Informative Notice
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Imports of drug precursors
Import means any entry of scheduled substances having the status of non-Union goods into the customs territory of the Union including temporary storage, entry into a free zone or free warehouse, entry for a suspensive procedure and release for free circulation.
A scheduled substance is any substance listed in Annex, 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.
The import activity is carried out by importers who are legal or natural persons who have primary responsibility for import activities due to the economic or legal relationship to the scheduled substance and to the consignor and who lodge the customs declaration or on whose behalf the customs declaration is lodged.
The competent authorities of each Member State may prohibit any entry into or exit from the customs territory of the Union of substances listed in that customs territory if there are grounds for suspecting that the substances are intended for the illicit manufacture of narcotic drugs or psychotropic substances.
The competent authorities shall detain or suspend the release of the scheduled substances for the time necessary to verify the identification of the scheduled substances or compliance with the rules of the Drug Precursor’s legislation.
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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Imports of Group 1 substances require an import license. An import license may only be issued to an operator established in the Union. The import license shall be issued by the competent authorities of the Member State in which the operator is established.
An import license shall not be required if the substances are unloaded or converted, stored in a free zone of control type I or in a free warehouse or placed under the Union transit procedure.
The import license shall accompany the consignment from the point of entry into the customs territory of the Union to the premises of the importer or final consignee. The import license shall be presented to the customs office when the scheduled substances are declared for customs clearance.