Amendments To The Cabinet Of Ministers Of 25 June 2013 Regulations No. 344 "active Substance Import And Distribution Procedures"

Original Language Title: Grozījumi Ministru kabineta 2013. gada 25. jūnija noteikumos Nr. 344 "Aktīvo vielu importēšanas un izplatīšanas kārtība"

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Cabinet of Ministers Regulations No. 32 in 2017. on 17 January (pr. Nr. 3 11) amendments to the Cabinet of Ministers of 25 June 2013 regulations No. 344 "active substance import and distribution order Issued in accordance with article 5 of the law on Pharmacy 23. point 1. make Cabinet 25 June 2013 regulations No. 344" active substance import and distribution procedures "(Latvian journal, 13, nr. 123.) the following amendments: 1. replace the words" in paragraph 5.1 regulations on medicine production to the requirements of good manufacturing practice requirements, "with the words and figures" the principles and guidelines of good manufacturing practice according to the European Commission 28 may 2014 the delegated Regulation (EU) no 1252/2014, supplementing the European Parliament and Council Directive 2001/83/EC, including the principles and guidelines of good manufacturing practice in respect of medicinal products for human use active substances (hereinafter Regulation No 1252/2014), and pharmaceutical law referred to in article 51.1 of the European Commission's Handbook on good manufacturing practice for medicinal products laid down in the guidelines on active substances the European Commission has published the European Union regulatory framework for medicinal products document item 4. the volume (of the State Agency of medicines available on the Web site); 1.2. deleting paragraph 9.4; 1.3. to convey the title of chapter III, the following: "(iii). The active substance distribution wholesale order"; 1.4. to express the point 15 as follows: "15. active substances authorised in the wholesale distribution of medicinal products in the national agencies established active substance manufacturer, importer and Distributor."; 1.5. to supplement the rules by 15.1 points as follows: "15.1 active substances permitted to buy from the Member States of the European Union, the competent authority for registered active substance manufacturers, importers and distributors." 1.6. to express 17 as follows: "17. Active substance manufacturer authorized to distribute active substances which have been produced in accordance with Regulation No 1252/2014 and pharmaceutical law referred to in article 51.1 of the European Commission's Handbook on good manufacturing practice for medicinal products laid down in the guidelines on active substances and active substance manufacturer, importer and distributor authorized to distribute active substances in accordance with good distribution practice established in the pharmaceutical law article 22 referred to in the third subparagraph of the European Commission of 19 March 2015 guidelines no 2015/C 95/01 for the people for medicinal products the active substance and good distribution practice principles (national agency of medicinal products available on website). "; 1.7. to supplement 27 to the second and third sentence by the following: "certificate is issued in the form of an electronic document by sending it to the applicant's e-mail address. Certificate in the form of a paper document shall be issued within three working days of receipt of the request for an additional charge, in accordance with the State Agency of medicines paid service price list. "; 1.8. to supplement 28 behind the words "persons" with the word "wholesale"; 1.9. to supplement the rules by 29.1 29.2 29.3 29.4 points, and such as: "29.1 active substance manufacturer, importer and distributor shall immediately – the State Agency of medicines and health inspection officers during checks-or within five working days after the State Agency of medicines and health inspection request, ensure that they have access to all documentation (all written procedures, instructions, contracts, records and data prepared on paper or in electronic form) relating to compliance with the action dealer for good distribution practices that certain pharmaceutical law article 22 referred to in the third subparagraph of the European Commission of 19 March 2015 guidelines no 2015/95/01 (C) for human medicinal products and active substances of good distribution practice principles (national agency of medicines available on the Web site). 29.2 the active substance manufacturer, importer and distributor that has the suspicion that he distributed or imported active ingredient is fake, finding the moment it apart physically or with the equivalent of an electronic system and immediately inform the State Agency of medicines and health inspection. 29.3 the active substance manufacturer, importer and distributor shall immediately – the State Agency of medicines and health inspection officers during checks-or within three working days after the State Agency of medicines and health inspection request, informed of the original active substance manufacturer. 29.4 If you have complained about the quality of the active substance, the active substance manufacturer, importer and distributor shall examine the complaint together with the original manufacturer of the active substance, in order to determine whether there are any additional measures to be taken, involving the active substance importers and distributors who might have received the active substance, or health inspections and the State Agency of medicines. Active substance manufacturer, importer and distributor of health inspection and State agency officials during checks ensure that records are available to them, including complaints about the quality of the active substance. If you have a serious situation or a situation that could endanger the lives of the active substance manufacturer, importer and distributor shall immediately inform the State Agency of medicines and health inspection. '; 1.10. to supplement the provisions of this chapter III1: "III1. Requirements for the active substances in pharmacies in purchasing, accounting, storage and monitoring

30.1 the merchant or operator of the economic activities for which a special permit issued by the (license) to open a drugstore (operation) to allow special operating conditions, the manufacture of medicines in pharmacies: 30.1 1. active substances of the medicinal products are purchased for the manufacture of medicinal products in pharmacies, National Agency for registered active substance manufacturers, importers and distributors; 2. the health inspection 30.1 officers during checks ensure the premises, facilities and equipment, as well as the availability of documentation; 3. develop 18.7 emergency plan, in cooperation with the manufacturer of the active substance concerned, the importer or the Distributor, or by order of the health inspection ensure effective withdrawal of active substances; 30.1 4. counts each transaction with active substances received by using purchase invoices, or electronically or in any other form, giving at least the following information: 30.1 4.1. acquisition date; 30.1 4.2. active substance name or designation; 30.1 4.3. manufacturer's serial number; 30.1 4.4 quantity received; 30.1 the supplier and 4.5 the original manufacturer's name and address; 30.1 4.6. validity period; If made, the date of the test; 30.1 5. ensure that rule 30.1. the data referred to in point 4 to be stored and accessible health inspection officials for at least one year after its active substances series expiration date to which they apply, and for the active substances that have a certain repeated testing, − at least three years after the series is used, but in relation to narcotic and psychotropic substances – at least 10 years from this rule 30.1 4. transactions referred to date. 30.2 the head of Pharmacy shall ensure that the following requirements are met: 1. space, 30.2 facilities and equipment shall be such as to ensure adequate preservation of the active substance in accordance with this provision, 30.2 30.2 2.3 and 4) (30.2. The measuring tools are calibrated and verified; 30.2 2. receipt of the active substance shall ensure that the following requirements are met: 30.2 2.1. active substances during unloading are protected from weather influences. The receive location is separated from the place of storage. Check that the received the ordered active substances or their packaging has not been damaged and that is added to the relevant certificate of analysis; 30.2 2.2. active substances that require special storage conditions (such as the narcotic drugs and psychotropic substances or substances which require special storage temperature or humidity), immediately identified and kept under these rules to a statement and 30.2 in point 3; 30.2 3. active substance in storage, ensure that the following requirements are met: 30.2 3.1. active substances stored according to the manufacturer's specified storage temperature regime, noting that: 30.2 3.1.1. room temperature is between 15 ° C and 25 ° C; 30.2 3.1.2. cool site is from 8 ° C to 15 ° C; 30.2 3.1.3. cold site is from 2 ° C to 8 ° C; 30.2 3.2. termolabil active substances (to higher or lower temperature sensitive substances) stored in a cold room (aukstumkamer) or refrigerator by providing appropriate temperature regime and its registration. 30.2 to the light sensitive 3.3 active substances stored in light-tight places (for example, tightly closed container, special container). If the active substance is not a special opaque packaging, they shall be kept in a dark place; 30.2 3.4. volatile active substances and moisture sensitive active substances stored in a cool place, tightly closed. Hygroscopic active substances stored in a dry room in hermetically sealed containers or plastic containers, if necessary, the container sealed and parafin. 30.2 periodically monitor 3.5 and note the active substance storage room temperature mode; 30.2 2.2. active substances which require special storage storage temperature or humidity, storage space shall be fitted with temperature or humidity recording devices or other items that indicated the periods when the storage mode is maintained; 30.2 3.7 ensure that the storage site should be clean, free from distracting things, dust and pests, and take appropriate precautions against the active substance spills, scattering or packaging defects, microbiological contamination and cross contamination of active substances or confusion; 30.2 4. active substances which are counterfeit, poor quality, or be withdrawn or for which there is a suspicion that they might be fake or low quality (for example, with damaged packaging (seals, contaminated) or which have expired, are separated from other goods physically or with the equivalent of an electronic system. The active substances to prevent their unauthorized use in the manufacture of medicinal products. Complaints about the quality of the active substance by active substance suppliers, informing the health inspectorate and the State Agency of medicines; 30.2 5. According to the law on the illicit manufacture of narcotic drugs and psychotropic substances of the medicinal product and purchasing, receiving, storage, distribution, delivery, and disposal procedures of accounting records, and recorded in the illicit manufacture of narcotic drugs and psychotropic substances recognized and mandatory, in addition to the journal in Latvia controlled the illicit manufacture of narcotic drugs and psychotropic substances in list II and III substances intended for the manufacture of medicinal products, the following substances: 30.2 atropine sulphate 5.1; 30.2 5.2. silver nitrate; 30.2 5.3 arsēnpaskāb anhydride; crystalline sodium 30.2 5.4 arsenate; 30.2 the hidrogenhlorīd tetrakaīn 5.5 (dikaīn). "; 1.11. to complement the 38 points in the second and third sentence as follows: "the certificate shall be issued in the form of an electronic document by sending it to the applicant's e-mail address. Certificate in the form of a paper document shall be issued within three working days of receipt of the request for an additional charge, in accordance with the State Agency of medicines paid service price list. "; 1.12. to supplement annex 2 to paragraph 5 and 6 by the following: "5. Brazil 6. Israel (with the exception of the territory that the Israeli administration since June, 1967, Golan Heights, Gaza Strip, East Jerusalem and the rest of the West Bank) "1.13. to complement annex 3 with the following note:" Note. Document property "signature" does not fill in, if an electronic document is drawn up according to the law on electronic document design. " 1.14. Add to the introductory part of annex 4 of the second paragraph by the following: "registration certificate would get in paper form (required mark with X) Yes No"; 1.15. deletion of annex 4, paragraph 1.6., the words "if any". 2. the rules shall enter into force on March 1, 2017. Prime Minister Māris kučinskis Health-Welfare Minister Minister John a Rare

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