Cabinet of Ministers Regulations No. 419, 2004 in Riga on April 22 (Mon. No 24 56) amendments to the Cabinet of Ministers on 27 February 2001, Regulation No 88 of "medicine import, export and distribution rules" Issued in accordance with article 5 of the law on Pharmacy (1) and (3) and article 19 to make a Cabinet of 27 February 2001, Regulation No 88 of "medicine import, export and distribution rules" (Latvian journal, 2001, 35, 52 no; 2003, 114 no) the following amendments: 1. Express provisions name following : "the medicine import, export and distribution rules and drug lieltirgotav open and operational requirements".
2. Make a point 2 as follows: "2. not allowed to distribute a product that is not registered and is not included in the Republic of Latvia registered in the list of medicinal products (hereinafter referred to as the Latvian register of medicinal products), except for the distribution of medicinal products in accordance with article 10 of the pharmaceutical law, paragraph 7, and article 20, as well as the provisions laid down in point 8 of the distribution of medicinal products, if: 2.1. non-profit organisation State joint stock company" national medicines agency "(hereinafter referred to as the national medicines agency) considered drugs under the pharmacy Act, article 1, paragraph 17 the definition laid down in based on the composition of the product, or on the product form, expressed in statements in the labelling, in the instructions for use, advertisement or other information;
2.2. product labelling, in the instructions for use, advertisement or other information in the attribute medicinal or therapeutic properties as well as properties associated with the diagnosis of disease or the modification of physiological function restoration, repair, or alteration. "
3. Replace, in paragraph 3, the words ' the medicine of lieltirgotav responsible pharmacist, his Deputy "with the words" pharmaceutical law referred to in article 46.1 officer ".
4. Express 3.3 subparagraph by the following: "3.3. wholesale distribution of medicinal products (including transport), the pharmaceutical law referred to in article 22 of the European Commission of good distribution practice and guidelines;".
5. Add to subparagraph of 3.4, after the word "requirements" with the words "as well as ensure that the vehicles and premises, in which medicine can maintain a certain temperature regime".
6. Make 3.6. the first sentence of the subparagraph as follows: "information related to the procurement and supply of medicines (drug name, serial number, quantity, country of manufacture, the supplier of the medicinal product (sender) or the buyer's name, registered office, business address, and the date of release), stored for not less than five years, but documents relating to narcotic and psychotropic drugs — 10 years, this provision and paragraph 15.21.1 and 107.2 points in the document on the transport and storage conditions store in no less than five years."
7. Express 3.7. subparagraph by the following: "3.7. pharmaceutical company allowed to distribute medications, if each product distributed series is a production company issued a quality certificate. Lieltirgotav of medicinal products medicinal products authorised for imports from countries which are not members of the European Union or the European Free Trade Association countries (EFTA) countries which have signed the agreement on the European economic area if for every sequence of medicines distributed drug lieltirgotav has been issued by the manufacturer attesting the quality certificate (does not apply to the distribution of medicinal products in accordance with article 10 of the law on Pharmacy 7); ".
8. To supplement the provisions under point 3.1, the following wording: "3.1 after receipt of the registration certificate, the holder of the registration certificate (owner) (hereinafter referred to as the owner of the registration) provides the following requirements: 3.1 1. written notice to the national medicines agency and the food and veterinary service of the Sanitary border inspection (hereinafter sanitary border inspection) on the commencement of distribution of medicinal products for the first time in the territory of Latvia (also applies to a particular medicine packaging size distribution started for the first time in the territory of Latvia). The notification shall specify the name of the medicinal product, the pharmaceutical form, quantified the content of active substances in one dosage, volume or mass unit (strength) and the registration number of the Latvian register of medicinal products;
3.1 2. writing the national medicines agency, national pharmaceutical inspection, the Sanitary border inspection, general type hospital pharmacies and medical institutions of the type that the holder of the registration (drug company) stopped the medicine, or specific product packaging size distribution on the territory of Latvia temporarily or permanently. The notification shall specify the name of the medicinal product, pharmaceutical form, strength of the medicinal products, the manufacturer of the medicinal product, the registration number of the Latvian register of medicinal products, the delivery of the reason and the time of delivery;
3.1 3. written notice to the national medicines agency and national pharmaceutical inspectorate for medicinal products registered in Latvia, which is banned or suspended, which have been withdrawn or removed from the market, as well as the registration of medicinal products in other countries has been suspended and withdrawn medicine safety, effectiveness or quality (also refers to a series of specific medicinal products and packaging size). The notification shall specify the name of the medicinal product, pharmaceutical form, strength of the medicinal product, the registration number of the Latvian register of medicinal products, the reasons, the State and the serial numbers, if it relates to a particular series;
3.1 4. ensures the removal of (withdrawal) from the market, if the registration is suspended or withdrawn, the grass is not re-registered or renewal is refused and the national medicines agency issued permission to release the remaining stocks of medicines for sale under that rule 59.3 points;
3.1 5. inform pharmacies, hospital type medical institutions (hospitals) and social care institutions for urgent security measures, as well as the national medicines agency approved changes to the registration documentation, which determines a measure on the registration procedure. If that applies to medicinal products with specific production series, indicate the serial number of the product. "
9. Make paragraph 5 by the following: "5. the Pharmacies that imported medicines, herbal and lieltirgotav pharmaceutical company in accordance with the request of the State Agency of medicines shall be submitted to the national medicines agency information on medicinal products (also) the import, export and sales of the previous calendar year or other period of time."
10. To supplement the provisions under point 5.1 by the following: "5.1 pharmacies and medical institutions in accordance with the request of the State Agency of medicines shall be submitted to the national medicines agency for drug sales in the preceding calendar year or other period of time."
11. Expressing points 7 and 8 of the following: "7. The parallel distribution of medicinal products is centralized registration procedure for medicinal products authorised in the distribution (movements) from one Member State of the European Union or European Free Trade Association (EFTA), which signed the agreement on the European economic area (hereinafter referred to as Member States), to another Member State if such products are imported by wholesalers of medicinal products, which is not the producer of these products, the owner of the registration or his authorized representative (the parallel Distributor). Parallel distribution of medicinal products is allowed even if the registration owner is initiated the distribution of medicinal products in Latvia. If parallel distribution of medicinal products in another Member State has changed the packaging of the medicinal product in the Member State indicated on the language (for example, a label with the label information specified in the Member State in which the medicinal products distributed) or, in exceptional cases, the size of the package, if it is included in the European Community the marketing authorisation of the medicinal product, the parallel distributor in writing notify the pharmaceutical trade mark owner for repacked (pārmarķēt) product distribution. Parallel distributor for parallel distribution of medicinal products distributed to provide written notification to the European Agency for the evaluation of medicinal products.
8. Parallel imports: 8.1 is the national registration procedure (also the mutual recognition procedure), the importation of medicinal products authorised in one Member State from another Member State if such products are imported by wholesalers of medicinal products, which is not the producer of these products, the owner of the registration or his authorized representative (hereinafter referred to as a parallel importer). This does not apply to the centralised registration of medicinal products established in the procedure established by Council Regulation No 2309/93;
8.2. it is acceptable, even if the owner withdraws the registration in Latvia registered registration, for economic reasons, and the reasons are not related to the safety, effectiveness and quality. "
12. To supplement the provisions under point 8.1 as follows: "the parallel imported medicinal products 8.1 is released for free circulation in the exporting country, and they may differ from the corresponding medicinal products registered in Latvia, in relation to which the parallel imports have been made, when the difference does not affect their therapeutic use (meaning) and they meet the requirements laid down in these provisions. On the parallel imported medicinal products not subject to the rules laid down by the regulations on the procedure for registration of medicinal products. "
13. Express 9 and paragraph 10 by the following: "9. the medicinal products imported into and distributed in Latvia, subject to the following requirements:

9.1. the importation of medicines from countries which are not members of the European Union or the European Free Trade Association countries (EFTA) countries which have signed the agreement on the European economic area (hereinafter third countries) is permitted if the national medicines agency issued a permit for the import of medicinal products in the territory of Latvia from third countries;
9.2. This provision in paragraph 8 that parallel imported pharmaceutical distribution started after the arrival of these medicinal products in the territory of Latvia is allowed if the parallel imported medicinal product has been granted the national medicines agency permit parallel distribution of medicinal products imported into the territory of Latvia;
9.3. the drug importation of humanitarian aid is allowed if the consignment of humanitarian aid and of import licences provided for in other laws and regulations for receiving humanitarian assistance requirements;
9.4. the person who imported this provision 7 referred to parallel distributed medicines and their distribution, before launching this start-up of distribution of medicinal products in the territory of Latvia shall submit the statement to the European Agency for the evaluation of medicinal products, as well as the national medicines agency and national pharmaceutical inspection;
9.5. the production of medicinal products, which are exported to another country are not allowed to be imported in the Republic of Latvia, if that is not the importer of the medicinal drug, the manufacturer or his authorised representative, except when the medicine lieltirgotav from Latvia exported product is not implemented and re-imported into the territory of Latvia.
10. The medicinal product may be imported in the territory of Latvia (move across national boundaries): 10.1 from third countries: 10.1.1. licensed medicine that lieltirgotav has received this rule 9.1. authorization referred to and given special permission (license) to open the medicinal lieltirgotav (operation) is specified in the special conditions, the importation of medicinal products coming from third countries and which responsible executive complies with this provision in paragraph 25 above requirements;
10.1.2. Latvia licensed pharmaceutical company (applies to produce medicines, dosage forms, and raw materials for the manufacture of medicinal products, including, if the medicinal product is produced or controlled in another State, on the basis of a written agreement);
10.1.3. the beneficiaries of humanitarian aid goods, which received the national medicines agency humanitarian shipment licence and comply with other laws and regulations for receiving humanitarian assistance requirements;
10.1.4. a licensed drug lieltirgotav or regulations for clinical trials of the medicinal product prescribed by the sponsor or his authorized representative, clinically researched for medicinal products for human use (preparation study), where it received the national medicines agency authorization in accordance with the provisions of chapter V;
10.1.5. This provision, paragraph 14;
10.1.6. registration the holder (or his representative) who submitted the national medicines agency medicine registration application or samples of medicinal products registration, renewal or change registration documentation for approval and for the import of medicines and the quantity of the samples received the national medicines agency import licence in accordance with the provisions of chapter V;
10.2. from: 10.2.1. licensed drug lieltirgotav and this rule 10.1.2. and 10.1.5. person referred;
10.2.2. an undertaking established in a Member State to which the host country has been granted a special permit (license) for the wholesale of medicines or pharmaceutical production (in accordance with article 31 of the law of pharmacy);
10.2.3. licensed pharmacies;
10.2.4. registration the owner or his authorised representative: samples of medicinal products registration, renewal or change registration documentation for approval;
10.2.5. humanitarian cargo recipient that received the national medicines agency humanitarian shipment licence and comply with other laws and regulations for receiving humanitarian assistance requirements;
10.2.6. licensed drug lieltirgotav or regulations for clinical trials of the medicinal product prescribed by the sponsor or his authorized representative, clinically researched for medicinal products for human use (preparation study), where it received the national medicines agency licence in accordance with chapter V of these regulations. "
14. To supplement the rules with 10.1, 10.2, 10.3 and 10.4 points as follows: "10.1 without taking into account the provisions of paragraph 10:10.1 1. licensed drug lieltirgotav, licensed pharmacy and pharmaceutical law 25.1 article referred to in the first subparagraph of the company registered in a Member State to which the host country issued a special permit (license) for the wholesale of medicines or for the production of medicinal products may be imported into the territory of Latvia not registered medicinal products according to the pharmaceutical law article 10 paragraph 7. If you have received the national medicines agency permission for the importation of medicines not registered in Latvia, but the pharmaceutical law article 10 paragraph 7 "c" case in point — other persons in accordance with the order of the Ministry of health. A person who has received the consent of the Ministry of health, may leave Latvia and return unused medicines for medical care in disasters, natural disasters, epidemics or other cases;
10.1 2. National armed forces and foreign armed forces in their needs for (if there is a reconciliation with defence ministers) may leave the Hall of Latvian territory and return unused medicines;
10.1 3. National Medicines Agency is entitled to import medicinal products (medicinal products, starting materials standard), intended for testing. Other people in drug imports from third countries allowed their activity (drug testing laboratories for testing, research and training needs), if you have received a national medicines agency issued a permit.
10.2 the narcotic drugs and psychotropic drugs may be imported into the territory of Latvia or removal from the territory of Latvia, if you have received a national medicines agency permit this drug for single importation or exportation under the laws and regulations on the import and export authorizations for drugs and psychotropic substances and medicines.
10.3 drugs may leave the licensed company whose licence to practise medicine or pharmaceutical wholesale retail trade, as well as the rules referred to in paragraph 10.2.2. company.
10.4 the medicinal product may be imported from third countries through the customs points that support sanitary border inspection controls. "
15. Replace the words in paragraph 11.2. "two thirds" with the word "half".
16. Add to paragraph 14 behind the number "10." with numbers and the word "10.1 and 10.3".
17. Make 17 the following: "17. persons entering and leaving the Hall, draws up the relevant customs procedure, customs authorities and the Sanitary border inspection to produce import licences for medicinal products, if any, are required in accordance with these rules, and the corresponding special permit (licence) pursuant to this provision, 10.1, 10.2 and 10 10.3 point."
18. Make 19.2 point as follows: "19.2 quality certificate for each distributed series if the medicinal product from third countries are introduced into the drug lieltirgotav in accordance with this subparagraph 10.1.1. rules."
19. Make 20 as follows: "20. Natural persons crossing the State border, may be imported or exported for personal use of the medicinal product for the treatment, no more than three months. The fact that the person concerned proves, by presenting the recipe, recipes or copy of a copy, or other documents proving this fact (regarding prescription drugs). "
20. Make the following paragraph 21: ' 21. Mailings: 21.1. medications may send and receive, if complied with this provision 10, 10.1, 10.2, 10.3 and 10.4 to the requirements laid down in points. The person who receives or sends a shipment of medicines, this provision presented 17. documents listed. Drug shipments shall be accompanied by documents in accordance with paragraph 19 of these rules. The person who sent the drug, submit the mail service provider instructions indicating the specific medicine storage and transport requirements in accordance with chapter IX of these regulations. The postal service will ensure that the instructions in compliance with the requirements. Receive mailings from the Member State is also entitled to the medical establishment (including physician practices) their actions. If the product gets treatment, the person who receives the presentation Hall: 21.1.1. medical practice registration certificate about registration of the Latvian Physicians Association of doctors practice in the registry (if the consignee is a pharmaceutical physician practice);
21.1.2. certificate of registration of the hospital's medical practices of institutions, companies and register issued by the non-profit organisation State joint stock company "health statistics and medical technology agency" (if the drug the consignee is the medical establishment);

21.2. the natural persons at their request is allowed only in the Republic of Latvia registered the OTC medications (for which the registration is in force) from the drugstore, located in a Member State if they are intended only for personal use and if the pharmacy is provided by the customer to the time of day to contact the Pharmacy and get from the free information and advice on such products according to the regulations for pharmaceutical care (also applies to domestic mailings). Medicinal products from third countries receiving mail is not allowed. "
21. Express 23.2. subparagraph as follows: "ensure national pharmaceutical 23.2. inspection and sanitary border inspection officials free access to medicines the storage space in the customs control zone to the country (Customs) border, customs warehouses and free zones in customs;".
22. Express 24 as follows: "sanitary border inspection 24:24.1. controls, or imports from third countries comply with this provision 10, 10.1, 10.2, 10.3, 10.4, 12, 14, 17, 18, 19, 20 and 21 and the requirements of the Council of 8 February 1993 on the application of Regulation (EEC) No 339/93 on checks of products regarding compliance with the rules on product safety, if they are imported from a third country (hereinafter referred to as the Council Regulation No 339/93) the control of medicines, as well as transportation and storage conditions of compliance (including customs control area to the country (Customs) border, customs warehouses and free zones in customs) the requirements of this regulation. Inform the national pharmaceutical inspection, if a medicine storage and transportation rules of the customs control zone in the country (Customs) border, customs warehouses and free customs zones;
24.2. provide national pharmaceutical inspection information about irregularities detected, in accordance with the requirements of this regulation. "
23. Chapter III be expressed by the following: "(iii) imported from a third country drug control 25. If the product (including clinically researched for medicinal products for human use (preparation study)) imported from third countries, importers of medicinal products shall ensure that they have permanently and continuously at his disposal at least one qualified person (does not apply to this rule 10.1.2 10.1.3, 10.1.4, 10.1.5. and 10.1 and above), which is responsible for this provision set out in paragraph 26 of the performance of the duties and qualifications and experience meet the regulations for the production and control of medicinal products prescribed officers qualifications and experience requirements. If the importer of medicines complies with the laws and regulations on the production and control of medicinal products prescribed officers qualifications and experience requirements, he allowed himself to take paragraph 26 of these rules for the performance of the duties laid down in.
26. the commencement of distribution of medicinal products for wholesale from third countries is permitted, provided that the provisions referred to in paragraph 25 of the qualified person before the commencement of distribution of medicinal products (output) Latvia (this also applies to investigational medicinal products for human use) under the Pharmacy Act referred to in article 51.1 of the European Commission recommendations (manual) on good manufacturing practice principles and guidelines listed on the confirmation provided by the qualified person and serial output, the European Commission has published a European Community regulatory framework for medicinal products volume 4. have been approved for each of the distributed production conformity of production series that: 26.1. any medicinal product series is manufactured and tested in accordance with the laws and regulations on the production and inspection requirements and comply with the law of article 51.1 of the Pharmacy;
26.2. each distributed the medicine series is made a full qualitative analysis and quantitative analysis of active substances as well as a check on the label and instructions for use compliance with legislation requirements to ensure the quality of medicinal products in accordance with the registration dossier requirements. Drug testing is allowed in any drug testing laboratory (shall not apply to this rule 65), which is accredited for the testing of medicinal products in the national agency "Latvian National Accreditation Bureau" and that the Ministry of Economic Affairs has published a newspaper "journal", or the national medicines agency drug testing laboratory in the Ministry of economy has issued a communication to the European Commission. Expenses associated with these inspections shall be borne by the medicine lieltirgotav. Investigational medicinal products for human use (comparable preparation) that have been registered but can not get the document of compliance with good manufacturing practice, each of the series and that it was carried out according to the conditions needed for a clinical trial authorisation;
26.3. the series of medicinal products which have been tested in a Member State, this rule 26.2. tests prescribed in paragraph does not need to be conducted if the medicinal product is imported from another Member State, together with a series of signed by the qualified person certificates of output (control message);
26.4. log or other document intended for that purpose make the exact record that confirms the compliance of all medicinal products series. Log or document complements and keep the company not less than five years from the date of the last entry;
26.5. the medicinal products distributed series does not apply this rule 26.2. If the conditions of paragraph between the European Community and the exporting country has concluded mutual recognition of conformity assessment of the agreement on good manufacturing practice of medicinal products and the exporting country has made this rule 26.2. control referred to.
27. the sanitary border inspection, on the basis of the legislation drawn up by officials, is entitled to act and stop the medicine (the series) for further distribution when: 27.1. it establishes that the documents do not comply with paragraph 19 of these rules the requirements and/or drug labelling does not comply with the legislation on the labelling of medicinal products (not subject to the requirements of language use and registration number);
27.2. the medicinal products concerned being imported medicine import licence (or licences issued is void), not where consent or special permission (license) according to the requirements of these regulations;
27.3. it is a violation for the storage and transportation regulations;
27.4. the product is expired (in this case, decide on the destruction of all or part of the cargo).
28. Sanitary border inspection this provision in paragraph 27 of that medicinal product placed in a customs warehouse, which has this rule 126.5. referred to public opinion of the pharmaceutical inspection conditions support for drug storage in a customs warehouse if the medicine storage conditions comply with the specifications of the medicinal product or when the product is implying, licensed drug lieltirgotav in a separate room or in a separated area marked "not allowed to be placed in free circulation ', if adopted this rule 27.1. 27.2. and 27.3., referred to in the decision. Sanitary border inspection on the written notice of the decision taken by the national pharmaceutical inspection on the date of adoption of the decision.
29. If the sanitary border inspection takes this rule 27.4. the decision referred to in the decision, it shall notify the State in writing the pharmaceutical inspection on the day of adoption of the decision. If the boundaries of the State found that the drug shipment is damaged, sanitary border inspection by harmonization with national pharmaceutical inspection, the goods sent for disposal. Expenses associated with the shipment and arrival to destroy destruction shall be borne by the holder.
30. If a State pharmaceutical inspectorate believes that the drug, which has been adopted that rule 27.1, 27.2 and 27.3.. in that decision, presents a serious and immediate risk to health and safety or don't comply with the regulations laid down in the product safety requirements, the national pharmaceutical inspection shall take a decision on the distribution of the medicinal product concerned (release turnover) the prohibition or suspension of the distribution to final clarification of circumstances within three working days after When the sanitary border inspection has adopted this provision the decision referred to in paragraph 27. National pharmaceutical inspection within that period, declare the decision taken for the Sanitary border inspection. If the national pharmaceutical inspection decision on medicines for the Sanitary border inspection is not announced, it is considered that national pharmaceutical inspection acknowledges that the product does not pose a serious and immediate risk to health and safety and comply with the regulations laid down in the product safety requirements. In this case, the release of the medicinal product concerned is authorised, of the turnover and, on this basis, the sanitary border inspection by the next working day shall be repealed this provision of the decision referred to in paragraph 27. State Pharmacy Inspectorate shall notify the State Agency of medicines of the decision taken on the day of its adoption.
31. where national pharmaceutical inspection check reveals that the drug for which sanitary border inspection has adopted this provision the decision referred to in paragraph 27:

31.1. comply with Council Regulation No 339/93 article 6 part 1 requirements, but the State Pharmacy Inspectorate has taken a decision on the prohibition of distribution of medicinal products in accordance with the provisions of paragraph 30, national pharmaceutical inspection shall notify the decision to the Sanitary border inspection on the day of its adoption. Sanitary border inspection of the decision shall be notified to the Customs officers concerned. Customs officers accompanying the medicinal products in question ' Dangerous product-release for free circulation is not allowed ". State Pharmacy Inspectorate shall notify the State Agency of medicines of the decision taken on the day of its adoption.
31.2. comply with Council Regulation No 339/93 article 6 in part 2 of the requirements, but the national pharmaceutical inspection has decided to suspend further distribution of medicines to final clarification of the circumstances in accordance with the provisions of paragraph 30, national pharmaceutical inspection shall notify the decision to the Sanitary border inspection on the day of its adoption. Sanitary border inspection of the decision shall be communicated to the appropriate customs employee responsible. Customs employee responsible for the medicinal product concerned on the accompanying documents indicates "non-conforming product-release for free circulation is not allowed". After a fact-finding national pharmaceutical inspection shall take a decision on the withdrawal of the suspension of distribution of medicinal products, or the prohibition of distribution of medicinal products and of the decision concerning the Sanitary border inspection to be notified of the date of adoption of the decision. If the national pharmaceutical inspection is decided on the suspension of the withdrawal, distribution sanitary border inspection of that decision shall be repealed on the date of receipt of the documents accompanying the medicines ' inappropriate product – release for free circulation is not allowed ". State Pharmacy Inspectorate shall notify the State Agency of medicines of the decision taken on the day of its adoption.
32. the sanitary border inspection no later than three working days after this rule 27.1 27.2 in and and 30 and 31, paragraph in the decision shall inform the person in writing, covered by that decision.
33. Expenditure relating to specific drug shipments by destruction or return shall be borne by the person subject to the provisions of section 27.1. and 27.2. and in paragraph 30 and 31 of that decision. Council Regulation No 339/93 article 6 part 4 the requirements for the implementation of the sanitary border inspection shall inform the national pharmaceutical inspection, which shall notify the Sanitary border inspection of the decision within three working days after the receipt of the information. "
24. Make 34 as follows: "34. for or re-registered this rule 9.2. authorization referred to in the permit the applicant or authorization holder (owner) be submitted to the national medicines agency submissions (two copies) Latvian language according to the form set out in annex 1. Unless the medicinal product are different shapes and/or strength for each pharmaceutical form and strength of the submitted application. The application shall state the following particulars: 34.1. the applicant (name, registration number, registered office, business address, special permission to license number, phone number, fax number, e-mail address);
21.3. the parallel imported medicinal product identity in relation to the relevant medicinal products registered in Latvia (to which the parallel imports are made), the name of the medicinal product, the pharmaceutical form, the composition of the medicinal product (including quantified the content of active ingredient per dosage, volume or weight of the unit, showing the active substance), a description of the difference (if any);
21.3. the parallel imported medicinal products and the exporting country, country of origin, the name of the medicinal product, the registration number, the registration holder and the manufacturer of the medicinal product (name, registered office, business address, telephone and fax numbers, electronic mail address);
21.4. the registration number of the registered products in Latvia, in relation to which the parallel imports has been made;
34.5. pharmaceutical wholesaler from which the product is purchased (name and special permission (license) number);
21.5. information on whether the drugs are repacked (secondary packaging change, new instructions into the Latvian language, pārmarķēšan in the package (for example, the label on the primary or secondary packaging)), as well as information about the medicine pārpakotāj and repacked (pārmarķēt) product. "
25. To complement the rules with 34.1 points as follows: "this rule 34.1, 34 an application referred to in paragraph add: 34.1 1. instructions for use of medicinal products in the language of the country of origin and its translation into Latvian language, as well as the document a statement by the applicant that the translation corresponds to the original instruction for use;
34.1 2. instructions for use of the medicinal product and a statement that the project mentioned in the package leaflet of the medicinal product is identical to the instructions established in Latvia except for allowable differences according to this rule 40.2 1.;
34.1 3. mock-up of the label (primary and secondary) drug, which is intended for distribution, and drug samples (3 originals);
34.1 4. information if drugs are repacked (including pārmarķēt): 34.1 4.1. certificate of good manufacturing practice, if the medicinal product is repacked (including pārmarķēšan) in foreign countries;
4.2. special permit 34.1 (license) for the manufacture of the medicinal product number if grass repacked (including pārmarķēt) in Latvia;
4.3 34.1 (copy) a contract between a parallel importer and the person who repacked (pārmarķēj) grass if she are one and the same person;
34.1 5. special permission (license) and a copy of a written agreement between the parties that are involved in the storage of the medicinal product imported in parallel (the presentation of the original);
34.1 6. proof of the fact that the parallel imported medicinal products there is no difference from Latvia registered medicinal products that might affect their therapeutic use (meaning), and if drugs are repacked (pārmarķēt), that the product does not change;
34.1 7. This provision, paragraph 46, a document showing the medicine control costs. "
26. Express 35 as follows: ' 35. Parallel imported medicinal product distribution the holder (owner) provides the following procedures: 21.8. after any actions associated with the import of medicines, log or other document intended for that purpose make accurate records showing the parallel imported medicinal product, the origin of the imported medicines production serial numbers and quantity;
35.2. before distribution commences in Latvia within 15 working days after this provision 9.2. the authorisation referred to in paragraph shall inform the proprietor of the medicinal product (also in Latvia registration holder) for parallel imported and repacked (pārmarķēt) start of distribution of medicinal products in Latvia, as well as submit samples of medicines distributed;
35.3. provide national pharmaceutical inspectorate and the national medicines agency information at their request. "
27. Express 37 as follows: "37. Parallel imported pharmaceutical distribution permission is valid for a period of five years from the date of the award."
28. Replace paragraph 38, the number "30" by the number "45".
29. Make the following paragraph 39:39. "the national medicines agency: 24.3. decide on a parallel imported medicinal product: 39.1.1. distribution authorisation or refusal of service;
39.1.2. renewal of the distribution authorization or refusal of renewal;
39.1.3. distribution permit suspension or lifting of the suspension;
39.1.4. distribution of any withdrawal of permission;
39.1.5. change approval or refusal of approval of the change;
24.4. This provision referred 39.1.1. the decision shall be taken no later than 30 days after the submission of the application and shall be entitled to extend that deadline, but it may not exceed four months from the date of submission of the application. the 30-day time limit for the examination of the application does not include the period from the date of the request for additional information and oral or written explanation and the date of receipt of the additional information and oral or written explanation. The decision shall be extended in accordance with the administrative procedure law. The decision taken not later than 15 working days after the decision and notify the applicant of the decision in the case of positive authorization of parallel distribution of medicinal products imported in the Republic of Latvia pursuant to this provision to the form set out in annex 2;
39.3. Decides on the parallel imported medicinal prescription or non-prescription classification of medicinal products according to the classification of medicines registered in Latvia and thus the distribution authorization. Classification of medicines registered in Latvia Exchange also apply to parallel imported medicinal product;
24.5. the parallel imported medicinal product granted registration (re-registration) number, and drugs Latvian register of medicinal products shall be included. "
30. Supplement with 24.9 25.0 25.0 25.1, 25.2,,,,,,, 25.4 25.4 40.6 and 40.7 40.10 points by the following: "After this provision 40.24.9 point inspection completed parallel imported medicines in the National Medicines Agency requested from the competent institution of the Member State concerned, which is involved in the marketing and the parallel imported medicinal product, the following information about the parallel imported medicinal product (if necessary):

24.9 1. or grass is a registered exporting country and released for free circulation or the registration (marketing authorization) is in force, as well as the authorization (registration) number and date of the award;
2. the registration owner 24.9 name, legal address and place of business;
24.9 3. name of the manufacturer, the legal and business sites, as well as information on whether the manufacturer's licence is in force;
4. medicinal 24.9 qualitative and quantitative composition;
24.9 5. shelf life of the medicinal product and recommended storage conditions;
24.9 6. manufacturing formula.
40.2 the national medicines agency checks the received documents and data, taking into account of other Member States of the information received, and compares it with the corresponding medicinal products registered in Latvia, as well as evaluate the data, or a parallel imported medicinal product shall meet the following requirements: 1. the product is registered 40.2 (marketing authorisation) and released for free circulation in the country from which they were exported;
40.2 2. a manufacturer of medicinal products is a license for the production and manufacture of medicinal products meet the good manufacturing practice of medicinal products;
40.2 3. where medicinal products are repacked (pārmarķēt), or it does not present a risk for human health: 40.2 3.1. or circumstances is not affected, which were at the time of manufacture of the product;
40.2. the products remain 3.2 intact;
40.2 3.3. do not open the primary container;
40.2 3.4. Latvian language or instruction, provide accurate information and or label, or other information to the primary or secondary packaging, does not cover other important information;
40.2 4. information on the use and dosage of the manufacturer introduced the method of use and dose;
40.2 5. medications are identical medicinal products registered in Latvia (if no, or no difference to use therapeutic (meaning) or in the form of medicinal products);
40.2 6. medicinal products complies with these regulations and in paragraph 25.1 25.2;
40.2 7. permissible differences are not exceeded in relation to the parallel imported medicinal product manufacturer (if you have a contract with the owner of the registration or individual producers working on the basis of manufacturing license).
25.0 If you need additional testing to evaluate whether the parallel imported medicinal products and medicinal products registered are manufactured using the same production formula, the State Agency of medicines shall inform in writing the applicant. Biological medicinal products, the State Agency of medicines has the right to require the applicant to submit additional information on the safety of the medicinal product, as well as each series and their raw material samples.
40.4 user manual parallel imported medicinal products comply with the established in the instruction for use of medicinal products, with the exception of the following permitted differences: 25.1 1. instruction contains the parallel importer;
40.4 2. other adjuvants or slight difference in colouring or colour codes, as well as the decomposition period. It is clearly stated in the instructions for use and labelling. These differences may not be therapeutic, tolerate health risks for citizens and create a misleading picture of the patient.
25.2 the parallel importer ensures that therapeutic indications on the labelling of medicinal products which are approved in another Member State, but which are not approved, registered in Latvia is covered with stickers. If drugs are repacked (pārmarķēt), the label or the label: 40.5 1. originator is allowed to mention the serial number alone or with the production serial number;
25.2 2. indicate the parallel imported medicinal product distribution the holder (owner) and drug manufacturers, who repackage drugs (pārmarķēj).
40.6 If change registration documentation relating to a medicinal product imported in parallel, parallel imported medicinal product authorisation holders (owners) stops the distribution of medicinal products (medicinal products not subject to the change of classification): 1. submit 40.6 and national medicines agency an application for approval of the change. The application shall be accompanied by the provision of the information referred to in paragraph 34, which shows changes;
40.6 2. ensure appropriate changes in parallel with the imported medicine instructions after you have received the national medicines agency decision on the approval of the change.
National Medicines Agency 40.7 is entitled to request information from the competent authorities of the Member State concerned, which is involved in the registration and control of imported medicinal products in parallel.
25.4 If national medicines agency has approved the changes in the relevant registration in Latvia registered medicinal products in relation to which made parallel imports: 25.4 1. National Medicines Agency shall inform in writing the parallel imported medicinal product distribution the holder (owner) or the applicant for authorization of the approved changes to the summary of product characteristics, the labelling, in the instructions for use and the change of classification of the medicinal product concerned on the date of adoption of the decision and submitted to him by the national medicines agency and approved copy of the summary of product characteristics of the medicinal products registered in Latvia;
25.4 2. parallel distribution of medicinal products imported in Latvia holders (owners): 25.4 2.1. submit to the national medicines agency an application for approval of the change. The application shall be accompanied by the provision of the information referred to in paragraph 34, which shows changes;
25.4. end parallel imported 2.2 distribution of medicinal products, pending that the authorization referred to in paragraph 59.3;
2.3. submission of the new application 25.4 parallel imported pharmaceutical distribution authorisation by the national medicines agency, if the assessment of medicinal products have found that the parallel imported medicinal products in relation to medicinal products registered in Latvia registration dossier contains significant changes.
25.4 the national medicines agency: 25.4 1. shall draw up an assessment report on the parallel imported medicinal product compliance with the requirements set out in these rules;
25.4 2. ensure the parallel imported medicinal products issued for distribution authorization, approved an instruction manual (and change), as well as these rules and 39.1.4 39.1.3. decision referred to shall be published;
3. provide public 25.4 Pharmaceutical inspection information parallel imported pharmaceutical distribution monitoring and control;
25.4 4. ensure the parallel importer and the wholesaler (people involved in the parallel imported medicinal products at the wholesale distribution), list building, updating and publication (title, legal and business address, phone, fax number, and e-mail address);
25.4 5. provide Member States, at their request, information about the parallel imported medicinal product;
25.4 6. ensure parallel imported medicinal product testing (if necessary) and solubility testing this rule 40.2 40.4 7 and 2. in the cases referred to.
If the parallel imported medicinal 40.10 distribution authorisation holder (owner) properties change, the legal holder of the 10 working days written notice to the national medicines agency. The State Agency of medicines shall decide upon a new authorisation. "
31. Supplement with 41.1 points as follows: "Permission is refused if 41.1 distribution or distribution is prohibited has been stopped, and if the product is withdrawn from their market, security, efficiency and quality."
32. Make 42 as follows: "42. National Medicines Agency permit parallel distribution of medicinal products imported in Latvia, suspend or revoke the if: the country, exporting country 42.1. or Latvia registration (marketing authorization) has been withdrawn or suspended for reasons related to the risk to the health of the population (drug safety, quality or effectiveness), don't force the conditions on the basis of which the authorisation was granted;
26.2. not approved changes to the parallel imported medicinal product or permits parallel distribution of medicinal products imported in Latvia holders (owners) have not given information about changes or no changes introduced in accordance with the procedure laid down in these provisions;
26.3. the production of medicinal products does not meet the good manufacturing practice requirements;
26.3. the parallel imported medicinal product authorised for distribution in Latvia is not re-registered or renewal is refused;
26.4. the distribution of medicinal products is prohibited or suspended, the product is removed from the market for safety, effectiveness or quality;
26.5. found that the national medicines agency provided false information about the parallel imported medicinal products. "
33. To supplement the rules by 42.1 points as follows: "this rule 42.1 the decision referred to in paragraph 42 of the State Agency of medicines shall notify the holder (owner) and the country's pharmaceutical authorities."
34. Make 47 by the following: "47. to ensure the parallel imported medicinal products distribution surveillance: 29.3. parallel importer and responsible for ensuring that the instructions in parallel imported medicinal product is refurbished, given the changes in the package leaflet of the medicinal product in Latvia registered medicinal products. If there have been changes to the parallel imported medicinal product, the parallel importer suspended distribution and resume their distribution only after having received the notification of national medicines agency for approval of changes to parallel imported medicinal product;
47.2. the registration of owners in due time inform the parallel imported medicinal product distribution permit holders (owners) on the foreseeable changes in Latvia registered medicinal products;

47.3. the national pharmaceutical Inspectorate monitors and controls the parallel imported medicinal product distribution. "
35. Express provisions of chapter V of this title by the following: "import licences for medicinal products V procedure".
36. To make 48 as follows: "48. for or re-registered this rule 9.1. authorisation for a medicinal product referred to in the import from third countries of lieltirgotav the national medicinal drug agency shall submit an application in two copies according to the rules laid down in annex 3 of the form. One application may require authorisation or renewal of several medicinal products. The application shall show the following: 48.1. the holding of the applicant (authorisation of medicinal products imported from third countries, the owner of the registration number, applicant's name, domicile and business address, special permission (license) to open the medicinal lieltirgotav (transaction) number, phone, fax number and electronic mail address;
48.2. name of the medicinal product to be imported, pharmaceutical form, strength of the medicinal product, the registration number of the Latvian register of medicinal products, the manufacturer of the medicinal product;
48.3. the exporting country and drug manufacturer (name, domicile and business address, phone, fax number, and e-mail address);
30.1. licensed drug wholesalers or licensed manufacturer from which the product is purchased (name, license number, phone, fax number, e-mail address);
30.1. document the applicant's declaration that the medicine purchased from a person who is entitled to distribute drugs exporting country. "
37. Make 49 as follows: "49. for this rule: 30.5.10.1.4 and 10.2.6. medicinal products referred to in the import licence, the applicant shall permit national medicines agency an application under this rule the form defined in annex 4, which justifies the need for the importation of medicinal products;
30.6.10.1.6. and 10.2.4. medicinal products referred to in the import licence, the applicant shall permit national medicines agency an application according to the rules laid down in annex 5 to the form in which the basic import of samples of medicinal products;
30.6. the authorisation referred to in paragraph 10.1 does not register the import of medicinal products, the applicant shall permit national medicines agency an application according to the rules laid down in annex 6 to the form in which the basic import of medicines. The application shall indicate the name of the medicinal product, in the form of active substances and quantified the active substance content in one dosage, volume or weight, packaging type and size, a pharmaceutical manufacturer, serial number, and the number of packages, as well as submit receipt to prove the conformity of the medicinal product by the pharmaceutical law article 7 requirements and indicates the country in which the medicinal product is authorised. "
38. Make the following introductory paragraph 50:50. "to get this rule 10.1.3 and 10.2.5. referred to the humanitarian aid shipment licence, permit the applicant shall state in the application the Agency of medicines. The application specifies the following information: ".
39. the express 51 the following: "51. National Medicines Agency: 51.1. the decision on the issue of the import authorization or refusal to issue a permit, not later than 30 days after receipt of the application, and may extend this period for a period not longer than three months from the date of submission of the application. 30-day time limit does not include the period from the date of the requested additional information and oral or written explanation and the date of receipt of the additional information and oral or written explanation. If necessary, oral or written explanation of the decision shall be extended in accordance with the administrative procedure law;
51.2. notify person to whom the decision relates, and the decision taken, if permission is granted, the authorisation shall be issued no later than 10 days after the decision. 9.1 these terms, 10.1.4, 10.1.6, and section 10.2.4.10.2.6. and 10.1 above permissions are presented according to the 7, 8, 9 and 10 form fixed in the annex. "
40. Make 52, 53 and 54 of the following paragraph: "52. This rule 9.1. authorization referred to the State Agency of medicines shall be issued for a period of up to five years. If you changed information in the authorisation, the authorisation-holder (owner) be submitted to the national medicines agency an application for approval of the change. Re-registered to this rule 9.1. authorization referred to in the holder (owner) not later than 30 days before the expiry date of the authorisation shall submit the application to the State Agency of medicines. The application of these provisions shall be included in the information referred to in paragraph 48. Re-register the authorization issue a new permit.
53. the application referred to in this chapter shall receive national medicines agency within five working days of the test, or information submitted satisfies the requirements laid down in these provisions and in writing notify the applicant about the incomplete or erroneous information or submit additional information. After the initial check of the completion of the national medicines agency, if required, submit one copy of the application to public inspection of Pharmacy and asking for proof of the application specified by the manufacturer of the medicinal product license validity and compliance with good manufacturing practice. National pharmaceutical inspection provides proof that, in evaluating the available information and, if necessary, requesting information to foreign authorities, or provide verification of good manufacturing practice in pharmaceutical company and the report shall be submitted to the State Agency of medicines.
54. a national medicines agency: 54.1. refuse authorisation or re-registering in the following cases: 54.1.1. information provided does not meet the requirements of these regulations or it is false or incomplete;
54.1.2. national pharmaceutical inspection report provided certifying that the production is not a medicinal product in accordance with good manufacturing practices or inspection found critical or significant deviations from good manufacturing practices, as well as pharmaceutical company is not responsible;
54.1.3. the special permit (license) is suspended or withdrawn;
54.1.4. imported medicinal product differs from medicinal products registered in Latvia, including the size of the packages differ compared to the information in the registration dossier;
54.1.5. distribution is suspended or banned, the product is removed from the market for safety, effectiveness or quality, registration has been cancelled or the certificate of registration has been suspended;
54.1.6. national pharmaceutical inspection has taken a decision on the suspension of the importation of medicinal products coming from third countries or on the prohibition of distribution of medicinal products, or the suspension of distribution of medicinal products;
54.1.7. has been refused or withdrawn the clinical research permit (refers to this provision, 10.1.4 and 10.2.6. authorization referred to);
54.1.8. the product is not registered in any country (applies to unregistered medicines licence);
54.2. stop issued action or revoke the permission for all specified in the authorisation of medicinal products or on individual products in the following cases: 54.2.1. This provision, 54.1.3., 54.1.4 54.1.2.., 54.1.5., 54.1.6., 54.1.7. and 54.1.8. in the case referred to in subparagraph;
54.2.2. If permission is not re-registered or renewal has been refused drug safety, effectiveness or quality;
54.3. This provision in 54.1 and 54.2. this decision shall be communicated to the holder (owner), the national pharmaceutical inspection and Sanitary border inspection for the day of adoption of the decision. "
41. Put 58 as follows: "58. Pharmacy is allowed to sell via the internet in Latvia only registered medicines, non-prescription drug advertising are complied with procedures laid down by the applicable laws and regulations, and if the client is able to communicate daily with the Pharmacy and get from the free information and advice (including via the internet) for such products according to the regulations on pharmaceutical care. Distribute the medicine sales (sales) is prohibited from vending machines. From third countries the distribution of medicines via the internet is prohibited. "
42. To supplement the rules with 59.1, 59.2, 59.3, 59.4, 59.5 and 59.6 points as follows: "The provisions of paragraph 59 59.1 conditions do not apply to the pharmaceutical Act 25.1 the first part companies. Pharmaceutical law in paragraph 25.1 in a given Member State, the registered company (which is the home country of the issued special permit (license) for the wholesale of medicines or pharmaceutical production) special permission (license) holders (owners) prior to the commencement of distribution of medicinal products in the territory of Latvia ensures the recognition of a licence, the national medicines agency and national pharmaceutical inspection notice of: 1. a Member State granted 59.1 license (license type, specify the assignment date, number, the national competent authority where the licence is granted, the legal and business site address, country, phone and fax numbers, electronic mail address);
59.1 2. drug storage and distribution site (address, contact person, telephone and fax numbers, electronic mail address);

59.1 3. Executive (indicate name and legal address of the workplace, telephone and fax numbers and other means of communication);
4. wholesale activities 59.1;
5. distributed products 59.1 (specify the name of the medicinal product, the pharmaceutical form, quantified the content of active substances in one dosage, volume or weight, registration number Latvia register of medicinal products and medicinal products is the name of the manufacturer).
59.2 pharmacy within 10 days after this rule 59.1 of the medicinal products referred to in paragraph 1 from the pharmaceutical Act 25.1 the first part in a given Member State, the registered organization shall provide the national medicines agency notification of products received (the name of the medicinal product, quantified the content of the active substance in the dosage, one volume or mass units, the manufacturer of the medicinal product and drug registration number Latvia register of medicinal products, serial numbers and quantity).
59.3 national medicines agency: 1. approve the changes to 59.3 registration documentation is registered in the national registration of the medicinal product, including the mutual recognition procedure for medicinal products registered in the medicinal product. In this case, the registration holder authorized to distribute only the medicine that registration dossiers comply with the approved changes, in the 12 months of the decision on the date of confirmation of the change. After the expiry of that remaining stocks of medicines are permitted to distribute only pharmacies to pharmacy medicine remaining in stock. Medications can also be used in the fixed medical institution (social care institutions) to the remaining stocks of medicinal products. In this case, the distribution is permitted for all medical representatives (users);
59.3 2. is entitled to impose shorter authorisation period remaining stocks of medicines for distribution or not allow the realization of the remaining items, if the changes are implemented and if it is associated with the urgent security-related restrictions or protection of public health and the safe use of the product (for example, changes in the therapeutic indications, contraindications, warnings, the user range due to new information obtained about the safe use of the medicinal product What state agency of medicines shall notify the owner of the registration of the medicinal product on the date of adoption of the decision). If the national medicines agency has set a shorter deadline, any remaining stocks of medicines registration holder may distribute after receiving the national medicines agency issued the permit distribution of the State Agency of medicines shall be issued no later than 10 working days from the date of confirmation of the change. Registration the owner is responsible for planning, to ensure the new packaging and the availability of instructions within the time limit specified in the permit.
If the product is not re-registered 59.4 or renewal is refused, and if the registration is suspended or cancelled, the State Agency of medicines has the right to determine the remaining inventory distribution, taking into account the use of the medicinal product safety considerations.
59.5 national medicines agency ensure that rule 59.3 points consents referred to in the disclosure of the information to be available for drug dealers and users.
59.6 subject to this provision and 59.4 59.3 points, after the national medicines agency registration at the request of the owners, drug wholesalers, pharmacies, medical institutions and social care institution shall notify the State Agency of medicines and the national pharmaceutical inspection on the remaining stocks of medicines (drug name, serial number and quantity). This also applies to parallel imported pharmaceutical distribution. "
43. To supplement the rules by 60.1 60.2 60.3 60.4,,, and 37.6 point as follows: "drug wholesalers, 60.1 including pharmacies that distribute drugs treatment facility, provides that the rules referred to in point 3.3 of good distribution practice deployment and monitoring procedure descriptions, which contain provisions and requirements provided in these rules, other laws and regulations, as well as the European Commission's guidelines on good distribution practice of medicinal products included the implementation of the rules and implemented in accordance with the procedure laid down in the description. These procedures for drug wholesalers in the development of activities that may affect the quality of the products and distribution, and include procedures for executable: 60.1 1. quality control of medicinal products;
60.1 2. initiation of the imported medicines distribution;
3. consignments of medicines 60.1, test and deployment;
4. delivery 60.1 drug inspection and shipment;
5. the storage of medicinal products 60.1, control and stock rotation;
6. order 60.1 of the reception and processing, including the distribution of protocols;
60.1 7. supplier and buyer status check (for example, special permissions (licenses) of existence);
8. storage of the medicinal 60.1 conditions (for example, security conditions of the premises, security measures, medication during transportation) and the respective temperature maintenance and monitoring;
9. measuring devices calibration 60.1 and facility inspections;
10. employee 60.1 learning;
60.1 11. sanitary premises and equipment cleaning and maintenance, including rodents and pests;
12. transport of medicinal 60.1;
13. drug withdrawal 60.1 from items sold;
14. return of 60.1 products;
15. distribution of 60.1 suspension and revocation (withdrawal);
60.1 16. complaint handling procedures;
17. a measure of self-control 60.1;
18. the treatment of 60.1 low quality product or action in the event of doubt or suspicion about the quality of the product.
60.2 60.1 points in these rules of procedure in the descriptions indicate the officials responsible for ensuring compliance with the procedure for the procedure description. Description of the signature and the data of the pharmaceutical law referred to in article 46.1 of the designated officer or the quality system officer.
If the national pharmaceutical inspection 60.3 finds that this rule 60.1 points in the description of the developed procedures are incomplete, the State Pharmacy Inspectorate is entitled to give instructions to the medicine wholesaler to refine or revise procedures to ensure compliance with regulatory requirements.
60.4 drug wholesalers recorded each case of product recall and withdrawal of the medicinal product shall notify the person to whom the product is delivered, by following the instructions of the European Commission published on good distribution practice of medicinal products are included, as well as the national pharmaceutical inspection order and the rules laid down in paragraph 116 and 116.1 registration owner notification.
60.5 medicine wholesalers news registration owner and the country's pharmaceutical authorities on counterfeit medicines on the opening day of the facts. "
44. Add to 63, after the word "documents" with the words "for buying, as well as delivery".
45. Express 64 as follows: "64. lieltirgotav medicinal products that are imported medicine, and pharmaceutical company permitted to distribute the medicine wholesale, if at the time of receipt to the labelling of the medicinal product in the specified expiration date is left no less than a year. If the total time of use of medicinal products not exceeding two years, at the time of receipt to the medicinal drug labels in the specified expiration date shall be not less than half of the total administration time. The State Agency of medicines has the right to health reasons in exceptional cases to take a decision on the issue of the distribution of the wholesale distribution of medicinal products, if the period of validity of the medicinal product is less than this, but the product is essential to the healing process, designed for the treatment of rare diseases or distributed in limited quantities. Responsible for the disposal of unused medicinal products is a supplier of medicines. "
46. Make 65. the introductory paragraph as follows: "65. medicinal products referred to in this paragraph of the distribution started in Latvia is authorised (medicinal products imported by the import of these products), if each distributable medicine series has made quality control (test), which allowed any State testing laboratory is accredited for the testing of medicinal products in the national agency" Latvian National Accreditation Bureau "and that the Ministry of Economic Affairs has published a newspaper" journal ", or the national medicines agency laboratory for which the Ministry of the economy has given notification to the European Commission, or if the distributed series, which is produced in other Member States, which signed the agreement on the European economic area, this country is inspected, certified by the competent national authorities issued a series of output certificate attesting the compliance of the series of proven quality indicator. These certificates are at least seven days before the commencement of distribution (does not apply to the pharmaceutical law, article 10, paragraph 7, and article 20 of the situations specified therein) be submitted to the national medicines agency the following medicinal product: ".
47. Make 68 the first sentence by the following:

"Before the commencement of distribution of medicinal products in the territory of Latvia, mandatory quality control is subject to the provisions of annex 11 list includes medicines and raw materials. Mandatory quality control is allowed in any public institution (testing laboratory), which is accredited for the testing of medicinal products in the national agency "Latvian National Accreditation Bureau" and that the Ministry of Economic Affairs has published a newspaper "journal", or the national medicines agency drug testing laboratory. "48. Supplement with 68.1 68.2 68.3 68.4, 68.5,, and point as follows:" this rule 68.1 11. included in the list set out in annex medicinal products and pharmaceutical raw materials, excluding list 3, 4, 5, 8, 9, 10, 11, 12 and 13 of the cases, the samples are removed to control national pharmaceutical inspection, which puts it in the national drug control agency. Other drugs samples removed the national medicines agency. The State Agency of medicines has the right to transfer the drugs to other testing laboratories for testing.
68.2 testing laboratory inspections and not later than 30 days from the date of receipt of the samples shall issue an opinion on the results of the inspection.
68.3 national blood establishment not later than the day after the finding of the national medicines agency news for series that do not have safe, effective and high-quality or may be dangerous to human health or life, and informs the national pharmaceutical inspection as well as quarterly provides a national medicines agency report on results of quality control.
68.4 national medicines agency not later than the day after the finding of the national pharmaceutical inspection report for series that do not have safe, effective and high-quality or may be dangerous to human health or life.
68.5 national medicines agency not less frequently than quarterly report submitted to the Health Ministry for drug quality control results and after a request by the competent national authorities shall provide information on the medicine, which carried out a series of quality control, and its result. "
49. Add to 69.1. subparagraph after the word "demand" with the words "and ensure any ordered quantity of medicinal products order acceptance and delivery of medicines under the pharmaceutical order specified amount".
50. Delete EB 69.2. section.
51. Make 70 as follows: "70. Pharmaceutical wholesalers, pharmaceutical lieltirgotav, medicine, and pharmacy, which distributes drugs wholesale, — special permissions concerned (license) holders (owners) designated officer (s) responsible for this provision, paragraph 69 public service obligations. Wholesalers of medicinal products shall ensure that the officer (s) would be sazvanām or using other means of communication, available any time of the day, including in case of an emergency (natural disaster, epidemic, disasters, urgent demand from pharmacies or medical authorities) urgently needed medication. "
52. Express 71 the second sentence as follows: "this distribution permit is issued on the basis of the medicinal products granted an import licence, if the holder (owner) or the applicant for authorization shall provide the recipes or motivate the hospital's request for the supply of medicinal products."
53. Replace paragraph 72, the words and figures "34.1, 34.2 34.5.,.,., and in paragraph 21.6 54.1.1., as well as 51 and 53" with the words and figures "53, 54 and 55.".
54. To supplement the rules with 73.1, 73.5 73.2 73.3, 45.6, and point as follows: "This 73 73.1 referred to rules do not apply to typical recipes where the period of validity of one year and to which medicine is prescribed according to the provisions specified in annex 12 of the diagnosis list, subject to the following requirements: 1. to ordinary 73.1 recipes that the validity period is one year, may prescribe medication treatment for up to one year;
2. the treatment course 73.1 to one year must not prescribe medicines containing narcotic substances to be controlled in Latvia, psychotropic substances and precursors included in list III of psychotropic substances and in Latvia controlled narcotic substances, psychotropic substances and precursors included in list II narcotic substances;
73.1 3. prescribing a prescription treatment for up to one year, a physician on the prescription indicates the diagnosis code, "course of treatment" and the issue of the periodicity of the medicinal product, the instructions for approving the signature and the stamp or seal of the personal.
the medicine that 73.2 for treatment for up to one year, the pharmacist or the pharmacist's Assistant recipes the other side made a check on the quantity of medicinal products granted approval, with a signature and a personal stamp or seal.
73.3 recipe that discharged a treatment course for up to one year, kept by the patient until the prescribed quantity of medicines. After all, in the volume of prescriptions issued by the pharmacy to keep the recipe.
45.6 not allowed patient pharmacy to issue a parallel imported medicinal product which is different from the registered products in Latvia, where the client and the doctor not be informed and not received the consent of the client and the doctor.
means of Narcosis allowed 73.5 from pharmacies to distribute only against the hospital's request. The release of funds for narcosis recipe is not allowed. "
55. the express section 74.1. the following wording: "the usual recipe: 74.1. one year, but the recipe on which prescription psychotropic medicines containing psychotropic substances and medicinal products in accordance with these rules determine the register mandatory log — three years;".
56. To supplement the rules by 74.4. subparagraph by the following: "medical authorities 74.4. medicinal products for service — three years, but the narcotic and psychotropic substances and medicines — five years."
57. Replace paragraph 75 of the introductory part, the words ' for the manufacture of medicinal products "by the words" for the manufacture of medicinal products and medicinal products ".
58. In expressing subparagraph following 75.5.: "tetrakaīn hidrogenhlorīd of 75.5. (dikaīn);".
59. To supplement the provisions of this subparagraph with 75.6.: "the analgētiķ 75.6. narcotic, which as such is recognized by the National Medicines Agency (such as medicinal products the active substance ingredients are tramadol or tramadol salts)."
60. The deletion of 76.1 in the words "and the national pharmaceutical inspection provides an opinion on company checks".
61. In expressing subparagraph following 76.2.: "medicine in lieltirgotav is 76.2. posted at least one pharmaceutical article 46.1 of law officer;".
62. Express 80. paragraph by the following: "80.59. These provisions referred to in the special permission (license) holder (owner), ensure that the following minimum requirements: 80.1. ensure at any time that rule 76.1. referred to space, availability of equipment and facilities for the persons responsible for inspecting them;
80.2. buy stocks of medicinal products only from persons who are under a license that gives you the right to engage in wholesale trade of medicinal products;
49.9. supply medicinal products only to persons who have a license that gives the right to engage in the activity of wholesaler in medicinal products as well as licensed pharmacies, medical institutions and social care institutions;
80.4. in order to ensure rapid and complete of the medicinal product (effective) withdrawals from the market ordered by the competent authorities or carried out in cooperation with the manufacturer of the medicinal product concerned or the owner of the registration, provides emergency plan and its implementation;
80.5. shall keep records for each transaction (purchase or sales invoices, or on computer, or in any other way) in medicinal products received or dispatched, specifying at least the following information: 80.5.1.;
80.5.2. name of the medicinal product;
80.5.3. received or sent;
80.5.4. the supplier or the recipient's name and the legal and business address;
50.1. five years keep that rule 80.5 in those records and inspection purposes provided to the competent authorities, but documents relating to narcotic and psychotropic drugs — 10 years;
80.7. The pharmaceutical law comply with the third paragraph of article 22, and the rules laid down in point 3.3. good distribution practice principles and guidelines;
80.8. comply with the requirements of the law on the illicit manufacture of narcotic drugs and psychotropic and recognized medicinal substances, psychotropic and distribution. "
63. Express 89 the following: "89. Average humidity in the room where the product is kept in the 40-75%. This does not apply to the storage of medicinal products according to technical regulatory documents are provided at different humidity regimes. "
64. To replace the words "in paragraph 93 of the space" by the word "site".
65. Supplement with 95.3 95.1, 95.2 and point as follows: "95.1 the vehicle and space that stores medicines, is equipped with a temperature recording devices.
If the discovery of 95.2 fake medicines, they are stored in a separate room or separate from the other products in the area and marked with a special label "not for sale".
Not registered medicinal products 95.3 of the market been revoked (withdrawn) the use and distribution of drugs, which banned or suspended, and medicines for which quality in doubt or suspicion, stored separately in the quarantine area (s). "

66. Add to paragraph 105, after the word "test" with the words "and ensure the transport of medicines pharmaceutical law article 22 referred to in the third subparagraph of the European Commission's guidelines on good distribution practice for medicinal products".
67. paragraphs 107 to express the following: "107. Medications removed from the customs control zone to the country (Customs) border, customs warehousing and free customs zones may be that rule 10 referred to the people."
68. To supplement the provisions and paragraph 107.2 107.1 as follows: "107.1 the requirements laid down in this chapter shall also be secured and the storage of the medicinal product during transport, customs control area to the country (Customs) border, customs warehouses and free customs zones.
the owner of the goods or goods 107.2 holder shall submit to the Customs the holder (owner) instruction that defines a particular medicine storage and transport requirements in accordance with chapter IX of these regulations. The holder of a customs warehouse (owner) provides the requirements. Medicine storage conditions according to this provision the opinion referred to in paragraph 126.5. conditions answer: 1. public 107.2 customs warehouse, customs warehouse holder concerned (owner) and the possessor of goods;
107.2 2. private customs warehouse, customs warehouse holder concerned (owner) and the owner of the goods. "
69.109. point be expressed as follows: "in addition to these provisions 109.108. cases laid down in point: 109.1. national pharmaceutical inspectorate has the right to decide to stop specific drug (or a series) the imports from third countries. National pharmaceutical inspection shall notify in writing the Sanitary border inspection and national medicines agency on the date of adoption of the decision, if: 109.1.1. production of medicines does not meet the statutory requirements and the manufacturer of the medicinal product does not fulfil this provision, paragraph 80;
109.1.2. these provisions are not complied with, paragraph 26;
109.1.3. the registration of the request by the owner and the holder of the manufacturing authorization (the owner) has not submitted proof of medicinal products or their ingredients and the controls at an intermediate stage of the manufacturing process control, in accordance with the registration request submission methods provided for control (each product ingredients and finished product qualitative and quantitative analysis, special tests, e.g. sterility tests, pyrogenic substances, the presence of heavy metals, stability, toxicity and biological control, also at an intermediate state of production process control);
109.1.4. this rule 9.1. the authorization referred to in paragraph is suspended or withdrawn;
109.2. distribution shall be terminated when the registration of the medicinal product has been withdrawn or suspended (not applicable if the registration is cancelled at the request of the applicant for registration and the reason not related to drug safety, effectiveness and quality of the medicinal product or when the remaining stock sales under this provision, 59.4 59.3, 148, 150 and 151). "
70. the express section 110.3. the following wording: "a permanent, effective 110.3. and rapid alert system development and implementation, including urgent measures to be taken according to established procedures (also if you have doubts or suspicions about the quality and safety of products, including counterfeit medicines) that rule 110.1. in paragraph 116, as well as the national pharmaceutical inspection and the Ministry of health in order requirements motivated."
71. To supplement the provisions under paragraph 110.1 as follows: "this rule 110.1 110. the requirements laid down in paragraph 1 shall also apply to pharmacies, medical institutions and social care institutions."
72. the express section 111.1. by the following: "drugs are dangerous to 111.1. consumers life or may cause a risk to the health of consumers."
73. To complement the 112.6. subparagraph after the word "is" with the words "unexpected (inappropriate)".
74. To supplement the provisions of the following paragraph 115.1: "this rule 115.1 115 requirements also apply to distributors of medicines (pharmaceutical company, pharmaceutical lieltirgotav, pharmacy, medical institutions, social care institutions)."
75. To supplement the provisions of the following paragraph 116.1: "these rules 116.1 116 requirements also apply to the distribution of the withdrawal or suspension of the distribution, as well as withdrawal or withdrawal from the market, if it is done under this provision in paragraph 124. The decision taken shall notify in writing the person at the date of adoption of the decision of the national pharmaceutical inspection, the State Agency of medicines and the persons to whom the medicine distributed (drug wholesalers, retailers, medical institutions, institutions of care institutions). The notification shall specify the drug collection and destruction policy and procedures will be covered. "
76.117. points to express the following: 117 ". If the medicine that found the product defect is exported, the holder of the registration of the medicinal products, the manufacturer of the medicinal or pharmaceutical wholesalers, who then export the product is defect detection of four hours shall be given written notice of defects in medicinal products the recipient abroad and national pharmaceutical inspection, including the product identified by the beneficiary abroad. National pharmaceutical inspection shall notify the competent authority of the importing country for the defect of the product in accordance with the provisions of section 128.1.. "
77. To supplement the provisions of the following paragraph with the 121.1 121.2 and: "Where courtroom 121.1 withdraw from circulation the safety, effectiveness or quality problems, which have arisen at the time of distribution, the owner of the registration or the manufacturer of the medicinal product in accordance with the laws and regulations cover damage to persons who acquired and used it remedies, as well as expenses related to the delivery of these products of the destruction and disposal (including, if the product is not designed for side effects).
121.2 If the medicinal product withdrawn from the market because of problems with the quality of the medicines that have arisen during the release, the person whose fault the halls have become noisy, the losses shall be borne by the parties that the medicinal product is purchased and used, as well as expenses related to the delivery of these products and destruction for destruction. "
78. in paragraph 124 of the expression as follows: "the decision on the medicine 124. revocation, withdrawal, suspension and the renewal of distribution, as well as the prohibition of distribution is entitled to accept the national pharmaceutical inspection, issuing a written reasoned order. That decision, it shall state the date of issue of the pharmaceutical inspection submitted to the sanitary border inspection, the State Agency of medicines and the Health Ministry. National pharmaceutical inspection assessed the level of risk of the medicinal product and, if necessary, in cooperation with the local authorities shall ensure the publication of notices in the law on the press and other media in these press, other media, as well as television and radio. In emergency situations, where a decision has been taken and found that the drugs are dangerous to the life or consumer can result in a risk to the health of consumers, the national pharmaceutical inspectorate and the Ministry of health, on the basis of the national operational medical opinion of the Commission, of the decision taken immediately after its adoption (same day) announces national radio and Television Council on public communication. Broadcasters under the jurisdiction of Latvia (television and radio) broadcasts received by the Ministry of health and the State Pharmaceutical inspection notice free of charge in accordance with the Ministry of health and the State Pharmaceutical inspection notification content, form and broadcasting (live, beginning with the date of the notice, or record) within the Ministry of health. "
79. To supplement the 125 introductory paragraph, after the word "Pharmacy" with the words "medical institutions, doctors surgeries and care institutions" of the institution.
80. To complement the 125.2. subparagraph after the word "Pharmacy" with the words "hospital, physician practice, as well as social care institutions".
81. To complement the 125.3. subparagraph after the word "computer" with the words "(this does not apply to pharmacies, medical treatment and social care institutions in which the receiving and sending of information is ensured by other technical means)".
82. In expressing subparagraph following 126.5.: "monitors, or medicinal 126.5. storage and transport of the customs control zone in the country (Customs) border, customs warehouses and free zones comply with the Customs drug storage and transportation regulations. By the holder of a customs warehouse (the owner's) request, check the location and storage of the medicinal product shall deliver an opinion to the holder of a customs warehouse (the owner) for the provision of medicinal products conditions for storage in a customs warehouse. The opinion referred to in the customs warehouse, the holder (owner) shall be lodged with the competent authority of the holding of a customs warehouse authorization legislation. The opinion referred to the national pharmaceutical inspection shall also submit the sanitary border inspection. "
83. To supplement the rules by 126.6.,.,., 126.7 126.8 126.9. and section follows 126.10.: "checks and controls the 126.6. this rule 25.2. States parties compliance with legislation requirements and submit a report to the Licensing Commission of the pharmaceutical activities;

126.7. requests from the appropriate foreign competent authorities of information on pharmaceutical law 25.1 referred to in the first paragraph of the company's license and the appropriate competencies for the exchange of information with foreign countries;
126.8. inform the pharmaceutical Act 25.1 referred to in the first subparagraph of article enterprises on public service obligations in accordance with the laws, regulations and rules 69 and 70 of these conditions provided;
126.9. inform the sanitary border inspection of pharmaceutical law in article 25.1 of the companies referred to in the first subparagraph, licence suspension and cancellation on the same day when the information has reached the national pharmaceutical inspection;
126.10. in cooperation with the development of sanitary border inspection and implement early warning systems related to the safety of the medicinal product. "
84. To supplement the provisions under section 127.4. following: 127.4. "have the right to ask the national authority (testing laboratory), which is accredited for the testing of medicinal products in the national agency" Latvian National Accreditation Bureau "and that the Ministry of Economic Affairs has published a newspaper" journal ", to take the drug testing rules 26, 65 and 68 points in certain cases and emergency situations."
85. The deletion of 38.1., 76.3 and 134.3. section and 22, 56, 77, 78, 86, 106, 123, 133, 134, 135.136, 137.138, 139, 140, 141,., 142, 143, 144 and 145 points.
86. To supplement the provisions of the following paragraph 146.1: "remaining stocks of medicines 146.1 realisation is allowed in the wholesale and retail to the remaining stocks of medicines, but not longer than until 31 December 2005 in accordance with the national medicines agency and national pharmaceutical inspection notice provided on the remaining stocks of medicines (drug name, serial number, quantity). The statement referred to a June 1, 2004, provides for the registration of owners and wholesalers (medicines lieltirgotav) after the State on 1 May 2004. "
87. Replace paragraph 147, the words "specific provisions" of the Cabinet, with numbers and words, "may 1, 2004".
88. Supplement with 148, 149, 150.., 151, 152, 153.. and 154. paragraph by the following: "148. to change the items in Latvia registered medicinal products medicinal products that have been registered also centralized registration procedure (labelling and the package leaflet are approved in the European Union in Latvian language) in accordance with the Council's 22 July 1993, Regulation No 2309/93 laying down Community procedures for how to confirm and monitor medications intended for use in veterinary medicine and people, and establishing a European Agency for the evaluation of medicinal products, the above registered in Latvia, distribution of stocks of medicinal products whose labelling and package leaflets are approved, the national medicines agency is allowed to rest for the disposal of stocks of these products, but not more than 1 May 2006. After this date it is authorized to distribute only the pharmacy to pharmacy medicine remaining in the inventory and use the fixed medical institution (social care institutions) to the remaining stocks of medicinal products by the end of this institution.
149. to change the medicine items with the labelling and the package leaflet, where the owner of the registration is not located within the territory of the European Community, with the packaging of medicinal products whose labelling and package leaflet of the specified registration owner located in the territory of the European Community, the abovementioned remaining stocks of medicines distribution (also import) is permitted in Latvia until 1 November 2005. After this date it is authorized to distribute only the pharmacy to pharmacy medicine remaining in the inventory and use the fixed medical institution (social care institutions) to the remaining stocks of medicinal products by the end of this institution.
150. The remaining inventory of products whose marketing registration dossier to 1 May 2004 has topped under the legislation on the registration of the medicinal product, in Latvia is allowed after 1 May 2004 for wholesale to the remaining stocks of medicines, but not longer than until 31 December 2005 in accordance with the registration of owners and wholesalers (medicines lieltirgotav) provide notice of the national medicines agency and national pharmaceutical inspection on the remaining stocks of medicines (the name of the medicinal product serial number, quantity). The statement said registration of owners and wholesalers (medicines lieltirgotav) until June 1, 2004, to be submitted to the national agency of medicinal products and the pharmaceutical inspection in State after State on 1 May 2004. After this date, the remaining stocks of medicines are permitted to distribute only the pharmacy to pharmacy medicine remaining in the inventory and use the fixed medical institution (social care institutions) to the remaining stocks of medicinal products by the end of this institution.
151.148. These provisions and 149. in the case referred to in paragraph registration owners, drug wholesalers, pharmacies, medical treatment and social care institution at the request of the Ministry of health shall notify the State Agency of medicines and the national pharmaceutical inspection on the remaining stocks of medicines (name, serial number, quantity).
152. If the registration of the holder of the registered products is not national medicines agency submitted this information, they are the national medicines agency before 1 May 2004 shall notify in writing the person responsible: 152.1. adverse reactions to medicinal products — a person's first name, last name, company name, legal and business address, country, phone number that you can be contacted 24 hours a day, fax (fax) number, electronic mail address and contact person);
152.2. medicine series distribution (serial output) — company name, legal and business address, country, telephone number, fax (fax) number, electronic mail address;
152.3. from human blood and plasma-derived medicinal product and a series of dissemination of immunological preparation of initiation in accordance with the provisions of paragraph 65: the name, the legal and business address, country, telephone number, fax (fax) number, electronic mail address;
152.4. medicine serial control and testing are in accordance with the provisions of section 16.2. — company name, legal and business address, country, telephone number, fax (fax) number, electronic mail address.
153. This provision 45.6 points shall enter into force on 1 May 2005.
154. This rule 25.1. the person referred to in fulfilling the obligations of the person qualified to this provision to the date of entry into force but which the qualifications and professional experience do not comply with the laws and regulations on the production and control of medicinal products prescribed officers qualifications and experience requirements, has the right to continue these duties. "
89. Make informative reference to European Union directives as follows: "Informative reference to European Union directives, the regulations include provisions resulting from: 1) of the European Parliament and of the Council of 6 November 2001 of the directive (EC) 2001/83 on the Community code relating to medicinal products for human use;
2) of the European Parliament and of the Council of 4 April 2001 of the directive (EC) 2001/20 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. "
90. To supplement the provisions of annex 1 (annex 1).
91. To supplement the provisions of the annex (annex 2).
92. To supplement the provisions of annex 3 (annex 3).
93. To supplement the provisions of the annex (annex 4).
94. To supplement the provisions of annex 5 (annex 5).
95. To supplement the provisions of annex 6 (annex 6).
96. To supplement the provisions of annex 7 (annex 7).
97. To supplement the provisions of Annex 8 (annex 8).
98. To supplement the provisions of Annex 9 (annex 9).
99. To supplement the provisions of annex 10 (annex 10).
100. To supplement the provisions under the annex (annex 11).
101. To supplement the provisions of annex 12 (annex 12). Prime Minister i. Emsis Health Minister r. Muciņš annex 1: Cabinet of 22 April 2004, regulations no 419 ' Annex 1 Cabinet of 27 February 2001, regulations No 88 Health Minister r. Muciņš annex 2 Cabinet of 22 April 2004, regulations no 419 ' Annex 2 Cabinet of 27 February 2001, regulations No 88 Health Minister r. Muciņš annex 3 Cabinet of 22 April 2004, regulations no 419 ' Annex 3 Cabinet of 27 February 2001, regulations No 88 Health Minister r. Muciņš 4. the annex to Cabinet of 22 April 2004, regulations no 419 ' Annex 4 of the Cabinet of Ministers of 27 February 2001, regulations No 88 Health Minister r. Muciņš annex 5 Cabinet of 22 April 2004, regulations no 419 ' Annex 5 Cabinet of 27 February 2001, regulations No 88 Health Minister r. Muciņš annex 6 Cabinet of 22 April 2004, regulations no 419 ' Annex 6 Cabinet of 27 February 2001, regulations No 88 Health Minister r. Muciņš annex 7 Cabinet of 22 April 2004 on the Regulation No. 419 ' Annex 7 Cabinet of 27 February 2001, regulations No 88 Health Minister r. Muciņš Annex 8 Cabinet of 22 April 2004, the provisions of no. 419

"Annex 8 Cabinet of 27 February 2001, regulations No 88 Health Minister r. 9. Annex Muciņš Cabinet of 22 April 2004, regulations no 419 of Annex 9" Cabinet of 27 February 2001, regulations No 88 Health Minister r. Muciņš annex 10 of the Cabinet of Ministers on 22 April 2004, regulations no 419 of annex 10 "Cabinet of 27 February 2001, regulations No 88 Health Minister r. Muciņš, annex 11 Cabinet of 22 April 2004, regulations no 419" 11. Annex 2001 the Cabinet of Ministers of February 27. Regulation No. 88 Health Minister r. Muciņš 12. attachment Cabinet of 22 April 2004, regulations no 419 ' Annex 12. Cabinet of Ministers of 27 February 2001, regulations No 88 Health Minister r. Muciņš