicating the reasons for the suspension; 91.10 4. not later than 90 days after approved clinical trial operational period end inform the food and veterinary service of the completion of the clinical trial, and no later than one year after clinical trials approved operational period submitted to the food and veterinary service of clinical trial results; 91.10 5. provide good clinical practice guidelines for clinical trials; 91.10 6. clinical trials adverse reactions during tracking and report on these food and veterinary service; 91.10 7. submitted to the food and veterinary service of the annual report on the progress of the study and the number of animals involved in research; 8. ensure 91.10 food and veterinary service officer access to any clinical information needed to ensure that clinical trials meet animal protection, environmental protection, public health or ethical conditions. 91.11 food and veterinary service, on the basis of animal protection, environmental protection or public health hazards, is entitled to stop clinical trials. If you stop multi-centre clinical trials, the food and veterinary service shall inform the competent authority of the Member State concerned. for this rule 91.12 referred to in chapter VI of the document, decision and authorisation of the sponsor or its authorized representative shall pay in accordance with the laws and regulations establishing procedures for food and veterinary service of State surveillance and control activities and fee services. "; 1.39.92. point be expressed as follows: "92. Sponsors or its authorized representative in clinical trials of veterinary medicinal products, and ensure the appropriate use of observations in this provision in 37.7, 2, and 3. the requirements of annex."; 1.40. supplement with 92.2, 92.3 and 92.4, 57.2 points as follows: "57.2 principal investigator is responsible for the conduct of the clinical trial at a trial site, as well as for all veterinary clinical trials related decisions. principal investigator 92.2 ensures that clinical studies: 1.92.2 uses the minimum number of animals; 2. the animal is created with 92.2 for the least possible damage, pain, suffering or discomfort. principal investigator and 92.3 the animal owner (holder) shall ensure that the animals used in the clinical trial is a species appropriate housing, care and nutrition conditions in accordance with the legislation on animal welfare. 92.4 products from clinical trials in animals used for food is prohibited, except when the following conditions are met: 1. the 92.4 investigational medicinal product composition in active substances is specified in the maximum amount of residue in food according to Regulation No. 37/2010; 2. principal investigator 92.4 has specified withdrawal period which is the equivalent of the withdrawal period in cases where the animal is not available for the necessary veterinary medicinal product in accordance with the laws and regulations on procedures for veterinary care and a practicing veterinarian purchased, stored, and used the accounts. "; 1.41. the deletion of paragraph 93; 1.42. the title of chapter IX be expressed as follows: "IX. Mah (the holder) change"; 1.43. to complement the introductory part of paragraph 109 behind the words "national registration procedures" with the words "the mutual-recognition procedure or the decentralised procedure"; 1. Add to paragraph 113 of the rules with the following wording: "113. This rule 8.11, 8.12, 8.14, 8.15 and 8.16 8.13, paragraph shall enter into force on January 1, 2017."; 1.45. replace paragraph 4 of annex 1, the word "owner" with the words "owner (holder)"; 1.46 Replace annex 1.1., the words "the owner of the registration certificate" (fold) with the words "registration certificate holder (holder)" (fold); 1.47. Replace annex 1.1 2.4 and 2.4.1. above the word "holder" with the words "owner (holder)"; 1.48. Express 1.1, annex 2.5.1. subparagraph by the following: "2.5.1. The producer (or the importer), responsible for the serial output of the European economic area in accordance with Regulation No 319 (1) (6) and indicate in the instructions for use and, if applicable, the label/manufacturer (s) of the Authorised (or importer) responsible for batch release in the EEA in accordanc with article 55 and article 53 of Directive 2001/82/EC transposed in the Regulation Of. 319 (1) (as shown in the package leaflet and where applicable in the labeling) name (merchant business)/(Company) name address/address State/Country telephone number/fax number/telephone Telefax email address/E-mail ▪ special permission (license) manufacture of veterinary medicinal products/Manufacturing authorisation number ▪ special permission (license) for the production of a copy of the veterinary medicinal product (add the application referred to in subparagraph annex 5.6)/Attach a copy of manufacturing authorisation (s) (Annex 5.6) ▪ rationale, if more than one producer is responsible for the serial output (add the application referred to in subparagraph annex 5.7)/Attach justification if more than one manufacturer responsible for batch release is proposed (Annex 5.7) vaccines/For information about vaccines laboratory which are carried out under official control of series or series of official control protocol (rule no. 326 (2) Chapter 11)/Details of the State laboratory ora laboratory designated for that purpose (OMCL) where the official batch protocol review (article 81 of Directive 2001/82/EC transposed in title 11 of Regulation No. 326 (2)) or the official control authority batch release takes place name (Company) name/address/address State/Country telephone number/fax number/telephone Telefax email address/E-mail notes. (1) the Cabinet of Ministers of 15 May 2007 No. 319 of the rules "rules for the manufacture of veterinary medicinal products and control the order in which the veterinary medicinal product, the manufacturer shall issue a certificate of good manufacturing practice for veterinary medicinal products, and the production of officers qualifications and professional experience requirements" (hereinafter Regulation No 319). (2) the Cabinet may 31, 2016. the Regulation No. 326 "distribution of veterinary medicinal products and the inspection rules". The notes. (1) the Regulation of the Cabinet of Minister of. 319 "Regulations Regarding the manufacture and Control of Veterinary Medicinal products, the procedure for the Issuance of a Good Manufacturing Practice certificate to a Manufacturer of Veterinary Medicinal products and Regarding the requirements for the Qualification and Professional experience of the Official Responsible for the manufacture of Veterinary Medicinal products" (Regulation No. 319) of 15 May 2007. (2) Regulations of the Cabinet of Minister of. 326 "Regulations Regarding the Distribution and Control of Veterinary Medicinal products" of 31 May 2016. "
1.49. Replace annex 2, paragraph 2, the words "the labelling, distribution, and control arrangements" with the word "marking"; 1.50. the deletion of Chapter 4 of annex 2 of the title, the word "(non-clinical)"; 1.51. replace paragraph 2.2 of annex 3, the words "the labelling, distribution, and control arrangements" with the word "marking"; 1.52. the deletion of annex 5; 1.53. supplement the provisions of annex 7 with the following: "7. the annex to Cabinet of Ministers of 18 July 2006, regulations no 600 food and veterinary service of the veterinary medicine Application clinical trial 1. information about the sponsor's name or the first name and last name registration number in the register of companies or State revenue service or social security number, address, or the address declared the actual address (fill in if different from the legal or the declared address) contact information : Configure the fax phone number e-mail adrese1 tīmekļvietn adrese1 of 2. information on the notified the sponsor name or pārstāvi1 name registration number in the register of companies or State revenue service or social security number, address, or the address declared the actual address (fill in if different from the legal or the declared address) contact details: phone number, configure fax e-mail adrese1 tīmekļvietn adrese1 of 3. information about the responsible researcher name or first name and last name registration number in the register of companies or State revenue service or social security number, address, or the address declared  Actual address (fill in if different from the legal or the declared address) contact details: phone number, configure fax e-mail adrese1 tīmekļvietn adrese1 of multi-centre clinical trials clinical research in EU Member States International multicenter clinical trials clinical research institutions involved in the territory of Latvia (number) multi-centre clinical research institutions involved in the territory of the EU Member States (number) multi-centre clinical research institutions involved in the territory of third countries (number of) information on multi-centre clinical research involved (name or first name and last name , address, contact information) other researchers responsible (first name, last name, address, contact information) 4. information about the clinical trials of the veterinary medicinal products nosaukums1 veterinary medicinal product name or code, used in veterinary medicine in the name of the active substance in veterinary medicinal products, the registration of veterinary medicinal products, configure the shape and strength (for example, tablets, injection) of the registration certificate holder (holder) or its authorized representative name and uzvārds1 mAh (the holder) or its authorised representative number in the register of companies or State revenue service or persons kods1 mAh (the holder) or its authorised representative registered office or the declared adrese1 mAh (the holder) or its authorized representative for the actual address (fill in if different from the legal or the declared address) 1 mAh (the holder) or its authorized representative telephone number kontaktinformācija1: configure fax e-mail adrese1 tīmekļvietn adrese1 Note: the corresponding studies of the veterinary medicinal product used in the shape and strength is registered in Latvia (State registration number of veterinary medicinal products) ___ _____ _____ _____ _____ _____ _____ _____ the application is for registration of veterinary medicinal products submitted to the food and veterinary service (specify the filing date or case number) _____ _____ _____ _____ _____ _____ _____ ___ veterinary medicinal products are registered with another form or the strength of Latvia (State registration number of veterinary medicinal products) _____ _____ _____ _____ _____ _____ _____ ___ other veterinary medicinal product application forms for registration or strength is submitted to the food and veterinary service (specify the filing date or case number) _____ _____ _____ _____ _____ _____ _____ ___ active substance has previously been used for studies in Latvia (specify the trial name, the date and the food and veterinary service decision number) ____ ____ ____ ____ ____ ____ ____ ____ ____ __ studies used the form and strength of the veterinary medicinal product is authorised in a European economic area country ( indicate the registration number of the veterinary medicinal product, country) ____ ____ ____ ____ ____ ____ ____ ____ ___ ___ research veterinary drug used with another form or strength is established in a European economic area country (indicate the registration number of the veterinary medicinal product, State) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 5. information about the clinical trials clinical trials a clinical trial name: placebo controlled the other control group (specify which) ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ _____ no control groups in clinical trials using animals: veterinary practice authority patient (specify the name of the veterinary the registration number of the register of enterprises or the State revenue service, the actual address and contact information, if different from 3. this submission of the information referred to in paragraph) ____ ____ ____ ____ ____ ____ ____ ____ ____ __ animal accommodation (specify the number of the accommodation and the animal owner's name, or first name and last name) ____ ____ ____ ____ ____ ____ ____ ____ ____ __ other (name) ____ ____ ____ ____ ____ ____ ____ ____ ____ __ clinical trial period: start date to end date 6. Application documents: to be added to the review of all active research with the relevant veterinary medicinal product on the ____ lapām1;
 the data collection of the investigational veterinary medicinal product, the reference on the quality of veterinary medicinal products, the placebo kvalitāti1, previously rezultāti1 and benefits of the research and assessment of the risk to the ____ pages;
 a copy of the manufacturer's licence and compliance with good manufacturing practice, a copy of the document to the ____ pages;
 the active substance of veterinary medicinal products in compliance with good manufacturing practice, a copy of the document to the ____ pages;
 a copy of the document under the animal's owner (holder) informed consent (national language);
 veterinary practice authority owner's consent to the conduct of clinical trials;
 sponsor pilnvara1;
 the document, which certifies responsible investigator and sponsor's liability insurance, including the conditions of clinical trials used in the animal's owner (holder) if the clinical trials used to the animal is harmed;
 responsible researcher's experience and qualifications described on _____ pages. 7. Applicant's mark permission to conduct a clinical trial I would like to receive in the form of a paper document.  I certify that the information submitted is true.
          (name, surname)   (date) (signature) 2 Z 2. v. 2 notes. 1 fill in if applicable. 2 document properties "date", "signature" and "Z" does not fill in the v. If an electronic document is drawn up according to the law on electronic document design. " 2. the rules shall enter into force on June 15, 2016. Prime Minister Māris kučinskis Minister of agriculture John Dūklav