CELEX: C2000/063/05
Language: en
Date: 2000-03-04 00:00:00
Title: Judgment of the Court of 16 December 1999 in Case C-94/98 (reference for a preliminary ruling from the High Court of Justice of England and Wales, Queen's Bench Division): The Queen v The Licensing Authority established by the Medicines Act 1968 (represented by the Medicines Control Agency), ex parte: Rhône-Poulenc Rorer Ltd, May & Baker Ltd (Medicinal products — Marketing authorisation — Parallel imports)

4.3.2000                EN                     Official Journal of the European Communities                                              C 63/3
The second indent of the second subparagraph of Article 17(2) of          Where it is sought to import medicinal product X from Member
Commission Regulation (EEC) No 3665/87 of 27 November 1987                State A into Member State B, it is permissible for the person who
laying down common detailed rules for the application of the system       proposes to place the imported product upon the market in Member
of export refunds on agricultural products must be interpreted as         State B to seek and obtain a parallel import licence from the
meaning that the countries parties to the Charter of the Cooperation      competent authority in Member State B without complying with all
Council for the Arab States of the Gulf are not regarded, where           the requirements of Council Directive 65/65/EEC of 26 January
products are processed before being cleared through customs on the        1965 on the approximation of provisions laid down by law,
territory of one of those countries and then exported to others, as a     regulation or administrative action relating to medicinal products
single non-member country into which all the products resulting from      (OJ, English Special Edition 1965-1966, p. 20), as amended by
that processing have been imported.                                       Council Directive 93/39/EEC of 14 June 1993, if:
(1) OJ C 166 of 30.5.1998.
                                                                          — medicinal product X is the subject of a marketing authorisation
                                                                              granted in Member State A and was the subject of a marketing
                                                                              authorisation which has ceased to have effect in Member State B;
                                                                          — medicinal product Y is the subject of a marketing authorisation
                                                                              granted in Member State B, but is not the subject of a marketing
                                                                              authorisation granted in Member State A;
                 JUDGMENT OF THE COURT
                      of 16 December 1999                                 — medicinal product X has the same active ingredients and
                                                                              therapeutic effect as medicinal product Y, but does not use the
                                                                              same excipients and is manufactured by a different manufacturing
in Case C-94/98 (reference for a preliminary ruling from                      process, where the competent authority in Member State B is in
the High Court of Justice of England and Wales, Queen’s                       a position to verify that medicinal product X complies with the
Bench Division): The Queen v The Licensing Authority                          requirements relating to quality, efficacy and safety in normal
established by the Medicines Act 1968 (represented by                         conditions of use and is in a position to ensure normal
the Medicines Control Agency), ex parte: Rhône-Poulenc                        pharmacovigilance;
                 Rorer Ltd, May & Baker Ltd (1)
(Medicinal products — Marketing authorisation — Parallel                  — the marketing authorisations referred to above were granted to
                              imports)                                        different members of the same group of companies and the
                                                                              manufacturers of medicinal products X and Y are also members
                           (2000/C 63/05)                                     of that group of companies; and
                    (Language of the case: English)                       — companies within the same group as the holder of the marketing
                                                                              authorisation for product X which has been withdrawn in
                                                                              Member State B continue to manufacture and market product X
In Case C-94/98: reference to the Court under Article 177 of                  in Member States other than Member State B.
the EC Treaty (now Article 234 EC) from the High Court of
Justice of England and Wales, Queen’s Bench Division, United
Kingdom, for a preliminary ruling in the proceedings pending
before that court between The Queen and The Licensing                     In such a situation, the competent authority is not required to take
Authority established by the Medicines Act 1968 (represented              into consideration the fact that medicinal product Y was developed
by the Medicines Control Agency), ex parte: Rhône-Poulenc                 and introduced in order to provide a particular benefit to public
Rorer Ltd, May & Baker Ltd — on the interpretation of Council             health which medicinal product X does not provide and/or that that
Directive 65/65/EEC of 26 January 1965 on the approximation               particular benefit to public health would not be achieved if product X
of provisions laid down by law, regulation or administrative              and product Y were both on the market in Member State B at the
action relating to medicinal products (OJ, English Special                same time.
Edition 1965-1966, p. 20), as amended, in particular, by
Council Directive 93/39/EEC of 14 June 1993 (OJ 1993 L 214,
p. 22), and of the provisions of Community law relating to the
grant of parallel import licences for medicinal products —
the Court, composed of: G.C. Rodrı́guez Iglesias, President,              (1) OJ C 166 of 30.5.1998.
D.A.O. Edward, L. Sevón, R. Schintgen (Presidents of Cham-
bers), C. Gulmann (Rapporteur), J.-P. Puissochet, G. Hirsch,
P. Jann and H. Ragnemalm, Judges; A. La Pergola, Advocate
General; D. Louterman-Hubeau, Principal Administrator, for
the Registrar, has given a judgment on 16 December 1999, in
which it has ruled: