MUST THEREFORE BE THAT RULES OR PRACTICES WHICH MAKE IT POSSIBLE FOR A MANUFACTURER AND HIS DULY APPOINTED REPRESENTATIVES SIMPLY BY REFUSING TO PRODUCE THE ' FILE ' OR THE ' RECORDS ' TO ENJOY A MONOPOLY OF THE IMPORTATION AND MARKETING OF THE PRODUCT IN QUESTION 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 PRACTICE WOULD OBVIOUSLY BE BEYOND THE MEANS WHICH CAN REASONABLY BE EXPECTED OF AN ADMINISTRATION OPERATING IN A NORMAL MANNER .
THE SECOND QUESTION
33 BY THE SECOND QUESTION THE COURT IS ASKED TO SAY WHETHER IN PRINCIPLE THE ANSWER WHICH MUST BE GIVEN TO THE FIRST QUESTION ALSO APPLIES TO THE CASE WHERE ( A ) THE PROCESS OF MANUFACTURE AND THE QUALITATIVE AND QUANTITATIVE COMPOSITION OF THE MEDICINAL PREPARATION IMPORTED BY THE PARALLEL IMPORTER COMING FROM ANOTHER MEMBER STATE ARE DIFFERENT FROM THOSE OF THE MEDICINAL PREPARATION BEARING THE SAME NAME AND IN RESPECT OF WHICH THE AUTHORITIES OF THE MEMBER STATE INTO WHICH IT HAS BEEN IMPORTED ALREADY HAVE THESE DATA BUT ( B ) ' THE DIFFERENCES BETWEEN THE ONE AND THE OTHER PRODUCT ARE OF SUCH MINOR IMPORTANCE THAT IT IS LIKELY THAT THE MANUFACTURER IS APPLYING OR INTRODUCING . . . THESE DIFFERENCES WITH THE CONSCIOUS AND EXCLUSIVE INTENTION OF USING THESE DIFFERENCES . . . IN ORDER TO PREVENT OR IMPEDE THE POSSIBILITY OF THE PARALLEL IMPORTATION OF THE PROPRIETARY MEDICINAL PRODUCT ' .
34 THE ANSWER MUST BE IN THE AFFIRMATIVE .
35 THE COMPETENT ADMINISTRATION OF THE IMPORTING MEMBER STATE IS CLEARLY ENTITLED TO REQUIRE THE MANUFACTURER OR HIS DULY APPOINTED IMPORTER , WHEN THE PERSON CONCERNED APPLIES FOR AN AUTHORIZATION TO MARKET THE MEDICINAL PREPARATION AND LODGES THE RELEVANT DOCUMENTATION ( A ) TO STATE WHETHER THE MANUFACTURER OR , AS THE CASE MAY BE , THE GROUP OF MANUFACTURERS TO WHICH HE BELONGS , MANUFACTURES UNDER THE SAME NAME FOR DIFFERENT MEMBER STATES SEVERAL VARIANTS OF THE MEDICINAL PREPARATION AND ( B ) IF HIS ANSWER IS IN THE AFFIRMATIVE , TO PRODUCE SIMILAR DOCUMENTATION FOR THE OTHER VARIANTS TOO , SPECIFYING WHAT ARE DIFFERENCES BETWEEN ALL THESE VARIANTS .
36 IT IS ONLY IF THE DOCUMENTS PRODUCED IN THIS WAY SHOW THAT THERE ARE DIFFERENCES WHICH HAVE A THERAPEUTIC EFFECT THAT THERE WOULD BE ANY JUSTIFICATION FOR TREATING THE VARIANTS AS DIFFERENT MEDICINAL PREPARATIONS , FOR THE PURPOSES 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 PROCEDURES WHICH HAVE BECOME NECESSARY .
Decision on costs
COSTS
37 THE COSTS INCURRED BY THE BRITISH , DANISH AND NETHERLANDS GOVERNMENTS AND THE COMMISSION OF THE EUROPEAN COMMUNITIES , WHICH HAVE SUBMITTED THEIR OBSERVATIONS TO THE COURT , ARE NOT RECOVERABLE .
38 AS THESE