allergen productshall mean any medicinal product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent.
generic medicinal productshall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies.
reference medicinal productshall mean a medicinal product authorised under Article 6, in accordance with the provisions of Article 8;