Category Archives: Right to effective judicial protection

Reference medicinal product – Directive 2001/83/EC

Judgment

C-104/13

23.10.2014

Parties

Jurisdiction

Formation

Judge Rapporteur

Advocate General

Subject-matter

Appeal

Olainfarm AS

v.

Ministry of Health of the Republic of Latvia

CJEU

5th Ch.

D. Svaby

N. Wahl

Directive 2001/83/EC

Key-words

Directive 2001/83/EC — Medicinal products for human use — Marketing authorisation — Article 8(3)(i) — Requirement to attach to the application for authorisation the results of pharmaceutical pre-clinical tests and clinical trials — Derogations relating to pre-clinical tests and clinical trials — Article 10a — Medicinal products of which the active substances have been in well-established medicinal use within the European Union for at least 10 years — Whether it is possible to use a medicinal product for which authorisation has been granted on the basis of the derogation provided for in Article 10a as a reference medicinal product for the purpose of obtaining a marketing authorisation for a generic product Article 10 — Whether the holder of a marketing authorisation for a reference medicinal product has an individual right to oppose the marketing authorisation of a generic of the reference product

Summary

The concept of a ‘reference medicinal product’ within the meaning of Article 10(2)(a) of Directive 2001/83 must be construed as encompassing a medicinal product for which the MA was granted on the basis of Article 10a of the directive. Article 10a of Directive 2001/83  has the effect of exempting the applicant from one of the requirements laid down in Article 8 of the directive for obtaining a MA under Article 6 thereof. Accordingly, a medicinal product for which the MA was granted pursuant to Article 10a of the directive, the applicant for that authorisation having availed himself of the derogation under that provision and also having fulfilled all the other requirements laid down in Article 8 of the directive, must be regarded as a medicinal product authorised under Article 6 of the directive, in accordance with the provision of Article 8 thereof.Directive 2001/83 does not contain any express provision to the effect that a judicial remedy is available to the holder of a MA granted for an original medicinal product to challenge the decision of the competent authority which granted, pursuant to Article 10 of the directive, a MA for a generic medicinal product for which the original product served as the reference product.It should be observed that Article 10 of Directive 2001/83 lays down the conditions under which the holder of a MA for a medicinal product is required to accept that the manufacturer of another medicinal product is entitled to refer to the results of pre-clinical tests and clinical trials contained in the dossier relating to the application for the MA for the former product, rather than perform those tests or trials himself, for the purpose of obtaining a MA for the other medicinal product. It is apparent that that provision confers a concomitant right on the holder of the MA for the former medicinal product to demand that the rights attaching to him by virtue of those conditions are observed. It should therefore be recognised that the holder of a MA for a medicinal product used as a reference product in an application for a MA under Article 10 of Directive 2001/83 is, by virtue of that provision, read in conjunction with Article 47 of the Charter, entitled to judicial protection in so far as concerns respect for his rights.

Noteworthy

Customs Code – Right to effective judicial protection

Judgment

C-437/13

23.10.2014

Parties

Jurisdiction

Formation

Judge Rapporteur

Advocate General

Subject-matter

Reference for a reliminary ruling

Unitrading Ltd

CJEU

6th Ch.

M. Berger

/

Community Customs code

Right to effective judicial protection

Key-words

Recovery of import duties – Origin of goods – Means of proof – Charter of Fundamental Rights – Article 47 – Rights of the defence – Right to effective judicial protection – Procedural autonomy of the Member States

Summary

Article 47 of the Charter of Fundamental Rights of the EU must be interpreted as not precluding proof of origin of imported goods adduced by the customs authorities on the basis of national procedural rules resting on the results of an examination carried out by a third party, with regard to which such third party refuses to disclose further information either to the customs authorities or to the customs declarant, as a result of which it is made difficult or impossible to verify or disprove the correctness of the conclusions reached, under the following conditions:

– it can validly be challenged by the party concerned, in particular by arguing that such evidence may only constitute indirect proof of the facts alleged and by putting forward further evidence to support his assertions;

– the courts seized in turn in the main proceedings are free to assess the relevance of the evidence submitted;

– and the principles of effectiveness and equivalence are upheld in these respects.

Noteworthy

The CJEU is not fully at ease with the interaction between right to effective judicial protection and the limits of procedural autonomy.