By judgment of 20 August 2015, the Obvodní soud pro Prahu 7 (Prague District Court 7, Czech Republic) found Mr Sokáč guilty, first, of the offence of obstruction of the implementation of a decision of the national authorities and obstruction of a removal order, and, secondly, of criminal offenses on the basis that he had unlawfully manufactured and otherwise engaged in transactions relating to narcotic drugs, psychotropic substances and poisons under the Czech Criminal Code. He was sentenced to a total of two years’ imprisonment and four years’ exclusion from the Czech Republic. As a security measure, 120 tablets of the medicinal product Nurofen Stopgrip, which he had in his possession, were also seized.

Following a linguistic analysis of the definition of ‘scheduled substance’, within the meaning of Article 2(a) of Regulation No 273/2004, the Obvodní soud pro Prahu 7 (Prague District Court 7) came to the conclusion that ‘medicinal products’, within the meaning of Directive 2001/83, which contain a ‘scheduled substance’, within the meaning of that provision, constitute drug precursors. In that regard, that court relied on Regulation No 111/2015, which expressly includes in its scope medicinal products containing ephedrine or pseudoephedrine. Accordingly, it concluded that the term ‘scheduled substance’, within the meaning of Regulation No 273/2004, should also be interpreted as covering, inter alia, medicinal products containing ephedrine and pseudoephedrine, notwithstanding the fact that the Annex to that regulation, which lists scheduled substances, does not expressly mention those medicinal products as such.

By judgment of 15 October 2015, the Městský soud v Praze (Prague City Court, Czech Republic) varied the judgment of the Obvodní soud pro Prahu 7 (Prague District Court 7), first, in so far as that decision relates to Mr Sokáč being found guilty of unlawfully manufacturing and otherwise engaging in transactions relating to narcotic drugs, psychotropic substances and poisons, and, secondly, in relation to the whole of the operative part concerning the sentence and the security measure imposed. Nevertheless, the Městský soud v Praze (Prague City Court) imposed the same sanctions on Mr Sokáč, on the basis of the same provisions of the Criminal Code, as those applied by the Obvodní soud pro Prahu 7 (Prague District Court 7).

Mr Sokáč brought an appeal on a point of law before the referring court, the Nejvyšší soud (Supreme Court, Czech Republic), against the judgment of the Městský soud v Praze (Prague City Court). In support of that appeal, he maintains, inter alia, that the product which was the object of the security measure, the medicinal product Nurofen Stopgrip, which contains pseudoephedrine, is not a drug precursor within the meaning of Regulation No 273/2004 and is excluded from the scope of that regulation. Accordingly, Mr Sokáč claims that the Městský soud v Praze (Prague City Court) erred in finding him guilty, on the basis of that regulation, of possessing a drug precursor.

In that context, the referring court observes, first, that the scope of Regulation No 111/2005 is different from that of Regulation No 273/2004 and, secondly, that, even though Regulation No 111/2005 provides for an exception relating to medicinal products containing ephedrine and pseudoephedrine, that exception does not appear in Regulation No 273/2004.

Furthermore, the referring court observes that it is not clear from the different language versions, in German, English, Polish and Slovak, of Article 2(a) of Regulation No 273/2004, whether medicinal products containing such a substance may be classified as ‘drug precursors’, within the meaning of that regulation.

In those circumstances, the Nejvyšší soud (Supreme Court) decided to stay the proceedings and to refer the following question to the Court for a preliminary ruling: ‘Can “medicinal products”, as defined in Directive [2001/83], which contain “scheduled substances”, within the meaning of [Regulation No 273/2004], be regarded as excluded, on the basis of Article 2(a) of that regulation, from the scope of the regulation, in accordance with the judgment of the Court of Justice of the European Union of 5 February 2015, M. and Others [C‑627/13 and C‑2/14, EU:C:2015:59], even after amendment of that provision by Regulation No 1258/2013 and in view of the fact that Article 2(a) of [Regulation No 111/2005] brings medicinal products containing ephedrine and pseudoephedrine within the scope of Regulation No 111/2005?’

By its question, the referring court asks, essentially, whether ‘medicinal products’, within the meaning of Article 1(2) of Directive 2001/83, containing ‘scheduled substances’, within the meaning of Article 2(a) of Regulation No 273/2004, such as ephedrine and pseudoephedrine, remain excluded from the scope of that regulation following the entry into force of Regulations Nos 1258/2013 and 1259/2013.

Under Article 99 of its Rules of Procedure, where a question referred to the Court for a preliminary ruling is identical to a question on which the Court has already ruled, where the reply to such a question may be clearly deduced from existing case-law, or where the answer to the question referred for a preliminary ruling admits of no reasonable doubt, the Court may at any time, on a proposal from the Judge-Rapporteur and after hearing the Advocate General, decide to rule by reasoned order.

It is appropriate to apply that provision in the present case.

The Court has previously been called upon to clarify the scope of the term ‘scheduled substance’ within the meaning of the original versions of Regulations Nos 273/2004 and 111/2005. The Court concluded that the definition of that term was identical in both of those regulations and held that ‘medicinal products’, within the meaning of Article 1(2) of Directive 2001/83, containing a substance included in Annex I to Regulation No 273/2004, were excluded from the definition of ‘scheduled substance’ within the meaning of Article 2(a) of both Regulation No 273/2004 and Regulation No 111/2005 (see, to that effect, judgment of 5 February 2015, M. and Others, C‑627/13 and C‑2/14, EU:C:2015:59, paragraphs 63 and 67).

The definition of the term ‘scheduled substances’ in Article 2(a) of Regulation No 273/2004 and Article 2(a) of Regulation No 111/2005 derives from the amendments made to those provisions by, respectively, Regulation No 1258/2013 and Regulation No 1259/2013.

In essence, the following modifications have been made. First, it has been specified that ‘scheduled substances’ are substances which can be used for the illicit manufacture of narcotic drugs or psychotropic substances. Secondly, that definition now also excludes ‘veterinary medicinal products’, within the meaning of Directive 2001/82. Thirdly, ‘pharmaceutical preparations’ and ‘other preparations’, inter alia, have been removed from the scope of the definition since they are already covered by ‘medicinal products’ or are duplicates of the term ‘mixtures’ already used in the definition. Fourthly, the Union legislature has changed the order in which the various products excluded from the definition of ‘scheduled substances’ are presented.

Nevertheless, with specific regard to Regulation No 111/2005, even though, following the amendment made to that regulation by Regulation No 1259/2013, Article 2(a) of Regulation No 111/2005 excludes, as did Regulation No 273/2004, ‘veterinary medicinal products as defined in point 2 of Article 1 of Directive [2001/82]’, it nevertheless includes an exception as regards ‘medicinal products and veterinary medicinal products listed in the Annex’. A new category, namely Category 4, has also been added to the list of scheduled substances set out in the Annex to Regulation No 111/2005, which includes ‘medicinal products and veterinary medicinal products containing ephedrine or its salts’ and ‘medicinal products and veterinary medicinal products containing pseudo-ephedrine or its salts’.

It follows from the foregoing considerations that, as regards the definition of ‘scheduled substance’ in Article 2(a) of Regulation No 273/2004, the original version of which already expressly excluded ‘medicinal products as defined in Directive [2001/83]’, the amendment made to that provision by Regulation No 1258/2013 was merely intended to clarify that term, as is clear from recital 4 of that regulation, and did not, in any way, affect the exclusion of ‘medicinal products’ from the scope of that definition.

It is therefore undoubtedly clear from the wording of Article 2(a) of Regulation No 273/2004 that ‘medicinal products’, within the meaning of Directive 2001/83, cannot, per se, be regarded as ‘scheduled substances’, as defined in that provision, as the Court previously held in its judgment of 5 February 2015, M. and Others (C‑627/13 and C‑2/14, EU:C:2015:59), in relation to the original version of Regulation No 273/2004.

That finding cannot be called into question by the fact that Regulation No 1259/2013 added medicinal products containing ephedrine and pseudoephedrine to the definition of ‘scheduled substance’, in Article 2(a) of Regulation No 111/2005.

In that regard, it should be borne in mind that, as the Nejvyšší soud (Supreme Court) rightly noted, the respective fields of application of Regulations Nos 273/2004 and 111/2005 are different.

Although it is true that the objective of both those regulations is to combat the diversion of substances commonly used in the illicit manufacture of narcotic drugs and psychotropic substances, it is clear from Article 1 of Regulation No 273/2004 that that regulation establishes harmonised measures across Member States for the control and monitoring of such substances, whereas Article 1 of Regulation No 111/2005 lays down rules for monitoring trade in those substances between the Union and third countries.

It is clear from recitals 2, 3 and 7 of Regulation No 1259/2013 that before the entry into force of that regulation, medicinal products were excluded from the definition of ‘scheduled substance’, within the meaning of Regulation No 111/2005, and, therefore, were not subject to the system for controlling international trade established by Regulation No 111/2005. The intention of the Union legislature was, through the amendments made to Regulation No 111/2005 by Regulation No 1259/2013, to strengthen the control of trade in medicinal products containing ephedrine or pseudoephedrine exported from or transiting through the customs territory of the Union, without impeding legitimate trade in those products, in order to prevent their diversion for the illicit manufacture of narcotic drugs or psychotropic substances, given that medicinal products containing those two substances are being diverted for the purpose of illicit drug manufacture outside the Union (see, to that effect, judgment of 5 February 2015, M. and Others, C‑627/13 and C‑2/14, EU:C:2015:59, paragraphs 64 and 65).

Accordingly, the amendment of Regulation No 111/2005 by Regulation No 1259/2013 cannot influence the interpretation of Article 2(a) of Regulation No 273/2004, according to which all ‘medicinal products’, within the meaning of Directive 2001/83, including those containing ephedrine and pseudoephedrine, are excluded from the definition of ‘scheduled substance’, in Article 2(a) of Regulation No 273/2004.

In those circumstances, the answer to the question referred is that ‘medicinal products’, within the meaning of Article 1(2) of Directive 2001/83, containing ‘scheduled substances’, within the meaning of Article 2(a) of Regulation No 273/2004, such as ephedrine and pseudoephedrine, remain excluded from the scope of that regulation following the entry into force of Regulations Nos 1258/2013 and 1259/2013.

Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court.