Cabinet of Ministers Regulations No. 542 in Riga, 15 June 2004 (pr. No 37, § 26.) amendments to the Cabinet of Ministers of 12 September 2000, the Regulation No 312 "drug clinical trials and observations using the order" Issued in accordance with article 5 of the law on Pharmacy 3 and 6 points to make a Cabinet of 12 September 2000, the Regulation No 312 "drug clinical trials and observations using the order" (Latvian journal, 2000, 323; 2001, 105/324.nr. No; 2003, 125 no) the following amendments : 1. The deletion of paragraph 1, the words "(hereinafter referred to as the investigational product)".
2. paragraph 1 shall be supplemented by the words "the preparation" with the words "(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 use, form, and the packaging is different from the registered)".
3. Delete paragraph 46.
4. Make 52 as follows: "52. The Sponsor shall ensure that all relevant clinical trials in the research centers involved in the observed serious unexpected adverse reactions that cause the death of the trial subject or a threat to his life and what may have caused the preparations examined, be registered. In the past, but they may not later than seven days after receipt of the relevant information, the sponsor shall notify the State Agency of medicines and other participating European Union Member States competent authorities, the Ethics Committee, as well as providing additional message eight days after the first message. For other serious unexpected adverse reactions that may indicate that the studied formulation, the sponsor shall notify the national medicines agency and the other Member States of the European Union as well as the responsible authorities, the Ethics Committee may sooner, but not later than 15 days after the receipt of the information. The sponsor of any serious unexpected adverse reactions that may indicate that the preparations examined, inform all clinical researchers involved in the research. "
5. Supplement with 52.1 52.2 52.3 52.4 points, and such as: "the national medicines agency 52.1 recorded information about any reported serious unexpected adverse reactions that may indicate that the preparations under study.
52.2 for all clinical investigator trials observed serious adverse events — any serious adverse side effects that appear in the subject being researched in the preparation of the study on the use of time regardless of the causal link with the preparations examined, shall be notified immediately to the sponsor except for those unwanted events, for which according to the study protocol or investigator's brochure specified does not need to report immediately. The original message followed by detailed, written reports. Both the original and the additional report of the study subject is marked by a special code in it.
52.3 for adverse events or laboratory abnormality that the Protocol specified as essential for the evaluation of the safety in use, according to the study protocol specified in reporting requirements and deadlines, reported to the sponsor. If there was a subject of study, the researcher provides the sponsor and the Ethics Committee with all of the requested additional information.
52.4 Sponsor detailed register of all researchers ziņoto unwanted events and assess their gravity, cause and predictability, as well as, upon request, submit the data to the national medicines agency. "
6. To express the 53 by the following: "53. Sponsor annually not later than 60 days after the end of the period of the report provided by the National Medicines Agency safety report on all the year observed serious adverse drug reaction that may indicate that the preparations under study, as well as a summary of the study subject's safety during a clinical trial. 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. "
7. Deletion of 54.
8. Supplement with an informative reference to European Union directives as follows: "Informative reference to European Union Directive provisions included in the law resulting from the April 4, 2001 the European Parliament and Council 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."
Prime Minister i. Emsis Health Minister r. Muciņš Editorial Note: the entry into force of the provisions by June 19, 2004.