Import And Export Of Medicinal Products Order

Original Language Title: Zāļu ievešanas un izvešanas kārtība

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Read the untranslated law here: https://www.vestnesis.lv/ta/id/159642

Specifies the share ownership between Latvia, no. 107 (3683) Cabinet of Ministers Regulations No. 436 in Riga in 2007 (26 June. No 37 35) import and export of medicinal products order Issued in accordance with article 5 of the law of Pharmacy (3) and the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" article 28 i. General questions 1. determines the order in which the medicinal product (with the exception of veterinary medicinal products) imported into the customs territory of the European Union (hereinafter referred to as the imports of medicines) and exported from the customs territory of the European Union (hereinafter referred to as the export of medicinal products), as well as customs control points through which allowed in Latvia controlled narcotic substances, psychotropic substances and precursors in list II and III substances included on the list and import and export of medicinal products.
2. These provisions apply to: 2.1. imports of the medicinal products established in the Republic of Latvia register of medicinal products or in a centralized registration procedure in accordance with the European Parliament and of the Council of 31 March 2004, Regulation (EC) No 726/2004 laying down the procedures for the authorisation and supervision of medicinal products for human and veterinary use Community procedures and establishing a European Medicines Agency (hereinafter referred to as the European Parliament and Council Regulation No 726/2004);
2.2. imports of the medicinal products which are not registered in the Republic of Latvia register of medicinal products or in a centralized registration procedure in accordance with European Parliament and Council Regulation No 726/2004, but are registered in third countries (hereinafter referred to as the unregistered drugs from third countries);
2.3. imports of medicinal products by the budgetary authority or the public good of the Organization, in accordance with the Council of 28 March 1983, Regulation (EEC) No 918/83 setting up a Community system of reliefs from customs duty (hereinafter referred to as the Council Regulation No. 918/83);
2.4. sample of medicines (standard);
2.5. the export of medicinal products;
2.6. the investigational medicinal product imports and exports.
3. These provisions shall not apply to: 3.1 medicine imports from European economic area countries and the export of medicines to countries of the European economic area;
3.2. imports of the medicinal product, by a natural person (the traveler);
3.3. import and export of medicinal products mailings.
4. The rules referred to in paragraph 2 of the medicines (including medicines containing controlled drugs in Latvia, psychotropic substances and precursors list II substances (narcotic drugs) and (iii) substances included in the list (psychotropic drugs)) allowed import and export through the customs control points referred to in the law on the State border crossings and border posts and border crossing point placement to the State border of the Republic of Latvia and allowed food and veterinary service of sanitary border inspection (hereinafter referred to as the sanitary border inspection) are not subject to the control of food and import and export of products.
5. the Customs authorities control the import and export of medicinal products in accordance with the Customs Act and applicable laws and regulations governing customs clearance and customs control procedures.
6. Sanitary border inspection carried out in accordance with the functions: 6.1. Council 8 February 1993 of Regulation (EEC) No 339/93 on the checks for conformity with the rules on product safety in products imported from third countries, article 2 (hereinafter referred to as the Council Regulation No 339/93);
6.2. the Council of 26 May 2003 of Regulation (EC) no 953/2003 to avoid from some of the most important pharmaceutical trade diversion into the European Union article 8 (hereinafter referred to as the Council Regulation No 953/2003);
6.3. The European Parliament and of the Council of 17 May 2006 Regulation (EC) no 816/2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems, article 14 (further – the European Parliament and Council Regulation No 816/2006).
7. the customs warehousing of medicinal products requires the State revenue service's main customs administration. The State revenue service's main customs administration shall issue the permit for the storage of the medicinal product, if you have received a national pharmaceutical inspection findings.
8. Drug cargo owner or possessor (hereinafter referred to as the drug possessor): 8.1. submit to the holder of a customs warehouse instruction, which contains requirements for the storage of the medicinal product. The holder of a customs warehouse ensures conditions of storage in a customs warehouse under the drug possessor instructions and regulations for the distribution of medicinal products medicinal products laid down requirements for storage;
8.2. shall bear the expenses related to the storage of medicinal products conditions for the customs warehouse;
8.3. ensure sanitary border inspection and national pharmaceutical inspection, as well as officials of the Customs authorities of the free access to the place of storage of the medicinal product, the customs control zone. Drug possessor officers are obliged to report the medications for the control of sanitary border inspection.
9. the drug shipment, which imports the drug possessor, add the appropriate accompanying document issued abroad, showing the following information: 9.1 drug delivery date, the name of the medicinal product, pharmaceutical form, strength of the medicinal products and medicinal products supplied for each production series number and quantity of the drug supplier (the consignor) the business name and address of the manufacturer of the medicinal product, the company name and country of manufacture of the medicinal drug company and address of the beneficiary;
9.2. the price at which the medicine of the medicine sold by the recipient.
10. If the possessor of goods imports of medicinal products on the basis of the Treaty uses the transport services provided by another person (hereinafter referred to as the commercial carriers), the commercial carriers, in addition to the provisions in paragraph 9 the requirements presented to the Customs authorities the contract concluded between the drug possessor and commercial carriers for the provision of transport services, or the possessor of a mandate to carry out the operation.
II. Drug imports 11. Medicinal products registered in the Republic of Latvia register of medicinal products from third countries may be imported by a person in accordance with the laws and regulations that govern the special permit (license) the pharmaceutical activity, suspension of service, the procedure for renewal and cancellation, medicine has received the National Agency issued a special permit (license) for the manufacture of medicinal products/import, indicating that allowed drug importing operations, as well as a person who is entitled to represent the licence holder. Investigational medicinal product may be imported in person, where the special permit (license) for the manufacture of medicinal products/import indicated that allowed import investigational medicinal product. The shipment of medicines, which are imported from third countries, on the basis of other European Union Member State competent authorities issued a license for the manufacture of medicinal products/import, and transported through the territory of Latvia in transit (including placed in a customs warehouse), the State Agency of medicines shall issued a special permit (license) for the manufacture of medicinal products/are not necessary.
12. the Person involved in the transaction, which requires that provision referred to in paragraph 11 special permit (license) manufacture of medicinal products/import away Joe (hereinafter importer of medicines), ensure that the following requirements are met: 12.1. imported medicinal products and investigational medicinal products are manufactured in accordance with requirements equivalent to or higher than the European Union laid down in the good manufacturing practice requirements;
12.2. the manufacturer of the medicinal product in the country concerned has the appropriate permission to manufacture medicinal products. As regards investigational medicinal product drug importer shall ensure that the manufacturer of the investigational medicinal product imported is notified to the competent national authorities and it was declared for the manufacture of investigational medicinal products;
12.3. the permanent and continuous there is at least one responsible person with appropriate education and professional experience (hereinafter referred to as the qualified person). On the change of qualified person immediately, but not later than within five days shall inform the State Agency of medicines;
12.4. it is the staff who comply with the laws and regulations on the production and control of medicinal products;
12.5. enables medicine State agency officials any time of the day to visit the premises of importers of medicinal products;
7.8. enable the qualified person to fulfil these rules 14, 15 and 16 of the obligations referred to in paragraph (for the investigational medicinal product – 21 and 22 of these regulations. the obligations referred to in paragraph), for example, placing at its disposal all the necessary facilities;
12.7. the imported medicinal product quality control and serial output comply with the principles and guidelines of good manufacturing practice laid down in the laws and regulations on the production and control of medicinal products;
12.8. the distribution of medicinal products to follow good distribution practice principles laid down in the regulations on the distribution and quality control procedures. As regards investigational medicinal product comply with the legislation on medicinal products for clinical trials.
13. a qualified person's education and professional experience corresponds to the qualifications and professional experience criteria laid down in the laws and regulations on the production and control of medicinal products.

14. The qualified person shall, without prejudice to its relationship with a drug importer is responsible for ensuring that each imported medicine series (even if the medicinal product is manufactured in the European Community (European Union and European economic area States) exported to third countries and imported back) the full qualitative analysis and all the quantitative analysis of active substances as well as perform any other tests and examinations that are necessary to ensure the quality of medicinal products in accordance with the registration dossier requirements. Quality control of medicinal products not imported medicines which are the series screened in any other Member State of the European Community, and the product is delivered to them from another Member State together with the signed by the qualified person of the control message.
15. The rules referred to in point 14 of the quality control of medicinal products may not be made if the product imported from the countries which have concluded with the European Community's good manufacturing practice for medicinal products conformity assessment of mutual recognition agreement (Australia, Canada, New Zealand, Switzerland), and this Agreement shall provide that the exporting country carries out a series of each drug testing (qualitative and quantitative analysis). In this case, each of the imported medicine series adds that rule 34 series of medicinal product referred to in the certificate.
16. in all cases, the qualified person medicine series certification, making exact records log or other equivalent provided for this purpose in the document and certify with signature that each series of medicines manufactured and controlled according to the provisions of paragraphs 14 and 15. After certain actions log or the relevant document and keep the company not less than five years since the last entry, providing the medicine State agency officials access to this journal or document.
17. in order to carry out the provisions mentioned in paragraph 14, the quality control of medicines, can be used by another person (hereinafter referred to as the contractor) quality control laboratories, where the drug importer and the contractor enters into a written contract, these rules 18, 19 and 20.
18. the Treaty precisely defines the obligations of the parties, with particular emphasis on contractor's obligation to comply with the principles and guidelines of good manufacturing practice, as well as the manner in which the qualified person responsible for certifying each batch is to discharge his responsibilities.
19. the contractor shall ensure the following requirements are met: 19.1. If the importer's written authorisation of medicinal products, subcontracted with third parties about the work in accordance with the provisions of the agreement referred to in paragraph 17 is entrusted to the contractor, not closed;
19.2. respect the principles and guidelines of good manufacturing practice laid down in the laws and regulations on the production and control of medicinal products, as well as the State Agency of medicines under control.
20. Before conclusion of the contract for carrying out the quality control of medicinal products, the importer shall ensure that the State Agency of medicines shall deliver an opinion on the compliance of laboratories of good manufacturing practice requirements.
21. with regard to the investigational medicinal product, produced in third countries, the qualified person shall be responsible for ensuring that each drug has been produced in series and tested in accordance with the principles and guidelines of good manufacturing practice (which is at least equivalent to those laid down in the European Union), as well as in accordance with the product specification and the information that the sponsor indicated in the application, the State Agency of medicines to get authorisation for a medicinal product in the clinical trial. Investigational medicinal product, which is comparable to the preparation of a third country and which are registered, but unable to obtain documentary proof that each series is manufactured under conditions which are at least equivalent to the principles and guidelines of good manufacturing practice, qualified person provides analyses, tests and checks for each series of the preparation, to demonstrate that it complies with the information provided by the sponsor of the State Agency of medicines to get authorisation for a medicinal product in the clinical trial.
22. with regard to the investigational medicinal product in all cases, the qualified person log or other respective equivalent made accurate records and certified with a signature that matches the product series of these regulations 21. After certain actions log or the relevant document and keep the company not less than five years since the last entry, providing the medicine State agency officials access to this journal or document.
23. Investigational medicinal products imported from third countries, analytical (qualitative and quantitative analysis) is optional.
24. in paragraph 11 of these rules this special permit (license) for the manufacture of medicinal products/import only applies to medicinal products (for the investigational medicinal product, to the types of medicinal products and pharmaceutical forms), which is specified by the importer of a medicinal product in the application for a special permit (license) for the manufacture of medicinal products/import, and which the State Agency of medicines shall issue the special permit (licence), is included in the database according to the laws that govern the special permit (license), the activity in issue in the pharmaceutical the suspension, cancellation, renewal and order.
25. the drug importer may import the narcotic drugs and psychotropic medicines, which are specified in the application for a special permit (license) for the import of medicinal products the NAIA/prod for and which the State Agency of medicines shall issue the special permit (licence), is included in the database according to the laws that govern the special permit (license) the pharmaceutical activity, suspension of service, re-registering and cancellation policy if a particular medicine imports is the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" order issued by the State Agency of medicines. In addition to the requirements laid down in these provisions the illicit manufacture of narcotic drugs and psychotropic drug importing respects the requirements of the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order".
26. This provision in the budget referred to in paragraph 2.3 of the institution or organization in the public good may be imported from third countries non-prescription medications, which included the Republic of Latvia register of medicinal products or registered centrally in accordance with European Parliament and Council Regulation No 726/2004 III. Pharmaceutical samples and unregistered drug imports from other third countries 27. Unregistered drugs from third countries may be imported to the legislation on distribution and quality control of medicinal products in the National Agency issued permits the distribution of medicinal products.
28. the samples of medicinal products may be imported to the State Agency for medicinal products authorised for the importation of samples of medicinal products in the Republic of Latvia (hereinafter permit for the importation of samples of medicinal products) (annex 1), in the following cases: 28.1. the registration of medicinal products;
28.2. for use in scientific research;
28.3. training needs;
28.4. the reference to drug testing.
29. in order to receive permission to import samples of medicinal products, the applicant shall state in the application the Agency for medicinal products according to this provision, 2. the requirements set out in the annex, in which the basic import of samples of medicinal products.
30. the State Agency of medicines within five working days after the rules referred to in paragraph 29 of receipt of the application checks whether the information provided meets the requirements set out in these provisions. If the information provided is incomplete or incorrect, the State Agency of medicines shall request additional information in writing.
31. the State Agency of medicines shall adopt a decision to refuse to issue the permit for the importation of samples of medicinal products, if a month after the rule referred to in paragraph 29 additional enquiry does not receive from the applicant the information requested (grounds).
32. the State Agency of medicines shall adopt a decision to issue a permit for the import of samples of medicinal products during the administrative procedure law.
IV. Drug export 33. Drugs, including investigational medicinal products, may be exported by a person in accordance with the laws and regulations that govern the special permit (license) the pharmaceutical activity, suspension of service, re-registering and cancellation procedures, has received a special permit (license) for the import of medicinal products the NAIA or prod/special permission (license) to open the medicinal lieltirgotav (performance), as well as a person who is entitled to represent the licence holder. A medicine shipment exported to third countries, based on another of the European Union, the competent authorities of the Member State issuing the licence for the manufacture of medicinal products/import, and transported through the territory of Latvia in transit (including placed in a customs warehouse), the State Agency of medicines shall issued a special permit (license) for the manufacture of medicinal products/are not necessary.
34. If a drug company is registered in Latvia exports the medicine to a country with which the European Community has concluded the drug good manufacturing practices compliance assessment of mutual recognition agreements, each series of medicinal products to be exported shall be accompanied by a signed by the qualified person medicine series a certificate that contains information in accordance with the provisions of annex 3.
35. the State Agency of medicines based on the medicine of the manufacturer, the exporter or the competent authorities of the importing State of the application, shall be issued:

21.8. the product certificate (annex 4). Product within the meaning of this paragraph is a medicinal product for human use in their final form of the medicinal product and the active substances of the medicinal product for use in these forms, which the pharmaceutical regulatory laws in the order subject to the control of both the exporting country and the importing country. Product certificate correspond to the World Health Organization (who) recommended that shape and determine the status of the product, as well as requesting status of the certificate in the exporting country. The certificate is intended for only one type of product;
35.2. notice of the registration status of the product (annex 5). This message is for the importer of medicines a delegate who participates in the international tenders (tendero) in accordance with the terms of the invitation. This statement means that the specific drugs in the Republic of Latvia (exporting country) are registered and they are permitted to distribute. Each of the products listed in the notice by the applicant and the holder of the registration certificate (the owner, if they are different individuals) the State Agency of medicines shall issue the regulations referred to in paragraph 21.8. bottom product certificate.
36. for this provision the products referred to in paragraph 21.8., the manufacturer of the medicinal product shall be submitted to the national agency in the application of medicinal products, stating: the certificate applicant 36.1. first name, last name or business name and address;
36.2. the status of the certificate applicant: 36.2.1. producing the pharmaceutical form;
36.2.2. packaged and labelled in pharmaceutical form, produced another independent manufacturer;
36.2.3. is not involved in these rules and in subparagraph 36.2.1.36.2.2. min on those activities;
36.3. the applicant if the certificate is not the manufacturer of the pharmaceutical form, indicates the manufacturer of the pharmaceutical form and the address of the company;
36.4. product name, dose and dosage forms: 36.4.1. in Latvia;
36.4.2. in other countries;
22.7. the active substance name (using the international non-proprietary name (INN) or the national non-proprietary name) and the quantity per dose;
22.7. the composition of the complete product including excipients (also indicate quantitative composition, when it is added to the agreement with the holder of the registration certificate of the product (owner));
22.8. the product is registered in Latvia;
22.9. or the product is distributed in Latvia;
22.9. product registration certificate number and date of the award (if necessary, indicate, or is temporary registration certificate or product not yet approved);
36.10. the holder of the registration certificate of the product (the owner's) name and address;
36.11. product registration holder (owner) status under this provision, 36.2.2 36.2.1.36.2.3. section and;
36.12. If the holder of the registration certificate of the product (the owner) is not the manufacturer of the pharmaceutical form, indicates the manufacturer of the pharmaceutical form and the address of the company and shall be accompanied by a document certifying that the holder of the registration certificate of the public agrees that information;
36.13. If the registration certificate is not required for the product, one of the reasons why it is required: 36.13.1. product generated only special treatment conditions, mainly of tropical diseases that have no endemic nature in Latvia;
36.13.2. products processed to improve its stability in tropical conditions;
36.13.3. the product was processed, so it should not use an adjuvant, which is not allowed in the importing country;
36.13.4. the product was processed, to create a different maximum dosage of the active substance;
36.13.5. other (specify which);
36.14. If the holder of the registration certificate of the product (the owner) or of the applicant for the certificate status corresponds to that provision or in 36.2.2.36.2.3 listed status (especially if the product is involved in the foreign manufacturer), the applicant for the certificate the State Agency of medicines shall provide information indicating each party involved in the production of responsibility for each stage of the production process and finished products, as well as each party's control type and volume.
37. for this rule 35.2. the notification referred to in the paragraph at the bottom of the product's registration status, a person shall submit to the State Agency of medicines of the petition, stating: 37.1. an applicant for a certificate, the name or business name and address;
37.2. the importing country;
37.3. product name, dose and pharmaceutical form, active substance name (using the international non-proprietary names (INNS) or national non-proprietary names) and their quantity in one dose, registration certificate number and date of the award. If the product is not registered, the point – "not required" or "not required" or "shall" in the registration process, or "registration is refused".
38. the State Agency of medicines that the products referred to in paragraph 35 certificate and notice of the registration status of the product shall be issued within 30 days after receipt of the application. Expenses related to the issuance of the certificate of the product shall be borne by the applicant in accordance with the State Agency of medicines of the public paid services price list.
39. If a certificate is issued for the product, which is an active substance for use in the form of medicinal products, active substances required production examination and certificate of conformity assessment, the applicant asked the State Agency of medicines to take active substance manufacturing site inspection (inspection). That the State Agency of medicines shall be carried out in accordance with the laws and regulations on the production and control of medicinal products.
V. monitoring and penalties 40. Sanitary border inspection: 24.9. controls the import of medicinal products compliance with that rule 6, 8, 9, 10, 11, 24 and 25 with the requirements set out in paragraph;
40.2. Customs control zones controlled drug transport and storage conditions, compliance with laws and regulations for the distribution and quality control procedures established medicine storage and transport requirements;
40.3. The State inspection of pharmacy provides information about these set of MOS requirements.
41. the sanitary border inspection, on the basis of sanitary border inspection officials drafted the Act, is entitled to decide and stop further imports of the medicinal product: 41.1. in accordance with Council Regulation No 339/93 article 2, if it is found that the cargo accompanying documents: 41.1.1. does not comply with this provision of the guarantees laid down in paragraph 9, or the product is not identifiable (no label);
41.1.2. imported medicinal products medicinal products not specified government agencies database according to the laws and regulations of the special permission (license), the activity in issue in the pharmaceutical, the suspension, cancellation, renewal and order;
41.1.3. drugs not the 27 and 28 of the provisions referred to in the import licence concerned;
41.1.4. is in violation of laws and regulations on the distribution and quality control procedures in certain drug storage and transport requirements;
41.1.5. the product is expired;
41.1.6. medicines to the consignor and the consignee are not identifiable;
41.2. in accordance with Council Regulation No 953/2003 article 8, if it finds that the imported medicines are tiered priced products contained in Council Regulation No 953/2003 in annex I;
41.3. in accordance with Council Regulation No 816/2006, article 14 if there is reasonable suspicion that a breach of Council Regulation No 816/2006 article 13, paragraph 1, the import ban in the case of medicinal products manufactured under a compulsory licence;
25.7. If the trader who import this rule 41.1.2. medicinal products referred to in the special permit issued by the (license) the pharmaceutical activities are not in force;
25.8. If the imported medicinal product in accordance with the laws and regulations on the distribution and quality control arrangements subject to national pharmaceutical inspection rapid notification of quality defects and the withdrawal from the market of the medicinal product.
42. the sanitary border inspection on the written notice of the decision taken by the national pharmaceutical inspection on the date of adoption of the decision, but not later than within three working days.
43. Medicinal products for which adopted this provision in paragraph 41, that decision, placed in a customs warehouse, which has this rule 51.2. the bottom above the national pharmaceutical inspection findings (if drug storage conditions in the customs warehouse, consistent with the summary of the specification).
44. where sanitary border inspection has adopted this provision the decision referred to in point 41, after final clarification of the circumstances of the State Pharmacy Inspectorate shall decide on the revocation of the suspension of the imports of the medicinal product or the prohibition of imports of medicinal products and of the decision concerning the Sanitary border inspection and notify the State Agency of medicines of the day of adoption of the decision. If the State Pharmacy Inspectorate shall decide on the revocation of the suspension of imports, sanitary border inspection of that decision on the date of receipt shall inform the Customs authorities that are authorised to apply to customs procedures, release for free circulation.
45. If the national pharmaceutical inspection shall take a decision on the prohibition of the import of medicinal products, in no respect the requirements laid down in these rules, it shall inform the customs authority and the destruction of the medicinal products may be initiated or re-export, which release for free circulation not authorised or otherwise put into circulation is prohibited. The decision taken shall be notified in writing to the relevant customs authority and the Sanitary border inspection in the day of adoption of the decision. In this case, all the accompanying documents of goods include marks under Council Regulation No 339/93/EC, article 6 paragraph 4.

46. Expenditure relating to specific drug shipments or re-export, destruction shall be borne by the person subject to the provisions of paragraph 45 of that decision (drug possession).
47. the State Agency of medicines shall control compliance with the importing of medicines that rule 12, 14, 15, 16, 17, 18, 19, 20, 21, 22 and 23 of the requirements set out in paragraph in accordance with regulations on the production and control of medicinal products.
48. Drug control during the importer provides drug national agency officials: 48.1. the data for each series of medicinal quality control (made in the European economic area country) in accordance with the registration dossier;
48.2. immunological preparations and from human blood and plasma-derived medicinal products – all qualified persons approved, copies of the control report.
49. the national pharmaceutical inspection, on the basis of the State Agency of medicines of the control message is entitled to suspend a specific drug or medicine, all imports referred to in the application, to get the special permission (license) for the manufacture of medicinal products/import, and the State Agency of medicines included in the database according to the laws and regulations of the special permission (license), the activity in issue in the pharmaceutical, the suspension, cancellation, renewal and, if the State Agency of medicines during the inspection at the drug importer finds and control report indicates that: 30.5. quality control of medicinal products and serial output does not meet these rules 14, 15 and 16 to the requirements;
30.6. the qualified person does not perform this rules 14, 15 and 16 (for investigational medicinal product – this rule 21 and 22) obligations;
30.6. the importer of medicines during control does not produce this provision set out in paragraph 48 of the data and documentation.
50. the State Agency of medicines of the European Parliament and Council Regulation No 726/2004 referred to in article 19 the competent supervisory authority in respect of the medicinal product, in accordance with that regulation established a centralized registration procedure and imported from third countries.
51. national pharmaceutical inspection: 51.1. monitor, or medicine storage and transportation under customs control zones comply with the legislation on the distribution of medicinal products;
51.2. the holder of a customs warehouse (the owner's) request, check the storage of medicinal products and shall give an opinion to the holder of a customs warehouse (owner) for compliance with the laws and regulations of the conditions for the distribution of medicinal products provided for good distribution practice. The opinion referred to in the customs warehouse holder (holder), in accordance with the legislation on the operation of a customs warehouse shall provide sanitary border inspection and the State revenue service's main customs administration;
51.3. is entitled to request and receive from the State Agency of medicines, sanitary border inspection and other competent national authorities the information related to that enforcement;
51.4. provides drug National Agency for Sanitary border inspection and other competent national authorities the information required;
51.5. inform the European Commission of any decisions adopted in accordance with Council Regulation No 953/2003 requirements;
51.6. inform the European Commission of any decisions relating to the confiscation or destruction of products, which are adopted in accordance with European Parliament and Council Regulation No 816/2006-52. The officials shall not disclose business secrets of the controlled person of which he becomes aware in the course of their duties in accordance with these rules.
53. national pharmaceutical inspection, the State Agency of medicines, sanitary border inspection and customs authorities within their competence provide the operational exchange of information, as well as to prevent the diversion of illicit drug circulation, provides law enforcement agencies and the Ministry of Health information on the facts which become known to them.
Vi. Closing questions 54. Be declared unenforceable in the Cabinet of 27 February 2001, Regulation No 88 "the medicine import, export and distribution rules and drug lieltirgotav open and operational requirements" (Latvian journal, 2001, 35, 52 no; 2003; 2004, nr. 114.69. no).
55. Drug lieltirgotav, which to this date of entry into force of the provisions have been issued a special permit (license) to open a lieltirgotav for medicinal products with special conditions for the import of medicinal products in Latvia from outside the European economic area, and the National Agency for medicinal products authorised for the importation of these products in the Republic of Latvia from third countries, are entitled to import medicine to law, which sets a special permit (license), the activity in issue in the pharmaceutical the suspension, cancellation, renewal and order those special permissions (licenses) for the manufacture of medicinal products/import, but no longer than 1 January 2008.
56. The Sponsor, which to this date of entry into force of the provisions is the National Agency for medicinal products authorised in the clinical investigational medicinal products for human use, to the import of the Republic of Latvia is entitled to import investigational medicinal products to the law that defines a special permit (license) the pharmaceutical activity, suspension of service, re-registering and cancellation procedures, the special permission (license) for the manufacture of medicinal products/import, but no longer than 1 January 2008.
57. the rules shall enter into force on the 1 august 2007.
Informative reference to European Union directives, the regulations include provisions resulting from: 1) of the European Parliament and of the Council of 4 April 2001, Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use;
2) of the European Parliament and of the Council of 6 November 2001, Directive 2001/83/EC on the Community code relating to medicinal products for human use;
3) Commission of 8 October 2003 Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (text with EEA relevance);
4) of the European Parliament and of the Council of 31 March 2004, Directive 2004/27/EC amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use (text with EEA relevance);
5) Commission of 8 April 2005 of Directive 2005/28/EC laying down the good clinical practice principles and detailed guidelines on investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (text with EEA relevance).
Prime Minister a. Halloween Health-Welfare Minister Minister d. Staķ is the Editorial Note: the entry into force of the provisions by 1 august 2007.
 
 
1. the annex to Cabinet of Ministers of 26 June 2007, regulations No 436 Health Minister-Minister of welfare (D). Annex 2 Staķ Cabinet of 26 June 2007, regulations No 436 Health Minister-Minister of welfare d. Staķ 3. attachment Cabinet 26 June 2007 Regulation No. 436 of the Health Minister, Welfare Minister d. Staķ in annex 4 of the Cabinet of Ministers of 26 June 2007, regulations No 436 Health Minister-Minister of welfare (D). Staķ 5. Annex a Cabinet of 26 June 2007, regulations No 436 of the Minister of health Instead, the Welfare Minister d.-Staķ