AS EFFECTIVELY PROTECTED BY MEASURES WHICH DO NOT RESTRICT INTRA-COMMUNITY TRADE SO MUCH .
18 IN PARTICULAR ARTICLE 36 CANNOT BE RELIED ON TO JUSTIFY RULES OR PRACTICES WHICH , EVEN THOUGH THEY ARE BENEFICIAL , CONTAIN RESTRICTIONS WHICH ARE EXPLAINED PRIMARILY BY A CONCERN TO LIGHTEN THE ADMINISTRATION ' S BURDEN OR REDUCE PUBLIC EXPENDITURE , UNLESS , IN THE ABSENCE OF THE SAID RULES OR PRACTICES , THIS BURDEN OR EXPENDITURE CLEARLY WOULD EXCEED THE LIMITS OF WHAT CAN REASONABLY BE REQUIRED .
19 THE SITUATION DESCRIBED BY THE NATIONAL COURT MUST BE EXAMINED IN THE LIGHT OF THESE CONSIDERATIONS .
20 B . - FOR THIS PURPOSE A DISTINCTION MUST BE DRAWN BETWEEN ON THE ONE HAND THE DOCUMENTS RELATING TO A MEDICINAL PREPARATION IN GENERAL , IN THIS CASE THE ' FILE ' PRESCRIBED BY THE NETHERLANDS LEGISLATION , AND , ON THE OTHER HAND , THOSE RELATING TO A SPECIFIC BATCH OF THIS MEDICINAL PREPARATION IMPORTED BY A PARTICULAR TRADER , IN THIS CASE THE ' RECORDS ' WHICH HAVE TO BE KEPT UNDER THE SAID LEGISLATION .
21 ( A ) WITH REGARD TO THE DOCUMENTS RELATING TO THE MEDICINAL PREPARATION IN GENERAL , IF THE PUBLIC HEALTH AUTHORITIES OF THE IMPORTING MEMBER STATE ALREADY HAVE IN THEIR POSSESSION , AS A RESULT OF IMPORTATION ON A PREVIOUS OCCASION , ALL THE PHARMACEUTICAL PARTICULARS RELATING TO THE MEDICINAL PREPARATION IN QUESTION AND CONSIDERED TO BE ABSOLUTELY NECESSARY FOR THE PURPOSE OF CHECKING THAT THE MEDICINAL PREPARATION IS EFFECTIVE AND NOT HARMFUL , IT IS CLEARLY UNNECESSARY , IN ORDER TO PROTECT THE HEALTH AND LIFE OF HUMANS , FOR THE SAID AUTHORITIES TO REQUIRE A SECOND TRADER WHO HAS IMPORTED A MEDICINAL PREPARATION WHICH IS IN EVERY RESPECT THE SAME , TO PRODUCE THE ABOVE-MENTIONED PARTICULARS TO THEM AGAIN .
22 THEREFORE NATIONAL RULES OR PRACTICES WHICH LAY DOWN SUCH A REQUIREMENT ARE NOT JUSTIFIED ON GROUNDS OF THE PROTECTION OF HEALTH AND LIFE OF HUMANS WITHIN THE MEANING OF ARTICLE 36 OF THE TREATY .
23 ( B ) WITH REGARD TO THE DOCUMENTS RELATING TO A SPECIFIC BATCH OF A MEDICINAL PREPARATION IMPORTED AT A TIME WHEN THE PUBLIC HEALTH AUTHORITIES OF THE MEMBER STATE OF IMPORTATION ALREADY , HAVE IN THEIR POSSESSION A FILE RELATING TO THIS MEDICINAL PREPARATION , THESE AUTHORITIES HAVE A LEGITIMATE INTEREST IN BEING ABLE AT ANY TIME TO CARRY OUT A THOROUGH CHECK TO MAKE CERTAIN THAT THE SAID BATCH COMPLIES WITH THE PARTICULARS ON THE FILE .
24 NEVERTHELESS , HAVING REGARD TO THE NATURE OF THE MARKET FOR THE PHARMACEUTICAL PRODUCT IN QUESTION , IT IS NECESSARY TO ASK WHETHER THIS OBJECTIVE CANNOT BE EQUALLY WELL ACHIEVED IF THE NATIONAL ADMINISTRATIONS , INSTEAD OF WAITING PASSIVELY FOR THE DESIRED EVIDENCE TO BE PRODUCED TO THEM - AND IN A FORM CALCULATED TO GIVE THE MANUFACTURER OF THE PRODUCT AND HIS DULY APPOINTED REPRESENTATIVES AN ADVANTAGE - WERE TO ADMIT , WHERE APPROPRIATE , SIMILAR