–

EG Labo Laboratoires Eurogenerics SAS, by M. Sanchez, avocate,

–

Biogaran SAS, by S. Englebert, O. Lantres and C. Mereu, avocats,

–

Eli Lilly Nederland BV and Lilly France SAS, by L. Bénard and R. Lazerges, avocats,

–

the French Government, by P. Chansou, B. Fodda and B. Travard, acting as Agents,

–

the Estonian Government, by M. Kriisa, acting as Agent,

–

the Netherlands Government, by M.K. Bulterman and H.S. Gijzen, acting as Agents,

–

the European Commission, by E. Mathieu, A. Spina and C. Valero, acting as Agents,

1

This reference for a preliminary ruling concerns the interpretation of Articles 10, 28 and 29 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 (OJ 2001 L 311, p. 67), as amended by Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 (OJ 2007 L 324, p. 121, and corrigendum OJ 2009 L 87, p. 174) (‘Directive 2001/83’).

2

The request has been made in proceedings between EG Labo Laboratoires Eurogenerics SAS (‘Eurogenerics’) and Theramex France SAS (‘Theramex’), on the one hand, and the Agence nationale de sécurité du médicament et des produits de santé (National Agency for Medicines and Health Products Safety) and Biogaran SAS, on the other, concerning decisions granting Biogaran SAS a marketing authorisation (‘MA’) for the medicinal product Tériparatide Biogaran 20 micrograms/80 microlitres, solution for injection in a pre-filled pen (‘Tériparatide Biogaran’), and including it in the generic group of the reference medicinal product Forsteo 20 micrograms/80 microlitres, solution for injection in a pre-filled pen (‘Forsteo’).

3

Recitals 2, 3, 9, 10 and 15 of Directive 2001/83 read as follows:

…

…

4

Article 1(2) of that directive provides:

‘For the purposes of this Directive, the following terms shall bear the following meanings:

5

Article 6(1) of that directive provides:

‘No medicinal product may be placed on the market of a Member State unless [an MA] 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 (EC) No 726/2004 [of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1)], read in conjunction with Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use [and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83 and Regulation No 726/2004 (OJ 2006 L 378, p. 1)] and Regulation No 1394/2007 [of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83 and Regulation No 726/2004 (OJ 2007 L 324, p. 121)].

…’

6

Under Article 8(3) of Directive 2001/83:

‘The application shall be accompanied by the following particulars and documents, submitted in accordance with Annex I:

…

…’

7

Article 10(1) to (4) of Directive 2001/83 provides:

‘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.

A generic medicinal product authorised pursuant to this provision shall not be placed on the market until [10] years have elapsed from the initial authorisation of the reference product.

The first subparagraph shall also apply if the reference medicinal product was not authorised in the Member State in which the application for the generic medicinal product is submitted. In this case, the applicant shall indicate in the application form the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is submitted, the competent authority of the other Member State shall transmit within a period of one month, a confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference product and if necessary other relevant documentation.

The ten-year period referred to in the second subparagraph shall be extended to a maximum of [11] years if, during the first [8] years of those [10] years, the [MA] holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies.

2.   For the purposes of this Article:

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. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in Annex I and the related detailed guidelines. The results of other tests and trials from the reference medicinal product's dossier shall not be provided.’

8

Under Article 28 of that directive:

‘1.   With a view to the granting of [an MA] 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 dossier shall contain the information and documents referred to in Articles 8, 10, 10a, 10b, 10c and 11. The documents submitted shall include a list of Member States concerned by the application.

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.

2.   Where the medicinal product has already received [an MA] at the time of application, the concerned Member States shall recognise the [MA] granted by the reference Member State. To this end, the [MA] holder shall request the reference Member State either to prepare an assessment report on the medicinal product or, if necessary, to update any existing assessment report. The reference Member State shall prepare or update the assessment report within 90 days of receipt of a valid application. The assessment report together with the approved summary of product characteristics, labelling and package leaflet shall be sent to the concerned Member States and to the applicant.

3.   In cases where the medicinal product has not received [an MA] 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.

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.’

9

Article 29(1) of that directive provides:

‘If, within the period laid down in Article 28(4), a Member State cannot approve the assessment report, the summary of product characteristics, the labelling and the package leaflet on the grounds of potential serious risk to public health, it shall give a detailed exposition of the reasons for its position to the reference Member State, to the other Member States concerned and to the applicant. The points of disagreement shall be forthwith referred to the coordination group.’

10

Part I of Annex I to that directive, entitled ‘Standardised [MA] dossier requirements’, provides details of the content of the standardised dossier for an MA application. That dossier is composed of five modules. Module 3 of that dossier is the subject of point 3 of Part I and concerns specifically chemical, pharmaceutical and biological information for medicinal products containing chemical and/or biological active substances. Point 3.2.1.1(b) of Part I sets out a definition of a biological medicinal product. It is worded as follows:

‘…

A biological medicinal product is a product, the active substance of which is a biological substance. A biological substance is a substance that is produced by or extracted from a biological source and that needs for its characterisation and the determination of its quality a combination of physico-chemical-biological testing, together with the production process and its control. The following shall be considered as biological medicinal products: immunological medicinal products and medicinal products derived from human blood and human plasma as defined, respectively in paragraphs (4) and (10) of Article 1; …

…’

11

Part II of that annex, entitled ‘Specific [MA] dossiers and requirements’ provides a derogation for ‘specific applications’, that is to say well-established medicinal use, essentially similar products, fixed combinations, similar biological products, exceptional circumstances and mixed applications (part bibliographic and part own studies). Points 2 and 4 of Part II are worded as follows:

‘2. Essentially similar medicinal products

…

4. Similar biological medicinal products

The provisions of Article 10(1) … may not be sufficient in the case of biological medicinal products. If the information required in the case of essentially similar products (generics) does not permit the demonstration of the similar nature of two biological medicinal products, additional data, in particular, the toxicological and clinical profile shall be provided.

…’

12

Article 3(3) of Regulation No 726/2004, as amended by Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018 (OJ 2019 L 4, p. 24) (‘Regulation No 726/2004’), provides:

‘A generic medicinal product of a reference medicinal product authorised by the [European] Union may be authorised by the competent authorities of the Member States in accordance with [Directive 2001/83] under the following conditions:

13

Annex I to that regulation, entitled ‘Medicinal products to be authorised by the Union’, states, in point 3 thereof:

‘Medicinal products for human use containing a new active substance which, on the date of entry into force of this Regulation, was not authorised in the Union, for which the therapeutic indication is the treatment of any of the following diseases:

[and with effect from 20 May 2008]

…’

14

The third paragraph of Article L. 5121-10 of the code de la santé publique (Public Health Code) provides:

‘The Director-General of [ANSM] shall enter the generic medicinal product in the register of generic groups after a period of 60 days has elapsed, after informing the holder of the [MA] for the generic medicinal product that the [MA] for that generic medicinal product has been granted. However, that generic medicinal product may be marketed only after the expiry of the intellectual property rights, unless the holder of those rights agrees.’

15

Under the first paragraph of Article R. 5121-5 of the Public Health Code:

‘With a view to their listing in the register of the generic groups referred to in Article L. 5121-10, generic medicinal products shall be identified by a decision of the [ANSM] mentioning the corresponding reference medicinal product. …’

16

On 10 June 2003, the European Commission granted an MA to Eli Lilly Nederland BV for Forsteo, a biological medicinal product indicated for the treatment of osteoporosis.

17

It is apparent from the documents before the Court that Forsteo is a medicinal product used in the treatment of confirmed post-menopausal osteoporosis, by stimulating the formation of bones and increasing the absorption of calcium. Its formulation is based on teriparatide, an active substance close to the human parathyroid hormone which plays a role in bone metabolism. The teriparatide used in Forsteo is produced from a biological source (in a non-pathogenic bacterial strain (E.coli)) processed using recombinant DNA technology. Forsteo takes the form of a solution for injection, in a pre-filled pen. A pre-filled pen of 3 millilitres contains 750 micrograms of teriparatide. The pre-filled pen contains the quantity of product required for 28 days of treatment. Each dose contains 20 micrograms (per 80 microlitres) of teriparatide.

18

By decisions of 11 January 2017 and 27 August 2020, the Commission granted an MA to Eurogenerics and Theramex for two biosimilars of Forsteo, namely Movymia and Livogiva, respectively. Like Forsteo, those two medicinal products contain teriparatide, as an active substance, produced from a biological source.

19

On 31 January 2019, Biogaran filed an application for an MA for a generic medicinal product of Forsteo, namely Tériparatide Biogaran, on the basis of Article 10(1) of Directive 2001/83. Like Forsteo, Tériparatide Biogaran is made from teriparatide and presented in the form of an injectable solution, in doses of 20 micrograms/80 microlitres, in a pre-filled pen. However, unlike Forsteo, Movymia and Livogiva, the teriparatide used in Tériparatide Biogaran is the result of a solid-phase peptide synthesis. That application for an MA was subject to a decentralised procedure, pursuant to Article 28 of that directive (‘the decentralised procedure’). In that decentralised procedure, Biogaran designated the Federal Republic of Germany as the reference Member State, and the French Republic as one of the Member States concerned. That decentralised procedure was closed on 11 August 2020, by an agreement on the assessment report, the summary of the product characteristics of the product concerned, the labelling and the package leaflet, prepared by the Federal Republic of Germany.

20

Following that agreement, the Director-General of ANSM granted, by decision of 1 September 2020, an MA for Tériparatide Biogaran and identified it as a generic medicinal product of Forsteo. Subsequently, by decision of 10 November 2020, it created a generic group whose reference medicinal product is Forsteo and whose generic medicinal product is Tériparatide Biogaran.

21

By two applications sent on 23 March 2022 to the Conseil d’État (Council of State, France), which is the referring court, Eurogenerics and Theramex, which market Movymia and Livogiva, respectively, seek annulment, on ultra vires grounds, first, of the decisions of the Director-General of ANSM of 1 September and 10 November 2020 and, second, of the implied decisions by which that director-general dismissed their administrative appeals against the first decisions.

22

They claim that the conditions for eligibility for the abridged procedure for the grant of an MA for a generic medicinal product, laid down in Article 10(1) of Directive 2001/83, have not been satisfied. They also ask the Conseil d’État (Council of State) to check whether, in the present case, the use of that procedure has led to a risk to public health.

23

ANSM submits that, in the context of the grant of an MA under the decentralised procedure, neither a national court nor itself can call into question the results of that procedure conducted pursuant to Article 28(4) of Directive 2001/83. Reference to a serious risk to public health should be made in the context of that procedure, before the acknowledgement of the general agreement on the assessment report, the summary of the product characteristics of the product concerned, the labelling and the package leaflet.

24

The referring court expresses doubts as to whether it has jurisdiction to carry out the review requested by the applicants in the main proceedings. According to that court, in the judgment of 14 March 2018, Astellas Pharma (C‑557/16, EU:C:2018:181; ‘the judgment in Astellas Pharma’), the Court of Justice accepted that a court of a Member State concerned by a decentralised MA procedure may hear an action brought against the MA granted following that decentralised procedure, irrespective of which Member State is the reference Member State. However, it asks whether that case-law is applicable in the present case, given that the applicant in the main proceedings in the case which gave rise to the judgment in Astellas Pharma was the holder of the MA for the reference medicinal product, whereas, in the present case, the applicants in the main proceedings are companies which market biological medicinal products similar to the reference medicinal product.

25

In addition, the referring court notes that the applicants in the main proceedings are not asking it to review the determination of the point in time from which the data exclusivity period starts to run, which was the subject of the judgment in Astellas Pharma, but to verify whether the decentralised procedure concerned was conducted in compliance with the provisions of Directive 2001/83 and that the placing on the market of Tériparatide Biogaran does not present a potential serious risk to public health, within the meaning of Article 29(1) of that directive.

26

Furthermore, the referring court raises the question of the validity of the MA for Tériparatide Biogaran. That MA was issued under the abridged procedure for the grant of an MA reserved for generic medicinal products. It asks whether such a procedure is applicable to a medicinal product deriving from a chemical synthesis where the medicinal product designated as the reference medicinal product is a biological medicinal product.

27

According to that court, in order to answer that question, it is necessary first to ascertain whether the MA was granted for Tériparatide Biogaran in infringement of Article 3(3)(a) and (b) of Regulation No 726/2004, which provides that a generic medicinal product of a reference medicinal product authorised by the European Union may be authorised where the application for authorisation is submitted in accordance with Article 10 of Directive 2001/83 and where the summary of the product characteristics is in all relevant respects consistent with that of the medicinal product authorised by the European Union.

28

If that were the case, the question then arises as to whether Tériparatide Biogaran should have been the subject of an EU MA, under Annex I to Regulation No 726/2004, since its active substance must be regarded as new.

29

In those circumstances, the Council of State decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

30

As a preliminary point, it is necessary to clarify whether a holder of an MA for a biosimilar of a biological medicinal product, which served as reference medicinal product for the purpose of obtaining an MA for a generic medicinal product, has a right to a judicial remedy against the decision to grant that MA, which was made following a decentralised procedure, provided for in Article 28(3) of Directive 2001/83.

31

Article 28 provides for a decentralised MA procedure for a medicinal product which has not yet received an MA in one of the Member States at the date of the relevant application, and which does not fall within the scope of Regulation No 726/2004. In that procedure, the applicant for the MA in question chooses one of the Member States in which he intends to obtain an MA, so that it may act as the reference Member State. That Member State then prepares a draft assessment report, a draft summary of the product characteristics of the product concerned and a draft of the labelling and package leaflet which it sends to that applicant and to the other Member States concerned.

32

Next, in accordance with Article 28(4) of Directive 2001/83, a co-decision phase, during which the Member States concerned approve those drafts and inform the reference Member State thereof, starts. That reference Member State records, where appropriate, the general agreement, closes the procedure and informs the applicant accordingly. It is then for each Member State concerned to adopt a decision granting an MA. However, if one of them cannot approve those projects on grounds of a potential serious risk to public health, the specific procedure provided for in Article 29 of Directive 2001/83 is triggered.

33

The Court has already provided some clarification concerning the right to a judicial remedy against a national MA, granted following such a decentralised procedure.

34

Thus, in paragraph 34 of the judgment of 23 October 2014, Olainfarm (C‑104/13, EU:C:2014:2316), the Court held that, in the context of Directive 2001/83, the procedure for the granting of an MA is conceived as a bilateral procedure, involving only the applicant and the competent authority, and that that directive does not contain any express provision to the effect that a judicial remedy is available to the holder of an MA granted for an original medicinal product to challenge the decision of the competent authority which granted, pursuant to Article 10 of the directive, an MA for a generic medicinal product for which the original medicinal product served as the reference product.

35

However, the Court has inferred from Article 47 of the Charter of Fundamental Rights of the European Union that such a holder does indeed have such a right to a judicial remedy because he enjoys a temporary right to the protection of his clinical data. In order to guarantee that protection, that holder must necessarily have the right to demand that the rights attaching to him by virtue of the conditions set out in Article 10 of Directive 2001/83 are observed (see, to that effect, judgments of 23 October 2014, Olainfarm, C‑104/13, EU:C:2014:2316, paragraphs 35 to 40, and judgment in Astellas Pharma, paragraphs 34 to 36).

36

In the present case, it is apparent from the documents before the Court that the applicants in the main proceedings do not hold the MA for the reference medicinal product, but merely two MAs for medicinal products which are biosimilars of that reference medicinal product. Such holders cannot rely on the rights provided for in Article 10 of Directive 2001/83, because they do not enjoy the protection afforded to clinical data which may be relied on against an applicant for an MA for a generic medicinal product which is based on that reference medicinal product.

37

That being so, access to the courts of a Member State concerned in order to bring an action against an MA, in circumstances such as those at issue in the main proceedings, cannot be limited solely to situations in which there is a right derived from Directive 2001/83. Even in the absence of such a right, and in so far as that directive does not lay down rules relating to the right to a judicial remedy, there is nothing to prevent, in the exercise of its discretion, such a Member State concerned from granting the holders of an MA for a biosimilar of a reference medicinal product access to its courts in order to challenge an MA issued under a decentralised procedure involving the same reference medicinal product.

38

It follows that Directive 2001/83 does not preclude a holder of an MA of a biosimilar of a biological medicinal product, which served as reference medicinal product for the purpose of obtaining a national MA for a generic medicinal product, from having, under the national law of a Member State concerned, within the meaning of Article 28 of that directive, a right to a judicial remedy against the decision to grant the latter national MA, adopted following a decentralised procedure, provided for in Article 28(3) of that directive.

39

According to settled case-law, in the procedure laid down by Article 267 TFEU providing for cooperation between national courts and the Court of Justice, it is for the latter to provide the national court with an answer which will be of use to it and enable it to determine the case before it. To that end, the Court should, where necessary, reformulate the questions referred to it. It is for the Court to extract from all the information provided by the national court, in particular from the grounds of the order for reference, the points of EU law which require interpretation, having regard to the subject matter of the dispute (see judgments of 29 November 1978, Redmond, 83/78, EU:C:1978:214; paragraph 26; of 28 November 2000, Roquette Frères, C‑88/99, EU:C:2000:652, paragraph 18; and of 2 December 2025, Russmedia Digital and Inform Media Press, C‑492/23, EU:C:2025:935, paragraph 44 and the case-law cited).

40

In the present case, as the Advocate General observed in point 69 of his Opinion, the referring court is seised of a dispute in which the applicants in the main proceedings ask it to ascertain whether the conditions – laid down in Article 10(1) of Directive 2001/83 – to be able to rely on the abridged procedure for the grant of an MA, applicable to generic medicinal products, have been satisfied. More specifically, that court’s questions focus on the condition relating to the concept of ‘generic medicinal product’, within the meaning of Article 10(2)(b) of that directive, where the reference medicinal product is a biological medicinal product.

41

Accordingly, it must be held that, by its first question, the referring court asks, in essence, whether Directive 2001/83 must be interpreted as precluding, in an action brought by the holder of an MA for a biosimilar of a biological medicinal product, against a decision to grant an MA for a generic medicinal product of that biological medicinal product, adopted following a decentralised MA procedure, a court of a Member State concerned from having jurisdiction to review whether the medicinal product the marketing of which has been authorised by that decision may be classified as a ‘generic medicinal product’, within the meaning of Article 10(2)(b) of that directive.

42

In that regard, and further to what has been stated in paragraph 37 of the present judgment, Directive 2001/83 does not govern the judicial review of national MAs granted following a decentralised procedure provided for in Articles 28 and 29 of that directive. It follows that, like the very existence of such a review, the scope of that review falls within the discretion of each of the Member States concerned and that of the reference Member State.

43

In the absence of EU rules on the matter, it is for the Member States to establish, by virtue of their discretion, the detailed procedural rules governing that review.

44

From that point of view, the national law of a Member State concerned may, in principle, provide that the national courts have, in a decentralised MA procedure for a medicinal product, jurisdiction to review the classification of the medicinal product concerned as a ‘generic medicinal product’, within the meaning of Article 10(2)(b) of that directive and, in the event of an incorrect classification, to annul the national MA granted following that procedure. By contrast, such an annulment cannot affect the validity of either the other national MAs issued following such a decentralised procedure in the other Member States concerned or that granted in the reference Member State.

45

However, it is for the referring court to ascertain whether, in the context of the exercise of the discretion of its Member State, the procedural provisions governing the action brought by the holder of an MA for a biosimilar of a biological medicinal product against a decision to grant an MA for a generic medicinal product following a decentralised MA procedure are consistent with the obligation for that Member State to take all the measures necessary to ensure that the directive concerned is fully effective, in accordance with the objective which it pursues.

46

In that regard, in the first place, recital 2 of Directive 2001/83 states that ‘the essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health’, in accordance with the first subparagraph of Article 168(1) TFEU, according to which a high level of human health protection is to be ensured in the definition and implementation of all EU policies and activities.

47

As the Advocate General stated in points 81 and 82 of his Opinion, judicial review which extends to the classification of the medicinal product concerned as a ‘generic medicinal product’, within the meaning of Article 10(2)(b) of Directive 2001/83, contributes to the attainment of that objective.

48

Reliance on the abridged procedure for the grant of an MA, restricted to, according to Article 10, generic medicinal products, relieves the applicant for such an authorisation from providing the results of the pre-clinical tests or clinical trials. That is explained by the fact that a generic medicinal product, defined in Article 10(2)(b), must have the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and be bioequivalent, which must have been demonstrated by appropriate bioavailability studies. It is only under those conditions that the results of the pre-clinical tests and clinical trials of a reference medicinal product, which concern, inter alia, its safety, also apply to a generic medicinal product of that reference medicinal product.

49

Should it have been wrongly found that the medicinal product concerned is a generic medicinal product of the reference medicinal product, that would result in a situation in which a medicinal product will be placed on the market without valid pre-clinical tests and clinical trials, which would amount to a confirmed risk to the health of patients to whom the latter medicinal product is administered.

50

Consequently, the possibility for the courts of a Member State concerned to review the classification of a medicinal product as a ‘generic medicinal product’ contributes to the attainment of the objective of safeguarding public health.

51

In the second place, it follows from recital 3 of Directive 2001/83 that that objective must be reconciled with the need to limit barriers to trade in medicinal products within the European Union. However, it cannot be ruled out that an extended jurisdiction of the national courts in proceedings concerning MAs granted following a decentralised procedure may give rise to inconsistent decisions in the different Member States concerned.

52

Some national MAs may indeed be annulled, while others may be maintained. That being so, that risk is, as the Advocate General observed in point 76 of his Opinion, the necessary corollary of the system of the decentralised MA procedure as currently provided for in Articles 28 and 29 of Directive 2001/83, in which each Member State concerned is competent to issue a national MA. Such a risk cannot therefore serve as an argument to limit the procedural autonomy of the Member States.

53

In the light of the foregoing considerations, the answer to the first question is that Directive 2001/83 must be interpreted as meaning that the Member States are free to provide that, in an action brought by the holder of an MA for a biosimilar of a biological medicinal product against a decision to grant an MA for a generic medicinal product of that biological medicinal product, adopted following a decentralised MA procedure, a court of a Member State concerned has jurisdiction to review whether the medicinal product the marketing of which has been authorised by that decision may be classified as a ‘generic medicinal product’, within the meaning of Article 10(2)(b) of that directive.

54

By its second question, the referring court asks, in essence, whether Article 10 of Directive 2001/83 must be interpreted as precluding an MA from being granted, following an abridged procedure provided for in Article 10(1), for a medicinal product deriving from chemical synthesis, where the reference medicinal product is a biological medicinal product.

55

In that regard, it should be borne in mind that, in accordance with Article 6 of Directive 2001/83, no medicinal product can, in principle, be placed on the market of a Member State unless an MA has been issued, whether in accordance with that directive or Regulation No 726/2004.

56

Article 8 of that directive lists all the documents and data which the applicant for an MA must provide to the competent authority in order for that authority to be able to examine whether the conditions for the issue of the MA concerned are satisfied. Those documents include, under Article 8(3)(i) of that directive, the results of the pharmaceutical and pre-clinical tests and of clinical trials which make it possible, inter alia, to test the safety and efficacy of the medicinal product concerned.

57

By way of derogation from that provision, it follows from Article 10(1) of Directive 2001/83 that an applicant for an MA is not required to provide the results of pre-clinical tests and clinical trials if he can demonstrate that the medicinal product which is the subject of his application for an MA is a generic of a reference medicinal product. As is apparent from paragraph 48 of the present judgment, Article 10(2)(b) of that directive provides that a generic medicinal product is 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 latter medicinal product has been demonstrated by appropriate bioavailability studies. That derogation is known as the ‘abridged procedure’.

58

In such an abridged procedure, it is necessary to determine whether the applicant for an MA for a medicinal product produced by chemical synthesis can designate as reference medicinal product a biological medicinal product, as defined in point 3.2.1.1(b) of Part I of Annex I to Directive 2001/83, namely a medicinal product the active substance of which is a biological substance, defined as a substance which is produced by or extracted from a biological source and that needs for its characterisation and the determination of its quality a combination of physico-chemical-biological testing, together with the production process and its control.

59

In order to answer the referring court’s questions, it is necessary to determine whether a biological medicinal product may serve as reference medicinal product in the context of an abridged procedure for the grant of an MA. If that is the case, it will be necessary to specify whether such a biological medicinal product may serve as reference medicinal product where the medicinal product which is the subject of the MA application concerned is a medicinal product deriving from a chemical synthesis.

60

As regards, in the first place, the scope of the concept of ‘reference medicinal product’ within the meaning of Article 10(1) of Directive 2001/83, it must be observed that that provision does not distinguish between a medicinal product deriving from a chemical synthesis and a biological medicinal product. That provision cannot therefore be read as precluding a biological medicinal product from being designated as reference medicinal product under the abridged procedure laid down in that provision.

61

That reading is borne out by Article 10(4) of that directive. That provision states that, where a biological medicinal product, which is similar to a reference biological medicinal product, does not meet the conditions in the definition of the concept of ‘generic medicinal product’, within the meaning of Article 10(2)(b) of that directive, owing to, in particular, differences relating to raw materials or differences in manufacturing processes, the results of appropriate pre-clinical tests or clinical trials relating to those conditions must be provided and, consequently, the abridged procedure provided for in Article 10(1) cannot be initiated.

62

By referring to the specific situation in which the reference medicinal product is a biological medicinal product, Article 10(4) clearly demonstrates that such a medicinal product may be designated as a reference medicinal product in the context of an application for an MA for a generic medicinal product. That provision states that it is only where the medicinal product which is the subject of an MA application is a biological medicinal product and cannot be classified as a ‘generic medicinal product’, within the meaning of Article 10(2)(b) of Directive 2001/83, that the abridged procedure for the grant of an MA cannot be initiated and that the results of pre-clinical tests and clinical trials must be provided.

63

It follows that a biological medicinal product may serve as reference medicinal product under the abridged procedure provided for in Article 10(1) of Directive 2001/83.

64

As regards, in the second place, the question whether such a biological medicinal product may serve as reference medicinal product in the context of an MA application for a medicinal product deriving from a chemical synthesis, reference should be made to the scope of the concept of ‘generic medicinal product’, defined in Article 10(2)(b) of Directive 2001/83.

65

According to that definition, a medicinal product may be classified as a ‘generic medicinal product’ of a reference medicinal product if it satisfies three cumulative conditions. First, it must have the same qualitative and quantitative composition in active substances as that reference medicinal product. Second, it must have the same pharmaceutical form. Third, its bioequivalence with the reference medicinal product must be demonstrated by appropriate bioavailability studies.

66

As the Advocate General observed, in essence, in points 103 to 118 of his Opinion, those conditions are worded in sufficiently general terms so as not to preclude an application for an MA for a medicinal product deriving from a chemical synthesis, whose reference medicinal product is a biological medicinal product, from being made under the abridged procedure for the grant of an MA provided for in Article 10(1) of Directive 2001/83.

67

In that connection, it must also be stated, as regards, in particular, the condition relating to the qualitative and quantitative composition of active substances, that that condition does not require an exact molecular match. In accordance with what the Advocate General stated in points 114 to 118 of his Opinion, it is apparent from Article 10(2)(b) of Directive 2001/83 that it is only where the active substances of the reference medicinal product and those of the medicinal product in respect of which the MA has been applied for have significantly different properties as regards safety or efficacy that additional information may be requested by the health authorities.

68

Moreover, it is primarily for the health authorities of the reference Member State which have received an application for an MA submitted in an abridged procedure for the grant of an MA provided for in Article 10(1) of Directive 2001/83 to ascertain, on a case-by-case basis, whether the three cumulative conditions referred to in paragraph 65 of the present judgment are actually satisfied and whether, where necessary, the manufacturing process concerned is relevant for assessing compliance with those conditions.

69

In the light of the foregoing, the answer to the second question is that Article 10 of Directive 2001/83 must be interpreted as meaning that it does not preclude an MA from being granted, following an abridged procedure provided for in Article 10(1) for a medicinal product deriving from a chemical synthesis, where the reference medicinal product is a biological medicinal product, provided that the conditions set out in Article 10(2)(b) are met.

70

Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.

On those grounds, the Court (Second Chamber) hereby rules: