Judgment of the General Court (Eighth Chamber) of 23 September 2020

Approximation of lawsMedicinal products for human useAuthorization to marketModification of the authorisationWithdrawal and prohibition on marketingJustification under the precautionary principle where there is uncertainty as to the existence and extent of risks to health

(European Parliament and Council Directive 2001/83, Art. 116)

(see paras 45-48)

Approximation of lawsMedicinal products for human useAuthorization to marketModification of the authorisationWithdrawal and prohibition on marketingConditionsEvidentiary requirementsNeed for new scientific data or informationScope

(European Parliament and Council Directive 2001/83, Art. 116)

(see paras 49-52)

Approximation of lawsMedicinal products for human useAuthorization to marketModification of the authorisationWithdrawal and prohibition on marketingOpinion of the committee on medicinal products for human usePurposeJudicial reviewLimits

(European Parliament and Council Directive 2001/83, Art. 31)

(see para. 53)

EU lawInterpretationActs of the institutionsStatement of reasonsTo be taken into considerationDecisions based on the opinion of a scientific authorityIncorporation of those opinions into the statement of reasons for such decisions

(see para. 62)

Approximation of lawsMedicinal products for human useAuthorization to marketModification of the authorisationWithdrawal and prohibition on marketingNo infringement of the proportionality principle through failure to examine possibility of ordering a clinical study

(European Parliament and Council Directive 2001/83, Art. 116)

(see paras 108, 113)

Approximation of lawsMedicinal products for human useAuthorization to marketModification of the authorisationWithdrawal and prohibition on marketingDiscretion of the institutionsJudicial reviewLimits

(European Parliament and Council Directive 2001/83, Art. 116)

(see para. 109)

Re:

Application pursuant to Article 263 TFEU for annulment of Commission Implementing Decision C(2019) 4336 final of 6 June 2019 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, marketing authorisations of medicinal products for human use containing ‘Omega-3 acid ethyl esters’ for oral use in secondary prevention after myocardial infarction.

Operative part

The Court:

Dismisses the action;

Orders BASF AS to pay the costs, including the costs relating to the interlocutory proceedings.