Cabinet of Ministers Regulations No. 590 Riga 2014 (30 September. No 51 19) amendments to the Cabinet of Ministers of 22 January 2013 by Regulation No 48 "pharmacovigilance" order Issued in accordance with article 5 of the law on Pharmacy-24 draw Cabinet-January 22, 2013 regulations No. 47 "pharmacovigilance procedures" (Latvian journal, 2013, 2014, 22 no; no 6) the following amendments: 1. Express 4 by the following: "4. the pharmacovigilance system consists, for information about the risks posed by medicinal products for patients and public health and participate in the pharmacovigilance process in the European Union. This information is mainly attributable to the adverse reactions of the medicinal product, where the medicinal product for human use in accordance with the registration documentation (including the summary of product characteristics) or do not comply with it, including: excessive use of the product 4.1 in quantities, using the medical person designated medicinal product exceeds the allowed maximum product information in the recommended dose or medicine cumulative result (overdose). Conclusion on drug overdose always justified with clinical assessment; 4.2. the targeted therapeutic use of medicinal products not subject to the registration documentation for information, also approved summary of product characteristics and the package leaflet of the medicinal product specified; 4.3. medicine and appropriate use of targeted, not subject to the registration documentation for information, also approved summary of product characteristics and the package leaflet of the medicinal product specified; 4.4. illegal use of medicines, including illegal sales of medicines and injection against the will of the people, to achieve a certain State of a person and a violent impact on the person; 4.5. the systematic and deliberate abuse of the use of medicines in certain physical or psychological condition; 4.6. the unexpected effects of the medicinal product, which is related to the person's professional or non-professional occupation; 4.7. unconscious error of drug prescribing, dispensing, appointment or supervision, as long as the medicine is treatment person pharmacist or patient control. " 2. Supplement with 9.1 points as follows: "The side effects, especially 9.1 important side effects, treatment of the person and the pharmacist shall notify the State Agency of medicines as soon as you notice a possible connection with the use of the product. If the reporting time is not available for all of the information in accordance with Annex 1 of these provisions, the medical and pharmacist repeatedly report, supplementing it with the necessary information and send it to the State Agency of medicines. " 3. Add to paragraph 11, after the words "the State Agency of medicines" by the words "or registration holder".
4. Supplement with 11.1 points as follows: 11.1 treatment person, "pharmacist or patient report on adverse reactions to medicinal products is entitled to submit to the State Agency of medicines or the registration owner electronic document sent to the electronic mail address, or paper form, submitting it personally or by sending by mail or fax. The report can be submitted electronically by filling in the online message form medicine State Agency's Web site. " 5. Add to subparagraph 15.1 behind the words "quality system" with the words "according to the rules referred to in paragraph 4, the system". 6. Add to paragraph 15.2., after the word "reduction" with the words "and prevention". 7. Replace the words "in paragraph 15.3. address and contact information" with the words "the site address, electronic mail address, telephone number and fax number (if any), including communication outside working hours". 8. Express 15.4. subparagraph by the following: "15.4. established by the national-level contacts in the area of pharmacovigilance (national level), who live and work in Latvia, if the person does not live and work in Latvia. National-level contacts contact information: first name, last name, address of place of business e-mail address, phone number and fax number (if any), including communication outside office hours, as well as changes to the contact information (if any) shall immediately be submitted to the National Agency for medicinal products; ". 9. Supplement 16. point after the words "national level contacts" with the words "report to the person responsible for pharmacovigilance activities and". 10. Add to 17.4. section behind the words "pharmacist" with the words "including, if it transfers the parallel importer and the parallel distributor". 11. To supplement the provisions of this paragraph 17.10: "17.10. following receipt of the information on significant potential adverse reactions to medicinal products, which then became known as soon as possible, but not later than 15 days, inform the State Agency of medicines." 12. To supplement the provisions of this chapter III1: "III1. The parallel importer of medicines and drug dealer's obligations in parallel

20.1 If the parallel importers of medicinal products acquires information about drug side effects it as soon as possible, but not later than two days after the report on adverse reactions to medicinal products receive forwarding it to the State Agency of medicines and the registration holder shall notify the submitter of the message that drug reactions should be reported directly to the State Agency of medicines or the owner of the registration. 20.2 If medicine parallel Distributor acquires the information about drug side effects it as soon as possible, but not later than two days after the report on adverse reactions to medicinal products forwards it to receiving registration holder shall notify the submitter of the message that drug reactions should be reported directly to the owner of the registration. 20.3 the medicine parallel importer and the parallel distributor shall designate a coordinator who is responsible for this rule 20.1 and 20.2 requirements referred to in paragraph 1 in respect of medicinal products, and provide distributed medicine State Agency Coordinator's contact information (name, site address, e-mail address, telephone number, and fax number (if any)). " 13. To supplement 21.1. section behind the words "pharmacists or patients" with the words "also parallel importers, which are transmitted to the relevant information, as well as communicated to the registration owner." 14. To supplement the provisions and paragraph 13.6.21.10. by the following: "shall maintain and 13.6. restores the list with contact information for the responsible persons and national-level contacts (name, site address, e-mail address, telephone number, and fax number (if any), including communication outside office hours); 21.10. following receipt of the information on significant potential adverse reactions to medicinal products which have become known in connection with the registered product, as soon as possible, but not later than 15 days inform the registration owner. Medicine side effects you can report this provision referred to in paragraph 15.4. national-level contact. " 15. Replace the words "in 55.1 to check the registration of the owner of the company and the owner of the marketing affiliates" with the words "check registration holder and, with their related undertakings and representations". 16. paragraphs 56 to express the following: "56. the National Agency for medicinal products authorised officials after the inspection, prepare a control message. Control report indicates whether the registration owner meets good pharmacovigilance practice. If the examination concludes that the registration of the holder of the pharmacovigilance system does not correspond to its description in the pharmacovigilance system master file or the requirements set out in these provisions, the State Agency of medicines control message indicates the discrepancy established and registration allows the owner to give explanations. " 17. To supplement the provisions under paragraph 71 the following wording: "71. This provision is the requirement referred to in paragraph 15.4. national-level contact to live and work in Latvia shall enter into force on July 1, 2015." 18. the introductory part of annex 1 Worded as follows: "If they fill out the report form, in paper form, the lack of available information, you must use an additional sheet of paper, and must be submitted along with the completed report form." 19. Put 4 of annex 1, paragraphs 5 and 6 by the following: "4. the medicinal product which is the likely side effects cause the name of the medicinal product, manufacturer, and serial number (assigned name of the manufacturer; the name of the active substance – see the packaging; important the serial number indicate the biological medicinal products) route times/frequency of use gave the home end of use use indication 5. Other medications that are applied to the last three months (including self-medication) name of the medicinal product and the form route times/frequency of use gave the home end of use use indication 6. PAPILDINFORMĀCIJAPiemēr: 1) as a serious disease, next to allergic reactions, increased drug sensitivity, pregnancy, significant findings; 2) used in parallel imported medicinal product, parallel distributed drugs or unregistered medicines; 3) or medicines are biological medicinal products such as immunological preparations, vaccines, serums, toxins, allergens, from human blood and plasma-derived medicinal products newly introduced therapy medications, such as gene therapy medicinal products, somatic cell therapy medicinal products. 20. Replace annex 1 and 2, the words "the completed report form, please provide the State Agency of medicines in person or send it by mail. A report on the possible side effects of medicines can also be filled in electronically (for more information on the medicine State Agency website URwww.zva.gov.lv) "with the words" document properties "Rapporteur" does not fill in the signature if the electronic document is drawn up according to the law on electronic document design. " The Prime Minister is the Rapidity of the Newsletters Finance Minister Andris Vilks