Keywords
Summary

Keywords

Free movement of goods – Quantitative restrictions – Measures having equivalent effect – Medicinal products – Application for a marketing authorisation with reference to a medicinal product that has already been authorised – Possibility of transposing the safety and efficacy assessment carried out for that medicinal product without any risk to public health – Rejection of the application because the medicinal products do not have a common origin – Not permissible – Justification – None

(Arts 28 EC and 30 EC)

Summary

In the case where

– an application for a marketing authorisation for a medicinal product is submitted with reference to a medicinal product that has already been authorised,

– the medicinal product which is the subject of the application is imported from a Member State in which it has obtained a marketing authorisation,

– the assessment of safety and efficacy carried out for the medicinal product which is already authorised can be used in the application for a marketing authorisation for the second medicinal product without any risk to public health,

Articles 28 EC and 30 EC preclude the application being rejected solely on the ground that the two medicinal products do not have a common origin, that is, that their manufacturers are not part of the same group of undertakings and they do not produce those medicinal products under agreement with the same licensor.

In such circumstances, the restriction on the free movement of goods between Member States which results from the refusal to issue a marketing authorisation to the second medicinal product cannot be justified on grounds of protecting public health if that refusal is based solely on the fact that the two medicinal products do not have the same origin. A common origin may indeed constitute an important element in establishing that the assessment of safety and efficacy carried out for the medicinal product which is already authorised can be used in the application for a marketing authorisation for the second medicinal product without any risk to public health. The absence of a common origin for the two medicinal products does not, however, in itself constitute a ground for refusing a marketing authorisation to the second medicinal product.

(see paras 15-18, 21, operative part)