Amendments To The Cabinet Of Ministers Of 28 February 2006, Regulation No 172 Of "regulations On Clinical Trials Of Medicines And The Use Of Observation, The Labelling Of The Investigational Medicinal Product And Procedures Are Evaluated Compliance Wit...
Original Language Title: Grozījumi Ministru kabineta 2006.gada 28.februāra noteikumos Nr.172 "Noteikumi par zāļu klīniskās izpētes un lietošanas novērojumu veikšanu, pētāmo zāļu marķēšanu un kārtību, kādā tiek vērtēta atbilstība labas klīniskās prakses prasībām"
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Cabinet of Ministers Regulations No 17, Riga, 15 January 2008 (pr. 3. § 18) the amendments to the Cabinet of Ministers of 28 February 2006, the 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" Issued in accordance with article 5 of the law on pharmacy, 3, 6, and 15-1. make Cabinet of 28 February 2006, the Regulation No 172 "rules for drug clinical trials and observations of the use of the performance the labelling of the investigational medicinal product, and the order in which it is assessed compliance with good clinical practice requirements "(Latvian journal, 2006, 45 no) the following amendments: 1. supplement to the second paragraph 18.8 sentence the following wording:" one of the parents or legal representative declares in writing that the minor according to the level of understanding is aware of the specific nature of the clinical trial, the risks and the benefits; "
1.2. expression 33 as follows: "33. to trial subject can get independent information about the clinical trial, the researchers provide the trial subject to the Ethics Committee (which has delivered an opinion on the clinical trial in question) and the State agency contacts.";
1.3. make the following subparagraphs 52.9.: 52.9. documents relating to the payment of compensation to the holder of a study of participation in clinical research, if such compensation is intended; ";
1.4. to supplement the rules with the bottom point of the 52.9.1 by the following: "52.9.1 documents that attest to the investigator and the sponsor's liability insurance and that includes provisions on the remuneration of research subject if he is harmed or early trial subject death attributable to a clinical trial;"
1.5. make 59.1. subparagraph by the following: "59.1. European clinical trials database (eudract) number to receive approval;";
1.6. to express, and 59.13 59.14.79.. bottom point as follows: "59.13. hospital's management approval to perform clinical research;
59.14. documents certifying the investigator and the sponsor's liability insurance and that includes provisions on the remuneration of research subject if he is harmed or early trial subject death attributable to a clinical trial;
79. the documents relating to payment of compensation to the holder of a study of participation in clinical research, if such compensation is intended; ";
1.7. replace paragraph 61, the number "45" with the number "60";
1.8. make 66 as follows: "66. clinical trial authorisations of medicinal products containing genetically modified organisms, the State Agency of medicines shall be issued after the sponsor received in accordance with the laws and regulations on genetically modified organisms in contained use and deliberate release into the environment of issued permissions.";
1.9. to make 69 the following: "69. Sponsor initiated clinical trials only after the Ethics Committee has given a favourable opinion and the State Agency of medicines has given 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). ";
1.10. the express 94. paragraph by the following: "94. Master documents stored in such a way as to be immediately available after the State Agency of medicines or health inspections, pursuant to their competence and legislation 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. ';
1.11. to make 99. paragraph by the following: "99. Master documents stored under conditions which ensure that they are complete and legible throughout the specified retention period and can be available after this rule 94, paragraph at the request of the authorities.";
1.12.112. points to express the following: "112. Clinical progress 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. Inspection of medicinal products may participate in the national representative of the Agency. ";
1.13.114 points to express the following: "114. 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. "
1.14. Express 126. paragraph by the following: "126. prior to the commencement of the use of the product of the doctor or the observation, if the observation made more doctors, the person in charge (a doctor or a drug company representative responsible for coordination of the observation) (hereinafter applicant) shall submit to the State Agency of medicines and the Ethics Committee in the following documents: 126.1. application that contains the following information: 126.1.1. name of the medicinal product observation, generic name, pharmaceutical form and strength;
126.1.2. observations of the project description (including criteria for patient involvement in the observation and data analysis methods used);
126.1.3. the doctors participating in the observation, indicating their name and specialty;
126.1.4. medical institutions participating in observation;
126.1.5. the planned number of clients involved;
126.1.6. information on whether the disease for which the treatment was intended for the observation Hall, is included in the compensation system of the medicinal product;
126.1.7. information on whether the observation Hall are included in the list of medicinal products sējam ingoffsetbya rapid rise;
126.1.8. for the duration of the observations indicating the start and end date;
126.2. it a sample of the document by which the patient declares the consent of treatment data collection and compilation;
126.3. observation data model document for registration. ";
1.15. in paragraph 131, replaced the words "national pharmaceutical inspectorate and medical care and integrity inspection quality control inspection" by the words "health inspection".
2. the rules shall enter into force on March 1, 2008. Prime Minister i. Godmanis Health Minister Morris I.
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