Keywords

Summary



Keywords

1 . PRELIMINARY QUESTIONS - JURISDICTION OF THE COURT - LIMITS

( EEC TREATY , ART . 177 )

2 . APPROXIMATION OF LAWS - PROPRIETARY MEDICINAL PRODUCTS - DIRECTIVE 65/65 - MEDICINAL PRODUCTS - CONCEPT - SUBSTANCES NOT INDICATED OR RECOMMENDED EXPRESSLY AS BEING SUITABLE FOR CURING , TREATING OR PREVENTING AN INFECTION - CLASSIFICATION WITH REFERENCE TO THE COMMUNITY DEFINITION

( COUNCIL DIRECTIVE 65/65 , ART . 1 )

3 . APPROXIMATION OF LAWS - PROPRIETARY MEDICINAL PRODUCTS - DIRECTIVE 65/65 - MEDICINAL PRODUCTS - SUBSTANCES CAPABLE OF BEING ADMINISTERED TO HUMAN BEINGS OR ANIMALS - CONCEPT - VITAMIN PREPARATIONS - INCLUSION - CRITERIA

( COUNCIL DIRECTIVE 65/65 , ART . 1 )

4 . FREE MOVEMENT OF GOODS - QUANTITATIVE RESTRICTIONS - MEASURES HAVING EQUIVALENT EFFECT - LEGISLATION PROHIBITING THE MARKETING OF VITAMINS AND VITAMIN PREPARATIONS WITHOUT PRIOR REGISTRATION BY THE AUTHORITIES

( EEC TREATY , ART . 30 )

5 . FREE MOVEMENT OF GOODS - EXCEPTIONS - PURPOSE - EXISTENCE OF DIRECTIVES PROVIDING FOR THE APPROXIMATION OF LAWS - EFFECTS

( EEC TREATY , ARTS 36 AND 100 )

6 . FREE MOVEMENT OF GOODS - EXCEPTIONS - PROTECTION OF HEALTH - POWERS OF MEMBER STATES - SCOPE

( EEC TREATY , ART . 36 )

7 . FREE MOVEMENT OF GOODS - EXCEPTIONS - PROTECTION OF HEALTH - PROHIBITION ON THE SALE , OR HOLDING IN STOCK FOR THE PURPOSE OF SUPPLY , OF VITAMIN PREPARATIONS IMPORTED FROM ANOTHER MEMBER STATE - JUSTIFICATION - LIMITS

( EEC TREATY , ART . 36 )

Summary

1 . WHILST IT IS NOT FOR THE COURT , IN THE CONTEXT OF ARTICLE 177 OF THE EEC TREATY , TO RULE ON THE COMPATIBILITY OF NATIONAL LEGISLATIVE PROVISIONS WITH THE TREATY , IT MAY NONE THE LESS FURNISH THE NATIONAL COURT WITH ALL THOSE CRITERIA FOR THE INTERPRETATION OF COMMUNITY LAW WHICH MAY ENABLE IT TO JUDGE THE ISSUE OF SUCH COMPATIBILITY .

2.SUBSTANCES , SUCH AS VITAMIN PREPARATIONS , WHICH ARE NOT ' ' INDICATED OR RECOMMENDED ' ' EXPRESSLY AS SUITABLE FOR CURING , TREATING OR PREVENTING AN INFECTION MAY NONE THE LESS CONSTITUTE SUBSTANCES ' ' PRESENTED FOR TREATING OR PREVENTING DISEASE IN HUMAN BEINGS OR ANIMALS ' ' WITHIN THE MEANING OF THE FIRST PART OF THE COMMUNITY DEFINITION OF A MEDICINAL PRODUCT CONTAINED IN DIRECTIVE 65/65 ON PROPRIETARY MEDICINAL PRODUCTS .

A SUBSTANCE WHICH IS ENDOWED WITH PROPERTIES ' ' FOR TREATING OR PREVENTING DISEASE IN HUMAN BEINGS OR ANIMALS ' ' , BUT WHICH IS NOT ' ' PRESENTED ' ' AS SUCH , FALLS IN PRINCIPLE WITHIN THE SCOPE OF THE SECOND PART OF THE COMMUNITY DEFINITION OF A MEDICINAL PRODUCT , ACCORDING TO WHICH ANY SUBSTANCE OR COMBINATION OF SUBSTANCES WHICH MAY BE ADMINISTERED TO HUMAN BEINGS OR ANIMALS WITH A VIEW TO MAKING A MEDICAL DIAGNOSIS OR TO RESTORING , CORRECTING OR MODIFYING PHYSIOLOGICAL FUNCTIONS IN HUMAN BEINGS OR IN ANIMALS IS LIKEWISE CONSIDERED A MEDICINAL PRODUCT .

A PRODUCT WHICH IS COVERED BY NEITHER PART OF THE COMMUNITY DEFINITION OF A MEDICINAL PRODUCT IN DIRECTIVE 65/65 ON PROPRIETARY MEDICINAL PRODUCTS MAY NOT BE REGARDED AS A MEDICINAL PRODUCT WITHIN THE MEANING OF THAT DIRECTIVE .

3.IT IS IMPOSSIBLE IN THE PRESENT STATE OF SCIENTIFIC KNOWLEDGE TO STATE WHETHER THE CRITERION OF CONCENTRATION ALONE IS ALWAYS SUFFICIENT IN ORDER TO BE ABLE TO DETERMINE WHETHER A VITAMIN PREPARATION CONSTITUTES A MEDICINAL PRODUCT ; STILL LESS THEREFORE IS IT POSSIBLE TO SPECIFY THE LEVEL OF CONCENTRATION ABOVE WHICH SUCH A VITAMIN PREPARATION FALLS WITHIN THE COMMUNITY DEFINITION OF A MEDICINAL PRODUCT IN DIRECTIVE 65/65 ON PROPRIETARY MEDICINAL PRODUCTS .

THUS , THE CLASSIFICATION OF A VITAMIN AS A MEDICINAL PRODUCT WITHIN THE MEANING OF THE SECOND PART OF THE DEFINITION IN THE AFORESAID DIRECTIVE MUST BE CARRIED OUT CASE BY CASE , HAVING REGARD TO THE PHARMACOLOGICAL PROPERTIES OF EACH SUCH VITAMIN TO THE EXTENT TO WHICH THEY HAVE BEEN ESTABLISHED IN THE PRESENT STATE OF SCIENTIFIC KNOWLEDGE .

4.ANY COMMERCIAL LEGISLATION BY MEMBER STATES WHICH IS LIABLE TO HINDER TRADE WITHIN THE COMMUNITY , WHETHER DIRECTLY OR INDIRECTLY , ACTUALLY OR POTENTIALLY , IS TO BE REGARDED AS A MEASURE HAVING AN EFFECT EQUIVALENT TO QUANTITATIVE RESTRICTIONS WITHIN THE MEANING OF ARTICLE 30 OF THE TREATY .

ANY LEGISLATION WHICH PROHIBITS THE MARKETING OF VITAMINS AND VITAMIN PREPARATIONS WITHOUT PRIOR REGISTRATION WITH THE AUTHORITIES CONSTITUTES SUCH A MEASURE , SINCE SUCH LEGISLATION IS LIABLE TO HINDER TRADE BETWEEN MEMBER STATES .

5.IT IS ONLY WHEN COMMUNITY DIRECTIVES , IN PURSUANCE OF ARTICLE 100 OF THE TREATY , MAKE PROVISION FOR THE FULL HARMONIZATION OF ALL THE MEASURES NEEDED TO ENSURE THE PROTECTION OF HUMAN AND ANIMAL LIFE AND INSTITUTE COMMUNITY PROCEDURES TO MONITOR COMPLIANCE THEREWITH THAT RECOURSE TO ARTICLE 36 CEASES TO BE JUSTIFIED .

6.IN SO FAR AS UNCERTAINTIES PERSIST IN THE PRESENT STATE OF SCIENTIFIC RESEARCH , IT IS FOR THE MEMBER STATES , IN THE ABSENCE OF HARMONIZATION , TO DECIDE WHAT DEGREE OF PROTECTION OF THE HEALTH AND LIFE OF HUMANS THEY INTEND TO ASSURE , HAVING REGARD HOWEVER TO THE REQUIREMENTS OF THE FREE MOVEMENT OF GOODS WITHIN THE COMMUNITY .

IN THAT CONNECTION IT IS FOR THE NATIONAL AUTHORITIES TO DEMONSTRATE IN EACH CASE THAT THEIR RULES ARE NECESSARY TO GIVE EFFECTIVE PROTECTION TO THE INTERESTS REFERRED TO IN ARTICLE 36 OF THE TREATY AND , IN PARTICULAR , TO SHOW THAT THE MARKETING OF THE PRODUCT IN QUESTION CREATES A SERIOUS RISK TO PUBLIC HEALTH .

7.WHERE CERTAIN VITAMIN OR MULTI-VITAMIN PREPARATIONS IMPORTED FROM ANOTHER MEMBER STATE MAY BE REGARDED AS MEDICINAL PRODUCTS WITHIN THE MEANING OF DIRECTIVE 65/65 ON PROPRIETARY MEDICINAL PRODUCTS , BUT ARE NOT COVERED BY THE LEGISLATION ON MEDICINAL PRODUCTS OF ONE OR MORE MEMBER STATES , OR ARE NOT COVERED BY THE COMMUNITY DEFINITION OF A MEDICINAL PRODUCT CONTAINED IN THAT DIRECTIVE , THE LAW OF A MEMBER STATE MAY PROHIBIT THE SALE OR HOLDING IN STOCK THEREOF FOR THE PURPOSE OF SUPPLY , IN PARTICULAR WHEN SUCH PREPARATIONS ARE PRESENTED IN A PHARMACEUTICAL FORM OR WHEN THEY ARE HIGHLY CONCENTRATED . HOWEVER , SUCH RULES ARE JUSTIFIED ONLY IF AUTHORIZATIONS FOR MARKETING ARE GRANTED WHEN THEY ARE COMPATIBLE WITH THE REQUIREMENTS OF HEALTH PROTECTION .