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Law No. 179 Of 18 October 2012 Amending And Supplementing Law No. 339/2005 Regarding The Legal Regime Of Plants, Substances And Preparations With Narcotic And Psychotropic

Original Language Title:  LEGE nr. 179 din 18 octombrie 2012 pentru modificarea şi completarea Legii nr. 339/2005 privind regimul juridic al plantelor, substanţelor şi preparatelor stupefiante şi psihotrope

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LEGE no. 179 179 of 18 October 2012 to amend and supplement Law no. 339/2005 on the legal regime of narcotic and psychotropic plants, substances and preparations
ISSUER PARLIAMENT
Published in OFFICIAL MONITOR no. 713 713 of 19 October 2012



The Romanian Parliament adopts this law + Article I Law no. 339/2005 on the legal regime of plants, narcotic and psychotropic substances and preparations, published in the Official Gazette of Romania, Part I, no. 1.095 of 5 December 2005, as amended and supplemented, shall be amended and supplemented as follows: 1. in Article 2, points i), k) and m) shall be amended and shall read as follows: "" i) preparation-a solution or a mixture, whatever its physical state, containing one or more narcotic or psychotropic substances; this term also designates one or more stupefying or psychotropic substances divided into units of administration or used in laboratory tests; .......................................................................... k) manufacture-all operations, other than production, which allow to obtain narcotic or psychotropic substances, including the purification and transformation of narcotic or psychotropic substances into other narcotic or psychotropic substances; this the term also includes the manufacture of preparations, other than those which are carried out on a prescription in a pharmacy; .......................................................................... m) manufacturer-natural or legal person carrying out production operations; ". 2. In Article 2, after letter m) a new letter, letter m ^ 1) is inserted, with the following contents: "" m ^ 1) manufacturer-natural or legal person carrying out manufacturing operations; '. 3. In Article 2, letter r) is amended and shall read as follows: " r) straw or poppy strain-all parts of the plant, including the capsule, except for the seeds of the opiate poppy after harvest; '. 4. In Article 7, paragraph 1 shall be amended and shall read as follows: "" Art. 7. -(1) Any natural or legal person carrying out an operation with plants, substances and preparations set out in Tables I, II and III of the Annex shall be under the control and supervision of the Ministry of Health and of the units in coordination or in subordinated to it, under the conditions established by the methodological norms for the application of this law. 5. In Article 7, after paragraph (1), three new paragraphs are inserted, paragraphs 1 ^ 1, (1 ^ 2) and (1 ^ 3), with the following contents: " (1 ^ 1) Control and supervision inspections can be carried out both by the specialized personnel of the Ministry of Health and by the representatives of the units in coordination or under the Ministry of Health, according to the norms methodological application of the present law. (1 ^ 2) By exception to the provisions of par. (1) and (1 ^ 1), the cultivation of plants containing narcotic or psychotropic substances are under the control and supervision of the Ministry of Agriculture and Rural Development, through the directions for county agriculture, respectively of the city of Bucharest. (1 ^ 3) By exception to the provisions of par. ((1) and (1 ^ 1), the stupefying and psychotropic plants, substances and preparations used in veterinary medicine are under the control and supervision of the National Veterinary Health and Food Safety Authority. " 6. In Article 10, paragraph 2 shall be amended and shall read as follows: " (2) The list of preparations containing narcotic and psychotropic substances shall be approved by order of the Minister of Health, at the proposal of the National Agency of Medicines and Medical Devices and the other competent institutions and shall be published in The Official Gazette of Romania, Part I, according to the methodological norms for the application of this law. " 7. In Article 12, paragraph 2 shall be amended and shall read as follows: " (2) The cultivation for industrial and/or food purposes or for the production of seed of plants containing substances under national control shall be authorized by the Ministry of Agriculture and Rural Development, by the directions for agriculture county, respectively of Bucharest. " 8. In Article 15, paragraphs 1 and 3 shall be amended and shall read as follows: "" Art. 15. -(1) The conduct of production, manufacture, storage, trade, intermediation, possession and distribution of plants, narcotic and psychotropic substances and preparations shall be prohibited without authorization issued by the Ministry of Health, under the methodological norms for the application of this law. ......................................................................... ((3) Authorizations for the operations referred to in par. (1) are released if the use of plants, substances and preparations set out in Tables II and III of the Annex is limited for use in industry or for the production of seed, as well as for medical, scientific or technical use. The models of authorizations are provided in the methodological norms for the application of this law 9. Article 16 is amended and shall read as follows: "" Art. 16. -(1) The Ministry of Health approves for each year the estimated quantities of different substances and preparations that any cultivator, producer, manufacturer, distributor, importer or approved exporter has the right to cultivate, produce, Manufacture them, import them or export them. These limits may be amended, if necessary, during the year. ((. Any manufacturer, manufacturer or importer authorised shall have the right to manufacture, manufacture or import only the quantities of substances and preparations necessary for the approved operation. " 10. Article 17 is amended and shall read as follows: "" Art. 17. -For the approval provided for in art. 16, manufacturers, manufacturers and importers shall annually transmit to the Ministry of Health the estimates of the quantities of the various substances and preparations they produce, manufacture or import them. " 11. Article 20 is amended and shall read as follows: "" Art. 20. -Export or import operations with plants, substances and preparations set out in Tables I, II and III of the Annex shall be carried out on the basis of an export or import authorisation issued for each operation by the Ministry of Health. through the specialized department, according to the model provided in the methodological norms for the application of this law. 12. Article 34 is amended and shall read as follows: "" Art. 34. -(1) Open circuit pharmacies and closed circuit pharmacies operate with plants, narcotic and psychotropic substances and preparations, based on the operating authorization, according to the legislation in force. (2) The health facilities and treatment centers for drug addicts carry out their activity with plants, narcotic and psychotropic substances and preparations, under the conditions established by the methodological norms for the application of this law. " 13. In Article 42 (1), letter f) shall be amended and shall read as follows: " f) a quarterly situation on the part of producers, manufacturers and distributors, specifying the movements of the quantities of plants, substances and preparations containing narcotic and psychotropic substances at national level carried out therein period. " + Article II Within 3 months from the date of entry into force of this Law, the institutions involved in the application Law no. 339/2005 on the legal regime of plants, narcotic and psychotropic substances and preparations, with subsequent amendments and completions, will develop the draft amendment and completion of the Methodological Norms for the application of the provisions Law no. 339/2005 on the legal regime of narcotic and psychotropic plants, substances and preparations approved by Government Decision no. 1.915/2006 ,, as amended. This law was adopted by the Romanian Parliament, in compliance with the provisions of art. 75 75 and art. 76 76 para. (2) of the Romanian Constitution, republished. CHAMBER OF DEPUTIES PRESIDENT VALERIU STEFAN ZGONEA SENATE PRESIDENT GEORGE-CRIN LAURENȚIU ANTONESCU Bucharest, October 18, 2012. No. 179. -----