The Procedure For The Issue, Suspend, And Revoke The Re-Registered At A Special Permit (License) Pharmaceutical And Veterinārfarmaceitisk Activities, Pay The State Fee For The Issue And Renewal Of It, As Well As Evaluate Pharmacies, Medicine And Veter...

Original Language Title: Kārtība, kādā izsniedz, aptur, pārreģistrē un anulē speciālas atļaujas (licences) farmaceitiskajai un veterinārfarmaceitiskajai darbībai, maksā valsts nodevu par to izsniegšanu un pārreģistrēšanu, kā arī novērtē aptieku, zāļu un veterināro zāļu lieltirgot

Read the untranslated law here: https://www.vestnesis.lv/ta/id/159644

Cabinet of Ministers Regulations No. 415 in Riga in 2007 (26 June. No 37 37) the procedure for the issue, suspend, and revoke the re-registered at a special permit (license) pharmaceutical and veterinārfarmaceitisk activities, pay the State fee for the issue and renewal of it, as well as evaluate pharmacies, medicine and veterinary medicine lieltirgotav, drugs and veterinary pharmaceutical company compliance and good distribution practice of medicinal products for compliance with the 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, and revoke the re-registered at a special permit (license) for veterinary medicinal products and pharmaceutical company to open (action), including investigational medicinal products and veterinary medicinal products, production or imports from countries which are not Member States of the European Union or European Free Trade Association (EFTA) countries which have signed the agreement on the European economic area (hereinafter third countries), medicine or veterinary medicine to open lieltirgotav (operation) and the opening of pharmacies (operation);
1.2. medicine and veterinary pharmaceutical company, pharmaceutical and veterinary medicine and pharmacy lieltirgotav of conformity assessment procedures;
1.3. procedures for assessing good practice of distribution of medicinal products;
1.4. the national toll for the special permit (license) and renewal, as well as the collection of State fees.
2. These provisions do not apply to special permit (license) for the issue, renewal and cancellation of the suspension, the General agenda, or the open veterinary pharmacies and the closed-end type, or veterinary care merchant pharmacies.
3. a decision on a special permit (license) and re-registering Pharmaceuticals activities adopted Licensing Commission (hereinafter the Commission) after the medicine or veterinary pharmaceutical company, pharmaceutical or veterinary medicine or pharmacy in compliance with lieltirgotav.
4. The Commission shall set up a national agency for medicinal products (hereinafter referred to as the Agency). Panelists include agency officials, Pharmacists Association of Latvia, as well as other competent pharmaceutical and veterinārfarmācij areas.
5. the Commission shall decide on such special permission (license) the issuance, suspension, cancellation, renewal and: 5.1. General types of pharmacies opening (operation): 5.1.1 pharmacist practice;
5.1.2. the pharmacist koppraks;
5.1.3. the pharmacist Corporation;
5.1.4. the municipality;
5.2. the closed pharmacy or hospital's pharmacy opening (operation);
5.3. lieltirgotav medicinal opening (the transaction);
5.4. lieltirgotav opening of the veterinary medicinal product (the transaction);
5.5. the medicinal product or the manufacture of veterinary medicinal products or import (manufacture).
6. The provisions referred to in point 5.5. special permit (licence) issued for the production of medicinal products, veterinary medicinal products medicinal products and investigational medicinal products (hereinafter referred to as halls) production activities, referred to in the laws of medicine or veterinary medicine production as well as medicines or importing of veterinary medicinal products from third countries. A special permit (license) for the production of medicinal products include authorization to distribute by wholesale the medicinal products (other than investigational medicinal products) covered by that special permit (license). Special permit (licence) issued by: 6.1. veterinary medicinal products or medicinal products manufacturing company (hereinafter referred to as the pharmaceutical company) – full or partial performance or the production process for the manufacture of investigational medicinal products or imports from third countries;
6.2. veterinary medicinal products or medicinal products lieltirgotav-different medicinal products or packaging of veterinary medicinal products, packaging and product design process or drug or importing of veterinary medicinal products from third countries;
6.3. drugstore-complete or partial drug production processes or different medicine packing, packaging and product design process.
7. the pharmaceutical company issued a special permit (license) for the manufacture of medicinal products is also a special permit (license) or veterinary medicinal products pharmaceutical company to open the (operation). Pharmaceutical company to apply these rules and regulations on medicinal products or the manufacture of veterinary medicinal products and control requirements.
8. the Agency has information about all issued special permits (licenses) provides food and veterinary service. The food and veterinary service pharmacies and drug lieltirgotav, which issued a special permit (license) including food distributors. Special permission (license) to open a drugstore (operation) and lieltirgotav (operation) to open the include authorization to distribute by: 8.1. dietary supplements;
8.2. drinking water, mineral water and spring water;
8.3. medicinal plants and herbal teas;
8.4. honey and beekeeping products;
8.5. dietary foods, including: 8.5.1. infant formulae and follow-on formulae for infants;
8.5.2. intended for infants and young children food;
8.5.3. dietary foods with reduced energy value;
8.5.4. dietary foods for special medical purposes;
8.6. chewing gum, mouth fresheners, cough candies and caramel with vitamins;
5.4. in the case of herbal organic food products.
9. special permission (license) is issued for an indefinite period, excluding pharmacies, which have received the special permission (license) and which do not conform to the law of Pharmacy article 36, first paragraph, the requirements of these regulations, as well as 23.7. in the case referred to in subparagraph. Special permission (license) If changing re-register information specified in the special permit (licence) and its annexes. If you change only a special permit (license) the information specified in annex a special permission (licence) in the annex, re-register the appropriate changes. A special permit (license) without the attachments specified is not valid. 
II. The applicant and the documents to be submitted 10. for special permission (license) for the manufacture of medicinal products, the applicant shall submit the application to the Agency and documents for conformity assessment and special permit (license) received, in accordance with the provisions of annexes 1 and 2.
11. The applicant shall ensure that the following requirements are met and to this provision the application referred to in paragraph 10 would provide the following information: 11.1. the type and form of the medicinal product, which is intended to produce or import;
11.2. where medicinal products are to be manufactured or imported, and a place to take control;
11.3. the terms referred to in 11.1 for the production or import of medicines suitable and appropriate facilities;
11.4. technical equipment and control facilities complying with the registration requirements specified in the documentation and legislation on the production and control of medicinal products, as well as legislation on the distribution of medicinal products;
11.5. the appropriate personnel, which is the applicant, and proof that the applicant have permanently and continuously at his disposal at least one of the officials responsible for the manufacture of medicinal products, whose qualifications and experience meet the regulations for the production and control of medicinal products requirements (hereinafter referred to as the qualified person);
11.6. ensure the illicit manufacture of narcotic drugs and psychotropic substances and medicines under the pharmaceutical chain, or veterinārfarmācij areas, regulations governing the requirements, as well as legislation on illicit traffic in narcotic drugs and psychotropic substances and the movement of medicinal products;
7.3. at least one officer who is the applicant and which is responsible for the illicit manufacture of narcotic drugs and psychotropic substances and medicines (if any is intended to manufacture or import).
12. in order to receive a special permit (license) for the manufacture of investigational medicinal products, the applicant shall submit the application to the Agency and documents for conformity assessment and a special permit (licence) issued in accordance with the provisions of annexes 1 and 2.
13. The applicant shall ensure that the following requirements are met and to paragraph 12 of these rules in the application the following information is given: 13.1. type and form the medicinal products intended for manufacture or import;
13.2. the relevant production or import operations;
13.3. the manufacturing process virus and not a traditional agent decontamination (if necessary);
13.4. the location for the medicine production, or a place that is the applicant for the manufacture of medicinal products;
13.5. the space, which is held by the applicant and which is suitable for the manufacture of medicinal products or import, technical equipment and control facilities complying with the laws and regulations on the production and control of medicinal products, as well as legislation on the distribution of medicinal products;
13.6. the appropriate personnel, which is the applicant, and proof that the applicant have permanently and continuously at his disposal at least one qualified person whose qualifications and experience meet the regulations for the production and control of medicinal products;

8.5. ensure that the illicit manufacture of narcotic drugs and psychotropic substances and medicines under the pharmaceutical chain, or veterinārfarmācij areas, regulations governing the requirements, as well as legislation on illicit traffic in narcotic drugs and psychotropic substances and the movement of medicinal products;
13.8. at least one officer who is the applicant and which is responsible for the illicit manufacture of narcotic drugs and psychotropic substances and medicines (if any is intended to manufacture or import).
14. to get the special permission (license) to open the medicinal lieltirgotav (performance), the applicant shall submit the application to the Agency and documents for conformity assessment and a special permit (licence) issued in accordance with the provisions of annex 3.
15. The applicant shall ensure that the following requirements are met and to the provisions referred to in paragraph 14, the application is given to the following: 15.1 the applicant is suitable and adequate premises, installations and equipment, to ensure the distribution of medicinal products according to the regulations on the distribution of medicinal products;
15.2. the applicant has staff and officer who meets the law of distribution of medicinal products;
15.3. ensure the illicit manufacture of narcotic drugs and psychotropic substances and medicines under the pharmaceutical chain, or veterinārfarmācij areas, regulations governing the requirements, as well as legislation on illicit traffic in narcotic drugs and psychotropic substances and the movement of medicinal products;
15.4. the applicant will provide good distribution practice of medicinal products according to the regulations on the distribution of medicinal products;
15.5. the applicant has at least one officer who is responsible for the illicit manufacture of narcotic drugs and psychotropic substances and medicines (if any will be distributed).
16. in order to receive a special permission (licence) lieltirgotav opening of the veterinary medicinal product (operation), the applicant shall submit to the Agency an application for conformity assessment and special permit (license), as well as issuing documents in accordance with the provisions of annex 3.
17. The applicant shall ensure that the following requirements are met and to paragraph 16 of these rules in the application the following information is given: 17.1. applicant is suitable and adequate premises, installations and equipment, to ensure the distribution of veterinary medicinal products in accordance with legislation on the distribution of the veterinary medicinal product and the storage of the medicinal product, according to technical regulatory documentation requirements;
17.2. the applicant has staff and officer, which according to the legislation on the distribution of the veterinary medicinal product shall ensure that the distribution of veterinary medicinal products containing substances with anabolic, pretinfekcij, anti-parasitic, anti-inflammatory, and hormonal characteristics;
17.3. ensure the illicit manufacture of narcotic drugs and psychotropic substances and medicines under the pharmaceutical chain, or veterinārfarmācij areas, regulations governing the requirements, as well as legislation on illicit traffic in narcotic drugs and psychotropic substances and the movement of medicinal products;
17.4. the applicant has at least one officer who is responsible for the illicit manufacture of narcotic drugs and psychotropic substances and medicines (if any will be distributed).
18. to receive the special permission (license) to open a drugstore (operation), the applicant shall submit the application to the agency assessment of the compliance of pharmacies and a special permit (license), as well as issuing documents in accordance with the provisions of annex 4.
19. The applicant shall ensure that the following requirements are met and to this provision the application referred to in paragraph 18 would provide the following information: 19.1. the applicant is suitable and adequate premises, installations and equipment, to ensure the distribution of medicinal products according to the regulations on the distribution and operation of pharmacies;
19.2. the applicant has staff and pharmacy manager of education and professional experience corresponds to the pharmaceutical Act;
19.3. supported the illicit manufacture of narcotic drugs and psychotropic substances and medicines under the pharmaceutical chain, or veterinārfarmācij areas, regulations governing the requirements, as well as legislation on illicit traffic in narcotic drugs and psychotropic substances and the movement of medicinal products;
19.4. the applicant has at least one officer who is responsible for the illicit manufacture of narcotic drugs and psychotropic substances and the movement of medicinal products.
III. The conformity assessment of a special permit (license) for the issue or renewal and of good distribution practice for conformity assessment agency these provisions 20.10, 12, 14, 16 and 18 of these submissions record the date of receipt. Within five working days after the receipt of the documents evaluated in order of registration of the document.
21. in order to assess the pharmaceutical, medicinal or veterinary medicine lieltirgotav and pharmacies for compliance work and character, after reading the submitted information and documents to inspection. The test will need to make sure that: 21.1. pharmacy premises, equipment, staff and equipment comply with laws and regulations on the operation of pharmacies and drug distribution, as well as special activities referred to in the application;
21.2. lieltirgotav area of medicines, equipment, facilities, personnel and good distribution practice of medicinal products complies with the regulations on the distribution of medicinal products, as well as special activities referred to in the application;
21.3. the lieltirgotav of the veterinary medicinal product, premises, equipment, staff and equipment comply with the legislation on veterinary medicine distribution requirements, as well as special activities referred to in the application;
21.4. the manufacture of medicinal products, the necessary premises, equipment, staff and equipment comply with the legislation on veterinary medicinal products or medicinal products manufacture, control and distribution requirements, as well as special activities referred to in the application.
22. This rule 21.1. verification shall be carried out referred to in national pharmaceutical inspection officials, but this rule 21.2 21.3 21.4., and check out referred to agency officials.
23. For this rule 21.1. inspection referred to in national pharmaceutical inspection officials, but for this rule 21.2 and 21.3. checks referred to agency officials presented checks two copies of legislation. One copy shall be issued by the appropriate pharmacy or medicine or veterinary medicine lieltirgotav. The other copy stays in Office which carried out the inspection. Check the signature law officer who carried out the inspection, and that rule 23.4. referred to a person who has the right to check the Act to record notes about the inspection process. Test Act: 23.1. merchants (individual traders also indicate name, surname and personal code) and veterinārfarmaceitisk activities of the pharmaceutical or corporate name, if different from the name of the economic operator (individual traders also indicate name, surname and personal code), pharmaceutical or veterinārfarmaceitisk activities site address, and the date of the check;
23.2. the special permit (license) number and expiration date (if the check was carried out a special permit (license) Re-registering);
23.3. the official name and job title, which carried out the inspection;
23.4. pharmacies or medicine or veterinary medicine lieltirgotav the officers name and or other officers name and job title, which is authorized to participate in the test;
14.6. the verification activities and findings;
14.7. information about quality control samples taken;
23.7. the identified deficiencies and irregularities and the deadlines for the correction.
24. After inspection the inspection or the State pharmaceutical agency official shall draw up a report. Report: 24.1. merchants (individual traders also indicate name, surname and personal code) and veterinārfarmaceitisk activities of the pharmaceutical or corporate 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;
24.2. the special permit (license) number and expiration date (if the check was carried out a special permit (license) Re-registering);
24.3. the verification activities and findings;
15.2. the information and document comparison with established facts and conclusions ERS;
15.2. special conditions of operation;
24.6. compliance with pharmaceutical or field of veterinārfarmācij-regulating laws. In case of discrepancy or veterinārfarmācij areas of Pharmacy regulatory laws and requirements specified in the Act or regulations in article;
24.7. information about pharmacy website compliance with legislation on the distribution of requirements (unless the General type of pharmacy medicines distributed or intended to distribute the medicines via the internet);
15.4. If compliance is evaluated repeatedly: 24.8.1. date when the previous conformity assessment and pharmaceutical or veterinārfarmaceitisk check;
24.8.2. information about the previous test of the deficiencies found;
24.8.3. information on administrative penalties imposed on pharmaceutical veterinārfarmaceitisk activities or threats (if any) in the previous tests, including the officials prosecuted, and details on the payment of the fine;

15.5. the information on the irregularities and shortcomings found (if any) that are preventable, and prevention;
24.10. the proposal for the special permission (license) or suspension of service, or re-registering, or cancellation;
24.11. the officials names and positions that have made, as well as message composition date.
25. This rule 21.4. check referred to officials of the Agency, taking into account legislation on the production and control of medicinal products in certain principles and guidelines of good manufacturing practice. After the checks made pursuant to regulations on the production and control of medicinal products laid down in the good manufacturing practice drawn up control message.
26. These rules 24 and 25 of the report referred to in paragraph shall be drawn up in triplicate. One copy shall be issued to the applicant, the second the Agency adds the application and documents, a copy of the third place national pharmaceutical inspection or the Agency's records.
27. After this provision in paragraph 24 and 25 of that report, the Agency documents and reports submitted to the Commission for a decision.
28. Where a change in the special permit (license), as well as information if there are changes in the information and documents submitted, the licensed person within five working days after the change occurs in the information submitted to the Agency in accordance with the provisions of 1, 2, 3 or 4 of the annex.
29. the Agency shall evaluate these rules the information referred to in paragraph 28 and: 29.1. adds it to the documents on the basis of which a special permit (license), you do not need a special permit (license) Re-registering;
29.2. the Commission, if you need a special permit (license) Re-registering (except when the Agency received information that the pharmacy manager or responsible medicine or veterinary medicine or pharmaceutical lieltirgotav for not more than three months replaces another officer), but should not be subject to a conformity assessment;
29.3. the agency or national pharmaceutical inspection officials assess conformity in accordance with the provisions of 23, 24 or 25, if according to the provisions of paragraph 30 of the required conformity assessment and a special permission to reregister (license).
30. the special permit (license) for issuing conformity assessment shall be carried out in the following cases: 30.1. pharmaceutical form before the commencement of production;
30.2. prior to the conclusion of the contract with laboratory or pharmaceutical manufacturer for the quality control of medicinal products or production;
30.3. If pharmaceutical or veterinārfarmaceitisk is intended to supplement the activities of any of these rules, 64, 65 and 67.66. referred to special operating conditions;
18.9. before the branch of medicine or pharmacy or veterinary medicine lieltirgotav chapter start-up or inception of the manufacture of medicinal products to a new location;
5. before the production methods or the quality changes;
30.6. the pharmaceutical or veterinārfarmaceitisk before the change of the site;
19.1. upon reasonable request of the licensed person;
19.1. If the Commission's decision on the irregularities found in the production of medicines or controlled, or distribution is received for the competent national authorities a written proposal for a special permission (licence) suspend or withdraw.
31. A special permission (licence) Re-register without repeating a conformity assessment if a licensed person shall submit information to the agency that: 31.1 any of the application and in the. documents such products or pharmaceutical forms (including investigational medicinal products and pharmaceutical forms) will not be produced;
31.2. one of the submissions and the documents will not be such products imported from third countries;
31.3. will not perform any of these rules, 64, 65 and 67.66. referred to special operating conditions, except where the specific operating conditions of the regulations on the operation of pharmacies are identified as mandatory.
32. in order to ensure that the appropriate legislation on the production, control and distribution of medicinal products is ensured of good distribution practice for medicinal products and production procedures, agency officials within three months after a special permit (license) for the manufacture of medicinal products or issuing a special permit (license) and renewal of these provisions for the assessment of conformity 30.1, 30.2, 30.3.., 18.9., 30.5 and 30.6. in the case referred to in point inspection. The test is conducted and a report shall be drawn up in accordance with the provisions of paragraph 25.
33. Within three months of the special permission (license) to open the medicinal lieltirgotav (operation) or issuing a special permit (license) and renewal of these provisions for the assessment of conformity 30.3 30.4 30.5.,., and 19.0. in the case referred to in subparagraph agency officials a check shall be made to ensure that the procedure of distribution of medicinal products comply with the regulations on the distribution of medicinal products medicinal products laid down good distribution practices. On good distribution practice assessment and prepare an inspection report in accordance with the provisions of paragraphs 23 and 24.
34. in order to ensure the supervision on special permit (license) issued, compliance is assessed: 34.1. the General type of Pharmacy and drugstore-closed type not less frequently than once every five years;
21.3. medicine and veterinary medicine and medicine lieltirgotav good distribution practice-not less frequently than once every three years;
21.3. the production or import of medicinal products, in accordance with the laws and regulations on the production and control of medicinal products.
35. The provisions referred to in paragraph 34 of the conformity assessment shall be carried out in accordance with the provisions of 23, 24 or 25. If the report shows that: 21.8. licensed pharmaceutical or veterinārfarmaceitisk actions, the enterprise corresponds to the veterinārfarmācij field in the pharmaceutical or regulatory laws, the report added, the document on the basis of which a special permit (licence) issued;
35.2. licensed pharmaceutical or veterinārfarmaceitisk activities company for the pharmaceutical or veterinārfarmācij found in the area of regulatory law violations and shortcomings and inspection agency officials or set a time limit for the message to be submitted to the Commission for information;
35.3. the licensed pharmaceutical or veterinārfarmaceitisk activities company for the pharmaceutical or veterinārfarmācij found in the area of regulatory law violations and shortcomings and inspection officials of the Agency have proposed a special permission (licence) to suspend or withdraw, the report shall be submitted to the Commission for a decision.
36. The applicant or the special permission (license) the holder shall ensure that the national pharmaceutical inspection and agency officials at any time, you can get into the pharmaceutical and veterinārfarmaceitisk activities at the premises of the company and the appropriate competence to control the activities of pharmaceutical and veterinārfarmaceitisk and the related documentation. Where the applicant or a special permit (license) the fault of the holder to carry out the examination is not possible, the national pharmaceutical inspection or agency officials prepare a written report and submit it to the Commission.
37. If a special permit (license) has been lost or corrupted, restore a special permit (license) the holder shall submit to the Commission an application stating the reason for the special permit (license) for the issue of a duplicate. The application shall be accompanied by the corrupt special permission (license). If a special permit (license) has been lost, the Commission shall publish in the Gazette "journal" announcement about its loss. The announcement indicates lost special permission (license) holder, its legal address, pharmaceutical or veterinārfarmaceitisk activities site address, special permission (license) number, date of issue and term of validity. The costs of publication shall be covered by a special permit (license) holder.
IV. The right of the Commission and decisions 38. Commission decision: 38.1. the special permit (license) for the issue or renewal, or a special permit (license) the issue of a duplicate;
38.2. the special permit (license) to open a drugstore (operation) suspension. If the special permissions (licenses) to open the pharmacy (the operation) has been stopped temporarily because of construction or repairs, then, to provide pharmaceutical care, shall take a decision on the temporary special permit (license) to open a drugstore (operation) of the service for a certain period of time not longer than two years, another pharmaceutical activities if: the pharmaceutical site 38.2.1. is a locality in its territory, which was in a pharmacy, where special permission (license) is stopped;
38.2.2. pharmacy provides a special operational conditions, which provided the Pharmacy where the special permit (license) is suspended;
38.3. the special permit (license) the suspension or special permit (license) the specified special operating conditions, or suspension of certain medicines (which the applicant has specified in annex 1 of these rules and in respect of which the Agency has issued a special permit (license)) the production or importation of suspension based on a special permit (license) holder's application;

23.9. the special permit (license) restoration, or special permit (license) the specified special operating conditions, or on a particular drug (which the applicant has specified in annex 1 of these rules and in respect of which the Agency has issued a special permit (license)) the production or importation of renewal;
38.5. the special permit (license) for the issue or renewal, provided that the special permit (license) holder within the period prescribed by the Commission provides space or equipment, or equipment, or staff compliance with pharmaceutical or veterinārfarmācij areas regulatory laws;
24.0. suspension of the proceedings for, if you need additional information (the information provided is not sufficient or there is doubt as to its veracity) or additional inspection;
36.6. the special permit (license) or special permit (license) for special operating conditions specified are revoked, or certain medicines (which the applicant has specified in annex 1 of these rules and in respect of which the Agency has issued a special permit (license)) or the cancellation of the import operation.
39. If the Commission shall adopt the provisions referred to in decision 24.0., the Agency shall forward the decision to the applicant and provides additional test in accordance with the provisions of article 23, 24 or 25.
40. If within the time limit fixed by the Commission the additional information requested or justified written explanation of the reasons for the failure to provide information have not been received, the Commission shall consider the matter and take a decision without the requested additional information.
41. The period of time from the provisions referred to in paragraph 39 of the decision to send the additional information is not counted within the time of adoption of the decision.
42. at the date of adoption of the decision (except this rule 50 of the cases referred to in paragraph) following the entry into force of the Commission decision: 42.1. the decision on the special permit (license) for cancellation;
26.2. the decision on the special permit (license) suspension;
26.3. the decision on the conditions of operation of certain special suspension;
26.3. the decision on a particular drug (which the applicant has specified in annex 1 of these rules and in respect of which the Agency has issued a special permit (license)) the production or importation of suspension.
43. Commission decision on a special permit (license) for the issue or renewal of the entry into force of the 10th day following that of its adoption. The Commission may fix a time for the entry into force of the decision on the special permit suspended (license) restoration, certain special conditions of operation or the activities of a particular drug (which the applicant has specified in annex 1 of these rules and in respect of which the Agency has issued a special permit (license)) production or import operation.
44. This provision, the Agency referred to in paragraph 42 of Commission decision a special permit (license) holder, no later than the next working day shall also be notified by phone and email (if the address is specified in the application).
45. following these rules 10, 12, 14 and 16 of the application referred to in paragraph and document receipt, the Agency shall, in the Act on administrative procedures the decision within the time limit set for the special permit (license) for the manufacture of medicinal products or medicinal or veterinary medicine to open lieltirgotav (operation). If the objective reasons that the time-limits laid down in this paragraph cannot be complied with, it may be extended by the administrative procedure law, but not more than 90 days.
46. The Agency shall ensure that a decision on a special permit (license) for the manufacture of medicinal products, if it involves re-registering with this rule 11.1, 11.2., 13.1 and 13.2. the conditions referred to in (a), not more than 30 days after the 10 and 12 of the rules referred to in the submission and receipt of documents. If the objective reasons that the time-limits laid down in this paragraph cannot be complied with, it may be extended by the administrative procedure law, but not more than 90 days.
47. A special permission (licence) or re-registered special permission (license) issued or sent by post after the applicant or a special permit (license) holder paid for the public, in accordance with the Agency's paid service price list, as well as the paid State fee. If the person, within three months after receipt of the invoice is not made, the Agency proposes to pay Commission to suspend a special permit (license).
48. Special permit (license) a duplicate shall be issued following payment in accordance with the Agency's public service charges, as well as a schedule for this rule 37, paragraph announcement.
49. A special permit (license) holder or person responsible for the reorganization or liquidation of authorised economic operator, together with the application for a special permit (license) the cancellation shall be submitted to the National Agency for the pharmaceutical inspection of harmonised information on the remaining inventory of the distribution of medicinal products or disposal, indicating the legal personality which the medicinal product will be distributed to, or information about the destruction of the medicinal product, or proof that the item will be destroyed.
50. If the Commission decides on a special permit (license), based on the application of the licensed person, the Commission may determine that a special permit (license) is cancelled within the specified time, to ensure the distribution of stocks of medicinal products or destruction.
51. the Commission has the right to: invite pharmaceutical or 51.1. veterinārfarmācij field experts with appropriate qualifications to assess the information provided, as well as to request information from pharmaceutical and veterinārfarmācij areas of professionals or non-governmental organizations;
51.2. writing and verbally to provide proposals and special permit (license) holder.
52. The decision on the refusal to issue or a special permission to reregister (license) shall be adopted by the Commission in the following cases: 52.1. If, on the basis of the information provided, the documents and the report finds that an applicant or a special permit (license) holder is unable to provide the pharmaceutical or veterinārfarmaceitisk area in regulating the statutory requirements or void a document, on the basis of which has been issued a special permit (license);
52.2. the discrepancy in veterinārfarmaceitisk area of pharmaceutical or regulatory laws;
52.3. provided incomplete or incorrect information or false documents are submitted;
52.4. pharmaceutical or veterinārfarmaceitisk activity carried out without adequate special permit (license);
52.5. declares the applicant or a special permit (license) holder's insolvency, as well as in other cases, if there is a proven inability to perform commercial activities;
52.6. pharmaceutical or veterinārfarmaceitisk activities company personnel does not meet or veterinārfarmācij areas of Pharmacy regulatory laws and requirements.
53. a decision on a special permit (license) or for the suspension of the special permit (license) a special operating conditions specified in the suspension, or for specific medicinal products (for which the applicant has specified in annex 1 of these rules and in respect of which the Agency has issued a special permit (license)) the production or importation of suspension, the Commission shall adopt, in the event of: 53.1. violated or veterinārfarmācij areas of Pharmacy regulatory laws and requirements the Commission has received from the competent authorities a motivated written proposal for a special permit (license) suspension;
53.2. medicines manufactured or distributed (also from third countries imported products), which are not specified in the special permit (license);
53.3. pharmacy does not provide special operating conditions laid down in the regulations on the operation of pharmacies;
53.4. details of changes in the information and documentation submitted in accordance with the provisions of paragraph 28, especially for skilled persons;
13. the Ministry of Health, the Agency, the national pharmaceutical inspection information is not provided, the specific areas of the pharmaceutical or veterinārfarmācij-regulating laws;
53.6. not satisfied within the time of the Commission decision or prevent deficiencies in national pharmaceutical inspection or within the time limit set by the Agency;
53.7. staff who have a special permit (license) holder, does not meet or veterinārfarmācij areas of Pharmacy regulatory laws;
53.8. special permit (license) holder does not have staff in the production of medicinal products and controls under the pharmacy or the scope of the veterinārfarmācij regulatory laws;
is 53.9. special permit (license) holder does not enable the competent authority at any time perform the distribution or production control or inhibit it;
53.10. special permit (license) holder or officers have not paid the administrative penalty imposed on the scope of the pharmaceutical or veterinārfarmācij regulatory law violations;
53.11. Court issued a special permit (license) holder's insolvency, as well as in other cases, if there is a proven inability to perform commercial activities;

53.12. the applicant or the special permission (license) the holder is not paid in accordance with the Agency's public service fees not paid the price list and the State fee;
53.13. violation of laws and regulations on the production and control of medicinal products or import or distribution requirements and the Commission has received competent State institutions written proposal to stop specific drug (which the applicant has specified in annex 1 of these rules and in respect of which the Agency has issued a special permit (license)) manufactured or imported;
53.14. special permit (license) holder submits to the Commission an application to suspend the special permit (license) or a special permit (license) the specified special operating conditions, or specific drug (which the applicant has specified in annex 1 of these rules and in respect of which the Agency has issued a special permit (license)) manufactured or imported.
54. in addition to the provisions of paragraph 53 of the said conditions, the Commission shall take a decision on a special permit (license) for the manufacture of the medicinal product, or suspension of certain medicines (which the applicant has specified in annex 1 of these rules and in respect of which the Agency has issued a special permit (license)) or the suspension of the import of production up to failures, if a special permit (license) holder: 54.1. manufactures or imports medicinal products from third countries not listed in annex 1 of these rules and in respect of which the Agency has issued a special permit (license);
54.2. the qualified person has not provided a chance to take control and other obligations laid down in the regulations on the production and control of medicinal products and the import and export of medicinal products;
54.3. production does not meet the regulations for the production and control of medicinal products in certain principles and guidelines of good manufacturing practice;
54.4. does not support the serial production of each drug and control in accordance with the laws and regulations on the production and control of medicinal products and the import and export of goods;
54.5. during the test cannot give assurances on the finished product, its components and intermediate production process control in accordance with the laws and regulations on the production and control of medicinal products and the import and export requirements or agency officials found deficiencies, which can not be eliminated faster than two months.
55. the Commission 53 and 54 of these regulations. the decisions referred to in paragraph determines a special permit (license) or for the suspension of the special permit (license) the specified special operating conditions of the suspension, or for specific medicinal products (for which the applicant has specified in annex 1 of these rules and in respect of which the Agency has issued a special permit (license)) the production or importation of the suspension period not longer than six months, or to a special permit (license) expire. In exceptional cases, on the basis of a special permit (license) holder's application, the Commission may extend the suspension period not exceeding three months, or until the end of the insolvency.
56. If this rule 53 and 54 in the Commission decision provides that special permission (license) to stop the observed lack of or the prevention of abuse and relevant information for submission to the Agency, a special permit (license) holder can resume the activities of pharmaceutical or veterinārfarmaceitisk (without a separate Commission decision) after the agency filed with the agency or the national pharmaceutical inspection officials agreed.
57. If a special permit (license) stopped to prevent national pharmaceutical inspection or examination findings of the Agency and reports in the field of pharmaceutical veterinārfarmācij of regulatory or legislative abuses or disadvantages and their prevention need conformity assessment (good distribution practice), a special permit (license) shall be renewed by decision of the Commission after a special permit (license) holder's application for a special permit (license) restoration and national pharmaceutical inspection or receipt of the report of the Agency.
58. Special permit (license) holder within three working days after the decision on the special permit (license) the suspension shall submit the entry into force of the special permission (license) within the Agency. By special permit (license) restoration of activity of the Agency special permit (license) on the other side of the suspension and the renewal date.
59. the decision on a special permit (license) or for a special permit (licence) specified in the special conditions of cancellation of the operation, the Commission shall adopt the following cases: 59.1. time of the year again found in the pharmaceutical or veterinārfarmācij area of regulatory law violations;
59.2. the special permit (license) holder medicine purchased from a person or company to which the relevant pharmaceutical or veterinārfarmācij in the area of controlling the laws is not permitted to distribute medications;
59.3. special permit (license) holder distributed free medicine law on the import, export and distribution requirements;
59.4. special permit (license) holder during the year has not made the conduct of business, which issued a special permit (license);
59.5. national pharmaceutical inspection agency or time of the year again, that is not respected and the documents specified in the application to the pharmacy or medicine or veterinary medicine lieltirgotav hours or pharmacy manager or the responsible working time;
59.6. special permit (license) has been stopped and that was on the basis of a special permit (license) for suspension of the time-limits laid down in the Commission decision does not prevent;
59.7. over this rule 55, paragraph, the period of suspension of the licence and special permit (license) holder does not submit an application for renewal of a licence or six months do not resolve identified deficiencies or irregularities and has submitted these provisions within the Agency, the information referred to in paragraph 56;
59.8. the Commission received by the national competent authority of a written permit before the special law (license) to cancel due to the findings or field of veterinārfarmācij of Pharmacy regulatory law violations and deficiencies;
59.9. finds that the applicant has provided incomplete or false information, which is essential when deciding on a special permit (license) or by conducting pharmaceutical and veterinārfarmaceitisk activities, the applicant used forged documents;
59.10. finds that the special permit (license) holder to produce or distribute counterfeit medicines;
59.11. pharmacy at the place of the pharmaceutical activities do not respect the special operating conditions laid down in the regulations on the operation of pharmacies;
the Agency has not been submitted in 59.12. stop special permission (license), and its annexes;
59.13. the Commission has received a special permit (license) holder's written application for special permit (license) due to the withdrawal of the pharmaceutical or veterinārfarmaceitisk is the winding up or a court ruling on the activities of the pharmaceutical or veterinārfarmaceitisk.
60. in addition to the 59 of these rules the conditions listed in the decision on the special permit (license) for the manufacture of medicinal products, the cancellation of a Commission is entitled to adopt, if the inspection carried out by the Agency are important deficiencies in the production of medicinal products specified in this rule referred to in paragraph 25 of the good manufacturing practices inspection report, and the Agency has submitted to the Commission in writing of the proposal to revoke the special permission (license).
61. Special permit (license) holder within three working days of receipt of the decision of a special permit (license) shall be submitted to the special cancellation of permission (license) within the Agency.
62. If special permission (license) shall withdraw or veterinārfarmācij field of the pharmaceutical regulatory law infringements, the Commission may fix a time limit (not less than three years), during which a special permit (license) holder, as well as new activities in the pharmaceutical company, whose founders, members and officials have cancelled the special permission (license) holders (owners), the founders, members and officials, is not entitled to a new special permit (license).
V. special permission information (license) and the national toll 63. These rules 5.1, 5.2, 5.3 and 5.4. bottom special permit referred to in paragraph (license) shall be drawn up in accordance with annex 5.
64. The provisions referred to in point 5.1. special permission (license) the General type of pharmacies opening (operation) in the annex indicates the following special activities: 64.1. psychotropic drug distribution;
64.2. the illicit manufacture of narcotic drugs and psychotropic medicines recognized distribution;
64.3. amount of countervailable distribution;
64.4. medicine. This requirement does not apply where, in accordance with the scope of pharmaceutical or veterinārfarmācij laws governing ERS must receive a special permit (license) for the manufacture of medicinal products;
64.5. non-prescription drug distribution via the internet;
64.6. wholesale distribution of medicinal products, medical institutions and social care institutions (ensuring a good distribution practice);

64.7. distribution of veterinary medicinal products.
65. This provision as referred to in point 5.2 of the special permission (license) closed to open pharmacies (operation) in the annex indicates the following special activities: 65.1. psychotropic drug distribution;
65.2. the illicit manufacture of narcotic drugs and psychotropic medicines recognized distribution;
65.3. the manufacture of medicinal products. This requirement does not apply where, in accordance with the scope of pharmaceutical or veterinārfarmācij laws governing ERS must receive a special permit (license) for the production of medicinal products.
66. The rules referred to in point 5.3 of the special permission (license) to open the medicinal lieltirgotav (operation) in the annex indicates the following special activities: 66.1. psychotropic drug distribution;
66.2. the illicit manufacture of narcotic drugs and psychotropic medicines recognized distribution;
66.3. the distribution of veterinary medicinal products;
66.4. the distribution of veterinary medicinal products containing substances with anabolic, pretinfekcij, anti-parasitic, anti-inflammatory, and hormonal characteristics, showing separately: 66.4.1. antimicrobials, sulphanilamide and hinolon;
66.4.2. features of anthelmintic substances;
66.4.3. kokcidiostatisko also nitroimidazole features;
66.4.4. carbamate and pyrethroids;
66.4.5. sedatīvo means;
66.4.6. non-steroīdo anti-inflammatory products;
66.4.7. 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.
67. The provisions referred to in paragraph 5.4 special permissions (licenses) of the veterinary medicinal product to open lieltirgotav (operation) in the annex indicates the following special activities: 67.1. psychotropic drug distribution;
67.2. the illicit manufacture of narcotic drugs and psychotropic medicines recognized distribution;
67.3. the distribution of veterinary medicinal products containing substances with anabolic, pretinfekcij, anti-parasitic, anti-inflammatory, and hormonal characteristics, showing separately: 67.3.1. antimicrobials, sulphanilamide and hinolon;
67.3.2. features of anthelmintic substances;
67.3.3. kokcidiostatisko also nitroimidazole features;
67.3.4. carbamate and pyrethroids;
67.3.5. sedatīvo means;
67.3.6. non-steroīdo anti-inflammatory products;
67.3.7. 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.
68. The rules referred to in point 5.5. special permit (license) for the manufacture of the medicinal product shall be drawn up in accordance with the provisions of annex 6.
69. special permission (license) and its annex, shall be signed by the Chairman of the Commission.
70. the national toll (rate) for a special permit (license) of the service is as follows: 70.1. General types of pharmacies opening (action): 70.1.1.-200 lats in cities;
outside the cities, 70.1.2.30 dollars;
70.2. medicines to open lieltirgotav (action)-150 lats;
70.3. lieltirgotav opening of the veterinary medicinal product (performance)-50 lats;
70.4. medicine and the manufacture of veterinary medicinal products – 500 lats;
70.5. medicine and the manufacture of veterinary medicinal products and pharmaceutical manufacturing process, in part to make the medicine or veterinary medicine lieltirgotav-300 lats;
70.6. production of medicines if the investigational medicinal products are produced just 100 lat –;
70.7. veterinary medicinal products or medicinal products medicinal products for import lieltirgotav from third countries-200 lats.
71. the special permit (license) a State fee is re-registering 10 percent of this provision set out in paragraph 70 government fees. The revenue from government fees included in the State budget.
72. the special permit (license) and renewal of closed pharmacies opening (operation) and the production of medicinal products, if the medicinal product is manufactured in a drugstore, a State fee is not charged.
73. Re-register a special permission (licence), retains its previous number and series.
74. If a special permit (license) is cancelled or suspended, the transaction is payment for the conformity assessment and the State fee shall not be refunded.
75. the Agency puts the Agency's website on the internet for information about a special permit (license) holders and the State: 75.1. merchants (for individual traders also indicate the merchant's name), and veterinārfarmaceitisk activities of the pharmaceutical or corporate name, if different from the name of the operator;
75.2. the operator's registered office;
75.3. the actions of the pharmaceutical or veterinārfarmaceitisk site address;
75.4. special permit (license) number and expiry date;
75.5. information about special activities;
75.6. pharmacies or medicine or veterinary medicine lieltirgotav of officers, or the manufacturer of the medicinal product by the qualified person name and surname;
47.0. information about special permissions (licenses) of the suspension and the date of adoption of the decision and the time limit;
75.8. information about special permissions (licenses) of the cancellation and the date of adoption of the decision.
Vi. Institutions and special permit (license) the obligations of the holder shall 76. Agency: 76.1. provide the Commission with written proposals on the Commission's proceedings pending issues;
76.2. at the request of the Commission, prepare and provide the Commission with information relating to pharmaceutical and veterinārfarmaceitisk activities of conformity assessment company and pharmaceutical veterinārfarmaceitisk activities and licensing;
76.3. creates, maintains and updates a database on medicinal products produced and imported by the applicant has specified in annex 1 of these rules and in respect of which the Agency has issued a special permit (license). Specify the database or imported medicinal products produced by type, name, form, dose, as well as information on where the production or import of medicines has been stopped;
76.4. cooperate with the national pharmaceutical inspection, if compliance would NASA test found in the pharmaceutical and veterinārfarmaceitisk activities;
76.5. provides instructions for correcting deficiencies and followed their due dates;
47.6. If irregularities are found in the production of medicinal products and of good distribution practices, provide the Commission with written proposals on special permit (license) the suspension or cancellation;
47.7. enables the members of the Commission and the national pharmaceutical inspection officials to become familiar with information related to conformity assessment;
76.8. within five working days after special permission (license) the suspension and cancellation shall inform the Customs and sanitary border inspection;
76.9. collects information about the detected shortcomings and deadlines for the correction of irregularities;
76.10. introduction the European Medicines Agency's database of information on issued and suspended special permits (licences) for the production of medicinal products.
77. the national pharmaceutical inspection: 77.1. the activities of the pharmaceutical or veterinārfarmaceitisk infringement detection shall provide the Commission with written proposals on special permit (license) the suspension or cancellation;
77.2. collect and provide information to the Agency about the deficiencies found during checks and deadlines for the correction of the irregularity;
77.3. at the request of the Commission, prepares and provides information related to pharmaceuticals and veterinārfarmaceitisk.
78. A special permit (license) holder: 78.1. provide activities under special permit (licence) and the annexes thereto and to the information in the veterinārfarmācij area of pharmaceutical and regulatory laws;
78.2. ensure that pharmaceutical and veterinārfarmaceitisk activities (manufacture, import, distribution) takes place only on the premises specified in the special permit (license);
78.3. ensure that are manufactured or imported only in the medicine and pharmaceutical forms specified in the information provided and in accordance with the provisions of annex 1 included in the Agency's database;
78.4. ensure the pharmaceutical inspection officials the opportunity at any time to enter the pharmaceutical and veterinārfarmaceitisk activities at the premises of the company and control of the activities of pharmaceutical and veterinārfarmaceitisk and related documentation;
78.5. officials of the Agency provides the opportunity at any time to enter the pharmaceutical and veterinārfarmaceitisk activities at the premises of the company and make the company's compliance with the good manufacturing practice and good distribution practice test;
78.6. ensure that the qualified person is able to take the obligations established for the production and control of medicinal products, the rules relating to the manufacture and quality control and the regulations on the import and export of medicinal products in respect of the imported medicinal product quality control;
78.7. provide health Ministry, agency and national pharmaceutical inspection information that certain pharmaceutical or veterinārfarmācij areas of regulatory laws;
78.8. According to the Commission, the Agency and the national pharmaceutical inspection request, provide information about the activities of pharmaceutical or veterinārfarmaceitisk.
79. the Agency, national pharmaceutical inspection officials and members of the Commission shall not disclose business secrets which become known to them in the performance of their duties.
80. information about the merchant submitted documentation relating to conformity assessment and licensing, is limited by the availability of information.

81. Commission 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 82. Be declared unenforceable in the Cabinet of Ministers of 29 April 2003 Regulation No 234 "special permit (license) the pharmaceutical activity, suspension of service, the procedure for renewal and cancellation, as well as pharmacies, drug lieltirgotav and drug production company compliance and good distribution practice evaluation order" (Latvian journal, 2003, 66 no).
83. Special permit (license) to open a drugstore (operation), medicine and veterinary medicine to open lieltirgotav (performance) that are assigned to the date of entry into force of the provisions, in force, but they re-register under these rules, if made to the assessment of conformity or a change in the submitted information and documents on the basis of which a special permit (licence) issued, changing the licence and its annexes specified information.
84. the special permit (license) the pharmaceutical company to open the (operation), the manufacture of the medicinal product (packaging and repackaging) drug lieltirgotav and drug production in the pharmacy that are assigned to the date of entry into force of the provisions, in force, but they re-register under the requirements laid down in these provisions not later than 1 January 2008. Special permit (license) holder of the licence shall be submitted to re-register documents no later than October 1, 2007.
85. lieltirgotav veterinary medicinal products that have received a special permit (license) for veterinary medicinal products to those rules for the operation of the lieltirgotav of entry into force and which imports a product from a third country or a divided and repackaged medicinal products for veterinary use, a special permission (license) to re-register under the requirements of this regulation until January 1, 2008. Special permit (license) holder license renewal documents to be submitted by 1 October 2007.
86. persons and veterinary medicine in Latvia imported from third countries, on the basis of the special permission (license) to open the medicinal lieltirgotav (transaction) with special operating conditions – drug importation for distribution in Latvia from outside the European economic area, are entitled to import the product from a third country to a special permit (license) for the manufacture of medicinal products, but no longer than 1 January 2008. Special permit (license) holder license renewal documents to be submitted by 1 October 2007.
87. The Pharmacy and medicine or veterinary medicine lieltirgotav, which up to this date of entry into force of the provisions of a special permit (license) received with a certain expiration date, not later than 30 days before a special permit (license) the expiry date for the conformity assessment of the submission, and a special permit (license) Re-registering under these rules.
88. the pharmacies that are necessary to rearrange the appropriate pharmaceutical law article 36, first paragraph, a special permit (license) to open a drugstore (operation) determines the term of validity up to the year 2010 December 31.
89. Pharmacies, which brought this provision to the date of entry into force and distributes medicine treatment institutions and social care institutions are obliged to 1 July 2008 for a re license under this regulation.
90. the pharmacies, which brought this provision to the date of entry into force and distributes medicines over the internet, is obliged to 2007 December 1, re the license according to the requirements of this regulation.
91. Pharmacies, which up to this date of entry into force of the rules to have received a special permit (license), this rule 64.3. condition referred to a special permit (license), to re-register licenses.
92. the regulations shall enter into force by 1 august 2007. 
Informative reference to European Union directives, the regulations include provisions resulting from: 1) of the European Parliament and of the Council of 6 November 2001, 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 6 November 2001 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products;
3) 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;
4) 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;
5) of the European Parliament and of the Council of 31 March 2004, Directive 2004/28/EC amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.
Prime Minister a. Halloween Health-Welfare Minister Minister d. Staķ is the Editorial Note: the entry into force of the provisions by 1 august 2007.
 
Annex 1-6 ZIP 114 kb