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