Brussels, 05/02/2015 (Agence Europe) - The Court of Justice of the EU ruled on Thursday 5 February (joined cases C-627/13 and C-2/14) that medicines should automatically be excluded from the EU regime on drug precursors, even though they contain substances which fall within this regime and which can easily be used or be extracted by means that are simple to put in place or are economically viable.
The regime - Regulations 273/2004 and 111/2005 on drug precursors and monitoring trade with third countries in drug precursors - requires an authorisation to hold, import/export or market substances that feature on a list of substances considered to be drug precursors. The regime does not apply, however, to medicines, pharmaceutical preparations, mixtures or natural products.
The German federal court of justice is hearing two cases of import/export of medicines containing substances that appear on the list (ephedrine or pseudoephedrine) that can be used in drug manufacture (methamphetamine). It sought advice from the Court of Justice on whether a medicine, simply by virtue of its being a “medicine”, are exclusions to the regulations or whether they may be subject to them if a substance it contains can be easily used or extracted by simple to apply or economically viable means.
In its ruling, the Court says medicines do not fall within the scope of the drug precursor regime, noting that they are subject to a separate authorisation and control regime. The two regulations are not, therefore, applicable, even though the medicines at issue contain listed substances that are easily used or extracted. For this type of medicine, medical prescriptions are required, the Court points out, thus allowing them to be closely monitored. (FG)