AS WELL AS THE METHOD OF PREPARATION ; THESE PARTICULARS HAVE TO BE SIGNED AND ENDORSED ' SEEN AND APPROVED ' BY ' THE PERSON WHO IS RESPONSIBLE FOR THE MANUFACTURE ABROAD ' .
4 IT IS THE PRACTICE FOR THE IMPORTER TO PRODUCE THE ' FILE ' TO THE COMPETENT AUTHORITIES FOR ' CERTIFICATION ' WHICH AT THE SAME TIME AUTHORIZES HIM TO MARKET THE PACKAGING IN THE NETHERLANDS SO THAT ONLY AN IMPORTER WHO HAS THE ' FILE ' IN HIS POSSESSION CAN OBTAIN THIS AUTHORIZATION .
5 UNDER THE NETHERLANDS LEGISLATION ' RECORDS ' MEAN DOCUMENTS WHICH AN IMPORTER MUST HAVE IN HIS POSSESSION WHEN HE SUPPLIES A PHARMACEUTICAL PREPARATION WHICH HE HAS IMPORTED AND WHICH ESTABLISH THAT THE LATTER HAS IN FACT BEEN MANUFACTURED AND CHECKED IN ACCORDANCE WITH THE PARTICULARS ON THE ABOVE MENTIONED ' FILE ' AND RELATING TO THE MANUFACTURING FORMULA AS WELL AS THE RULES FOR CHECKING THE PREPARATION AND THE SUBSTANCES OF WHICH THIS PREPARATION IS COMPOSED .
6 IT APPEARS THAT THE ' FILE ' RELATES TO THE PRODUCT IN GENERAL WHEREAS THE ' RECORDS ' REFER TO EACH SPECIFIC BATCH OF THE PRODUCT WHICH THE IMPORTER WISHES TO PLACE ON THE MARKET .
7 THE ACCUSED IN THE MAIN PROCEEDINGS DOES NOT DENY THE MATTERS OF WHICH HE IS ACCUSED BUT ARGUES THAT HE COULD NOT COMPLY WITH THE RULES IN QUESTION BECAUSE HE WAS UNABLE TO OBTAIN THE DOCUMENTS WHICH ARE AT ISSUE IN THOSE PROCEEDINGS .
8 THE EXPLANATION FOR THIS IS THAT THE MEDICINAL PREPARATIONS IN QUESTION WERE MANUFACTURED BY A BRITISH PRODUCER - BELONGING TO A GROUP WHOSE OPERATIONAL CENTRE IS IN SWITZERLAND - , THAT THE ACCUSED IN THE MAIN PROCEEDINGS PURCHASED THEM FROM A WHOLESALER ESTABLISHED IN THE UNITED KINGDOM AND THEN IMPORTED THEM ' IN PARALLEL ' INTO THE NETHERLANDS AND FINALLY THAT THE SAID MANUFACTURER OR THE REPRESENTATIVE OF THE GROUP IN THE NETHERLANDS REFUSED TO GIVE THE ACCUSED THE HELP WHICH WAS ABSOLUTELY NECESSARY IF THE LATTER WAS TO OBTAIN POSSESSION OF THE ABOVE-MENTIONED DOCUMENTS .
9 THE MAIN PURPOSE OF THE QUESTIONS REFERRED BY THE NATIONAL COURT IS TO FIND OUT WHETHER RULES AND PRACTICE SUCH AS THE ONES IN ISSUE ARE CONTRARY TO COMMUNITY LAW BECAUSE THEY CONSTITUTE A MEASURE HAVING AN EFFECT EQUIVALENT TO A QUANTITATIVE RESTRICTION WHICH IS PROHIBITED BY ARTICLE 30 OF THE TREATY AND CANNOT FALL WITHIN THE EXCEPTION SPECIFIED IN ARTICLE 36 OF THE TREATY IN FAVOUR OF RESTRICTIVE MEASURES JUSTIFIED ON GROUNDS OF THE PROTECTION OF HEALTH AND THE LIFE OF HUMANS .
THE FIRST QUESTION
10 THE FIRST QUESTION ENVISAGES A FACTUAL SITUATION WHICH THE KANTONRECHTER DESCRIBES AS FOLLOWS :
- A PHARMACEUTICAL PRODUCT PREPARED IN ACCORDANCE WITH A UNIFORM METHOD OF PREPARATION AND QUALITATIVE AND QUANTITATIVE COMPOSITION IS LAWFULLY IN CIRCULATION IN SEVERAL MEMBER STATES , IN THE SENSE THAT , IN PURSUANCE OF THE NATIONAL SYSTEMS OF LEGISLATION OF THESE STATES , THE REQUISITE AUTHORIZATIONS HAVE BEEN GRANTED IN