PROCEEDINGS ARE , IN SO FAR AS THE PARTIES TO THE MAIN PROCEEDINGS ARE CONCERNED , IN THE NATURE OF A STEP IN THE PROCEEDINGS PENDING BEFORE THE KANTONRECHTER OF ROTTERDAM , THE DECISION AS TO COSTS IS A MATTER FOR THAT COURT .
Operative part
ON THOSE GROUNDS ,
THE COURT
IN ANSWER TO THE QUESTIONS REFERRED TO IT BY THE KANTONGERECHT OF ROTTERDAM HEREBY RULES :
1 . NATIONAL RULES OR PRACTICES WHICH RESULT IN IMPORTS BEING CHANNELLED IN SUCH A WAY THAT ONLY CERTAIN TRADERS CAN EFFECT THESE IMPORTS , WHEREAS OTHERS ARE PREVENTED FROM DOING SO , CONSTITUTE A MEASURE HAVING AN EFFECT EQUIVALENT TO A QUANTITATIVE RESTRICTION WITHIN THE MEANING OF ARTICLE 30 OF THE TREATY .
2 . GIVEN A FACTUAL SITUATION SUCH AS THAT DESCRIBED IN THE FIRST QUESTION NATIONAL RULES OR PRACTICES WHICH MAKE POSSIBLE FOR A MANUFACTURER OF THE PHARMACEUTICAL PRODUCT IN QUESTION AND HIS DULY APPOINTED REPRESENTATIVES , SIMPLY BY REFUSING TO PRODUCE THE DOCUMENTS RELATING TO THE MEDICINAL PREPARATION IN GENERAL OR TO A SPECIFIC BATCH OF THAT PREPARATION , TO ENJOY A MONOPOLY OF THE IMPORTING AND MARKETING OF THE PRODUCT , MUST BE REGARDED AS BEING UNNECESSARILY RESTRICTIVE AND CANNOT THEREFORE COME WITHIN THE EXCEPTIONS SPECIFIED IN ARTICLE 36 OF THE TREATY , UNLESS IT IS CLEARLY PROVED THAT ANY OTHER RULES OR PRACTICES WOULD OBVIOUSLY BE BEYOND THE MEANS WHICH CAN REASONABLY BE EXPECTED OF AN ADMINISTRATION OPERATING IN A NORMAL MANNER .
3 . IT IS ONLY IF THE INFORMATION OR DOCUMENTS TO BE PRODUCED BY THE MANUFACTURER OR HIS DULY APPOINTED IMPORTER SHOW THAT THERE ARE SEVERAL VARIANTS OF THE MEDICINAL PREPARATION AND THAT THE DIFFERENCES BETWEEN THESE VARIANTS HAVE A THERAPEUTIC EFFECT THAT THERE WOULD BE ANY JUSTIFICATION FOR TREATING THE VARIANTS AS DIFFERENT MEDICINAL PREPARATIONS , FOR THE PURPOSE OF AUTHORIZING THEM TO BE PLACED ON THE MARKET AND AS REGARDS PRODUCING THE RELEVANT DOCUMENTS , IT BEING UNDERSTOOD THAT THE ANSWER TO THE FIRST QUESTION REMAINS VALID AS REGARDS EACH OF THE AUTHORIZATION PRODURES WHICH HAVE BECOME NECESSARY .