Judgment;Summary — ECLI:EU:C:2021:956
Date: 2021-11-25
Language of the case: Polish
Court formation: Third Chamber
Subject matter: Free movement of goods;Measures having equivalent effect;Quantitative restrictions
Procedure: Reference for a preliminary ruling
Origin: Poland

Summary C-488/20 – 1 
Case C-488/20 
Summary of a request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged: 
2 October 2020 
Referring court: 
Wojewódzki Sąd Administracyjny w Warszawie (Poland) 
Date of the decision to refer: 
9 September 2020 
Applicant: 
Delfarma Sp. z o.o. 
Defendant: 
Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów 
Medycznych i Produktów Biobójczych (President of the Office for 
Registration of Medicinal Products, Medical Devices and Biocidal 
Products) 
  
Subject matter of the case in the main proceedings 
Action brought by a company engaged in the parallel import of medicinal 
products against a decision on the expiry of a parallel import licence 
Subject matter and legal basis of the reference 
Compatibility with Articles 34 and 36 TFEU of the automatic expiry of a parallel 
import licence after one year from the expiry of the marketing authorisation for 
the reference medicinal product. 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-488/20 
 
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Questions referred 
1. Does Article 34 TFEU preclude national legislation under which a parallel 
import licence is to expire after one year from the expiry of the marketing 
authorisation for the reference medicinal product? 
2. In the light of Articles 34 and 36 TFEU, may a national authority adopt a 
decision of a declaratory nature to the effect that a marketing authorisation for a 
medicinal product in connection with parallel import is to expire automatically, 
solely on the ground that the period laid down by law has expired, as from the 
date on which the marketing authorisation for the reference medicinal product 
expired, without examining the reasons for the expiry of [the marketing 
authorisation for] that product or other requirements referred to in Article 36 
TFEU relating to the protection of the health and life of humans? 
3. Is the fact that parallel importers are exempt from the obligation to submit 
periodic safety reports, and the authority consequently has no current data on the 
benefit/risk of pharmacotherapy, sufficient to adopt a decision of a declaratory 
nature to the effect that a marketing authorisation for a medicinal product in 
connection with parallel import is to expire? 
Provisions of Community law relied on 
Articles 34 and 36 of the Treaty on the Functioning of the European Union 
(‘TFEU’) 
Provisions of national law relied on 
Article 2(7b), 21a and 33a of the Ustawa z dnia 6 września 2001 r. Prawo 
farmaceutyczne (Law on medicinal products; ‘PrFarm’) 
Succinct presentation of the facts and the main proceedings 
1 The applicant is an undertaking engaged in an economic activity consisting of the 
parallel import of medicinal products on the Polish market. 
2 Pursuant to a decision of the Minister Zdrowia (Minister for Health) of 27 January 
2011, the applicant obtained a licence for the parallel import from the Czech 
Republic of the medicinal product Ribomunyl, granules for oral solution, 0.750 
mg + 1.125 mg (licence No 8/11).  
3 In accordance with the requirement laid down in Article 2a(7b)(a) of the PrFarm, 
parallel import licence No 8/11 was issued on the basis of a valid marketing 
DELFARMA 
 
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authorisation in the territory of Poland for the medicinal product Ribomunyl, 
granules for oral solution, 0.750 mg + 1.125 mg – licence No R/3251 – granted to 
Pierre Fabre Medicament Polska Sp. z o.o. The marketing authorisation for 
reference medicinal product R/3251 expired on 25 September 2018 by decision of 
the President of the Urzędu Rejestracji Produktów Leczniczych, Wyrobów 
Medycznych i Produktów Biobójczych (Office for Registration of Medicinal 
Products, Medical Devices and Biocidal Products) of 25 September 2018. 
4 According to the applicant company, the authorisation under which the imported 
parallel medicinal product is placed on the market in the country of export, that is 
to say the Czech Republic, remains in force. 
5 By a decision of 24 September 2019, the President of the Office for Registration 
stated that parallel import licence No 8/11 for the medicinal product Ribomunyl, 
granules of oral solution, 0.750 mg + 1.125 mg, imported from the Czech 
Republic, the country of export, expired on 25 September 2019.  
6 Following re-examination of the case at the request of the applicant company, the 
President of the Office for Registration of Medicinal Products, Medical Devices 
and Biocidal Products upheld the decision of 24 September 2019, by decision of 
18 November 2019. The applicant brought an action before the referring court 
against the decision of 18 November 2019. 
Essential arguments of the parties in the main proceedings 
7 The applicant argued that the contested decision infringes Article 34 TFEU, in 
conjunction with Article 36 thereof, in that it entails a restriction on the free 
movement of goods which cannot be justified by reference to Article 36 TFEU. In 
particular, it is not justified by the need to protect the health and life of humans. 
Article 34 TFEU, as a provision negatively harmonising national rules relating to 
the conditions governing the parallel import of medicinal products, is interpreted 
in the settled case-law of the Court of Justice as excluding the validity and 
application in this regard of a provision of the national law of a Member State 
under which a licence for the parallel import of a medicinal product in that State is 
to expire following the expiry of the marketing authorisation for the reference 
medicinal product. 
8 It further argued that Article 21a(3a) of the PrFarm is contrary to Article 34 TFEU 
and that fact prevents its application by the national authorities in so far as it 
stipulates that a licence for the parallel import of a medicinal product to Poland is 
to expire after one year from the expiry of the marketing authorisation for the 
reference medicinal product in the territory of Poland. 
9 The applicant also argued that the contested decision misinterprets Article 21a(3a) 
of the PrFarm, in conjunction with Article 36 TFEU, in that it finds that the 
provision laid down in Article 21a(3a) of the PrFarm is justified on grounds of 
protection of the health and life of humans, whilst in actual fact that provision is 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-488/20 
 
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unrelated to that necessary requirement. Article 21a(3a) of the PrFarm provides 
that the very fact that the marketing authorisation for the medicinal reference 
product in the territory of Poland has expired is to be the sole and sufficient basis 
for the expiry of a licence for the parallel import of a medicinal product to Poland, 
without at the same time requiring the authority to establish the reason why the 
marketing authorisation in the territory of Poland for the medicinal reference 
product has expired. 
10 The applicant further argued that the contested decision infringed Article 36 
TFEU in that it failed to consider whether the expiry of the licence for the parallel 
import of the medicinal product to Poland after one year from the expiry of the 
marketing authorisation for the reference medicinal product in the territory of 
Poland is justified on grounds of protection of the health and life of humans, and 
in particular whether the further marketing of the medicinal product imported in 
parallel may pose a threat to the life and health of humans or animals. 
11 The defendant pointed out that whilst, according to the case-law of the Court of 
Justice concerning the parallel import of medicinal products, the validity of a 
parallel import licence for a medicinal product should not expire automatically 
where the marketing authorisation for the reference medicinal product expires, an 
exception in this regard is the need, laid down in Article 36 TFEU, to withdraw a 
parallel import licence where the marketing authorisation for the reference 
medicinal product is withdrawn on grounds relating to a threat to the life or health 
of humans. The authority noted the absence of a medicinal product to which the 
medicinal product from the parallel import is to ‘refer’ in the event of the need to 
modify or update the data etc. necessary for proper pharmacovigilance and the 
possible updating of the leaflets which, for the patient, constitute the main source 
of information on the medicinal product. It pointed to similar uncertainty which 
forms the subject matter of the reference for a preliminary ruling in the case of 
[kohlpharma] C-602/19. It noted that parallel importers are exempt by statute from 
the obligation to submit periodic safety reports on medicinal products and in the 
absence of national marketing authorisation for the reference medicinal product 
the authority has no current data on benefit/risk of the pharmacotherapy. Nor is 
there any other medicinal product with marketing authorisation in Poland which 
contains active substances such as those in the medicinal product Ribomunyl. 
Succinct statement of the reasons for the reference 
12 The referring court notes that essence of the dispute in the main proceedings is the 
need, arising from the application of Article 21a(3a) of the PrFarm, to establish 
the correct interpretation of the provisions of EU law, and in particular of 
Article 34 TFEU, which determines the assessment of the compatibility with EU 
law of the effect arising by operation of law (ex lege) in the form of the expiry of 
the parallel import licence after one year from the expiry of the marketing 
authorisation for the reference medicinal product.  
DELFARMA 
 
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13 The referring court considers that, according to the previous case-law of the Court 
of Justice the national authorities must not respond automatically, but are instead 
required to examine on a case-by-case basis the reasons for the expiry of the 
marketing authorisation and take account of the justifications in support of leaving 
the medicinal product on the market despite the fact that the marketing 
authorisation for the reference medicinal product has expired (see, for example, 
judgments of the Court of Justice of 10 September 2002, in Case C-172/00, 
Ferring Arzneimittel GmbH and of 8 May 2003, in Case C-15/01, Paranova 
Läkemedel AB and Others). 
14 The judgment of the Court of Justice of 3 July 2019 in Case C-387/18, 
Delpharma, concerning provisions of Polish law on medicinal products relating to 
marketing authorisations for a medicinal product, also militates in favour of a 
broad application of the obstacles to limitation of the movement of goods laid 
down in Article 34 TFEU. 
15 In the view of the referring court, in the case under consideration the structure of 
Article 21a(3) of the PrFarm, which provides for the effect of expiry by operation 
of the law, does not allow the case to be resolved merely by applying an 
interpretation consistent with EU law. It would be necessary, in applying the law, 
to disregard a clearly worded provision of national law, which, in the view of the 
referring court, goes beyond an interpretation of the law permissible under 
national law, which would then take the form of an interpretation contra legem. In 
addition, such an approach would still not resolve the question of how the 
administrative authority should carry out supervision of the safety of the use of a 
medicinal product imported in parallel in the absence of a reference medicinal 
product. 
16 The first question concerns the assessment of the compatibility with EU law of the 
rule relating to the expiry of a parallel import licence after one year from the 
expiry of the marketing authorisation for the reference medicinal product. The 
second question relates to the assessment of the lawfulness of not examining on a 
case-by-case basis the conditions for expiry of a market authorisation and the 
protection of the health and life of humans. The third question relates to the 
authority’s argument regarding the safety of leaving the medicinal product on the 
market, in respect of which there is no person required to update the data on the 
risk associated with its use. However, it should be noted that under the law in 
force, a Polish authority may also request, under Article 21a(5) of the PrFarm, the 
authorities of the Member State to send the relevant documents which allow a 
comparison to be made of the products concerned. It is worth considering the 
possible use of this evidence-taking procedure also where a medicinal product 
originating from parallel import is left on the market despite the fact that the 
marketing authorisation for the reference medicinal product has expired. 
17 At this juncture, it should be noted that the issue concerning the legal effects of 
the expiry of the marketing authorisation for the reference medicinal product in 
relation to a product originating from parallel import also arose in the case 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-488/20 
 
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pending before the Court of Justice as a result of a request for a preliminary ruling 
in [kohlpharma] (C-602/19), but there has not yet been a ruling which would be 
helpful in resolving the present case. 
18 The referring court is aware of the fact that the case under consideration concerns 
a particular type of goods which clearly has a direct effect on the health and life of 
humans. In the view of the referring court it is not clear whether or not the 
overriding need to protect the health and life of humans justifies the restrictive 
effect in the form of the automatic expiry of a parallel import licence on account 
of the expiry of the marketing authorisation for the reference product.