1. 

Actions for annulment — Admissibility criteria — Natural or legal persons — Action brought by several applicants against the same decision — Capacity to act of one of them — Admissibility of the action as a whole (Art. 263, fourth para., TFEU) (see para. 18)

2. 

EU law — Interpretation — Methods — Literal, systematic and teleological interpretation — Recourse to the origin of a provision — Lawfulness (see para. 30)

3. 

EU law — Interpretation — Principles — Independent interpretation — Limits — Reference in certain cases to the law of the Member States (see para. 31)

4. 

Approximation of laws — Medicinal products for human use — Authorisation to market — Modification of the authorisation — Withdrawal and prohibition on marketing — Reference to the committee on medicinal products for human use — Purpose (European Parliament and Council Directive 2001/83, Art. 31) (see paras 37, 38, 46)

5. 

Approximation of laws — Medicinal products for human use — Authorisation to market — Commission guide to procedures for marketing authorisation — Binding nature — None — Account taken by the EU judicature — Whether permissible (European Parliament and Council Directive 2001/83, Art. 31) (see para. 45)

6. 

EU law — Principles — Prohibition of abuse of right — Scope (see para. 53)

7. 

Approximation of laws — Medicinal products for human use — Authorisation to market — Modification of the authorisation — Withdrawal and prohibition on marketing — Reference to the committee on medicinal products for human use — Conditions — Existence of an EU interest — Scope (European Parliament and Council Directive 2001/83, fifty-seventh recital and Art. 31) (see paras 61, 63, 64)

8. 

Approximation of laws — Medicinal products for human use — Authorisation to market — Modification of the authorisation — Withdrawal and prohibition on marketing — Reference to the committee on medicinal products for human use — Nomination of a rapporteur having the nationality of the Member State of the party to the procedure — Not sufficient to establish the existence of a breach of the impartiality requirement (Charter of Fundamental Rights of the European Union, Art. 41; European Parliament and Council Directive 2001/83, Art. 31) (see paras 90, 91, 94)

9. 

Approximation of laws — Medicinal products for human use — Authorisation to market — Modification of the authorisation — Withdrawal and prohibition on marketing — Opinion of the committee on medicinal products for human use — Judicial review — Limits (European Parliament and Council Directive 2001/83, Art. 31) (see paras 117-119)

10. 

Approximation of laws — Medicinal products for human use — Authorisation to market — Modification of the authorisation — Withdrawal and prohibition on marketing — Conditions — Not cumulative — Recourse by the competent authority to a series of serious and conclusive indicators likely to cast doubt on the harmlessness and therapeutic effect of the medicinal product — Admissibility (European Parliament and Council Directive 2001/83, Art. 116) (see paras 128-130)

11. 

Approximation of laws — Medicinal products for human use — Authorisation to market — Modification of the authorisation — Withdrawal and prohibition on marketing — Conditions — Evidentiary requirements — Allocation between the applicant and the competent authority — Subsistence of scientific uncertainties concerning the harmlessness or effectiveness of a medicinal product — Application of the precautionary principle — Scope — Limits (European Parliament and Council Directive 2001/83, Art. 116) (see paras 135-140, 174-178)

12. 

EU law — Principles — Proportionality — Scope (Art. 5(4) TEU) (see para. 203)

13. 

EU law — Principles — Equal treatment — Concept (see para. 211)

1. 

Dismisses the action;

2. 

Orders Dr. August Wolff GmbH & Co. KG Arzneimittel and Remedia d.o.o. to pay the costs of the proceedings and of those relating to the application for interim measures.