Cabinet of Ministers Regulations No. 624 in 2012 (on 11 September. No 51 7) amendments to the Cabinet of Ministers of 26 June 2007 Regulation No 416 "the distribution and quality control procedure" Issued in accordance with article 5 of the law of Pharmacy (3) and article 19 1. make Cabinet 26 June 2007 Regulation No 416 "the distribution and quality control procedure" (Latvian journal, 2007, 104 no; 2008, 167. no; 2009, 126, 154 no, No 123; 2010) follows : 1.1. to complement the introductory part of paragraph 11, after the word "businessman" with the words "or a person who is registered in the State revenue service as economic operator (hereinafter referred to as the economic operator)"; 1.2. to complement the 11.1 point after the word "the" with the words "a trader or analyst of economic activity"; 1.3. to complement the 12.1 point after the word "the" with the words "a trader or analyst of economic activity"; 1.4. to replace the words "in paragraph 18.2. registration number Latvia register of medicinal products" by the words "product identification number assigned by the State Agency of medicines each medicinal product registered for the size and shape of the package specified in the Latvian register of medicinal products; 1.5. to replace in paragraph 18.3. number and the word "94." with the figures and the words "in paragraph 86 and 94"; 1.6. to replace the words "in paragraph 18.4 (if any)" with the words "(specifying, if any)"; 1.7. to complement the 19.1 points, after the word "the" with the words "a trader or analyst of economic activity"; 1.8. to supplement paragraph 23, after the word "businessman" with the words "and" performer "of economic activity; 1.9. adding to 38 after the word "quality" with the words and the number "If the parallel importer has issued the rules referred to in paragraph 34 of the parallel imported medicinal product authorised for distribution in the Republic of Latvia and this permission is valid"; 1.10. supplement with 45.3 45.4 45.5.,., and 45.6. subparagraph by the following: "45.3. in Latvia registered registration is cancelled or suspended under the pharmaceutical laws and regulations for the registration of the medicinal product. That provision does not apply to the case where the applicant has submitted a registration application to stop the registration and the reason is not associated with risk for public health; 28.2. the registration owner registered in Latvia has withdrawn registration and the revocation reason is related to the risk to the health of the population (drug safety, quality and efficacy); 28.3. the product is not re-registered; 45.6. the renewal for medicinal products shall be applied. "; 1.11. delete paragraph 47; 1.12. subparagraph 72.3.1 to replace the words "health economics Centre" with the words "national health service"; 1.13. supplement 78. point after the words "record holder" with the words "or the parallel importer"; 1.14. the deletion of the words in paragraph 86 (registration process) "; 1.15. replace 86.1 points, the words "health economics Centre" with the words "national health service"; 1.16. the express follows 87.1 points: "87.1 decision granting permission for the State Agency of medicines shall be adopted by the European economic area national competent authorities for medicinal products provided an assessment report and of the marketing authorisation for a medicinal product. If the assessment report of the medicinal product in the European economic area State approved by the competent authority, the State Agency of medicines require relevant to the European economic area to the national competent authority to present the corresponding operating instructions of registered medicines and the summary of the original language or in English, if the instructions for use of the medicinal product and of the summary of product characteristics approved in English. In this case, the decision on the authorisation of the State Agency of medicines shall be adopted by the marketing authorisation of medicinal products, the use of the medicinal product instructions and the receipt of the summary of product characteristics. If this rule 86, paragraph requires the permission of the holder of the registration of the medicinal product or when the product is in the process of registration, the registration of the applicant State Agency of medicines require the use of the medicinal product instructions and a certified translation of the summary of product characteristics in accordance with the laws of the order in which the documents of which a translation in the language of the country. " 1.17. replace paragraph 88, the words "Not registered distribution permissions" with the words "this provision mentioned in paragraph 86 permissions"; 1.18. to replace the words "in paragraph 89 of the unregistered medicines distribution permission" with the words "these rules permit referred to in paragraph 86"; 1.19. the introductory part of paragraph 90 to replace the words "unregistered distribution permissions" with the words "this provision mentioned in paragraph 86 permissions"; 1.20. paragraph 93 expressed as follows: "93.86. These provisions permit referred to in this provision entitles the 11 and 13 above drug wholesaler to distribute the medicine wholesale, but these provisions 11.1 the person referred-to distribute drugs in accordance with the provisions of paragraph 12.1."; 1.21. adding to 94.2 points, after the word "the" with the words "trader and analyst of economic activity"; 1.22. adding to 94.4 points, after the word "businessman" with the words "and" performer "of economic activity; 1.23. replace paragraph 107, the number and the word "in" Annex 8 with the numbers and the words "Annex 8 1.3 and 2.2., 3., 4. and in paragraph 5 and paragraph 6.2."; 1.24. replace paragraph 109 figures and the words "4, 5, and 6" with numbers and the words "paragraphs 4 and 5 '; 1.25. the supplement to chapter X 111.1 points as follows: "this rule 111.1 111. test referred to in paragraph 1 shall be borne by the State Agency of medicines of the medicines that have been registered: 111.1 1. mutual recognition procedure and decentralised procedure when testing samples taken or send the market surveillance framework, coordinated by the European Directorate for the quality of medicines; 111.1 2. national registration procedure, which is not a mutual recognition procedure or the decentralised procedure, if testing samples taken or return based on 13 October 2011 at the conclusion of the agreement between the State Agency of medicines and the relevant Estonian and Lithuanian competent authorities on a common procedure for the monitoring of the quality of medicinal products in the field of drug testing in the monitoring and control of medicinal products, including Lithuania and Estonia after the request to the competent authorities of the as well as in the context of market surveillance, which is coordinated by the European Directorate for the quality of the medicinal product. '; 1.26. the supplement 149.7.4. section behind the words "the name of the manufacturer of the medicinal product" with the word "address"; 1.27. the supplement section 153.1. drug follows the words "progress towards market" with the words "including registration and renewal planning process and terms so as not to increase the provision of medicinal products referred to in paragraph 78 of the items"; 1.28. Replace subparagraph 153.3.1., the words "subject to the different packing types of medicinal products" by the words "and the number indicating that rule 18.2. referred to drug identification number to each registered medicine form the size of packages"; 1.29. supplement 159. paragraph after the word "the" with the words "economic operators and economic agents"; 1.30. supplement with 171.4 and 171.5 points as follows: "the State Agency of medicines of 171.4 issued permit: 171.4 1. European economic area country, but not registered in the Republic of Latvia for the distribution of medicinal products issued by the State Agency of medicines to the 2012 October 1, are valid until the end of the period of validity; 2. unregistered 171.4 medicine distribution to individual medicinal products granted by the State Agency of medicines to the 2012 October 1 with the specified validity period is valid until the end of the period of validity; 3. the remaining medicine 171.4 inventory distribution, issued by the State Agency of medicines to the 2012 October 1, are valid until the end of the period of validity. 171.5 application for European economic area country, but registered in the Republic of Latvia does not register the distribution authorization and application for individual grant unregistered distribution authorization which is submitted to the State Agency of medicines to the 2012 October 1, be considered valid. "; 1.31. delete Note 2 in annex 2; 1.32. Amend Note 2 to annex 3; 1. Express 3. Note 3 of the annex by the following: "3. the authorisation, indicating the remaining inventory of the distribution of medicinal products at the time the medicine name also indicates the serial number, expiry date, number of packages and packaging. '; 1.34. Express annex 4 by the following: "4. in the annex to Cabinet of Ministers of 26 June 2007, the provisions of the Republic of Latvia no 416 medicine State Agency (legal address, registration number, telephone and fax number) to the European economic area country, but not registered in the Republic of Latvia of distribution of medicinal products authorised in the Riga Nr.   (date)      
On the basis of the State Agency of medicines of the decision No.     (date) on the issue of the European economic area country, but not registered in the Republic of Latvia, public health, the Republic of Latvia authorized to distribute the following products: Application No.   Received

    (registration number, the State Agency of medicines)    (date of registration in the State Agency of medicines)
 
1. Name of the medicinal product, shape, strength or concentration and number of packages 2. active (active) components (components of) the international name 3. the marketing authorisation holder (name, address, country) 4. Member State of the European Union or the European economic area country, which has granted a marketing authorization (registration certificate) and the number 5. Medicine manufacturer (name, address, country) 6. ATC codes and DDD code identification number 7 8. Distribution conditions allowed the importation of medicines from countries of the European economic area.

Permit is valid until (date) National Medicines Agency Director (signature) Z.v. Notes. 1. table 3. box the owner of the registration certificate or registration of the applicant according to the regulations on the registration of the medicinal product. 2. table 6. box the anatomic therapeutic chemical classification (ATC code) code and defined daily dose (DDD) code. 3. table 7. box the State Agency of medicines of the medicines assigned identification number for each pharmaceutical form of packaging. 4. table 8. box the group classification of medicinal products granted in accordance with the laws and regulations on the classification of the medicinal product, and its legend. Non-prescription medicinal products, the designation does not specify. 5. If a table column or row is not filled in, pull the bar. 6. Document Properties "date" and "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design. " 1.35. to make annex 5 by the following: "5. the annex to Cabinet of Ministers of 26 June 2007 Regulation No 416 of the application of the European economic area, but registered in the Republic of Latvia does not register the distribution authorization (required mark with x) the application for the granting of authorisation application for changes to the documentation, please state agency of medicines shall issue the authorisation within the European economic area country, but in the Republic of Latvia does not register the application specified in part I of the distribution of medicinal products in the Republic of Latvia. (I) the particulars of the applicant and the medicine 1. Applicant: 1.1. legal persons name, type 1.2. registration number 1.3. phone number fax number 1.4. electronic mail address 2. Medicinal product: the name 2.1 2.2 2.3 pharmaceutical form concentration or strength 2.4. packing size 2.5. active ingredients international name 3. The holder of the registration certificate (owner) (name, country, legal address) 4. Member State of the European Union or the European economic area country that has granted the marketing authorisation (registration certificate), and the registration number in the country 5. Drug manufacturer: 5.1 5.2. name, registered office and place of business address 5.3. phone number fax number e-mail address 6. 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 attached) 1. labelling of the medicinal product : 1.1. primary and secondary packaging mock-up mock-up of the label authentic 1.2, containing the label location label text 1.3 certified translation in accordance with the laws and regulations on the procedures which are translations of documents in the language of the country 1.4. information on pārmarķētāj (pārpakotāj)-name, registered and operating address, license number of the manufacture of medicinal products medicinal products 2 instructions for use and description: the original 2.1 2.2. instructions for use certified translation in accordance with the laws and regulations on the procedures for that document, a translation of which national Edition 3. professional associations of doctors opinion on medicine with public health rationale 4. proof of drug control related to the payment of expenditure, I, (name, officers, the applicant or his authorized representative) certify that the information given by me is true. 
Executive (the applicant's authorized representative): first name, last name, title, signature _____ _____ _____ _____ _____ date ____ ____ ____ ____ ____ ____ place ___ _____ _____ _____ _____ _____ date of receipt of the application, the State Agency of medicines of the _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ notes. 1. If a column or row is not filled in, pull the bar. 2. the document properties "date" and "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design. " 1.36. Express annex 6 by the following: "6. the annex to Cabinet of Ministers of 26 June 2007, the provisions of the Republic of Latvia no 416 medicine State Agency (legal address, registration number, telephone and fax number) is not a registered drug distribution permission individually assigned halls in Riga No. ____ _____ (date) on the basis of the State Agency of medicines no ____ ____ ____ on authorisation of medicinal products not registered for distribution in the Republic of Latvia, the distribution of medicinal products authorised in the Republic of Latvia (legal name , type, registration number) Application No.   Received (the registration number of the State Agency of medicines) (date of registration in the State Agency of medicines) identification number for the drug name, form, strength or concentration and number of packages number of packages medicinal products authorized to distribute a drug company, the State allowed the importation of medicinal products 1 2 3 4 5 from: (mark with x required): European economic area countries third countries permit is valid until (date) National Medicines Agency Director (signature)

Z.v. If permission is given the number of packages of medicines, medicinal products specified in the authorisation number of the package distribution for repeated distribution of medicinal products need not register the distribution of medicines. The notes. 1. If a table column or row is not filled in, pull the bar. 2. In the table in section "allowed drug imports from:" fill in the relevant information contained in the application shall not be registered individually assigned distribution authorization. 3. Tables 4. box the person permit holder is entitled to distribute drugs specified in the permit (not applicable to Notes 4 and 5 of the said licence), including: 3.1 "the drugstore", and indicate its name and license number; 3.2. the "medical establishment" and indicate its name and registration number of treatment institutions register; 3.3. the "social body", and the name of the State revenue service taxpayer ID number State revenue service taxpayer register; 3.4. "practicing veterinarian" and indicate its name, address and registration number of the food and veterinary service of the company in the register; 3.5. the "veterinary care operator", and indicate its name and registration number of the food and veterinary service of the company subject to the registry. 4. Allow unregistered medicinal products which meet the applicable list of medicinal products or that are prevalent in outpatient treatments the purchase of medicinal products in the framework of the system of compensation (not subject to the authorisation referred to in note 3): table 4.1-3. do not fill in the box; 4.2. table 4 include the in box: 4.2.1. "medicinal product meets the hospitals use drug list"; 4.2.2. "drugs are common outpatient treatments the purchase of medicinal products in the framework of the system of compensation". You do not have to specify a particular Pharmacy and hospital's name. 5. Compassion in medicine: 5.1. table 4 column "medications be distributed" shall include: 5.1.1 "halls available for use on compassionate grounds" of the European Parliament and of the Council of 31 March 2004, Regulation (EC) No 726/2004 laying down the procedures for the authorisation and supervision of medicinal products for human and veterinary use Community procedures and establishing a European Medicines Agency, article 83; 5.1.2. specific known patient's name or "patient group"; 5.1.3. the treatment in which the patient; grass extract 5.2. table 5 indicates in box: 5.2.1 medicine manufacturer's name, address, contact person (name, title, phone, fax, e-mail address (if any)); 5.2.2. the name of the country; 5.2.3. the applicant's name, address, and contact (name, title, phone, fax, e-mail address (if any)); 5.3. the attachment adds: 5.3.1. this rule 94.3 3.3 use of the product referred to in point (except drug labelling and instructions for use for the project); 5.3.2. the medicine label and instructions for use of the national language; 5.3.3. European Medicines Agency's Committee for medicinal products for an opinion on the use of the medicinal product and the conditions for distribution and the patients targeted (if any). 6. the introductory part of the name of the legal person and number of the registration of the medicinal product for a manufacturer of medicinal products lieltirgotav and specifies special permissions (licenses) number. Where the medicinal product is issued on compassionate medical treatment institution, indicate the registration number of the hospital's medical authorities of the registry. 7. table 1. box the State Agency of medicines of the assigned drug identification number. 8. the permit shall contain the indication "permit valid until", if the permit is issued for: 8.1. medicinal products which comply with the use of the medicinal product in the list; 8.2. for medicinal products, which are distributed in the outpatient treatments the purchase of medicinal products in the framework of the system of compensation; 8.3. compassionate medicine. The expiration date indicates, in the light of this rule 94.3 3.3. program referred to in subparagraph includes information on the estimated number of patients, the volume and duration of the use of the product. 9. The permit shall include reference to "specified in the authorization number of the packaging of medicinal products in the distribution reinvestment distribution (import) need not register the distribution licence", contains a number of packages. 10. Document Properties "date" and "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design. " 1.37. to supplement annex 7, part I, with a 2.8 point as follows: "2.8. country in which the product is registered, and the registration number in it";    
1.38. the supplement to annex 7 with paragraph 5 by the following: "5. the drug supplier (name, registered and operating address)";    
1.39. deletion of annex 7. Note 4; 1.40. supplement of Annex 8 of the introductory part of paragraph 1, after the word "eye drops" with the words "and eye ointments"; 1.41. Replace annex 8 in point 1.2, the word "one" with the words "at least one"; 1.42. Express 8. point 3 of the annex by the following: "3. the ampoules and powder flasks (other than immunological preparations and insulin preparations): 3.1. lieltirgotav of medicinal products and the pharmaceutical company for at least one drug series calendar year 3.2. medicine lieltirgotav medicine in each series before the commencement of distribution of medicinal products, if the medicinal product is intended to be distributed on the basis of the hospital's request, in accordance with article 10 of the law on Pharmacy 7 ' b ' section "1.43. Express 8. point 6 of the annex by the following:" 6. sterile dosage forms: 6.1. lieltirgotav of medicinal products and the pharmaceutical company for at least one series in each of the medicinal dosage forms in the calendar year of 6.2. medicine lieltirgotav medicine in each series before the commencement of distribution of medicinal products, if the medicinal product is intended to be distributed on the basis of the hospital's request, in accordance with article 10 of the law on Pharmacy 7 ' b ' section "1.44. to supplement annex 8 with the following note:" Note. 1.1. This annex, paragraph 2.1., and 3., 4. and 5. and in paragraph 6.1. control referred to also apply to pharmaceutical wholesaler who imported drugs (person with these regulations referred to in paragraph 11.2. special permit (license) for the production or import of medicines). " 2. This rule 1.4, 1.5 and 1.6. subparagraph shall enter into force on January 1, 2013. 3. the rules shall enter into force on the 1 October 2012. Prime Minister-Minister of prosperity I. Viņķel Minister of health, Minister of education and science r. wedge