Introduction and background
Designated substances (drug precursors) are chemicals legally used in industry, pharmacy, health or research, but can also be used for the illicit manufacture of narcotic drugs and psychotropic substances.
For this reason, it is only possible to treat scheduled substances under conditions laid down by specific legislation. Their manufacture, import, export, distribution, brokering and marketing are subject to authorisations, declarations and registrations.
With effect from 1 January 2026 there is a change in the competence of state administration in the field of drug precursors, this agenda passes from the Ministry of Economy of the Slovak Republic at the Ministry of Health of the Slovak Republic.
Legislation
National legislation
Law No 331/2005 Coll. on State Administrations in the Matters of Drug Precursors and on the Amendment of Certain Laws
Decree of the Ministry of Economy of the Slovak Republic No. 380/2005 Coll., laying down the scope, form and deadline for reporting to operators on international trade in scheduled substances and on the marketing of scheduled substances
European law
Regulation (EC) No 273/2004 European Parliament and Council of 11 February 2004 on drug precursors
Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors
Delegated Regulation Commission Regulation (EU) 2015/1011 of 24 April 2015 supplementing Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors and repealing Commission Regulation (EC) No 1277/2005
Commission Implementing Regulation (EU) 2015/1013 of 25 June 2015 laying down rules in respect of Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors
Delegated Regulation Commission Regulation (EU) 2016/1443 of 29 June 2016 amending Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005 as regards the inclusion of certain drug precursors in the list of scheduled substances
Delegated Regulation Commission Regulation (EU) 2018/729 of 26 February 2018 amending Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005 as regards the inclusion of certain drug precursors in the list of scheduled substances
Delegated Regulation Commission Regulation (EC) No 273/2004 of 14 July 2020 amending Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005 as regards the inclusion of certain drug precursors in the list of scheduled substances
Authorisations for the import and export of a scheduled substance
Each application for authorisation for import or export of a scheduled substance shall be submitted to the Ministry of Health of the Slovak Republic separately and shall contain all the requirements specified in the relevant form.
Forms for applications for import and export of a scheduled substance:
Form No 1 - Application for authorisation to import a scheduled substance
Form No 2 - Application for authorisation to export a scheduled substance
Warning: Each form shall contain all the particulars and specific requirements for the type of application. You can find the exact details directly in the individual forms.
Notifications of operators on international trade in scheduled substances and on the placing on the market of scheduled substances
The operator authorised to handle scheduled substances shall be obliged to report annually by 15 February for the previous calendar year at the Ministry of Health of the Slovak Republic.
Form of notification: electronic form (www.e-vuc.sk) and written form (Printing No 3)
Forms for reporting obligations of holders of authorisations for the treatment of scheduled substances of categories 1 and 2:
Form No 3 - Written report on the placing on the market of a scheduled substance of category 1 or 2