Cabinet of Ministers Regulations No. 313, Riga, 30 March 2010 (pr. 23. § 16) pharmaceutical and veterinārfarmaceitisk operating licensing Issued in accordance with article 5 of the law on Pharmacy 1, 14 and 19, 37, 45 and 51 article and the law "On the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" 12. the first paragraph of article i. General questions 1. determines: 1.1. procedures for issue, suspend, renew, and revoke the re-registered at any of the following special permissions (licenses) and pharmaceutical veterinārfarmaceitisk activities indicating according to the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" with the operations allowed in Latvia controlled narcotic substances, psychotropic substances and precursors included in list II and III substances (hereinafter referred to as controlled substances) and medicinal products containing the lists included the narcotic drugs and psychotropic substances (hereinafter referred to as the narcotic drugs and psychotropic drugs): 1.1.1. special permit (license) veterinary medicinal products or medicinal products, or for the manufacture of investigational medicinal products or import from countries Member States of the European Union or the European Free Trade Association countries that are signatories to the agreement on the European economic area (third countries);
1.1.2. special permit (license) or active pharmaceutical ingredients for the production of controlled substances;
1.1.3. the special permit (license) veterinary medicinal products or medicinal products to open lieltirgotav (operation);
1.1.4. the special permit (license), or general open pharmacies opening (action) (hereinafter referred to as the General type of license for the operation of pharmacies);
1.1.5. special permit (license) for the closed-end type, or medical treatment institutions pharmacies opening (the transaction);
1.2. operation of pharmacies;
1.3. the medicine or veterinary medicine, medicine lieltirgotav or veterinary medicinal products or investigational medicinal product production start-up and conformity assessment procedures;
1.4. the order in which the valued drug (excluding veterinary medicine) distribution compliance with good distribution practice;
1.5. the national toll for the special permission (license) and renewal, as well as the collection of State fees.
2. These provisions do not apply to special permissions (licenses) of the issuing, suspension, cancellation, renewal and veterinary pharmacy veterinārfarmaceitisk order.
3. the decision of the special permission (license) and re-registering adopted medicine Government Agency (hereinafter Agency) after it is assessed or veterinary medicinal products medicinal products or investigational medicinal products or the production or import of production of controlled substances, or drug or lieltirgotav matches the veterinary medicinal product (does not apply to active pharmaceutical substances, except for controlled substances) or in accordance with the provisions of paragraph 19 of the assessed that the pharmacy premises, equipment , equipment, personnel and documentation comply with those rules, regulations on the operation of pharmacies, distribution of medicines and other pharmaceutical regulatory laws and requirements.
4. the Agency shall decide on the following special permission (license) (hereinafter licence) the issuance, renewal, suspension, cancellation, renewal and: 4.1 General type of pharmacies opening (operation): 4.1.1 pharmacist practice;
4.1.2. a pharmacist koppraks;
4.1.3. a pharmacist Corporation;
4.1.4. the municipality;
4.2. the closed pharmacy or hospital's pharmacy opening (operation) (hereinafter referred to as the licence closed pharmacy operation);
4.3. lieltirgotav medicinal opening (operation) (hereinafter referred to as the licence for the operation of the lieltirgotav of medicinal products);
4.4. veterinary medicinal products to open lieltirgotav (operation) (hereinafter referred to as the licence of a veterinary medicinal product lieltirgotav action);
4.5. veterinary medicinal products or medicinal products, or for the manufacture of investigational medicinal products or import (hereinafter referred to as the licence for production or import of medicines);
4.6. active pharmaceutical substance or the production of controlled substances or alcohol (excipient) packaging (for use in medicine and veterinary medicine).
5. in paragraph 4 of these regulations: 5.1 that license drug lieltirgotav activities include authorization to distribute by wholesale the medicinal products for veterinary use, if the license is specified in the annex to these provisions concerned and 62.7 38.9. referred to special operating conditions allowed. In this case, get some of this provision 4.4. license referred to is not necessary;
5.2. the license for the production of medicines or for import include authorization to distribute by wholesale the medicinal products produced or veterinary medicinal products or investigational medicinal products covered by the specific license;
5.3. the license active pharmaceutical substance or the production of controlled substances or alcohol packaging to include authorization to distribute by wholesale the produced substances and bulk alcohol subject to specific license;
5.4. the license for the production of medicines or for import into or license active pharmaceutical substance or the production of controlled substances or alcohol for packing is also issued in the following cases: 5.4.1. If the veterinary medicinal product or veterinary medicinal products or investigational medicinal products or active pharmaceutical substance or a controlled substance or alcohol is not intended for distribution in the territory of the Republic of Latvia or is only intended for export to third countries;
5.4.2. full or partial production (packing, packaging and product design) process.
6. veterinary medicinal products or medicinal products or investigational medicinal products or active pharmaceutical substance, or the production of controlled substances the start-up requirements and conformity assessment procedures are laid down in these regulations and laws on medicine or veterinary medicine production and control.
7. General License type and license for the operation of pharmacies, drug action entitle lieltirgotav to distribute the following products: 7.1 dietary supplements;
7.2. drinking water, mineral water and spring water;
7.3. medicinal plants and herbal teas;
7.4. honey and beekeeping products;
7.5. dietary foods, including: 7.5.1. artificial blends and formulae for infants;
7.5.2. intended for infants and young children food;
7.5.3. dietary foods with reduced energy value;
7.5.4. dietary foods for special medical purposes;
7.6. chewing gum, mouth fresheners, cough candies and caramel with vitamins;
7.7. in the case of herbal organic food products.
8. The licence shall be issued for an unlimited duration (except this rule 78 of the cases referred to in paragraph). If the information changes, specified in the license and its annexes, re-register the license in accordance with these rules. License without the attachments specified is not valid.
II. The applicant and documents 9. for that rule 4.5 license referred to drug production or importation, the person in whose name the licence be issued for (hereinafter applicant) shall submit an application to the Agency (annex 1) and for the assessment of conformity or re-registering for the issue of licences for the manufacture or import of medicines. The application shall be accompanied by the required information and documents, including a description of the production site (annex 2) and, if the medicinal product or veterinary drug is manufactured only for export, the export of medicinal products produced or lists of veterinary medicinal products (annex 3).
10. The applicant shall ensure that the following requirements are met and the rules of application referred to in paragraph 9 and the attached documents to provide the following information: 10.1 the medicine or veterinary medicinal products or investigational medicinal product list, intended to produce or to import. Investigational medicinal product name, strength, shape and form (1. and annex 3);
10.2. the relevant production or import operations;
10.3. where these rules 10.1 referred to medicine or veterinary medicinal products or investigational medicinal products are to be manufactured or imported, and the place where their quality control;
10.4. This provision 10.1 referred to medicine or veterinary medicinal products, or for the manufacture of investigational medicinal products or for import into suitable and sufficient premises, technical equipment and installations, including the control of equipment which complies with the drug or the registration of veterinary medicinal products referred to in the documentation requirements, as well as the law on veterinary medicinal products or medicinal products manufacture, control and storage requirements;
10.5. the appropriate personnel, which is the applicant, and proof that the applicant have permanently and continuously at his disposal at least one medicine or veterinary medicine production and control of the responsible official, whose qualifications and work experience meets the relevant legislation on medicinal products or the manufacture of veterinary medicinal products and control requirements (hereinafter referred to as the qualified person);
10.6. If the produce or import the narcotic drugs and psychotropic medication, provided the illicit manufacture of narcotic drugs and psychotropic drug circulation according to the legislation on illicit traffic in narcotic drugs and psychotropic medicine movement, as well as the pharmaceutical or veterinārfarmācij areas of regulatory laws;
10.7. in at least one official, which is held by the applicant and is responsible for the illicit manufacture of narcotic drugs and psychotropic medicines (if intended to manufacture or import) movement;

10.8. ensure the circulation of alcohol according to the regulations on the procedure for the circulation of alcohol and pharmaceutical activities veterinārfarmaceitisk enterprises (if used in the manufacture of alcohol or of alcohol use treatment fast and in veterinary medicine);
10.9. investigational medicinal products – manufacturing process virus inactivation or unconventional agents (if necessary).
11. for this rule 4.6 license: referred to in 11.1. for the production of controlled substances (also when substances are manufactured only for export) or alcohol packaging, the applicant shall submit the application to the Agency (annex 1) and for the assessment of conformity for the issue of licences for the production of controlled substances (also when substances are manufactured only for export). The application shall be accompanied by the required information and documents, including a description of the production site (annex 2) and the list of controlled substances (annex 3);
11.2. the active pharmaceutical ingredients (except controlled substances) (hereinafter referred to as the active pharmaceutical ingredient) manufacturing (also when substances are manufactured only for export), the applicant shall submit to the Agency an application for the issue of the licence. The application shall indicate the following: 11.2.1. license applicant (manufacturer) company in the commercial register, registration number, registered office and pharmaceutical site – shop floor address;
11.2.2. active pharmaceutical ingredients (the international non-proprietary name (INN) or, if not, the chemical name and CAS registry number of the substance);
11.2.3. active substance;
11.2.4. license applicant status: 11.2.4.1. manufactures;
11.2.4.2. packed and labelled substance which produced other independent producers;
11.2.5. information on whether the active pharmaceutical substance distributed in Latvia or only produced for export;
11.2.6. for active pharmaceutical ingredients production officers name and surname;
11.2.7. If active pharmaceutical ingredients production involving a foreign manufacturer, the production involved responsibility for each stage of the production process and finished products, as well as each party's control and extent.
12. The applicant shall ensure that the following requirements are met and the rules of application referred to in paragraph 11 and the attached documents to provide the following information: 12.1. list of controlled substances. If the substance is manufactured only for export, the export of medicinal products produced or lists of veterinary medicinal products (annex 3);
12.2. the relevant production or export activities;
12.3. the location intended for the manufacture of active pharmaceutical substance or controlled substance or alcohol, and wrapped the place to take it for quality control, or a place that is the applicant active pharmaceutical substance or the production of controlled substances or alcohol packaging;
12.4. If produce controlled substances, – provided the illicit manufacture of narcotic drugs and psychotropic substances circulation according to the legislation on Narcotic Drugs and psychotropic substances circulation, as well as the pharmaceutical or veterinārfarmācij areas of regulatory laws;
12.5. in at least one official, which is held by the applicant and is responsible for the movement of controlled substances;
12.6. If the production use of alcohol or the use of alcohol treatment fast and veterinary, ensure the circulation of alcohol according to the regulations on the procedure for the circulation of alcohol and veterinārfarmaceitisk activities of the pharmaceutical companies.
13. in order to receive a license in medicine or veterinary medicine, lieltirgotav transaction, the applicant shall submit to the Agency an application for conformity assessment and the issue or renewal of the license or veterinary medicinal products medicinal products lieltirgotav action (annex 4). The application shall be accompanied by the required information and documents.
14. The applicant shall ensure that the following requirements are met and the rules referred to in paragraph 13 of the application and the attached documents to provide the following information: 14.1. where medicines or veterinary medicinal products or investigational medicinal products, or controlled substance will be stored and distributed, and a place to take it;
14.2. suitable and adequate premises, technical equipment and installations (including control equipment) to ensure the medicine or veterinary medicinal products or investigational medicinal product, or controlled substances proper conservation and distribution of appropriate legislation on medicinal products and distribution of veterinary medicinal products;
14.3. the applicant has staff and Executive (pharmaceutical lieltirgotav of good distribution practices), corresponding to the legislation on medicine or veterinary medicine distribution requirements (hereinafter referred to as the officer in lieltirgotav);
14.4. the commitment to fulfil the obligations, which licenses medicines or veterinary medicine lieltirgotav holder for the operation of certain laws on medicine or veterinary medicine distribution, including good distribution practice principles and guidelines (does not apply to veterinary medicinal products);
14.5. If you distribute the narcotic drugs and psychotropic drugs and controlled substances, – provided the illicit manufacture of narcotic drugs and psychotropic medicines and the movement of controlled substances under the regulations for the illicit manufacture of narcotic drugs and psychotropic substances and drugs, as well as the movement of pharmaceutical or veterinārfarmācij areas of regulatory laws;
14.6. the applicant has at least one officer who is responsible for the illicit manufacture of narcotic drugs and psychotropic drugs and controlled substances (if any is intended to store and distribute) movement;
9.1. If you distribute the alcohol-alcohol movement supported according to the regulations on the procedure for the circulation of alcohol and veterinārfarmaceitisk activities of the pharmaceutical companies.
15. for 4.1 or 4.2. license referred to a general type of pharmacies or closed pharmacy (pharmacy), the applicant shall submit to the Agency an application for the issue of licences for the operation of pharmacies or re-registering or of changes in the information submitted and documents (annex 5). The application shall be accompanied by the required information and documents, including proof of space, equipment, personnel and documentation of compliance with these rules and regulations on the operation of pharmacies.
16. The applicant shall ensure that the following requirements are met and the rules referred to in paragraph 15 of the application and accompanying information and documents (including the certificate on the premises, equipment, personnel and documentation) provided the following information: 16.1. applicant is suitable and sufficient premises, technical equipment and installations (including control equipment), as well as documentation to ensure the medicine or veterinary medicine (if such will be distributed) that comply with the laws and regulations on the opening and operation of pharmacies and medicine and distribution of veterinary medicinal products;
16.2. the applicant has staff and pharmacy manager of education and professional experience corresponds to the pharmaceutical Act;
16.3. If narcotic or psychotropic distributes drugs and controlled substances, – provided the illicit manufacture of narcotic drugs and psychotropic medicines and the movement of controlled substances under the regulations for the illicit manufacture of narcotic drugs and psychotropic substances and drugs, as well as the movement of pharmaceutical or veterinārfarmācij areas of regulatory laws;
16.4. the applicant has at least one officer who is responsible for the illicit manufacture of narcotic drugs and psychotropic drugs and controlled substances (if such will be distributed).
III. Conformity assessment licence or re-registering and good distribution practice for conformity assessment procedures the Agency this rule 17.9, 11, 13 and 15 of these submissions and the accompanying information and documents (hereinafter referred to as the license case) recorded it on the date of receipt. Within five working days after the receipt of the documents it assesses the initial inspection of a document, and issue the registration order (or by mail) the invoice to the applicant for the document inspection and conformity assessment in accordance with the Agency's public service price list.
18. in order to assess the pharmaceutical or veterinary medicinal products or investigational medicinal products or the production or import of production of controlled substances, or drug or lieltirgotav of the veterinary medicinal product for compliance work and character, after the initial inspection and get to use the licence, the Agency shall assess the case and carry out conformity assessment test this provision 10.3, and 14.1 in 12.3 at the specified location. The test will ensure that: 18.1. lieltirgotav area of medicines, equipment, facilities, personnel and documentation comply with the legislation on the distribution of medicinal products, as well as the applications listed in the special conditions of operation. The verification shall be carried out not later than 30 days after receipt of the application;
18.2. lieltirgotav veterinary medicines, equipment, facilities, personnel and documentation comply with the legislation on veterinary medicine distribution requirements, as well as special activities referred to in the application. The verification shall be carried out not later than 30 days after receipt of the application;

18.3. veterinary medicinal products or medicinal products, or for the manufacture of investigational medicinal products or for the import or production of controlled substances the necessary premises, facilities, equipment, personnel and documentation comply with the legislation on veterinary medicinal products or medicinal products manufacture and controls the requirements of good manufacturing practice requirements referred to in the application, as well as the specific operating conditions. The verification shall be carried out no later than 60 days after receipt of the application.
19. in order to assess the conformity of the application in pharmacy given the volume and nature of work, after the initial inspection and get to use the licence, the Agency shall assess the case and make sure that the pharmacy premises, equipment, facilities, personnel and documentation comply with the legislation on the operation of pharmacies and drug distribution and other pharmaceutical regulatory laws and requirements, as well as the applications listed in the special conditions of operation.
20. by paragraph 19 of these rules in the compliance review officer shall draw up the Agency's opinion and adds it to the corresponding license file.
21. following this rule 18.1 and 18.2. conformity assessment as referred to in point inspection agency official shall draw up a report. Report: 21.1. Merchant firm (individual merchant – also the name, surname and personal code), registered office, or the actions of the pharmaceutical veterinārfarmaceitisk object name, if different from the name of the economic operator, the actions of the pharmaceutical or veterinārfarmaceitisk site address, and the date of the check;
21.2. the license number and the indication ' license issued for an indefinite period ". If conformity assessment test taken license and license renewal is due, indicate the period of validity of a licence;
21.3. the verification activities and findings;
21.4. the conclusions of the compliance findings to the information in the application and the documents submitted;
13.4. information about compliance with the findings or field of veterinārfarmācij of Pharmacy regulatory laws and requirements. If you identify any non-conformity or veterinārfarmācij areas of Pharmacy regulatory laws or non-compliance with the requirements laid down in the illicit manufacture of narcotic drugs and psychotropic substances circulation in the laws regulating the requirements specified in the legislation, or the name of the article;
21.6. the infringements established and deadlines for the correction of deficiencies, as well as the obligation to submit a remedial plan;
21.7. If compliance is assessed in the context of the licence renewal: 21.7.1. date when the previous testing or good distribution practice for conformity assessment;
21.7.2. information on whether the previous control report said irregularities and deficiencies are not identified;
21.7.3. information on the administrative penalties imposed on pharmaceutical or veterinārfarmaceitisk actions for infringement of the law or to the illicit manufacture of narcotic drugs and psychotropic substances and drug chain law violations by previous inspections, including the officials prosecuted, and details of payment of the fine;
21.8. the proposal for the issuance of licence renewal, suspension, or cancellation;
13.6. the official name, position and signature, which carried out the inspection, as well as message composition date.
22. This rule 18.3. conformity assessment referred to in point inspection officials of the Agency, taking into account legislation on medicinal products or the manufacture of veterinary medicinal products and control of certain veterinary medicinal products or medicinal products good manufacturing practice principles, guidelines and the guidelines of the European Commission. After checking the control report shall be drawn up according to the law on the production and control of medicinal products laid down.
23. This provision paragraph 21 of that report shall be drawn up in triplicate. One copy shall be issued to the applicant, the other copy shall be kept in the records of the Agency, the third copy to the Add license case.
24. If a medicine or veterinary medicinal products or investigational medicinal products, the manufacturer or importer or producer of controlled substances are found in a check and this provision in paragraph 22 that report contains a critical or important deficiencies, the applicant 10 calendar days after the inspection for conformity assessment report submitted to the deficiencies in the agency plan. If the failures are necessary for more than five days, together with the lack of prevention plans submitted an application for the extension of the proceedings. For the correction of deficiencies, the applicant shall inform the Agency in writing.
25. The licence holder shall submit to the agency within 10 working days of the submission (free-form) with a request to supplement the license case with new information and documents, if there are changes to: 1 these provisions 25.1., 3, 4 or 5 in the annex in the application and the attached documents in the information provided in the following cases: 25.1.1. If pharmacies leader or Executive lieltirgotav for a period of 30 to 120 days shall be replaced by another official;
25.1.2. change on special conditions action Officer (if this person is not listed in the annex of the licence);
25.1.3. added or changed or imported medicinal products manufactured or produced in the veterinary medicinal product or the list of controlled substances (annex 3) (this provision does not apply to the list with the addition of a new pharmaceutical form or type);
25.1.4. change in medicine or veterinary medicine or pharmacy lieltirgotav working time (except if the pharmacy will not work or will work round the clock below);
25.1.5. change in the operator's Board members or members;
25.1.6. changes the information on pharmaceuticals action (annex 5);
25.2. this rule 11.2. the information referred to in the following cases: 25.2.1. officials responsible for three months or more shall be replaced by another official;
25.2.2. added or changed active pharmaceutical substances.
26. If there are changes to the licence or its annexes specified in the information that is not referred to in paragraph 25 of these rules (especially if the change of the qualified person, the officer or the head of the pharmacy, including, if the pharmacy manager or Executive lieltirgotav for a period exceeding 120 days, replaced by another officer), the holder of the licence within five working days after the change occurs in the Agency submitted the application for license renewal. The application shall indicate the changes in accordance with these rules 1, 2, 3, 4 or 5 the form laid down in annex I or the provisions mentioned in paragraph 11.2. information to include only information about the change.
27. These regulations 4.3, 4.4, 4.5 and 4.6 in (apply to controlled substances and alcohol packaging) Re-register such a licence, without this provision, paragraph 18, of the conformity assessment test, if the holder of the licence shall submit to the Agency an application accompanied by the information and documents in accordance with the provisions of 1, 3 or 4, or in accordance with the provisions of paragraph 11.2., and which States that: 27.1. change license or its annexes referred to in the information (except this rule 28.1. , 28.2, 28.3, 28.4.. and 17.7. cases referred to);
27.2. the following will not produce any of the licences in case such products or veterinary medicinal products or investigational medicinal products or medicinal forms, or controlled substances or active pharmaceutical substances or alcohol will be carried out Prepackaging;
27.3. one of the license in case such products or veterinary medicinal products or investigational medicinal products or substances not controlled will be imported from third countries;
27.4. not to take any of these rules, and 62 63.64. Special activities referred to in paragraph 1;
17.1. change of the qualified person, the responsible officer of the lieltirgotav, of active pharmaceutical substance or the production of controlled substances the designated officer or the special action conditions officer specified in the license for the production or import of medicines;
17.1. change of active pharmaceutical ingredients production site address.
28. This provision 4.3, 4.4, 4.5 and 4.6 in (does not apply to active pharmaceutical substances, except for controlled substances) for the license to re-register, making this the rule laid down in paragraph 18 the conformity assessment test, in the following cases: 28.1. before a new medication or veterinary medicinal products or investigational medicinal product or a new pharmaceutical form or new production or import controlled substances in the production;
28.2. If you changed the laboratory, with which an agreement on quality control, or the manufacturer, with whom a contract for production activities;
17.6. If pharmaceutical or veterinārfarmaceitisk activity is intended to supplement with any of these terms, or 62 63.64. Special activities referred to in paragraph 1;
28.4. before the medicine or veterinary medicinal products or investigational medicinal products, or the production of controlled substances or medicines and veterinary medicine lieltirgotav activities in the new location;
28.5. other cases relating to manufacturing, quality control, or the distribution of the premises, facilities, equipment, personnel and documentation material changes;
28.6. at the substantiated request of the licence holder;

28.7. If the license for the production or import of medicines or controlled substances suspended production on the basis of the competent national authorities a written proposal concerning the alleged infringements or medicinal products, veterinary medicinal products or investigational medicinal product production or import, controlled or in distribution or manufacture of controlled substances, control or distribution.
29. Three and six months after licensed entities (which deals with the production of medicines or importing) start-up or license renewal this provision, paragraph 28, case officers conducted licensed agency conformity assessment the person check to ensure that the appropriate legislation on medicinal products or the manufacture of veterinary medicinal products and medicinal products is control and veterinary medicinal products good manufacturing practices. Medicine and veterinary medicine good manufacturing practice compliance assessment, the Agency shall prepare a report in accordance with the laws and regulations on drug production.
30. The three and six months after the lieltirgotav of the licensed drug start-up or license renewal this provision, 28.4 and 28.5 28.3..., in the case referred to in subparagraph agency official licensed persons make conformity assessment test to make sure that (with the exception of veterinary medicinal products) distribution procedures comply with the legislation on the distribution of medicinal products medicinal products laid down good distribution practices. On good distribution practice for conformity assessment, the Agency shall prepare a report in accordance with paragraph 21 of these rules.
31. The three and six months after the lieltirgotav of the licensed veterinary medicinal product or the start-up license renewal this rule 28.3, 28.4 and 28.5.. in the case referred to in subparagraph agency officials carry out conformity assessment checks to verify that the distribution of veterinary medicinal products, procedures comply with the legislation on veterinary medicine distribution distribution principles laid down. On the distribution of the evaluation of veterinary medicinal products, the Agency shall prepare a report in accordance with paragraph 21 of these rules.
32. The three and six months after the start-up of the licensed pharmacy or re-registering the license in connection with a change of room pharmacies (move), or this rule 60.3 60.4.,.,.,., and 38.1 37.7 61.4. special actions referred to in the conditions of the health inspection (hereinafter Inspectorate) officials control the pharmacy to make sure that the pharmacy operation meets the pharmaceutical and illicit traffic in narcotic drugs and psychotropic substances and the movement of medicinal products regulatory laws and requirements. On the control dial control.
33. in order to ensure a regular Pharmacy and medicine or veterinary medicine monitoring of lieltirgotav by the license or veterinary medicinal products medicinal products lieltirgotav for the operation of the service, according to the competence and agency officials of the inspection at least every three years to reassess the Pharmacy and medicine and lieltirgotav of the veterinary medicinal product in conformity with the relevant laws and regulations on the operation of pharmacies and pharmaceutical and distribution of veterinary medicinal products, including compliance with good distribution practice of medicinal products, the principles and guidelines lieltirgotav.
34. following this rule 33. the checks referred to in paragraph 1 shall draw up the rules in paragraph 21 of that report. If the report shows that: 34.1. veterinary medicinal products or medicinal products complies with pharmaceutical or lieltirgotav veterinārfarmācij and the illicit manufacture of narcotic drugs and psychotropic substances and regulating the movement of medicinal products regulations requirements, message added to the license file;
21.3. the medicine or veterinary medicine lieltirgotav pharmaceutical or veterinārfarmācij found in the area of regulatory law, as well as the illicit manufacture of narcotic drugs and psychotropic substances and the movement of medicinal products regulatory legislation and weaknesses, agency officials determine the time limit for the elimination or, if necessary, request the submission of remedial plan. The report added the license file;
21.3. the medicine or veterinary medicine lieltirgotav lieltirgotav found in the previous control provisions in the field of Pharmacy regulatory legislation, as well as the illicit manufacture of narcotic drugs and psychotropic substances and the movement of medicinal products regulatory law violations and serious shortcomings, agency officials proposes to suspend or revoke the licence. The report added to the license file.
35. If the paper form issued license is lost or irrecoverable damaged, the holder of the licence shall submit an application to the Agency. The application shall specify the reasons for the issue of a duplicate licence, as well as a duplicate receipt for payment of the service in accordance with the Agency's public service price list.
IV. decisions of the Agency 36. the Agency shall take such decisions: 36.1. the issue of a licence or renewal;
36.2. the suspension of the licence or the licence of the special operational conditions of the suspension;
36.3. for the renewal of a licence or a licence of the special operational conditions in the restoration;
36.4. for the issue or renewal of the license, the applicant to comply with the specific conditions that the holder of the licence within the Agency and provides space or equipment, or equipment, or staff compliance with pharmaceutical or veterinārfarmācij areas regulatory laws as well as regulations for the illicit manufacture of narcotic drugs and psychotropic substances and the movement of medicinal products;
22.7. about the extension, if you need additional information (submission of documents or the information provided is not sufficient or there is doubt as to its truthfulness), additional testing or received an application for a license with the new additions of the case information or documents;
22.7. the withdrawal of the licence or the licence of the special cancellation conditions;
22.8. the license for the production of medicines or for import into or controlled substances or active pharmaceutical substances, or alcoholic dividing suspension for certain veterinary medicinal products or medicinal products or investigational medicinal products, or any controlled substances or active pharmaceutical ingredients (listed in the license case) respectively – production (on alcohol – packaging) or import, on the basis of the report of the competent national authority on the provision referred to in paragraph 52 of the pharmaceutical veterinārfarmaceitisk activities or irregularities;
22.9. the license for the production of medicines or for import into or controlled substances or active pharmaceutical substances or alcohol to restore the packing for a particular medicine or veterinary medicinal products or investigational medicinal products, or the production of controlled substances or the import or manufacture of active pharmaceutical ingredients, or packaging if the alcohol licence suspended, on the basis of the report of the competent authority;
22.9. the refusal to issue a licence to that rule 50. in the cases referred to in point.
37. This provision 36.2. the decision referred to in paragraph shall be adopted by the Agency in respect of the licensed pharmacy, if the license suspension is based on the initiative of the person licensed, no more than two times for each time not exceeding six months.
38. If the decision requires additional information, additional testing or received an application for a license with the new additions of the case information or documents, the Agency's administrative procedure law is entitled to take a decision about the extension, not exceeding 90 days. If additional testing required in accordance with the provisions of paragraph 24 of that application, the decision of the administrative procedure law, administrative procedure, exceeding the statutory deadlines.
39. If the Agency has adopted a decision on the extension of the proceedings, the date of adoption of the decision shall notify by telephone and that decision 10 days by fax and e-mail (if e-mail address is specified in the application) sent to the applicant. If you need additional testing, agency officials provide the exercise and control report shall be drawn up in accordance with the provisions of paragraph 21.
40. Within the period requested additional information is not received, the Agency shall consider the matter and take a decision.
41. at the date of adoption of the decision, if it is justified by the urgency that any delay to directly threaten the national security, public order, the environment, a person's life, health or property, the entry into force of the following agency decision: 25.5. decision on the withdrawal of the licence;
41.2. the decision on the suspension of the licence;
41.3. decision on the conditions of operation of certain special suspension;
25.7. decision on licences for the production or import of medicines or controlled substances or active pharmaceutical substances or alcohol to stop packing on a particular medicine or veterinary medicinal products or investigational medicinal products, or any controlled substances or active pharmaceutical ingredients (listed in the license case) respectively – manufactured or imported or alcohol packaging.

42. the Agency's decision on the issue or renewal of a licence shall enter into force on the 10th day following that of its adoption. The Agency may set a shorter time of entry into force of the decision on the suspension of the licence (if the licensee submits an application in the Agency with a request to suspend the licence or some special operating conditions), for the renewal of a licence, a separate special operating conditions of renewal or for the renewal of a licence in respect of the veterinary medicinal product or medicinal products or investigational medicinal products or for the production or import of controlled substances or active pharmaceutical ingredients production , or alcohol packaging.
43. the Agency for the provision of paragraph 41 of the decision referred to in the licence holder on the date of adoption of the decision communicated by telephone and sent by fax and e-mail (if e-mail address is specified in the application).
44. following these rules 9, 11, 13 and 15 of the application referred to in the paragraph, and the receipt of information agency in the Act on administrative procedures the prescribed period shall take a decision on the production or import of medicines or controlled substances or active pharmaceutical substances, or alcohol or drug or the packaging of veterinary medicinal products for the operation of the lieltirgotav, or the operation of pharmacies, hearing the extension of or refusal to issue a license.
45. The Agency shall ensure that the time of adoption of the decision on the license for the production or import of medicines or for the production of controlled substances in re-registering when it is associated with this rule 10.1, 10.2, 12.1 and 12.3. the conditions referred to in point, not more than 30 days after this rule 9 and 11 in the application referred to and the receipt of the document.
46. The licence or a licence issued or transferred by post after the applicant or licensee paid for the inspection of documents and conformity assessment in accordance with the Agency's public charges service price list, as well as the paid State fee for issue of the licence.
47. licences for the production or import of medicines or controlled substances or active pharmaceutical substances, or alcohol or drug or the packaging of veterinary medicinal products for the operation of the lieltirgotav, or the operation of a pharmacy or a person who is responsible for the reorganization or liquidation of authorised economic operator, together with the application for withdrawal of the licence shall submit to the Agency the assurance that the remaining medicine or veterinary medicinal products or investigational medicinal products, or any controlled substances or active pharmaceutical ingredients , or alcohol distribution or destruction of items will be provided in accordance with the legislation on veterinary medicinal products or medicinal products.
48. in addition to these regulations, paragraph 47 information license to manufacture or import, or controlled substances or active pharmaceutical substances, or dividing up the alcohol or the person responsible for the reorganization or liquidation of authorised economic operator, provide the Agency with information about the document and or controlled substances of the medicinal product (sample) of storage space.
49. If the Agency accepts this provision 22.7. the decision referred to in the subparagraph on the withdrawal of the licence on the basis of the controlling officers report, it shall set a time period (not more than two months), from which the license is cancelled, and shall indicate the decision taken. On this decision the agency within three days, inform the merchant and inspection.
50. The decision on the refusal to issue or re license, the Agency takes in the following cases: 50.1. If, on the basis of the information provided, the documents and reports (does not apply to active pharmaceutical substances), found that the applicant or licence holder is unable to provide the pharmaceutical or veterinārfarmaceitisk, or to the illicit manufacture of narcotic drugs and psychotropic drugs, controlled substances, alcohol and active pharmaceutical substance in regulating the movement of the statutory requirements or is not valid for a document on the basis of which the licence is issued;
50.2. of non-compliance with the pharmaceutical or veterinārfarmaceitisk area and the illicit manufacture of narcotic drugs and psychotropic medicines and the movement of controlled substances regulatory laws;
50.3. provided incomplete or false information or submitted information and documents are fake;
50.4. the pharmaceutical or veterinārfarmaceitisk activity or transaction with the narcotic and psychotropic drugs, controlled substances, active pharmaceutical substances or alcohol packaging has been carried out without the appropriate license;
50.5. the judgment of the Court in the insolvency proceedings the applicant established insolvency (new licences).
51. This provision 36.2. referred a decision on drug or lieltirgotav of the veterinary medicinal product, or suspension or for the operation of pharmacies on the licence of the special conditions of the suspension of operation of the Agency shall be adopted in the following cases: 51.1. violation of pharmaceutical or veterinārfarmācij, the illicit manufacture of narcotic drugs and psychotropic substances and regulating the movement of medicinal products legislation requirements and the Agency has received from the competent national authorities a reasonable written proposal for the suspension of the licence;
51.2. medications, investigational medicinal products, veterinary drugs, psychotropic and narcotic drugs and controlled substances stored or distributed in rooms that are not specified in the licence;
51.3. the pharmacy does not support this provision as referred to in paragraph 60 of the license prescribed in annex special operating conditions laid down in the regulations on the operation of pharmacies;
51.4. inspection time of year again, that does not adhere to the application and the documents attached to the specified pharmacies or medicine or veterinary medicine lieltirgotav hours or pharmacy manager or officers (lieltirgotav) working time;
51.5. details of changes in the information and documentation submitted in accordance with the provisions of paragraphs 25 and 26;
51.6. Agency or Office does not provide information that certain pharmaceutical or veterinārfarmācij areas of regulatory laws;
32.1. the deadline set by the competent authorities is not remedied or the lack of irregularities found in these rules, or 22.6. in the case referred to in subparagraph – the deadline is not met the Agency's decision or not prevent deficiencies;
32.2. the personnel that are in the possession of the licence holder does not comply with pharmaceutical or veterinārfarmācij, the illicit manufacture of narcotic drugs and psychotropic substances and the movement of medicinal products regulatory laws;
51.9. licensee does not provide the possibility for the competent authority at any time to take the medicine, veterinary medicine, the investigational medicinal product and distribution of controlled substances control or prevent its;
51.10. licensee or responsible Executive is not paid the administrative fine imposed on pharmaceutical or veterinārfarmācij, the illicit manufacture of narcotic drugs and psychotropic substances and the movement of medicinal products regulatory law violations;
51.11. the judgment of the Court in the insolvency proceedings of the licence holder found on insolvency and bankruptcy proceedings have been initiated;
51.12. licensee shall submit an application to the Agency to suspend a licence or licence of the special operational conditions.
52. This provision, 36.2. referred a decision on production or import of medicines or for the production of controlled substances or active pharmaceutical substances, or alcohol for the suspension of the packing or on the special operations specified in the licence conditions of the suspension or of the provisions referred to in 36.7. decision on license suspension for up to deficiencies with respect to license this particular medicine or veterinary medicinal products or investigational medicinal products or for the production or import of controlled substances or active pharmaceutical ingredients production , or alcohol packaging Agency adopted in cases where the holder of the licence: 52.1. deadline is not provided by this rule 22.6. as referred to in point provided by licences issued requirements;
52.2. the involvement of personnel in manufacturing that is not adequately trained law on medicinal products and veterinary medicinal products manufacture and controls in the order;
52.3. distribution (sale) does not comply with the legislation on veterinary medicinal products medicinal products or distribution requirements;
52.4. failed to provide details of the changes in the information and documentation submitted in accordance with 25.1.2. these rules section and paragraph 26;
52.5. does not support the officials of the competent authority at any time to enter the premises of the manufacturer to make medicine or veterinary medicinal products or investigational medicinal products, or any controlled substances or active pharmaceutical substances or alcohol packaging control or prevent it;
52.6. qualified person has not provided a chance to take control and other obligations laid down in the legislation on medicine or veterinary medicinal products or investigational medicinal product production and control of medicinal products and the import and export of goods;
the production or import of 52.7. does not comply with the legislation on medicinal products (investigational medicinal products) and veterinary medicinal products or active pharmaceutical substances and control certain principles and guidelines of good manufacturing practice and therefore produced product can pose a risk to human health;

52.8. disposal of the producer does not contain information on the active substances that are used as medicinal (investigational medicinal products) and the raw material for the production of veterinary medicinal products, active substances the production compliance with the good manufacturing practice requirements;
52.9. qualified person has not complied with its obligations laid down in legislation on veterinary medicinal products or medicinal products production and control of medicinal products and the import and export of goods;
52.10. during the test the officials of the competent authority cannot give assurances on the finished product or veterinary medicinal products or investigational medicinal products, their components or active pharmaceutical ingredients made at intermediate stages of the manufacturing process control, in accordance with the legislation on veterinary medicinal products or medicinal products manufacture and controls;
52.11. made a drug (excluding veterinary medicines) or investigational medicinal products or active pharmaceutical ingredients in the manufacture of significant irregularities and shortcomings, which the product may present a risk to human health and that prevention requires more than six months.
53. the Agency this rule 36.2. and 22.8. decisions referred to set a time limit for the suspension of the licence or the licence of the special operational conditions for the suspension, or suspension of the licence in respect of a particular medicine or veterinary medicinal products or investigational medicinal products or the production or import of controlled substances or active pharmaceutical substance or alcohol production, packaging activities. The said period shall not be more than six months, or until the license expires. In exceptional cases, on the basis of a reasoned application to the licence holder, the Agency may extend the period of suspension of the licence for a period not exceeding three months.
54. If this provision in the decision referred to in paragraph 36 States that license suspended until the deficiencies found or the prevention of abuse (if you do not want additional conformity assessment), for information on the deficiencies of its receipt, the Agency shall adopt a decision on the licence renewal.
55. If the licence is suspended to avoid inspection or examination carried out by the Agency identified and specified in the message field of the pharmaceutical or veterinārfarmācij regulatory violations of the laws or shortcomings, and after their elimination required additional conformity assessment (check), licence renewed after the licence holder's application for renewal of licence and inspection Control Act or the Agency's receipt of the report.
56. Information on the suspension of the licence and for the renewal of licence places the Agency's Web site (http://www.zva.gov.lv) (hereinafter referred to as the Agency's Web site) in accordance with the provisions of 68.
57. The decision on the withdrawal of the licence or the licence conditions for the operation of the special cancellation of the Agency shall be adopted in the following cases: 57.1. Merchant manufacture or import license case unspecified medication or veterinary medicinal products or investigational medicinal products or medicinal forms, or controlled substances or active pharmaceutical ingredients or fast the alcohol license is not specified;
57.2. veterinary medicinal products or medicinal products or investigational medicinal products, or any controlled substances or active pharmaceutical substances or alcohol packaging operations, which are not mentioned in the description of the application and production facilities (annex 2);
57.3. time of the year again in significant areas of the pharmaceutical or veterinārfarmācij regulatory breaches of the laws relating to risks to human health;
57.4. licensee product or veterinary drug or controlled substance purchased from the person according to the veterinārfarmācij field in the pharmaceutical or regulatory regulations, it is not permitted to distribute drugs, veterinary drugs or controlled substances;
57.5. licensee product or veterinary drug, or controlled substances distributed without a law on the import and export of goods, medicine or veterinary medicine distribution, the illicit manufacture of narcotic drugs and psychotropic substances and controlled the movement of medicinal products laid down in authorizations;
57.6. license has been suspended and deficiencies, which were the basis for the suspension of the licence, the Agency is not remedied within the time limit set;
57.7. over this rule 53 paragraph, the period of suspension of the licence and the holder of the licence has not submitted an application for the renewal of a licence or the renewal, or within six months is not a remedy identified deficiencies or irregularities;
57.8. Agency received the competent national authorities a written proposal to revoke the license because of the findings in the pharmaceutical or veterinārfarmācij, as well as the illicit manufacture of narcotic drugs and psychotropic substances and the movement of medicinal products regulatory law violations and deficiencies;
57.9. found that the applicant has provided false information, which is essential when deciding on the issue of the licence, or by conducting pharmaceutical and veterinārfarmaceitisk activities, the applicant used forged documents;
57.10. found that the licensee manufacture, import or distribute counterfeit medications or veterinary medicinal products or investigational medicinal products, or controlled substances or active pharmaceutical ingredients;
57.11. licences for the operation of the holder by the drugstore pharmaceutical site Exchange does not provide a license under certain special conditions of operation;
57.12. Agency received the licence holder a written notice of withdrawal of the licence due to the actions of the pharmaceutical or veterinārfarmaceitisk.
58. The holder of the licence after receipt of the decision on the cancellation of a licence shall be submitted to the Agency license within three working days after the deadline set by the Agency in accordance with the provisions of paragraph 49.
V. information on and public toll 59.4.1, 4.2, 4.3 and 4.4. license referred to shall be drawn up in accordance with the provisions of annex 6.
60. This provision as referred to in point 4.1 the General type of the license for the operation of pharmacies in the annex the following shall be allowed special operating conditions: 60.1. psychotropic drug distribution;
60.2. the proliferation of psychotropic substances;
60.3. the illicit manufacture of narcotic drugs and psychotropic medicines recognized distribution;
60.4. the illicit manufacture of narcotic drugs and psychotropic substances recognized as distribution;
60.5. amount of countervailable distribution;
60.6. manufacture of medicines in pharmacies;
60.7. non-prescription drug distribution via the internet;
60.8. the distribution of veterinary medicinal products;
60.9. working round the clock.
61. The rules referred to in point 4.2 of the closed-end type of license for the operation of pharmacies in the annex the following shall be allowed special operating conditions: 61.1. psychotropic drug distribution;
61.2. distribution of psychotropic substances;
38.1. the illicit manufacture of narcotic drugs and psychotropic medicines recognized distribution;
61.4. the illicit manufacture of narcotic drugs and psychotropic substances recognized as distribution;
61.5. manufacture of medicines in pharmacies.
62. This rule 4.3. license referred to in subparagraph lieltirgotav of the annex to the action of the medicinal product indicates the following permitted special operating conditions: 62.1. psychotropic drug distribution;
62.2. distribution of psychotropic substances;
38.7. the illicit manufacture of narcotic drugs and psychotropic medicines recognized distribution;
38.8. the illicit manufacture of narcotic drugs and psychotropic substances recognized as distribution;
62.5. distribution of alcohol;
38.9. distribution of veterinary medicinal products;
62.7. the distribution of veterinary medicinal products containing substances with anabolic, pretinfekcij, anti-parasitic, anti-inflammatory, and hormonal characteristics, showing separately: 62.7.1. antimicrobials, sulphanilamide and hinolon;
62.7.2. features of anthelmintic substances;
62.7.3. kokcidiostatisko also nitroimidazole features;
62.7.4. carbamate and pyrethroids;
62.7.5. sedatīvo means;
62.7.6. non-steroīdo anti-inflammatory products;
62.7.7. other pharmacologically active substances and drugs which are not included in the register of the veterinary medicinal product, but which could be used in the treatment of animals.
63. This provision 4.4. license referred to in lieltirgotav of veterinary medicinal products for the operation of the annex indicates the following permitted special operating conditions: 39.2. psychotropic medicines for veterinary distribution;
39.3. recognized as veterinary drugs and psychotropic medicines distribution;
63.3. the distribution of veterinary medicinal products containing substances with anabolic, pretinfekcij, anti-parasitic, anti-inflammatory, and hormonal characteristics, showing separately: 63.3.1. antimicrobials, sulphanilamide and hinolon;
63.3.2. features of anthelmintic substances;
63.3.3. kokcidiostatisko also nitroimidazole features;
63.3.4. carbamate and pyrethroids;
63.3.5. sedatīvo means;
63.3.6. non-steroīdo anti-inflammatory products;
63.3.7. other pharmacologically active substances and drugs which are not included in the register of the veterinary medicinal product, but which could be used in the treatment of animals.
64. The licence referred to in this rule 64.1.: 4.5 above, shall be drawn up in accordance with the provisions of annex 7. If Licensee manufactures or imports narcotic drugs or psychotropic medicines, in annex 8 of the licence specifies the conditions for special operations officers (responsible official) name, as well as the following special operating conditions: 64.1.1. the illicit manufacture of narcotic drugs and psychotropic medicines recognized production;
64.1.2. the illicit manufacture of narcotic drugs and psychotropic medicines recognized importing;
64.1.3. psychotropic drug production;
64.1.4. psychotropic drug importing;

64.2. the provision in paragraph 4.6, shall be drawn up in accordance with the provisions of Annex 8. If the licence holder manufactured controlled substances, licenses indicate the responsible (responsible official) name, as well as the specific conditions of the action: special 64.2.1. drug production;
64.2.2. psychotropic substances.
65. License and its annexes shall be signed by the Director of the Agency. Each license page draws up the footer indicating the license number, type, date of issue and the name of the license holder.
66. the national toll (rate) the issue of a licence is as follows: 66.1. General type for the operation of pharmacies: 66.1.1. cities – 200 lats;
66.1.2. outside cities – 30 lats;
66.2. lieltirgotav medicinal action-300 lats;
66.3. veterinary medicinal products for the operation of the lieltirgotav-50 lats;
66.4. veterinary medicinal products or medicinal products or active pharmaceutical ingredients (including controlled substances) – 500 lats;
41.3. partial medicine or veterinary medicine manufacturing process (repackaging, pārmarķēšan) for pharmaceutical or veterinary medicine lieltirgotav-300 lats;
66.6. investigational medicinal products or for the production of controlled substances or import-100 lats;
66.7. veterinary medicinal products or medicinal products medicinal products or lieltirgotav for importing of veterinary medicinal products-200 lats.
67. On the license of the State fee is re-registering 10 percent of this provision set out in paragraph 66 of the State fees. The revenue from government fees included in the State budget.
68. the Agency on its Web site information about license holders and the State: 68.1. the merchant firm (the individual economic operator, the operator's name and surname) and veterinārfarmaceitisk activities of the pharmaceutical or corporate name, if different from the name of the operator;
68.2. the operator's registered office and registration number in the register of companies;
68.3. pharmaceutical or veterinārfarmaceitisk activities site address;
68.4. license number and expiration date, date of adoption of the decision;
68.5. information on special operating conditions;
68.6. pharmacies or medicine or veterinary medicine lieltirgotav of officers, or medicine or veterinary medicine manufacturer or importer by the qualified person, or, in the case of the production of active substances – the officers name and surname;
68.7. information about the suspension of the licence and the date of adoption of the decision and the time limit;
68.8. information about the renewal of the licence and the date of adoption of the decision;
42.8. information about the withdrawal of the licence and the date of adoption of the decision;
68.10. for license medicines or active pharmaceutical substances in addition to indicate the scope of license: 68.10.1. the production of medicinal products for human use;
68.10.2. import of medicinal products for human use;
68.10.3. the manufacture of veterinary medicinal products;
68.10.4. importing of veterinary medicinal products;
68.10.5. the production of investigational medicinal product;
68.10.6. import investigational medicinal product;
68.10.7. partial manufacturing operations (only medicine or packaging of veterinary medicinal products (repackaging) and pārmarķēšan);
68.10.8. active pharmaceutical substances.
Vi. Institutions and obligations of the holder of the licence, the Agency shall: 69.1.69. create, maintain and update the database on medicinal products produced and imported (type of activity), veterinary medicinal products, controlled substances and active pharmaceutical substances (products) that are listed in the license file. Database indicate their type, name, form, dose, as well as the mode of operation and information on medicinal products, veterinary medicinal products, the investigational medicinal product, controlled substances and active pharmaceutical substances whose production or import is stopped;
EB 69.2. cooperate with inspection (also if conformity assessment test irregularities);
69.3. provides instructions for correcting deficiencies and followed their due dates;
69.4. If irregularities are found in the production, import or distribution of, propose the license suspension or withdrawal;
69.5. enables inspection officials to become familiar with information related to conformity assessment;
72.2. the working day following the suspension or cancellation of a licence shall inform the State revenue service and the food and veterinary service;
69.7. Enter the European Medicines Agency database of information about licenses issued and suspended production or import of medicines;
69.8. According to the European Commission or a Member State of the European Union at the request of the competent authority, provide information on medicinal products issued licences or lieltirgotav of the veterinary medicinal product;
43.4. inform the European Commission and European Union Member States of suspended or withdrawn the licences of medicine or veterinary medicine lieltirgotav;
69.10. provide food and veterinary service information about licenses issued.
70. Inspection: 70.1. control of the licence holder;
70.2. provides instructions for correcting irregularities and deficiencies and followed their due dates;
70.3. at infringement detection shall provide the Agency with written proposals on a license suspension or revocation;
70.4. cooperate with the Agency in matters related to conformity assessment;
70.5. inform European Union involved, the competent authorities of the Member States, if it is established that a person who works in the territory of the Republic of Latvia with other European Union Member State authorisation of medicinal products, wholesale trade in licences does not fulfil these conditions.
71. a food and veterinary service at 69.10. This provision referred to the inbound operators which have received licenses for the operation of pharmacies and pharmaceutical lieltirgotav license, included in the register of the food distributors, which entitles the operator, on the basis of the relevant license, distribute the rules referred to in paragraph 7 of food without the food and veterinary service licence.
72. The holder of the licence: 72.1. ensure in accordance with license and its annexes specified information, special operational conditions and pharmaceutical and veterinārfarmācij areas, the illicit manufacture of narcotic drugs and psychotropic substances and the movement of medicinal products regulatory laws;
72.2. ensure that medicine or veterinary medicinal products or investigational medicinal product manufacture, import and distribution of controlled substances and manufacture active pharmaceutical ingredients and the distribution and packaging of alcohol takes place only on the premises specified in the licence;
72.3. ensure inspection officials the opportunity at any time to enter premises and to control the activities of pharmaceutical and veterinārfarmaceitisk, as well as the illicit manufacture of narcotic drugs and psychotropic drugs, controlled substances and active pharmaceutical ingredients and related documentation;
72.4. Agency officials provide an opportunity at any time to enter the premises to carry out the conformity assessment and verification, including good manufacturing practice or good distribution practice test;
72.5. received and delivered medicine, veterinary medicinal products and investigational medicinal product, any controlled substances inventory and accounting control under the legislation on medicine and veterinary medicine distribution requirements and the illicit manufacture of narcotic drugs and psychotropic substances and the movement of medicinal products regulatory laws;
72.6 at. provide the Agency and the inspection of the information laid down in the field of pharmaceutical or veterinārfarmācij-regulating laws;
72.7. after inspection officials of the Agency and requests on the basis of the interests of public health, provides information on activities;
72.8. after an agency decision on issue or renewal of a licence in another site or for renewal of a licence the licensed activities commence no later than the time of year (if the licence was issued, the drugstore-three months) after the adoption of the decision in question and of the start-up of two working days shall notify the Agency.
73. in addition to the provisions referred to in paragraph 72 license medicines or active pharmaceutical ingredients (including controlled substances) holder: 73.1. ensure that are manufactured or imported only in the medicine, veterinary drug, investigational medicinal products and their forms, controlled substances and active pharmaceutical ingredients that are specified in the license file and included in the database of the Agency;
73.2. handling authorised medicinal products, veterinary medicinal products, the investigational medicinal product, controlled substances and active pharmaceutical substances only in accordance with the legislation on medicinal products or the manufacture of veterinary medicinal products, the import and export of medicinal products and veterinary medicinal products or medicinal products and the illicit manufacture of narcotic drugs and psychotropic medicines and the movement of controlled substances;
73.3. ensure that she has the staff to comply with the legislation on veterinary medicinal products or medicinal products or investigational medicinal products, the production and inspection requirements laid down or, in the case of substances to the illicit manufacture of narcotic drugs and psychotropic medicines and the movement of controlled substances regulatory legislation requirements;
45.6. report to the Agency in advance of any changes to that wishes to information submitted in accordance with the provisions referred to in annex 1 of the application (especially if there is a change in this rule 10.5. and the person referred to in paragraph 11.2.6.);
73.5. ensure that the qualified person is able to perform the obligations imposed by the laws on medicine or veterinary medicine manufacture and controls;

73.6. medicine, veterinary medicine, the investigational medicinal product, any controlled substances and active pharmaceutical substances and controls comply with the principles of good manufacturing practice laid down in law on veterinary medicinal products or medicinal products and active pharmaceutical ingredients production and control, and the European Commission in the good manufacturing practice guidelines, as well as the raw materials used, only active substances which have been manufactured in accordance with the active substance of good manufacturing practice guidelines.
74. the Agency's decision on the refusal to issue a license, the license cancellation, renewal or suspension may be challenged in the administrative process law, submit the relevant application to the Health Ministry. The decision of the Ministry of health regulations in the order can be appealed in court.
VII. Closing questions 75. rules shall enter into force on 1 April 2010.
76. the licence for the operation of pharmacies and pharmaceutical or veterinary medicine lieltirgotav, assigned to the date of entry into force of the rules, in effect, but if the re-register repetitive conformity assessment (refer to medicine or veterinary medicine lieltirgotav), or if a change in the submitted information and documents on the basis of which the licence is issued in accordance with the requirements laid down in these provisions. This renewal is not applied for licences for the operation of pharmacies, which contain special operating conditions-wholesale distribution of medicinal products, medical institutions and social care institutions (ensuring a good distribution practice).
77. Persons who up to this date of entry into force of the provisions has issued licenses for the operation of the pharmacy or medicine or veterinary medicine lieltirgotav activity with a certain expiration date, not later than 30 days before the licence expires, submit an application for conformity assessment (refer to medicine or veterinary medicine lieltirgotav) and re-registering the license in accordance with the procedure laid down in these provisions.
78. for pharmacies that do not need to rearrange the appropriate pharmaceutical law article 36, first paragraph, the conditions for the operation of a pharmacy licence validity period is determined by 2010 31 December.
79. the Agency, in assessing the specific locality by January 1, 2011 for the expected type of the General number of pharmacies under the legislation on pharmacy placement criteria, adopt the submissions license general type for the operation of the pharmacy service of persons who meet the pharmaceutical Act, article 36, first paragraph, of the new general type of Pharmacy (operation) to open areas with 1 January 2011 for the General type of the expected reduction in the number of pharmacies under the law on pharmacy placement criteria specified the maximum permitted number of and licenses granted shall enter into force on January 1, 2011.
80. A pharmacy that has a license for the General type of pharmacy, or closed pharmacy operations that manufacture of the medicinal product used for narcotic drugs and psychotropic substances recognized and psychotropic substances, and which is not specified in the licence of the special operational conditions – the proliferation of psychotropic substances or narcotic and psychotropic substances recognized as distribution, is entitled to continue to take appropriate action in accordance with these provisions on the basis of the existing license If it as special operating conditions is indicated in the illicit manufacture of narcotic drugs and psychotropic medicines recognized and psychotropic drug distribution, to license renewal, but not longer than until 1 April 2011. Re-register a licence, the Agency shall indicate the appropriate licence of the special operational conditions according to this provision, 60.4, 60.2 and 61.2 61.4.. If the pharmacy is working the clock and announced the Agency up to the date of entry into force of the rules and has suspended the action, but its license this action – working round the clock – is specified as the special operating conditions, the pharmacy is entitled to continue to perform this action in accordance with these rules to license renewal, but no longer than up to 2010 31 December. Re-register a licence, the Agency shall specify the special conditions of operation under this provision. 60.9.
81. the medicinal products or licenses the manufacture of veterinary medicinal products or import that are assigned to the date of entry into force of the rules, in effect, but if the re-register repetitive conformity assessment or if changes in the submitted information and documents on the basis of which the licence is issued in accordance with the requirements laid down in these rules, in the light of this provision, paragraph 82.
82. People who have a license for the drug or the manufacture of veterinary medicinal products for which import or manufactures or imports narcotic drugs or psychotropic medicines, but these operations as a separate special operating conditions not specified in the license, in annex 8 are entitled to continue to take appropriate action on existing licenses for the manufacture of medicinal products or for import into basic to license the production or import of medicines for renewal. Re-register the license to manufacture or import licence, the Agency shall indicate in annex 8 of this provision concerned 64.1. referred to special operating conditions.
83. This provision is referred to in paragraph 82 of the person 64.2.1 this regulation. and 64.2.2. do the activities referred to in the licence for the production or import of medicinal products, shall be entitled to submit documents to the rules referred to in point 4.6 of the licence for the production of controlled substances until January 1, 2011.
84. A Person who has received a license in medicine or veterinary medicine production or import (including the production of controlled substances), re-register the appropriate licence, submit to the Agency a list of controlled substances (annex 3).
85. The persons to whom these provisions at the date of entry into force of the food and veterinary service licences of the veterinary medicinal product, lieltirgotav, 2011 January 1, provide the Agency with submissions and documents for conformity assessment and re-registering the license in accordance with the procedure laid down in these provisions.
86. the Agency shall ensure that the provisions referred to in point 4.6 of the licences from 1 July 2010.
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, Directive 2001/83/EC on the Community code relating to medicinal products for human use;
2) of the European Parliament and of the Council of 31 March 2004, Directive 2004/27/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use;
3) 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;
4) of the European Parliament and of the Council of 31 March 2004, Directive 2004/28/EC amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products;
5) of the European Parliament and of the Council of 4 April 2001, Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use;
6) Commission of 8 April 2005 of Directive 2005/28/EC laying down the good clinical practice principles and detailed guidelines on investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
Prime Minister v. Minister of Interior, Dombrovskis Health Minister ad interim Mūrniec of annex 1 of the Cabinet of Ministers of 30 March 2010 the rules no 313 application for conformity assessment and special permission (license) issued (re-registering): drug production or importation of controlled substances for the production of packaging for spirits (mark with x required) the State Agency of medicines shall 1. information on the applicant: 1.1 name 1.2. economic operator. the merchant's legal address and Office address (if different from the registered office) 1.3. registration number in the trade register of the pharmaceutical operations 1.4. company name 1.5. pharmaceutical activities site address
  
 1.6. special permission (license) number (if any) 1.7 1.8 1.9 phone fax. e-mail address (if any) 1.10 1.11. individual website economic operator: 1.11.1. first name and last name 1.11.2. the registration number of the commercial register 1.11.3. residence address 1.12. information on other activities of the pharmaceutical sites: 1.12.1. address 1.12.2. the responsible name 1.12.3. phone 1.12.4. fax 1.12.5. e-mail address (if any) Note. If a company has multiple pharmaceutical sites, this annex referred to in point 1.12. information about other places and officers indicate on a separate sheet and attach to the application.
2. Please issue a special permit (license) (mark with x required): 2.1 2.2. production of medicines for importing medicinal products 2.3. manufacture of the veterinary medicinal product 2.4. import veterinary medicinal products 2.5. manufacture of investigational medicinal products 2.6. import investigational medicinal product 2.7. for the production of controlled substances

 2.8. dividing the alcohol 3. Please reregister the special permission (license) (mark with x required): 3.1 the special permission (license) holder's name change 3.2. special permission (license) holder's legal change of address pharmaceutical activities 3.3 place of 3.4. production or quality control of substantial changes in the methods of 3.5. changes in the import operation 3.6. medicinal products or substances production operations on a contractual basis or change of 3.7 līgumražotāj substances or medicinal products quality control contractual or personal with which an agreement on drug quality control, shift 3.8 change of qualified person 3.9. departmental head change 3.10 quality control Department Manager change 3.11. new special operations launch 3.12. responsible for special operations shift 3.13. new pharmaceutical form or type of the production launch of the 3.14 new pharmaceutical form or type of initiation of import 3.15. Another reason for the note. 3.8. Of this annex, and 3.14 3.13) (does not apply to an application for the production of controlled substances and alcohol packaging.
4. information on the persons who are authorised to represent or who have the right to represent the company: 4.1 the name and surname of the person code 4.2 4.3 4.4. residence address post note. If there is more than one person with signature rights authorized to represent the company, the information referred to in paragraph 4 shall be added to the separate page.
5. information on the qualified person: first name and last name 5.1 5.2 5.3 the identity number of the experience qualifications 5.4 5.5 5.6. contact address phone fax 5.7 5.8. e-mail address (if any) notes.
1. in the annex, accompanied by a copy of the document and of education resume. 2. Does not apply to an application for the production of controlled substances and alcohol packaging.
6. information about the officers: 6.1. pharmaceutical business unit manager: 6.1.1. first name and last name of the person code 6.1.2 6.1.3. detailed information on the liability of 6.1.4.6.1.5. contact address phone fax 6.1.6 6.1.7. e-mail address (if any) 6.2 medicine quality control Department Manager: 6.2.1 6.2.2. name and surname identity number 6.2.3. detailed information on the liability of 6.2.4.6.2.5 contact address phone fax 6.2.7.6.2.6. e-mail address (if any) Note. In the annex, add each of the persons responsible for the education of the copy of the document and resume. If the production operations are the responsibility of the people, on a separate sheet in annex this annex provides the information referred to in paragraph 6 of each person.
 7. information on the special mode of operation – operation with psychotropic substances and medicines: 7.1. information about the type of action (required mark with x): 7.1.1 7.1.2 of psychotropic medicines production. psychotropic drug importing 7.1.3. psychotropic substances 7.2. information on the Executive: 7.2.1 officers name 7.2.2. ID code 7.2.3. phone 7.2.4. the responsible Deputy (if any) name and surname of the person code 7.2.5. Note. In the annex, accompanied by any responsible education and RESUME copy of the document. 8. information on specific types of activities – with the narcotic (and immersive psychotropic) substances and medicines: 8.1. information about the type of action (required mark with x): 8.1.1. narcotic drug production 8.1.2. narcotic drug importing 8.1.3. drug production 8.2. information on the Executive: 8.2.1. officers name 8.2.2. ID code 8.2.3. phone 8.2.4. the responsible Deputy (if any) name 8.2.5. ID code 8.2.6. phone note. In the annex, add each of the persons responsible for the education of the copy of the document and RESUME information on 9 līgumražotāj and the place of manufacture *: name of the company 9.1 9.2 9.3. legal address special permission to manufacture medicinal products number, date, issuing the actual address 9.4 9.5 9.6. plant name. the responsible name 9.7 9.8. phone fax note. If your organization has multiple līgumražotāj or līgumražošan sites, the information referred to in paragraph 9 shall be added to the individual pages for each site and of the officials responsible.
10. information on the laboratory that performs the quality control on the basis of the Treaty and complying with the legislation on medicinal products or the manufacture of veterinary medicinal products and control requirements: 10.1 10.2 the laboratory name. address 10.3 officers name 10.4. phone 10.5 Fax note. If the company has several laboratories with which an agreement on quality controls, the information referred to in paragraph 10 shall be added to the individual pages for each laboratory.
11. information on the production or import operation (necessary to mark with x): 11.1. medicinal products for human use, in the manufacture of complete medicine 11.1.1 11.1.2. partial production medicine manufacturing (including packaging, re-packaging, pārmarķēšan) 11.2. import of medicinal products for human use, in the manufacture of veterinary medicinal products 11.3 11.3.1. the complete manufacture of the veterinary medicinal product 11.3.2 partial manufacture of the veterinary medicinal product (including repackaging, repackaging, pārmarķēšan) 11.4. importing of veterinary medicinal products 7.1. manufacture of the investigational medicinal product 11.6. import investigational medicinal product 7.3. production 12. information on the sterile dosage forms * : table at the respective pharmaceutical form or type specifies the name of the medicinal product.
12.1. aseptically obtained (list of products) are large volume liquid 12.1.1. packaging of 12.1.3.12.1.2. lyophilisate soft dosage forms for small volume liquid 12.1.4. package 12.1.5. solid pharmaceutical forms, and implants are aseptically 12.1.6. other derived products (free listing) 12.2 sterilized end products (list of products) 12.2.1. volume of liquids in a large packaging 12.2.2. soft dosage forms of 12.2.3. volume of liquids in a small package 12.2.4. solid pharmaceutical forms, and implants 12.2.5. other sterilized end products (free listing) 12.3. only series certification (medicine) 12.4. sterile production of controlled substances * note. Does not apply to the application of alcohol packaging.
13. information on non-sterile dosage forms *: table at the respective pharmaceutical form or type specifies the name of the medicinal product.
13.1. non-sterile drug (medicinal) 13.1.1 13.1.2 hard capsules, soft capsules 13.1.3. chewing gum 13.1.4. impregnated-matrix 13.1.5. liquids should use 13.1.6. liquid for oral use 13.1.7 13.1.8. medical gas. other solid pharmaceutical form 13.1.9. aerosol preparations (under pressure) 13.1.10 13.1.11. radionuclide generators. soft 13.1.12. pharmaceutical form of 13.1.13 13.1.14 rectal. pills. transdermal patch 13.1.15 13.1.16. intrarumināl. devices feed additives. other non-sterile 13.1.17 pharmaceutical forms (free listing) 13.2. only series certification (medicine) 13.3. without the sterile manufacturing of controlled substances * note. Does not apply to the application of alcohol packaging.
14. information on the biological medicine production or series of certification: each type of the product indicates the name of the medicinal product and the form.
  14.1. a biological pharmaceutical (drug list) 14.1.1. from human blood and plasma-derived medicinal product 14.1.2. immunologicals 14.1.3. cell therapy medicinal products 14.1.4. gene therapy medicinal products 14.1.5. biotechnology 14.1.6. preparations from human or animal materials revealed preparations 14.1.7. other biological medicinal products (free listing) 14.2. only series certification (medicine) 14.2.1 from human blood and plasma-derived medicinal product 14.2.2. immunologicals 14.2.3. cell therapy medicinal products 14.2.4. gene therapy medicinal products 14.2.5 14.2.6. preparations of biotechnology. from a human or animal materials distributed to preparations
 
  14.2.7. other biological medicinal products (free listing) Note. Does not apply to the application of alcohol packaging.
15. information on other products or production activities *: indicates other manufacturing activities or types of medicinal products other than those referred to in this annex, 12, 13 and 14. At the appropriate point in the nature of the medicinal drug name and form.
9.4. other products (list of products) 15.1.1. herbal medicine herbal substance 15.1.2.15.1.3. a homeopathic medicine 15.1.4. raw materials of biological origin 15.1.5. other (free listing) 15.2. active substances or excipients, or sterilization of the final product if sterilization by the method indicates the active substance or product name.
  15.2.1.15.2.2. sterilization of the filter with hot dry air 15.2.3. sterilization with steam
 

  15.2.4. chemical sterilisation 15.2.5. irradiation with gamma rays 15.2.6. with electron beam irradiation 15.2.7. other (free listing) 16. information on the production of only a partial packing operations *: If only the packaging, at the respective pharmaceutical form indicates the name of the medicinal product.
  16.1 16.1.1. primary packaging of hard capsules, soft capsules 16.1.2.16.1.3.-Matrix impregnated 16.1.4. liquids should use 16.1.5. liquid for oral use 16.1.6. medical gas 16.1.7. other solid pharmaceutical form 16.1.8. aerosol preparations (under pressure) 16.1.9. radionuclide generators 16.1.10. soft 16.1.11. the pharmaceutical form of rectal 16.1.12. pills 16.1.13. transdermal patch 16.1.14. intrarumināl device 16.1.15. feed additives not sterile 16.1.16. other pharmaceutical forms (free listing) 16.2. secondary packaging (list of products) 17. information on quality control (required mark with x) : imported medicinal products 17.1. microbiological: sterility 17.2. microbiological: non-sterile dosage forms of the purity or physico-chemically 17.3 17.4. organic alcohol 18. controlled substances information on imported medicine series certification *: If the imported medicine series certification, at the respective pharmaceutical form indicates the name of the medicinal product.
  18.1. the pharmaceutical form sterile 18.1.1. aseptically obtained 18.1.2. sterilized end products non-sterile drug 18.2 form (pharmaceutical form) 18.3 18.3.1 biological medicinal products of human blood and plasma-derived medicinal product 18.3.2. immunologicals 18.3.3. cell therapy medicinal products 18.3.4. gene therapy medicinal products 18.3.5. biotechnology 18.3.6. preparations from human or animal materials revealed preparations 18.3.7. other biological medicinal products 18.4. other significant import transactions or radiopharmaceuticals 18.4.1. radionuclide generators 18.4.2. medical gas 18.4.3. herbal medicine homeopathic medicine 18.4.5 18.4.4. biologically active. 18.4.6. other materials (free listing) Note. Does not apply to an application for the production of controlled substances and alcohol packaging.
19. the following documents attached to the application (required mark with x): 19.1.  Decision on the business register and other members of the Board representing the economic operator person entitled to represent the economic operator (certified copy) to the __ _____ pages 19.2.  inventory file space plan (certified copy) to the _____ and leaves 19.3 a document certifying the applicant's right to use the facilities (certified copy), click the _____ and leaves 19.4.  certificate of employer and 5 and 6 of this annex, paragraph officers legal relations, their duration, the employee's work, the documents certifying the person's appointment to the appropriate position (certified copies), to ____ ____ pages 19.5.  5 and 6 of this annex, of the persons referred to in paragraph education document (certified copies) and CV-qualified person also diploma and supplement (certified copies) and supporting documents according to the rules of procedure of the manufacture of medicinal products is to _____ and leaves 19.6.  the order for the responsible for the illicit manufacture of narcotic drugs and psychotropic substances and medicine movement posting (certified copy) and the applicant's statement that his founders (list) and members (list) corresponds to the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" article 11, paragraph 2 of the above requirements, the _____ ____ pages 19.7.  responsible for the illicit manufacture of narcotic drugs or psychotropic substances and medicine movement written proof that the person complies with the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" article 11, paragraph 1 and 3 above requirements, to ____ ___ pages 19.8.  the applicant's organisation chart, which shows the administrative responsibility of officials, according to functional responsibilities to ____ pages 12.4. Description of the production of medicines to ____ pages ** 19.10. medicinal products or substances produced list on ___ ___ pages ** 19.11. list of products imported to the __ _____ pages ** 19.12. receipt for payment of the State fees 19.13. additional information other (specify) on _____ and leaves 19.14. the document with which the person authorizes a merchant to submit a drug submission and the State Agency documents to ____ ___ pages of notes.
1. This annex, point 19.5.19.11. shall not apply to an application for the production of controlled substances. 19.8. and 12.4. subparagraph shall not apply to an application for the production of controlled substances if the controlled substances license applicant is required by good manufacturing practice compliance assessment.
2. This annex is 19.5, 19.7, 19.8 19.6.,.,., 19.10 and 19.11.12.4. subparagraph shall not apply to the application of alcohol packaging.
20. information about the person that is authorized by the applicant to submit the application to the State Agency of medicines: 20.1. name post 20.3 20.2. phone 20.4 20.5. fax. e-mail address (if any) (place, date) (signature) * ** *** notes.
1. Delete the paragraphs and sections, are not covered.
2. You can submit the digital form.
3. Document Properties "date" and "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design.
Minister of the Interior, the Minister of health ad interim Mūrniec of annex 2 of the Cabinet of Ministers of 30 March 2010 the rules no 313 plant description the name of the merchant and _____ _____ _____ _____ _____ _____ _____ _____ address _____ _____ _____ _____ _____ _____ _____ _____ _____ __ shop floor address ___ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ plant describes the version number ____ ____ requirements instructions 1 General information 1.1. Brief information about manufacturing companies (indicate the company name and address), the relation with other production and all production operation understanding necessary information describes the production of the company's operations and relationships with other production (no more than 250 words one A4 page) 1.2. Pharmaceutical activities according to the State Agency of medicines shall issued a special permission (licence) to manufacture or import a reference to existing special permit (license) for the production of medicinal products issued by the State Agency of medicines. Specifies special permissions (licenses) duration (if it was issued for a fixed period) and any special conditions or restrictions 1.3. Other types of production that is performed in the site covers both pharmaceutical forms, both for international actions (see also point 1.6) 1.4. Shop floor the exact name and address, telephone (also 24-hour) and fax numbers, the name of the shop floor and 1.4.1. economic, legal address (including postal code), actual location address (if different);
1.4.2. contact's telephone number;
1.4.3. contact fax number;
1.4.4. the 24-hour phone number 1.5. Manufacturing and products manufactured transaction information with particular toxic and hazardous substances, the mention of it in the form of production (specialized compartments or kampaņveidīg) 1.5.1. indicate the type of products manufactured;
1.5.2. individual marks all used toxic or dangerous substances, such as antibiotics, hormones, cytostatic drugs. Indicate whether these products are produced in specialized compartments provided for them or kampaņveidīg;
1.5.3. indicate whether the plant produced only medicinal products for human or veterinary use 1.6. brief description of the plant and the nearest 1.6.1. neighborhood;
1.6.2. shop floor the size, type and age of the building;
1.6.3. plant made other types of production activities (no more than 250 words, one A4 page) 1.7. Quality assurance, production, quality control, storage and distribution as well as in the number of employees involved in 1.7.1. the quality of workers;
1.7.2. in production workers;
1.7.3. the quality control workers;
1.7.4. in storage and distribution workers;
1.7.5. the engineering support service workers;
1.7.6. total number of employees in those positions.
Note the. Part-time employees shall be converted into the equivalent full load. Indicates the number of persons with an academic education and without its 1.8. contracts To manufacture and quality control of other involved in scientific, analytical or technical institutions (if it is, see. 7. the requirements specified in chapter) on each contract manufacturing or quality control organisations involved: 1.8.1. name and address of the establishment;
1.8.2. telephone number;
1.8.3. fax number;
1.8.4. actions for a short outline (no more than 100 words, half of A4 pages) 1.9. Medicines manufacturer's quality management system, a brief description of the nature of the production 1.9.1. quality policy;
1.9.2. defined responsibilities for quality assurance;
1.9.3. a description of the quality system elements, such as the organizational structure, duties and responsibilities, procedures, processes;
1.9.4. describes the audit programs (self-control or with another organization carried out audit);

1.9.5. describe how to evaluate results, to obtain an objective belief on the effective operation of the quality system, it is that the production of the product is high quality and safe for use (see 6.1.2);
1.9.6. If a drug company has partnered with suppliers whose quality management system is certified according to the standard LVS EN ISO 9001:2009 A/L ' quality management systems. Requirements (ISO 9001:2008);
1.9.7. if evaluates critical raw materials and packaging materials (active substances, excipients, primary packaging container and CAP or printed material) suppliers, detailed description of how it is carried out;
1.9.8. describes the procedure by which the finished products released for sale (no more than 750 words, three A4 pages) (500 words, two A4 pages) 2. personnel 2.1 organizational structure that shows how to achieve quality assurance, including production and quality control (see 1.9.3) chart, which represents the quality assurance system, including tapping production and quality control. Notes only to management and control staff personnel with qualifications 2.2, experience and obligated to brief messages about academic education, job qualifications and job duration in this qualification And 2.3 and the periodic training arrangements and training record keeping Provides brief details of the training programme, including periodic training and and: 2.3.1. describe how and to identify training needs;
2.3.2. a detailed description of the training on good manufacturing practice requirements;
2.3.3. provide training, such as internal, external, and describes what staff and in no way takes practice;
2.3.4. explain how to evaluate the effectiveness of training (such as anketēj);
2.3.5. explain how to determine the need for training;
2.3.6. briefly outline how keep records of the training requirements of 2.4 production staff employed in health 2.4.1. responsible for employee health screening;
2.4.2 or before the recruitment medical examination is carried out;
2.4.3. are employees periodically investigated depending on the nature of their work;
2.4.4. is there a procedure that the employees concerned before critical report on the presence, or contact with sick people;
2.4.5. are there procedures that employees reported after illness;
2.4.6., or that work to clean (A-D), subject to payment of an additional monitoring stations for 2.5. requirements of staff hygiene, including their clothing is suitable for 2.5.1 or washing, changing and rest rooms;
2.5.2. do wear complies with the action to be taken. Brief description of clothing;
2.5.3. is drawn up clear instructions on how to use protective clothing and when they need to change (a detailed description is not necessary). Or wash clothing or laundry outside the shop floor 3. Premises and equipment premises 3.1. production station (space) simple plan or description indicating the scale (architectural or engineering drawings of the project not required) 3.1.1. territory plan indicating the production station (space);
3.1.2. each manufacturing circuit simple plan, indicating scale. Plan room number and add the appropriate number key;
3.1.3. plans should be understood and deployed on A4 sheets. If necessary, you can also deploy plans to A3 format pages;
3.1.4. sterile product indicating the space station and station cleanliness classification and pressure difference between adjacent compartments with different purity class 3.2 nature of the design and decoration detailed description only 3.2.1 key (critical) stations;
3.2.2. the critical workstations includes all production and packaging facilities, as well as the main (critical) storage premises;
3.2.3. Description of the way the narrative form (500 words, two A4 pages) 3.3. brief description of ventilation systems. A more detailed description of the critical circuits with air pollution risk (schematic drawings of the systems are desirable). Rooms used for sterile products, indicate the classification of standard LVS EN ISO 14644-1:2001 clean rooms and related monitoring environment-part 1: classification of air cleanliness "notes.
1. Detailed description of the critical area with air pollution risk. This applies to the sterile product circuit, as well as the powder processing, pelletizing and tabletēšan stations. Sterile products gives the station the last qualification or made a summary of the results of the reclassification.
2. to reduce the amount of explanatory text, use patterns.
The description shall: 3.3.1. project criteria, such as: (a) air supply) specification;
(b));
c) relative humidity;
(d)) and air pressure differential exchange rate;
e) one-way flow or recirculation (%);
3.3.2. the design and efficiency of the filter, such as: (a) the effectiveness of 99%) filters;
b) HEPA filter efficiency% 99.997.
Details of any alarm ventilation system;
3.3.3. filter replacement period;
3.3.4. dioktilflalāt (DOP) use case specifies the input for it;
3.3.5. the validation system frequency (500 words, two A4 pages) 3.4 special circuit which performs a very toxic, dangerous or sensitising substances 3.4.1. special processing circuit for working with highly toxic, hazardous and sensitising substances;
3.4.2. Description of the types of analogy 3.1. bottom above 3.5. brief description of water systems (schematic drawings of the systems are desirable) including sanitation scheme, and 3.5.1 connects the city's water supply system;
3.5.2. system capacity (maximum quantity per hour);
3.5.3. tanks and pipeline construction materials;
3.5.4. the entire system of the filters you have set up in the nature;
3.5.5. If water is stored and recirkul, indicate what is the temperature of the return;
3.5.6. water used in production specifications indicators: (a) chemical);
b) conductivity;
c) microbiological;
3.5.7. sampling and testing frequencies;
3.5.8. sanitation procedure and frequency.
Note the. Desired system scheme (500 words, two A4 pages) 3.6. maintenance (planned preventive maintenance program and the enforcement of the registration system description) 3.6.1. systematic preventive maintenance program;
3.6.2. is documented procedure and appropriate reporting forms for maintenance and service maintenance? Or documents specified events (maintenance, control, maintenance operations, concrete repair, change) frequency;
3.6.3. is there a clearly identified maintenance activities that may affect the quality of the product;
3.6.4. or with reporting introduces users.
Note the. Maintenance-operations carried out by the same manufacturer; service-maintenance activities carried out in the outer līgumizpildītāj (250 words, one A4 page) equipment (250 words, one A4 page) 3.7 major production and control laboratories equipment brief description (a list of equipment is not necessary) 3.7.1. equipment and machinery or are made of appropriate material (for example, equipment that is in contact with the product are made from 316 AIS brand stainless steel);
3.7.2. or other materials used are appropriate to the validated, e.g. polypropylene, chrome surface, polyvinyl chloride (PVC), non-reactive (non-reactive) plastic materials;
3.7.3. or equipment is easy to clean;
3.7.4. provides only a general description, such as Rotary Tablet press. If the equipment is installed on additional devices, they only accounted for, such as automatic scales with printers; the marker with the barcode reader; serial number and expiration date printer; refrigeration dryers (liofilizator) with steam sterilization node;
3.7.5. the quality control laboratory equipment General description, such as pH meters, chromatographic equipment-gas-liquid chromatography (GLC), high resolution liquid chromatography (HPLC) with computer systems, particle size analysers;
3.7.6. microbiology facilities also describes the General, such as incubators (temperature range), LAL (limul to the amebocyt lysate) testing, membrane filtration equipment of facilities, the level of inspection, detection of antibiotics;
3.7.7. provide brief information about your computer, the microprocessor chip manufacturing.
Note the. Machine type and model point 3.8. maintenance (planned preventive maintenance program and the enforcement of the registration system description) 3.8.1. responsible for technical maintenance and service maintenance;
3.8.2. are there documented procedures and the conditions of the operating contract outsourcing of equipment maintenance;
3.8.3. is there a clearly identified maintenance activities that may affect the quality of the product;
3.8.4. do you store notes about: service maintenance or 3.8.4.1 control types and periodicity;
3.8.4.2. service repairs and changes made;
3.8.5. do the present users of equipment (250 words, one A4 page) 3.9. verification of the calibration and Qualification system, including their enforcement. Measures of the computerised system validation for 3.9.1. a brief description of the company's qualification and validation (prospective and retrospective) general policy and protocols;

3.9.2. indicate whether the critical equipment regularly and repeatedly validated;
3.9.3 process validation principles set out in this paragraph may provide or link to production (5.4);
3.9.4. the description, arrangements of product development and validation process time series produced in the output distribution;
3.9.5. measures of validation for your computer, including software validation;
3.9.6. Description of the equipment calibration policy and records (see also section 4.2.9) (750 words, three A4 pages) sanitation (cleaning) 3.10. production and equipment circuit cleaning procedure written instructions and specifications being (accessibility) 3.10.1. are there written instructions and specifications for cleaning methods, cleaning products and their concentration, as well as for cleaning frequency.
3.10.2. or cleaning agents change;
3.10.3. or cleaning procedures are validated and what method is used for evaluating the effectiveness of cleaning;
3.10.4. or the effectiveness of the cleaning procedure regularly monitor using chemical or microbiological test methods;
3.10.5. What are the cleaning methods (and their frequency) water supply system, air preparation system and the atputekļošan system (250 words, one A4 page) Note 4 documentation. This chapter applies to all documentation that is used in the manufacture of medicinal products. Production includes all activities related to the production and control of medicinal products (500 words, two A4 pages) 4.1 the procedures developed, reviewed and distributed manufacturing necessary documentation or the documentation is available in 4.1.1. system description;
4.1.2. for document distribution, review, and development of the responsible person;
4.1.3. the original documents;
4.1.4. is there a specific form and instructions on how to prepare the document. Or is available in the following documents: (a)) product or process specifications;
(b)) Bill of materials;
c) packaging material specifications;
(d) basic process instructions) including packaging;
(e) production and packaging) series of notes;
f) analytical methods;
g) quality system procedures of output;
4.1.5. How is documentation control;
4.1.6. as long as the documents are stored by serial output;
4.1.7. the description of the agenda if the notes are made electronically or on microfiches 4.2 With the quality of the product related documentation not mentioned in other chapters (such as air and water microbiological examination) 4.2.1. machine specifications;
4.2.2. disposable materials (such as cleaning) specifications;
4.2.3. operating procedures (SOPs);
4.2.4. quality control procedures;
4.2.5. training procedures;
4.2.6. the computer program specifications;
4.2.7. process the control deviation records;
4.2.8. calibration and test documents (see also paragraph 3.9.5.);
4.2.9. the validation documents (see also 3.9 and 5.4);
4.2.10. the documents that define the series and the main raw materials packaging materials (primary packaging and printed material) the outcome of conversion;
4.2.11 involving. other documents (statement), and a brief explanation of their use in the manufacture of 5 Provides a description of the form by using the General schemes 5.1. brief description of production operations using flow charts and diagrams showing the most important indicators 5.1.1 parameter describes which operations can be performed on-site with the existing equipment, and according to the list of products indicates the types of medicinal products specified in the application;
5.1.2. when only the package, give a brief description, such as labelling, packaging and containers used, for example, sticks, glass packaging with security locks;
5.1.3. If handle cytotoxic or radioactive substances, provided that the characteristics of the product;
5.1.4. production operations as possible in the description used in the flow chart. Technical details need not be included;
5.1.5. the description of how the product is identified at the time of manufacture and what is the intermediate storage procedure 5.2. Procedures adopted for raw materials and packaging materials and products are produced in bulk and finished products, including sampling, quarantine, release and storage processes · Vendor serial number serial number and company identification · Sampling plans · Raw material and packaging material compliance status labelling, for example using labels or computerised system · The issue of material production and packaging · Weighing control · Control methods · How is identified and provided to industrial materials 5.2.1. loose control of production of the products: 5.2.1.1. main control parameters during production, such as mixing time control, filter integrity testing;
5.2.1.2. the main characteristics of the sign;
5.2.1.3. the validation process;
5.2.1.4. the inspection records;
5.2.1.5. compliance with the registration dossier;
5.2.2. packing: 5.2.2.1. without packed products, packaging materials, intermediate and release;
5.2.2.2. the product identity and purity testing of the line;
5.2.2.3. the validation process;
5.2.3. the finished product quarantine and release; compliance with the registration dossier;
5.2.4. explain the authorised (-o) person (s) responsible (s) role 5.3. handling and processing procedures, what is the product of a series of repeated treatment or processing procedure 3.4. procedure for action with rejected materials and products 5.4.1. indicate whether rejected materials and products are clearly labelled and kept separate or enclosed spaces;
5.4.2. Description of the procedure of adoption of the decision on rejection or destruction of products and indicates whether the document destruction process 5.5. Process validation the general policies of a brief description only required process validation protocol reference outline (see 3.9.3) 6.6.1. Quality control quality control systems and quality control Department in the description of the action. The output of the final procedure 6.1.1. Description of the quality control system elements, such as specifications, test methods and other quality related data collection, as well as a brief description of the analytical testing, testing, packaging materials, biological and microbiological testing;
6.1.2. If the quality control Department also series documentation and final documentation, it describes in detail (see also 1.9.5);
6.1.3. the description of the quality control Department's participation in the development of the document, review and dissemination, in particular those relating to methods of testing the specifications and product release criteria, if it is not described elsewhere (see also 1.9. section and Chapter 4) 7. Production and analysis on contract 7.1. Description of the way in which assessed compliance of the artist contract good manufacturing practice briefly describes the details of the contract between the contract giver and the contract Acceptor as well as a way to assess the conformity of the bailiff good manufacturing practices and ensure compliance with the registration of the product documentation 8. Distribution, complaints and product recall procedures for Release 8.1 and 8.1.1 system of records or inventory is safe;
8.1.2. or storage conditions;
8.1.3. can storage at reduced temperature;
8.1.4. how materials stored, such as shelves, on pallets;
8.1.5. what controls the status of the product, such as with labels or computer system;
8.1.6. what method is used to send products to customers;
8.1.7. the service or product is in stock movement sequence – first received the item is served first, and that is indicated in the serial number 8.2. Complaints and product recall procedures 8.2.1. distribution records. Or saved records completely supports serial traceability from the production site to the client, or they contain sales date, details of the client and the quantity shipped;
8.2.2. complaints: 8.2.2.1. are there documented complaint handling procedure;
8.2.2.2. responsible for: (a) the recording of complaints);
(b) classification);
c) investigation;
8.2.2.3. do written reports are being prepared;
8.2.2.4. who examine these messages;
8.2.2.5. how long to keep records of complaints;
8.2.3. product recall: 8.2.3.1. is there a documented procedure available that determines the order of actions, including: (a) the distribution of the data) (recovery);
(b) notification to clients);
(c) the receipt of the products returned), abstraction, verification;
(d) investigation and reporting of the causes);
e) reporting corrective actions;
8.2.3.2. the responsibility for the coordination of the withdrawal of products;
 
 
8.2.3.3. the person you report to the control authorities on complaints and cancellations;
8.2.3.4. the complaint handling and withdrawal or decision involving a control institution;
8.2.3.5. the possible withdrawal of the products in other lower levels following the wholesale level 9. Self control 9.1. Self-control system brief description (see also "1.9.4) 9.1.1. describe how self-control system checks that all the actions taken to comply with the quality, the intended purpose;
9.1.2. how to verify the effective operation of the quality system;

9.1.3. are there documented procedures available for the exercise of self-control and lack of prevention measures identified;
9.1.4 or self-control results document, or present personnel responsible for audited and circuit activities;
9.1.5. is self-control system shall ensure that the personnel responsible for the circuit or the actions carried out in a timely corrective action on deficiencies found responsible of the preparation of plant description (title) (name) (signature) date _____ _____ _____ notes.
1. Description of the production site shall be prepared by the manufacturer of the medicinal product shall contain detailed information on the pharmaceutical quality assurance, production or quality control activities the specific plant and the nearby existing buildings with inventory to production-related activities. If the plant is only part of the activities of the manufacture of medicinal products, the description should reflect only those operations that are performed on the site, such as analysis, packaging.
2. a description of the Plant drawn up so that each Department and the points that are listed as "requirements", follow the instructions under "", which explain how to reflect those requirements.
3. Shop floor the description should be in the form, if possible, in the amount not exceeding 25 to 30 A4 pages.
4. Shop floor the description Specifies the version number and the date of entry into force.
5. If possible, a description of information replaces the text with the plans and schemes. Plans and schemes shall not exceed A4 page.
6. Document Properties "date" and "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design.
Minister of the Interior, the Minister of health ad interim l. Mūrniec annex 3 Cabinet 30 March 2010 the rules no 313 export manufactured products, veterinary drugs or controlled substances * 1. Exports manufactured products or medicinal products for veterinary use the merchant's name, the name of the shop floor production site address no PO box
The name of the medicinal product international name (INN) strength (dose) pharmaceutical form Narcotic Drugs Psychotropic medicines Only packaging (primary, secondary) registration number Latvia register of medicinal products manufactured for export only 1 2 3 4 5 6 7 8 9 10 the applicant Information name, title date signature 2. Controlled substances * merchant name, name of the manufacturer-plant production site, the address of the importer-import site address no PO box
The name of the substance, the international name (INN) or, if not, the chemical name and CAS registry number of the substance in the active substance content of the Psychotropic Drug substance substance Just packaging or labelling the manufacturer's name, address, country of production plant manufactures only export 1 2 3 4 5 6 7 8 9 the applicant Information name, title date signature notes.
1. Latvia controlled the illicit manufacture of narcotic drugs and psychotropic substances in list II and III substances.
2. name of the medicinal product and one shape any strength (dose).
3. The qualifying mark with x 4 List submitted electronically-individual products for human use and veterinary medicinal products.
5. Document Properties "date" and "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design.
Minister of the Interior, the Minister of health ad interim l. Mūrniec 4. Annex Cabinet 30 March 2010 the rules no 313 application for conformity assessment and special permission (license) for the issue or renewal of a medicine or veterinary medicine to open lieltirgotav (operation) the State Agency of medicines shall 1. information on the applicant: 1.1 name 1.2. economic operators. drug name lieltirgotav pharmaceutical activities 1.3 address, post index 1.4. license number to open the medicinal lieltirgotav (operation) (if applicable) phone fax 1.6 1.5 1.7. e-mail address (if any) 1.8 1.9 website. the merchant's legal address and Office address, if different from the registered office (the foreign merchant's affiliate, also the foreign merchant's legal address) 1.10. registration number in the trade register of the individual merchant 1.11:1.11.1. name 1.11.2. residence address 1.11.3. phone 1.11.4. fax 1.11.5. e-mail address (if any) Please 2 (mark with x required): 2.1 2.2 perform conformity assessment issued a special permit. (license) to open the medicinal lieltirgotav (operation) 2.3. issue a special permit (licence) lieltirgotav opening of the veterinary medicinal product (operation) to reregister the special permit 2.4 (license) : 2.4.1. special permission (license) holder's change of name 2.4.2. special permission (license) holder's legal change of address pharmaceutical site 2.4.3 Exchange 2.4.4. actions veterinārfarmaceitisk the place of 2.4.5. the responsible change. new special 2.4.6 mode of action of opening a new chapter of the action 2.4.7. initiation of 2.4.8. for other reasons (specify) _____ _____ _____ _____ _____ _____ 3. information about the company to persons who are authorized or entitled to represent the company: 3.1 a person's name first name, last name, ID code 3.2 3.3. post note. If there are several persons entitled to represent the company, indicates that information about each person.
 4. information about the officers: 4.1 the designated officer for the distribution of medicinal products: 4.1.1 4.1.2 name, identity number Title 4.1.3 4.1.4 4.1.5 4.1.6. fax phone. e-mail address of the responsible officer of the 4.2 for the distribution of medicinal products for veterinary use: 4.2.1 4.2.2. name, surname, personal code 4.2.3 4.2.4 4.2.5 phone post. fax 4.2.6. e-mail address 4.3 officer public service obligations: 4.3.1 4.3.2. name, surname. ID code 4.3.3 4.3.4 4.3.5. phone post. fax 4.3.6. e-mail address of the responsible officer of 4.4 on the illicit manufacture of narcotic drugs or psychotropic substances and distribution of medicinal products: 4.4.1 4.4.2. name, surname, personal code 4.4.3. post 4.4.4. phone 4.4.5 4.4.6. fax. e-mail address 4.5. officer on the circulation of alcohol: 4.5.1 4.5.2. name, surname, personal code 4.5.3 4.5.4 4.5.5. phone post. fax 4.5.6. e-mail address note. If there are multiple persons provide that information for each person.
 5. information about the medicine lieltirgotav branch or Department (if any): 5.1 5.2 5.3 the name address. the officers name, identity number 5.4 5.5 5.6 5.7 phone fax. e-mail address (if any) 5.8. website (if different from the lieltirgotav website) Note. About other medicines lieltirgotav branches or sections (if any) information indicate on a separate sheet and attach to the application.
 6. information about the special activities (mark with x required): 6.1 6.2 distribution of psychotropic medicines. psychotropic substances release 6.3. the illicit manufacture of narcotic drugs and psychotropic medicines recognized release 6.4. the illicit manufacture of narcotic drugs and psychotropic substances recognized distribution distribution of veterinary medicinal products 6.5 6.6  veterinary medicinal products containing substances with anabolic, pretinfekcij, anti-parasitic, anti-inflammatory, hormonal characteristics and distribution (required mark with x): 6.6.1. antibacterials, sulphanilamide and hinolon also in 6.6.2. features 6.6.3. coccidiostats anthelmintic substances, also of nitroimidazole carbamate and pyrethroid in 6.6.4 6.6.5. sedative features current page is 2.7.6. the anti-inflammatory steroids not 6.6.7. other features of pharmacologically active substances and drugs which are not included in the register of the veterinary medicinal product, but which could be used in the treatment of animals in the distribution of alcohol 6.7.7. Additional information (desired mark with x) : 7.1.  foreign-owned companies in the storage of the medicinal product in accordance with the contract (foreign drug manufacturer's authorized representatives distributing medicine lieltirgotav) 7.2. medicines order acceptance around the clock (24 hours).
Contact details: 7.2.1 7.2.2 7.2.3. fax phone. e-mail address (if any) 7.3. parallel distribution of medicinal products imported 7.4. centrally registered parallel distribution of medicinal products 7.5. distribution of medicines not registered 7.6 from human blood and plasma derived distribution of immunological preparations 7.7 7.8. distribution of radiopharmaceutical distribution is 7.9. special permit (license) for the manufacture of medicinal products, the following activities (state license number and date) _____ _____ _____ 7.9.1. drug importing from third countries

  7.9.2. repackaging of medicines (re) and 8 pārmarķēšan. information about the lieltirgotav equipment and installations (required mark with x): 8.1. premises and equipment ensures the required storage temperature mode: 8.1.1. at room temperature (between 15 ° C and 25 ° C) 8.1.2. cool place (from 8 ° C to 15 ° C) 8.1.3 cold places (from 2 ° C to 8 ° C) 8.2. other facilities and equipment: 8.2.1. computer (specify number) _____ 8.2.2. softwares (specify What) ____ ____ ____ ____ ____ ____ ____ ____ 8.2.3. internet connection 8.2.4. lift (specify number) _____ 8.2.5. lieltirgotav medicinal facilities secured by individual technical security system lieltirgotav of medicinal 8.2.6. space secured by the central security system connected to the security system of the narcotic drugs and 8.2.7. storage space provided with sound or light alarm 8.2.8. the existence of 8.2.9. aukstumsom fax or containers (number) 9. information on the working hours of lieltirgotav (tells the work start and end times) : Monday Tuesday Wednesday Thursday Friday Saturday Sunday 10. applications the following documents attached (desired mark with x): 10.1.  Decision on the business register and other members of the Board representing the economic operator person entitled to represent the economic operator (certified copy) to the __ _____ pages 10.2.  floor plans of technical inventory file (certified copy) to the _____ and leaves 10.3. a document certifying the applicant's right to use the space for the intended pharmaceutical activities (title deed or lease contract) (certified copy) to the _____ and leaves 10.4. document establishing the conformity of the construction space requirements (an act for commissioning) (certified copy) to the _____ and leaves 10.5.  certificate of employer and this submission (4) and (5) the officers referred to in legal relations, their duration, the work carried out by the employee, to ____ ____ pages. document of the 10.6 lieltirgotav posting of the officials responsible, attesting the appointment of persons to the appropriate position (certified copy), on ___ ___ pages 10.7.  document of the officials responsible for special operations detachment of the provision (certified copy) to the _____ and leaves 10.8.  This submission (4) and (5) the education of the persons referred to in a certificate (certified copy) and resume to _____ and leaves 10.9.  the applicant's written confirmation that their founders (list) and members (list) corresponds to the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" paragraph 2 of article 11, to the _____ ____ pages 10.10.  responsible for the illicit manufacture of narcotic drugs or psychotropic substances and medicine movement written proof that the person complies with the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" article 11 1 and paragraph 3, to the __ _____ pages 10.11.  written information on good distribution practice of medicinal products, which according to assortment and lieltirgotav activities, as well as special activities listed in the written procedures designed to _____ and _____ pages 10.12.  emergency plan to ensure effective withdrawal from the market (copy) ____ pages 10.13.  receipt of payment of State fee for additional information other 10.14. on the ___ ___ pages 10.15. the document with which the merchant authorizes this submission was the person referred to in paragraph 11 of the present national agency submissions and documents on ____ ___ pages 11. information about the person that is authorized by the applicant to submit the application to the State Agency of medicines shall: 11.1. first name and last name of the applicant, 11.2 11.3 11.4. address phone fax 11.5.11.6. e-mail address (if any) (date , site) (signature) Note. Document properties "date" and "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design.
Minister of the Interior, the Minister of health ad interim Mūrniec of annex 5 of the Cabinet of Ministers of 30 March 2010. the Regulation No. 313 application for special permission (license) to open a drugstore (operation) or re-registering or of changes in the information and documents submitted to the medicines agency information about applicant 1:1.1 name 1.2. individual economic operator in the operator's name, registration number of the commercial register 1.3 1.4. operator's registered office or individual trader's declared place of residence address pharmacy name 1.5 1.6. pharmaceutical activities site address , zip code 1.7. license number of pharmacies opening (operation) (if any) 1.8 1.9 1.10 phone fax. e-mail address (if any) for 1.11. bank details, information about local 2 or hospital, which established a pharmacy (General of the applicant's type of pharmacies opening (operation) or the closed-end type, or the hospital's pharmacy (operation) to open): 2.1. authorities or the medical establishment, address phone fax 2.3 2.2 2.4. e-mail address (if any) 3. Please (required mark with x) : 3.1.  the issue of a special permit (license) the General type of pharmacies opening (operation): a pharmacist practices 3.1.1 3.1.2 3.1.3. koppraks pharmacist to pharmacist Corporation 3.1.4. the municipality to issue a special permit 3.2 (license) of the closed-end type, or the hospital's pharmacy opening (operation) 3.3 to special permission to reregister (license) due to: 3.3.1. special permission (license) holder's name change 3.3.2. special permission (license) holder's legal change of address pharmaceutical activities 3.3.3. the place of new special 3.3.4 activities started in 3.3.5. changing the head of Pharmacy 3.3.6. new pharmacy opening branch 3.3.7. for other reasons (Please specify What) 3.4. make changes to the information submitted, the special permission (license) in case 4. information about the members of a partnership who is specifically authorised to represent a partnership, or a corporation of persons entitled to represent the company: 4.1 a partnership or a Corporation Member of the person's first name, last name _____ ____ ____ ____ ____ ____ ____ ____ ____ ____ 4.2. ID code _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ 4.3 post _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ note. If more than one person is entitled to represent the company, indicates that information about each person.
 
5. information on pharmaceutical activity (mark with x required): 5.1. distribute medicine medical authorities 5.2. distributed medicine social care institutions 5.3. distributed veterinary drug 5.4. obtain purified water 5.5 provides additional services (specify) __ ____ ____ ____ ____ ____ ____ 5.6 consists of permanent visitors register pharmacy (specify the number of patients included in the registry) and _____ _____ _____ _____ _____ 5.7 provides the service of a medicinal product not registered against medical treatment institutions of recipes and requests information about the 6 officers : head of the Pharmacy: 6.1 6.1.1 6.1.2. name, surname. ID code 6.1.3 6.1.4. registration number of the qualifications of the Latvian Association of Pharmacists in the register and the certificate number 6.2. Deputy Head of pharmacy or pharmacist, pharmacy Manager replaces: 6.2.1. name, surname, personal code 6.2.2 6.2.3. the registration number of the Latvian Association of Pharmacists in the register and the number of the certificate of qualification 7.6.2.4 information about pharmacy affiliate (if any): 7.1 the name of the branch of Pharmacy 7.2 7.3 7.4 address phone fax 7.5. e-mail address (if any) 7.6. pharmacy affiliate manager : 7.6.1. name 7.6.2. ID code 7.6.3. registration number of the pharmacist society of Latvia register qualification Note: 7.6.4. If the Pharmacy has several branches, the information about each branch separately.
8. information on special operating conditions (mark with x required): 8.1 psychotropic drug distribution of psychotropic drug distribution officer: 8.1.1. name 8.1.2. personal code 8.1.3. registration number of the pharmacist society of Latvia register 8.1.4. qualification 8.2. the illicit manufacture of narcotic drugs and psychotropic medicines recognized on the illicit manufacture of narcotic drugs and psychotropic medicines recognized distribution officer: 8.2.1 8.2.2. name, surname. ID code 8.2.3. registration number of the pharmacist society of Latvia register 8.2.4. qualification 8.3. production of medicines the pharmacy officer for the manufacture of medicinal products in pharmacies : 8.3.1 8.3.2. first name, last name, registration number of the pharmacist society of Latvia register 8.3.3. qualification 8.4. dissemination of the veterinary medicinal product Executive for the distribution of veterinary medicinal products: 8.4.1. name, surname
  

8.4.2. the registration number of the pharmacist society of Latvia register 8.4.3 qualification 8.5. non-prescription drug distribution via the internet: 8.5.1. "domain name and e-mail address 8.5.2. the responsible name registration number 8.5.3. Pharmacist society of Latvia register 8.5.4. qualification 8.5.5. telephone number (work day) receiving 8.6 8.6.1 the countervailable distribution. the responsible name 8.6.2. register number of the pharmacist society of Latvia register 8.6.3. qualification 8.6.4. telephone number (work day) receiving 9. information on the pharmacy (pharmacy Branch) premises and equipment (note the required with x): 9.1. information about pharmacy pharmacy pharmacy 9.1.1 or branch building located _____ floor 9.1.2. pharmacy (pharmacy Branch) visitor service Hall in the building of the _____ floor 9.1.3.
entrance for visitors with Airlock 9.1.4.
visitors are provided with limited mobility service 9.1.5.
pharmacy is space of unity 9.2. information about pharmacy or pharmacy branch premises: no PO box
The name of the space, the room number in the inventory file space plan spaces area (m2) 9.2.1.
 Visitor Service Hall (General type pharmacy or branch) 9.2.2.
 Visitor service halls part, where you can stay for visitors (General type pharmacy or branch) 9.2.3.
 Goods receipt with a separate quarantine area 9.2.4.
 Pharmacy (branch) Office Manager (if any) 9.2.5.
 Product storage space (if any) 9.2.6.
 Hospital's request and order room service (closed type pharmacy) 9.2.7.
 Pharmaceutical manufacturing space 9.2.8.
 Employee toilet 9.3. information on other premises or places separate different spaces: no PO box
Space or place name the name of the space where the separated Space number counting things space plan spaces or on a separate site area (m2) 9.3.1.
 Employee wardrobe 9.3.2.
 Goods storage area (if any) 9.3.3.
 Driver's workplace 9.3.4.
 Cleaning inventory storage space 9.3.5.
 Scrap area to hold the goods in badly 9.3.6.
 Windscreen (if any) 9.3.7.
 Other premises 10. information on officials responsible for drug storage conditions and compliance statement: 10.1 officials name 10.2. registration number of the pharmacist society of Latvia register 10.3. qualifications 11. information on the storage of medicinal products required temperature mode: no PO box
The required temperature of the Room in which the temperature is provided or of equipment used in the provision of the relevant temperature 11.1.
 At room temperature (15 to 25 ° C) 11.2.
 Cool place (from 8 to 15 ° C) 11.3.
 Cold place (from 2 to 8 ° C) 12. In special circumstances, drug store and other goods storage no PO box
Medications that require special storage conditions of the premises and equipment the medicine and other goods for storage in 12.1.
 The narcotic drugs and substances of 12.2.
 Psychotropic drugs and substances 13. information about facilities and equipment (mark with x required): 13.1.
 computer (specify) ____ __ _____ 13.2.
 computer programs (specify) ____ ____ ___ 13.3.
 Internet connection in 13.4.
 lift (specify number) _____ _____ _____ 13.5.
 Pharmacy (pharmacy Branch) room secured by individual technical security systems 8.5.
 Pharmacy (pharmacy Branch) room secured by the central security system connected to the security system 8.5.
 the illicit manufacture of narcotic drugs and substances of the medicinal product storage space provided with sound or light alarm 14. information on the state metrological control of measuring instruments subject to verification of no PO box
Measuring the number of the name of the Measurement verification date 15. information on cooperation with other companies and institutions: 15.1.
 the contract with the health compulsory insurance State Agency for the purchase of medicines compensation system in distribution of 15.2.
 contract with a pharmaceutical company for the activities of the pharmacy made the supply of the medicinal product, if not finished medicines in pharmacy (pharmaceutical operations specify the company name and address) 15.3.
 the contract with the insurance companies (indicate the name of the insurance company) 9.6.
 the staff is organized professional training (indicate the number of employees involved in training and the type of training) 16. Pharmacy (pharmacy affiliates) working time: 16.1 provides 24-hour on-call service of the population supports 16.2. working day of the week during working time (point the work start and end times) Monday Tuesday Wednesday Thursday Friday Saturday Sunday note. This point may not perform closed pharmacies.
17. Drugstore (drugstore Branch) and pharmacy (pharmacy Branch) the Deputy head or a pharmacist, which replaces the pharmacy manager, the working time distribution day pharmacy (pharmacy Branch) the driver's working time pharmacy (pharmacy Branch) the Deputy head or the pharmacist working time, which replaces the pharmacy (pharmacy Branch) heads from to from to Monday Tuesday Wednesday Thursday Friday Saturday Sunday 18. the following documents attached to the application (required mark with x) : 18.1. partnerships personally responsible companion and komandit name, surname, personal code and residence, a legal person – name, registration number and registered office at _____ and leaves it to the members of the partnership 18.2. name, surname, personal code and residence, a legal person – name, registration number and registered office, which are specifically authorized to represent a partnership, whether they have the right to represent the partnership of individually or jointly (companies register statement of rights of the person to sign the documents in the name of the economic operator) ___ to ___ pages 18.3. members of the Board of a corporation, the members of the Council (if the Corporation has established a Council) name, surname, personal code, place of residence and position on the ___ ___ pages 18.4. a document which certified by one or more members of the Board of the Corporation the right to represent the company alone or jointly, on ___ ___ pages proof space 18.5, equipment, personnel and documentation of compliance with the legislation requirements: "I certify that the pharmacy (the merchant's name, the name and address of the pharmacy) space , equipment, personnel and documentation comply with the requirements of: (a) the Pharmacy Act;)
(b)) (a specific list of laws) (place, date) (signature) "If you distribute the narcotic drugs and psychotropic substances and drugs:" I certify that the pharmacy (the merchant's name, the name and address of the pharmacy) to the illicit manufacture of narcotic drugs or psychotropic substances and medicines have been provided in storage requirements: a) the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order";
(b)) (a specific list of laws) (place, date) (signature) "Pharmacy and drugstore 18.6. affiliate (if any) inventory file space for a copy of the plan (the original show) on _____ and leaves 11.6. a document certifying the applicant's right to use the drugstore and pharmacy affiliate area (certified copy) to ____ __ lapām-12.8. the employer was issued a written statement of employer and the pharmacy manager, Deputy Head of the drugstore (if any), pharmacy affiliate manager labour relations the duration of the employee, the work performed, as well as a manager of an undertaking approved document (copy) proving the person's appointment to the position, on ___ ___ pages 11.7. order of the employer (copy) designated as a special operational conditions of officials responsible for the provision, on ___ ___ pages 18.10. pharmacy (pharmacy Branch) of persons employed by the pharmaceutical training list (name, surname, qualification, registration number of the Latvian Association of Pharmacists in the registry), which is confirmed by the employer ___ to ___ pages 18.11. document (copy) proving that the pharmacy's founder is a pharmacist (if the General type of Pharmacy created a sole proprietor), on ___ ___ pages 18.12.  documents (copies), which certifies that all the founders have pharmacists (General type to established pharmacies as a pharmacist, koppraks), on ___ ___ pages 18.13. municipalities contract with pharmacists about pharmaceutical care in pharmacy (if the General type of Pharmacy created a municipality) to the ___ ___ pages

 18.14. mobile jaunatveram pharmacy location indication planning map with a circle whose RADIUS is 500 m and is located in the center of the circle to move in jaunatveram pharmacy, and an indication of the nearest pharmacy location for _____ and leaves 18.15. pharmacies leader signed the statement on the distribution of medicinal products over the internet, which contains also a responsible officer, on ___ ___ pages 18.16. pharmacies, not manufactured the drug, a medicine production contract with pharmacies carrying out the manufacture of the medicinal product (copy) ___ ___ pages 18.17. receipt of payment of State fee for additional information other 18.18. on the ___ ___ pages 18.19. the document with which the person authorizes a merchant to submit national agency of medicinal products and the application documents to the __ _____ pages Informing that the pharmacy manager and Deputy Head of the drugstore (merchant or merchant's executive body involved) one year before the submission of the application does not have been punished for offences relating to the manufacture of pharmaceutical activity as well as criminal record not removed or deleted in accordance with regulations.
Confirm that the place of business (premises): is put into is not put into operation 19. information about the person that is authorized by the applicant to submit the application to the State Agency of medicines: 19.1. name and surname 19.2 19.3 19.4. phone Office fax 19.5. e-mail address (if any) (place, date) (signature) Note. Document properties "date" and "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design.
Minister of the Interior, the Minister of health ad interim Mūrniec of annex 6 of the Cabinet of Ministers of 30 March 2010 the rules no 313, Health Minister for the Interior Minister's duty to artist l. Mūrniec of annex 7 Cabinet 30 March 2010 the rules no 313, Health Minister for the Interior Minister ad interim Mūrniec of Annex 8 of the Cabinet of Ministers of 30 March 2010 the rules no 313, Health Minister for the Interior Minister ad interim Mūrniec of L.