Amendments To The Cabinet Of Ministers Of 26 June 2007 The Regulation No 416 "distribution And Quality Control Procedure"

Original Language Title: Grozījumi Ministru kabineta 2007.gada 26.jūnija noteikumos Nr.416 "Zāļu izplatīšanas un kvalitātes kontroles kārtība"

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Cabinet of Ministers Regulations No. 1046 Riga 2013 (October 8. No 52 54) amendments to the Cabinet of Ministers of 26 June 2007 Regulation No 416 "the distribution and quality control procedure" Issued in accordance with article 5 of the law on Pharmacy 3 and 25 and article 19 1. make Cabinet 26 June 2007 Regulation No 416 "the distribution and quality control procedure" (Latvian journal, 2007, no. 104, 2008, no. 167; 2009, 126, 154. No; No 123; in 2010, 2012 147. no), the following amendments: 1. express an indication on what basis the provisions of the law, issued by the following: "Issued in accordance with article 5 of the law on Pharmacy 3 and 25 and article 19"; 1.2. the replace text (except paragraph 12.3., paragraph 116 and 3.5 of annex 6), the words "veterinary care Merchant" (fold) with the words "veterinary care institutions" (the fold); 1.3. adding to paragraph 1, after the word "procedures" with the words "as well as the availability of medicinal products required for the analysis of wholesale sales and distribution of data"; 1.4. deletion of 5.7. 1.5. to supplement the provisions under paragraph 5.9. following: "5.9. brokering with medicines are all activities relating to the sale or purchase of medicines (except wholesale of medicines), which does not include the physical handling and consists of conversations taking place in whatever other legal or natural persons. '; 1.6. delete paragraph 11.1; 1.7. replace paragraph 12.3., the words "veterinary care business operators who" with the words "veterinary care institutions; 1.8. make 12.5. the introductory part of subparagraph by the following: "5. counts each transaction in medicinal products received and sent, through the purchase and sales invoices, or electronically using your computer, or in any other way. For medicinal products, including products that are the subject of brokering, specify at least the following information: "; 1.9. to supplement the provisions under section 12.5.3.1 as follows: "12.5.3.1 brokering of medicinal products medicinal products specified;"; 1.10. to supplement the rules with the following paragraph 12.11.: "No 12.11., without delay, inform the health inspection and, if necessary, the registration certificate holder, if received or offered drugs are counterfeit or have reason to suspect that they could be fake."; 1.11. to replace the 12.1 point and figure "that rule 11.1 persons referred to in point" with the words "medical institutions, social care institutions, practicing veterinarians and the veterinary care institutions"; 1.12. supplement with 12.2, 12.3 and 12.4 points as follows: "for the purposes of implementing this rule 12.2 12.2. condition referred, drug wholesaler in cases where medications obtained from other pharmaceutical wholesaler, check whether the supplier of the medicinal product wholesalers comply with the following rules laid down in chapter III of the good distribution practices and supplier of medicinal products or medicinal products lieltirgotav has this provision in paragraph 11.1 or 13 a licence referred to in paragraph. If the medicinal product is obtained from a drug company, a pharmaceutical wholesaler to verify that the manufacturer is 11.2. these provisions referred to in the licence for the manufacture of medicinal products or the rules referred to in paragraph 13 of the license. Where a medicinal product derived from herbal medicine wholesalers, importers shall verify that the importer has this rule 11.2. the license referred to in the import of medicines. 12.3 the wholesale distribution of medicines to third countries: 12.3 1. shall not be subject to medicinal product wholesalers distribute requirements (export-export from the customs territory of the European Union) registered in Latvia or the provisions referred to in paragraph 8. centralized registration of medicinal products established in the procedure and apply this rule 12.2. the requirements referred to in point a; 2. pharmaceutical wholesaler 12.3 medicines exported by taking delivery of medicinal products to persons in third countries, which are entitled to wholesale distribution of medicinal products or deliver its people in third countries, this provision, 12.5.4.12.5.6.2 12.5.2.,.,., and 30.2.2 30.2.1. requirements referred to in point. 12.4 If the grass directly receives from a third country and they are not intended to be placed on the market in Latvia or in another European economic area country, but drugs are purchased from third countries who are authorised to supply medicinal products, a wholesaler of medicinal products do not apply these rules to the requirements referred to in point 12.2. "; 1.13. the introductory part of paragraph 18, replace the number "11.1" with the number "12.1"; 1. replace paragraph 18.1., the words "common volume of" with the words "number of packages number of packages distributed"; 1.15. replace paragraph 19, the word "ls" with the word "Euro"; 1.16. replace paragraph 19.1 "11.1" with the number "12.1"; 1.17. replace paragraph 20, the words "monitoring the side effects of medicinal products (pharmacovigilance) system" with the words "pharmacovigilance"; 1.18. the introductory part of paragraph 22 be expressed in the following wording: "22. Drug wholesaler shall establish and maintain a quality system which, in connection with his activities, the nature and extent of the obligations are laid down, processes and risk management measures to ensure that:"; 1.19 replace paragraph 60 of introductory paragraph, the words "a centrally registered Hall" with the words "distribute centrally registered medicinal products"; 1.20. the deletion of the text in point 63. "http://www.ema.europa.eu"; 1.21. supplement with 39.2 point as follows: "39.2 parallel distributor in the European Medicines Agency pays a fee for products that have been registered in accordance with European Parliament and Council Regulation No 726/2004, the European Medicines Agency to verify whether the conditions laid down in the marketing authorisations are fulfilled."; 1.22. the deletion of paragraph 64, the words "http://www.ema.europa.eu"; 1.23. to supplement the provisions of this chapter with V1: "V1. Mediation deals with the medicinal product if the product obtained by 66.1 through mediated drug wholesaler, check whether the intermediary concerned has complied with the requirements set out in this chapter. 66.2 mediation deals with medicine can only be registered in the State Agency of medicines. To register for the State Agency of medicines shall be submitted by the person in the State Agency of medicines of the application for registration of the person conducting the mediation business of medicinal products (hereinafter registration application) (2.1). The application for registration shall specify at least the following information: 1. name and surname 66.2 (economic agents) or business name, registered office; 66.2 2. site address in Latvia; 3. contact information of 66.2 in Latvia. 66.3 this provision of any changes to the data referred to in paragraph 66.2 person making mediation business with drugs, shall immediately notify the State Agency of medicines shall submit a registration application to the indicated changes (annex 2.1). 66.4 medicine State Agency shall register the person conducting the mediation business with drugs, making a decision on its inclusion in a register which is accessible to the public of medicinal products the State Agency's Web site. The person who conducted the mediation business with drugs, the medicines agency the register indicates that rule 66.2 66.2.1 and 2, the data referred to in point. the fact of the recording of 41.3 medicine State Agency issued a registration certificate (annex 2.2). The State Agency of medicines of the registration certificate of the electronic form of the document to the person registered on the application specified electronic mail address within three working days after payment for the issuance of the registration certificate of the dossier submitted for inspection and testing. Paper document in the form of a certificate of registration shall be issued within three working days of receipt of the request and for an additional charge for this service in accordance with the State Agency of medicines of the public paid services price list. 66.6 persons doing business with drugs, through: 1. ensure that the 66.6 medicine that is brokering the subject, would be registered in Latvia or in these rules referred to in paragraph 8. centralized registration procedure; 66.6 2. establishes and maintains a quality system in relation to their activities, the nature and extent of the obligations are laid down, processes and risk management measures. 66.7 requirements laid down this rule 12.4, 12.5, 12.6, 12.7, and 12.11., also apply to the mediation business of medicinal products. If the person who made 41.5 brokerage business with drugs, don't follow that rule 66.3, 66.6 and 66.7 of the type referred to in paragraph 1, the State Agency of medicines has the right to decide on the exclusion of the person concerned from this rule 66.4 referred to in the registry. The decision on the removal from the register of the State Agency of medicines shall notify such person of notice in accordance with the procedure prescribed by law. "; 1.24. replace the words "in 71.1 veterinary care merchant who has requested a Hall" with the words "veterinary care authority that the medicinal product is requested"; 1.25. replace 86.4 points, the words "under the supervision of the side effects of medicinal products (pharmacovigilance)" with the words "pharmacovigilance"; 1.26. supplement with 87.2 point as follows: "If the State Agency of medicines 87.2 has received other European economic area countries request the competent authorities to submit an assessment report of the medicinal product copy for products registered in Latvia and the medicinal product concerned on the a certificate of registration, the State Agency of medicines within 30 days after receipt of the request, submit a copy of the assessment report and the relevant marketing authorisation of a medicinal product. '; 1.27. replace the words "in 90.1 regulations for pharmacovigilance procedures" with the words "legislation on pharmacovigilance procedures"; 1.28. the deletion of the text in paragraph 91 (http://www.zva.gov.lv) (hereinafter referred to as the medicine State Agency website) "; 1.29. to replace the words in paragraph 93 and the number "referred to in paragraph 11.1 of these rules to the person" with the words "a trader or an economic analyst who issued a special permit (license) to open a drugstore (operation)"; 1.30. replace paragraph 94.2 figure "11.1" with the number "12.1"; 1.31. replace 94.3 words in paragraph 3.3.4. "monitoring" adverse "pharmacovigilance"; 1.32. supplement with 94.13 points as follows: "this rule 94.1.94.13 referred to unregistered medicines distribution permission granted specific individual medicines known to the individual patient or patients (annex 6), using a good faith (bona fide) order, it is not necessary that the economic operators referred to in point 11.1 or economic operator for the distribution of medicinal products not registered if they comply with the use of the medicinal product list or are distributed outpatient treatments the purchase of medicinal products in the framework of the system of compensation and the drug wholesaler medicine receives from pharmaceutical wholesaler that this rule is issued the authorization referred to in paragraph 94. In this case, the 95.2.1 of these provisions and rules referred to in paragraph 95.2.2. shall not apply. '; 1. Add to 100 introductory paragraph after the words "only" with the words "General or open type"; 1.34. supplement with 100.3 100.4. subparagraph and the following wording: "received special permission from 100.3. (license) or general open pharmacy to open that attachment contains the special operating conditions authorised" non-prescription drug distribution with Web sites through "; 100.4. Health authorities announced the date from which the population offers non-prescription drug distribution in retail Web sites, as well as the cessation of the activity in question and the reconstruction. " 1.35.102. supplementing point after the words "electronic mail address" with the words "address of Web site"; 1.36. supplement with 103.5. subparagraph by the following: "103.5. contact information for the State Agency of medicines and the link to the State Agency of medicines website."; 1.37. supplement with 103.1 point as follows: "the State Agency of medicines of 103.1 publishes on its website the following information at least: 103.1 1. information about the laws and regulations applicable to the retail distribution of medicinal products to the Web site, including the information that a particular medicinal product in other Member States can be classified in different ways; 2. licensed pharmacies 103.1 list that allowed Hall to distribute to retail Web sites, indicating that individual Web site addresses; 103.1 3. for more information about the risks of the use of the product, supplied by people illegally with the Web site; 4. link to 103.1 of the European Medicines Agency Web site with this rule 103.1 1. referred to information on European Union legislation, applicable to medicinal products, as well as links to the Member States of the European Union websites. "; 1.38. the deletion of the words in paragraph 112.1. "it is used under normal conditions of use"; 1.39. the deletion of the words in subparagraph 112.3. "permitted conditions of use"; 1.40. supplement with 112.2 points as follows: "this rule 112.1 112.2 points in that decision, the health inspection may also accept a possible fake drugs and suspicion of drug quality defects."; 1.41. replace paragraph 113, the words "for which the quality of the suspect" with the words "for which there is a suspicion of fraud or the potential quality defects"; 1.42. supplement with 113.1 points the following wording: "113.1 for the supply of medicinal products is prohibited or which have been withdrawn from the market in accordance with the provisions of paragraph 112 and 113., in exceptional circumstances, the transition period health inspection with the State Agency of medicines has the right in exceptional cases allow to supply the medications patients already being treated with them (not applicable to counterfeit medicines)."; 1.43. the express section 115.1. the following: 115.1. "immediately of any action that it takes, to stop the distribution of medicinal products, to request withdrawal from the market of the medicinal product, request the cancellation of the registration or log on to medicine, and on the renewal of the action concerned. Health authorities in the communication and the State Agency of medicines shall specify that the information referred to in paragraph 119. The owner of the registration, in particular, whether the action is based on one of these rules 112. criteria referred to in paragraph 1, when the supply of medicinal products prohibited and the medicinal product withdrawn from the market, or the law on the procedure of registration of the said decision making criteria for registration or re-registration or on the suspension or withdrawal of registration amendment (applies to cases where it is recognized that the medicinal product is harmful in medicine is not the therapeutic efficiency , the risk-benefit balance is not favourable, its qualitative or quantitative composition is not as described in the registration dossier, in connection with the registration or re-registration application specified data is not accurate or complete, or they are not amended, the holder of the registration are not fulfilled the obligations laid down in connection with pharmacovigilance or the product is not manufactured according to the description of the manufacturing method, or the control is not carried out according to the description of control methods). If the action is based on one of these criteria, the registration holder shall inform the health inspection for the State Agency of medicines and also in cases where the operation is performed in the third country. The owner of the registration shall also inform the European Medicines Agency, if the action is based on one of the criteria; " 1. make the following paragraph 116: "116. If there is a suspicion of possible fake drugs and sub-standard medicines as possible, this provision in paragraph 11 and 13 of that person, a trader or an economic operator, which has served the special permission (license) to open a drugstore (operation), the medical institutions, social care institutions, medical veterinarians, veterinary care or other person shall notify the Health Office. The notification shall specify: 116.1. name of the medicinal product, the strength or the strength and the pharmaceutical form; the labelling of the medicinal product and 116.2. instructions for use and registration of the manufacturer specified owner (if any); 116.3. serial number of the medicinal product; 116.4. the party from which the medicine purchased. "; 1.45. supplement with 116.1 points as follows: "If the suspected 116.1 medicines essential to public health, health inspections, in cooperation with the State Agency of medicines shall assess the situation, immediately sends a response message to all other Member States of the European Union and supports sending notifications to all existing supply chain participants, subject to this provision in chapter XII of the procedure and of the procedure and the rules laid down in paragraph 122. If it is considered that such drugs have reached patients, in accordance with the provisions of paragraph 117 and 118.24 hours are provided urgent public announcements on this medicine to patients. In those notices is sufficient information on the potential quality defects or counterfeit medicines and the risks associated with them. " 1.46. express the introductory part of paragraph 122 the following wording: "122. If the drugs found quality defect (annex 9), health inspections, in cooperation with the State Agency of medicines shall assess the situation and take a decision, including on further action, based on considerations of public health, and inform the relevant authorised distributors of the decision taken, indicating that rule the information referred to in paragraph 119 and information on further action. Notification shall be given orally (such as by phone), and writing (via fax and electronic): "; 1.47. replace paragraph 146.1. the words "monitoring" adverse "pharmacovigilance"; 1.48. the supplement with 146.7.,.,., 146.9 146.8 146.10.,.,., 146.13 146.12 146.11. and section follows 146.14.: 146.7. carry out checks on the "distribution of compliance with good distribution practices at least every five years and, if necessary, carry out checks for which has not been notified. If you do not take the test, for which it is notified, agreed with the drug wholesalers and individuals who do business with products of mediation, of a time when will start the inspection and shall notify in writing the medicine wholesaler and the person who is doing business with the brokerage. If necessary, the State Agency of medicines has the right to request a European economic area country official medicines control laboratory or a laboratory of the Agency of the country to carry out the check; 146.8. This provision 146.7 in These drug wholesaler after other checks of the Member State of the European Union, the European Commission or the European Medicines Agency's request may also be carried out in third countries. Checks may also be carried out at the premises of the person who conducts the mediation business with drugs; 146.9. after each 146.7. these provisions and 146.8. the checks referred to in paragraph prepares the control message. Control message indicates whether the pharmaceutical wholesaler and the person who conducts the mediation deals with medicines, follow good distribution practice. The State Agency of medicines before the control message confirmation within three working days after the message dial sends it to the person checking in the form of electronic documents to the electronic mail address or, on request, in the form of a paper document and provides the possibility to submit comments. Control message, if necessary, shall forward to the authority that requested the verification; 146.10. issue a check to the person of good distribution practice certificate of compliance, which meets European Union good distribution practice certificate (annex 14), if the Party examined correspond to good distribution practice. The certificate is issued in the form of an electronic document, by sending them to verify the person's electronic mail address within three working days after the drug wholesaler of medicinal products in accordance with the national agency of the public paid the price list has paid the prescribed fee for document assessment and good distribution practice test. If good distribution practice conformity assessment related to the trip, a pharmaceutical wholesaler of medicinal products shall be borne by the national road Agency (transport) costs to the test object and back, spending on hotels (accommodation), health insurance and subsistence expenses in accordance with the laws and regulations on the procedures for recoverable with missions and staff travel-related expenses. Certificate in the form of a paper document shall be issued within three working days of receipt of the request and for an additional charge for this service in accordance with the State Agency of medicines of the public paid the price list; 146.11. enter information about issued good distribution practice certificate in the database of the European Union on production and import licenses and certificates of good manufacturing practice (hereinafter referred to as the Eudr of GMDP database) within three working days after the decision on the issue of the certificate; 146.12. where this provision is 146.7. the results of the examination referred to medicinal product wholesalers shows that does not comply with the law and these rules of Pharmacy requirements have not been followed and good distribution practice requirement, information entered in the database of GMDP Eudr within three working days after the decision is taken; 146.13. information is entitled to issue the requestor for medicines, including parallel imported, exported and distributed medicines in parallel (with the exception of veterinary medicinal products), wholesale sales data required for the analysis of access to medicines, the following distribution: 146.13.1 sales of pharmaceutical standard report (quarter by months, half year, year)-includes anatomic therapeutic chemical classification code (ATC code), international non-proprietary name (INN), shape, strength or concentration, number of packages , the number of packages sold, turnover in euro; 146.13.2. sales of the medicinal product in the extended report (quarter by months, half year, year) – includes standard information contained in the report and requested the Group of medicinal products in accordance with the provisions of section 18.4 or membership classification group; 146.13.3. the medicine sales full review (quarter by months, half year, year) – includes standard information contained in the report, the beneficiary group of medicinal products in accordance with the provisions of section 18.4 and drug classification of group membership; 146.13.4. drug sales data individual reports, which shall be restricted to the registration certificate holder about his registered medicinal products-includes international non-proprietary name (INN), registration number, anatomic therapeutic chemical classification code (ATC code), pharmaceutical form, strength or concentration, number of packages number of packages sold; 146.14. contract with the applicant for the medicine, including parallel imported, exported and distributed medicines in parallel (with the exception of veterinary medicinal products), wholesale sales services 146.13. in the cases referred to in accordance with the State Agency of medicines a public charge price list. "; 1.49. supplement with 146.1 points as follows: "this provision and 146.1 146.7.146.8. inspection referred to in the National Agency for medicines authorised officials have the right to: 1. examine 146.1 medicine wholesalers and persons doing business with the mediation; 146.1 2. take samples in order to perform an independent test of the European economic area and the official medicines control laboratory or a laboratory of the Agency of the country of the medicinal product. '; 1.50. the deletion of the text in paragraph 148 (http://www.vi.gov.lv) '; 1.51. supplement with 151.3. subparagraph by the following: "these rules 151.3.115. in paragraph 116 above and receive notifications and handling procedures in respect of the drug, for which there is a suspicion of possible counterfeits or quality defects, and drug withdrawal procedures and a series of work during and outside working time. '; 1.52. Express 153.3.2. subparagraph as follows: "153.3.2. registered medicinal products on a permanent or on a temporary basis shall not be placed on the Latvian market. Such notification shall be given at least two months (except in exceptional circumstances) before it suspended the placing on the market of medicinal products. The owner of the registration in accordance with the provisions of section 115.1. inform the State Agency of medicines of the reasons for such a measure. " 1.53. replace the words "in 153.5 drug safety" with the words "drug safety"; 03. supplement with 171.6, 171.8 171.7 and point as follows: "1. The provisions of 171.6 12.3, 12.4 and section 113.1 and 151.3. shall enter into force on 28 October 2013. This provision 171.7 41.3 points in relation to the issuance of the registration certificate of the person who conducted the mediation business with drugs, and this provision subparagraph relating to 146.10 good distribution practice certificate of compliance is issued in the form of a paper document for the fee shall enter into force on 1 July 2014. 146.13.1. These provisions 171.8 States turnover to 31 December 2013 to be in. "; 1.55. to complement the informative reference to European Union directives, with 5, 6, and 7, paragraph by the following: "(5)) of the European Parliament and of the Council of 8 June 2011-2011/62/EU directive, amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards how to prevent counterfeit medicines from entering the legal supply chain; 6) the European Parliament and of the Council of 15 December 2010, the EU directive 2010/84/as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use; 7) the European Parliament and of the Council of 25 October 2012 the 2012/26/EU directive, amending Directive 2001/83/EC as regards pharmacovigilance. "; 1.56. the express 1 and 2, note 3 of the annex by the following: "3. the document property" signature "does not fill in, if an electronic document is drawn up according to the law on electronic document design." 1.57. supplement with 2.1 and 2.2 of the annex by the following: "2.1 Annex Cabinet 26 June 2007 the Regulation No 416 persons registering the application that performs the brokerage business with medicine medicine State Agency (required mark with x) for registration changes 1. information on the applicant: 1. the firm name registered office 1.3 1.2. registration number or foreign merchant affiliate company registration number in the trade register 1.4. actual site address in the Republic of Latvia 1.5. special permission (license) number of pharmaceutical activity (if any) 1.6. contact information : phone fax e-mail address website contact (name, title) information on the company, which carries out brokerage transactions with medication (indicate the start and end of work time) Monday Tuesday Wednesday Thursday Friday Saturday Sunday 2. Please track changes (needed to mark with x): 3.1 persons registered in name or firm registered address 3.2 3.3 3.4 in place of the actual action.  contact phone fax email address contacts Annex: 1. Description of the system the mediation transactions in products (quality systems) to ___ ____ pages. 2. the document with which the business person or economic operator authorised this application referred to in point 1.6 of contact to submit national agency of medicinal products and the application documents to the __ _____ pages. I certify that the information provided in the application is complete and true and corresponds to the Cabinet of Ministers of 26 June 2007 the Regulation No 416 "medicine distribution and quality control".
The person responsible for the registration contact information: first name and last name title address phone, fax, e-mail (place, date) (signature) (signature of the person who has the right of representation) notes. 1. If a company has multiple sites, 1.4 this submission referred to information on other sites and officers indicate on a separate sheet and attach to the application. 2. Economic operator who is not required to register with the commercial register, section 1.1 this application shall indicate the name, surname and personal code, section 1.2, the declared place of residence address, do not fill in point 1.3. 3. the document property "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design. 4. By submitting the application for the change when you fill in the parts of the form that are subject to the data about the changes. 2.2 the attachment Cabinet of 26 June 2007, the provisions of no. 416 of Latvia's State Agency of medicines of the REPUBLIC OF Latvia, the State AGENCY OF medicines (legal address, registration number, telephone number, fax number, e-mail address) (legal address, registration number, phone, fax number, e-mail) persons doing business with products of mediation, registration certificate a Person engaged in the brokering of medicinal products REGISTRATION certificate 1. Registration number Registration number 2. Persons registered in the firm (name) name or corporate name of Registrant 3. Persons registered in the official address of the Permanent or legal address of Registrant 4. Actual activity location address address of a site where registered activities take place 5. legal basis of the National legal basis of registration This certificate of registration is valid only in full, including all the pages.
This registration form is only valid in full, including all the pages.
This registration certificate referred to in paragraph 2, the person shall report any changes immediately.
The registered party referred to in Paragraph 2 should report immediately of any changes.
The State Agency of medicines of the responsible amatpersonaNam of the authorised person of the State Agency of medicines (signature/signature) (position, name, surname/position, name, surname) Note. Document property "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design.
Callout. Document property "signature" is not filled in if the document is prepared in accordanc with the law of electronic documents.
1. to express 3. Note 4 by the following: "4. the document property" signature "does not fill in, if an electronic document is drawn up according to the law on electronic document design." 1.59. Express 4. Annex 6. Note the following: "6. the document property" signature "does not fill in, if an electronic document is drawn up according to the law on electronic document design." 1.60. the Express 5. Note 2 of the annex by the following: "2. the document property" signature "does not fill in, if an electronic document is drawn up according to the law on electronic document design." 1.61. Express 3.5. of annex 6, note the following: "3.5" veterinary care authority ", and the name and registration number of the food and veterinary service of the companies register;"; 1.62. Express 6 to annex 10. Note as follows: "10." document properties "does not fill in the signature if the electronic document is drawn up according to the law on electronic document design." 1.63. the Express 5. Annex 7 Note by the following: "5. the document property" signature "does not fill in, if an electronic document is drawn up according to the law on electronic document design." 1. make a note of the annex 10 the following: "Note. Document property "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design. " 1.65. the express 11., note 3 of the annex by the following: "3. the document property" signature "does not fill in, if an electronic document is drawn up according to the law on electronic document design." 1.66. Annex 12 express note 7 by the following: "7." document properties "does not fill in the signature if the electronic document is drawn up according to the law on electronic document design." 1.67. make note of annex 13 as follows: "Note. Document property "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design. " 1.68. the supplement to annex 14 rules with the following wording: "annex 14. Cabinet of Ministers of 26 June 2007, the provisions of no. 416 of Latvia's State Agency of medicines of the REPUBLIC OF Latvia, the State AGENCY OF medicines (address, registration number, telephone number, fax number, e-mail address) (address, registration number, phone, fax number, e-mail) certificate No. ___/___/___ certificate Of.  
  Drug dealer's good distribution practice certificate of conformity for medicinal products for human use the certificate OF compliance OF GDP (A) DISTRIBUTOR OF MEDICINAL PRODUCTS FOR HUMAN use part 1 part 1 Issued after official verification (inspection) in accordance with the provisions of Directive 2001/83/EC article 111 the following official United Nations inspection Issued in accordanc with art. 111 of Directive 2001/83/EC on medicinal products public agency certifies : the State Agency of medicines of the confirm the following: pharmaceutical wholesaler wholesale distributor distribution site address site address is officially inspected in accordance with the provisions of Directive 2001/83/EC article 111, paragraph 1 of which engrossed in the legislation of the Republic of Latvia: has been inspected in accordanc with art. 111 (1) of Directive 2001/83/EC transposed in national legislation the following: drug dealer's official tests , the last of which was made of ___ ___ ___/__/____ ____ ____ [date], the information obtained suggests that it meets the active substance good distribution practice referred to in Directive 2001/83/EC article 47.
From the knowledge gained during inspection of the active substance by the distributor, the latest of which was conducted on .../… …/… … [date], it is considered that it stay with the principles compl of good distribution practice for active substances referred to in article 47 of Directive 2001/83/EC.
This certificate reflects the status of the site the official examinations referred to in time and may not reflect the compliance status, if it has been more than five years since the official checks when the certificate was issued. The validity period can be shortened by using risk management principles and regulatory requirements by making a record field that allowed limit, or explanation.
This certificate will reflect the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflec the compliance status if more than five years have elapsed since the date of the official inspection, after which time the issuing authority should be consulted. This period of validity may be reduced by using regulatory risk management principles by an entry in the "Restriction" or "Clarifying Remarks" field. The authenticity of the certificate can be checked in the database of the Union. If the certificate is not in the database, please contact your national agency for medicinal products.
The authenticity of this certificate may be verified in the Union's database '. If it does not appear, please contact the issuing authority. Any limitations or explanations in relation to the scope of this certificate: Any restriction or clarifying remarks related to the scope of this certificate: ____ ____/____/____ ____ (date/date) National Agency for medicinal products authorised officials name and signature name, surname and signature of the authorized person of the Competent Authority of United Kingdom (name, position, authority, telephone number, e-mail address, questions/name, surname, position, national authority , phone number, email in case of enquiries) Note. Document property "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design.
Callout. Document property "signature" is not filled in if the document is prepared in accordanc with the law of electronic documents. 2. This rule 1.15. subparagraph shall enter into force on January 1, 2014. Prime Minister Valdis Dombrovskis Health Minister Ingrida Cricket»


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