Order Ssi/1091/2015, 2 June, Which Include Certain Substances In The Annex I To Royal Decree 2829 / 1977, Of 6 October, Which Regulates Substances And Psychotropic Medicinal Preparations, As Well As The Control And I...

Original Language Title: Orden SSI/1091/2015, de 2 de junio, por la que se incluyen determinadas sustancias en el anexo I del Real Decreto 2829/1977, de 6 de octubre, por el que se regulan las sustancias y preparados medicinales psicotrópicos, así como la fiscalización e i...

Read the untranslated law here: http://www.boe.es/buscar/doc.php?id=BOE-A-2015-6496

(2014/688/EU Decision of the Council of 25 September 2014, which are subject to measures of control substances 4-yodo-2,5-dimetoxi-N-(2-metoxibencil) phenethylamine (25I-NBOMe), 3, 4-Dichloro-N-[[1-(dimethylamino) cyclohexyl] methyl] benzamide (AH-7921), 3, 4-metilendioxipirovalerona (MDPV) and 2-(3-metoxifenil) - 2-(ethylamino) cyclohexanone (methoxetamine), establishes that Member States shall, in accordance with their national legislation to these new psychotropic substances the control measures and criminal penalties, as provided for in the national legislation in force in the matter in accordance with its obligations under the Convention on psychotropic substances of 1971 United Nations.

Also, the Commission of narcotic of them Nations United, in its 58.º period of sessions adopted, between others, it Decision 58 / 3 of 13 of March of 2015, under which the Commission decided to include the substance AH-7921 in it list I of the Convention only of 1961 on narcotic, amended by the Protocol of 1972.

In fulfilment of the commitments entered into by Spain following their accession to the single Convention of 1961 on Narcotic Drugs of the United Nations, to the AH-7921 substance you shall apply measures of control and criminal sanctions that correspond to the narcotic substances included in list I of the single Convention on Narcotic Drugs of 1961.

Therefore, the AH-7921 substance is not included in this order by prevailing Decision 58/3 adopted by the United Nations Narcotics Commission on the Decision 2014/688/EEC adopted by the Council of the European Union.

In addition, in Decision 2014/688/EU of the Council of the European Union, of 25 September 2014, include substances 25I-NBOMe, MDPV and Methoxetamine which, according to the health risks posed by the consumption of these substances, to the fact that may be consumed inadvertently and that lack therapeutic value established or recognized, is necessary to submit to control measures commensurate with the risks that generate health.

At present, there are no approved drugs in Spain containing 25I-NBOMe, AH-7921, MDPV and Methoxetamine in its composition.

On this basis, and in development of the powers conferred by the first final provision of the Royal Decree 2829 / 1977, of 6 October, which regulates substances prepared medicinal psychoactive, as well as the control and inspection of its manufacture, distribution, prescription and dispensation, this provision is approved.

In processing the sectors concerned have been heard.

By virtue, I have: article 1. Inclusion of the substance 4-yodo-2,5-dimetoxi-N-(2-metoxibencil) phenethylamine (25I-NBOMe) in the list I of annex I to Royal Decree 2829 / 1977, of 6 October, which regulates substances and psychotropic medicinal preparations, as well as the control and inspection of its manufacture, distribution, prescription and dispensation.

Includes the substance 4-yodo-2,5-dimetoxi-N-(2-metoxibencil) phenethylamine (25I-NBOMe) in list I of the annex I to Royal Decree 2829 / 1977, of 6 October, which regulates substances and psychotropic medicinal preparations, as well as the control and inspection of its manufacture, distribution, prescription and dispensation, as well as its stereochemical variants, racemates and salts, their existence possible being applied, the control measures and criminal penalties laid down for substances that make up the list of control.

Article 2. Including 3, 4-metilendioxipirovalerona (MDPV) substances and 2-(3-metoxifenil) - 2-(ethylamino) cyclohexanone (methoxetamine) in list II of annex I to Royal Decree 2829 / 1977, of 6 October, which regulates substances and psychotropic medicinal preparations, as well as the control and inspection of its manufacture, distribution, prescription and dispensation.

Include substances 3, 4-metilendioxipirovalerona (MDPV) and 2-(3-metoxifenil) - 2-(ethylamino) cyclohexanone (methoxetamine) in list II of annex I to Royal Decree 2829 / 1977, of 6 October, which regulates substances prepared medicinal psychoactive, as well as the control and inspection of its manufacture, distribution, prescription and dispensation, as well as its stereochemical variants, racemates and salts , their existence possible, being applied, the control measures and criminal penalties laid down for substances that make up the list of control.

Sole additional provision. Performance of entities.

From the entry into force of this order, authorities, manufacturers, importers, exporters, distributors or dispensing of substances concerned, performances to satisfy legal requirements imposed for products psychotropic substances from the list I or list II, as appropriate, annex I to Royal Decree 2829 / 1977, of 6 October, which regulates substances and prepared medicinal psychoactive , as well as the control e inspection of its manufacturing, distribution, prescription and dispensation and in the order of 14 of January of 1981, by which is develops the Real Decree 2829 / 1977, of 6 of October, that regulates them substances and prepared medicinal psychotropic, and is dictate them standards complementary of control for the manufacturing, trade, development and distribution of substances psychotropic.

First final provision. Skill-related title.

This order is issued on the basis of article 149.1.16. ª of the Spanish Constitution, which attributes to the State the exclusive competence in pharmaceutical products legislation.

Second final provision. Entry into force.

This order shall enter into force the day following its publication in the "Official Gazette".

Madrid, 2 June 2015.-the Minister of health, social services and equality, Alfonso Alonso Aranegui.