Opinion of the Advocate General — ECLI:EU:C:2025:1007
Date: 2025-12-18
Language of the case: Greek

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Translation C-604/24 – 1 
Case C-604/24 
Reference for a preliminary ruling 
Date lodged: 
16 September 2024 
Referring court: 
Symvoulio tis Epikrateias 
Date of the decision to refer: 
16 July 2024 
Applicant: 
PHARMAKEIO YZ & SIA O.E. 
Defendants: 
Ypourgos Anaptyxis kai Ependyseon 
Ypourgos Ygeias 
Intervener: 
Panellinios Pharmakevtikos Syllogos 
  
TO SYMVOULIO TIS EPIKRATEIAS (THE COUNCIL OF STATE) 
… 
sat in open court on 28 March 2023 …, 
in order to rule on the application lodged on 25 May 2022 by: 
the general partnership ‘PHARMAKEIO YZ KAI SIA O.E.’, established in 
Karditsa …, against: (1) Ypourgos Anaptyxis kai Ependyseon (Minister for 
Development and Investment) … and (2) Ypourgos Ygeias (Minister for 
EN 
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Health), … and against the intervener, the public limited liability company 
‘Panellinios Pharmakevtikos Syllogos’ (‘Panhellenic Pharmaceutical 
Association’) established in Athens …. 
1 … [procedural issue] 
2 The present application seeks the annulment of koini apophasi G.P. oik. 
22609/19.4.2022 (Joint Decision G.P. Oik. 22609/19.4.2022) of the Minister for 
Development and Investment and the Minister for Health, entitled ‘Tropopoiisi 
tou arthrou 116 tis ypo stoicheia D. YG3a/G.P.32221/2013 koinis apophaseos ton 
Ypourgon Anaptyxis, Antagonistikotitas, Ypodomon, Metaphoron kai Diktyon kai 
Ygeias …’ (Amendment of Article 116 of Joint Decision 
D.YG3a/G.P.32221/2013 of the Ministers for Development, Competitiveness, 
Infrastructure, Transport and Networks and Health) (Government Gazette, Series, 
II, No 1965, GG II/1965 of 20.4.2022), laying down the categories of medicinal 
products which may be sold at a distance by electronic pharmacy establishments 
to the public by means of information society services. 
3 … [reference to the seven-member composition, due to the case’s importance] 
4 … [intervener’s legitimate interest] 
5 Directive 2001/83/ΕC of the European Parliament and of the Council of 
6 November 2001 (‘on the Community code relating to medicinal products for 
human use’, OJ L 311) repealed the relevant earlier provisions of Community law 
(Article 128) and established new rules on, inter alia, the manufacture, import, 
placing on the market and wholesale distribution of medicinal products in the 
European Community. The directive, which aims first and foremost to safeguard 
public health (recital 2 states: ‘the essential aim of any rules governing the 
production, distribution and use of medicinal products must be to safeguard public 
health’), provides in Article 6(1) that ‘no medicinal product may be placed on the 
market of a Member State unless a marketing authorisation has been issued by the 
competent authorities of that Member State in accordance with this Directive or an 
authorisation has been granted in accordance with Regulation (EEC) 
No 726/2004 …’. It also provides, in Title VI (‘Classification of medicinal 
products’) as follows: Article 70 ‘1. When a marketing authorisation is granted, 
the competent authorities shall specify the classification of the medicinal product 
into: – a medicinal product subject to medical prescription, – a medicinal product 
not subject to medical prescription. To this end, the criteria laid down in 
Article 71(1) shall apply. 2. The competent authorities may fix sub-categories for 
medicinal products which are available on medical prescription only. In that case, 
they shall refer to the following classification: (a) medicinal products on medical 
prescription for renewable or non-renewable delivery; (b) medicinal products 
subject to special medical prescription; (c) medicinal products on “restricted” 
medical prescription, reserved for use in certain specialised areas’, Article 71 ‘1. 
Medicinal products shall be subject to medical prescription where they: – are 
likely to present a danger either directly or indirectly, even when used correctly, if 
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utilised without medical supervision, or – are frequently and to a very wide extent 
used incorrectly, and as a result are likely to present a direct or indirect danger to 
human health, or – contain substances or preparations thereof, the activity and/or 
adverse reactions of which require further investigation, or – are normally 
prescribed by a doctor to be administered parenterally. 2. Where Member States 
provide for the sub-category of medicinal products subject to special medical 
prescription, they shall take account of the following factors: – the medicinal 
product contains, in a non-exempt quantity, a substance classified as a narcotic or 
a psychotropic substance within the meaning of the international conventions in 
force, such as the United Nations Conventions of 1961 and 1971, or – the 
medicinal product is likely, if incorrectly used, to present a substantial risk of 
medicinal abuse, to lead to addiction or be misused for illegal purposes, or – the 
medicinal product contains a substance which, by reason of its novelty or 
properties, could be considered as belonging to the group envisaged in the second 
indent as a precautionary measure. 3. Where Member States provide for the sub-
category of medicinal products subject to restricted prescription, they shall take 
account of the following factors: – the medicinal product, because of its 
pharmaceutical characteristics or novelty or in the interests of public health, is 
reserved for treatments which can only be followed in a hospital environment, – 
the medicinal product is used in the treatment of conditions which must be 
diagnosed in a hospital environment or in institutions with adequate diagnostic 
facilities, although administration and follow-up may be carried out elsewhere, 
or – the medicinal product is intended for outpatients but its use may produce very 
serious adverse reactions requiring a prescription drawn up as required by a 
specialist and special supervision throughout the treatment. 4. …’. Article 72 
‘Medicinal products not subject to prescription shall be those which do not meet 
the criteria listed in Article 71.’ 
6 Directive 2001/83/ΕC was amended by, inter alia, the more recent Directive 
2011/62/ΕU of the European Parliament and of the Council of 8 June 2011 
(‘amending Directive 2001/83/ΕC on the Community code relating to medicinal 
products for human use, as regards the prevention of the entry into the legal 
supply chain of falsified medicinal products’, OJ L 174), which introduced rules 
relating to sale at a distance to the public. The preamble to that directive 
(recitals 21 to 25) provides: ‘(21) the illegal sale of medicinal products to the 
public via the Internet is an important threat to public health as falsified medicinal 
products may reach the public in this way. It is necessary to address this threat. In 
doing so, account should be taken of the fact that specific conditions for retail 
supply of medicinal products to the public have not been harmonised at 
[European] Union level and, therefore, Member States may impose conditions for 
supplying medicinal products to the public within the limits of the Treaty on the 
Functioning of the European Union (TFEU). (22) When examining the 
compatibility with [EU] law of the conditions for the retail supply of medicinal 
products, the Court of Justice of the European Union (‘the Court of Justice’) has 
recognised the very particular nature of medicinal products, whose therapeutic 
effects distinguish them substantially from other goods. The Court of Justice has 
also held that health and life of humans rank foremost among the assets and 
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interests protected by the TFEU and that it is for Member States to determine the 
level of protection which they wish to afford to public health and the way in 
which that level has to be achieved. Since that level may vary from one Member 
State to another, Member States must be allowed discretion as regards the 
conditions for the supply on their territory of medicinal products to the public 
(judgment of 19 May 2009, Apothekerkammer des Saarlandes and Others, 
(C-171/07 and C-172/07, EU:C:2009:427, paragraphs 19 and 31)). (23) In 
particular, in the light of the risks to public health and given the power accorded to 
Member States to determine the level of protection of public health, the case-law 
of the Court of Justice has recognised that Member States may, in principle, 
restrict the retail sale of medicinal products to pharmacists alone (judgment of 
19 May 2009, cited above, paragraphs 34 and 35). (24) Therefore, and in the light 
of the case-law of the Court of Justice, Member States should be able to impose 
conditions justified by the protection of public health upon the retail supply of 
medicinal products offered for sale at a distance by means of information society 
services. Such conditions should not unduly restrict the functioning of the internal 
market. (25) The public should be assisted in identifying websites which are 
legally offering medicinal products for sale at a distance to the public …’. 
7 Article 1(20) of Directive 2011/62/ΕU, cited above, inserts, before Title VIII of 
Directive 2001/83/ΕC, a new Title VIIA (‘Sale at a distance to the public’). That 
title includes Article 85c of Directive 2001/83/ΕC, which provides: ‘1. Without 
prejudice to national legislation prohibiting the offer for sale at a distance of 
prescription medicinal products to the public by means of information society 
services, Member States shall ensure that medicinal products are offered for sale 
at a distance to the public by means of information society services as defined in 
Directive 98/34/EC of the European Parliament and of the Council of 22 June 
1998 laying down a procedure for the provision of information in the field of 
technical standards and regulations and of rules on Information Society services 
under the following conditions: (a) the natural or legal person offering the 
medicinal products is authorised or entitled to supply medicinal products to the 
public, also at a distance, in accordance with national legislation of the Member 
State in which that person is established; (b) the person referred to in point (a) has 
notified the Member State in which that person is established of at least the 
following information: … (c) …, (d) without prejudice to the information 
requirements set out in Directive 2000/31/EC of the European Parliament and of 
the Council of 8 June 2000 on certain legal aspects of information society 
services, in particular electronic commerce, in the Internal Market (Directive on 
electronic commerce), the website offering the medicinal products contains at 
least: (i) the contact details of the competent authority or the authority notified 
pursuant to point (b); (ii) a hyperlink to the website referred to in paragraph 4 of 
the Member State of establishment; (iii) the common logo referred to in 
paragraph 3 clearly displayed on every page of the website that relates to the offer 
for sale at a distance to the public of medicinal products. The common logo shall 
contain a hyperlink to the entry of the person in the list referred to in point (c) of 
paragraph 4. 2. Member States may impose conditions, justified on grounds of 
public health protection, for the retail supply on their territory of medicinal 
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products for sale at a distance to the public by means of information society 
services. 3. A common logo shall be established that is recognisable throughout 
the Union, while enabling the identification of the Member State where the person 
offering medicinal products for sale at a distance to the public is established. That 
logo shall be clearly displayed on websites offering medicinal products for sale at 
a distance to the public in accordance with point (d) of paragraph 1. … 4. Each 
Member State shall set up a website providing at least the following: (a) 
information on the national legislation applicable to the offering of medicinal 
products for sale at a distance to the public by means of information society 
services, including information on the fact that there may be differences between 
Member States regarding classification of medicinal products and the conditions 
for their supply; (b) information on the purpose of the common logo; (c) the list of 
persons offering the medicinal products for sale at a distance to the public by 
means of information society services in accordance with paragraph 1 as well as 
their website addresses; (d) background information on the risks related to 
medicinal products supplied illegally to the public by means of information 
society services … 5. … 6. Without prejudice to Directive 2000/31/EC and the 
requirements set out in this Title, Member States shall take the necessary 
measures to ensure that other persons than those referred to in paragraph 1 that 
offer medicinal products for sale at a distance to the public by means of 
information society services and that operate on their territory are subject to 
effective, proportionate and dissuasive penalties.’ 
8 In order to harmonise Greek legislation with Directive 2001/83/ΕC, as amended 
by Directive 2011/62/ΕU, Joint Decision D.YG3a/G.P. 32221/29.4.2013 of the 
Minister for Development, Competitiveness, Infrastructure, Transport and 
Networks and of the Deputy Minister for Health was issued (GG II/1049). 
Article 7(1) of that joint decision provides: ‘No medicinal product may be placed 
on the Greek market without a marketing authorisation issued by the EOF 
[National Organisation for Medicines], issued in accordance with the provisions 
of this Ministerial Decree, unless a marketing authorisation has been granted 
under the centralised procedure in accordance with Regulation (EC) 
No 726/2004 …’. Articles 95, 96 and 97 of the joint decision also provide as 
follows: Article 95 ‘1. When the EOF issues a marketing authorisation for a 
medicinal product, it shall specifically designate: – medicinal products on medical 
prescription, – medicinal products not subject to medical prescription. To that end, 
the EOF shall apply the criteria listed in Article 96(1). 2. The EOF may fix sub-
categories for medicinal products which are available on medical prescription 
only. In that case, it shall refer to the following classification: (a) medicinal 
products on medical prescription for renewable or non-renewable delivery; (b) 
medicinal products subject to special medical prescription; (c) medicinal products 
on medical prescription for restricted use, reserved for use in strictly specialised 
areas’, Article 96 ‘1. Medicinal products shall be subject to medical prescription 
where they: – are likely to present a danger either directly or indirectly, even when 
used correctly, if utilised without medical supervision, or – are frequently and to a 
very wide extent used incorrectly, and as a result are likely to present a direct or 
indirect danger to human health, or – contain substances or preparations thereof, 
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the activity and/or adverse reactions of which require further investigation, or – 
are normally prescribed by a doctor to be administered parenterally. 2. In order to 
classify medicinal products in the sub-category of medicinal products subject to 
special medical prescription, account shall be taken of the following factors: – the 
medicinal product contains, in a non-exempt quantity, a substance classified as a 
narcotic or a psychotropic substance within the meaning of the international 
conventions in force, such as the United Nations Conventions of 1961 and 1971, 
or – the medicinal product is likely, if incorrectly used, to present a substantial 
risk of medicinal abuse, to lead to addiction or be misused for illegal purposes, 
or – the medicinal product contains a substance which, by reason of its novelty or 
properties, could be considered as belonging to the group envisaged in the second 
indent as a precautionary measure. 3. In order to classify medicinal products in the 
sub-category of medicinal products subject to restricted medical prescription, 
account [shall be taken] of the following factors: – the medicinal product, because 
of its pharmaceutical characteristics or novelty or in the interests of public health, 
is reserved for treatments which can only be followed in a hospital environment, – 
the medicinal product is used in the treatment of conditions which must be 
diagnosed in a hospital environment or in institutions with adequate diagnostic 
facilities, although administration and follow-up may be carried out elsewhere, 
or – the medicinal product is intended for outpatients but its use may produce very 
serious side effects requiring a prescription drawn up as required by a specialist 
and special supervision throughout the treatment. 4. …’. Article 97 ‘Medicinal 
products not subject to prescription shall be those which do not meet the criteria 
listed in Article 96.’ 
9 Moreover, Article 116 of Joint Ministerial Decision D.YG3a/G.P. 
32221/29.4.2013 referred to above, with a view to bringing Greek legislation into 
line with Article 85c of Directive 2001/83 referred to above (Article 1(20) of 
Directive 2011/62/ΕU), initially provided as follows: ‘The sale at a distance to the 
public of prescription medicinal products or medicinal products that are 
reimbursed by social security bodies shall be prohibited. For other medicinal 
products, sale at a distance to the public by means of information society services 
is permitted only by legally operating pharmacies. The entry into force of this 
provision, together with all the detailed rules necessary for its implementation, 
shall be laid down by a new, identical ministerial order after the establishment and 
harmonisation of the functioning of the common logo for the whole of the 
European Union, as provided for in Article 85c of Directive 2011/62/ΕU.’ 
10 Article 116 of Joint Ministerial Decision D.YG3a/G.P. 32221/29.4.2013 referred 
to above, Article 4 of Law 4316/2014 (GG I/270) on the operation of electronic 
pharmacy establishments online and Joint Decision G5(b)/G.P. Oik. 
20293/15.3.2016 of the Minister for the Economy, Development and Tourism and 
the Minister for Health, entitled ‘Appointment of the competent authority for the 
certification of electronic pharmacy establishments’ (GG II/787), established a 
system of rules governing the operation of electronic pharmacy establishments 
and the retail supply of medicinal products for sale at a distance to the public by 
means of information society services in Greece, for the purpose of harmonising 
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domestic legislation with the corresponding European legislation. In particular, 
those provisions laid down that (a) the retail sale at a distance to the public, by 
means of information society services, of medicinal products not subject to 
prescription, according to the classification established by the EOF, and medicinal 
products which are not reimbursed by social security bodies is permitted, (b) sales 
may be made by electronic pharmacy establishments, which may be operated only 
by legally operating physical pharmacies, (c) the competent authority to certify the 
legal operation of electronic pharmacy establishments, by issuing the common 
logo provided for, is the Panhellenic Pharmaceutical Association (‘PPS’), which 
will create a website for that purpose, inter alia, for the submission of applications 
for certification from the pharmacists concerned, and (d) with a view to obtaining 
the certificate, the persons concerned are to submit an application containing the 
details referred to in Joint Ministerial Decision G5(b)/G.P. oik. 20293/15.03.2016 
referred to above. 
11 Greek law has long included a rule that the retail sale of medicinal products is to 
be conducted solely by pharmacies, by hand by a pharmacist … – a rule that also 
applies to non-prescription medicinal products under Decision 
D.YG3(a)/127858/5.2.2004 of the Deputy Minister for Health and Welfare, GG 
II/284, section A1. An exception to that rule was introduced by Article 68 of Law 
No 4389/2016 (GG I/94) and Decision G5(a)51194/14.7.2016 of the Minister of 
Health (GG II 2219) issued pursuant to that law in respect of non-prescription 
medicinal products classified in the sub-category of generic pharmaceutical 
products. Those non-prescription medicinal products may also be offered at points 
of sale (shops without the presence of a pharmacist or an auxiliary pharmacist) 
other than pharmacies. Those provisions laid down, in particular, that medicinal 
products may be classified by the EOF as generic medicines if (a) they have 
already been classified as medicinal products not subject to prescription or they 
meet the conditions for classification as medicinal products not subject to 
prescription and there are no more recent scientific data that would lead to them 
being re-classified as medicinal products subject to prescription, (b) they are 
medicinal products intended to treat a clear symptom (headache, nausea, and so 
forth) or an incident that may be easily treated (such as an insect bite), (c) the 
dosage schedule is simple and easy for the patient to follow, (d) their interactions 
with other commonly administered treatments (such as treatments for chronic 
diseases) are minimal and, if they exist, are low-risk, (e) they do not require 
special storage or movement conditions, according to the approved data in their 
marketing authorisation, (f) they come in small packages and, in combination with 
the content, the total quantity of the medicinal product does not exceed a dose that 
might endanger the recipient, and (g) there is no serious and substantiated 
evidence from the published literature in reputable scientific journals that have a 
selection committee that carries out evaluation on serious risks associated with the 
long-term use of the medicinal products. Those medicinal products are made 
available to the public on a retail basis by legally operating pharmacies and by 
certain health establishments (supermarkets and grocery stores), but the law 
provides (paragraphs 9 and 11 of Ministerial Decision G5(a)51194/2016, 
respectively) that, first, ‘it is prohibited to sell generic medicinal products to 
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minors. It is also prohibited to sell more than two identical packs of generic 
medicinal products per transaction’ and, second, ‘establishments who are 
authorised to supply generic medicinal products on a retail basis are prohibited 
from selling them at a distance, unless they are pharmacies that have been legally 
certified as electronic pharmacies pursuant to Joint Ministerial Decision 
G5(b)/G.P. oik. 20293/2016 (GG II/787 of 23.3.2016)’. 
12 Finally, Article 1 of the contested joint [ministerial] decision … replaced 
Article 116(1) of Joint Decision D.YG.3a/G.P. 32221/2013 of the Minister for 
Development, Competitiveness, Infrastructure, Transport and Networks and the 
Minister for Health (GG II/1049, paragraph 9 above) with the following wording: 
‘The sale at a distance of to the public of medicinal products subject to medical 
prescription shall be prohibited. For other medicinal products, sale at a distance to 
the public by means of information society services is permitted, by electronic 
pharmacy establishments that have been certified in that regard by the Panhellenic 
Pharmaceutical Association, a legal entity governed by public law, pursuant to 
Joint Decision G5(b)/G.P.oik.20293/2016 of the Minister for the Economy, 
Development and Tourism and the Minister for Health (GG II/787), only for 
medicinal products which, in accordance with their marketing authorisation, are 
classified or have been placed in the sub-category of generic medicinal products 
within the category of non-prescription medicinal products, pursuant to Decision 
No G5(a)51194/2016 of the Minister for Health (GG II/2219). Those infringing 
those provisions shall be subject to a fine of twenty thousand euro (EUR 20 000) 
to one hundred thousand euro (EUR 100 000) and, in the event of a repeated 
offence, of fifty thousand euro (EUR 50 000) to two hundred thousand euro 
(EUR 200 000), by decision of the Board of Directors of the EOF. Those penalties 
shall be imposed together with any other penalty provided for’. 
13 The applicant, a general partnership which has a brick-and-mortar pharmacy in 
Karditsa and the purpose of which, according to its articles of association, is, inter 
alia, the electronic sale (online) of ‘goods from the pharmacy permitted by 
pharmaceutical legislation’, is applying in its legitimate interest and in all other 
respects for the annulment of the contested joint ministerial decision in so far as it 
authorises the sale at a distance to the public by means of information society 
services, by certified electronic pharmacy establishments, solely of generic 
medicinal products and not of other non-prescription medicinal products. 
14 Pursuant to Article 116 of Joint Ministerial Decision D.YG3a/G.P. 
32221/29.4.2013, in the version in force before the contested decision was 
adopted, that is to say, when it provided for the online sale by certified electronic 
pharmacy establishments of all non-prescription medicinal products without 
distinction and medicinal products which are not reimbursed by social security 
bodies, the … legal representative of the applicant general partnership 
[pharmacist], by his applications [of] … 20 May 2019 and … 10 October 2019, 
applied to the Panhellenic Pharmaceutical Association (‘PPS’) for certification of 
the applicant company’s electronic pharmacy and for the grant of the common 
logo provided for in Article 85c of Directive 2001/83/ΕC, and subsequently 
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brought an action before the Council of State for annulment of the relevant 
omissions on the part of that authority to take the legal action required. Those 
applications for annulment … were finally dismissed by … decisions … of the 
[referring] court, published on 15 December 2022, on the ground that the PPS was 
under no obligation to take the steps sought, in the first case … because the 
legislative and regulatory regime relating to the retail sale of medicinal products at 
a distance by online pharmacy establishments had not been supplemented by the 
rules that would ensure communication between the pharmacist and the purchaser 
of the medicinal product, and, in the second case … because the application 
submitted to the PPS was not accompanied by all the elements required by law. … 
[The referring court definitively rejects the second plea, which claimed that the 
contested joint ministerial decision had attempted to intervene unacceptably in the 
proceedings pending at that time, regarding which the decisions referred to above 
had been issued. The referring court considers that the second plea concerns other 
proceedings in which the contested act had no effect whatsoever]. 
15 The first plea … alleges that, in breach of Article 5(1) of the Syntagma 
(Constitution), Articles 15(1) and 16 of the Charter of Fundamental Rights of the 
European Union (on the freedom to choose an occupation and the freedom to 
conduct a business) and Article 85c(1) of Directive 2001/83/ΕC, in its current 
version, the contested act permits the sale at a distance by means of information 
society services, by electronic pharmacy establishments, of the sub-category of 
generic medicinal products alone, not of all non-prescription medicinal products. 
The applicant submits, in that regard, that the legislation at issue is meaningless 
since no medicinal product has been classified to date on the Greek market by the 
National Organisation for Medicines in the sub-category of generic medicinal 
products. The applicant also submits that, in any event, in the present case there 
are no public health protection grounds that would justify the restrictive measure, 
for the purposes of Article 85c(2) of Directive 2001/83/ΕC, in question. 
16 However, the State, …, and the Panhellenic Pharmaceutical Association, …, 
maintain that, pursuant to Article 85c(2) of Directive 2001/83/ΕC, public interest 
considerations relating to public health protection required the adoption of the 
contested provision. They argue, in particular, that pursuant to the previous 
wording of Article 116 of Joint Ministerial Decree No D.YG3a/G.P. 
32221/29.4.2013, the possibility for electronic pharmacy establishments to sell all 
non-prescription medicinal products and all non-reimbursed medicinal products 
without distinction would have resulted in over 1 000 medicinal products (723 
non-prescription medicines and 302 non-reimbursed medicinal products) being 
made available on the internet, at the risk of making it more difficult to monitor 
overmedication (excessive consumption of medicinal products) and the trafficking 
of counterfeit or inappropriate medicinal products. According to the State and the 
Panhellenic Pharmaceutical Association, the online sale of medicinal products, 
even if they are non-prescription products, poses risks to public health since it 
‘essentially deprives the pharmacist of the opportunity to monitor the end user’ 
and removes the ‘guarantee of safety [that] is inherent when a pharmacist 
manually dispenses medicinal products’, whereas such risks do not exist in the 
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case of generic medicinal products on account of their particular characteristics 
(see paragraph 11 above). Further, again according to the statements of the State 
and the PPS, the provision of all non-prescription medicinal products and non-
reimbursed medicines by electronic pharmacy establishments would not meet any 
need in Greece ‘because of the excellent and rational geographical distribution’ of 
pharmacies in Greece. Finally, the Panhellenic Pharmaceutical Association relies, 
in support of its claims, on the examples of other Member States of the European 
Union (Cyprus and Portugal) which, it maintains, restrict the supply of non-
prescription medicinal products online, pointing out that, of all the pharmacy 
establishments operating in Greece, the applicant company alone has challenged 
the lawfulness of the contested act. 
17 According to the unanimous opinion of the Chamber, the question of the 
compatibility of the contested provision with EU law, namely the compatibility 
with EU law of a national regulatory provision which does not authorise the 
online sale of all non-prescription medicinal products, but only of a subcategory 
of them, namely generic medicinal products, must be examined solely in the light 
of Article 1(20) of Directive 2011/62/ΕU and Article 85c of Directive 
2001/83/ΕC, not of other EU provisions (such as, for example, Directive 
2000/31/ΕC on electronic commerce, OJ L 178, transposed into national law by 
Presidential Decree No 131/2003, GG I/116; see judgment of 1 October 2020, A 
(Advertising and sale of medicinal products online) (C-649/18, EU:C:2020:764, 
paragraphs 28 to 33)). Paragraph 1 of Article 85c of Directive 2001/83/ΕC [which, 
as Advocate General Saugmandsgaard Øe observed in his Opinion in A 
(Advertising and sale of medicinal products online) (C-649/18, EU:C:2020:134, 
footnote 11) referred to above, ‘reflects the lessons drawn from the judgment of 
11 December 2003, Deutscher Apothekerverband [C-322/01 … paragraph 112], in 
which the Court [of Justice] ruled that an absolute prohibition on the online sale of 
non-prescription medicines was incompatible with the free movement of goods’], 
does not authorise the national legislature, whether taking action itself or through 
a regulatory body, to exclude non-prescription medicinal products from the scope 
of online sales. Although Article 85c(2) provides, as stated above, that Member 
States may impose conditions, justified on grounds of public health protection, for 
the retail supply on their territory of medicinal products for sale at a distance to 
the public by means of information society services, the conditions imposed by 
that provision may not have the effect of calling into question the basic rule 
referred to in paragraph 1 of that article or of prohibiting the online sale of non-
prescription medicinal products. That view is supported by the case-law of the 
courts of other Member States of the European Union (see French Conseil d’État 
(Council of State) – judgment of 17 July 2013, M L. and Others, Joined Cases 
365317, 366195, 366272 and 366468. That judgment, having taken into account 
the provisions of Directive 2001/83/ΕC referred to above, which provide only for 
sub-categories of prescription-only medicinal products and not of non-prescription 
medicinal products, annulled as unlawful a legislative measure providing for the 
online sale of only certain sub-categories of non-prescription medicinal products). 
The Court of Justice has also already accepted, however, in its judgment of 
29 February 2021, Doctipharma (C-606/21, EU:C:2024:179), first (in 
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paragraph 42), that ‘paragraph 1 of Article 85c of Directive 2001/83 lays down the 
conditions relating to persons, medicinal products and websites which must be 
met by the distance selling of medicinal products to the public by means of 
information society services and which the Member States must ensure are 
complied with’, and second (in paragraph 41) that ‘it follows from that provision 
[paragraph 1 of Article 85c] that the Member States must authorise the distance 
selling to the public, by means of information society services …, of medicinal 
products not subject to medical prescription. A prohibition under the legislation of 
a Member State on the offer for distance selling to the public is permissible only 
in respect of medicinal products subject to prescription’. In the light of the 
foregoing, the contested joint ministerial decision should be annulled, as the 
applicant effectively argues, on the ground that it is contrary to Directive 
2001/83/ΕC, in so far as it prohibits the sale at a distance to the public by means 
of information society services, by electronic pharmacy establishments, of non-
prescription medicinal products other than the specific sub-category of generic 
medicinal products. First, the issue of EU law which arises in the present case, 
namely whether Article 85c(2) of Directive 2001/83/ΕC permits the prohibition, 
on grounds of public health protection, of the sale of certain non-prescription 
medicinal products by means of information society services, has not yet been 
settled by case-law of the Court of Justice on the subject. Second, the intervening 
Panhellenic Pharmaceutical Association is thus relying on the legislation of other 
Member States (Cyprus and Portugal), under which, it maintains, not all non-
prescription medicinal products, without exception, may be sold on the internet. It 
is therefore necessary to stay the proceedings and to refer the questions for a 
preliminary ruling set out in the operative part to the Court of Justice. 
On those grounds 
Suspends final judgment on the application. 
Refers the following questions to the Court of Justice of the European Union for a 
preliminary ruling: 
(a) Must Article 85c(1) of Directive 2001/83/ΕC be interpreted as precluding a 
national provision which permits the sale at a distance to the public by means of 
information society services, by electronic pharmacy establishments, not of all 
non-prescription medicinal products, but of one sub-category only thereof (in the 
present case, generic medicinal products)? 
(b) Or, on the contrary, does Article 85c(2) of Directive 2001/83/ΕC permit the 
national legislature to prohibit sales at a distance to the public by means of 
information society services, by electronic pharmacy establishments, of certain 
medicinal products not subject to medical prescription, on grounds of public 
health protection? 
(c) If the answer to question (b) is in the affirmative, are the grounds relied on in 
the present case by the Greek state and the Panhellenic Pharmaceutical 
REQUEST FOR A PRELIMINARY RULING OF 16. 7.  2024 – CASE C-604/24 
 
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Association to justify the restriction in question (combating overmedication and 
the trafficking of counterfeit or inappropriate medicinal products, and so forth) 
grounds of public health protection within the meaning of Article 85c(2) of 
Directive 2001/83/ΕC? 
(d) If the answer to question (c) is in the affirmative, is the national court to 
review the proportionality of the restrictive measure by carrying out negative 
screening, that is to say, is it to assess only whether the restriction appears to be 
manifestly inappropriate or manifestly unnecessary, or, conversely, is the court to 
carry out positive screening, that is to say, is it to assess whether the restriction 
appears to be an appropriate and strictly necessary measure for public health 
protection? 
… the judgment was delivered in open court on 16 July 2024. …