Informative Notice
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Trade and brokering activities with drug precursors
Transport of scheduled substances includes any supply, whether in return for payment or free of charge, of scheduled substances to the Union. It also includes the storage, manufacture, production, processing, trade, distribution and distribution of these substances for the purpose of supply to the Union.
An intermediary activity is any activity of arranging for the purchase and sale or supply of scheduled substances by any natural or legal person who aims to obtain agreement between two parties or to do so through acting on behalf of at least one of these parties without taking these substances into its possession or taking control of such a transaction. It also includes any activity carried out by a natural or legal person established in the Union, which involves the purchase and sale or supply of scheduled substances without those substances being introduced into the customs territory of the Union.
A scheduled substance is any scheduled substance on the list, including mixtures and natural products containing such substances. Medicinal products, pharmaceutical preparations, mixtures, natural products and other preparations containing scheduled substances that are formulated in such a way that they cannot be easily used or extracted by available or economically viable methods are excluded.
Obligations regarding customer declarations and record-keeping shall not apply to transactions involving substances listed in Group 2, where the quantities do not exceed the prescribed quantities over a period of one year.
The competent authorities of each Member State may prohibit the introduction into or exit from the customs territory of the Union of substances listed in that customs territory if there are reasonable grounds for suspecting that the substances are intended for the illicit manufacture of narcotic drugs or psychotropic substances.
Competent authorities shall suspend or suspend the release of a scheduled substance for as long as is necessary to verify the identity of the scheduled substance or compliance with the rules of the regulations.
The Contractor, the holder of a license/special license or registration/special registration, is obliged to report to the competent authority for the previous calendar year on transactions with substances on the list by 15 February each year at the latest. The completed form is sent to the Chemicals Office of the Republic of Slovenia. Contractors who benefit from the exemption under Article 6 of Regulation 273/2004 or Article 6 of Commission Delegated Regulation (EU) 2015/1011 are also obliged to report, as well as contractors who have not performed any transactions in the previous calendar year.
Applies for SKD:
Conditions
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Applicants who wish to pursue this activity must register the business activity, and have the appropriate legal status.
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Operators wishing to trade substances listed in Groups 1, 2 and 3 shall be required to appoint an officer responsible for the trade in scheduled substances and to notify the competent authorities of the name and contact details of that officer and to notify them immediately of any subsequent modification of this information. The officer should ensure that the trade in scheduled substances conducted by the operator takes place in compliance with the rules of the Drug Precursor’s legislation. The officer shall be empowered to represent the operator and to take the necessary decisions to carry out the prescribed tasks.
Evidence
Legal basis
- REGULATION (EC) No 273/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 February 2004 on drug precursors (2004/273)
- COMMISSION REGULATION (EC) No 1277/2005 of 27 July 2005 laying down implementing rules for Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and for Council Regulation (EC) No 111/2005 laying down rules for the m (2005/1277)
- Decree on the implementation of Regulations (EC) on precursors for illicit drugs
- 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 (2005/111)
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Operators and users shall obtain a licence from the competent authorities of the Member State in which they are established before they may possess or place on the market scheduled substances of category 1 of Annex I of the Drug Precursor’s legislation. Any operator holding a licence shall supply scheduled substances of category 1 of the previous mentioned Annex I only to operators or users who also hold a licence and have signed a customer declaration.
Cases where a license is not required:
Pharmacies, dispensaries of veterinary medicine, customs, police, armed forces and official laboratories of competent authorities may be exempted from the requirement of licensing pursuant to Article 6(1) of Regulation (EC) No 111/2005 as far as these operators use drug precursors within the scope of their official duties. The operators set out in the first paragraph are also exempted from the following:
(a) the provision of the documentation referred to in Article 3 of Regulation (EC) No 111/2005; (b) the obligation to appoint a responsible officer set out in Article 3(1) of the Commission Delegated Regulation (EU) 2015/1011.
The license shall be issued by the competent authority of the Member State in which the operator is established. In Slovenia, licenses are issued by the Chemicals Office of the Republic of Slovenia. The competent authority may suspend or revoke a license when the conditions under which it was granted are no longer met or when there are reasonable grounds to suspect that there is a risk of diversion of the scheduled substances.
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Operators shall obtain registration from the competent authorities of the Member State in which they are established before placing on the market scheduled substances of category 2 of previous mentioned Annex I.
From 1 July 2015 users shall obtain a registration from the competent authorities of the Member State in which they are established before possessing scheduled substances of subcategory 2A of Annex I.
Any operator holding a registration shall supply scheduled substances of subcategory 2A of Annex I only to other operators or users who also hold registration and have signed a customer declaration Operators trading in substances of category 2 have to register by the competent authorities and update the addresses of the establishments where they manufacture these substances or from which they trade in these substances before they start trading.
Cases where registration is not required:
The following categories may be exempt from the registration requirement pursuant to Article 7(1) of Regulation (EC) No 111/2005:
(a) pharmacies, dispensaries of veterinary medicine, customs, police, official laboratories of competent authorities and armed forces, as far as these operators use drug precursors within the scope of their official duties;
(b) operators engaged in the export of scheduled substances listed in Category 3 of the Annex to Regulation (EC) No 111/2005, if the sum of quantities concerned by their exports during the course of the preceding calendar year (1 January-31 December) does not exceed the amounts specified in Annex I to the Commission Delegated Regulation (EU) 2015/1011. When those amounts are exceeded within the current calendar year, the operator shall comply with the registration requirement immediately;
(c) operators engaged in export of mixtures containing scheduled substances listed in Category 3 of the Annex to Regulation (EC) No 111/2005, if the amount of the scheduled substance contained in the mixtures does not exceed, during the course of the preceding calendar year, the amounts specified in Annex I to the Commission Delegated Regulation (EU) 2015/1011. When those amounts are exceeded within the current calendar year, the operator shall comply with the registration requirement immediately.
Operators established in the Union who are not customs agents and carriers, when acting solely in that capacity in the performance of import, export or brokering activities involving scheduled substances listed in Category 2 or exporting substances in Category 3, shall be registered immediately and, where appropriate, update the addresses of the premises in which they carry out these activities. This obligation shall be fulfilled by the competent authority of the Member State in which the contractor is established.
The lists of the individual countries of destination for exports of scheduled substances listed in Category 2 and 3 of the Annex is published on the Commission's website.
Operators exporting substances in Category 3 are exempted from the registration conditions if the quantity in question during the previous calendar year does not exceed the prescribed quantities. If these quantities are exceeded in the current calendar year, the contractor must immediately comply with the provisions for registration.
Operators exporting mixtures containing substances in Category 3 are exempted from the conditions of registration if the quantity of the substance in the list contained in the mixture does not exceed the prescribed quantity during the transitional year.
If these quantities are exceeded in the current calendar year, the contractor must immediately comply with the provisions for registration.
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Any operator established within the Union who supplies a customer with a scheduled substance of category 1 or 2 of Annex I shall obtain a declaration from the customer which shows the specific use or uses of the scheduled substances. The operator shall obtain a separate declaration for each scheduled substance. That declaration shall conform to the model set out in point 1 of Annex III. In the case of legal persons, the declaration shall be made on headed notepaper.
As an alternative to the above declaration for an individual transaction, an operator who regularly supplies a customer with a scheduled substance of category 2 of Annex I may accept a single declaration in respect of a number of transactions involving this scheduled substance over a period not exceeding one year, provided that the operator is satisfied that the following criteria have been met:
- the customer has been supplied by the operator with the substance on at least three occasions in the preceding 12 months,
- the operator has no reason to suppose that the substance will be used for illicit purposes,
- the quantities ordered are consistent with the usual consumption for that customer.
This declaration shall conform to the model set out in point 2 of Annex III. In the case of legal persons, the declaration shall be made on headed notepaper.
An operator supplying scheduled substances of category 1 of Annex I shall stamp and date a copy of the declaration, certifying it to be a true copy of the original. Such copy shall always accompany those substances being moved within the Union and shall be presented on request to the authorities responsible for checking vehicle contents during transport operations.
Evidence
- Customer statement
Legal basis
- REGULATION (EC) No 273/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 February 2004 on drug precursors (2004/273)
- 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 (2005/111)
- Decree on the implementation of Regulations (EC) on precursors for illicit drugs