Recent Legislative Amendments

Updates to two key pieces of legislation relating to precursor chemicals, also known as scheduled substances, have recently been published in the Official Journal of the European Union (L 330). The original pieces of legislation are Regulation (EC) No. 273/2004 (as amended) and Council Regulation (EC) No. 111/2005 (as amended). The amending regulations are Regulation (EU) No. 1258/2013 and Regulation (EU) No. 1259/2013 respectively.

The main objective of these amendments is to strengthen the rules for registration and licensing of operators and users of scheduled substances in order to prevent diversion towards illicit production of drugs.

These amendments have an effective date of 30 December 2013 with the exception of the requirements for category 2A scheduled substances which will only become obligatory as of 30 June 2015.

The main amendments to Regulation (EC) No. 273/2004, which deals with trade within the EU, that are relevant to operators are: 

  • Addition of alpha-phenylacetoacetonitrile (APAAN) to Annex I as a category 1 scheduled substance.
  • Division of category 2 into two new subcategories, 2A and 2B in Annex I. All previous category 2 scheduled substances will now be in subcategory 2B with the exception of acetic anhydride which will be placed in subcategory 2A.
  • Requirement for end users of Annex I subcategory 2A scheduled substances to obtain a registration in order to receive and/or possess a category 2A scheduled substance.
  • Suppliers of acetic anhydride should note that they can only supply to those in possession of a subcategory 2A registration above certain thresholds
  • Creation of an EU database, to include a list of licensed and registered operators of scheduled substances, for licensing authorities.

 

The main amendments to Council Regulation (EC) No. 111/2005, which deals with trade between the EU and third countries, that are of relevance to operators are:

  • Addition of alpha-phenylacetoacetonitrile (APAAN) to the Annex as a category 1 scheduled substance.
  • Creation of a new category for scheduled substances, category 4, in the Annex.
  • Addition of human medicinal products and veterinary medicinal products containing ephedrine and pseudoephedrine into category 4.
  • Requirement for all exports of scheduled substances listed in category 4 to obtain an export authorisation prior to export from the EU.

 

In order to comply with the above new requirements, operators within Ireland that meet any of the criteria identified below are requested to contact the HPRA at controlleddrugs@hpra.ie.

  • Possess, supply, or produce acetic anhydride and do not currently hold a registration with the HPRA for acetic anhydride.
  • Possess, supply or produce alpha -phenylacetoacetonitrile (APAAN)
  • Export medicinal products containing ephedrine or pseudoephedrine to third countries