Council Decision 2014 /688/EU of 25 September 2014 on the control of substances 4-iodine-2,5-dimethoxy-N-(2-methoxybenzyl) phenethylamine (25I-NBOME), 3,4-dichloro-N-[[1-(dimethylamino) cyclohexyl] methyl] benzamide (AH-7921), 3,4-methylenedioxypirovalerone (MDPV) and 2-(3-methoxyphenyl) -2-(ethylamino) cyclohexanone (methoxetamine), provides that the Member States shall apply, in accordance with their legislation (a) national, to these new psychoactive substances the control measures and the criminal sanctions, provided for in the national legislation in force on the matter in accordance with the obligations under the 1971 Convention on Psychotropic Substances of the United Nations.

In addition, the United Nations Commission on Narcotic Drugs, at its 58th session, adopted, inter alia, Decision 58/3 of 13 March 2015, pursuant to which the Commission decided to include the substance AH-7921 in the List I of the 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol.

In compliance with the commitments made by Spain following its accession to the United Nations Single Convention of 1961 on Narcotic Drugs, the substance AH-7921 will apply the control and sanctions measures. (a) criminal law relating to narcotic substances included in List I of the 1961 Single Convention on Narcotic Drugs.

Therefore, the substance AH-7921 is not included in this order by prevailing Decision 58/3 adopted by the United Nations Commission on Narcotic Drugs on Decision 2014 /688/EU 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, substances 25I-NBOME, MDPV and Methoxetamine are included which, taking into account the health risks posed by the consumption of these substances, substances, the fact that they can be consumed inadvertently and that they lack established or recognized therapeutic utility, it is necessary to subject control measures proportional to the risks that they generate for health.

Currently, there are no authorised medicines in Spain containing 25I-NBOME, AH-7921, MDPV and Methoxetamine in their composition.

On the basis of this, and in the development of the powers conferred by the final provision of Royal Decree 2829/1977 of 6 October on the regulation of psychotropic substances and preparations, as well as the audit and inspection of their manufacture, distribution, prescription and dispensing, this provision is approved.

The affected sectors have been heard in their processing.

In its virtue, I have:

Article 1. Inclusion of the substance 4-iodine-2,5-dimethoxy-N-(2-methoxybenzyl) phenethylamine (25I-NBOME) in list I of Annex I to Royal Decree 2829/1977 of 6 October on the regulation of psychotropic substances and preparations as well as the monitoring and inspection of their manufacture, distribution, prescription and dispensing.

The substance 4-iodine-2,5-dimethoxy-N-(2-methoxybenzyl) phenethylamine (25I-NBOME) is included in list I of Annex I to Royal Decree 2829/1977 of 6 October on the regulation of psychotropic substances and preparations, as well as the inspection and inspection of their manufacture, distribution, prescription and supply, as well as their stereochemical variants, racemates and salts, provided that their existence is possible, if they are applied, the control measures and criminal penalties provided for for the substances that make up the control list.

Article 2. Inclusion of substances 3,4-methylenedioxypirovalerone (MDPV) and 2-(3-methoxyphenyl) -2-(ethylamino) cyclohexanone (methoxetamine) in Annex I, List II to Royal Decree 2829/1977 of 6 October 2001 on the psychotropic substances and preparations, as well as the audit and inspection of their manufacture, distribution, prescription and dispensing.

The substances 3,4-methylenedioxypirovalerone (MDPV) and 2-(3-methoxyphenyl) -2-(ethylamino) cyclohexanone (methoxetamine) are included in list II of Annex I to Royal Decree 2829/1977 of 6 October on the control of substances and psychotropic medicinal preparations, as well as the inspection and inspection of their manufacture, distribution, prescription and dispensing, as well as their stereochemical variants, racemates and salts, provided that their existence is possible, implementation, control measures and criminal penalties provided for in the substances that make up that control list.

Single additional disposition. Performance of the entities.

As of the entry into force of this order, the manufacturers, importers, exporters, distributors or dispensers of the aforementioned substances will adapt their actions to the legal requirements imposed by the psychotropic products in list I or list II, as appropriate, in Annex I to Royal Decree 2829/1977 of 6 October for the control of psychotropic substances and preparations, as well as the audit and inspection of their manufacture, distribution, prescription and supply and in the Order of 14 January 1981, on the development of Royal Decree 2829/1977 of 6 October, which regulates psychotropic substances and medicinal preparations, and the accompanying rules for taxation for the manufacture, trade, manufacture and distribution of psychotropic substances.

Final disposition first. Competence title.

This order is issued under Article 149.1.16 of the Spanish Constitution, which gives the State exclusive competence in the field of pharmaceutical legislation.

Final disposition second. Entry into force.

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

Madrid, 2 June 2015.-The Minister of Health, Social Services and Equality, Alfonso Alonso Aranegui.