L 330/30 Official Journal of the European Union 10.12.2013 REGULATION (EU) No 1259/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 November 2013 amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) On 7 January 2010, the Commission adopted a report, pursuant to Article 32 of Council Regulation (EC) No 111/2005 (3, on the implementation and functioning of the Community legislation on monitoring and control of trade in drug precursors. Trade in medicinal products is not controlled in the existing Union control system for drug precursors, since they are currently excluded from the definition of scheduled substances. The Commission report pointed out that medicinal products containing ephedrine and pseudoephedrine were diverted into the illicit drug manufacture outside the Union, as a substitute for internationally controlled ephedrine and pseudoephedrine. The Commission therefore recommended strengthening the control of international trade in medicinal products containing ephedrine or pseudoephedrine exported from or tran- siting through the customs territory of the Union in order to prevent their diversion for the illicit manufacture of narcotic drugs or psychotropic substances. In its Conclusions of 25 May 2010 on the functioning and implementation of EU drug precursors legislation, the Council invited the Commission to propose legis- lative amendments after carefully assessing their potential impact on Member States’ authorities and economic operators. (1) Position of the European Parliament of 23 October 2013 (not yet published in the Official Journal) and decision of the Council of 15 November 2013. (%) Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors (O] L 22, 26.1.2005, p. 1). ©) ®) (10) This Regulation clarifies the definition of a scheduled substance: in this regard, the term ‘pharmaceutical prep- aration’, which stems from the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic ~ Substances adopted in Vienna on 19 December 1988 (the United Nations Convention’), is deleted as it is already covered by the relevant terminology of Union legal acts, namely ‘medicinal prod- ucts’. Moreover, the term ‘other preparations’ is deleted as it duplicates the term ‘mixtures’ already used in that definition. Rules on suspending or revoking the registration of an operator should be introduced in order to match the existing rules for suspending or revoking a licence. Medicinal products and veterinary medicinal products (‘medicinal products) containing ephedrine or pseudoep- hedrine should be controlled without impeding their legitimate trade. To that end, a new category (Category 4) should be added to the Annex to Regulation (EC) No 111/2005 listing medicinal products containing certain scheduled substances. The export of medicinal products listed in Category 4 of the Annex to Regulation (EC) No 111/2005, as amended by this Regulation, should be preceded by an export authorisation, and a pre-export notification sent by the competent authorities in the Union to the competent authorities of the country of destination. Member States’ competent authorities should be given the powers to stop or seize those medicinal products where there are reasonable grounds for suspecting that they are intended for the illicit manufacture of narcotic drugs or psychotropic substances, when they are exported, imported or in transit. With a view to enabling Member States to react more quickly with regard to new trends in drug precursors’ diversion, their possibilities to act in cases of suspicious transactions involving non-scheduled substances should be clarified. To that end, Member States should be able to empower their competent authorities to obtain information on any orders for or operations involving non-scheduled substances, or to enter business premises to obtain evidence of suspicious transactions involving such substances. In addition, competent authorities should prevent the introduction into, or the departure from, the customs territory of the Union of non- scheduled substances, where it can be demonstrated