Case C‑269/13 P

Acino AG

v

European Commission

(Appeal — Medicinal products for human use — Suspension of the marketing and the withdrawal of certain consignments of medicinal products containing the active ingredient Clopidogrel —Variation of marketing authorisations — Prohibition on marketing — Regulation (EC) No 726/2004 and Directive 2001/83/EC — Precautionary principle — Proportionality — Obligation to state reasons)

Summary — Judgment of the Court (Sixth Chamber), 10 April 2014

1.        Appeals — Grounds — Incorrect assessment of the facts and evidence — Inadmissibility — Review by the Court of the assessment of the facts and evidence — Possible only where the clear sense of the evidence has been distorted

(Art. 256 TFEU; Statute of the Court of Justice, Art. 58, first para.)

2.        Appeals — Grounds — Mere repetition of the pleas and arguments put forward before the General Court — Error of law relied on not identified — Inadmissibility — Challenge to the interpretation or application of EU law by the General Court — Admissibility

(Art. 256 TFEU; Statute of the Court of Justice, Art. 58, first para.; Rules of Procedure of the Court of Justice, Art. 169(2))

3.        Approximation of laws — Medicinal products for human use — Authorisation to market — Variation of the authorisation — Withdrawal and prohibition on marketing — Justification under the precautionary principle where there is uncertainty as to the existence and extent of risks to health

(European Parliament and Council Regulation No 726/2004; European Parliament and Council Directive 2001/83, Art. 116)

4.        Approximation of laws — Medicinal products for human use — Authorisation to market — Obligation for the holder of the authorisation to comply with good practice

(European Parliament and Council Directive 2001/83, Art. 46(f))

5.        Acts of the institutions — Statement of reasons — Obligation — Scope — Decision granting, refusing, varying, suspending, withdrawing or revoking a marketing authorisation — Minimum requirements

(Art. 296 TFEU; European Parliament and Council Regulation No 726/2004, Art. 81(1))

1.        See the text of the decision.

(see paras 33, 34, 86)

2.        See the text of the decision.

(see paras 35-37, 95, 108)

3.        In accordance with the precautionary principle, where there is uncertainty as to the existence or extent of risks to human health, protective measures may be taken without having to wait until the reality and seriousness of those risks become fully apparent. In particular, where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because of the insufficiency, inconclusiveness or imprecision of the results of studies conducted, but the likelihood of real harm to public health persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures. Therefore, while it is true that all the grounds set out in the first paragraph of Article 116 of Directive 2001/83 on the Community code relating to medicinal products for human use aim to prevent certain risks to health, the fact remains that those risks need not be specific, but only potential.

(see paras 57-59)

4.        The grant of a manufacturing authorisation necessarily involves the holder thereof being obliged to comply with good practice concerning the manufacture of medicinal products.

(see para. 68)

5.        See the text of the decision.

(see paras 120, 121)