SECOND PART OF THE COMMUNITY DEFINITION OF A MEDICINAL PRODUCT MAY NOT BE REGARDED AS A MEDICINAL PRODUCT WITHIN THE MEANING OF DIRECTIVE 65/65 .
THIRD QUESTION
24 IN ITS THIRD QUESTION , THE NATIONAL COURT , PROCEEDING ON THE ASSUMPTION THAT VITAMINS IN LOW CONCENTRATIONS MAY BE REGARDED AS FOODSTUFFS , ASKS IN SUBSTANCE WHETHER A HIGHER CONCENTRATION SHOULD LEAD TO THEIR BEING REGARDED AS MEDICINAL PRODUCTS WITHIN THE MEANING OF THE DIRECTIVE , AND , IF SO , ON THE BASIS OF WHAT CRITERIA .
25 THE ANSWER TO THAT QUESTION MUST BE SUCH AS TO ENABLE THE NATIONAL COURT TO ASSESS THE IMPORTANCE OF THE CRITERION OF CONCENTRATION FOR THE PURPOSE OF ESTABLISHING WHETHER A VITAMIN FALLS WITHIN THE SECOND PART OF THE COMMUNITY DEFINITION OF A MEDICINAL PRODUCT .
26 INASMUCH AS VITAMINS ARE USUALLY DEFINED AS SUBSTANCES WHICH , IN MINUTE QUANTITIES , FORM AN ESSENTIAL PART OF THE DAILY DIET AND ARE INDISPENSABLE FOR THE PROPER FUNCTIONING OF THE BODY , THEY MAY NOT , AS A GENERAL RULE , BE REGARDED AS MEDICINAL PRODUCTS WHEN THEY ARE CONSUMED IN SMALL QUANTITIES .
27 SIMILARLY , IT IS A FACT THAT VITAMIN OR MULTI-VITAMIN PREPARATIONS ARE SOMETIMES USED , GENERALLY IN LARGE DOSES , FOR THERAPEUTIC PURPOSES IN COMBATING CERTAIN DISEASES OTHER THAN THOSE OF WHICH THE MORBID CAUSE IS A VITAMIN DEFICIENCY . IN SUCH CASES , IT IS BEYOND DISPUTE THAT THE VITAMIN PREPARATIONS CONSTITUTE MEDICINAL PRODUCTS .
28 IT IS , HOWEVER , APPARENT FROM THE FILE AND FROM THE OBSERVATIONS SUBMITTED TO THE COURT , TAKEN AS A WHOLE , THAT 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 WOULD FALL WITHIN THE COMMUNITY DEFINITION OF A MEDICINAL PRODUCT .
29 THE ANSWER TO BE GIVEN TO THE NATIONAL COURT SHOULD THEREFORE BE THAT THE CLASSIFICATION OF A VITAMIN AS A MEDICINAL PRODUCT WITHIN THE MEANING OF THE SECOND PART OF THE DEFINITION IN DIRECTIVE 65/65 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 .
FOURTH , FIFTH AND SIXTH QUESTIONS
30 THE FOURTH , FIFTH AND SIXTH QUESTIONS ASK , IN SUBSTANCE , WHETHER , WHERE THE CERTAIN VITAMIN OR MULTI-VITAMIN PREPARATIONS MAY
( A ) BE REGARDED AS MEDICINAL PRODUCTS WITHIN THE MEANING OF DIRECTIVE 65/65 , BUT ARE NOT COVERED BY THE LEGISLATION ON MEDICINAL PRODUCTS OF ONE OR MORE MEMBER STATES , OR
( B)ARE NOT COVERED BY THE COMMUNITY DEFINITION OF MEDICINAL PRODUCT ,
THE LAW OF ONE MEMBER STATE MAY NONE THE LESS PROHIBIT THE SALE OR THE HOLDING IN STOCK