Requirements for Operators and End Users

End users of precursor chemicals and operators who manufacture, supply, possess, and/or use precursor chemicals must comply with the following requirements:

  • Appoint a responsible officer.
  • Operators wishing to obtain a licence for category 1 or registration for category 2 schedules substances must appoint an officer responsible for the trade in the scheduled substances. The appointment of a responsible officer for category 3 and 4 is strongly encouraged.

    The responsible officer must have appropriate experience and knowledge of the legislation, the  licence/registration conditions, and the company’s quality system. The HPRA must be notified of the name and contact details of the responsible officer and must be notified of any subsequent modifications of this information.

    A responsible officer must ensure that:

    • trade complies with the legislation
    • relevant information is communicated to the HPRA e.g. annual reporting and disclosure of suspicious transactions
    • staff are appropriately trained and educated
    • a quality management system is in place to comply with the legislation. These procedures must cover but are not restricted to:
      • Identification and notification of suspicious transactions
      • Customer declarations
      • Licencing and registration
      • Import and export authorisations
      • Documentation and labelling
      • Audit and record keeping
      • Security measures
      • Annual reporting
      • Staff training
      • Supplier and customer approval
  • Obtain a licence or registration as required.

  • Obtain import or export authorisation as required.

  • Ensure customers have the appropriate licence/registration/authorisations as required.

  • Obtain customer declarations as required

    • Any operator supplying a customer within the EU with a scheduled substance of categories 1 or 2 must obtain a declaration from the customer showing the specific use(s) of the scheduled substances. A separate declaration is required for each scheduled substance. 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 may accept a single declaration in respect of a number of transactions involving this scheduled substance over a period not exceeding one year provided certain criteria have been met. More information on customer declarations and the required format can be found detailed in Regulation (EC) No. 273/2004 (as amended).

    • Document and label transactions as required.
      • Documentation and labelling requirements to be carried out by operators are detailed in Regulation (EC) No. 273/2004 (as amended) and Council Regulation (EC) No. 111/2005 (as amended). Records are required to be retained for three years for internal EU trade for category 1 and 2 scheduled substances and for external trade for category 1, 2 and 3 scheduled substances.

    • Report annually to the HPRA on transactions and annual usage.
      • The HPRA must report annually to the INCB about the import, export and legal uses of precursor chemicals relating to Ireland. All precursor chemical operators are required to provide information annually to the HPRA about their transactions and annual usage using the annual reporting form

    • Have appropriate security arrangements in place including restricted and controlled access to the area, appropriate alarms and/or CCTV.
    • Report all thefts and losses to the HPRA using the reporting form for theft or unaccounted loss of precursor chemicals.

    • Notify suspicious transactions (including non-scheduled substances).
      • Operators must notify the HPRA immediately of any circumstances, such as unusual orders and transactions involving scheduled substances, which suggest that such substances might be diverted for the illicit manufacture of narcotic drugs or psychotropic substances.