Article 1
1. A favourable decision is hereby taken, according to which, consent, subject to paragraph 2 below, shall be given under Article 13 of Directive 90/220/EEC by the authorities of Belgium for the placing on the market of the following product, notified by Rhône Mêrieux (Ref. C/B/92/B28 and C/F/93/03-02): - Raboral V-RG (Vaccinia virus, Copenhagen strain, tk-phenotype, expressing glycoprotein G of the rabies virus, ERA strain) - Oral live anti-rabies vaccine for foxes, to be administered in bait. 2. The conditions of use and labelling shall be as follows: (i) Raboral is an oral vaccine against rabies administered in bait to foxes and shall not be used for human vaccination; (ii) Raboral shall only be made available to and used by duly designated competent administrative authorities or their authorized agents; (iii) Raboral baits shall be distributed manually or by low-altitude aerial drops, at approximately 15 vaccine-baits per square kilometre, and shall not be distributed in inhabited areas, roads, rivers or other bodies of water; (iv) Raboral shall only be made available to the third parties indicated in (ii) above in the form indicated in the notification, that is, in liquid form, as a viral suspension in a polyethylene sachet, itself enclosed in a bait for foxes, which is resistant to temperature variation and shock. The packaging shall be sealed bags or cases of 200 vaccine-baits contained in secondary packaging (carton). The labelling on each vaccine-bait shall be 'vaccine - do not touch'. On the packaging the labelling shall be in conformity with the veterinary legislation in force; (v) Raboral vaccine and vaccine-baits shall be destroyed by Rhône-Mêrieux or the duly designated competent administrative authorities, by incineration, when the vaccine-baits are out of date or are otherwise rendered unsuitable for use due to, for example, accidents during the production, storage, delivery or distribution of the vaccine or vaccine-baits.