Judgment of the General Court (Sixth Chamber) 15 July 2026

JUDGMENT OF THE GENERAL COURT (Sixth Chamber)

15 July 2026 ( * )

( Access to documents – Regulation (EC) No 1049/2001 – Document from a scientific advice procedure for the medicinal product ferric carboxymaltose – Decision to grant a third party partial access to the document – Exception relating to the protection of commercial interests )

In Case T‑666/24,

Teva Pharma BV, established in Haarlem (Netherlands), represented by C. Lindenthal and A. Säurig, lawyers,

applicant,

v

European Medicines Agency (EMA), represented by G. Gavriilidou, G. Ramo and H. Kerr, acting as Agents,

defendant,

THE GENERAL COURT (Sixth Chamber),

composed of P. Škvařilová-Pelzl (Rapporteur), President, D. Kukovec and R. Pezzuto, Judges,

Registrar: A. Marghelis, Administrator,

having regard to the order of 27 March 2025, Teva Pharma v EMA (T-666/24 R, not published, EU:T:2025:343),

having regard to the written part of the procedure,

following the hearing on 26 February 2026,

gives the following

Judgment

1 By its action under Article 263 TFEU, the applicant, Teva Pharma BV, seeks annulment of Decision EMA/391476/2024 Rev. 1 of the European Medicines Agency (EMA) of 28 October 2024 granting a third party, under Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43), access to a document from a scientific advice procedure for the medicinal product ferric carboxymaltose, subject to certain redactions (‘the contested decision’).

Background to the dispute

2 The applicant is a pharmaceutical company established in the Netherlands.

3 On 17 January 2020, the applicant requested scientific advice for the medicinal product ferric carboxymaltose (‘the medicinal product at issue’), a generic version of the medicinal product Ferinject (‘the reference product’), which is indicated for the treatment of iron deficiencies, pursuant to Article 57(1)(n) of 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).

4 On 26 March 2020, the EMA’s Committee for Medicinal Products for Human Use (‘the CHMP’) rendered its scientific advice on the medicinal product at issue (‘the scientific advice’).

5 On 22 August 2024, the EMA informed the applicant that it had received a request pursuant to Regulation No 1049/2001, seeking access to, inter alia, the document ‘Ferric carboxymaltose_FAL_4401-1-2020’ produced as part of a first batch of documents relating to the scientific advice (‘the document requested’) and asked the applicant to identify any information the disclosure of which it objected to, in accordance with Article 4(4) of that regulation.

6 On 29 August 2024, the applicant informed the EMA that it objected to the disclosure of some commercially confidential information contained in the requested document.

7 On 19 September 2024, the EMA notified the applicant of its decision to disclose a redacted version of the requested document, but refused some of the redactions proposed by the applicant.

8 On 9 October 2024, the applicant informed the EMA that it accepted the EMA’s rejection of some of its proposed redactions, but disagreed with its decision to reject a number of other proposed redactions.

9 On 28 October 2024, the EMA adopted the contested decision, granting access to the requested document in a redacted form while upholding its position regarding the rejection of certain redactions requested by the applicant.

10 On 29 October 2024, the applicant informed the EMA of its intention to bring an action before the General Court on the basis of Article 263 TFEU and an application for interim measures under Articles 278 and 279 TFEU against the contested decision in so far as the EMA was disclosing commercially confidential information contained in the document requested. It therefore requested the EMA to refrain from disclosing the document requested without having made the redactions requested by its letter of 9 October 2024, until a decision had been given on the application for interim measures.

11 On 18 December 2024, the EMA informed the applicant of some additional considerations as regards the contested decision and undertook not to disclose the document requested if the applicant notified the EMA of its intention to bring an action for annulment of that decision before the Court prior to 3 January 2025, and expressly stated that it would not be necessary to submit an application for interim measures in order to obtain suspension of the operation of that decision.

Procedure and forms of order sought

12 On 28 December 2024, the applicant brought the present action. By a separate document of the same date, it brought an application for interim measures pursuant to Article 278 TFEU, for the suspension of operation of the contested decision.

13 By order of 27 March 2025, Teva Pharma v EMA (T‑666/24 R, not published, EU:T:2025:343), the President of the General Court dismissed the application for interim measures in so far as the EMA had again undertaken before the Court to suspend the operation of the contested decision pending the Court’s decision on the present action for annulment.

14 The applicant claims that the Court should:

– annul the contested decision;

– prohibit the EMA from disclosing the document without the redactions proposed in Annex 18 to the application;

– order the EMA to pay the costs.

15 The EMA contends that the Court should:

– dismiss the action as inadmissible in so far as it concerns the second head of claim;

– in any event, dismiss the action as unfounded;

– order the applicant to pay the costs.

Law

Admissibility of the applicant’s second head of claim

16 The EMA considers that the applicant’s second head of claim amounts to an application to the Court to issue directions to the EMA, which does not fall with the Court’s jurisdiction.

17 In the present case, it must be held that the second head of claim seeks, in essence, that the Court order the EMA not to disclose the requested document without the redactions requested by the applicant.

18 In that regard, it is sufficient to note that, according to settled case-law, in an action for annulment, the jurisdiction of the Courts of the European Union is limited to reviewing the legality of the contested measure and the Court may not, in the exercise of its jurisdiction, issue directions to EU institutions. It is for the institution concerned to adopt, under Article 266 TFEU, the measures necessary to implement a judgment given in proceedings for annulment (see judgment of 5 February 2018, Pari Pharma v EMA , T‑235/15, EU:T:2018:65, paragraph 31 and the case-law cited).

19 It follows that the applicant’s second head of claim must be rejected on the ground of lack of jurisdiction.

Offer of further evidence submitted by the applicant

20 By letter lodged at the Registry of the General Court on 10 November 2025, the applicant submitted an offer of further evidence pursuant to Article 85(3) of the Rules of Procedure of the General Court.

21 In its observations lodged at the Court Registry on 28 November 2025, the EMA contends that that offer of further evidence must be rejected as ineffective since it concerns facts which occurred after the adoption of the contested decision.

22 It is settled case-law that the legality of an EU measure is assessed on the basis of the elements of fact and of law existing at the time when the measure was adopted (judgments of 7 February 1979, France v Commission , 15/76 and 16/76, EU:C:1979:29, paragraphs 7 and 8, and of 12 December 1996, Altmann and Others v Commission , T‑177/94 and T‑377/94, EU:T:1996:193, paragraph 119). It follows that elements post-dating the adoption of the contested measure cannot be taken into account in assessing the legality of that measure (see, to that effect, judgment of 27 September 2006, Roquette Frères v Commission , T‑322/01, EU:T:2006:267, paragraph 325).

23 In that regard, it should be noted that the offer of further evidence submitted by the applicant comprises the minutes of a meeting of the Coordination Group for Mutual Recognition and Decentralised Procedures for Medicinal Products for Human Use held from 16 to 18 September 2025. It follows that it relates to factual elements post-dating the contested decision, and so cannot be taken into account for the purpose of assessing the legality of that decision, in accordance with the case-law referred to in paragraph 22 above.

24 Accordingly, without it being necessary to rule on the admissibility of the offer of further evidence, it must be rejected since it has no effect on the examination of the legality of the contested decision.

Subject of the action

25 The EMA contends that it was the letter of 18 December 2024 that finalised vis-à-vis the applicant the procedure for the handling of the request for access to the requested document, and not the contested decision, with the result that the decision which is the subject of the present action should rather be regarded as being that contained in the letter of 18 December 2024. Indeed, the letter of 18 December 2024 expressly states that the considerations contained therein ‘complement the revised decision letter of 28 October 2024’, with the result that the EMA replaced, de facto, the contested decision and its statement of reasons by the letter of 18 December 2024, which incorporates the statement of reasons contained in that decision.

26 The applicant disputes the EMA’s arguments and submits that it is indeed the contested decision which must be the subject of the present action. First, the contested decision constitutes a full official decision, since it contains the final decision to disclose the requested document and a note on the available legal remedies against that official decision. Secondly, it is clear from the wording of the letter of 18 December 2024 that it merely complements the contested decision. Thirdly, the contested decision is labelled as a revised version of the initial decision to disclose the requested document of 19 September 2024, whereas the letter of 18 December 2024 was issued under a new reference number.

27 According to settled case-law, actions for annulment under Article 263 TFEU are available in the case of all measures adopted by the institutions, whatever their nature or form, which are intended to have binding legal effects (see judgment of 26 March 2019, Commission v Italy , C‑621/16 P, EU:C:2019:251, paragraph 44 and the case-law cited).

28 In order to determine whether a measure produces such effects, the substance of that measure must be examined (judgments of 11 November 1981, IBM v Commission , 60/81, EU:C:1981:264, paragraph 9; of 22 June 2000, Netherlands v Commission , C‑147/96, EU:C:2000:335, paragraph 27; and of 18 November 2010, NDSHT v Commission , C‑322/09 P, EU:C:2010:701, paragraph 46). In that regard, it is in principle those measures which definitively determine the position of the institution upon the conclusion of an administrative procedure, and which are intended to have legal effects capable of affecting the interests of the applicant, which are open to challenge and not intermediate measures whose purpose is to prepare for the definitive decision, or measures which are mere confirmation of an earlier measure (see, to that effect, judgments of 26 January 2010, Internationaler Hilfsfonds v Commission , C‑362/08 P, EU:C:2010:40, paragraph 52 and the case-law cited, and of 26 March 2019, Commission v Italy , C‑621/16 P, EU:C:2019:251, paragraph 45).

29 In that regard, it is clear from both the context and the content of the various exchanges between the applicant and the EMA that the contested decision definitively sets out the EMA’s position as regards consulting the applicant on the disclosure of the requested document.

30 First, the contested decision was adopted in response to the applicant’s letter of 9 October 2024, in which the applicant asked the EMA to reconsider its position as regards some of the proposed redactions relating to the quantitative composition of the excipients of the medicinal product at issue, to a statement regarding the medicinal product at issue and the reference product and to a statement concerning the biodistribution studies which the EMA had rejected in its initial decision of 19 September 2024 to disclose the requested document.

31 Secondly, in the contested decision, which contains the same reference number (‘EMA/391476/2024 Rev.1’) as that appearing in the initial decision letter of 19 September 2024 (‘EMA/391476/2024’) and which is entitled ‘Notification to [the applicant] of the [EMA’s] decision to disclose documents’, the EMA expressly stated that it had now finalised the assessment of the request for access to the requested document pursuant to Articles 4 and 7 of Regulation No 1049/2001, after carrying out an individual and specific assessment of the comments submitted by the applicant in its letter of 9 October 2024, to which it had replied in detail, and that it had decided, further to that assessment, not to change its position as regards the applicant’s proposed redactions. Lastly, it stated that it was no longer possible to submit any additional comments concerning the proposed redactions and that the applicant could bring an action based on Article 263 TFEU against the decision contained in the letter of 28 October 2024.

32 By contrast, in the letter of 18 December 2024, of which the reference number (‘EMA/543655/2024’) is different from that in the contested decision, and which is entitled ‘Reply to [the applicant’s] intention to challenge the [EMA’s] decision’, the EMA expressly states that it is the contested decision which constitutes a revised decision and that the clarifications set out in the letter of 18 December 2024 merely complement the considerations already set out in the letter of 28 October 2024.

33 Moreover, it must be borne in mind that, according to settled case-law, the reasoning for a measure must be provided to the person concerned by the measure before the latter brings an action against it, and non-compliance with the duty to state reasons cannot be regularised by the fact that the person concerned becomes cognisant thereof during proceedings before the EU judicature (see, to that effect and by analogy, judgment of 11 December 2012, Sina Bank v Council , T‑15/11, EU:T:2012:661, paragraph 56 and the case-law cited).

34 The requirement to state reasons must therefore be assessed in the light of the information which an applicant possessed at the time when proceedings were brought, it being understood, however, that the institution or agency is not permitted to replace the original statement of reasons by an entirely new statement (see, to that effect, judgments of 25 February 2003, Renco v Council , T‑4/01, EU:T:2003:37, paragraph 96; of 10 September 2008, Evropaïki Dynamiki v Commission , T‑465/04, not published, EU:T:2008:324, paragraph 59; and of 26 September 2017, Quimitécnica.com and de Mello v Commission , T‑564/10 RENV, not published, EU:T:2017:666, paragraph 62).

35 First, the points made in the EMA’s letter of 18 December 2024 do not constitute reasons that are new by comparison with those set out in the contested decision, given that they serve merely to clarify the contested decision and, secondly, the letter of 18 December 2024 was communicated to the applicant before the present action was brought.

36 Consequently, account must also be taken of the points made by the EMA in its letter of 18 December 2024, for the purposes of reviewing the legality of the contested decision.

Substance of the case

37 In support of the action, the applicant raises two pleas in law, alleging, first, infringement of the first indent of Article 4(2) of Regulation No 1049/2001 and, secondly, a failure to weigh up the relevant interests.

The first plea, alleging infringement of the first indent of Article 4(2) of Regulation No 1049/2001

38 The applicant submits, in essence, that the EMA infringed the first indent of Article 4(2) of Regulation No 1049/2001 in so far as it considered that the information contained in the requested document, relating to the quantitative composition of the excipients of the medicinal product at issue, to a statement regarding the medicinal product at issue and the reference product, and to a statement regarding the biodistribution studies did not constitute commercially confidential information protected by that provision.

39 The EMA disputes the applicant’s arguments.

40 As a preliminary point, it should be recalled that Article 15(3) TFEU provides that any citizen of the Union, and any natural or legal person residing or having its registered office in a Member State, has a right of access to documents of the European Union’s institutions, bodies, offices and agencies subject to the principles and the conditions defined in accordance with the ordinary legislative procedure.

41 Regulation No 1049/2001 seeks, as indicated in recital 4 and Article 1 thereof, to give the public a right of access to documents of the institutions which is as wide as possible (see judgment of 14 November 2013, LPN and Finland v Commission , C‑514/11 P and C‑605/11 P, EU:C:2013:738, paragraph 40 and the case-law cited).

42 Furthermore, it must be borne in mind that the procedure for applying for a marketing authorisation for medicinal products is governed by Regulation No 726/2004, which establishes a procedure under EU law in that regard. Article 73 of Regulation No 726/2004 provides that Regulation No 1049/2001 applies to documents held by the EMA. It follows that the principle that the public should have the widest possible access to the documents must in principle be respected with regard to the documents held by the EMA.

43 The principle that the public should have the widest possible access to the documents is nonetheless subject to certain limits based on reasons of public or private interest. Regulation No 1049/2001, in particular in recital 11 and Article 4 thereof, provides for a system of exceptions requiring institutions and bodies not to disclose documents in the event that such disclosure would undermine one of these interests (see, to that effect, judgments of 14 November 2013, LPN and Finland v Commission , C‑514/11 P and C‑605/11 P, EU:C:2013:738, paragraph 40 and the case-law cited, and of 13 January 2017, Deza v ECHA , T‑189/14, EU:T:2017:4, paragraph 51).

44 Since the exceptions provided for in Article 4 of Regulation No 1049/2001 derogate from the principle that the public should have the widest possible access to the documents, they must be interpreted and applied strictly (see, to that effect, judgments of 21 July 2011, Sweden v MyTravel and Commission , C‑506/08 P, EU:C:2011:496, paragraph 75, and of 3 July 2014, Council v in ’t Veld , C‑350/12 P, EU:C:2014:2039, paragraph 48).

45 It must also be noted that the system of exceptions laid down in Article 4 of Regulation No 1049/2001, particularly in Article 4(2) thereof, is based on a weighing of the opposing interests in a given situation, that is to say, on the one hand, the interests which would be favoured by the disclosure of the documents in question and, on the other, those which would be jeopardised by such disclosure. The decision taken on a request for access to documents depends on which interest must prevail in the particular case (judgments of 14 November 2013, LPN and Finland v Commission , C‑514/11 P and C‑605/11 P, EU:C:2013:738, paragraph 42, and of 23 September 2015, ClientEarth and International Chemical Secretariat v ECHA , T‑245/11, EU:T:2015:675, paragraph 168).

46 According to settled case-law, in order to justify a refusal to grant access to a document, it is not sufficient, in principle, for that document to fall within an activity mentioned in Article 4 of Regulation No 1049/2001. The institution concerned or, as the case may be, the person who submitted the information contained in the document at issue must also explain how access to that document could specifically and effectively undermine the interest protected by an exception under Article 4 of that regulation (see, to that effect, judgment of 27 February 2014, Commission v EnBW , C‑365/12 P, EU:C:2014:112, paragraph 64 and the case-law cited) and show that the risk of that interest being undermined is reasonably foreseeable and not purely hypothetical (judgments of 13 April 2005, Verein für Konsumenteninformation v Commission , T‑2/03, EU:T:2005:125, paragraph 69, and of 22 May 2012, Sviluppo Globale v Commission , T‑6/10, not published, EU:T:2012:245, paragraph 64).

47 As regards the concept of commercial interests, it is apparent from the case-law that it is not possible to regard all information concerning a company and its business relations as requiring the protection which must be guaranteed to commercial interests under the first indent of Article 4(2) of Regulation No 1049/2001 without frustrating application of the general principle of giving the public the widest possible access to documents held by the institutions (see judgment of 9 September 2014, MasterCard and Others v Commission , T‑516/11, not published, EU:T:2014:759, paragraph 81 and the case-law cited). It should also be pointed out that the joint guidance document of the EMA and the Heads of Medicines Agencies on the identification of commercially confidential information and personal data within the structure of the marketing authorisation procedure defines ‘commercial confidential information’ as any information which is not in the public domain or publicly available and where disclosure may undermine the economic interest or competitive position of the owner of the information (judgment of 5 February 2018, MSD Animal Health Innovation and Intervet international v EMA , T‑729/15, EU:T:2018:67, paragraph 67).

48 Consequently, in order to apply the exception provided for by the first indent of Article 4(2) of Regulation No 1049/2001, it must be shown that the document at issue contains elements which may, if disclosed, seriously undermine the commercial interests of a legal person. That is the case where the document at issue contains commercially sensitive information relating, in particular, to the business strategies of the undertakings concerned or to their commercial relations or where that document contains information particular to that undertaking which reveals its expertise (see, to that effect, judgment of 9 September 2014, MasterCard and Others v Commission , T‑516/11, not published, EU:T:2014:759, paragraphs 82 to 84).

49 It is in the light of the above considerations that the first plea must be examined.

– The quantitative composition of the excipients of the medicinal product at issue

50 The applicant submits, in essence, that certain statements regarding the quantitative composition of the excipients of the medicinal product at issue appearing in Table 1 of the requested document, namely the statement ‘quantum sufficit to adjust pH’ for hydrochloric acid and sodium hydroxide and the statement ‘up to … ml’ for water, are not in the public domain and that the disclosure of that information, which reveals a distinct portion of the formulation strategy for the medicinal product at issue, would undermine its commercial interests and would spare its competitors from carrying out certain analytical tests needed to determine the quantitative composition of that medicinal product.

51 In the justification table annexed to the contested decision, together with the letter of 18 December 2024, the EMA considered, in essence, that, first, the list of excipients of the medicinal product at issue and their function as pH adjusters appeared in two publicly available sources and that the statement ‘quantum sufficit to adjust pH’ could not be regarded in itself as a quantitative composition, since it did not reveal any information on the acceptance criteria for the pH or on the specific amount of each excipient necessary to adjust the pH. Secondly, it considered that the quantitative composition of the water, as stated in Table 1 of the requested document, merely indicated a maximum quantity which coincided with the volume of each vial. The different volumes of the vials used for the medicinal product at issue are included in the summary of product characteristics (SmPC) of that medicinal product, which is in the public domain.

52 First, it must be observed, first of all, that the two publicly available sources referred to by the EMA do indeed indicate that the medicinal product at issue contains, as excipients, hydrochloric acid and sodium hydroxide ‘for pH adjustment’, so that the identity of the excipients of the medicinal product at issue and their function as pH adjusters are in the public domain. By contrast, as the applicant correctly pointed out, that is not the case for the term ‘quantum sufficit’, which does not appear, as such, in the sources cited by the EMA.

53 With regard, next, to the question whether the disclosure of the term ‘quantum sufficit’ would undermine the applicant’s commercial interests, it should be noted that that term merely indicates, in a general manner, that the medicinal product at issue should contain the amount of excipients necessary to adjust the pH, and does not reveal any information on the amount or range of pH to which the medicinal product at issue is adjusted, or on the amount of excipients needed to adjust that medicinal product to the optimum amount or range of pH referred to, as the EMA has correctly stated. In those circumstances, the applicant’s argument that the term ‘quantum sufficit’ reveals, in itself, how it determined an optimum pH for the medicinal product at issue cannot succeed. The applicant’s complaint that disclosure of the term ‘quantum sufficit’ in relation to hydrochloric acid and sodium hydroxide in Table 1 of the requested document would undermine its commercial interests must therefore be rejected.

54 Secondly, although it is true that it is apparent from the publicly available sources referred to by the EMA that water is one of the excipients of the medicinal product at issue and that that product will be marketed in three vial formats, namely a 2-ml vial, a 10-ml vial and a 20-ml vial, the fact remains that none of those publicly available sources refers specifically to the fact that the quantity of water in the medicinal product at issue may be ‘up to 1, 2, 10 or 20 ml’, with the result that, contrary to the EMA’s claim, that information is not in the public domain.

55 However, it should be noted that the statements at issue merely reveal that the quantity of water in the medicinal product at issue may be up to the maximum volume of the vial in question, which means that those statements may be referring to any amount of water, whether fixed or variable, that does not exceed the maximum volume of the vial. It is therefore a vague indication which does not specify any precise amount or range concerning the ratio of water in the medicinal product at issue. Thus, the applicant has not sufficiently substantiated how the disclosure of the statements at issue would reveal a distinct portion of the applicant’s know-how or could enable the applicant’s competitors to reverse-engineer the formulation of the medicinal product at issue and to avoid carrying out certain analytical studies needed to confirm the exact ratio of water, especially since there is no specific information on the quantitative composition of the other excipients in the document requested or in the public domain.

56 The applicant’s complaint that disclosure of the statements relating to water in Table 1 of the requested document would undermine its commercial interests must therefore be rejected.

– The identical composition of the medicinal product at issue and the reference product

57 The applicant submits, in essence, that, first, the statement that the qualitative and quantitative composition of the medicinal product at issue is identical to that of the reference product is not in the public domain. The publicly available information on the formulation of each of those medicinal products is not complete, so it is not ascertainable from a comparison of that information that the products are identical in their composition. Secondly, the applicant claims that the disclosure of that statement would undermine its commercial interests in so far as it would allow its competitors to draw a conclusion on the specific quantitative composition of the medicinal product at issue, to avoid carrying out the tests needed to establish that the two medicinal products are identical, and to be able to rely entirely on the scientific advice as if it were a ‘roadmap’, given that the medicinal product at issue has been granted a marketing authorisation.

58 In the justification table annexed to the contested decision, together with the letter of 18 December 2024, the EMA considered, in essence, that the qualitative and quantitative composition of the medicinal product at issue and that of the reference product were publicly available and that, by comparing the two publicly available formulations of those products, it could easily be inferred that they were identical. In addition, the EMA considered that disclosure of the statement that the two medicinal products were identical would not undermine the applicant’s commercial interests, since competitors wishing to apply for a marketing authorisation for a similar generic medicinal product would have to conduct their own studies in order to demonstrate the bioequivalence of their products with the reference product by submitting appropriate bioavailability studies. Consequently, disclosure of the statement at issue would not enable competitors to reduce the time, effort and resources required for the pharmaceutical development of their products. Lastly, the statement at issue does not reveal a ‘precise recipe’ for the medicinal product at issue, since much of the information is incomplete.

59 First, it must be noted that the fact that the qualitative composition of the medicinal product at issue and that of the reference product are identical and the fact that those products have the same quantitative composition in terms of their active substance are both acknowledged by the applicant as being information that is in the public domain.

60 On the other hand, as the applicant has correctly stated, the quantitative composition of the excipients of the medicinal product at issue is not in the public domain. Similarly, it is not apparent either from the documents before the Court or from the submissions of the parties that the quantitative composition of the excipients of the reference product is in the public domain. When questioned in that regard at the hearing, the parties confirmed that that was not the case. Therefore, although it is true that the information that the qualitative composition of the medicinal product at issue is identical to that of the reference product is in the public domain, that is not the case as regards the information that the full quantitative composition of the medicinal product at issue is identical to that of the reference product. It follows that the statement at issue is only partly in the public domain.

61 Secondly, it should be noted that disclosure of the fact that the quantitative composition of the excipients of the medicinal product at issue is identical to that of the reference product cannot confer a competitive advantage on the applicant’s competitors, since there is no specific information on the quantitative composition of the excipients of those products in the requested document or in the public domain, and it is recognised that a generic medicinal product, such as that developed by the applicant which has been granted a marketing authorisation, is, by definition, identical or equivalent to the reference product. The EMA’s reflection paper of 26 March 2015 on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product (‘the EMA reflection paper’) expressly states that, in order to obtain a marketing authorisation, it is necessary to prove that the qualitative and quantitative composition of the developed product is identical to, or very closely matches, that of the reference product. In those circumstances, the applicant’s argument that disclosure of the information at issue would enable competitors to draw a conclusion on the specific quantitative composition of the medicinal product at issue cannot succeed. In that respect, the applicant has not sufficiently substantiated how disclosure of the statement at issue would allow competitors to rely on the requested document as a ‘roadmap’ to obtain a marketing authorisation.

62 The applicant’s complaint that disclosure of the statement that the medicinal product at issue and the reference product are identical in their qualitative and quantitative composition would undermine its commercial interests must therefore be rejected.

– The CHMP’s position on biodistribution studies

63 The applicant argues, first, that the CHMP’s position on biodistribution studies, referred to in the requested document, is not in the public domain. Indeed, contrary to what is apparent from the contested decision, the EMA reflection paper clearly advocates an approach which is different from that referred to by the CHMP in the requested document. Furthermore, even if the approach referred to by the CHMP has already been described in recent, publicly available scientific literature, there is still a significant difference between purely academic statements and a formal statement by the CHMP in a scientific advice procedure. It would thus be risky and uncertain to follow an approach based solely on the scientific literature, when that approach is in direct contradiction to the approach advocated in the EMA reflection paper. Similarly, the fact that a number of competent national authorities have already adopted the approach referred to by the CHMP in the requested document does not confirm that the EMA would take the same approach.

64 Secondly, whilst the applicant acknowledges that the CHMP’s position on biodistribution studies is not proprietary, it nevertheless states that the CHMP’s opinion was formulated, at the applicant’s request, within the scientific advice that the applicant requested and paid for. That opinion was given on the basis of specific scientific facts relating to the medicinal product at issue and to the applicant’s procedures, which are commercially sensitive.

65 Thirdly, the applicant submits that the disclosure of the CHMP’s position on biodistribution studies would undermine its commercial interests, given that it could significantly influence the future approach to the development of generic ferric carboxymaltose products and would allow competitors to save time, effort and resources.

66 In the justification table annexed to the contested decision, together with the letter of 18 December 2024, the EMA considered, in essence, that, first, the CHMP’s position on biodistribution studies was a matter of general scientific relevance and did not become confidential merely because the applicant had requested advice on that subject. Secondly, the EMA noted that the approach referred to by the CHMP in the requested document was not innovative per se, as it had already been described in the EMA reflection paper. Similarly, that approach could not only be inferred from scientific literature, but had also already been adopted by a number of competent national authorities. Thirdly, the EMA observes that the applicant ultimately did not follow the approach referred to by the CHMP and that that approach was suggested only if it allowed the similarity between the medicinal product at issue and the reference product to be sufficiently well established. It follows that competitors would not be able to establish, on the basis of that information, whether the approach referred to by the CHMP would be a viable option in practice, in so far as the applicant did not ultimately follow that approach. In those circumstances, the EMA considered that disclosure of the CHMP’s position on biodistribution studies would not enable the applicant’s competitors to acquire an unfair competitive advantage by reducing the time, effort and resources needed for the pharmaceutical development of their products, with the result that that position does not constitute commercially confidential information.

67 First, as regards the question whether the CHMP’s position on biodistribution studies as presented in the requested document is in the public domain, the subsection entitled ‘Biodistribution studies’ in Section 3.2, entitled ‘Non-clinical [studies]’, of the EMA reflection paper states the following:

‘Some pharmacokinetic aspects of nanoparticular iron products with regard to their performance in humans can be modelled by animal or cell-based models. Nevertheless, distribution studies in a relevant animal model are essential to evaluate distribution, metabolism and excretion of these nanoparticles and of their in vivo degradation or solubilisation products. … These studies should provide pivotal evidence of the comparability of the in vivo disposition of nanoparticular iron products, as it is not possible to fully explore distribution in humans from blood/plasma data alone’.

68 It must therefore be noted that the EMA reflection paper refers solely to in vivo biodistribution studies and that the CHMP’s position on biodistribution studies, which essentially confirms that the approach suggested by the applicant is feasible, is not mentioned in that paper at all.

69 Moreover, contrary to what the EMA stated in its letter of 18 December 2024, the fact that the EMA reflection paper refers to the fact that ‘development of additional and more accurate analyses of the degradation process of the nanoparticles is encouraged’, which, according to the EMA, shows that that document endorses a ‘dynamic approach’ as regards the collection of the necessary relevant data and that applicants for marketing authorisations for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product may also explore different types of analyses to meet the requirements for the authorisation of their generic products, does not support the claim that the approach referred to by the CHMP in the requested document was set out in the EMA reflection paper.

70 Lastly, the applicant does not dispute that the approach it suggested, which was endorsed by the CHMP in the requested document, can be inferred from recent scientific literature or that a number of competent national authorities of the Member States have already adopted that same approach. However, as the applicant has correctly observed, those factors do not, in themselves, confirm that the EMA will necessarily follow the same approach as that set out in recent scientific literature or that adopted by competent national authorities, even though the CHMP is predominantly composed of representatives from the competent national authorities of the Member States, as the EMA argues.

71 It follows from the foregoing considerations that the EMA was incorrect to consider, in the contested decision, that the CHMP’s position on biodistribution studies, as such, was in the public domain.

72 Secondly, as regards the question whether the CHMP’s position on biodistribution studies constitutes commercially confidential information, it should first be noted that the infringement of the protection of the commercial interests of a person as referred to in Article 4(2) of Regulation No 1049/2001 is not necessarily determined by reference to the financial value of the information subject to disclosure (see, to that effect, judgment of 5 February 2018, MSD Animal Health Innovation and Intervet international v EMA , T‑729/15, EU:T:2018:67, paragraphs 82 and 89). It follows that, contrary to what the applicant submits, the mere fact that the CHMP’s position was set out in scientific advice paid for by the applicant does not demonstrate that the disclosure of that information would undermine its commercial interests.

73 In addition, as is apparent from the case-law referred to in paragraph 48 above, elements which may undermine the commercial interests of a legal person are, in particular, commercially sensitive information relating to the business strategies of the undertaking concerned or to its commercial relations, or documents containing information particular to the undertaking which reveals its expertise.

74 Moreover, in accordance with the case-law cited in paragraph 46 above, in order to justify a refusal to grant access to a document, it must be shown, first, that disclosure of the information at issue specifically and effectively undermines the commercial interests of the undertaking concerned and, secondly, that the risk of those interests being undermined is reasonably foreseeable and not purely hypothetical.

75 However, in the present case, it should be noted that the CHMP’s position as regards biodistribution studies, which is based on the conclusions drawn in recent, publicly available scientific literature about studies confirming the bioequivalence of generic medicinal products and the reference ferric carboxymaltose products, is couched in conditional terms, since it merely states, in essence, that the approach suggested by the applicant may be followed only if the applicant is able to demonstrate sufficiently convincingly that the medicinal product at issue is comparable to the reference product, and that any unexpected findings should lead to further clarification or additional experiments.

76 Furthermore, as the EMA has pointed out, it is apparent from the public assessment report on the medicinal product at issue that the applicant did not follow the approach it had suggested to the CHMP and does not dispute that the details relating to the biodistribution study design for which it had initially requested scientific advice were redacted from the requested document, as indicated by the EMA in the justification table annexed to the contested decision.

77 Lastly, it should be noted, as the EMA did, that any competitor wishing to develop a generic product similar to that of the applicant would have to demonstrate the bioequivalence of its generic product with the reference product by submitting appropriate bioavailability studies. In that context, such competitors would in any event need to conduct their own studies and provide all the data required in order to obtain a marketing authorisation for their medicinal product, and would therefore have to make financial investments in the same way as the applicant. As is apparent from the CHMP’s position on biodistribution studies, data obtained using the approach suggested by the applicant could prove inconclusive, meaning that further experiments and, consequently, additional financial investments might even prove necessary.

78 Thus, contrary to what the applicant submits, it does not appear reasonably foreseeable that the disclosure of the CHMP’s position on biodistribution studies would allow competitors to accelerate their own marketing authorisation application procedures or to save time, effort and resources.

79 The applicant’s complaint that the disclosure of the CHMP’s position on biodistribution studies would undermine its commercial interests must therefore be rejected.

80 In the light of all the foregoing considerations, the first plea in law must be rejected as unfounded.

The second plea, alleging failure to weigh up the relevant interests

81 The applicant submits, in essence, that the EMA erred in law by failing to weigh up the relevant interests, in accordance with the final limb of Article 4(2) of Regulation No 1049/2001.

82 It is sufficient to note, however, that it is apparent from the examination of the first plea that the EMA was correct to conclude that the information at issue should not be protected by the exception referred to in the first indent of Article 4(2) of Regulation No 1049/2001. As a result, it was under no obligation to determine or assess the public interest in the disclosure of that information or to weigh it against the applicant’s interest in keeping that information confidential (see, to that effect, judgment of 22 January 2020, PTC Therapeutics International v EMA , C‑175/18 P, EU:C:2020:23, paragraph 134).

83 The second plea in law must therefore be rejected as unfounded and, consequently, the action must be dismissed in its entirety.

Costs

84 Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

85 In the present case, since the applicant has been unsuccessful, it must be ordered to pay the costs, in accordance with the form of order sought by the EMA, including the costs relating to the proceedings for interim measures.

On those grounds,

THE GENERAL COURT (Sixth Chamber)

hereby:

1. Dismisses the action;

2. Orders Teva Pharma BV to pay the costs, including those relating to the proceedings for interim measures.

Škvařilová-Pelzl | Kukovec | Pezzuto

Delivered in open court in Luxembourg on 15 July 2026.

V. Di Bucci | | S. Papasavvas

Registrar | | President

* Language of the case: English.