Opinion of the Advocate General — ECLI:EU:C:2025:815
Date: 2025-10-23
Language of the case: French

Summary C-118/24 – 1 
Case C-118/24 
Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged: 
14 February 2024 
Referring court: 
Conseil d’État (France) 
Date of the decision to refer: 
1 February 2024 
Applicants: 
EG Labo Laboratoires Eurogenerics SAS 
Theramex France SAS 
Defendants: 
Agence nationale de sécurité du médicament et des produits de 
santé (ANSM) 
Biogaran SAS 
  
1. Subject of the case 
1 On 10 June 2003, the European Commission granted a marketing authorisation to 
Eli Lilly Nederland B.V. for the proprietary medicinal product Forstéo 20 
micrograms/80 microlitres, solution for injection in a pre-filled pen, a biological 
medicinal product indicated for the treatment of osteoporosis. 
2 On 31 January 2019, Biogaran filed an application for a marketing authorisation 
for the chemically synthesised proprietary medicinal product Teriparatide 
Biogaran 20 micrograms/80 microlitres, solution for injection in a pre-filled pen, 
under Article 10(1) of 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, designating Germany as the reference State under a 
decentralised procedure. 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-118/24 
 
2  
3 By a decision of 1 September 2020, the Director-General of the Agence nationale 
de sécurité du médicament et des produits de santé (National Agency for 
Medicines and Health Products Safety) granted a marketing authorisation for the 
proprietary medicinal product Tériparatide Biogaran and identified it as a generic 
of the proprietary medicinal product Forstéo, and then, by a decision of 
10 November 2020, created a generic group with Forstéo as reference medicinal 
product and Tériparatide Biogaran as generic medicinal product. 
4 EG Labo Laboratoires Eurogenerics and Theramex France market Movymia and 
Livogiva respectively, which are biosimilars of Forstéo, each with a marketing 
authorisation issued by the European Commission. 
5 These two laboratories are seeking the annulment of the abovementioned 
decisions of the Director-General of the National Agency for Medicines and 
Health Products Safety. EG Labo Laboratoires Eurogenerics is also seeking the 
annulment of two opinions by which the Comité économique des produits de santé 
(Economic Committee for Healthcare Products) set the manufacturer’s price and 
the public price of the proprietary medicinal product Tériparatide Biogaran and of 
the proprietary medicinal product Movymia. 
6 These requests for annulment have been referred to the Conseil d’État (Council of 
State). 
2. Provisions of Union law relied on 
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 
7 Article 8 stipulates that, outside the procedure for the granting of a marketing 
authorisation by the European Commission, applications for marketing 
authorisations must be submitted to the competent national authorities and must 
include the particulars and documents listed in that article and in Annex I to the 
directive, in particular the results of pharmaceutical and pre-clinical tests and 
clinical trials. 
8 Article 10 reads: 
‘1. By way of derogation from Article 8(3)(i), and without prejudice to the law 
relating to the protection of industrial and commercial property, the applicant 
shall not be required to provide the results of pre-clinical tests and of clinical 
trials if he can demonstrate that the medicinal product is a generic of a reference 
medicinal product which is or has been authorised under Article 6 for not less 
than eight years in a Member State or in the Community. 
… 
LABORATOIRES EUROGENERICS AND THERAMEX FRANCE 
 
3 
2. For the purposes of this Article: 
… 
(b) “generic medicinal product” shall mean a medicinal product which has the 
same qualitative and quantitative composition in active substances and the same 
pharmaceutical form as the reference medicinal product, and whose 
bioequivalence with the reference medicinal product has been demonstrated by 
appropriate bioavailability studies. … Bioavailability studies need not be required 
of the applicant if he can demonstrate that the generic medicinal product meets 
the relevant criteria as defined in the appropriate detailed guidelines. 
3. In cases where the medicinal product does not fall within the definition of a 
generic medicinal product as provided in paragraph 2(b) or where the 
bioequivalence cannot be demonstrated through bioavailability studies or in case 
of changes in the active substance(s), therapeutic indications, strength, 
pharmaceutical form or route of administration, vis-à-vis the reference medicinal 
product, the results of the appropriate pre-clinical tests or clinical trials shall be 
provided. 
4. Where a biological medicinal product which is similar to a reference biological 
product does not meet the conditions in the definition of generic medicinal 
products, owing to, in particular, differences relating to raw materials or 
differences in manufacturing processes of the biological medicinal product and 
the reference biological medicinal product, the results of appropriate pre-clinical 
tests or clinical trials relating to these conditions must be provided. … .’ 
9 Article 28 defines the decentralised marketing authorisation procedure for a 
medicinal product: 
‘1. With a view to the granting of a marketing authorisation for a medicinal 
product in more than one Member State, an applicant shall submit an application 
based on an identical dossier in these Member States. … 
The applicant shall request one Member State to act as ‘reference Member State’ 
and to prepare an assessment report on the medicinal product in accordance with 
paragraphs 2 or 3. 
… 
3. In cases where the medicinal product has not received a marketing 
authorisation at the time of application, the applicant shall request the reference 
Member State to prepare a draft assessment report, a draft summary of product 
characteristics and a draft of the labelling and package leaflet. The reference 
Member State shall prepare these draft documents within 120 days after receipt of 
a valid application and shall send them to the concerned Member States and to 
the applicant. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-118/24 
 
4  
4. Within 90 days of receipt of the documents referred to in paragraphs 2 and 3, 
the Member States concerned shall approve the assessment report, the summary 
of product characteristics and the labelling and package leaflet and shall inform 
the reference Member State accordingly. The reference Member State shall record 
the agreement of all parties, close the procedure and inform the applicant 
accordingly. 
5. Each Member State in which an application has been submitted in accordance 
with paragraph 1 shall adopt a decision in conformity with the approved 
assessment report, the summary of product characteristics and the labelling and 
package leaflet as approved, within 30 days after acknowledgement of the 
agreement. .’ 
10 Article 29 governs the procedure applicable in cases where, because of a potential 
serious risk to public health, a Member State is unable to approve the assessment 
report, the summary of product characteristics, the labelling and the package 
leaflet within the period laid down in Article 28(4). 
Regulation (EC) No 726/2004 of the European Parliament and of the Council 
of 31 March 2004 laying down Union procedures for the authorisation and 
supervision of medicinal products for human use and establishing a European 
Medicines Agency 
11 Article 3(3) states: 
‘A generic medicinal product of a reference medicinal product authorised by the 
Union may be authorised by the competent authorities of the Member States in 
accordance with Directive 2001/83/EC under the following conditions: 
(a) the application for authorisation is submitted in accordance with Article 10 of 
Directive 2001/83/EC; 
(b) the summary of the product characteristics is in all relevant respects 
consistent with that of the medicinal product authorised by the Union except for 
those parts of the summary of product characteristics referring to indications or 
dosage forms which were still covered by patent law at the time when the generic 
medicine was marketed; and 
… .’ 
LABORATOIRES EUROGENERICS AND THERAMEX FRANCE 
 
5 
3. Succinct presentation of the reasoning in the reference for a 
preliminary ruling 
Is a court in a Member State that is not the reference Member State entitled to 
verify that the decentralised marketing authorisation procedure has been 
conducted in compliance with Directive 2001/83/EC? 
12 The applicants are asking the Council of State to verify that the conditions laid 
down in Article 10(1) of Directive 2001/83/EC for access to the simplified 
marketing authorisation procedure applicable to generic medicinal products are 
met, and that the procedure followed in the present case does not create any risk to 
public health if the conditions laid down in that regard were not met. 
13 The National Agency for Medicines and Health Products Safety submits in its 
defence that neither it, when granting marketing authorisation in accordance with 
the assessment report, the summary of product characteristics and the labelling 
and package leaflet as approved in accordance with the procedure laid down in 
Article 28(4) of Directive 2001/83/EC, nor the national court, in the context of an 
action brought against that marketing authorisation, has the possibility of calling 
into question the results of the decentralised procedure, and any claim of a 
potential serious risk to public health must be made, before the agreement of all 
parties is recorded, within the period referred to in that article. 
14 The Court of Justice of the European Union ruled in its judgment of 14 March 
2018 in Astellas Pharma (C-557/16, EU:C:2018:181) that: 
‘Article 10 of Directive 2001/83, as amended by Directive 2012/26, read in 
conjunction with Article 47 of the Charter of Fundamental Rights of the European 
Union, must be interpreted as meaning that a court of a Member State involved in 
a decentralised procedure for marketing authorisations, hearing an action 
brought by the holder of the marketing authorisation for the reference medicinal 
product against the marketing-authorisation decision for a generic medicinal 
product in that Member State taken by its competent authority, has jurisdiction to 
review the determination of the point in time from which the data exclusivity 
period for the reference medicinal product starts to run. …’ 
15 In so doing, the Court accepted that the courts of a Member State involved in a 
decentralised marketing authorisation procedure may hear an action brought 
against the marketing authorisation granted as a result of that decentralised 
procedure, irrespective of the Member State of reference. 
16 However, in contrast to the Court’s Astellas Pharma judgment, in the present case 
the applicants, which are laboratories marketing medicinal products that are 
biosimilars of the reference medicinal product and not the holders of the 
marketing authorisation for that reference medicinal product, are asking the 
Council of State not to review the determination of the starting point for data 
exclusivity of the reference medicinal product, but to verify that the medicinal 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-118/24 
 
6  
product at issue does indeed fulfil the conditions laid down in Article 10(1) of 
Directive 2001/83/EC for being granted a marketing authorisation as a generic 
medicinal product, so that its placing on the market does not give rise to a risk to 
public health as a result of the procedure followed. 
17 The question arises whether a court of a Member State involved in a decentralised 
marketing authorisation procedure without being the reference Member State, 
seised of an action brought against the decision granting marketing authorisation 
in that Member State taken by the competent authority of that State, is competent 
to verify that the decentralised procedure was conducted in compliance with the 
provisions of Directive 2001/83/EC and that the placing of the medicinal product 
on the market does not present a potential serious risk to public health within the 
meaning of Article 29(1) of that directive. That is a serious question. 
Can a marketing authorisation for a chemical medicinal product be granted 
under the simplified procedure when the reference medicinal product is a 
biological medicinal product? 
18 The applicants submit that Article 10 of Directive 2001/83/EC provides for two 
mutually exclusive procedures. 
19 First, the option under Article 10(1) creates a simplified marketing authorisation 
procedure, exempting the applicant from the requirement to produce the results of 
pre-clinical tests and clinical trials for generic medicinal products, since both the 
reference medicinal product and the generic medicinal product must, in their view, 
be chemical medicinal products. 
20 Second, the option provided for in paragraph 4 of the same article creates another 
simplified marketing authorisation procedure for biosimilar medicinal products, 
exempting the applicant from having to produce the results of certain pre-clinical 
tests and clinical trials, since both the reference medicinal product and the similar 
medicinal product must in this case, in their view, be biological medicinal 
products. 
21 The applicants infer that the procedure laid down for generic medicinal products 
cannot be followed when the reference medicinal product is a biological medicinal 
product, the active substances being, moreover, in their view necessarily different 
depending on whether they are produced using a chemical process or a biological 
process, owing to the variability inherent in the production of an active principle 
by biological means. 
22 Conversely, the National Agency for Medicines and Health Products Safety and 
Biogaran contend that Article 10(1) of Directive 2001/83/EC does not require the 
reference medicinal product of a generic medicinal product to be a chemical 
medicinal product and that Article 10(4) of that directive, by providing for the 
eventuality that a biological medicinal product does not satisfy the conditions laid 
down for it to be classified as a generic medicinal product, implicitly provides for 
LABORATOIRES EUROGENERICS AND THERAMEX FRANCE 
 
7 
the opposite eventuality in which those conditions might be satisfied and the 
procedure under Article 10(1) could be followed even though the reference 
medicinal product is a biological medicinal product. 
23 The question is thus whether the provisions of Directive 2001/83/EC preclude a 
marketing authorisation from being granted to a chemical medicinal product in 
accordance with the simplified procedure laid down in Article 10(1) of that 
directive where the reference medicinal product is a biological medicinal product. 
That is a serious question. 
The remaining pleas 
24 The applicants also raise a plea alleging infringement of Article 3(3) of Regulation 
No 726/2004, which makes the authorisation of a generic medicinal product of a 
reference medicinal product authorised by the EU subject to the submission of an 
application in accordance with Article 10 of Directive 2001/83/EC and to the 
compliance of the summary of product characteristics with that of the medicinal 
product authorised by the Union ‘in all relevant respects’. 
25 They also raise a plea alleging infringement of Annex I to Regulation 
No 726/2004, which requires certain medicinal products to be authorised by the 
Union, thereby precluding their authorisation under the decentralised procedure. 
26 The fate of these pleas depends on the response given to the questions referred for 
a preliminary ruling, as that response is decisive for the resolution of the dispute. 
4. Questions referred for a preliminary ruling 
27 The Council of State refers the following questions for a preliminary ruling: 
1. Should Articles 28 and 29 of Directive 2001/83/EC of the European 
Parliament and of the Council of 6 November 2001 be interpreted as meaning that 
a court of a Member State involved in a decentralised marketing authorisation 
procedure without being the reference Member State, which has jurisdiction to 
hear an action brought against that decision granting marketing authorisation 
taken by the competent authority of that Member State in accordance with what 
the Court held in its judgment of 14 March 2018, Astellas Pharma (C-557/16), is 
competent, in such a case, to verify that the decentralised procedure was 
conducted in compliance with the provisions of Directive 2001/83/EC and that the 
placing of the medicinal product on the market does not present a potential serious 
risk to public health within the meaning of Article 29(1) of that directive? 
2. Should Article 10 of Directive 2001/83/EC of the European Parliament and 
of the Council of 6 November 2001 be interpreted as meaning that it precludes a 
marketing authorisation from being granted to a chemical medicinal product in 
accordance with the simplified procedure laid down in Article 10(1) of that 
directive where the reference medicinal product is a biological medicinal product?