Judgment of the General Court (Fifth Chamber) of 11 December 2014 —
PP Nature-Balance Lizenz v Commission
(Case T‑189/13)
Medicinal products for human use — Active substance tolperisone — Article 116 of Directive 2001/83/EC — Commission decision ordering the Member States to vary the national marketing authorisations for medicinal products for human use containing the active substance at issue — Burden of proof — Proportionality
1. 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, Arts 116 and 117) (see para. 34)
2. Approximation of laws — Medicinal products for human use — Authorization to market — Modification of the authorisation — Withdrawal and prohibition on marketing — Conditions — Evidential requirements — Need for new scientific data or information — Scope — Assessment of toxicity and effectiveness — Examination and reciprocal relationship — Evolutionary character (European Parliament and Council Directive 2001/83, Arts 116 and 117) (see paras 35-37, 41-43, 105)
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 for Medicinal Products for Human Use — Subject-matter — Judicial review — Limits (European Parliament and Council Directive 2001/83, Art. 31) (see paras 47, 52)
4. Approximation of laws — Medicinal products for human use — Authorization to market — Modification of the authorisation — Withdrawal and prohibition on marketing — Opinion of the Committee for Medicinal Products for Human Use — No obligation of consistency between the opinions of rapporteurs and co-rapporteurs — No obligation to take account of assessments by national authorities — Committee members not obliged to adopt unanimously (European Parliament and Council Regulation No 726/2004, Art. 61(7); European Parliament and Council Directive 2001/83, Arts 31 and 32(2)) (see paras 78, 89, 91)
5. Approximation of laws — Medicinal products for human use — Authorization to market — Abridged procedure — Subject-matter (European Parliament and Council Directive 2001/83, Arts 8 and 10a) (see paras 100‑102)
6. 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, Arts 22a(1)(b), and 116) (see paras 111, 113, 114)
Re:
| APPLICATION for partial annulment of Commission Implementing Decision C(2013) 369 (final) of 21 January 2013 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations for the medicinal products for human use which contain the active substance ‘tolperisone’. |
Operative part
The Court:
2. | | Orders PP Nature-Balance Lizenz GmbH to bear its own costs and pay those incurred by the European Commission. |