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 ;
NATIONAL RULES OR PRACTICES WHICH MAKE IT POSSIBLE FOR A MANUFACTURER OF THE PHARMACEUTICAL PRODUCT IN QUESTION AND HIS DULY APPOINTED REPRESENTATIVE , 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 EXCEPTION 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 BE REASONABLY EXPECTED OF AN ADMINISTRATION OPERATING IN A NORMAL MANNER .
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 TRATING 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 PROCEDURES WHICH HAVE BECOME NECESSARY .
Parties
IN CASE 104/75
REFERENCE TO THE COURT UNDER ARTICLE 177 OF THE EEC TREATY BY THE KANTONGERECHT ROTTERDAM FOR A PRELIMINARY RULING IN THE CRIMINAL PROCEEDINGS PENDING BEFORE THAT COURT AGAINST
ADRIAAN DE PEIJPER MANAGING DIRECTOR OF CENTRAFARM BV ,
Subject of the case
ON THE INTERPRETATION OF ARTICLE 36 OF THE EEC TREATY ,
Grounds
1 BY ORDER OF 29 SEPTEMBER 1975 , WHICH REACHED THE COURT ON 2 OCTOBER 1975 , THE KANTONRECHTER OF ROTTERDAM REFERRED TO THE COURT PURSUANT TO ARTICLE 177 OF THE EEC TREATY TWO QUESTIONS CONCERNING THE INTERPRETATION OF ARTICLE 30 ET SEQ ., AND IN PARTICULAR OF ARTICLE 36 , OF THE SAID TREATY .
2 THESE QUESTIONS WERE RAISED DURING CRIMINAL PROCEEDINGS INSTITUTED BY THE OFFICIER VAN JUSTITIE FOR THE DISTRICT OF ROTTERDAM AGAINST A NETHERLANDS TRADER WHOM HE ACCUSES OF HAVING INFRINGED THE NETHERLANDS PUBLIC HEALTH LEGISLATION , ON THE ONE HAND BY SUPPLYING PHARMACIES IN THAT MEMBER STATE WITH MEDICINAL PREPARATIONS WHICH HE HAD IMPORTED FROM THE UNITED KINGDOM WITHOUT THE CONSENT OF THE NETHERLANDS AUTHORITIES AND , ON THE OTHER HAND , BY FAILING TO HAVE IN HIS POSSESSION CERTAIN DOCUMENTS CONNECTED WITH THESE MEDICINAL PREPARATIONS , NAMELY THE ' FILE ' AND THE ' RECORDS ' PRESCRIBED BY THE SAID LEGISLATION .
3 UNDER THAT LEGISLATION ' FILE ' MEANS A DOCUMENT WHICH THE IMPORTER MUST KEEP FOR ' EVERY PHARMACEUTICAL PACKAGING OF A PHARMACEUTICAL PREPARATION WHICH HE IMPORTS ' AND WHICH MUST CONTAIN DETAILED PARTICULARS CONCERNING THE SAID PACKAGING AND ESPECIALLY OF THE QUANTITATIVE AND QUALITATIVE COMPOSITION