ES04 Receiving reports from operators involved in placing of scheduled substances on the market

Created on: 03.09.2015     Updated on: Fri Aug 21 10:12:07 CEST 2020

The Ministry of Economy of the Slovak Republic (MoE SR) allows operators to submit the Report on the marketing of a scheduled substance electronically. Operators are required to report annually to the MoE SR. If the report is not provided repeatedly, the MoE SR is obliged to notify the State Institute for Drug Control with the proposal to repeal the relevant authorization.
Within the service, operators have the opportunity to submit the Report on the marketing of a scheduled substance electronically. You can submit an application only in the Slovak version of the portal.

Administrative fees
The service is free of charge.

Attachments
The application does not require an attachment.

Legislation
National legislation governing the state administration in matters of drug precursors

• Act No 331/2005 Coll. on State Administrative Authorities in matters of drug precursors and on the amendment and supplement of some acts, as amended
• Decree of the MoE SR No 380/2005 Coll. determining the scope, form and term of filing of report of operators on international business with determined substances and on introducing of determined substances to market, as amended by the Decree of the MoE SR No 12/2011 Coll.

EU legislation in the field of drug precursors

• Regulation (EU) No 1258/2013 of the European Parliament and of the Council amending Regulation (EC) No 273/2004 on drug precursors
• Regulation (EU) No 1259/2013 of the European Parliament and of the Council amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors
• Commission Delegated Regulation (EU) 2015/1011 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 Union and third countries in drug precursors, and repealing Commission Regulation (EC) No 1277/2005
• Commission implementing regulation (EU) 2015/1013 laying down rules in respect of Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and of Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors
• Commission Delegated Regulation (EU) 2016/1443 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

Users

Business

Manual

When using the service, please, follow this procedure:

• Submit the Report on the marketing of a scheduled substance electronically.

Electronic service manual
Electronic manual [.pdf, 1,47 MB]