Cabinet of Ministers Regulations No. 693 Riga 2010 (27 July. No 38 28) amendments to the Cabinet of Ministers of 26 June 2007 Regulation No 416 "the distribution and quality control procedure" Issued in accordance with article 5 of the law on Pharmacy 3 and 19 points to make a Cabinet of 26 June 2007 Regulation No 416 "the distribution and quality control procedure" (Latvian journal, 2007, 104 no; 2008, 167. no; 2009, 126, no. 154) the following amendments: 1. Replace the text, the words "on the internet" with the words "with" through the Web.
2. Replace the text, the words "home page" on the internet (the fold) with the words "Web site" (fold).
3. Replace the text, the words "home page" (fold) with the words "Web site" (fold).
4. Express 2.4 and 2.5. subparagraph as follows: "a natural person by 2.4 imported, exported, sent by post or receive by post, for personal use;
2.5. you receive and send mailings. This also applies to countries which are not members of the European Union and European economic area countries (hereinafter third countries); ".
5. Make 3 by the following: "3. the free ports and special economic zones and customs law article 9 referred to in the second subparagraph apply to the distribution and quality control requirements, as well as the control and monitoring measures laid down in these regulations."
6. Delete the second sentence of paragraph 5.6.
7. To express point 5.8 as follows: "drug donations is 5.8 distribution free of charge, subject to the provisions of paragraph 10 of these requirements no matter which market medicinal products as gifts."
8. Express 10.2. subparagraph by the following: "10.2. treatment services has been received or a social care institution written consent for specific medicinal products, stating the name of the medicinal product, dāvinām strength or concentration, form, quantity and packaging in the same package. If the medication treatment, donates donated medicines and their quantity corresponds to the hospital's operating profile, and the volume of work is suitable for the treatment of patients for treatment. If the product presents social care institution, donated medicines are suitable for social care institution for treatment of the patient; "
9. Express 10.4. subparagraph by the following: "medical authority 10.4 in donations entitled to: 10.4.1 the registered medicines, which are not included in the legislation for the outpatient treatment of medicinal products and medical equipment purchase expense compensation procedures in that the list of eligible medicines (hereinafter referred to as the eligible list of medicinal products) (does not apply to the eligible list of medicinal drugs list C);
10.4.2. unregistered medicines, which are available for use on compassionate grounds this rule 94.3 3.3. programme referred to, only medical authority that is specified in the distribution of medicinal products not registered individually assigned permissions. Medicine the donor supports the European Parliament and Council Regulation No 726/2004, article 83, paragraph 8 of the conditions; ".
10. Replace the words "in paragraph 10.6. not more than one year" with the words "is less than one year".
11. Delete paragraph 11.3.
12. Supplement with 11.1 points as follows: "the merchant that issued 11.1 special permission (license) to open a drugstore (operation), redistribute the medicine wholesale medical institutions, social care institutions, practicing veterinarians and the veterinary care business operators."
13. Express 12.3. subparagraph by the following: "12.3. supply medicinal products (or mailing) only the persons who have the right to distribute the medicines wholesale and retail, and medical institutions, social care institutions, practicing veterinarians and the veterinary care business operators who have the right medicine to buy under the legislation on medicine purchase, storage, use, and disposal procedures of accounting treatment and social care institutions, the order in which the person dealing with veterinary practices, take action with the narcotic and psychotropic drugs, and the order in which the person engaged in veterinary practice, acquired, stored, and used drugs; ".
14. Express section 12.5.2. by the following: "12.5.2. name of the medicinal product, pharmaceutical form and strength or concentration".
15. Replace paragraph 12.5.4. the word "or" by "and".
16. Add to subparagraph 12.8 with the second sentence by the following: "wholesaler specializing in specific manufacturer's drug sales and supply, guarantees the obligations of this paragraph relating to this manufacturer's products;".
17. Make the following paragraph 12.9.: "12.9. drugs which require urgent delivery and in the inventory of medicines, pharmaceutical wholesaler supplies as soon as possible, taking into account the distance to the place of delivery. The drug, which is included in the list of products eligible under the legislation on medicinal products to treat the purchase of compensation arrangements for on-demand delivery of pharmacy drugstore in 24 hours; ".
18. To supplement the provisions of this paragraph 12.10:12.10. "distributed only the medicine that prices provide information in accordance with the laws and regulations on drug pricing principles. This requirement is not applicable to unregistered medicines. "
19. To supplement the provisions under paragraph 12.1, as follows: "the merchant that issued 12.1 special permission (license) to open a drugstore (operation), distributes medicines that rule 11.1 persons referred to in point 12.1, by ensuring that rules, 12.2, 12.3, 12.4, 12.5, 12.6 and 12.7 in. specific requirements."
20. Make 17 the following: "17. Medicine lieltirgotav: 17.1. provides on its website the public easily accessible information about the distributed medicinal products and prices;
17.2. notify the State Agency of medicines and medicinal lieltirgotav specify the website address, which contains information on medicinal products and their prices. "
21. Express 18 as follows:

"18. The provision in paragraph 11.1 and 11.2 and 11.1 and 13 persons referred to in paragraph shall notify the State Agency of medicines of the medicines marketing data (including parallel and distributed parallel imported medicinal products) for each month until the 15th date of the following month or other period requested by the national agencies. The notification shall specify: 18.1. name of the medicinal product, pharmaceutical form, strength or concentration, the volume of distributed and drug sales price;
18.2. registered medicinal products – the registration number of the Latvian register of medicinal products;
18.3. unregistered medicinal products – identification number specified in this rule referred to in paragraph 94 of the unregistered individual authorization of distribution of medicinal products medicinal products granted;
18.4. the recipient of the medicinal product, including a reference to "Pharmacy", "lieltirgotav", "medicinal herbs", "veterinary care authority", "official veterinarian", "medical practitioner", "exported to third countries", "exported to the countries of the European economic area" and "other recipients" (if any). "
22. Supplement with 19.1 points as follows: "If this rule 19.1, paragraph 11.1 the merchant receives the Hall or to the European economic area, he shall ensure that the requirements referred to in point 19."
23. To complement the introductory part of paragraph 35, after the word "communicate" with the words "and in accordance with the provisions of paragraph 39".
24. Make 39 the first sentence as follows: "to get that provision referred to in paragraph 34, the parallel importer of a drug shall be submitted to the National Agency for medicinal products imported in parallel distribution permission request application (hereinafter referred to as the application) in accordance with the provisions of annex 1, which contains the attestation that the parallel importer on the intention to launch a parallel imported medicinal product distribution has announced the registration holder (the holder of the marketing authorisation) and trademarks (brand)."
25. replace paragraph 43, the word "solution" with the word "dissolution".
26. The deletion of the introductory phrase of paragraph 46, the words and figures "according to the Commission of 3 June 2003, Regulation (EC) no 1084/2003 concerning the examination of variations to the terms of a marketing authorisation, the competent authority of the Member State which issued for medicinal products for human use and veterinary medicinal products".
27. To complement the introductory part of paragraph 60, after the word "communicate" with the words "and in accordance with this rule 60.1 points".
28. To supplement the provisions of the following paragraph 60.1: "parallel distributor submitted 60.1 medicine State Agency certifying that: 60.1 1. intention to launch a specific parallel distribution of medicinal products distributed in Latvia have declared the registration holder (the holder of the marketing authorisation) and trademarks (brand) owner, selecting specific recipients, which is announced, and the date of the notification;
60.1 2. on certain parallel medicinal izplatāmaj is filed this rule 63 and 64 the notification referred to in paragraph (notification) of the European Medicines Agency, and indicate its filing date. "
29. Make 63 and 64 the following wording: "63. Parallel distributor shall submit to the European Medicines Agency, notification of a centrally registered parallel distribution of medicinal products (hereinafter referred to as the notice) to the European Medicines Agency to the prescribed form (published by the European Medicines Agency website http://www.ema.europa.eu) to the European Medicines Agency to meet European Parliament and Council Regulation No 726/2004 article 57 1 of the" o "part.
64. If the European Community annex of the marketing authorisation for a medicinal product or changing data in parallel retailer in the information provided in the notification (for example, change the data on the drug pārpakotāj or parallel distributors), parallel distributors shall provide notice of a change centrally registered parallel distribution of medicinal products in the European Medicines Agency to the prescribed form (published by the European Medicines Agency, the European Medicines Agency website http://www.ema.europa.eu). This statement must be filed, even if changes in the country in which the medicine will be distributed. "
30. Delete paragraph 67, the number "29.4.".
31. Make 69 the following: "69. Unregistered medicinal products to be issued with a pharmacy: 69.1. to the recipe, which according to the legislation on prescription;
EB 69.2. without a prescription, if the product is included in this rule referred to in paragraph 86 of the distribution authorization, and the State Agency of medicines has a particular affiliation, non-prescription medicinal products, in accordance with the regulations on the classification of the medicinal product. "
32.71 and 72 to express the point as follows: "71. If the item is not a medicinal chemist, pharmacy by patient, medical institutions, social care institutions, practicing veterinarians or veterinary care merchant request (hereinafter referred to as the institutions and practicing veterinarian request) on the same day of receipt of the request the necessary medications ordered this provision in paragraph 11.1 and 11.2 and paragraph 13 of that person. For non-registered medicines pharmacy provide this rule laid down in paragraph 72 of the requirements. After the receipt of the pharmacy medicinal product: 71.1. supply medicinal products immediately or inform about arrival of the medicinal treatment, social care institutions, practicing veterinarian or veterinary care merchant who has requested a medicinal product;
71.2. receipt of a medicinal product shall notify the patient who the product is ordered.
72. the pharmacy distribution of medicines not registered, the following requirements shall be met: 72.1. If the drugstore stocks of medicines not registered is not in medicine, pharmacy and recorded the recipe or the provisions referred to in paragraph 71 of the authorities and a practicing veterinarian requests;
72.2. contact 11. these provisions or persons referred to in paragraph 13 of the unregistered drug delivery and provide that person a written request for medicine Pharmacy delivery. Pharmacy request is not necessary to add this rule 72.1. recipe and referred to authorities and a practicing veterinarian. Pharmacy request: 72.2.1. unregistered medicines to be supplied the name, pharmaceutical form, strength or concentration, the unit number, the packing unit quantity;
72.2.2. the person who asserts, the Hall and the medical establishment, social care institutions, veterinary care, and proprietorship practicing veterinarian, who drugs requires;
72.2.3. producers of medicinal products, if appropriate;

72.3. a wholesaler of medicinal products may not make a request in writing for a medicinal product: 72.3.1. in accordance with the laws and regulations on the acquisition, storage, use, and disposal procedures of accounting treatment and social care institutions meet health economic center to the list of medicinal products defined and required from the State budget paid inpatient health services (hereinafter referred to as the list of medicinal products used) (applies to institutions and practicing veterinarians request);
72.3.2. are common outpatient treatments the purchase of medicinal products in the framework of the system of compensation in accordance with the laws and regulations of the outpatient treatments and medicines for the purchase of medical equipment for compensation procedures (hereinafter referred to as the drugs that are common in the outpatient treatments the purchase of medicinal products in the framework of the system of compensation) (applies to pharmacy request);
72.4. recipe, as well as institutions and practicing vets the requests stored in the pharmacy. "
33. To replace the words "in paragraph 73 of the medical institutions and social care institutions" with the words "institutions and practicing vets the requests".
34. the express section follows 74.6.: "the analgētiķ, 74.6. narcotic which is recognized by the State Agency of medicines."
35. paragraph 75 to make the first sentence by the following: "institutions and practicing veterinary medicine service demand pharmacy store in three years."
36. To make 78. the fourth sentence as follows: "drug can also use medical institution and social care institutions, as well as the veterinary care of a trader or a practicing veterinarian until the remaining stocks of medicines."
37. Make 79. introductory paragraph as follows: "79. State Agency of medicines has the right to decide on:.
38. To complement the introductory part of paragraph 82 behind the words "medical institutions" with the words "the veterinarians, veterinary medical care business operators".
39. To complement the 83 point after the words "health inspection" by the words "but as regards medicinal products for human use intended for animals, the food and veterinary service".
40. Add to 84 after the word "reasonableness" with the words "but for medicinal products intended for Administration to animals, food and veterinary service".
41. Make 85 and 86 above. as follows: "85." the doctor, the medical establishment, as well as a practicing veterinarian and veterinary care the merchant before the unauthorised medicinal product discharge and appointment of the patient (does not apply to products for which it has issued that rule referred to in paragraph 86 of the European economic area country, but not registered in the Republic of Latvia-permit distribution) collects information on the characteristics of these medicinal products, to be able to assess their therapeutic effects and safety of the patient and to ensure monitoring of use as well as being responsible for this medicine discharge or designation.
86. in order to receive permission to the European economic area country (in the registration process), but not registered in the Republic of Latvia for the distribution of medicinal products (annex 4), the European economic area country issued marketing authorization holder (owner) or registration of the applicant (if the product is in the process of registration) of medicinal products shall be submitted to the national agency in the application (annex 5). "
42. To supplement the rules by 86.1, 86.2 and 86.3 86.4 points, as follows: "the State Agency of medicines of 53.5 may decide to issue these rules permit referred to in paragraph 86, the economic Center for health or hospital's suggestion, as well as to propose the authorization based on public health considerations, if the State Agency of medicines has not filed the rule 86 request paragraph.
86.2 medicine State agency this rule 86, paragraph permit is issued on the European economic area country issued marketing authorization holder (owner) or, if the product is a European economic area country registration process, the applicant for marketing authorisation.
the State Agency of medicines of 86.3 decides to issue that rule 86, paragraph permission for a definite period of time-five years. The said decision shall cease to be valid in Latvia and Latvia register of medicinal products included in this rule referred to in paragraph 86 or analog drugs.
86.4 after five years since this rule 86.3 points a decision referred to in the State Agency of medicines has the right to take the decision to issue the rule referred to in paragraph 86 of the permit for an unlimited period of time, except in the case where, on the basis of the monitoring of adverse reactions of the medicinal products (pharmacovigilance) of the evidence obtained, the State Agency of medicines has decided to issue the permission for a definite period of time-five years. The said decision shall cease to be valid in Latvia and Latvia register of medicinal products included or mentioned in the authorisation of medicines. "analog
43. To supplement the provisions under section 87.4.101.8. and by the following: "101.8. shall inform the authorisation holder on advertising, labelling and package leaflet;
87.4. shall inform the authorisation holder of the requirements of pharmacovigilance. "
44. To supplement the rules with 87.1 points as follows: "the decision on authorisation 87.1 of the State Agency of medicines shall be adopted by the European economic area national competent authorities for medicinal products provided and the assessment report of the medicinal product marketing authorisation."
45. To supplement the provisions and paragraph 89.2 89.1 as follows: "this rule 86 issued 89.1. above does not register the distribution authorization, the State Agency of medicines shall approve the drug labelling and instructions for use of the national language, if necessary, in consultation with the owner of the registration, the manufacturer and the other competent authorities.
drug wholesaler 89.2 who supply medicinal products, medicinal products izplatāmaj provides drug labelling and package leaflet of the country according to laws and regulations on labelling procedures and instruction for use izvirzāmaj requirements. "
46. To complement the 90.1. subparagraph after the word "procedures" with the words "analogy, as defined in the register of medicinal products".
47. Make 91 as follows:

"91. the State Agency of medicines ensures the State Agency Web site address (http://www.zva.gov.lv) (hereinafter referred to as the medicine State Agency website) publicly available information on medicinal products registered in accordance with the provisions of paragraph 86 issued unregistered medicines distribution authorisation in accordance with this provision. 149.7."
48. Make the first sentence of paragraph 93 of the following: "The rules referred to in paragraph 86 of the unregistered medicines distribution permission gives right to that rule 11 and 13 above drug wholesaler to distribute the medicine wholesale, but this provision in accordance with the operator to distribute 11.1 medicines in accordance with the provisions of paragraph 12.1."
49. the express 94. paragraph by the following: "94. unregistered medicinal products for which a licence has not been granted that authorization referred to in paragraph 86, permitted to distribute wholesale, if received: 94.1. distribution of registered medicinal products not authorised medicinal products individually assigned (applies to other countries registered and medicinal products): some patients given 94.1.1. or for individual patients (annex 6), using a good faith (bona fide) order, and the person who asserts or designated by the grass taking responsibility for the appointment and discharge of the medicinal product;
94.1.2. on the basis of the pharmaceutical law article 10 paragraph 7 "c" referred to a decision of the Minister of health, if the medication requires medical assistance to disasters, natural disasters, or epidemic, and to avoid potential of pathogenic agents, toxins, chemical agents or the suspected or confirmed spread of which could cause harm;
94.2. distribution of registered medicinal products not authorised individually assigned halls (annex 6), which is available for use on compassionate grounds pursuant to European Parliament and Council Regulation No 726/2004, article 83 (2) (hereinafter referred to as the medicine of compassion). If you do not register the therapeutic indications of medicinal product differs from that indicated in the summary of product characteristics, they are not considered compassionate medicine (use such products shall be considered as "ārpusmarķējum"). "
50. To supplement the rules by 94.1, 94.2, 94.3, 94.4, 94.5, 94.6, 94.7, 94.8, 94.9, 94.11 and 94.12 points 94.10, as follows: "this rule 94.1 94.2. the conditions referred to in subparagraph shall not apply to medicinal products: 1. not subject to 94.1 the centralised registration procedure in accordance with European Parliament and Council Regulation No 726/2004;
94.1 2. dissemination of which was issued this rule 94.1. the authorization referred to in paragraph;
94.1 3. which are registered in the centralised registration procedure in accordance with European Parliament and Council Regulation No 726/2004, but these circumstances the use of the medicinal product and the target group is different from registration documentation contains the information.
This rule 94.1 94.2. unregistered referred to drug distribution permission granted specific individual medicines known to the individual patient or patients (annex 6), using a good faith (bona fide) order, does not require that the operator referred to in paragraph 11.1 that unregistered medicines received from drug wholesalers that issued this provision 94. the authorization referred to in paragraph 1.
94.3 to receive this rule permit referred to in paragraph 94, the person referred to in that provision and paragraph submitted 94.4 94.5 medicine government agency application (annex 7), which added: 1. this rule 94.3 72.2. pharmacy referred to in the request for the purchase of medicinal products, if the product ordered is a pharmacy, and a practicing veterinarian authorities or the request for the purchase of medicinal products, if the product ordered or practicing veterinarian. The request for the purchase of medicinal products may not be provided if the product meets the applicable drug list or outpatient treatments are distributed for the purchase of medicines compensation system. Requirement does not apply to this rule 94.2. the authorization referred to in (a);
2. the labelling of the medicinal product 94.3, instructions for use, and its translation into the language of the country where drugs for delivery to the medical institution, social care institution, a practicing veterinarian and veterinary care for the economic operators. Requirement does not apply in the case of medicinal products intended for a specific patient, and communicated on this rule 94.2. the authorization referred to in (a);
3. with regard to 94.3 compassionate medicine: 94.3 3.1 permissions the requesting proof of compliance with European Parliament and Council Regulation No 726/2004, article 83, paragraph 2, established the requirement that the application for registration of the medicinal product is submitted to the European Medicines Agency or the grass is in clinical trials.
94.3 3.2. hospital's reasoned justification for the use of the medicinal product – medical or epidemiological data on patients and patient groups (special treatment program) European Parliament and Council Regulation No 726/2004, article 83 (2): 94.3 3.2.1. chronic or severe debilitating disease or illness is considered life-threatening.
94.3 3.2.2. treating patients with Latvia national registration procedure, the mutual recognition procedure and decentralised registration procedure registration of the medicinal product in the European Union or the centralised procedure for the registration of the medicinal product may not get satisfactory treatment result;
3.3. the requesting 94.3 made use of the medicinal product. The description contains information about the medicinal product and how to use them: 94.3 3.3.1. Summary of product characteristics, labelling of the medicinal product and the instructions in one of the official languages of the project;
3.3.2. the patient prescribed 58.6 information, including sample form for informed consent according to the patients ' Rights Act;
94.3 3.3.3. Description of the groups of patients, including the expected number of patients in Latvia, information as to whether the medicinal product is used in other countries, the estimated duration of use and the number of packages;
3.3.4. the treatment of persons 94.3 and permissions obligations on recipients, including patient monitoring, data collection, monitoring of adverse effects of medicinal products, the order in which the medical person report on adverse reactions to medicinal products, existing and proposed clinical trial (also indicate the sponsor, clinical research sites in Latvia and abroad);
3.4 94.3. If necessary, the European Medicines Agency submitted the registration application and its accompanying data and documents;

94.3 3.5. Medicinal products of the European Medicines Agency Committee (if any) and other European Community opinion of the competent authority of the Member State for the medicinal product concerned.
the application of this rule 94.1 94.4. authorization referred to is entitled to submit to the rules referred to in paragraph 11 the operator.
the application of this rule 94.2 94.5. authorization referred to is entitled to submit a person's name for the medicinal product in the centralised register registration procedure pursuant to European Parliament and Council Regulation No 726/2004 and which have submitted a registration application or the European Medicines Agency in whose name the permit is issued to initiate clinical trials.
Before this rule 94.6 94.2. the authorization referred to in the medicine of compassion: 94.6 1. State Agency of medicines shall notify the European Medicines Agency for the opportunity to use the medicinal product concerned and may ask the European Medicines Agency's Committee for medicinal products for an opinion on such products: 94.6 1.1. target groups of patients – limited population, including age groups, of which the treatment benefits (with regard to the therapeutic indications provided) and identified the European Medicines Agency's Committee for medicinal products;
94.6 1.2. conditions of use of medicinal products – recommendations for health care professionals about the safe and effective use of the designation and to include relevant information on the clinical, pharmacological and pharmaceutical characteristics and patient monitoring;
1.3. distribution of 94.6 conditions – drug supply and usage restrictions or conditions under European Parliament and Council Regulation No 726/2004, article 9, paragraph 4, point "b" and article 14 paragraph 10 (does not apply to the delivery of the strategy in the Member States, for example, the quantity of product, the choice of the Member State);
2. the medicinal 94.6 manufacturer (if the European Medicines Agency has not filed registration application) or the applicant for authorization (the European Medicines Agency an application for registration has been filed): 94.6 2.1 is entitled, on its own initiative to inform the European Medicines Agency for this rule 94.2. the medicinal products referred to in the national agency of the permits submitted in the request;
2.2. inform 94.6 medicine State Agency for consultations with the European Medicines Agency.
94.7 permission in the: 1. This provision 94.7 94.1.1. the permit issued in the name of the applicant;
2. this rule 94.2 94.7., issued for the hospital's name, which gives this rule 94.3 3.2 referred to the justification of the use of the medicinal product.
94.8 this provision 94. authorization referred to in paragraph 1:58.9 medicinal products 1 is not in the list of medicinal products used or which are not common in the outpatient treatments for the purchase of medicines compensation system, indicate the number of packages, after which distribution for repeated drug distribution (import from third countries) need to get a new permit. This condition applies to this provision 94.1.1. the authorization referred to in (a);
94.8 2. medicinal products which comply with the use of the medicinal product list or that are prevalent in outpatient treatments the purchase of medicinal products in the framework of the system of compensation, does not indicate the number of packages and the authorisation is granted for a period of one year. This condition applies to this provision 94.1.1. the authorization referred to in (a);
3. the medicine of compassion 94.8 number of packages may not be specified in the light of this rule 94.3 3.3. Description of the programme referred to in the information on the expected number of patients, the duration of use of the product and the number of packages. This condition applies to 94.2. these provisions referred to in the authorization.
Before this rule 94.2 94.9. designation of the medicinal products referred to in (a) the patient is always an option to consider participation in clinical research. Medical person initiates treatment with medicinal product: 1. inform the 94.9 the particular patient or other person who has the right to accept the patient for treatment according to the Patient's rights law (hereinafter referred to as the notified person): 94.9 1.1. conditions, why a particular medicinal product is designated;
1.2. the designated medicinal 94.9 and gives their characteristics (for example, the expected benefits, risks);
1.3 94.9. patient monitoring;
2. receive written 94.9 patient informed consent of the person or for the use of the product according to the rules referred to in point 3.3.2 of 94.3 specimen.
94.10 person or of treatment the medical establishment that rule 94.3 3.2. use of the product referred to in the reasons prepared after reading permissions of the requester that rule 94.3 3.3 use of the product referred to in the program or treatment of treatment a person receives from the authority of these provisions persons referred to 94.5.
If the medicinal product has been granted 94.11 this rule 94.2. the authorization referred to in paragraph stating this rule 94.3 3.3 use of the medicinal product referred to in programming, this provision and paragraph 94.5 94.4 person provides: 94.11 1. European Parliament and Council Regulation No 726/2004, article 24, paragraph 1, and article 83 of the conditions referred to in paragraph 8;
2. This provision 94.11 94.12 conditions referred to in paragraph 1.
94.12 Compassion medicinal products distributed free of charge. "
51. paragraph 95 Express as follows: 95. "the Person issued the rules referred to in paragraph 94. unreported distribution licence: 95.1. before commencement of distribution of medicinal products, notify the State Agency of medicines of the medicines distributed series of numbers;
95.2. in unregistered medicines are authorised to distribute only pharmacies, medical institutions, social care institutions, practicing veterinarians and veterinārmedicīniskaj-care institutions in accordance with the authorisation (annex 6), the information specified. If permission is not granted for a medicinal product registered: 95.2.1. which suits to a list of the medicinal products specified in the authorisation, the medicine distributed in hospitals and the closed-end type, or medical treatment institutions and General or open pharmacies;
95.2.2. which are propagated outpatient treatments the purchase of medicinal products in the framework of the system of compensation, permission given in the medicine distributed in pharmacies;
95.2.3. use compassionate grounds, given in medicinal products laid down in the authorisation, circulated only to a patient or group of patients;

95.3. before the commencement of distribution of medicinal products, notify the public agency for medicinal products imported and distributed the quantities, if permission is granted, not registered with the use of the medicinal product list or that are prevalent in outpatient treatments the purchase of medicinal products in the framework of the system of compensation;
95.4. notify immediately any changes in the data and documents submitted for authorization;
95.5. compassionate medicine supplied free of charge to the patient;
95.6. for medicinal products provides that compassion rule 94.3 3.3 use of the product referred to in subparagraph in specific medical personal and the recipient's obligations. "
52. In expressing subparagraph following 98.1. "98.1. register given in Hall, as well as a drug that is analogous to the provisions of the permit referred to in paragraph 86 of the drugs;".
53. To replace the words "104.1 in health statistics and medical technologies State Agency" with the words "health inspection".
54. To replace the words "in subparagraph 106.2. send medicine" with the words "to export medicines for personal use or to send medicine by post".
55. To supplement the provisions under paragraph 112.1 by the following: "health inspection, 112.1 deciding on distribution of suspension or withdrawal from the market of the medicinal product, the decision shall specify a specific date by which the distribution or stopping medication withdrawn from the market."
56. Make such paragraph 116: "116. If there is suspicion of drug quality defects, this provision 11, 11.1 and 13 persons referred to in the statement of health inspection (if the notice has not been received from the owner of the registration, of a pharmaceutical manufacturer, importer or health medicines inspection). The health inspection information on poor quality products from the population, the medical institutions, social care institutions, practicing veterinarians, veterinary care of merchants, it can take a decision on the suspension of distribution of medicinal products. The notification shall specify: 116.1. name of the medicinal product, the strength or the strength and the pharmaceutical form;
116.2. drug company and the owner of the registration (if any);
116.3. If necessary, the serial number of the medicinal product;
116.4. the party from which the medicine purchased. "
57. Add to subparagraph with the sentence 119.1. the following wording: "the date on which the decision on the suspension of distribution of medicinal products and the withdrawal from the market of the medicinal product distribution and stopping drugs withdrawn from the market."
58. To complement the introductory paragraph 124 follows the words "medical establishment" with the words "a practicing veterinarian, veterinary care Merchant".
59. the introductory part of paragraph 125 to replace the words "National Agency for medicinal products" with the words "national agency of medicinal products and, if the medicinal product is intended for use in animals, the food and veterinary service".
60. To complement the 125.1. subparagraph after the word "people" with the words "and in the case of medicinal products intended for use in animals, the animals".
61. Add to 125.4. subparagraph after the word "people" with the words "and in the case of medicinal products intended for use in animals, the animals".
62. The deletion of the second sentence of paragraph 142.
63. the express section 145.1. the following wording: "145.1. monitor and verify common parallel distribution of medicinal products and their compliance with the European Union and of the marketing authorisation for a medicinal product in the amendments;".
64. Delete 146.5.3 in the names "or" recipes ".
65. Make the following introductory paragraph 148: "148. Health inspections puts health inspection website (http://www.vi.gov.lv) the following information on withdrawn products:".
66. Make 149. paragraph by the following: "149. Medicine government agency provides drug National Agency's website the following information: 149.1. marking and instructions for use approved parallel imported medicinal product. If the parallel imported medicinal product differs from the registered product, indicate the difference;
149.2. parallel importers and parallel imported medicinal product. The information is prepared according to the laws and regulations on drug registration procedures governing the State Agency of medicines of Latvia website register of medicinal products sensitive information about the parallel imported medicinal product;
149.3. parallel distributors and parallel distributed medicines in Latvia according to the European Medicines Agency website published information;
149.4. remaining authorization for disposal of stocks of medicinal products;
149.5 lieltirgotav and pharmaceutical drug company Web site address;
application model of 149.6. Latvian language in this provision the communication referred to in paragraph 63 of the centrally established parallel distribution of medicinal products;
149.7. unregistered medicinal products for which issued these regulations referred to in paragraph 86 of the unregistered medicines distribution permit specifying: 149.7.1. name of the medicinal product, the strength or the strength and the pharmaceutical form;
149.7.2. active ingredients international name;
149.7.3. the permit holder (marketing authorisation, the marketing authorisation holder or the applicant) name, address and country of the European economic area is a name that has granted the marketing authorisation or in which the application for marketing authorization;
149.7.4. name of the manufacturer of the medicinal product and the name of the country of manufacture;
149.7.5. the "anatomic therapeutic chemical classification and defined daily code;
149.7.6. drug identification number that you assign to the State Agency of medicines;
149.7.7. classification groups label prescription drugs. Non-prescription medicinal products, the legend does not specify;
drug wholesaler 149.8. (name, license number, address), which distributes medicines not registered for which this rule 86 issued the authorization referred to in paragraph. "
67. To complement the introductory paragraph 155 behind the words "medical establishment" with the words "a practicing veterinarian, veterinary care Merchant".
68. To supplement the provisions of the following paragraph 162.1:162.1 "Parallel importers, which have received the permission of parallel distribution of medicinal products imported in the Republic of Latvia and distributed parallel imported medicinal product in Latvia until the 2010 October 1 the State Agency of medicines shall be submitted in proof of the fact that the registration holder (the holder of the marketing authorisation) and trademarks (brand) the owner is given notice of the intention to launch a specific permission specified in the parallel distribution of medicinal products imported in the Republic of Latvia. The statement included this provision in annex 1. the information referred to in paragraph 25.
69. Delete paragraph 169.

70. To supplement the provisions of the following paragraph to 171.2 and 171.3: "171.2 Parallel distributors who distribute parallel distributed products in the Republic of Latvia, on which the State Agency of medicines has not submitted evidence that parallel the Distributor about their intention to launch a parallel of the distributable distribution of medicinal products in the Republic of Latvia has declared the registration holder (the holder of the marketing authorisation) and trademarks (brand) to the owner until the 2010 October 1 the State Agency of medicines shall submit the said certified statement of , which contains the specific recipient who is notified, and the date of delivery of the notice.
12.10. These provisions section 171.3 shall enter into force on January 1, 2011. "
71. Replace annex 1 of part IV of the title, the word "imported" by the word "imported".
72. To supplement annex 1 to 25 the following: 73. Supplement to annex 1, paragraph 3 of the note with the following: "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. "
74. To supplement the notes to annex 2 to paragraph 3 by the following: "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. "
75. the supplement to annex 3 notes in paragraphs 3 and 4 by the following: "3. where the authorization specifies the remaining inventory of the distribution of medicinal products, you must also specify the period the medicine serial number, expiration date and the number of packages.
4. Document Properties "date" and "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design. "
76. Make annex 4 by the following: "4. in the annex to Cabinet of Ministers of 26 June 2007, the provisions of the Republic of Latvia no 416 medicine State Agency (address, registration number, telephone and fax numbers) in the Riga Nr.
 
(date)
 
 
European economic area country, but not registered in the Republic of Latvia-permit distribution on the basis of the State Agency of medicines _ _ _ _ _ _ _ _ _ _ no _ _ _ _ _ _ on the issue of the European economic area country, but not registered in the Republic of Latvia, public health, the Republic of Latvia authorized to distribute the following medicinal product: the name of the medicinal product, shape, strength or concentration and number of active packaging (active) ingredients (ingredient) name of the marketing authorisation holder (name , address, country) in the Member States of the European Union or the European economic area country, which has granted a marketing authorization (certificate of registration) of medicinal products manufacturer, national ATC code identification number distribution condition 1 2 3 4 5 6 7 8 permission is valid for five years after the adoption of the decision.
Permit is valid until (date) National Medicines Agency Director (signature) Z.v.
The notes.
1. table 3. box the owner of the registration certificate or registration of the applicant according to the regulations on the registration of the medicinal product.
2. table 6. box the anatomic therapeutic chemical classification code.
3. table 7. box the State Agency of medicines of the medicines assigned identification number.
4. table 8. box the group classification of medicinal products granted in accordance with the laws and regulations on the classification of the medicinal product, and its legend. Non-prescription medicinal products, the designation does not specify.
5. If a table column or row is not filled in, pull the bar.
6. sign, date, and contact information is on the page of each permission.
7. Document Properties "date" and "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design. "
77. Supplementing of annex 5, paragraph 4 of the note with the following: "4." document properties "date" and "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design. "
78. Annex 6 to express the following: "6. the annex to Cabinet of Ministers of 26 June 2007 the Regulation No 416 After permission specified in the packaging of the medicinal products in the distribution of the number of repeated drug distribution (import) repeating the import of medicines need not register the distribution of medicines.
The notes.
1. If a table column or row is not filled in, pull the bar.
2. sign, date, and contact information is on the page of each permission.
3. Tables 4. box the person permit holder is entitled to distribute drugs specified in the permit (not applicable to the notes (4) and (5) of that permission), including: 3.1 "the drugstore", and indicate its name and license number;
3.2. the "medical establishment" and indicate its name and registration number of treatment institutions register;
3.3. the "social body", and the name of the State revenue service taxpayer ID number State revenue service taxpayer register;
3.4. "practicing veterinarian" and indicate its name, address and registration number of the food and veterinary service of the company in the register;
3.5. the "veterinary care operator", and indicate its name and registration number of the food and veterinary service of the company subject to the registry.
4. Allow unregistered medicinal products which meet the applicable list of medicinal products or that are prevalent in outpatient treatments the purchase of medicinal products in the framework of the system of compensation (not subject to the authorisation referred to in paragraph 3): table 4.1-3. do not fill in the box;
4.2. table 4 include the in box: 4.2.1. "medicinal product meets the hospitals use drug list";
4.2.2. "drugs are common outpatient treatments the purchase of medicinal products in the framework of the system of compensation". You do not have to specify a particular Pharmacy and hospital's name.
5. Compassion in medicine: 5.1. table 4 column "medications be distributed" shall include: 5.1.1 "halls available for use on compassionate grounds" of the European Parliament and of the Council of 31 March 2004, Regulation (EC) No 726/2004 laying down the procedures for the authorisation and supervision of medicinal products for human and veterinary use Community procedures and establishing a European Medicines Agency, article 83;
5.1.2. specific known patient's name or "patient group";
5.1.3. the treatment, in which the medicinal product means the patient;

5.2. table 5 indicates in box: 5.2.1 medicine manufacturer's name, address, contact person (first name and last name, title, phone, fax, e-mail address (if any));
5.2.2. the name of the country;
5.2.3. the applicant's name, address and contact person (first name and last name, title, phone, fax, e-mail address (if any));
5.3. the attachment adds: 5.3.1. this rule 94.3 3.3 use of the product referred to in point (except drug labelling and instructions for use for the project);
5.3.2. the medicine label and instructions for use of the national language;
5.3.3. European Medicines Agency's Committee for medicinal products for an opinion on the use of the medicinal product and the conditions for distribution and the patients targeted (if any).
6. the introductory part of the name of the legal person and number of the registration of the medicinal product for a manufacturer of medicinal products lieltirgotav and specifies special permissions (licenses) number. Where the medicinal product is issued on compassionate medical treatment institution, indicate the registration number of the hospital's medical authorities of the registry.
7. table 1. box the State Agency of medicines of the assigned drug identification number.
8. the permit shall contain the indication "permit valid until", if the permit is issued for: 8.1. medicinal products which comply with the use of the medicinal product in the list;
8.2. for medicinal products, which are distributed in the outpatient treatments the purchase of medicinal products in the framework of the system of compensation;
8.3. compassionate medicine. The expiration date indicates, in the light of this rule 94.3 3.3. program referred to in subparagraph includes information on the estimated number of patients, the volume and duration of the use of the product.
9. The permit shall include reference to "specified in the authorization number of the packaging of medicinal products in the distribution reinvestment distribution (import) need not register the distribution licence", contains a number of packages.
10. Document Properties "date" and "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design. "
79. Annex 7 shall be expressed as follows: "Annex 7 Cabinet 26 June 2007 the Regulation No 416 individual grant application will not register the distribution authorization please state agency of medicines shall issue the authorisation granted to an unregistered individual distribution of medicinal products in the Republic of Latvia concerning the medicinal products listed in part I.
(I) the particulars of the applicant and the applicant for Authorisation 1 1.1 name ____ ____ ____ ____ ____ ____ ________. License No. _____ _____ _____ _____ 1.2. phone number _____ _____ _____ _____ fax number ____ ____ ____ ____ ____ ____ ____ 1.3. e-mail address _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ ___ 1.4. address ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ 2. Medicinal product 2.1. name ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ 2.2. pharmaceutical form ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ 2.3. active substance and strength or concentration ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ 2.4. packaging size and number of packages (not applicable if not registered medicinal products meet the applicable list of medicines or drugs are common outpatient treatments the purchase of medicinal products in the framework of the system of compensation) ____ ____ ____ ____ ____ ____ _____ 2.5 medicine outpatient treatments are distributed for medicinal products the purchase of the compensation framework (mark with x required): Yes No 2.6. meet the hospitals use drug list (required mark with x): Yes No 2.7. meet the compassionate medicine in accordance with European Parliament and Council Regulation No 726/2004, article 6 (mark with x required): Yes No 2.7.1. pharmacovigilance program is designed (mark with x required): Yes No 2.7.2. medicines used in compassion or used in the European Union (required mark with x) : Yes No if the answer is "Yes", indicate the country ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ___ 2.7.3. person responsible for recording and reporting of adverse reactions, as laid down in European Parliament and Council Regulation No 726/2004, article 24, paragraph 1 (first name, last name, contact address, phone, fax, e-mail address) ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ___ 2.7.4. or by using medicines, have found compassion side effects mentioned in European Parliament and Council Regulation No 726/2004, article 24, paragraph 1 (the desired mark with x) : Yes No if the answer is "Yes", indicate the country _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 3. Drug manufacturer: 3.1 name ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ 3.2. legal address and place of business address _____ _____ _____ _____ _____ _____ _____ _____ 3.3. phone number ____ ____ ____ ____ ___ fax _____ _____ _____ _____ _____ _____ 4. Person to contact in connection with the application (first name and last name, title, phone, fax, e-mail address (if any)) _____ _____ _____ _____ _____ _____ _____ _____ _____ part II annexed documents necessary to mark with an x, and specify the number of pages attached 1. labelling of the medicinal product in the case of medicinal products intended to deliver to the medical institution, social care institutions, practicing veterinarian and veterinary care for the economic operators.
Note the. Box 15 need not be completed if the medicinal product is intended for a specific patient and if some medicines that use compassionate grounds, located in clinical research 2. Instructions for use of the products in their country of origin and its translation into Latvian language, if the medicinal product for delivery to the hospital, the social care institution, a practicing veterinarian and veterinary care for the economic operators.
Note the. Box 15 need not be completed if the medicinal product is intended for a specific patient and if some medicines that use compassionate grounds, located in clinical trials 3. Drugstore, medical institutions, social care institutions, practicing veterinarians and veterinary care to the merchant.
Note the. Box need not be completed for the list of medicinal products used in medicinal products and which are common outpatient treatments the purchase of medicinal products in the framework of the system of compensation, as well as the compassionate medicine 4. compassionate medicine:


4.1. the hospital's reasoned justification for the use of the medicinal product in particular to a certain patient group and use compliance to European Parliament and Council Regulation No 726/2004, article 83, paragraph 2, for a specific chronic or debilitating disease or hard disease, considered life-threatening and can not be treated satisfactorily with Latvia in the European Union or the medicinal 4.2. proof of applicant: 4.2.1 on the discharge of the registration application submitted pursuant to European Parliament and Council Regulation No 726/2004, article 6 4.2.2. that drugs are in clinical trials 4.3. pharmacovigilance program 4.4 description of drug product labelling and instructions for use of the national language project 4.5. European Medicines Agency submitted the registration application and its accompanying data and document copy 4.6. European Medicines Agency Committee for medicinal products or other Member State of the European Union opinion of the competent authority (scientific advice) 5. proof of drug control related to the payment of expenditure, I, (name, officers, the applicant or his authorized representative) certify that the information given is true. 
Executive (the applicant's authorized representative): first name, last name, position in ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ___ signature _____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ____ ___ (place, date) (signature) date of receipt of the application, the State Agency of medicines of the _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ notes.
1. in point 1.1 of part I the license number does not indicate if permission requests compassionate medicine. In this case in point 1.1 of part I specifies the hospital's registration number in the register of medical institutions.
2. If a column or row is not filled in, pull the bar.
3. If the form is sent without the use of electronic media, the applicant shall sign each page of the attached form.
4. If the application is presented on several pages, the officer signed each page.
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. "
80. To supplement annex 10 behind "date" with a note as follows: "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. "
81. Make 11. point 1 of the annex by the following: "1. the information provider: the appropriate mark with an x to indicate the document number, registration 1 owner registration certificate number 2. Medicine manufacturer special permission (license) number 3. Drug wholesaler special permission (license) number 4. importer of medicinal products special permission (license) number 5. General types of Pharmacy-distributed medicine just retail special permission (license) number 6. General types of Pharmacy-distributed medicine retail and wholesale special permission (license) number 7. Closed type special permissions pharmacies (license) number
  
8. The medical establishment registration number in the register of medical institutions 9. Doctor practices (practitioner Association and koppraks) registration number in the register of medical institutions 10. Social care institution of the State revenue service taxpayer ID number for the State revenue service taxpayer register 11. Practicing veterinarian registration number food and veterinary service of the company in the register 12. Veterinary care merchant registration number food and veterinary service of the company in the register "82. To supplement the annex to note 3 in this version : 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."
83. To supplement the notes to annex 12 with point 7 by the following: "7." document properties "date" and "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design. "
84. To supplement annex 13 with the note as follows: "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. "
The Prime Minister's site-traffic Minister k. Gerhard Health Minister d. Gabor