Judgment of the General Court (Fifth Chamber) of 20 October 2016

1. Actions for annulmentAdmissibility criteriaNatural or legal personsAction brought by several applicants against the same decisionCapacity to act of one of themAdmissibility of the action as a whole (Art. 263, fourth para., TFEU) (see para. 18)

2. EU lawInterpretationMethodsLiteral, systematic and teleological interpretationRecourse to the origin of a provisionLawfulness (see para. 30)

3. EU lawInterpretationPrinciplesIndependent interpretationLimitsReference in certain cases to the law of the Member States (see para. 31)

4. Approximation of lawsMedicinal products for human useAuthorisation to marketModification of the authorisationWithdrawal and prohibition on marketingReference to the committee on medicinal products for human usePurpose (European Parliament and Council Directive 2001/83, Art. 31) (see paras 37, 38, 46)

5. Approximation of lawsMedicinal products for human useAuthorisation to marketCommission guide to procedures for marketing authorisationBinding natureNoneAccount taken by the EU judicatureWhether permissible (European Parliament and Council Directive 2001/83, Art. 31) (see para. 45)

6. EU lawPrinciplesProhibition of abuse of rightScope (see para. 53)

7. Approximation of lawsMedicinal products for human useAuthorisation to marketModification of the authorisationWithdrawal and prohibition on marketingReference to the committee on medicinal products for human useConditionsExistence of an EU interestScope (European Parliament and Council Directive 2001/83, fifty-seventh recital and Art. 31) (see paras 61, 63, 64)

8. Approximation of lawsMedicinal products for human useAuthorisation to marketModification of the authorisationWithdrawal and prohibition on marketingReference to the committee on medicinal products for human useNomination of a rapporteur having the nationality of the Member State of the party to the procedureNot sufficient to establish the existence of a breach of the impartiality requirement (Charter of Fundamental Rights of the European Union, Art. 41; European Parliament and Council Directive 2001/83, Art. 31) (see paras 90, 91, 94)

9. Approximation of lawsMedicinal products for human useAuthorisation to marketModification of the authorisationWithdrawal and prohibition on marketingOpinion of the committee on medicinal products for human useJudicial reviewLimits (European Parliament and Council Directive 2001/83, Art. 31) (see paras 117-119)

10. Approximation of lawsMedicinal products for human useAuthorisation to marketModification of the authorisationWithdrawal and prohibition on marketingConditionsNot cumulativeRecourse by the competent authority to a series of serious and conclusive indicators likely to cast doubt on the harmlessness and therapeutic effect of the medicinal productAdmissibility (European Parliament and Council Directive 2001/83, Art. 116) (see paras 128-130)

11. Approximation of lawsMedicinal products for human useAuthorisation to marketModification of the authorisationWithdrawal and prohibition on marketingConditionsEvidentiary requirementsAllocation between the applicant and the competent authoritySubsistence of scientific uncertainties concerning the harmlessness or effectiveness of a medicinal productApplication of the precautionary principleScopeLimits (European Parliament and Council Directive 2001/83, Art. 116) (see paras 135-140, 174-178)

12. EU lawPrinciplesProportionalityScope (Art. 5(4) TEU) (see para. 203)

13. EU lawPrinciplesEqual treatmentConcept (see para. 211)

Re:

APPLICATION based on Article 263 TFEU and seeking the annulment of Commission Decision C(2014) 6030 final of 19 August 2014 concerning, in the context of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations for high concentration of estradiol containing human medicinal products for topical use in so far as it requires Member States to comply with the obligations imposed in the implementing decision for the medicinal products listed in Annex I to the implementing decision and those not listed with 0.01% estradiol by weight for topical use, with the exception of the restriction that the medicinal products named in Annex I to the implementing decision with 0.01% estradiol by weight for topical use may be administered only intravaginally.

Operative part

The Court:

1. Dismisses the action;

2. Orders Dr. August Wolff GmbH & Co. KG Arzneimittel and Remedia d.o.o. to pay the costs of the proceedings and of those relating to the application for interim measures.