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On Amendments And Additions To The Federal Act "on State Regulation In The Field Of Genetic Engineering Activity"

Original Language Title: О внесении изменений и дополнений в Федеральный закон "О государственном регулировании в области генно-инженерной деятельности"

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RUSSIAN FEDERATION FEDERAL LAW On introducing changes and additions to the Federal Law on State Regulation in the Field of Genetically Engineering Activities " Adopted by the State Duma on June 21, 2000 Approved by the Federation Council on 28 June 2000 Article 1. To amend the Federal Law of 5 July 1996 N 86-FZ On State Regulation in the Field of Genetically Engineering Activities (Assembly of the Russian Federation, 1996, No. 28, art. 3348) the following changes and additions: 1. Article 1, after "his body", should be supplemented with the words ", except for agnostics and gene therapy (gene therapy),". 2. Article 2 should read as follows: " Article 2. Basic concepts Basic concepts used in this Federal Law: gene engineering-a set of methods and technologies, including technologies to receive recombinant ribonucleic acid and deoxyribonucleic acid, to release genes from the body, to manipulate genes, and to introduce them into other organisms; gene therapy (gene therapy) is a set of genetically engineered (biotechnological) and medical methods of change to the genetic apparatus of human somatic cells for the treatment of diseases; Genetically-engineered activities-activities carried out using genetic engineering techniques and genetically modified organisms; agnostic-a set of methods for detecting changes in genome structure; genetically modified organism or organism, any non-cellular, single cell or multicellular education that can reproduction or transfer of hereditary genetic material other than natural organisms derived from the use of genetic engineering techniques and containing genetically engineered material, including genes, fragments or combinations of genes; issue genetically modified organisms in the environment-action or inaction that resulted in the introduction of genetically modified organisms into the environment (this concept does not apply to activities related to Change in hereditary genetic material of a person through the use of methods genetic engineering for gene therapy (gene therapy); biological protection-the creation and use in genetic engineering of a combination of biological material whose properties are excluded Undesirable survival of genetically modified organisms in the environment and (or) the transfer of genetic information to them; Protection of the physical-creation and use of special techniques and techniques to prevent genetically modified organisms the environment and/or the transmission of genetic information; clinical trials-verification of the effectiveness and safety of gene therapy (gene therapy); Zenknutai is a system of genetic engineering, that genetic modification is made in organisms or genetically modified organisms, processed, cultivated, stored, used, transported, destroyed or buried in the existence of physical, chemical and biological barriers or their combinations, -preventing genetically modified organisms with populations and the environment; system is open-system of genetic engineering activities involving genetically modified organisms with the population and the environment, with their deliberate release into the environment, medical and nutritional targets, exports and imports, transfer of technology; transgenic organisms-animals, plants, microorganisms, viruses, genetic program modified using genetic engineering. ". 3. Part 2 of Article 5 is supplemented with a new paragraph by the third paragraph reading: "the safety of clinical tests of the methods of general diagnostic and gene therapy (gene therapy) at the level of somatic cells;". 4. Article 6 add a new paragraph to the third paragraph reading: " genetic manipulation of molecular, cellular levels with the participation of recombinant ribonucleic and deoxyribonucleic acids for the purposes of agnostic and genetic of therapy (gene therapy) with respect to person; ". Article 2. This Federal Law shall enter into force on the date of its official publication. President of the Russian Federation Vladimir Putin Moscow, Kremlin 12 July 2000 N 96-FZ