Adriaan de Peijper, Managing Director of Centrafarm BV.
Date: 1976-05-20
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 RELATION TO THAT PRODUCT TO THE MANUFACTURER ' OR THE PERSON RESPONSIBLE FOR PUTTING THE PRODUCT ON THE MARKET '  IN THE MEMBER STATE IN QUESTION ;

- THE FACT THAT SUCH AUTHORIZATIONS HAVE BEEN GRANTED IN EACH OF THE MEMBER STATES IS MADE KNOWN BY GENERAL NOTICE GIVEN BY OFFICIAL PUBLICATION OR IN SOME OTHER WAY ; AND
- THIS PRODUCT IS IN EVERY RESPECT SIMILAR TO A PRODUCT IN RESPECT OF WHICH THE PUBLIC HEALTH AUTHORITIES OF THE MEMBER STATE INTO WHICH THE FIRST PRODUCT HAS BEEN IMPORTED ALREADY POSSESS THE DOCUMENTS RELATING TO THE METHOD OF PREPARATION AND ALSO TO THE QUANTITATIVE AND QUALITATIVE COMPOSITION , SINCE THESE DOCUMENTS WERE PRODUCED TO THEM PREVIOUSLY BY THE MANUFACTURER OR HIS DULY APPOINTED IMPORTER IN SUPPORT OF AN APPLICATION FOR AUTHORIZATION TO PLACE THEM ON THE MARKET .
12 1 . NATIONAL MEASURES OF THE KIND IN QUESTION HAVE AN EFFECT EQUIVALENT TO A QUANTITATIVE RESTRICTION AND ARE PROHIBITED UNDER ARTICLE 30 OF THE TREATY IF THEY ARE LIKELY TO CONSTITUTE AN OBSTACLE , DIRECTLY OR INDIRECTLY , ACTUALLY OR POTENTIALLY , TO IMPORTS BETWEEN MEMBER STATES .
15 HEALTH AND THE LIFE OF HUMANS RANK FIRST AMONG THE PROPERTY OR INTERESTS PROTECTED BY ARTICLE 36 AND IT IS FOR THE MEMBER STATES , WITHIN THE LIMITS IMPOSED BY THE TREATY , TO DECIDE WHAT DEGREE OF PROTECTION THEY INTEND TO ASSURE AND IN PARTICULAR HOW STRICT THE CHECKS TO BE CARRIED OUT ARE TO BE .
16 NEVERTHELESS IT EMERGES FROM ARTICLE 36 THAT NATIONAL RULES OR PRACTICES WHICH DO RESTRICT IMPORTS OF PHARMACEUTICAL PRODUCTS OR ARE CAPABLE OF DOING SO ARE ONLY COMPATIBLE WITH THE TREATY TO THE EXTENT TO WHICH THEY ARE NECESSARY FOR THE EFFECTIVE PROTECTION OF HEALTH AND LIFE OF HUMANS .
17 NATIONAL RULES OR PRACTICES DO NOT FALL WITHIN THE EXCEPTION SPECIFIED IN ARTICLE 36 IF THE HEALTH AND LIFE OF HUMANS CAN 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 .
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 .
25 THIS QUESTION IS ALL THE MORE IMPORTANT BECAUSE PARALLEL IMPORTERS ARE VERY OFTEN IN A POSITION TO OFFER THE GOODS AT A PRICE LOWER THAN THE ONE APPLIED BY THE DULY APPOINTED IMPORTER FOR THE SAME PRODUCT , A FACT WHICH , WHERE MEDICINAL PREPARATIONS ARE CONCERNED , SHOULD , WHERE APPROPRIATE , ENCOURAGE THE PUBLIC HEALTH AUTHORITIES NOT TO PLACE PARALLEL IMPORTS AT A DISADVANTAGE , SINCE THE EFFECTIVE PROTECTION OF HEALTH AND LIKE OF HUMANS ALSO DEMANDS THAT MEDICINAL PREPARATIONS SHOULD BE SOLD AT REASONABLE PRICES .
26 NATIONAL AUTHORITIES POSSESS LEGISLATIVE AND ADMINISTRATIVE METHODS CAPABLE OF COMPELLING THE MANUFACTURER OR HIS DULY APPOINTED REPRESENTATIVE TO SUPPLY PARTICULARS MAKING IT POSSIBLE TO ASCERTAIN THAT THE MEDICINAL PREPARATION WHICH IS IN FACT THE SUBJECT OF PARALLEL IMPORTATION IS IDENTICAL WITH THE MEDICINAL PREPARATION IN RESPEKT OF WHICH THEY ARE ALREADY INFORMED .
27 MOREOVER , SIMPLE CO-OPERATION BETWEEN THE AUTHORITIES OF THE MEMBER STATES WOULD ENABLE THEM TO OBTAIN ON A RECIPROCAL BASIS THE DOCUMENTS NECESSARY FOR CHECKING CERTAIN LARGELY STANDARDIZED AND WIDELY DISTRIBUTED PRODUCTS .
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 .