Keywords

Summary



Keywords

1 . QUANTITATIVE RESTRICTIONS - MEASURES HAVING EQUIVANLENT EFFECT - CONCEPT

( EEC TREATY , ARTICLE 30 )

2 . QUANTITATIVE RESTRICTIONS - PHARMACEUTICAL PRODUCTS - IMPORTATION - MARKETING - RESTRICTION - PROHIBITION - EXCEPTION WITHIN THE MEANING OF ARTICLE 36 OF THE EEC TREATY - CONDITIONS

Summary

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 RE- STRICTION WITHIN THE MEANING OF ARTICLE 30 OF THE TREATY .

2 . 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 .

NATIONAL RULES OR PRACTICES DO NOT FALL WITHIN THE EXCEPTION SPECIFIED IN ARTICLE 36 IF THE HEALTH AND LIFE OF HUMANS CAN BE AS EFFECTIVELY PROTECTED BY MEASURES WHICH DO NOT RESTRICT INTRA-COMMUNITY TRADE SO MUCH .

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 .

WHERE

- A PHARMACEUTICAL PRODUCT PREPARED IN ACCORDANCE WITH A UNIFORM METHOD OF PREPARATION AND QUALI- TATIVE AND QUANTITATIVE COMPO- SITION 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 BEING GIVEN BY OFFICIAL PUBLICATION OR IN SOME OTHER WAY ;

- THIS PRODUCT IS IN EVERY RESPECT SIMILAR TO A PRODUCT IN RESPECT OF WHICH THE PUBLIC HEALTH1 - LANGUAGE OF THE CASE : DUTCH .

AUTHORITIES OF THE MEMBER STATE INTO WHICH THE FIRST PRODUCT HAS BEEN IMPORTED ALTREADY POSSESS THE DOCUMENTS RELATING TO THE METHOD OF PREPARATION AND ALSO TO THE QUANTITATIVE AND QUALITATIVE COM- POSITION , 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 ;

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 .