The opinion of the Advocate General (AG) Mazák in the case cp- Pharma Handels GmbH v. Bundesrepublik Deutschland (Case C-448/06) was delivered on 16 January 2008. The case referred from the German Court concerns the route of administration of veterinary products containing progesterone. The German Court action arose after the revocation of the cp-Pharma marketing authorisation for “progesterone as us. vet” by the German Authorities on 22 January 2004. This product is administered by intramuscular injection to the bovine species, to treat follicle cysts. Progesterone is a female hormone, and its administration to food-producing animals to promote growth is illegal in the EU.
The AG concluded in his opinion that Commission Regulation (EC) No 1873/2003 of 24 October 2003 which amended Annex II to Council Regulation (EEC) No 2377/990 is invalid in its entirety. Also that the interim the effects of the Regulation (EC) No 1873/2003 should be preserved until the Commission has adopted a new regulation on the matter.
Regulation No 1873/2003 inserted progesterone into Annex II of Regulation 2377/90, in relation to females of the animal species bovine, ovine, caprine and equidae. This was qualified by a footnote which provided for only the intravaginal therapeutic or zootechnical use and in accordance with the provisions of Directive 96/22/EC. It was doubted whether the Commission has the power to impose conditions on the mode of application i.e. limit the use to intravaginal use, in the light of the ruling by the Court in Case C-32/00 P Commission v. Boehringer Ingelheim Vetmedicannd C. H.
Boehringer Sohn. Here, the Court considered that Regulation No. 2377/90 does not authorise the Commission to limit the maximum residue limit of a veterinary medicinal product to certain therapeutic indications.
Regulation No 2377/90 lays down a community procedure to establish maximum residue limits of veterinary medicinal products in foodstuffs of animal origin. Directive 96/22, as amended, requires the Member States to provisionally prohibit the administration of substances which have a gestagenic action, such as progesterone, to farm animals; although under Article 4(1) of Directive 96/22 provides that Member States may authorise the administration of progesterone for therapeutic purposes
The Commission considered that Regulation (EC) No 1873/2003 was compatible with Regulation No 2377/90 and Directive 96/22. It considered that it has established a distinction between different forms of administration and that administration by any other route other than intravaginal can lead to residues and an increase the total quantity of progesterone in animal tissues.
The decision is awaited from the Court, probably later this year