Cabinet of Ministers Regulations No. 47 in 2013 (January 22. 5. § 15) pharmacovigilance procedure Issued in accordance with article 5 of the law on Pharmacy's 24 i. General questions 1. determines the procedure of pharmacovigilance. 2. the rules relating to medicinal products for human use. 3. The terms used in the following terms: 3.1 significant adverse side effects, which, results in death, is life-threatening, requires inpatient hospitalisation or prolongation of hospitalization, which creates a lasting or significant disability or incapacity, is a congenital anomaly, or the other way is essential to health; 3.2. minor side effects – side effects of medicinal products, which does not match any of the significant side effects of the medicinal product; 3.3. the pharmacovigilance system – the system used for registration and the holder of the European economic area (hereinafter EEA countries) the competent institution, in order to fulfil certain pharmacovigilance tasks and responsibilities, and which is designed to monitor the safety of medicinal products authorised and determine any balance of risk and benefit changes; 3.4. the pharmacovigilance system master file-details of registration set out in the owner's description of the pharmacovigilance system in relation to one or more authorised medicinal product; 3.5. post-registration safety research – all the research on medicinal products, to establish the health risks, describe it or define it in quantitative terms, confirming drug safety characteristics, or to assess the effectiveness of risk management measures; 3.6. risk management system – the registration of the holder of such a set of pharmacovigilance activities the purpose of which is to identify, characterise, prevent or minimise the use of drug-related risks, including to assess the effectiveness of these measures; 3.7. the risk management plan-details set forth in the registration owner's risk management system. 4. the pharmacovigilance system consists, for information about the risks posed by medicinal products for patients and public health. 5. the pharmacovigilance system is used to collect and evaluate scientific information on drug side effect expressions that people encountered, use appropriate or inappropriate in the registration dossier, and to consider options for risk reduction, prevention and to make, where necessary, regulatory action with respect to registration. 6. when all the established pharmacovigilance activities, the registration holder shall comply with European regulations adopted by the Commission and decisions.
II. Treatment of parties, pharmacist and patient rights and responsibilities 7. to ensure the effective functioning of the pharmacovigilance system, treatment of the person or pharmacist about possible drug side effects observed in the report of the National Agency for Medicines (message sample in annex 1 of these rules) or the owner of the registration. 8. Medical person or pharmacist in accordance with these rules shall notify the State Agency of medicines of the medicines adverse reactions observed using an unregistered medicine, including if they are available for use on compassionate grounds, as well as participating in drug safety studies post-registration. 9. The report on the possible adverse effects of medicinal treatment of the person or pharmacist will provide in-depth and accurate information, to ensure that the pharmacovigilance system message it is possible to scientifically analyze.
10. Medical person or pharmacist follow the additional monitoring and reporting terms and conditions (for example, in the summary of product characteristics and package leaflet of the medicinal product in the supplementary supervision), where specific medicinal products or active substances that have been identified. 11. The patient has the right to report to the State Agency of medicines of suspected adverse reactions to medicinal products (using the rules specified in annex 2 of the report of the sample or the State Agency's Web site URwww.zva.gov.lv). 12. Treatment of a person or patient, pharmacist by the State Agency of medicines or the owner of the registration request, provide additional information on the observed potential adverse reactions to medicinal products. 13. Treatment services, treatment of individuals and professional organizations of pharmacists and patient organisations followed pharmacovigilance risk mitigation measures and the exchange of information on pharmacovigilance matters (also on adverse reactions to medicinal products) with the State Agency of medicines, in order to ensure the effective functioning of the pharmacovigilance system. 14. the national health care system authorities jurisdiction involved in pharmacovigilance risk mitigation measures and the exchange of information on pharmacovigilance matters (including adverse reactions to medicinal products) with the State Agency of medicines and registration holders, in order to ensure the effective functioning of the pharmacovigilance system.
III. Registration obligations of the owner

15. the registration owner: 15.1 provides pharmacovigilance system and quality system. Quality systems in accordance with the Commission's June 19 2012 implementing Regulation (EU) No 520/2012 for a European Parliament and Council Regulation (EC) No 726/EC and European Parliament and Council Directive 2001/83/EC, for the operation of pharmacovigilance (hereinafter Regulation No 520/2012) article 8; 15.2. using these provisions 15.1 the pharmacovigilance system referred to, carried out an assessment of the scientific information and, if necessary, take appropriate risk mitigation measures; 15.3. to constantly and continuously employed for a qualified person responsible for pharmacovigilance (hereinafter responsible person) who live and work in the European Union and is responsible for pharmacovigilance system set up and maintenance. Persons name, surname, address and contact information submitted to the State Agency of medicines, as well as the European Medicines Agency reporting format, which is used for the electronic submission of information to the European Medicines Agency, the European Union, for all registered medicinal products for human use; 15.4. national-level contact pharmacovigilance matters (hereinafter referred to as the national-level contacts), if the person does not live and work in Latvia. National-level contacts contact information, how to change contact information (if any) shall be submitted immediately to the State Agency of medicines; 15.5. diet and by the European Medicines Agency or the National Agency's request within seven days provide a copy of the pharmacovigilance system master file available; 15.6. ensure that the risk management system is up and running for all drugs except medication for which the registration is entered into force until July 21, 2012, when the law on the procedure of registration of medicinal products not otherwise specified; 15.7. watch what results provide risk mitigation measures that are included in a risk management plan or determined in accordance with the regulations on the registration of the medicinal product; 15.8. regularly update risk management system and monitor pharmacovigilance data to determine if new risks have appeared, the risks have changed or there are changes in the use of the product risk and gains balance. Medicines developed risk mitigation measures shall be submitted to the National Agency for medicines reconciliation; 15.9. the regular audit of the pharmacovigilance system, the pharmacovigilance system master made a record of major audits identified inconsistencies and ensure that, based on the audit, be prepared and implemented in accordance with the corrective action plan. 16. National-level contact in accordance with the instructions of the person responsible. 17. the registration owner regarding pharmacovigilance data acquisition, logging, reporting and evaluation: 17.1. record any significant potential side effects of medicines, which are observed in one of the EEA States or in a third country, on which it became known from the medical people, pharmacists, patient or post-registration during the study, and immediately, but not later than 15 days following the receipt of the information electronically sends the message to the European Union side to insert message database (hereinafter referred to as the EudraVigilance database); 17.2. register all the less relevant the possible drug side effects observed in one of the EEA States, and no later than 90 days after the receipt of such information electronically transmitted message into the EudraVigilance database; 17.3. ensure that rule 17.1 and 17.2. messages referred to would be available to the EudraVigilance database; 17.4. adopt and review the State Agency of medicines, herbs, pharmacists and patient person, provided reports on the possible side effects of the medicinal product; 17.5. develop written procedures to get the accurate and verifiable data to report on possible drug side effects, as well as the assessment of the scientific information on potential adverse reactions to medicinal products; 10.9. cooperate with the European Medicines Agency and national competent authorities to open a report on the possible side effects of the medicinal product duplication; 17.7. in accordance with the provisions of chapter V of the electronically submitted to the European Medicines Agency periodic safety updated reports (periodic reports); 11.1. the State Agency of medicines shall be submitted in the application for the registration of the medicinal product documentation changes, adding an updated summary of product characteristics and the package leaflet of the medicinal product in accordance with the regulations on the registration of the medicinal product; 11.1. inform the European Medicines Agency and the national agencies, if new risks have appeared, changed the existing risks, or the risk and benefits are open to the public. 18. Reporting on adverse reactions to medicinal products, use international terminology in accordance with Regulation No. 520/2012 article 25. 19. prior to the provision of information to the general public of the registration holder on propagation of medicinal products authorised use shall inform the State Agency of medicines, the European Medicines Agency and the European Commission. Registration holder shall ensure that the information provided would be objective, it must not be misleading. 20. Clinical studies revealed the possible side effects of medicinal products registered in accordance with the laws and regulations on the use of clinical trials and observational procedure.
IV. the State Agency of medicines of the obligations of the State Agency of medicines 21:21.1. record all possible drug side effects observed on the territory of the Republic of Latvia of which reported treatment of individuals, pharmacists or patients; 21.2. immediately make public information on the observed pharmacovigilance issues if they present serious threats to public health; 21.3. no later than 24 hours before the disclosure, inform the European Medicines Agency and the European Commission on the observed serious problem pharmacovigilance; 21.4. the registration of the holder of the risk management plan included in the risk mitigation measures and monitor their results; 21.5. evaluate medicinal products registered in the system of risk management updates; 21.6. monitor the EudraVigilance database to determine whether there are new risks or risks have changed and whether these risks affect the risk/benefit balance; 21.7. ensure regular audits of their pharmacovigilance system and the results every two years to the European Commission; 21.8. ensure Web sites linking to the European Medicines Agency website, set up by 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 (hereinafter Regulation No 726/2004), article 26 of which are available in at least the following information: 21.8.1. public assessment reports and summaries; 21.8.2. Summary of product characteristics and the package leaflet of the medicinal product; 21.8.3. registered medicines risk management plan summary; 21.8.4. list of the medicinal products referred to in Regulation No 726/2004, article 23; 21.8.5. information about the reporting possibilities (also the form to report suspected adverse reactions to medicinal products), as well as other relevant information on pharmacovigilance matters. 22. the National Agency for medicines after this rule 21.1. the report referred to the evaluation of electronically to the EudraVigilance database inserting messages: 22.1. about essential potential drug side effects – 15 days; 22.2. the less significant potential adverse reactions to medicinal products – 90 days.
23. the State Agency of medicines shall cooperate with other competent authorities of EEA countries, and the European Medicines Agency registration owners to open a report on the possible side effects of the medicinal product duplication. 24. By publishing this rule 21.2. information referred to in respect of the personal data protection Act requirements in relation to the provision of information, if that information is not required to disclose, in order to ensure the protection of public health. 25. the State Agency of medicines shall inform the other competent authorities of EEA countries, European Medicines Agency, as well as registration of owners, if new risks have appeared, changed the existing risks, or the risk and benefits are open to the public.
V. periodically updated the safety messages

26. In submitting this provision 17.7. referred to in the periodic report of the European Medicines Agency: 26.1. registration holder shall include: 26.1.1. a summary of the data on the risks and benefits of all research results, together with the reasons, or they change the conditions for the registration of the medicinal product; 26.1.2. medicine risk and gains balance scientific assessment, based on available data, also information obtained in clinical research for inappropriate indications and populations; 26.1.3. all data on the volume of sales of the medicinal product and any registration of the owner of the possession of the data relating to the volume of prescriptions, also count of the number of people exposed to the action of the medicinal product; 26.2. the holder of the registration to which the registration is entered into force until 2012 July 21 and periodic reporting is not required as a condition of registration, periodic reports shall be submitted without delay by the State Agency of medicines or the request in the following order: 26.2.1.  If the product is not yet put on the market – not less frequently than every six months after authorisation and until the placing on the market; 26.2.2. where a medicinal product is placed on the market: 26.2.2.1. – the first two years following the initial placing on the market not less frequently than every six months; 26.2.2.2. next two years – once a year; 26.2.2.3. further, every three years. 27. the State Agency of medicines shall assess periodic reports to determine if new risks have appeared, the risks have changed or there is a change in the balance of risk and benefit. 28. the Joint report prepared by the European Medicines Agency Coordination Group (hereinafter referred to as the coordination group) chosen by the Member State or the European Medicines Agency, the pharmacovigilance risk assessment committee appointed a Rapporteur. 29. If the reference State or Rapporteur is Latvia, State Agency of medicines within 60 days of the periodic report to prepares an assessment report and send to the European Medicines Agency, as well as to the competent authorities in the EEA countries. 30. If the reference State or Rapporteur is another EEA country, medicine State agency within 30 days after the receipt of the assessment report can be the European Medicines Agency, the competent institution of the EEA State or Rapporteur to submit their comments on the assessment report. 31. If the reference State or Rapporteur is Latvia, medicine State agency within 15 days after the receipt of the updated observations, an assessment report taking into account all the comments submitted, and send it to the pharmacovigilance risk assessment Committee. 32. the periodic report of the State Agency of medicines of the screening, if required, shall decide on the registration, modification, suspension or cancellation in accordance with the regulations on the registration of the medicinal product.
Vi. Urgent safety associated with the European Union procedure 33. If after evaluation of the pharmacovigilance data need urgently to take action, the State Agency of medicines shall decide on: 33.1. registration suspension or cancellation in accordance with the regulations on the registration of the medicinal product; 33.2. the prohibition of the supply of medicinal products in accordance with the laws and regulations on the distribution and quality control procedures; 33.3. the refusal of a renewal of the medicinal product in accordance with the regulations on the registration of the medicinal product; 20.8. this rule 33.1 33.2 33.3.,., or the measures referred to in point, if the holder of the registration in informed that drug safety reasons it stopped distribution of the medicinal product, the reference medicinal product registration or intend to do so; 33.5. changes in registration dossier in respect of new contraindications, dosage reduction or indicating the fall. 34. In adopting one of these rules the decision referred to in paragraph 33, the State Agency of medicines in accordance with the provisions of this subparagraph shall inform the 21.3. European Medicines Agency and the European Commission, as well as other competent authorities of EEA countries and registration the owner, who is responsible for the distribution of medicinal products. 35. If the need for urgent measures to ensure the protection of public health, State Agency of medicines until the final decision is entitled to suspend the registration, and to prohibit the use of the medicinal product concerned on the territory of Latvia, no later than the following working day inform the European Medicines Agency, the European Commission and the other competent authorities of EEA countries. 36. in the Urgent safety-related procedures of the European Union may relate to certain drugs or medicine group. 37. the information Received from the European Commission or other competent authorities of the Member States with urgent safety related procedures of the European Union, the State Agency of medicines available to it all the important scientific data and all medicine State Agency's assessment shall be submitted to the European Medicines Agency. 38. If the coordination group has ruled on the question of the owner of the registration of the medicinal product registration, modification, suspension, cancellation or refusal to reregister them as well as on the implementation of the agreed position of the graphic, the owner of the registration according to the implementation timetable laid down for the State Agency of medicines shall be submitted in the application for the change, adding an updated summary of product characteristics and package leaflet in accordance with the regulations on the registration of the medicinal product. 39. the National Agency for medicines, these rules referred to in paragraph 38 of the agreed position, proceed in accordance with its implementation timetable, vary, suspend or revoke the registration of the medicinal product or re.
VII. Post-registration safety studies 40. Registration the owner not the intervention of the safety studies post-registration (post-registration study) data on the safety of the treatment of persons, the German pharmacists and patients, post-registration studies initiated, managed or funded voluntarily or to comply with the conditions for registration in accordance with the regulations on the registration of the medicinal product. 41. Registration the owner is responsible for post-marketing study according to the professional standard, ensuring the right of persons engaged in the study and protection of data. 42. the purpose of the study is not a post-registration encourage the consumption of medicinal products. 43. The study at the time of the registration holder shall monitor the findings and take into account their impact on the risk of the medicinal product concerned and gains balance. 44. All new data (except data that indicates the registration owner to update periodically the safety report) that may affect the risk and benefits of medicinal products balance evaluation, registration, the owner shall notify the State Agency of medicines. 45. the registration owner within 12 months after the end of the study, submitted to the post-registration medicine State agency study final report, if the study has been carried out in the Republic of Latvia. 46. in order to comply with the laws and procedures for the registration of medicinal products, these registration conditions, the registration holder in accordance with Regulation No. 520/2012 pharmacovigilance activities in contained conditions of performance shall submit the research protocol a post-registration project: 46.1. the pharmacovigilance risk assessment committee – where the research will be carried out in more than one country; 46.2. the State Agency of medicines – if the research will be carried out in the Republic of Latvia. 47. the State Agency of medicines within 60 days of this provision in the Protocol referred to in paragraph 46 of the draft receipt prepare registration owner opinion on the draft Protocol approval or opinion with reasonable objections in any of the cases referred to in this paragraph, if it considers that: 29.3. the study will encourage the consumption of medicinal products; 47.2. the way in which the research will be carried out, does not meet the objectives of the study; 47.3. the study is a clinical trial. 48. That rule 46.2. post-registration studies referred to the duration of the registration the owner any substantive amendments to the Protocol shall submit for assessment before implementation of the National Medicines Agency. 49. the National Agency for medicinal products within 30 days evaluate amendments and shall inform the holder of the registration or approval of the Protocol. 50. the registration owner within 12 months after the end of the study, submitted to the post-registration medicine State Agency final report of the study.
51. the registration holder shall assess whether the post-registration study results affect the registration and, if necessary, submit to the medicines agency an application for changes in registration. 52. the registration of the medicinal product shall be submitted electronically by the owner, a government agency in the research summary and final report. 53. If a post-registration studies is carried out in several countries of the EEA, the study can start only after the pharmacovigilance risk evaluation committee registration holder has issued the written permission.
VIII. The pharmacovigilance surveillance

54. in order to assess the conformity of the owner of the registration of the medicinal product for good pharmacovigilance practices, the State Agency of medicines shall verify the registration of the holder of the pharmacovigilance system compliance with the requirements laid down in these rules, making routine, repetitive and exceptional checks. 55. This rule 54. the checks referred to in point, the State Agency of medicines of the competent official shall have the right to: 55.1. to check the registration of the company and the owner of the registration of the holder of the related companies, including premises, equipment, personnel, quality assurance measures, relating to the registration of the holder of the pharmacovigilance system; 55.2. to examine the test object's documentation, and verify its records; 55.3. to check the pharmacovigilance system master file. 56. If the rules referred to in paragraph 54 tests concluded 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 shall prepare a written inspection report. The message is sent to the owner of the registration, pointing to failures and enables the registration owner to provide explanations. 57. the owner of the registration of medicinal products, if necessary, within 30 days of the State Agency of medicines shall submit the corrective action plan. 58. the State Agency of medicines on the basis of this provision, the plan referred to in paragraph 57, prepare a final report for the control and forward it to the owner of the registration of medicinal products, as well as other competent authorities in the EEA national or the European Medicines Agency, if you have received a reasoned request. 59. If the test results show 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 shall assess and, if necessary, be informed of the discrepancies identified another EEA country by the competent authorities, the European Medicines Agency and the European Commission. 60. the State Agency of medicines shall suspend, withdraw or change registration documentation or extend the registration on the basis of the provisions of the law on the registration of the medicinal product. 61. the State Agency of medicines shall adopt a decision to cancel the provision of the decision referred to in paragraph 60 of the suspension of the registration of the medicinal product, if the circumstances which were the basis for a decision. 62. the State Agency of medicines in accordance with Regulation No 726/2004, article 19 is entitled, if necessary, carry out checks before registration. 63. as this provision 62. checks referred to in paragraph State Agency of medicines shall prepare a report electronically by the European Medicines Agency, the competent authorities of the EEA countries and the European Commission. 64. the State Agency of medicines and health inspection according to competency work together to ensure that the requirements laid down in these provisions.
IX. Closing questions 65. Be declared unenforceable in the Cabinet of Ministers of 6 December 2005 rules no 919 "of pharmacovigilance procedures" (Latvian journal, 2005, nr. 196; 2008, nr. 10). 66. the State Agency of medicines shall prepare, and by 2013. on 21 September, the European Commission presented the first report on the audit of the pharmacovigilance system. 67. The provisions referred to in paragraph 15.5. requirement of registration to the owner to maintain and make available on request a pharmacovigilance system master file of one or more medicinal products for which a decision on registration before July 21, 2012, the applicable as of the date of adoption of the decision on registration of the medicinal product, or with 21 July 2015 (whichever is earlier). 68. Chapter VII of these rules apply to those post-marketing studies that start after the 21 July 2012. 69. Until such time as the European Medicines Agency started to provide a complete database of EudraVigilance action for all the critical potential adverse reactions to medicinal products, which are found on the territory of Latvia, the owner of the registration no later than 15 days following the receipt of the information reported to the State Agency of medicines, but for all the possible side effects of the medicinal product, which is found in the territory of a third country, the European Medicines Agency. 70. Until such time as the European Medicines Agency started to provide a periodic report repository, harmonised registration owner periodic reports shall be submitted to the national agency of medicinal products, if the product is registered in Latvia.
Informative reference to European Union directives, the regulations include provisions resulting from: 1) of 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; 2) of the European Parliament and of the Council of 6 November 2001, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Prime Minister v. Minister of health I dombrovsky. Cricket is annex 1 Cabinet January 22, 2013 regulations No 47 drug treatment agency in the country, PHARMACISTS PERSONAL report on drug side effects if they fill out the report form, the lack of available information, please use additional paper and submit it together with the completed report form. Significant adverse, if it caused the death of a patient, threatened life, applied for inpatient hospitalisation or prolongation of existing hospitalisation, medicinal products must be reported immediately to the national agency or the next working day. The report form must be completed and sent to the seven days of essential medicine side effects of sighting. In other cases, the report on adverse to be sent as soon as possible.
1. information on notifying 2. Patient information first name, last name, first name last name initials (or code) specialty sex V S certificate number age (Please specify full year or number of months) business address (Please indicate the exact weight in kilograms) contact information (to clarify (if necessary) the information referred to in the report, please indicate the contact numbers and/or e-mail address), hospital (Please indicate if the patient is hospitalized) 3. Adverse reactions in the description of the starting date (dd./mm./gggg.) The reaction of the starting time, noon.   Description (symptoms, laboratory and other studies, the side effects of medicinal treatment) caused the death of a patient Or drug side effect disappeared or grass used for the first time to threaten the patient's life completely Yes No patient required hospitalization or prolongation of hospitalization is not yet extinct created a lasting or severe disability or incapacity for work Has lasting consequences if the medicinal product is used repeatedly, or the last time had similar side effects is a congenital anomaly is unknown yes no Is the other way medically essential drugs 4. who are the likely side effects cause the name of the medicinal product, manufacturer, and serial number route times/frequency of use gave the home end of use 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 6. additional information (such as a serious allergic reactions, co-morbidity, increased drug sensitivity, pregnancy, significant study results) reporting date (signature name first name, last name) (/mm./gggg. dd.)
Signing the message, the authorisation for a medicinal product, a government agency staff to contact me to clarify the information referred to in the report and asked the necessary questions. 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 Government Agency's website URwww.zva.gov.lv). Health Minister i. Cricket 2. Annex Cabinet January 22, 2013 regulations No 47 national agency for medicinal products Report No. (fill in the State Agency of medicines employee)
Patient drug adverse reactions report please provide as accurate information about adverse reactions to medicinal products found. If you fill in the report form, the lack of available information, please use additional paper and submit it together with the completed report form.

1. information on the rapporteur, first name last name phone number e-mail to clarify (if necessary) the information referred to in the report, please indicate the contact numbers and/or e-mail address. 2. information about the person that is provided in the report on the same rapporteur For another person (a person whose legal or authorised representative is rapporteur, the minor children of the person, the person who has been declared legally incompetent) on the effects on the fetus during pregnancy on the impact on children of breastfeeding during the first name last name sex V's weight (Please specify the exact weight in kg) date of birth (dd./mm./gggg.) Age (Please specify full year or month) Please specify ages as accurately as possible. If you do not know the specific date of birth, age, specify the full years or months. 3. a description of the adverse reactions start date and time (dd./mm./gggg. Chair.) Response end date (if the reaction is over) (/mm./gggg. dd.) Or for medicinal side effects found were informed of the person's doctor Yes No (if the person on the side has informed the doctor, please fill in point 7 of the report), please briefly describe the side effects of medicinal products, giving you think key information (brief description of symptoms, laboratory and other examination results, if available, the side effects of medicinal treatment).    What were the effects of the medicinal side effects caused the death (dd./mm./gggg.) After the person's opinion, was a life-threatening condition required hospitalization or prolongation thereof created a lasting or significant disability or incapacity, is a congenital anomaly of the none of the above Or the use of the medicinal product was terminated, finding the side effects of medicinal products yes no or side effect disappeared entirely Have lasting consequences have not yet disappeared in unknown Or medications, which can cause the side effects, used for the first time in my life Yes No if the medicinal product is used repeatedly or the last time had similar side effects Yes No 4. Medications, which can cause the side effects information on medicinal products, the name of the medicinal product (see on the packaging of medicinal products) of the registration certificate holder/parallel importer (see on the packaging of medicinal products) serial number of medicines (see on the packaging of medicinal products) use the start date (dd./mm./gggg.) Information on the use of the product as a medicinal dose used only once (for example, 2 tablets, injection, 1 other) how often the medicines used (for example, twice a day, other) what purpose used drugs (a symptom or disease treatment) Where the drug was obtained by a pharmacy in hospital (if possible, specify the Web site address) imported from another country (if possible, please specify the country) Elsewhere (if possible a different production site) 5 other medications that are applied to the last three months or the last three months was applied to another medicine yes no name of the medicinal product (complete, if the last three months were used more medication. See the package) name of the medicinal product (complete, if the last three months were used more medication. See the packaging) 6. Other information (severe co, allergies, hypersensitivity to some drugs, pregnancy) 7. Details of the person's doctor authorisation for a medicinal product, a government agency to communicate with family doctors or other medical person (including doctors, that provide information about the identified adverse) to specify (if necessary) the information referred to in the report, as well as information about the person's State of health and medicines used. Yes, Yes, the family doctor with another treatment (treatment person's first name, last name) Yes, other (medical practices of the person name, contact info) I do not know the person's family doctor/any other treatment the person notifying the signature date (name, surname) (/mm./gggg. dd.)
Signing the message, the authorisation for a medicinal product, a government agency staff to contact me to clarify (if necessary) the information referred to in the report and ask additional questions as needed. 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 Government Agency's website URwww.zva.gov.lv). Minister of health of Cricket.