Opinion of the Advocate General — ECLI:EU:C:2021:416
Date: 2021-05-20
Language of the case: Hungarian
Subject matter: Free movement of goods;Measures having equivalent effect;Approximation of laws;Quantitative restrictions
Procedure: Reference for a preliminary ruling
Origin: Hungary

Translation C-178/20 — 1 
Case C-178/20 
Request for a preliminary ruling 
Date lodged: 
7 April 2020 
Referring court: 
Fővárosi Közigazgatási és Munkaügyi Bíróság (Budapest 
Administrative and Labour Court, Hungary) 
Date of the decision to refer: 
10 March 2020 
Applicant: 
Pharma Expressz Szolgáltató és Kereskedelmi Kft 
Defendant: 
Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet 
(National Institute of Pharmacy and Nutrition) 
  
Fővárosi Közigazgatási és Munkaügyi Bíróság (Budapest Administrative and 
Labour Court, Hungary) 
06.K.31 290/2019/24. 
In the administrative proceedings concerning the trade in medicinal products 
brought by Pharma Expressz Szolgáltató és Kereskedelmi Korlátolt 
Felelősségű Társaság ([…] Budapest […]), applicant, […] against Országos 
Gyógyszerészeti és Élelmiszer-egészségügyi Intézet (National Institute of 
Pharmacy and Nutrition […] Budapest […]), defendant, the Fővárosi 
Közigazgatási és Munkaügyi Bíróság (Budapest Administrative and Labour 
Court, Hungary) has given the following 
Decision 
This court hereby commences the procedure for a reference to the Court of Justice 
of the European Union for a preliminary ruling concerning the interpretation of 
Articles 70 to 73 of Directive 2001/83/EC of the European Parliament and of the 
Council of 6 November 2001 on the Community code relating to medicinal 
EN 
REQUEST FOR A PRELIMINARY RULING OF 10. 3. 2020 — CASE C-178/20 
 
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products for human use (OJ 2001 L 311, p. 67; ‘Directive 2001/83’) and 
Article 36 of the Treaty on the Functioning of the European Union (‘TFEU’). 
This court refers the following questions to the Court of Justice of the European 
Union: 
1. Does an obligation flow from Articles 70 to 73 of Directive 2001/83 to 
regard a medicinal product which can be dispensed without medical 
prescription in one Member State as a medicinal product which can also 
be dispensed without medical prescription in another Member State, 
including where, in that other Member State, the medicinal product in 
question does not have a marketing authorisation and has not been 
classified? 
2. Is a quantitative restriction which makes the possibility of ordering and 
dispensing to a patient a medicinal product which does not have a 
marketing authorisation in one Member State but does have such an 
authorisation in another [Member State of the EEA] conditional on the 
existence of a medical prescription and a declaration from the 
pharmaceutical authority, including where the medicinal product is 
registered in the other Member State as a medicinal product not subject 
to medical prescription, justified in the interests of protection of the 
health and life of humans, as referred to in Article 36 TFEU? 
[…] [procedural aspects of national law] 
Grounds 
This court requests from the Court of Justice of the European Union an 
interpretation of Articles 70 to 73 of Directive 2001/83 and Article 36 TFEU in a 
case relating to the import of medicinal products from another Member State. 
I. Relevant legislative provisions 
EU law 
Articles 70 to 73 of Directive 2001/83. 
Article 36 TFEU. 
Hungarian law 
Law XCV of 2005 on medicinal products for human use and amending other laws 
governing the market in medicinal products (az emberi alkalmazásra kerülő 
gyógyszerekről és egyéb, a gyógyszerpiacot szabályozó törvények módosításáról 
szóló 2005. évi XCV. törvény; ‘Law on medicinal products’) 
PHARMA EXPRESSZ 
 
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Paragraph 25(2): ‘Medicinal products that do not have a marketing authorisation 
in a State which is a party to the EEA Agreement but do have a marketing 
authorisation in another country may be used for medical purposes in special cases 
where their use is justified in the pursuit of an interest relating to patient care to 
which particular regard must be had and where the State pharmaceutical 
administrative body has authorised their use in accordance with the specific 
conditions laid down in a special provision. Medicinal products that have a 
marketing authorisation in a State which is a party to the EEA Agreement may be 
used for medical purposes if they have been notified to the State pharmaceutical 
administrative body in accordance with a special provision. The assessment of an 
interest relating to patient care to which particular regard must be had shall be 
carried out, where necessary, in the light of the professional association’s opinion 
concerning the safety and effectiveness of the therapeutic procedure.’ 
Ministry of Health and Social and Family Affairs Regulation 44/2004 of 28 April 
on prescribing and dispensing medicinal products for human use (az emberi 
felhasználásra kerülő gyógyszerek rendeléséről és kiadásáról szóló 44/2004. (IV. 
28.) ESzCsM rendelet; ‘Regulation 44/2004’), in force until 13 February 2018. 
Paragraph 3(5): ‘In accordance with Paragraph 25(2) of the [Law on medicinal 
products], medical practitioners may prescribe medicinal products which are not 
authorised to be placed on the market in Hungary but which are authorised to be 
placed on the market in another Member State of the European Economic Area 
(EEA), or in a State which has the same legal status as that held by Member States 
of the EEA pursuant to an international treaty concluded with the European 
Community or the EEA (“State party to an EEA treaty”), only if, before 
prescribing those medicinal products, they lodge a notification with the Országos 
Gyógyszerészeti és Élelmezés-egészségügyi Intézet (National Institute of 
Pharmacy and Nutrition, Hungary) and they obtain a declaration from that 
Institute.’ 
Paragraph 12/A: ‘In the context of the direct supply of medicinal products to the 
public, pharmacists may supply medicinal products prescribed in accordance with 
Paragraph 3(5) and Paragraph 4(1) only after lodging a copy of the declaration 
issued by the National Institute of Pharmacy and Nutrition or a copy of the 
authorisation.’ 
Government Regulation 448/2017 of 27 December on authorisation of the 
prescription and individual use of medicinal products for human use (az emberi 
felhasználásra kerülő gyógyszerek egyedi rendelésének és felhasználásának 
engedélyezéséről szóló 448/2017. (XII. 27.) Korm. rendelet; ‘new Government 
Regulation’), in force since 1 January 2018. 
Paragraph 5(1). ‘In accordance with Paragraph 25(2) of the [Law on medicinal 
products], medical practitioners may prescribe medicinal products which are not 
authorised to be placed on the market in Hungary but which are authorised to be 
placed on the market in another Member State of the European Economic Area 
REQUEST FOR A PRELIMINARY RULING OF 10. 3. 2020 — CASE C-178/20 
 
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(EEA), or in a State which has the same legal status as that held by Member States 
of the EEA pursuant to an international treaty concluded with the European 
Community or the EEA (“State party to an EEA treaty”), only if, before 
prescribing those medicinal products, they lodge a notification with the Országos 
Gyógyszerészeti és Élelmezés-egészségügyi Intézet (National Institute of 
Pharmacy and Nutrition, Hungary) and they obtain a declaration from that 
Institute concerning the following matters: 
a) whether the medicinal product which the medical practitioner wishes to 
prescribe has a marketing authorisation in a Member State of the EEA or in a 
State party to an EEA treaty identified by the medical practitioner, in relation to 
the indications given by that practitioner, 
b) whether the competent authority has withdrawn the marketing authorisation 
for the medicinal product which the medical practitioner wishes to prescribe or 
suspended its distribution, and 
c) whether, in the medical practitioner’s opinion and based on information 
provided by the medical practitioner, there is an interest relating to patient care to 
which particular regard must be had, as defined in Paragraph 1(23) of the [Law on 
medicinal products]. 
(2) Medical practitioners shall request that the declaration referred to in 
subparagraph 1 be issued on the data sheet included in Annexes 3 to 5 of 
Regulation 44/2004. The National Institute of Pharmacy and Nutrition shall notify 
the medical practitioner who is prescribing the medicinal product of its opinion on 
the matters set out in subparagraph 1 within eight working days of receipt of the 
data sheet. 
(3) Where the National Institute of Pharmacy and Nutrition issues a declaration 
according to which the conditions set out in subparagraph 1 are satisfied, the 
medical practitioner shall give the patient — in the case of a prescription-only 
medicine — a copy of the declaration from that Institute together with the 
prescription. 
(4) Where the National Institute of Pharmacy and Nutrition issues a declaration 
according to which, in its opinion, there is no interest relating to patient care to 
which particular regard must be had, as defined in Paragraph 1(23) of the Law on 
medicinal products, the medical practitioner shall give the patient — if the 
practitioner continues to maintain that it is necessary to prescribe the medicinal 
product and it is a prescription-only medicine — a copy of the declaration from 
that Institute together with the prescription and shall provide the patient with 
information concerning the contents of the declaration and its possible 
consequences.’ 
PHARMA EXPRESSZ 
 
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II. Subject matter of the dispute and relevant facts 
1. The National Institute of Pharmacy and Nutrition, the defendant in the present 
case, in its capacity as the authority with competence for overseeing the 
distribution of medicinal products, found, following an investigation of retail sales 
by the applicant of medicinal products, that the applicant had, on a number of 
occasions, imported from another EEA Member State a medicinal product not on 
the market in Hungary and that that product was registered in that other EEA 
Member State as a medicinal product not subject to medical prescription. On those 
occasions, the patient ordered the medicinal product directly from the pharmacy 
without a prescription. Then the applicant, acting in its own name, obtained and 
stocked the medicinal product from the other Member State and finally, acting in 
its own name, the applicant sold and supplied the medicinal product directly to the 
patient who had ordered it. 
2. Under national law, a medicinal product imported from another Member State 
which does not have a national marketing authorisation can be used for medical 
purposes if it has been notified to the State pharmaceutical administrative body. 
Medical practitioners may prescribe that medicinal product if they give prior 
notice to the pharmaceutical authority and obtain a declaration from that authority. 
The content of the declaration from the authority covers the following matters: 
– whether the medicinal product has a marketing authorisation in another 
Member State; 
– the active substances and indications of the medicinal product; 
– whether the medicinal product has been withdrawn from the market or its 
distribution has been suspended; 
– whether there is an interest relating to patient care to which particular regard 
must be had. 
The previous national legislation, which must be applied to this case, did not 
provide that the medicinal product could be ordered or dispensed on the basis of 
the content of the declaration from the authority. In accordance with the 
provisions now in force, the wording of which is essentially the same, in the 
absence of any interest relating to patient care to which particular regard must be 
had, the medical practitioner is required to make the patient aware of that fact, 
although that does not preclude the medicinal product from being ordered. It 
follows that the mere fact that there is a declaration, whatever its wording, is 
sufficient to comply with the legislative requirement. On the other hand, in the 
case of medicinal products imported from a third country which is not party to an 
EEA treaty, the national legislation requires authorisation from the pharmaceutical 
authority. 
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3. The defendant concluded that the national rule referred to must apply to medicinal 
products imported from any other Member State, regardless of whether or not the 
medicinal product in question has been registered in the other Member State as a 
medicinal product the acquisition of which is subject to medical prescription. 
4. At the patient’s request, the applicant ordered, from another Member State, 
medicinal products not subject to medical prescription, without requiring a 
medical prescription or a declaration from the National Institute of Pharmacy and 
Nutrition to order and dispense those products. In view of this, by decision of 
7 March 2019, the defendant authority, together with other measures, prohibited 
the applicant from continuing to carry out that unlawful conduct on the grounds 
that it breached the provisions on the dispensation of individually acquired 
medicinal products. The legal basis for the offence was the infringement of 
Paragraph 12/A of the Regulation, since, in the absence of a declaration from the 
pharmaceutical authority, the applicant was supplying medicinal products 
obtained in another Member State which did not have a national marketing 
authorisation. 
Essential aspects of the parties’ submissions 
5. The applicant brought an action against the decision before this court and sought, 
inter alia, a declaration that it had not committed any offence in the context of the 
individual acquisition of medicinal products. The applicant submits, in particular, 
that the legal interpretation adopted by the defendant and the application of a 
provision of restrictive national legislation to the individual acquisition of 
medicinal products registered in another Member State as medicinal products not 
subject to medical prescription constitute a prohibited quantitative restriction on 
imports contrary to Article 34 TFEU. That type of quantitative restriction cannot 
be justified in the interests [of the objective] of [protecting] the health and [life] of 
humans laid down in Article 36 TFEU. The declaration from the pharmaceutical 
authority does not serve to protect the health of humans because it does not 
provide additional information regarding the matters it should include, referred to 
above. The medicinal product can be dispensed even if the declaration is 
unfavourable because the legislation does not contain any requirements regarding 
its content. Nor does the legislation provide for a penalty if medicinal products are 
dispensed in spite of an unfavourable declaration. Furthermore, practical 
experience shows that it can take several weeks or even several months to obtain a 
declaration, which can jeopardise the patient’s health rather than serving to protect 
it. 
6. The applicant submits that a restriction of that kind is also disproportionate. First, 
because, in the case of medicinal products that have a national marketing 
authorisation, the legislation does not provide that a declaration must be obtained. 
Second, in the case of medicines which can be freely acquired without 
prescription in another Member State, the condition regarding a medical 
prescription and a declaration from the authority is an unnecessary and 
disproportionate requirement, because that other Member State has authorised the 
PHARMA EXPRESSZ 
 
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placing of the medicinal product concerned on the market in accordance with 
criteria which are compatible with the harmonised provisions and principles of the 
European Union and has classified the medicinal product in the category of 
medicines which can be acquired without a prescription. Therefore, making 
acquisition of the medicine within the country subject to a medical prescription is 
a disproportionate restriction which does not really contribute to protecting the 
patient’s health. In certain Member States, such as, for example, Germany and 
Austria, patients can order directly, in pharmacies, medicines not subject to 
medical prescription which are on the market in another Member State, because 
the classification of medicinal products carried out by the other Member State is 
accepted. Member States classify medicines in accordance with uniform criteria 
which comply with the applicable directive. Accordingly, a medicinal product 
classified as a medicinal product not subject to medical prescription in another 
Member State must also be treated as a medicinal product not subject to medical 
prescription in Hungary. 
7. The defendant contends that the national legislation constitutes a quantitative 
restriction aimed at protecting the health and life of humans, which can be 
justified under Article 36 TFEU. The defendant points out that the provision of 
medicines falls within the sphere of competence of the Member States and that it 
is for the Member States to decide what level of protection of public health they 
are seeking to ensure. The defendant states that, when examining the principle of 
proportionality, it is necessary to take into consideration the fact that the health 
and life of humans rank foremost among the assets protected by the TFEU. The 
Member States may adopt measures which reduce the risks to public health and 
[the risks which threaten] the safe and high-quality supply of medicinal products 
to society. 
8. The national legislation does not preclude the import of foreign medicinal 
products. The National Institute of Pharmacy and Nutrition ensures that the 
population has access to safe medicines, in the exercise of its State function, by 
gathering information from equivalent authorities of the Member States 
concerning the use of foreign medicinal products for medical purposes, 
concerning whether a marketing authorisation exists and concerning whether it 
can be used in relation to the indications given by the medical practitioner. If the 
medical practitioner has the declaration, he or she may issue a prescription to the 
patient and this ensures that, if the opinion is negative, no prescription will be 
issued, which guarantees the protection of patients’ health. 
9. The classification of medicinal products as subject to or not subject to medical 
prescription takes place in the context of the marketing authorisation procedure. 
Therefore, as long as a medicinal product does not have a marketing authorisation 
in Hungarian territory, it is not possible to decide whether it can be dispensed with 
or without a medical prescription. In that regard, it should be noted that, during 
the investigation, the defendant did not even examine which category the 
medicinal products imported from abroad were classified under in the Member 
State. 
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III. Reasoning on which the reference for a preliminary ruling is based 
Question 1 
10. The placing of medicinal products on the market in the territory of the European 
Union is an area harmonised by Directive 2001/83. The EU legislation also 
provides that each Member State, in the exercise of its own powers, is to handle 
the procedure to authorise the placing of medicinal products on the market, using 
a procedure compatible with the provisions of the Directive. Recognition of a 
marketing authorisation is not automatic and is instead subject to the procedure 
laid down in in Title IV of the Directive. 
11. Title VI of the Directive concerns the classification of medicinal products, for 
which the Member States have competence provided that they respect the uniform 
principles set out in Articles 70 to 75. In accordance with Article 73 of the 
Directive, the competent authorities of the Member States are to draw up a list of 
the medicinal products which are subject, on their territory, to medical 
prescription. 
12. The resolution of the present proceedings requires an interpretation of whether the 
fact that the Directive lays down uniform principles for the classification of 
medicinal products imposes on a Member State an obligation to accept 
unconditionally the classification — that is, whether or not the medicinal product 
is subject to medical prescription — carried out by another Member State of a 
medicine placed on the market in that other Member State, and to treat that 
medicine in the same way as medicinal products which have a national marketing 
authorisation. 
Question 2 
13. In the interests of security of the supply of medicinal products to the population 
and the protection of public health, the national legislation makes the import from 
another EEA State of medicinal products which do not have a national marketing 
authorisation subject to the existence of a medical prescription and the obtaining 
of a declaration from the pharmaceutical authority. The legislation does not 
distinguish in any way between medicinal products which are subject to medical 
prescription and those which are not and this suggests that it is also applicable to 
medicinal products which can be acquired without medical prescription in another 
Member State. 
14. The referring court has reached the conclusion, in the light of the case-law of the 
Court of Justice of the European Union, that the national legislation set out above 
constitutes a measure restricting the free movement of goods. 
15. The resolution of the dispute requires an interpretation of Article 36 TFEU in 
order to determine whether the restrictive measure in question can be justified by 
PHARMA EXPRESSZ 
 
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the protection of the health and life of humans, including where the medicinal 
product can be dispensed without a medical prescription in another Member State. 
16. The restriction introduces two additional requirements to those laid down in 
respect of medicinal products which have a national marketing authorisation and 
which can be dispensed without a medical prescription: 1) a declaration from the 
pharmaceutical authority and 2) the existence of a medical prescription. The 
medical practitioner requests the declaration from the authority in advance and, 
therefore, the involvement of a medical practitioner is also necessary for that 
purpose. 
17. The reply that the Court of Justice gives to question 1 is also relevant for the 
purposes of determining whether or not, in the case of a medicinal product which 
has been classified in another Member State as a medicinal product not subject to 
medical prescription in accordance with the provisions of Directive 2001/83, the 
fact that use of that medicinal product is allowed only in the context of medical 
treatment is justified in the interests of the protection of the health of humans. If 
the classification of a medicinal product carried out by another Member State 
must be recognised, there are not necessarily any grounds for making its use 
conditional on a medical recommendation since the medicine may be dispensed to 
patients in that other Member State without the involvement of a medical 
practitioner. On the other hand, if the Court finds that a Member State is not 
obliged to accept a classification carried out by another Member State, it is not 
clear which category a medicinal product that has not been placed on the market 
should fit into, meaning that, in such a case, the involvement of a medical 
practitioner and the obtaining of an opinion are necessary to protect the patient’s 
health. 
18. The declaration from the pharmaceutical authority must be examined in 
conjunction with the medical prescription and also separately from that 
prescription in order to assess whether it constitutes a restriction on the movement 
of goods. The declaration contains information that is important from the 
perspective of public health and the patient. The matter of whether or not the 
medicinal product has a foreign marketing authorisation, the indications relating 
to the medicine and its active substances constitute the minimum information that 
can be required in order to be able to determine whether a medicinal product is 
safe. The Hungarian pharmaceutical authority obtains from the equivalent 
authority of the other Member State [particulars which comprise] the subject 
matter of objective information in the declaration. The patient, the medical 
practitioner and the pharmacy may not consult that information directly. The 
declaration must also contain the authority’s opinion concerning whether there is 
an interest relating to patient care to which particular regard must be had. That is a 
professional medical question which may reflect a subjective view. 
19. Unlike the situation with regard to the previous legislation, the legislation in force 
since 2018 lays down specific provisions governing the procedure to be followed 
on the basis of the content of the declaration. In accordance with the legislation in 
REQUEST FOR A PRELIMINARY RULING OF 10. 3. 2020 — CASE C-178/20 
 
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force, if the authority does not consider that there is an interest relating to patient 
care to which particular regard must be had, the medical practitioner must make 
the patient aware of that fact. The medical practitioner may, with knowledge of 
the content of the declaration, prescribe the medicine to the patient. 
20. The referring court takes the view that the declaration from the authority contains 
relevant information from the point of view of the safety of medicinal products 
which must be brought to the attention of the patient before the medicine is 
ordered. Obtaining that information in advance can also be justified if it is 
accepted that the medicine may be dispensed without a prescription and on the 
basis of a direct order from the patient. 
21. In addition, for health protection purposes, the length of time which it takes to 
obtain the declaration is also important. On that point, the referring court does not 
have any conclusive information. The legislation currently in force lays down a 
time limit of eight days for the authority to issue its declaration. The previous 
legislation did not lay down a specific time limit. The defendant referred to an 
instance in which the declaration took approximately three months. 
[…] [procedural aspects of national law] 
Budapest, 10 March 2020. 
[…] [signatures]