Cabinet of Ministers Regulations No. 195 in 2013 (April 9. 17. § 18) the amendments to the Cabinet of Ministers may 9 2006, regulations No. 376 "registration procedure for medicinal products" Issued in accordance with article 5 of the law of Pharmacy (3) to make the Cabinet may 9 2006, regulations No. 376 "registration procedure for medicinal products" (Latvian journal, 2007, no. 137; 2008, 117. no; 2009, nr. 178.80., 2010; 105, no. 174, 81 no; 2011) follows: 1. Replace all text (except 45.2.) the word "security" (fold) with the word "safety" (fold). 2. Be deleted throughout the text (except 15.1) the words ' (http://www.zva.gov.lv). 3. Make 10, second sentence by the following: "where a medicinal product is re-registered, once registration is valid for an unlimited period (as indicated in the certificate of registration of medicinal products), except when the State Agency of medicines of the pharmacovigilance based reasons arising from legislation on pharmacovigilance and these terms (including the medicinal products in question, the number of patients exposed), shall take a decision on the registration of the medicinal product again for five years." 4. Delete 15.1 points ' (http://www.zva.gov.lv) (hereinafter referred to as the Web site (http://www.zva.gov.lv)) ". 5. To replace the words "in paragraph 17.6. undesirable side effects (adverse reactions)" with the words "pharmacovigilance side effects (adverse)". 6. Express section 17.11. by the following: "registration summary 17.11. applicant's pharmacovigilance system according to the legislation on pharmacovigilance procedures (hereinafter referred to as the pharmacovigilance system). The summary includes: 17.11.1. confirmation that the registration applicant has appropriately qualified person responsible for pharmacovigilance, as well as to the European economic area Member State in which that person is present and shall carry out their duties, and that person's contact information. 17.11.2. the registration of the applicant's signed statement that he is in possession of the pharmacovigilance tasks required features; 17.11.3. space, storing the pharmacovigilance system master file that corresponds to the legislation on pharmacovigilance requirements procedures (hereinafter referred to as the pharmacovigilance system master file); ". 7. To supplement the provisions under section 17.11.1 follows: 17.11.1 "risk management plan, which according to the legislation on pharmacovigilance procedure details the risk management system (hereinafter referred to as the risk management plan) and which will be implemented by the applicant for registration in respect of the medicinal product, as well as a summary of the plan. The risk management system is commensurate with the data on pharmacovigilance and identified potential risks and the need for a post-marketing drug safety data; ". 8. To supplement the provisions of the following paragraph 17.17.1: "summary of safety data 17.17.1, including data contained in the legislation on pharmacovigilance procedures mentioned in the safety reports to be updated periodically (hereinafter referred to as the safety report), where such data is available, and the reports of suspected adverse reactions to medicinal products;". 9. Make the following paragraph 17.18: "17.18. detailed information about any decision, on the basis of which the European economic area country or in a third country is the refusal of the granting of authorisation and the justification for the decision. The information referred to in the registration application, the applicant regularly; ". 10. Delete 17.20. section. 11. Supplement with 17.3 points as follows: "The provisions of paragraph 17 17.3 data referred to update if you need to make changes." 12. To supplement the rules by 21.2 point as follows: "in addition to this rule 21.2 21 and 21.1, the information referred to in the summary of the following information: 21.2 1. medicinal products which require additional monitoring and which are covered by Regulation (EC) No 726/2004 list referred to in article 23, adds" this medication is in addition to the monitor ". Before the references according to the Regulation (EC) No 726/2004 and article 23 European Commission 7 March 2013 implementing Regulation No. 198/2013 for symbol selection the identification of medicinal products for human use, which are subject to supplementary supervision (hereinafter the implementing Regulation No. 198/2013), insert a black symbol approved and standardized the explanatory text; 21.2 2. any medicinal product – information that clearly calls for health care professionals-medical persons or pharmacists, about any potential side effects, using the direct reporting system to report to the State Agency of medicines, as well as possible ways of reporting in accordance with the laws and regulations for pharmacovigilance procedure. " 13. Replace the words "in paragraph 23.2. Medicinal products" with the words "the European Medicines Agency's Committee for medicinal products for human use (hereinafter – the Committee for medicinal products)". 14. Replace the introductory paragraph of subparagraph 82.6., the words "adverse side effects" with the words "pharmacovigilance order". 15. Replace subparagraph 82.6.1., the words "drug side effects monitoring" with the word "pharmacovigilance". 16. Express 84.2.2. subparagraph as follows: "84.2.2. assessment of the data provided in the report about the potential side effects and safety messages, and, if necessary, a summary of all the security of registration reports, as well as information about all changes made since the granting of the registration." 17. Replace 84.1 points, the word "six" with the word "nine". 18. Replace paragraph 85:18.1. the word "surveillance" with the word "maintenance"; 18.2. the words and figures "in accordance with the Cabinet of Ministers of 17 January 2006, the Regulation No 61" rules for the State Agency of medicines of the public paid service price list "with the words" in accordance with the laws and regulations of the State Agency of medicines paid services price list ". 19. Delete the 85.1, 85.5 85.2 85.3, 85.4, and point. 20. Delete 53.3 points. 21. the express section 89.3 and 89.4. the following wording: "89.3. in developing the evaluation report and the relevant registration documentation comments on medicinal pharmaceutical, non-clinical tests and clinical trials, pharmacovigilance and risk management systems, as well as prepare the public assessment report. If you become aware of new information that is important to the quality of the medicinal product concerned, safety or performance evaluation, the assessment report shall be updated. Assessment report development does not extend to the homeopathic, antropozofaj and herbal medicinal products established in the simplified registration procedure; 89.4. the evaluation report after it, in cooperation with the owner of the registration is deleted the information that the owner of a registration filed as restricted access information, and which is commercial in nature, public, immediately putting it on the Agency's Web site. For each indication provided separate reasons. The evaluation report made public include the public easy-to-understand summary that contains a section on the conditions of use of the product. " 22. Supplement with 89.1 and 89.2 points as follows: "in addition to this rule 89.1 86. points to the State Agency of medicines in connection with pharmacovigilance of medicinal products are eligible to register, registration to the owner in determining duties: 1. to execute specific 89.1 measures to ensure the safe use of medicinal products, which the applicant shall include the risk management system; 2. execute 89.1 post-registration safety study of medicinal products in accordance with the laws and regulations for pharmacovigilance; 3. register the 89.1 possible drug side effects or for them to report, if the obligation is stricter than the regulations for pharmacovigilance requirements procedures; 89.1 4. with regard to the safe and effective use of the medicinal product, to meet any conditions or restrictions proposed; 5. ensure appropriate 89.1 pharmacovigilance system; 6. take 89.1 post-registration studies of the effectiveness of medicinal products, if the effectiveness of a medicinal product is to identify problems that can only be addressed after the commencement of distribution of medicinal products; 7. submit 89.1 safety report, subject to the decision on registration of the safety report frequency and the date. This rule 89.2 89.1 obligation referred to as executable condition the State Agency of medicines shall include the decision on the registration of the medicinal product and, if appropriate, also indicate the deadline. " 23. To make 90. point as follows: "90. Medicine State Agency in exceptional cases, after consultation with the principal applicant for the registration of the medicinal product is authorised to register, the decision shall state the owner of the registration obligations, particularly if it relates to the safety of the medicinal product, notification to the National Agency for medicines of any drug-related incident and enforceable actions. In this case, the medicine can be registered only if the applicant can prove that the objective and verifiable reasons not able to provide an extensive and detailed data about the effectiveness and safety of the medicinal product under normal conditions of use, and is based on one of the following reasons: 90.1. the indications for which the product in question is intended are encountered so rarely that the applicant cannot provide reasonable evidence; 90.2. detailed information may not provide sufficient scientific experience; 90.3. the collection of such information would be contrary to generally accepted principles of medical ethics. " 24. To supplement the rules with 90.1, 90.2, 90.3, 90.4, 90.5, 56.3, 56.4, 90.8 and 90.9 points as follows: "in addition to this rule 90.1 90. the obligations referred to in paragraph 1 may include the following requirements: 1. the registration of 90.1 applicant State Agency of medicines on time complete research programme, the results of which will be repeated in the benefit and risk assessment; 2. the medicinal product concerned 90.1 distributes to the recipe, that in some cases they may be used only under strict medical supervision, if necessary, only the fixed medical institution and authorized treatments under the supervision of a person (for radiopharmaceuticals, this); 90.1 3. instructions for use and medical information is drawn person, treatment focuses on the fact that the available data for the medicinal product concerned is still not enough. 90.2 If the medicinal product in accordance with the provisions of paragraph 90 are registered, registration is the responsibility of the owner to submit safety reports, subject to the decision on the registration of certain safety reporting frequency and the date. 90.3 in connection with the registration deadline for the State Agency of medicines shall be revalued each year 90. these provisions referred to the owner of the registration under certain conditions. 90.4 After registration of the medicinal product in accordance with national laws and regulations for pharmacovigilance procedures is entitled to impose the obligation of the holder of the registration: 1. take medicine 90.4 post-registration safety studies if the registered drug risks causing concern for the safety of the medicinal product. If concerns about the safety of the medicinal product applies to more than one product, the State Agency of medicines shall, after consultation with the European Medicines Agency, the pharmacovigilance risk assessment Committee (hereinafter referred to as the pharmacovigilance risk assessment Committee) recommends that the registration of the owners of the joint safety studies of post-registration; 2. take medicine 90.4 post-registration efficiency study, if understanding of the disease or clinical methodology indicates that previous estimates of effectiveness could be substantially transparent. If the State Agency of medicines 90.5 sees no need to make that rule 90.4 referred to safety or efficacy studies in medicine, so that a reasoned, written reasons shall inform the owner of the registration and State study objectives and deadlines, as well as the submission of the results obtained. 56.3 registration owner within 30 days after this rule 90.5 points in writing referred to in the notification is entitled to ask the State Agency of medicines shall be the provision of a written explanation for this rule 90.4 obligation referred to in paragraph 1. evaluation of registration owner 56.4 written explanations, the State Agency of medicines shall adopt the appropriate decisions – to determine the owner of registration to make that rule 90.4 referred to safety or efficacy studies drugs or perform. If the State Agency of medicines shall take a decision on the registration of the holder of the obligation to make that rule 90.4 referred to safety or efficacy studies medicinal products, it shall carry out the appropriate amendments to the decision on the registration of medicinal products, to include these obligations as a condition of registration. the owner of the registration includes this 90.8 rule 89.1, and 90.1 90. He referred to the obligations under the risk management system and restores it accordingly. 90.9 registration the owner of the pharmacovigilance system master file of the diet and ensure the safety of research must, in accordance with the legislation on pharmacovigilance procedure. " 25. replace 91.1 in the names and the number "that rule 90 of the conditions referred to in paragraph list" with the words and figures "obligations to the owner of the registration pursuant to this provision certainly 89.1 90.1 90. and point". 26. Express the following subparagraphs 91.3. "91.3. to ensure that the risk-benefit balance of regular evaluation, may at any time ask the holder of the registration to submit drug national agency data, which shows that the risk-benefit balance remains favourable;". 27. Supplement with 91.4 and 91.6., 56.9. subparagraph by the following: "91.4. decision on registration indicates how often the owner of the registration shall submit to the safety message. Safety message submission deadline shall be determined taking into account the date of entry into force of the decision; 56.9. registration holder shall be entitled at any time to request the applicant to submit a copy of the pharmacovigilance system master file; 91.6. is entitled to ask the owner of the registration to ensure risk management system with respect to any product, if there is concern about the risks that affect the registered drug the risk-benefit balance. In this case, the State Agency of medicines: 91.6.1. the owner is requested to submit a detailed description of the risk management system, which provides for the establishment of the medicinal product; 91.6.2. written notice to the owner of the registration management system detailed in the description of the period; 91.6.3. determine the owner of the registration deadline for providing written explanations, if the owner of such a registration option asked within 30 days after receipt of the written notice; 91.6.4. on the basis of the written explanation of the owner of the registration, shall decide whether the decision on registration as a condition of registration required under this provision subparagraph 1 89.1 include risk management measures. If the State Agency of medicines is of the opinion that the conditions required for registration include, it shall carry out the appropriate amendments to the decision on the registration of the medicinal product. " 28. To supplement the rules with 91.1, 91.2, 91.3, 91.4, 56.9, 91.6, 91.7 and 91.8 point as follows: "91.1 registration owner safety reports submitted to the State Agency of medicines shall immediately upon receipt of a reasoned request or in accordance with the following procedures: 1. If the product still 91.1 is not placed on the market,-at least every six months after authorisation and until the placing on the market; 2. where a medicinal product is 91.1 market: 91.1 2.1. the first two years following the initial placing on the market, not less frequently than every six months; 91.1 2.2. next two years – once a year and then every three years. If medicinal 91.2 assigns different registration certificate, containing the same active substance or the same combination of active substances, safety reporting frequency and dates in accordance with the provisions of point can change. 56.9 To promote the single assessment for safety messages work sharing procedure, establish harmonised safety reporting periodicity and the European Union to determine the reference date, after which the safety message submission date (hereinafter referred to as the period of the European Union), information about changes regarding safety reports, the frequency and the date submitted or the Committee for medicinal products of the European Medicines Agency Coordination Group established by registration (or of marketing authorisations for medicinal products) in two or more European economic area countries related questions (hereinafter referred to as the coordination group). The maturity of the European Union is one of the following dates: 1. the date the 91.2 medicinal products containing that active substance or combination of active substances that, in the European Union is the first registration certificate; 2. the earliest known 91.2 date, when products containing that active substance or combination of active substances that have been granted the certificate of registration, if this rule 91.2 date referred to in point 1 may not be possible to find out. 91.3 Safety reports on medicine widely used medicines, generic medicines, homeopathic medicinal products registered in the simplified procedure, and traditional herbal medicinal products, the owner of the registration shall be submitted in the following cases: 1. If the decision on 91.3 registration of such an obligation is made as a condition of registration referred to in these regulations and in paragraph 90 89.1; 2. after 91.3 National Agency a reasoned request, if there were problems associated with pharmacovigilance data, or after registration has not submitted a report in connection with the safety of active substances. The evaluation report on the reliability of the reports referred to submit pharmacovigilance risk assessment Committee, which is considering whether the provisions referred to in paragraph 91.2 unified assessment for safety messages are required, and inform the coordination group or Committee that these provisions apply accordingly 56.9 points or regulations for pharmacovigilance. 91.4 registration submitted to the State Agency of medicines application for approval of changes to the registration documentation after the European Medicines Agency has published this provision of the information referred to in paragraph 91.8. safety message consistent 56.9 submission periodicity and deadlines of the European Union, referred to in this rule 91.2 points, after consultation with the Committee of the pharmacovigilance risk assessment can be determined by one of the following institutions: 56.9 1. Medicinal products, if at least one of the marketing authorisations for medicinal products containing the active substance concerned has been granted in accordance with Regulation No 726/2004, section II in Chapter 1 of the centralised procedure; 2. the coordination group of the 56.9-other cases not mentioned in this provision in subparagraph 1 56.9. 91.6 registration holder is entitled Drug Committee or steering group to submit a written reasoned application to determine this rule 91.2 points above the European Union limit or change the reporting frequency of safety in relation to public health, or in order to avoid duplication of the assessment, or achieve international harmonisation. the Committee for medicinal products or 57.0 coordination group shall, after consultation with the pharmacovigilance risk assessment These rules the Committee referred to in paragraph 91.6 application is approved or rejected. 91.8 safety reporting periodicity and deadlines of the European Union, as well as the changes they made public the European Medicines Agency. " 29. the express section 101.2. by the following: "101.2. the matters on which agreement has been reached, shall be submitted to the Steering Group." 30. Replace the words "in paragraph 104 of the European Medicines Agency Committee for medicinal products for human use (hereinafter – the Committee for medicinal products)" with the words "in the opinion of the Committee for medicinal products". 31. Make the following introductory paragraph 107: "107. If you have affected the interests of the European Union, the national agency of medicinal products, the applicant for registration or the registration holder is entitled to turn to the question of the Committee for medicinal products, before taking a decision on registration, registration suspension, cancellation of the registration and any other changes in relation to the changes required for the approval or registration of the extension: ". 32. To supplement the provisions of the following paragraph 107.1: "107.1 if based on the pharmacovigilance of medicinal products registered related data assessment, National Agency for medicinal products, the applicant for registration or the registration holder shall submit the matter to the pharmacovigilance risk assessment Committee. If you require urgent action, apply to the urgent safety related procedures under the legislation on pharmacovigilance procedure. " 33. To replace the words "in 108.2.1.3 of pharmacovigilance" with the word "pharmacovigilance". 34. To supplement the provisions of this subparagraph with 108.9.: "the coordination group: 108.9.108.9.1. appearance with marketing authorisation of a medicinal product in two or more Member States issues; 108.9.2. with Member States as regards pharmacovigilance of medicinal products issues; 108.9.3. with Member States of the European Union registered drug-related issues; 108.9.4. the performance of pharmacovigilance tasks including the risk management system and monitor their effectiveness based on the scientific assessment and recommendations of the European Parliament and Council Regulation No 726/2004, article 56 paragraph 1 "aa" referred to pharmacovigilance risk evaluation Committee. " 35. To replace paragraph 109 a number and the word "paragraph" to number 110, and the word "108.". 36. Delete paragraph 110. 37. To supplement the provisions under paragraph 112.1 by the following: "112.1 Ministry of health after consulting with the State Agency of medicines shall designate a representative to the Working Group in the coordination work and his replacement (hereinafter agent). Representative is entitled to call in experts. The State Agency of medicines shall contribute, as well as representatives and experts supervises the operation and carried out scientific assessment. " 38.114 points to express the following: 114. "State Agency of medicines: 114.1. Decides on the registration or re-registration or on the suspension or withdrawal of the registration of the amendment on the basis of the following considerations: 114.1.1. it is recognized that the medicinal product is harmful; 114.1.2. for medicinal products is not the therapeutic efficiency (use of the medicinal product are not for therapeutic result) or the risk-benefit balance is not favourable. The requirement to base therapeutic effectiveness are not applicable to homeopathic medicinal products, which recorded the simplified registration procedure; 114.1.3. its qualitative or quantitative composition is not as described in the registration dossier; 114.1.4. receipt of the application of the owner of the registration to cancel or suspend the registration; 114.2. is entitled to take a decision on the registration or re-registration or on the suspension or withdrawal of the registration of the amendment, taking account of the following reasons: 114.2.1. in connection with the registration or re-registration application specified data is not accurate or complete, or they are amended in accordance with the provisions of section 120.4.1. and 120.4.2., or not make that medicinal products referred to in paragraph 112.1. and their components; 114.2.2. the owner of the registration are not fulfilled as set by this provision, 90 and 90.5 89.1. the obligation referred to in paragraph 1. " 39. Express 120.4.1. and 120.4.2. subparagraph as follows: "120.4.1." to this rule 17.5. and down in point 11.1. production and control methods take into account scientific and technical progress and make necessary changes to medicines could be produced and verified using generally accepted scientific methods. Those changes approved by the national agency of medicinal products; 120.4.2. immediately submitted to the State Agency of medicines of any new information which may result in the need to amend the registration documentation, as well as notify you of any prohibition or restriction imposed by the other competent authorities of the country in which the product is distributed, and other new information that may affect the benefits of the medicinal product concerned, and a risk assessment. The information indicates both positive and negative clinical trials or other studies for all, not just the registration included in the dossier, the State Agency of medicines of the approved indications and populations, as well as data on the use of the product, where such data are not part of the summary of the rules. " 40. To supplement the rules by 120.4.6., 120.4.7. and 120.4.8. subparagraph as follows: "120.4.6. ensure that information on medicinal products renewed in the light of developments in scientific knowledge, including the conclusions and recommendations of the evaluation, published in the European Medicines Agency website (created in accordance with European Parliament and Council Regulation No 726/2004, article 26); 120.4.7. immediately provide the State Agency of medicines complete information under this rule 91.3.; 120.4.8. seven days after receipt of the request submitted to the State Agency of medicines this provision 56.9. referred to pharmacovigilance system master copy. " 41. Supplement with 122.6.1.3. section as follows: "122.6.1.3. registration, on the basis of this provision, and 90.1 90.89.1 the point." 42. To supplement the rules with 122.8. and 122.9. subparagraph by the following: "registration issued to 122.8. or a duplicate certificate in paper form and, upon request, by electronic means; 122.9. competent authority carries out the tasks conferred on it in accordance with the requirements laid down by the implementing Regulation No. 198/2013. " 43. To replace the words "in paragraph 135 to periodically regenerate security messages "with the words" safety messages ". 44. To supplement the rules by 135.1, 135.2 and 135.3 points as follows: "this rule 91.1 135.1 referred to in paragraph 1, the rules shall apply to the registration of the owners of the Hall have been registered up to July 21, 2012 and that safety reports, the frequency and the date are not required as a condition of registration, except where there is another safety reporting frequency or dates or submission of periodic safety report is coherent and has a specific deadline for the European Union after which calculates the safety message submission date in accordance with the provisions of paragraph 56.9 This rule 91.1 135.2 points in that provision apply in the national registration procedure (other than mutual recognition or decentralised procedure) of the medicinal product in respect of which does not apply this rule 91.2 and 56.9 of this norm. Any changes to the safety 135.3 reporting dates and frequency specified in the registration decision, the application of this rule 91.2, 56.9, 91.6 and 57.0 of the rules referred to in paragraph 1, shall enter into force six months after the date of the European Medicines Agency has made public safety a harmonised reporting periodicity and deadlines laid down in the European Union or the changes. " 45. paragraph 139 of the following expressions: "139.  the 10-year period of protection provided for in paragraph 28 of these rules do not apply to reference medicinal products for which a registration application filed before 30 October 2005. If the application for registration in relation to chapter III of these rules is filed, indicating the reference medicinal product submitted for registration until 30 October 2005, generic medicinal product must not be significantly different from the reference medicinal product for at least six years have been registered in the European economic area country. For the centralised procedure for the registration of the registered reference product as Regulation (EC) No 726/2004. " 46. To complement the provisions of the following paragraph 143: "143. Registration of owners that the medicinal product is registered until 21 July 2012, not to provide a risk management system for all registered medicinal products, with the exception of those provisions referred to appropriate 91.6.." 47. Add to the informative reference to directives of the European Union with paragraph 8 by the following: ' 8) of the European Parliament and of the Council of 15 December 2010, the EU directive 2010/84/as regards pharmacovigilance of the European Parliament and the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. " 48. To supplement the annex 1 to the note 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. " 49. Replace annex 3 (except for 22.2. and 37.5.) the word "security" (fold) with the word "safety" (fold). 50. Annex 4 be replaced (except the 7.2.) the word "security" with the word "safety". 51. in annex 5, replace the words "security" (fold) with the word "safety" (fold). 52. To replace paragraph 6 of annex 6, the word "security" with the word "safety". 53. Replace annex 7, the word "security" with the word "safety". 54. To replace 7.1 annex (except point 8 "d" section, paragraph 8.1.3., 24. "b", paragraph 4, subparagraph 24.1.6.51.1.3. and 87) the word "security" (fold) with the word "safety" in the fold). 55. Replace annex 3, section 7.1 the title, the words "monitoring the side effects of medicinal products (pharmacovigilance)" with the words "pharmacovigilance". 56. Replace paragraph 7.1, annex 65, introductory part, the words "adverse surveillance system (pharmacovigilance)" with the words "pharmacovigilance". 57. Replace subparagraph 65.1.1 of annex 7.1., the words "monitoring the side effects of medicinal products (pharmacovigilance)" with the words "pharmacovigilance system". 58. Replace annex 7.1 65.2. subparagraph the words "adverse surveillance system (pharmacovigilance)" with the words "pharmacovigilance system". 59. Express 7.1 66 of the annex by the following: "66. C.i. 9. Changes to the current system of pharmacovigilance, indicated in the detailed description of the pharmacovigilance system: (a)) responsible for pharmacovigilance by suitably qualified persons; Condition: 1. Document: 1. the scene I b) changes responsible for pharmacovigilance by suitably qualified persons contact information; Condition: 1. Document: 2. I PICTURE c) changes responsible for pharmacovigilance under the substitution by the qualified person; Condition: 1. Document: 2. I PICTURE d) safety database changes (such as new safety database, including safety data collection and analysis and reporting the new system); Condition: 1., 2., 3. Document: 2. the scene I e) changes to the framework agreements with other persons or bodies and institutions involved in pharmacovigilance system described the duties, in particular when a sub-contracted in connection with electronic notification of specific pharmacovigilance-related side effects, the major databases, signal detection or periodically renewed safety reports; Condition: 1. Document: 2. I f) deleted SCENE issues described in the written procedure relating to pharmacovigilance system; Condition: 1. Document: 2. I PICTURE g) changes that apply to the site where the pharmacovigilance system; Condition: 1. Document: 2. I PICTURE h) pharmacovigilance system, other changes that do not affect its operation (for example, changes that apply to the main storage and archiving, administrative changes, the acronym, function and procedure name changes); Condition: 1. Document: 2. I A i) pharmacovigilance system changes to take into account its own evaluation of the pharmacovigilance system in conjunction with other drugs for the same registration, the owner. Condition: 4. Document: 2., 3. I AIN'T 66.1. condition: 1. the pharmacovigilance system is not changed.   2. the Database system has been validated (accepted).   3. data transfer from other database systems have been validated (accepted).   4. Any one of the owner of the registration of the medicinal product is make the same changes to the description of the pharmacovigilance system. The final version of the description of the pharmacovigilance system is no different. 66.2. document: 1. Description of the pharmacovigilance system with the latest version, which includes: a) the new responsible for pharmacovigilance by suitably qualified persons work (life) description (curriculum vitae); (b) proof that the pharmacovigilance) to suitably qualified person in charge has been registered "EudraVigilance" database; (c) the registration of the owner and on) pharmacovigilance responsibility signed by the qualified person under the new notice of their availability and the adverse reporting methods reflecting any other consequential changes, such as a structure diagram. 2. Description of the pharmacovigilance system with the latest version of and/or specific products with the latest version of the Appendix. With respect to paragraph 66 of this annex b) of the above changes, if not originally in the pharmacovigilance system was responsible for pharmacovigilance specified appropriately qualified persons contact information, description of the pharmacovigilance system, the revised version is to be provided, but only change application form or statement.   3. The reference to the application, the procedure changes, and medicine for the approved changes. 66.3. Note: this annex 66) i of the pharmacovigilance system referred to in the assessment, presented as a new registration or a registration or application changes enlargement, by the competent authorities of the Member States or the European Medicines Agency, can be the basis for the request to the proposed changes in the description of the pharmacovigilance system. In such cases, the same pharmacovigilance system can also make changes to other registrations of the same holder permits, submitting (grouped) IAIN type. "
60. Replace annex 8, 28, 33 and 36, the word "security" with the word "safety". Prime Minister-Minister of prosperity I. Viņķel Health Minister i. Cricket»