Cabinet of Ministers Regulations No. 82 in 2016 (2 February. Nr. 5 26) amendments to the Cabinet of Ministers of 26 June 2007 No. 436 "provisions of the 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 to make a Cabinet of 26 June 2007 No. 436" terms of the medicine import and export procedures "(Latvian journal, 2007, nr. 104.; 2008 92., no; 2009, no. 157; 2010, no. 148; 2013, 158. No.) the following amendments: 1. Replace the text of the provisions: 1.1., the words "law, which sets a special permit (license), the activity in issue in the pharmaceutical, the suspension, cancellation, renewal and order" (fold) with the words "regulations on pharmaceutical activity licensing" (fold); 1.2. the words "public charge price list" with the words "paid service price list". 2. To supplement the provisions of paragraph 2.1 the following: "2.1 free ports, special economic zones and the Customs Act 9. referred to in the second subparagraph of article distribution sites, is subject to supervision in accordance with these rules." 3. To supplement the provisions under point 5.1 by the following: "5.1 health inspection carried out surveillance of the market for medicinal products for human use and carry out market surveillance measures provided to the authority in accordance with the requirements set by the European Parliament and of the Council of 9 July 2008. Regulation (EC) no 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (European Parliament and Council Regulation No 765/2008)." 4. Express 6.1. subparagraph by the following: "6.1. European Parliament and Council Regulation No 765/2008;". 5. Replace the paragraphs 7 and 8, the words "legislation on the distribution of medicinal products medicinal products laid down the requirements for the storage of" with the words "a medicine storage requirements according to the European Commission published the summary of good distribution practice guidelines (available in the national language of the State Agency of medicines tīmekļvietn)". 6. To make the first sentence of paragraph 11 the following: "drugs may be imported by the person in accordance with the laws and regulations on pharmaceutical licensing activities is the State Agency of medicines shall issued a special permit (license) for the production or import of medicines to the authorised transaction-import medicinal product (does not apply to unregistered drugs, drug samples, and the transit of drug-drug shipment, imported from the third countries referred to in paragraph 2.1, this provision places and exported to non-member countries)." 7. Add to subparagraph 12.5. after the words ' the State Agency of medicines "by the words" and health inspection ". 8. Replace the words "in paragraph 12.8. legislation on medicinal products in the distribution and quality control procedures" with the words "published by the European Commission of good distribution practice guidelines (available in the national language of the State Agency of medicines tīmekļvietn)". 9. Delete paragraph 15, the words "(Australia, Canada, New Zealand, Switzerland)". 10. Supplement with 15.1 points as follows: "15.1 these rules referred to in point 15 exception applicable only to production activities or dosage forms that are specified in the agreement between the European Union and the countries concerned." 11. Add to paragraph 16 of the drug after the words "national agencies" with the words "and health inspection". 12. To make the first sentence of paragraph 25, as follows: "drug importer may import the narcotic drugs and psychotropic medicines, which are specified in the application for a special permit (license) for the production or import of medicines and medicinal products of which the National Agency shall issue the special permit (licence), is included in the database according to the legislation on pharmaceutical activity licensing procedures, if the import of medicinal products in accordance with the law on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" is the State Agency of medicines issued by the United Nations (hereinafter referred to as UN) economic and Social Council Drug requirements from the Commission. " 13. Replace paragraph 27, the words "the State Agency of medicines allows the distribution of" with the words "the State Agency of medicines shall not register the distribution of medicinal products authorised medicinal products granted individually." 14. To supplement the rules with 27.1 points as follows: "unregistered 27.1 the narcotic drugs and psychotropic drugs from third countries may be imported if the person in addition to the provisions of paragraph 27 of the specific requirements of the import of medicinal products in accordance with the law on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" is the State Agency of medicines issued by the UN Economic and Social Council Commission of drugs from the requirements of the permit. "

15. Express 28 the following: "28. Samples of medicinal products coming from third countries may be imported in the following cases: 28.1. submission to the State Agency of medicines in connection with registration; 28.2. for use in scientific research; 28.3. the use of training needs; 17.6. use of standard samples for the testing of medicinal products. " 16. To supplement the rules with 28.1 and 28.2 of the paragraph by the following: "28.1 samples of medicinal products (except for the illicit manufacture of narcotic drugs and psychotropic drug samples) from third countries may be imported to the State Agency for medicinal products authorised for the importation of samples of medicinal products in the Republic of Latvia (annex 1). After the permit contains the number of the packaging of medicinal products in the import re import of medicines requires a new permission. 28.2 the illicit manufacture of narcotic drugs and psychotropic drug samples may be imported by the person in accordance with the law on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order "is the State Agency of medicines issued by the UN Economic and Social Council Commission of drugs from the requirements of the permit." 17. To express in paragraph 33 the first sentence by the following: "drugs, including investigational medicinal products, may be exported by a person in accordance with the laws and regulations on pharmaceutical activity licensing procedures has received the medicine government agency issued a special permit (license) for the production or import of a medicinal product or a special permission (licence) for human medicinal products for distribution, which contains special operating conditions – the export of medicinal products, or special permission (license) to open the medicinal lieltirgotav (action) as well as the person who has the right to be represented by the licence holder. " 18. To supplement the rules with 33.1 33.2 points and by the following: 33.1 "narcotic drugs and psychotropic products may be exported the person in addition to the provisions referred to in paragraph 33 the special permissions (licenses) are given for the export of medicines to the law" on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order "within the State Agency of medicines issued by the UN Economic and Social Council Commission of drugs from the requirements of the permit. 33.2 the Person who exports the medicine to ensure that: 1. the compliance of 33.2 European Commission published good distribution practice guidelines (available in the national language of the State Agency of medicines tīmekļvietn) requirements; 2. medicinal products supplied 33.2 persons in third countries, which are entitled to wholesale distribution of medicinal products or deliver its citizens in third countries. All supplies of medicinal products shall be accompanied by a document which contains: 33.2 2.1. delivery date; 33.2 2.2. name of the medicinal product, pharmaceutical form and strength or concentration; 33.2 2.3. quantity delivered (for each medicinal product); 2.4. beneficiary and 33.2 supplier's name and address; 33.2 every 2.5 production of medicines supplied serial number. " 19. Replace the words "in paragraph 40.2. legislation on medicinal products in the distribution and quality control procedures established medicine storage and transportation requirements" by the words "drug storage and transportation requirements according to the European Commission published the summary of good distribution practice guidelines (available in the national language of the State Agency of medicines tīmekļvietn)." 20. Replace paragraph 25.5. the words and figures "Council Regulation No 339/93 article 2" with the words and figures "European Parliament and Council Regulation No 765/2008 article 27." 21. Make the following subparagraphs 41.1.4.: "a breach of the medicine 41.1.4. storage and transportation requirements in accordance with the European Commission published the summary of good distribution practice guidelines (available in the national language of the State Agency of medicines tīmekļvietn);". 22. Delete paragraph 45. 23. Replace the words in paragraph 46 and the number "45 of these rules the decision referred to in paragraph" with the words and figures "European Parliament and Council Regulation No 765/2008 of the prohibition referred to in article 29 of the medicinal products to be placed on the market". 24. the introductory part of paragraph 49 be expressed in the following wording: "49. Health inspections on the basis of the State Drug Agency report, is entitled to suspend a specific drug or all the special permission of the importer (license) in the case of medicinal products imported, or, in cooperation with the State Agency of medicines on a case-by-case basis, decide on the suspension of the imports of the medicinal product, if:". 25. To complement the rules with 30.8 30.8 30.7.,.,.,., and 49.7 49.8. subparagraph by the following: "49. importer of medicines carried out their activities in the pharmaceutical field (address) and spaces that are not specified in the special permit (license), and the licence application and the licence; 30.8. drug importer imports a product that is not listed in the relevant application of the special permission (license) and license (does not apply to specimens of the unregistered medicinal products medicinal products); 30.8. drug importer lacks qualified persons of his qualifications and professional experience to meet the regulations for the production and control of medicinal products order requirements; 49.7 medicinal production. imported or active substance production does not meet the good medicine or active substance manufacturing practice requirements; 49.8. medicinal products or active substances of the medicinal product is fake. " 26. Express 51.1 and 51.2. subparagraph such.: "51.1. monitoring, or distribution and transport this provision places referred to in paragraph 2.1 complies with those rules, regulations on the distribution of medicinal products and the European Commission in published good distribution practice guidelines (available in the national language of the State Agency of medicines tīmekļvietn); 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 (the owner) as to its compatibility with the European Commission in published good distribution practice guidelines (available in the national language of the State Agency of medicines of tīmekļvietn) provided 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 be submitted to the food and veterinary service; ". 27. Express 1 and 2 of the annex by the following: "1. the annex to Cabinet of Ministers of 26 June 2007, regulations No 436 permission for imports of samples of medicinal products in the Republic of Latvia, the State Agency of medicines (legal address, phone number, fax number, e-mail address) in the Riga Nr.   (date)  
On the basis of medicine State agency decision No. _____ (date) for the authorization of medicinal products samples for imports from third countries (legal person of the name, type, registration number) (permit application No.   ), (registration number, the State Agency of medicines, the date of filing and registration) are allowed the following sample imports of medicinal products in the Republic of Latvia from third countries: the model name of the medicinal product, shape, strength, package size, the number of samples of medicinal products medicinal use of samples samples of medicines allowed to receive medicine producer, State Government agency of medicinal products 1 2 3 4 5 Director (name, surname, signature)

Z.v. date _____ _____ _____ _____ _____ _____ notes. 1. the table in the column or row that is not filled in, draw the line. 2. table 3. box the use of samples of a medicinal product "to submit the medicine government agency in connection with the registration," "use for scientific purposes", "use" or "used as the reference drug testing". 3. Tables 4. box the person permit holder is entitled to distribute the permit specified in samples of medicinal products, including: 3.1 "applicant registration certificate", and indicate its name and country; 3.2. "registration of the owner", and indicate its name and country; 3.3. "research institution", and the name of the State revenue service taxpayer ID number State revenue service value added tax payer register; 3.4. "training institution", and the name of the State revenue service taxpayer ID number State revenue service value added tax payer register; 3.5. "testing lab", and the name of the State revenue service taxpayer ID number State revenue service value added tax register. 4. the document properties in the "signature" and "Z.v." does not fill in, if the electronic document is drawn up according to the law on electronic document design. 2. the annex to Cabinet of Ministers of 26 June 2007 Regulation No. 436 of the application for authorization for the import of samples of medicinal products in the Republic of Latvia please medicine government agency to issue a permit for the following sample imports of medicinal products in the Republic of Latvia from third countries intended for (mark with X required): submit the State Agency of medicines in connection with registration to use scientific studies to use the training needs of the reference medicinal product use testing permission to want to get a paper form (required mark with X) : Yes No I share details of the applicant and the medicine 1. Applicant: 1.1 name the State revenue service value added tax payer ID number for the State revenue service value added tax register 1.2. legal address 1.3. actions address 1.4 telephone number fax number 1.5. electronic mail address: 2. Medicinal product name 2.2 2.1 pharmaceutical form 2.3. active substance and strength or concentration 2.4. packing size 2.5. registration number Latvia register of medicinal products (medicinal products registered) 2.6. packaging quantity (number of) 3. consignor of samples of medicinal products , address, telephone number, fax number, electronic mail address of the manufacturer of the medicinal product: 4 4.1 4.2 name registered office and place of business of the address of the 4.3 phone number fax number 5. Person to contact in connection with the application (first name, last name, telephone number, fax number, e-mail address) is added to part II documents (required mark with X, specify the number of pages in the document attached) 1. Proof that drug samples from drug manufacturer (if the sample into the registration of medicinal products), or from the person which country has the right to distribute the medicine 2. proof that the samples of medicinal products intended for submission to the State Agency of medicines in the context of registration 3. A statement that the samples of medicinal products intended for use in scientific research (research and study site address) 4. Proof that drug samples for use learning needs (school's name and location, specialty (study)) 5. A statement that the samples of medicinal products intended for use as a drug testing standard I , (name, officers (authorised representative of the tenderer) posts) I certify that the information given by me is true.
  Executive (the applicant's authorized representative) (position, name, surname, signature) date ___ ___ ____ ____ ____ ____ date of receipt of the application, the State Agency of medicines of the _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ notes. 1. In the column or row that is not filled in, draw the line. 2. If the form is sent without the use of electronic media, the applicant shall sign each form added to her page. 3. If the application is presented on several pages, the officer signed each page. 4. The document property "signature" does not fill in, if the electronic document has been prepared according to the law on electronic document design. " The Prime Minister is the Rapidity of the Newsletters Health Minister Guntis Belēvič in