E-7/20 Criminal Proceedings against M & X AG


E-7/20 Criminal Proceedings against M & X AG


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Deadlines: Motivation ministry:    16 July 2020
Written observations:                    2 September 2020

Keywords : medicinal products for human use; freedom of establishment;

Subject :

-           Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice (SCA)

-           Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use;


Facts of the case:

The first accused, M, has been practising as a doctor for 30 years. The second accused, X AG, was entered in the Liechtenstein Commercial Register and has its seat in Liechtenstein. M is the only board member and managing director. Further persons are not employed by X AG. X AG was trading in “burnout infusions”; these ampoules contain essential amino acids, taurine and a vitamin B complex. The content of the ampoules must be intravenously injected with 250ml saline solution. In the period 23-01-2015 to 23-12-2016 X AG sent the “burnout infusions” manufactured by Arnika Pharmacy in Unterhaching under the name “Neurostress” to customers in Germany, Austria and Switzerland. By a letter of the Office for Health of 27-10-2015 the Office explained that the manufacture of medicinal products - the Office presumed that the infusions were manufactured by X AG - requires an authorisation. By an email of 04-11-2015, M informed the Office for Health that the burnout infusions are not subject to the EEA Medicinal Products Act as they are not medicines but simply essential nutrients. Criminal proceedings were brought before the Princely Court against M and X AG. Neither M nor X AG have ever possessed an authorisation from the Office for Health for trade in medicinal products. M knew that the infusions must be qualified as medicinal products and accepted the risk of sending the infusions via X AG to customers in Germany, Austria and Switzerland without possessing a corresponding authorisation from the Office for Health. The accused have appealed to the Princely Court of Appeal against their conviction at first instance. The appellants suggested that a reference to the EFTA Court for an advisory opinion be made.


Request for an advisory opinion:

1. Must burnout infusions with the combination of substances determined here be qualified as “medicinal products” within the meaning of Article 1(2) of Directive 2001/83/EC?

(a)       If the answer to this question is in the affirmative: Does in the present case the manufacture, supply and administration of the burnout infusion constitute a placing on the market within the meaning of Article 2(1) of the Directive?

(b)       If the preceding questions are answered in the affirmative: Do the burnout infusions constitute medicinal products which, within the meaning of Article 2(1) of the Directive, are prepared industrially or manufactured by a method involving an industrial process?

(c)        Are the burnout infusions due to the method of their manufacture covered by the exception provided for in Article 3(2) of the Directive?

2. What must be understood under “wholesale distribution” within the meaning of Directive 2001/83/EC as amended by Directive 2011/62/EU and what criteria must be fulfilled for this?

3. In the event that the above Directives are, in principle, applicable to the present case: Is it compatible with the freedom of establishment pursuant to Article 31 et seq. EEA and, moreover, must it be regarded as proportionate, if commercial trading in medicinal products of the kind in question carried out from the State of residence of a natural or legal person within the EEA or between an EEA State and a third country, without these medicinal products coming in contact the territory of the State of residence, is subjected to a statutory authorisation obligation, whose infringement may be penalised as a misdemeanour by a custodial sentence of up to six months?

4. Does it have an influence on the answer to the above questions if in another EEA State (here: EU Member Germany) the medicinal products in question do not require authorisation?


Cited (recent) case-law:

Policy Area: VWS;