1. 

Judicial proceedings – Intervention – Claim of inadmissibility of the action not maintained by the defendant – Inadmissibility

(Statute of the Court of Justice, Art. 40, fourth para.; Rules of Procedure of the General Court, Art. 142)

(see paras 41-43)

2. 

Approximation of laws – Uniform legislation – Medicinal products for human use – Orphan medicinal products – Medicinal products similar to an orphan medicinal product and with the same active substance, therapeutic indication, route of administration and dosage as a reference medicine – Marketing authorisation – Hybrid procedure – No obligation to provide clinical studies to demonstrate the therapeutic equivalence of those medicinal products

(European Parliament and Council Regulation No 141/2000, Art. 8(1) and (3); European Parliament and Council Directive 2001/83, Arts 8(3)(i) and 10(1) and (3))

(see paras 52-60)

3. 

Approximation of laws – Uniform legislation – Medicinal product for human use – Orphan medicinal products – Procedure for designating a medicinal product as an orphan medicinal product – Significant benefit – Criteria for assessment – Criteria identical to the criteria applicable for clinical superiority

(European Parliament and Council Regulation No 141/2000, Art. 3(1)(b); Commission Regulation No 847/2000, Art. 3(2))

(see paras 92-96, 113, 120, 121, 124, 131)

4. 

Approximation of laws – Uniform legislation – Medicinal products for human use – Orphan medicinal products – Medicinal products similar to an orphan medicinal product already authorised and having the same therapeutic indication – Placing on the market – Market exclusivity – Derogation – Conditions – Clinical superiority – Criteria for assessment – Criteria identical to the criteria applicable for significant benefit

(European Parliament and Council Regulation No 141/2000, Recital 8 and Art. 8(1) and (3); Commission Regulation No 847/2000, Art. 3(3)(b) and (d))

(see paras 99-102, 114, 116, 120, 124, 130, 132, 148)

5. 

Approximation of laws – Uniform legislation – Medicinal products for human use – Orphan medicinal products – Medicinal products similar to an orphan medicinal product already authorised and having the same therapeutic indication – Commission decision authorising the placing on the market of such a medicinal product – Discretion – Judicial review – Limits

(European Parliament and Council Regulation No 141/2000, Art. 5)

(see paras 103-107, 162)

6. 

Approximation of laws – Uniform legislation – Medicinal products for human use – Orphan medicinal products – Medicinal products similar to an orphan medicinal product already authorised and having the same therapeutic indication – Commission decision authorising the placing on the market of such a medicinal product – Infringement of the duty of care – Infringement of the right to be heard of a third party to the procedure – None

(Charter of Fundamental Rights of the European Union, Arts 41, 47 and 48; European Parliament and Council Regulation No 141/2000, Art. 5)

(see paras 160, 161, 163-166, 170-172, 181)

1. 

Dismisses the action;

2. 

Orders Mylan IRE Healthcare Ltd to bear its own costs and pay those incurred by the European Commission and by UAB VVB, including those relating to procedure for the replacement of a party.