The Procedure For The Authorisation To Be Issued Coded Tissue Sample (Aliquot) And Coded Description Of The Health Status Of The Copy Outside Of Latvia, For The Removal And Use Of Tissue Samples Of Control Procedures

Original Language Title: Kārtība, kādā izsniedzamas atļaujas kodētu audu paraugu daļu (alikvotu) un kodētu veselības stāvokļa aprakstu kopiju izvešanai ārpus Latvijas, un audu paraugu izmantošanas kontroles kārtība

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Read the untranslated law here: https://www.vestnesis.lv/ta/id/92351

 
Cabinet of Ministers Regulations No. 696 Riga 2004 (august 10. No 47 11) the procedure for the authorisation to be issued coded tissue sample (aliquot) and coded description of the health status of the copy outside of Latvia, for the removal and use of tissue samples for the control order Issued in accordance with human genome research of the law article 15 the third paragraph of rule 1 defines the procedure for the authorisation to be issued coded tissue sample (aliquot) and coded description of the health status of the copy outside the Latvian export (hereinafter referred to as the export licence) as well as tissue samples of the use of control procedures.
2. to obtain export licences, genome database the main processor (main controller), genome databases authorized processor (hereinafter authorised processor) or gene researcher submitted to Genome Research Council (hereinafter Council). The application shall be accompanied by the following: 2.1 coded tissue sample (aliquot) and coded description of State of health the need to export a copy of the reasons for and details of the genetic research to be conducted outside of Latvia, its scope and tasks; 2.2. Description of genetic research and information about the research time; 2.3. certified the international scientific project (program), which provided the genetic research; 2.4. certified by the Republic of Latvia, a copy of the contract concluded on participation in internationally recognized genetic database creation; 2.5. the gene donor's written permission to show him a coded tissue sample (aliquot) and the encoded description of the health status of the copy outside of the Latvian population genetic research or genome State Register (hereinafter register) proof that such permission is received and stored in the registry; 2.6. coded tissue sample (aliquot) and the encoded description of the health status of the copy control mechanisms on the use of the description; 2.7. information on coded tissue sample (aliquot) and the encoded description of the health status of the copy of the return or disposal and deadlines;
2.8. information about the Customs point through which the exported part of the coded tissue samples (aliquot) and coded description of State of health.
3. within 10 working days after the main controller, the controller authorized or gene researcher's receipt of the application to the Council shall review the information submitted in compliance with the legislation requirements and shall inform the applicant for authorization for the additional information to be submitted, if necessary. 4. the decision on the export permit or refusal to issue a permit, the Council shall adopt, within 30 days after receipt of the application by an applicant. If you need additional information, the Council may extend the review of the information submitted in writing informing the applicant for authorization. 5. If the decision has been taken on the issue of export licences, the Council shall authorise the export licence to the applicant and to the main processor – a copy of the export licence. 6. the export licence holder shall provide quarterly reports to the Council on the left coded tissue sample (aliquot) and the encoded description of the State of health of the use of the copy outside Latvia. The report added to the existing relevant sample abroad and a description of the requested review copies of documents. 7. the recipient of the export licence will be obliged to report to the Council on changes to the rules in the information referred to in paragraph 2. 8. the Council shall refuse to issue an export licence in the following cases: 8.1. information submitted the false data; 8.2. all these provisions have been submitted to the documents referred to in paragraph 2, or is not completely and within 30 days after the requested this provision referred to in paragraph 3, additional information, it has not been submitted; 8.3. the documents submitted do not meet the legislative requirements for the physical protection of personal data, documentation, or human genome research.
9. the Council shall suspend the operation of the export licence issued or revoke the permit in the following cases: 9.1. information submitted the false data; 9.2. the genetic research is not complied with statutory human genome research and the general ethical principles; 9.3. no respect for laws on the protection of personal data; 9.4. no submitted statement on leaving the coded tissue sample (aliquot) and the encoded description of the State of health of the use of the copy outside Latvia; 9.5. the beneficiaries of the export licence is immediately informed the Council about the changes to this provision the information referred to in paragraph 2.
Prime Minister i. Emsis Health Minister r. Muciņš Editorial Note: regulations shall enter into force with the 14 august 2004.