Cabinet of Ministers Regulations No. 289, Riga, 23 March 2010 (pr. No 15 34 §) rules on drug clinical trials and observations of the use of the procedure, the labelling of the investigational medicinal product and the order in which the medicinal product is assessed clinical trial compliance with good clinical practice requirements Issued in accordance with article 5 of the law on pharmacy, 3, 6, and 15, paragraph i. General questions 1. sets out procedures for the taking of medicinal product (with the exception of veterinary medicinal products) clinical trials (including multi-centre studies) according to the requirements of good clinical practice and the use of the medicinal product observations as well as the labelling of the investigational medicinal product order and the order in which the medicinal product is assessed clinical trial compliance with good clinical practice requirements.
2. the person examined is a person who participates in a clinical trial using investigational medicinal products, or the control group.
3. the investigational medicinal products are pharmaceutical form with or without the active substances that are being studied or used as a reference in a clinical trial, including registered medicinal products usage, shape, packaging or indications differ from the registered or used to get additional information about the registered type.
4. The investigator is the doctor to whom, in accordance with the laws governing the treatment have the right to independently deal with treatment and who have practical experience in the medical industry, associated with the clinical research field.
5. Sponsor means a natural or legal person who assumes responsibility for the clinical trial initiation, management or financing.
6. Protocol (the Protocol amendments) is a document that describes the purpose of the research, design, methodology, statistical considerations and organisation of research procedures, be sure to include the person being studied and not the conditions of inclusion, as well as the study and publication of the results of the monitoring procedure.
7. the multicenter clinical trials according to a single protocol performs several researchers in several places. Trial sites may be located in one or more Member States of the European Union (hereinafter referred to as Member States) or in Member States and third countries.
8. Studies with gene and somatic cell therapy medicinal products must only be performed in specialized medical centers in clinical University Hospital.
9. Preclinical and clinical trials information on the investigational medicinal product are sufficient to support the proposed clinical trial.
10. rights of the person Examined, safety and well-being is more important than science and the public interest.
11. Each of the clinical trials involved qualifications (education, training and experience) with its tasks.
12. the clinical trial is scientifically sound and in all respects is based on ethical principles.
13. in clinical trials, including bioavailability and bioequivalence studies shall be designed, conducted and reported in accordance with good clinical practice requirements.
14. Good clinical practice is a set of internationally recognised ethical and scientific quality requirements which observed for designing, conducting and registering clinical trials with human participation in or providing reports on it.
15. The clinical trial information shall be recorded, handled and stored in such a way as to ensure the accurate reporting, interpretation and verification, while ensuring the protection of personal data being studied.
II. The Sponsor and the investigator responsibility 16. The investigator and the sponsor, launches and clinical trials comply with these provisions, as well as treatment and individual data protection regulatory framework legislation.
17. For persons under medical care and all related clinical trials with medical decisions responsible is a researcher. The investigator is also responsible for conducting the clinical trial at a trial site. If the clinical trials carried out group, the researchers responsible for this group are referred to as the responsible researcher.
18. The Sponsor selects researchers, taking into account his qualifications and experience. If necessary, the sponsor provides the additional training of researchers.
19. the investigator may participate in the first phase of the trials, if they have prior experience in clinical trials of the medicinal product.
20. The Sponsor, in whole or in part of its functions may authorize other natural or legal person (hereinafter referred to as the sponsor's authorized person). Also in this case, the sponsor shall fully remain responsible for the conduct of clinical trials and research data mining compliance with the requirements of this regulation.
21. The investigator and the sponsor may be one and the same person.
22. The Sponsor and the investigator shall take out civil liability insurance, and conditions of remuneration. Sponsor is not responsible for damage caused by the investigator or other clinical studies involved the person being studied caused intentionally or inadvertently.
23. The Sponsor or the sponsor's legal representative is registered in one of the Member States. If the sponsor or the sponsor's representative is a natural person, it is the European Union's declared place of residence. 
24. the Sponsor shall provide the necessary clinical trials of investigational medicinal product delivery. The product is manufactured and quality controlled in accordance with the good manufacturing practice requirements.
25. The Sponsor is responsible for the quality of the investigational medicinal product, delivery of a clinical trial venue (Research Center), storage conditions, the duration and, if necessary, the dilution solution and medical equipment the medicine infusion for detection. The said conditions shall be informed of all investigational medicinal product chain involved. This person is obliged to respect the investigational medicinal product storage conditions.
26. On the investigational medicinal product storage and accounting research centre is responsible researcher.
27. the investigational medicinal products, as well as their use for entering the medical device, if they are needed, the sponsor supplied free of charge.
III. the investigator's brochure 28. The investigator's brochure is an investigational medicinal product in clinical and pre-clinical information summary of drug research that involves people. The information in the investigator's brochure provides a concise, simple, objective, balanced and not advertising to treatment or potential investigator would be able to understand it and make an unbiased planned clinical trial compliance assessments, taking into account the anticipated risks and benefits. These requirements also apply to changes to the investigator's brochure.
29. where investigational medicinal products are established in the Member State or the European economic area country, investigator's brochure may be replaced with the summary of product characteristics.
30. The Sponsor will be evaluated and updated investigator's brochure not less frequently than once a year.
IV. protection of the person Examined 31. Clinical trials must be performed just in case: 31.1. opinion of the Ethics Committee, and the State Agency of medicines of the authorisation to initiate clinical trial indicated that the anticipated therapeutic benefit to the person examined and other present and future patients, as well as society as a whole is examined, and this justifies the estimated risk, and clinical trials may continue, if compliance with this requirement is continuously monitored;
31.2. the person being investigated or, if the person is not able to give consent, its legal representative after due information about the research nature, significance, implications and risks are stated in writing that voluntarily agree to participate in a clinical trial, the sponsor of the signature of the person under the consent document and specifying a date (hereinafter referred to as the informed consent). If the person concerned is unable to write, in exceptional cases it can provide oral consent in the presence of at least one witness;
31.3. the person being investigated or, if the person is not able to give informed consent, the legal representative has previously had the opportunity in an interview with a researcher or other individual involved in the conduct of clinical trials, clinical research to understand the objectives, risks and inconveniences, as well as the conditions under which it will be carried out, and the person being investigated or, if the person is not able to give informed consent, the legal representative is aware of the right at any time to refuse from participation in clinical trials.
19.5. investigational personal data are protected according to the legislation on the protection of the data of natural persons;
31.5. informed consent document provides for the possibility of the person being investigated at any time to discontinue participation in the clinical trial, the sponsor or the investigator, be informed on their informed consent to the withdrawal, and will have no adverse effect on the person being studied provided health care quality;
19.6. informed consent document provides insurance and reimbursement conditions associated with the investigator and the sponsor's civil liability.
32. in addition to the rules of 31 conditions listed in clinical trials, which are being studied in the minors, you can do only if you comply with the following conditions: 32.1. is aware consent provided by at least one of the parents or legal representative. Informed consent represent the minor's views expressed and can be withdrawn at any time without adverse consequences for the minor party;

32.2. the staff with experience with minors, has informed the minors concerned according to its capacity of understanding about clinical trials, its risks and benefits. One of the parents or legal representative declares in writing that the minor person according to his/her capacity of understanding is aware of the specific nature of the clinical trial, the risks and benefits;
32.3. the investigator or principal investigator is considered minor's express desire to opt out of participation or at any time to discontinue participation in clinical research, if the minor is able to express and justify your opinion and assessing this rule 31.3. the information referred to in subparagraph a;
32.4. the minor is not encouraged or financially supports, except for compensation for expenses associated with participation in clinical research (including transport costs), as well as compensation for damage to health or clinical trials due to intervening death;
32.5. the clinical trial expected to direct benefit for the patient group and such research is essential to validate data obtained in clinical trials on persons able to give informed consent or by other research methods. The studies must be directly linked with the disease suffer from a particular person or minor in nature such that it can only be performed on minors;
32.6. in compliance with the European Medicines Agency's scientific guidance;
32.7. clinical trials are designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and the degree of development of the child. Both the risk threshold and the degree of suffering is a specially defined and constantly monitored;
20.4. the Ethics Committee which is competent in the field of paediatric is it consulted with experts in clinical, ethical and psychosocial problems in the field of Paediatrics, has endorsed the Protocol;
32.9. patient interests prevail over those of science and society.
33. Persons who are not able to give informed consent, subject to all the rules of 31 referred to the requirements that apply to persons who are able to give such consent. If clinical trials include people who are not able to give informed consent and it is not provided or is not refused to give informed consent before this ability loss, exploration is allowed if, in addition to those requirements comply with the following conditions: 33.1. legal representative has been obtained informed consent. Informed consent of the person being studied reflect the views expressed and can be withdrawn at any time without any adverse effects on the person being studied;
33.2. the person who cannot give informed consent, has received its capacity of understanding relevant information on clinical trials, its risks and benefits;
33.3. the investigator or principal investigator is considered the person's explicit desire to relinquish at any time the membership or stop participating in the clinical trial, if the person is capable of expressing their views and evaluate the information;
33.4. a person cannot give informed consent, are not encouraged or financially supports, except for compensation for expenses associated with participation in clinical research (including transport costs), as well as compensation for damage to health or clinical trials due to intervening death;
33.5. This clinical trial is essential to validate data obtained in clinical trials on persons able to give informed consent or by other research methods and relates directly to a life-threatening or debilitating clinical condition from which the person concerned suffers;
20.9. clinical trials are designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the understanding of disease and disability. Both the risk threshold and the degree of suffering is a specially defined and constantly monitored;
20.9. the Ethics Committee, which has jurisdiction in matters relating to relevant disease and the patient population concerned, or who has consulted experts in clinical, ethical and psychosocial problems in the relevant disease and the patient population concerned, has endorsed the Protocol;
33.8. the interests of the patient are more important than the interests of science and society;
21.1. There is reason to believe that participation in clinical research will be a benefit to the patient by setting or produce no risk at all.
34. In an emergency, if it is not possible to obtain informed consent of the person being investigated and the person examined is not a legal representative or a legal representative is not available, the person being investigated in clinical trials may involve only if the Protocol is defined in the investigational procedure of personal involvement in emergency situations.
35. to the person being studied can get independent information about the clinical trial, the researchers provide the person being investigated by the Ethics Committee (which has delivered an opinion on the clinical trial in question) and the State agency contact information.
36. Clinical investigations shall be prohibited during pregnancy and her mother, who was breastfeeding, except if otherwise it is not possible to provide a clinical trial and the risk of doing clinical trials is reasonable compared with the expected benefits of the embryo, fetus or infant.
37. The person who needs the active involvement of the disease treatment, control group, in which a person receives under the comparison without active substances preparation may be only in the case where compliance with this provision, 32 and 31, paragraph 33 and Protocol gives the person examined the scientific and ethical engagement justification.
38. in order to ensure the protection of personal data under study, the investigator assigned to each person under identification code, which replaces the person examined, providing reports to the sponsor, the State Agency of medicines and the Ethics Committee. The patient's first and last name of a researcher may decode only at the request of the authorities, in accordance with the law of medical treatment have the right to consult the records of the patient.
39. If in the course of the clinical trial you will get information about the conditions that can cause hazard to the researched person's life or health, the investigator shall immediately inform the person being investigated. The person examined information provided is documented. In such cases, in accordance with the rules of 31 extra-person volunteer researched receives written consent for future participation in clinical research.
40. If the clinical trial is interrupted or completed before the run time specified in the Protocol, researchers shall inform the person to be examined and determined her further treatment and observation.
V. 41. The Ethics Committee the Ethics Committee prior to the commencement of the clinical trial, said any research related to public interest in the matter to ensure the rights of the person examined, safety and well-being, as well as to the public beliefs about this protection. The Ethics Committee is an independent organization, operating in the medical institution or outside.
42. The Ethics Committee is made up of qualified and experienced individuals who can assess the relevant ethical clinical trials and scientific aspects. Personnel of the Ethics Committee for an indeterminate period of time approved by the Minister of health.
43. the Ethics Committee shall be not less than nine members. The Ethics Committee shall include at least two persons who lack medical training, as well as at least two independent parties who are not affiliated with the Research Centre (the location where clinical trials are conducted with related transactions). The Ethics Committee is composed of representatives of both sexes. 
44. The Ethics Committee shall have the right to call upon experts without voting rights.
45. the Ethics Committee shall be in accordance with the Ethics Committee approved charters. Charter has been developed according to these rules, the good clinical practice recommendations and regulations for physical protection of personal data.
46. The Ethics Committee shall be valid if they are sitting on more than half of the members of the Ethics Committee.
47. the opinion of the Ethics Committee shall be adopted by a simple majority of the members of the ethics committee vote openly.
48. the Ethics Committee meeting and recorded meetings decisions are recorded in the minutes. A member of the Committee whose opinion differs from the final decision of the Committee is entitled to make their views known in the annex to the Protocol.
49. To vote and comment on specific clinical trial issues may be binding only from the investigator and sponsor-independent members of the Commission.
50. The Ethics Committee all documents shall be kept for a period of five years after the completion of clinical trials, unless the legislation on medical records filing procedure is laid down for longer documents.
51. information on the establishment of the Ethics Committee and the qualifications of the members of the Ethics Committee, as well as in the Bylaw is available on request the researcher, sponsor, the State Agency of medicines and the Health Ministry.

52. The Ethics Committee shall submit to the Ministry of health information on the personnel of the Committee, indicating the contact information as well as information on expertise and fee for clinical trial application review. The Ministry of health this information on its home page on the internet. 
53. every year (to February 1) Ethics Committee shall submit to the State Agency of medicines in all the previous year in the clinical trial application and a list of the decisions taken.
54. in order to obtain the opinion of the Ethics Committee, the sponsor or the sponsor's authorized person submitted to the Ethics Committee in the following documents and particulars: 54.1. number the European clinical trials database (eudract);
54.2. sponsor or sponsor's authorized person sign the petition, drawn up on the basis of the European Commission, the sample application (available on the website of the national agency of medicines on the internet);
54.3. sponsor and the investigator shall sign the Protocol and Protocol amendments, if any, do;
54.4. the sponsor develop investigational person informed consent documents in the language of the country. If the clinical trial is planned to involve people who are not familiar with the national language level, which allows you to understand the informed consent document, it shall also submit a typed language research stakeholders can understand;
54.5. other written information in the language of the country associated with the clinical trial and investigational. If the clinical trial is planned to involve people who are not familiar with the national language level, which allows you to understand the information, it shall also be submitted in the language of the research involved can understand;
54.6. persons under engagement measures;
54.7. the investigator's brochure or paragraph 29 of these rules in the case provided for in the summary of product characteristics;
54.8. clinical researchers and research experience of the persons involved and a description of the qualifications (curriculum vitae), which the researchers choose to study centre and working under the supervision of researchers (Assistant researcher);
54.9. documents relating to the payment of compensation to the person being studied for participation in clinical research, if such compensation is intended;
54.10. documents certifying the investigator and the sponsor's liability insurance and that includes conditions for remuneration to the person being investigated, if she has suffered damage or causing the death of the person examined, attributable to a clinical trial;
54.11. treatment services management consent to carry out clinical trials;
54.12. sponsor privileges if the document shall be submitted to the sponsor's authorized person.
55. In considering an application for commencement of a clinical trial and preparing the opinion of the Ethics Committee, particular attention: 55.1. clinical meaning and purpose;
the expected benefits and 55.2. risk assessment under this provision and conclusion paragraph 31.1. reasonableness;
55.3. Protocol;
55.4. researchers and staff for compliance;
55.5. the investigator's brochure;
57.5. premises and equipment quality;
written to be 55.7. the relevance of the information to the particular clinical research, informed consent acquisition procedures, as well as the support of clinical research with people who cannot give informed consent, taking into account the rules of 31, 32 and 33. restrictions referred to in paragraph 1;
55.8. conditions for remuneration or compensation if the clinical trials because of injury to health or death;
34.7. any insurance or indemnity related to the liability of the investigator and sponsor;
the researcher and the researched 55.10. party for indemnity or compensation provided for and, if necessary, the conditions, as well as between sponsor and the Research Center concluded the contract in which it is determined;
the person raising 55.11. measures.
56. The Ethics Committee shall within 30 days after the registration for such application, which shall include all the information referred to in these provisions, shall provide a written opinion for the applicant, stating the grounds for the opinion given in the opinion. A copy of the opinion submitted to the State Agency of medicines.
57. During the examination of the application for an opinion, the Ethics Committee may send a single additional information to the applicant's request. The period laid down in paragraph 56 of these rules, to additional information.
58. The Ethics Committee extended this provision during the period referred to in paragraph 56, if the clinical trial is planned, including gene therapy or somatic cell (any cell of the organism which is not known), treatment for drug or medicinal products containing genetically modified organisms. In this case, these rules, the period referred to in paragraph 56 was extended, but it is not more than 180 days from the date of registration of the application. Xenogeneic cell (foreign to the human body cells) therapy in the case of the opinion of the period of limitation is not.
59. If a multi-centre clinical trial and all the study centres located in Latvia, the Ethics Committee shall give its opinion on the single of this clinical trial. If the multicenter clinical trial conducted simultaneously in more than one Member State, the Ethics Committee shall give an opinion on a single clinical trial in Latvia.
60. the Ethics Committee shall entitle the applicant to challenge the central medical ethics Committee. Central Medical Ethics Committee decision is final.
Vi. State Agency of medicines authorisation-61. for the State Agency of medicines of the permission to start a clinical trial, the sponsor or the sponsor's authorized person shall submit to the State Agency of medicines in the following documents and particulars: 61.1. European clinical trials database (eudract) number acknowledgement of receipt;
61.2. sponsor or sponsor's authorized person sign the petition, drawn up on the basis of the European Commission, the sample application (link available on the European Commission website http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-10/11_an1_14-2005_en.pdf) (also submit XML files);
38.1. the sponsor and the investigator shall sign the Protocol and Protocol amendments, if any, do;
61.4. Overview of all active trials with investigational medicinal product concerned;
61.5. use of the investigational medicinal product that summarizes data on the investigational medicinal product, including the reference formulation and placebo (inert form of medicinal products without active substances which do not have the specific objective of the activity in relation to the specific treatment) quality, include pre-clinical and clinical studies carried out previously for results, as well as the efficiency and risk assessment summary that critically analyses the preclinical and clinical data for the planned clinical trials the risks and the benefits or a simplified search of the investigational medicinal product used, if a government agency of the medicinal product investigational medicinal products evaluated again;
61.6. Summary of product characteristics of the medicinal product in the Member States;
38.3. a list of those Member States in which the application was submitted, as well as information on the decisions of those bodies, if available;
38.4. the manufacturer's license copy, if the investigational medicinal products manufactured in a Member State or of the European economic area;
61.9. finding that the plant complies with the requirements of good manufacturing practice at least equivalent to the European Union good manufacturing practice requirements, as well as the importer's copy of the licence, if the investigational medicinal products manufactured outside the European Union;
61.10. attestation of investigational medicinal products the active substance production compliance with the good manufacturing practice requirements;
No 61.11. sponsor develop investigational person informed consent documents in the language of the country. If the clinical trial is planned to involve people who are not familiar with the national language level, which allows you to understand the document written, submit information in a language that the study involved can understand;
No 61.12. other written information in the language of the country, related to the clinical trial and for the person being investigated. If you planned to engage in clinical research by persons not familiar with the national language level, which allows you to understand the information, submit information in a language that the study involved can understand;
No 61.13. hospital's management's written consent to perform clinical research;
61.14. documents certifying the investigator and the sponsor's liability insurance and that includes conditions for remuneration to the person being investigated, if she has suffered damage or causing the death of the person examined, attributable to a clinical trial;
61.15. documents relating to the payment of compensation to the person being studied for participation in clinical research, if such compensation is intended;
61.16. the investigator's brochure or paragraph 29 of these rules in the case provided for in the summary of product characteristics;
61.17. preparations examined a sample of the label of the packaging in the national language;
61.18. researchers the investigator and Assistant experience and qualifications;
61.19. written evidence that the researcher is trained in good clinical practice requirements and regulations for the conduct of clinical trials of medicinal products;
61.20. sponsor privileges if the document shall be submitted to the sponsor's authorized person.
62. The applicant, in accordance with the State Agency of medicines of the public paid the price list shall bear the expenses related to the pharmaceutical clinical trial application. If the clinical trial is denied, the paid expenses are not reimbursed.
63. the State Agency of medicines application (plus all the rules listed in paragraph 61) appearance within 60 days after its receipt.

64. During the examination of the application, the State Agency of medicines can be send to the applicant a request for additional information. The period laid down in point 63 of these regulations, to additional information.
65. the State Agency of medicines shall extend this provision during the period referred to in paragraph 63, where the clinical trial is planned, including gene therapy or somatic cell (any cell of the organism which is not known), treatment for drug or medicinal products containing genetically modified organisms. In this case, this provision during the period referred to in paragraph 63 is extended, but not more than 180 days from the date of registration of the application. Xenogeneic cell therapy in case of issue of term limits.
66. the State Agency of medicines of the 63 and 64 of these rules the time limit referred to in paragraph shall take a decision on the commencement of a clinical trial or on a ban to launch clinical trials, if these rules are not satisfied those requirements, and within five working days after the decision shall inform the applicant in writing, stating the grounds for the decision. Permission not granted, pending the provision referred to in paragraph 62. Permit is issued for Protocol clinical trial.
67. A permit is not issued for a gene therapy research, which produces a gamete of the person examined genetic identity modificēšano.
68. the clinical examination with the permission of the medicinal products containing genetically modified organisms, the State Agency of medicines shall be issued after the sponsor received authorization in accordance with the laws and regulations on genetically modified organisms in contained use and deliberate release into the environment.
69. The applicant State Agency of medicines has the right to challenge the decision of the Ministry of health. The Ministry of health decision may appeal to the Court.
70. If you make a multi-centre clinical trial and all the study centres located in Latvia, the State Agency of medicines shall adopt a single decision about this clinical trial. If the multicenter clinical trial conducted simultaneously in more than one Member State, the State Agency of medicines shall adopt a decision on a single clinical trial in Latvia.
VII. Clinical trials started 71. Sponsor initiated clinical trials only after the Ethics Committee has given a favourable opinion and the State Agency of medicines shall issued the permission to start clinical trial. Sponsor shall have the right to submit the application at the same time the Ethics Committee, and the State Agency of medicines. Before the commencement of the clinical trial, the sponsor shall sign a contract with each treatment, which planned to carry out a particular clinical trial, providing the Contracting Parties ' obligations and responsibilities for the conduct of clinical trials (including intellectual property rights and confidentiality) as well as financial conditions (including the amount of the medical authority of its human and material base for use in clinical research and payment schedule).
72. If the Medicines Agency informed the sponsor of the decision to ban the launch of clinical trials because of these rules has not been complied with those requirements, the sponsor may be only once to amend that rule 61.2. the application referred to in the content, in order to take account of the grounds of the decision in these arguments. If a sponsor has not taken note of the decision referred to in the grounds of arguments, the application shall be deemed to have been rejected and the clinical trials may not start.
VIII. conduct clinical trials 73. After the commencement of the clinical trial, the sponsor shall have the right to amend the application and the documents attached thereto. If these amendments can dramatically affect the security of the person examined, the physical or mental integrity of the person, the scientific value of the study, the study's progress or driving, the quality of the product of the study or their safety, the sponsor shall provide the State Agency of medicines of the application on the basis of the European Commission approved the amendment of the relevant application sample (link available on the European Commission website http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-10/11_an2_14-2005_en.pdf), as well as in writing inform the Ethics Committee.
74. The Ethics Committee shall give its opinion, and the State Agency of medicines shall take a decision within 30 days of this provision the amendment referred to in paragraph 73.
75. If the Ethics Committee has delivered a favourable opinion and the State Agency of medicines has adopted a positive decision, the sponsor continues to perform clinical trials, subject to the amendments to the Protocol. 
76. If the opinion of the Ethics Committee or State agency decision is unfavourable because of those rules have not been complied with those requirements, the sponsor may not introduce amendments to the Protocol before it is taken into account and the reasons of the decision in the opinion contains arguments. If a sponsor has not taken note of the opinion or decision justification arguments listed in, sponsor amendments to the Protocol is considered rejected.
77. If clinical trials during the trial or investigational medicinal product research or development related conditions which may affect the safety of the person examined, the sponsor and the investigator shall take appropriate urgent safety measures to protect the person being investigated. The sponsor shall immediately inform the State Agency of medicines of the circumstances and the measures taken and shall ensure that the well is brought to the Ethics Committee. 
78. If the amendments to the Protocol related to administrative issues, sponsor for them in writing to the Ethics Committee and the State Agency of medicines. The Ethics Committee opinion and national agency for medicinal products authorised in this case is required.
79. within 90 days of the end of a clinical trial the sponsor shall notify the State Agency of medicines and the Ethics Committee that the clinical trial has been completed in the Republic of Latvia. The sponsor shall provide the State Agency of medicines of the application on the basis of the European Commission approved the completion of the clinical trial application (link available on the European Commission website http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-10/11_an3_14-2005_en.pdf). The sponsor shall notify the State Agency of medicines of Latvia patients involved in clinical trials. If the clinical trials are stopped before the end of the research, scheduled for termination of the research sponsor, within 15 days after the termination of a clinical trial shall inform the State Agency of medicines and the Ethics Committee, explaining the reason for termination of a clinical trial.
IX. Information Exchange 80. State Agency of medicines shall enter in a European database of clinical trials information for each territory of Latvia applied clinical trials, including: 80.1. the sponsor submission to the National Agency for medicines for permission request to initiate a clinical trial;
80.2. any amendments to the application or the documents attached to it, according to the State Agency of medicines and the provision of paragraph 72;
49.9. any amendments to the Protocol after the commencement of the clinical trial in accordance with this provision, 74 and 75 73;
80.4. in the opinion of the Ethics Committee;
80.5. notification of completion of the clinical trial in the Republic of Latvia;
50.1. information about the clinical trial monitoring and how to evaluate its compliance with the requirements of good clinical practice.
81. the State Agency of medicines in addition to these regulations, paragraph 80 information provides the necessary information according to any Member State, or the European Medicines Agency, the European Commission's reasoned request.
X. termination of a clinical trial and 82 infringements. If the State Agency of medicines has reasonable grounds to believe that this rule 61.2. in terms of the application of subparagraph are not complied with, as well as to meet the requirements of these regulations or is in possession of information that casts doubt on the safety of clinical trials or scientific validity, the State Agency of medicines has the right to suspend the clinical trials, informed the investigator and sponsor.
83. before the State Agency of medicines shall decide that rule 82. in the case referred to in the paragraph, the sponsor and the investigator so requests a week to provide information on the reasons for non-compliance with the conditions, except where there is a serious risk to the person being investigated.
84. If the State Agency of medicines has reasonable grounds to believe that the sponsor or the investigator or any other clinical trial involving the person does not comply with certain obligations, it shall inform the person concerned and indicate the actions that it needs to take to rectify the situation. The State Agency of medicines shall inform the Ethics Committee, the other competent authorities and the European Commission on the activities undertaken.
85. the State Agency of medicines has the right to prohibit the clinical trial if the clinical trial poses a serious risk to the person being studied, but not by the sponsor and the investigator shall take the necessary measures for security of the person being investigated. 
86. Of the decision to suspend or prohibit the clinical trial, if these rules are not satisfied those requirements, as well as the reasons for that decision the State Agency of medicines shall inform the other competent authorities, the Ethics Committee, the European Medicines Agency and the European Commission.
XI. the production of investigational medicinal product, import and labelling requirements 87. manufacture of investigational medicinal products and the import of determined by law on the production and control of medicinal products and the importation and distribution of medicinal products.

88. the secondary packaging investigational medicinal product or, if not, the primary language of the country of the packaging indicates the information, in accordance with article 25.2 of the pharmaceutical law laid down in the European Commission's recommendations (guidelines), published in the European Community pharmaceutical legislative framework document inventory (Eudralex).
XII. The clinical trial set of documents and their storage requirements 89. Clinical research document is a master document that supports clinical research and research on the quality evaluation of the data obtained. These documents will show whether the investigator and the sponsor to act in accordance with the principles of good clinical practice and guidelines, as well as legislation on the registration of the medicinal product.
90. The clinical trial set of documents are the basis for an audit by the sponsor's independent auditors appointed, as well as monitoring and evaluation, conducted by the State Agency of medicines.
91. The basic document content relevant to the clinical trial phase.
92. The Sponsor and the investigator trials master documents shall be kept for at least five years after completion of the study in question, except that rule 93 and 94. documents listed.
93. researchers are responsible for the identification of the person in possession of a list of at least 15 years. 
94. The Sponsor is responsible for the Protocol, SOPs, the investigator's brochure, the personal data of each investigational registration document, clinical trial reports, written opinion on the clinical trial protocol and its progress in storage for at least five years after the preparations examined registrations.
95. the documents shall be kept for longer, as determined by the laws and regulations on medical records filing order or agreement between the sponsor and the investigator.
96. the documents shall be stored so that they are at the State Agency of medicines or the request of the Inspectorate of health should be immediately available to the appropriate people competency and regulations on personal data protection. The identification code available only to the bodies in accordance with the law of medical treatment have the right to consult the records of the patient.
97. Medical records about persons kept under in accordance with the laws and regulations on medical records filing procedure.
98. the data or a change of ownership of a master document. The new owner assumes responsibility for data storage and archiving in accordance with this provision, 93.92, 94, 95, 96 and 97. point. 
99. The Sponsor shall designate the person responsible for archives (person in charge). 
100. the approach to the archive are only allowed on this provision in paragraph 99.
101. The master shall be kept under conditions which ensure that they are complete and legible throughout the specified retention period and is available after this rule 96 bodies referred to in the request. 
102. Any changes to documents are easily traceable by storing the text in which the change was made.
XIII. The procedure is monitored and evaluated clinical trial compliance with good clinical practice requirements 103. evaluation is an official inspection carried out by the national agency of medicinal products and which time it checks the documents, facilities, records, quality assurance arrangements, and any other resources that the State Agency of medicines shall be deemed related to the clinical trial and Research Centre located in the sponsor or the sponsor's authorized persons rooms as well as any other authority, the State Agency of medicines of which considers it appropriate to evaluation.
104. in order to monitor and evaluate compliance with good clinical practice requirements, the State Agency of medicines of the qualified person has the right to visit places associated with clinical trials, particularly research center and any laboratory used for analyses in the clinical trial.
105. the State Agency of medicines shall comply with the data protection requirements for good clinical practice during the monitoring and evaluation of the information obtained.
106. the monitoring and evaluation of the medicinal product may be carried out by the national agency of a qualified person is: 106.1. higher education or relevant experience in medicine, pharmacy, pharmacology, toxicology or other relevant field;
106.2. knowledge of the principles and activities related to drug development and clinical trials, as well as knowledge of the European Union and the Republic of Latvia legislation on clinical trials and registration of the medicinal product;
106.3. knowledge of clinical trial data logging system and logging related activities, as well as the health system organization and regulation.
107. the State Agency of medicines information for qualified individuals is entitled to supervise and evaluate the clinical trial compliance with good clinical practice, their qualifications, training and experience and, upon request, relevant information provided by the European Medicines Agency. The State Agency of medicines shall ensure that individual training, regularly evaluate training needs, as well as take appropriate measures for the persons concerned the maintenance and development of skills.
108. the State Agency of medicines shall ensure that persons referred to in paragraph 107 of the SOPs, as well as the description of the duties, responsibilities and training requirements for detailed descriptions. The State Agency of medicines shall regularly update the description of the SOPs, as well as other rules 107. persons referred to in paragraph 1 for information.
109. the State Agency of medicines that rule 107 of the person referred to in paragraph provides a document (ID card), proving their right to monitor and evaluate clinical trial compliance with good clinical practice requirements.
110. This provision a person referred to in paragraph 107, when starting, writing Specifies any financial or other relationship with persons or monitored drug clinical trial sites and confirms this information. The proof of the State Agency of medicines are taken into account in assigning an individual clinical trial, concerned the conduct of monitoring and evaluation.
111. Good clinical practice compliance assessment can be performed in the following cases: 111.1. prior to the commencement of the clinical trial, the clinical trial, or after its completion;
111.2. a medicinal product registration application.
112. If this rule 111.2. required the good clinical practice compliance assessment related to the trip, the applicant shall bear the National Medicines Agency official travel (transport) spending to research center or a research institution associated with the back and forth, spending on hotels (accommodation), visa fees, health insurance and subsistence expenses in accordance with the laws and regulations on the procedures for recoverable with missions and staff travel-related expenses.
113. On the evaluation of the State Agency of medicines shall inform the European Medicines Agency. Monitoring and evaluation may be carried out on behalf of the European Union, and the results shall be recognised by the other Member States. The State Agency of medicines has the right to request the assistance of another Member State, the monitoring and evaluation.
114. After the evaluation, the State Agency of medicines shall draw up an evaluation report. The report is available on the sponsor, providing the necessary data protection. It is available to the other Member States, the Ethics Committee and the European Medicines Agency, if you received a reasoned request.
115. the progress of a clinical trial is entitled to inspect also the competent foreign authority. In this case, the relevant foreign authority shall inform the State Agency of medicines of the inspections provided for 30 days before its launch. May participate in the inspection of the State Agency of medicines.
116. in order to ensure the monitoring and evaluation of all clinical research stakeholders are required to ensure the State Agency of medicines, as well as foreign evaluators direct access to all documents related to clinical trials.
117. Clinical trials testing competency may carry a health inspection. On this point the results of the inspection referred to in the inspection report to the State Agency of medicines.
118. If necessary, the State Agency of medicines of the medicines evaluation in clinical trials may involve experts, qualifications and experience of which corresponds to a given clinical trial.
XIV. The reporting of adverse events 119. researchers will immediately inform the sponsor in writing of any person examined adverse medical events that occur during the use of the investigational medicinal product, regardless of the causal link with the use of the investigational medicinal product irrespective of the dose results in death, is life-threatening, results in the need for hospitalization or extended existing hospitalization, causes permanent or severe forms of disability or incapacity, or is a congenital anomaly or what birth defect (hereinafter referred to as the major adverse event) except for the essential unwanted events that the Protocol or investigator's brochure is not listed among those that require immediate reporting. After the instant message sent to the sponsor, the investigator detailed written report. Instant and future reports for investigational use of personal identification to the person under the assigned unique identification code.

120. the significant adverse events and laboratory abnormalities that Protocol as essential for the use of the investigational medicinal product security evaluation, researchers will report in writing to the sponsor in accordance with the Protocol specified in the reporting requirements and deadlines.
121. If there's the death of the person being studied, the researchers provide the sponsor and the Ethics Committee with all of the requested additional information.
122. The Sponsor shall record all details of researchers ziņoto unwanted events and assess their gravity, cause and predictability, as well as, on request, provide the data to the competent authorities of the Member States that are in a specific clinical trial.
XV. Reporting of significant side effects. The Sponsor provides 123, to all the relevant clinical trials in the research centers involved in the observed significant adverse and unexpected response to the use of the investigational medicinal product irrespective of the dose used, the nature or severity of which degree does not match the available information on investigational medicinal products (hereinafter referred to as the unintended side effects), which causes death or investigational threatens its life and likely led to the investigational medicinal products to be registered. Information about the possible earlier, but not later than seven days after the receipt of such information the sponsor entered the European Medicines Agency, the European medicines side effects surveillance system (EudraVigilance) clinical trials database module (EVCTM). On significant unforeseen side effects that cause death or investigational threatens its life and likely led to the investigational medicinal products, and the observed clinical trial centres in Latvia, the sponsor shall notify the State Agency of medicines, giving the State Agency of medicines of the EVCTM address, and to the Ethics Committee by providing additional report within eight days after the first message.
124. Major unexpected side effects, causing no death or investigational does not endanger its life, potentially causing investigational medicinal products, the sponsor will enter the European Medicines Agency, the European medicines side effects surveillance system (EudraVigilance) clinical trials database module (EVCTM). On significant unforeseen side effects, causing no death or investigational does not endanger its life, potentially causing investigational medicinal products, and the observed clinical trial centres in Latvia, the sponsor shall notify the State Agency of medicines, indicating the medicine EVCTM national agencies, as well as possible before the Ethics Committee, but not later than 15 days after the receipt of the information.
125. the State Agency of medicines shall record information on all reported suspected serious unexpected adverse reactions to an investigational medicinal product.
126. The Sponsor of any significant unexpected side effects that could have been caused by the use of the investigational medicinal product, periodic (frequency determines the nature of the study and a number of side effects) inform all clinical researchers involved in the research.
127. Clinical trial, the sponsor shall annually not later than 60 days after the reference period laid down in the Protocol end provides drug national agency and to the Ethics Committee's report on the security of all the observed during the year not provided substantial side effects, which may have given rise to investigational medicinal products, as well as a summary of the personal safety of investigational clinical trials. If clinical trials lasting less than a year, the security report may be submitted together with the notice concerning the completion of the clinical trial.
XVI. observations of the use of the medicinal product administration 128. observations collects only such data which the operator observations (the doctor) gets the professional activities on the basis of the opinion of the patient's medical condition and treatment. Patients do not perform additional diagnostic and monitoring procedures and the analysis of the data collected using epidemiological methods.
129. observations of the use of the medicinal product Before the launch of the doctor or a drug company representative responsible for coordination of the observation shall be submitted to the State Agency of medicines and the Ethics Committee in the following documents: 129.1. application that contains the following information: 129.1.1. name of the medicinal product observation, generic name, pharmaceutical form and strength;
129.1.2. observations of the project description (including criteria for patient involvement in the observation and data analysis methods used);
129.1.3. the doctors participating in the observation, indicating their name and specialty;
129.1.4. medical institutions participating in observation;
129.1.5. the planned number of clients involved;
129.1.6. State whether the disease for which the treatment was intended for the observation Hall, is included in the compensation system of the medicinal product;
129.1.7. State whether the observation Hall are included in the list of medicinal products eligible;
129.1.8. for the duration of the observations indicating the start and end date;
129.2. it a sample of the document by which the patient declares the consent of treatment data collection and compilation;
129.3. observation data in the registration document.
130. The applicant, in accordance with the State Agency of medicines of the public paid the price list shall bear the expenses related to the observations of the use of the medicinal product with consideration of the application. 
131. the observation of the use of the medicinal product may be launched if the Ethics Committee has delivered a favourable opinion and the State agency within 30 days after the registration of the application is not notified the applicant of the reasons why the Administration should not initiate the observations.
132. Concerning the observations of the use of the medicinal product drug dangers identified side effects doctor under the laws and regulations for pharmacovigilance of the medicinal products in the national news agency.
133. within 90 days after the end of the doctor or of the observations that rule 129. responsible person referred to in the written report to the State Agency of medicines of the observation end, providing a summary of observations number of patients involved and identified drug-related side effects.
134. the observations of the use of the product for compliance with those rules according to the competence of the State Agency of medicines shall monitor and review health inspection.
135. the observations of the use of the medicinal product concerned is obliged not to disclose patient and clinical data, unless the data in question requires the authorities which, in accordance with the law of medical treatment have the right to consult the records of the patient.
XVII. Closing questions 136. Be declared unenforceable in the Cabinet of Ministers of 28 February 2006, Regulation No 172 "regulations on clinical trials of medicines and the use of observation, the labelling of the investigational medicinal product and procedures are evaluated compliance with good clinical practice requirements" (Latvian journal, 2006, 45 no; 2008, no. 10).
137. the rules shall enter into force on 1 April 2010.
Informative reference to European Union directives, the regulations include provisions resulting from: 1) of the European Parliament and of the Council of 4 April 2001, Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use;
2) Commission of 8 April 2005 of Directive 2005/28/EC laying down the good clinical practice principles and detailed guidelines on investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
Prime Minister v. Minister of Interior, Dombrovskis Health Minister ad interim Mūrniec of L.