Judgment of the General Court (Eighth Chamber) of 23 September 2020 –
BASF v Commission

(Case T472/19)

(Medicinal products for human use – Marketing authorisation for medicinal products for human use containing omega-3 acid ethyl esters – Variation of the terms of the authorisation – First paragraph of Article 116 of Directive 2001/83/EC – Manifest error of assessment – Proportionality)

1.      Approximation of laws – Medicinal products for human use – Authorization to market – Modification 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 Directive 2001/83, Art. 116)

(see paras 45-48)

2.      Approximation of laws – Medicinal products for human use – Authorization to market – Modification of the authorisation – Withdrawal and prohibition on marketing – Conditions – Evidentiary requirements – Need for new scientific data or information – Scope

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

(see paras 49-52)

3.      Approximation of laws – Medicinal products for human use – Authorization to market – Modification of the authorisation – Withdrawal and prohibition on marketing – Opinion of the committee on medicinal products for human use – Purpose – Judicial review – Limits

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

(see para. 53)

4.      EU law – Interpretation – Acts of the institutions – Statement of reasons – To be taken into consideration – Decisions based on the opinion of a scientific authority – Incorporation of those opinions into the statement of reasons for such decisions

(see para. 62)

5.      Approximation of laws – Medicinal products for human use – Authorization to market – Modification of the authorisation – Withdrawal and prohibition on marketing – No 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)

6.      Approximation of laws – Medicinal products for human use – Authorization to market – Modification of the authorisation – Withdrawal and prohibition on marketing – Discretion of the institutions – Judicial review – Limits

(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:

1.

Dismisses the action;

2.

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