Keywords
Summary

Keywords

1 . MEASURES ADOPTED BY THE INSTITUTIONS - DIRECTIVES - DIRECT EFFECT - CONDITIONS

( COUNCIL DIRECTIVE 65/65 , ART . 21 )

2.APPROXIMATION OF LAWS - PROPRIETARY MEDICINAL PRODUCTS - DIRECTIVE 65/65 - PURPOSE - PROTECTION OF PUBLIC HEALTH - REGULATION OF PRICES - EXCLUDED

( COUNCIL DIRECTIVE 65/65 )

3.APPROXIMATION OF LAWS - PROPRIETARY MEDICINAL PRODUCTS - AUTHORIZATION TO MARKET - REFUSAL , SUSPENSION OR REVOCATION OF AUTHORIZATION - GROUNDS - PROTECTION OF PUBLIC HEALTH

( COUNCIL DIRECTIVE 65/65 , ART . 21 )

Summary

1 . THE PROVISIONS OF DIRECTIVE 65/65 LAYING DOWN THE CONDITIONS FOR THE GRANT , SUSPENSION OR REVOCATION OF AUTHORIZATION TO MARKET , PROPRIETARY MEDICINAL PRODUCTS , IN PARTICULAR ARTICLE 21 , ARE UNCONDITIONAL AND SUFFICIENTLY PRECISE FOR THEM TO BE RELIED UPON BEFORE A NATIONAL COURT BY THE PERSONS CONCERNED IN ORDER TO CHALLENGE ANY NATIONAL PROVISION LAID DOWN BY LAW , REGULATION OR ADMINISTRATIVE ACTION WHICH IS INCOMPATIBLE WITH THE DIRECTIVE .

2 . DIRECTIVE 65/65 SEEKS TO APPROXIMATE PROVISIONS LAID DOWN BY LAW , REGULATION OR ADMINISTRATIVE ACTION IN MEMBER STATES RELATING TO PROPRIETARY MEDICINAL PRODUCTS ONLY IN SO FAR AS SUCH PROVISIONS ARE CONNECTED WITH PUBLIC HEALTH . IT DOES NOT CONTAIN ANY PROVISION AIMED AT LIMITING THE POWER OF THE MEMBER STATES TO REGULATE THE PRICES OF THOSE PRODUCTS . IN THE ABSENCE OF ANY PROVISION TO THAT EFFECT , SUCH A LIMITATION CANNOT BE INFERRED .

3 . ARTICLE 21 OF DIRECTIVE 65/65 MUST BE INTERPRETED AS MEANING THAT THE AUTHORIZATION TO MARKET A PROPRIETARY MEDICINAL PRODUCT MAY BE REFUSED , SUSPENDED OR REVOKED ONLY ON THE GROUND OF THE PROTECTION OF PUBLIC HEALTH REFERRED TO BY THE DIRECTIVE .