Keywords

Summary



Keywords

1 . FREE MOVEMENT OF GOODS - DEROGATION - PROTECTION OF THE HEALTH OF HUMANS - PHARMACEUTICAL PRODUCTS - PARALLEL IMPORTS - INSPECTIONS - LAWFULNESS - CONDITIONS

( EEC TREATY , ART . 36 )

2 . FREE MOVEMENT OF GOODS - DEROGATION - MONITORING PROCEDURE JUSTIFIED WITHIN THE MEANING OF ARTICLE 36 OF THE TREATY - CHARGING OF FEES - NOT PERMISSIBLE

( EEC TREATY , ART . 36 )

3 . FREE MOVEMENT OF GOODS - CUSTOMS DUTIES - CHARGES HAVING EQUIVALENT EFFECT - REGISTRATION FEES PAYABLE BY PARALLEL IMPORTERS OF PHARMACEUTICAL PRODUCTS - CLASSIFICATION

( EEC TREATY , ARTS 9 , 12 AND 13 )

4 . TAXATION PROVISIONS - INTERNAL TAXATION - DISCRIMINATORY TAXATION - CLASSIFICATION OF A CHARGE HAVING EQUIVALENT EFFECT - CRITERIA

( EEC TREATY , ARTS 9 , 12 , 13 AND 95 )

5 . TAXATION PROVISIONS - INTERNAL TAXATION - DISCRIMINATION - UNEQUAL INCIDENCE OF A TAX ON THE COSTS OF UNDERTAKINGS BY REASON OF PARTICULAR FEATURES OF THEIR ECONOMIC STRUCTURE - IRRELEVANT

( EEC TREATY , ART . 95 )

Summary

1 . IN THE CASE OF IMPORTED PHARMACEUTICAL PRODUCTS WHICH HAVE ALREADY BEEN REGISTERED AT THE REQUEST OF THE MANUFACTURER OR THE DULY APPOINTED IMPORTER , ARTICLE 36 DOES NOT PREVENT NATIONAL AUTHORITIES FROM CHECKING WHETHER THE PRODUCTS IMPORTED IN PARALLEL ARE IDENTICAL TO THOSE WHICH HAVE ALREADY BEEN REGISTERED OR , WHERE VARIANTS OF THE SAME MEDICINAL ARE PLACED ON THE MARKET , WHETHER THE DIFFERENCES BETWEEN THOSE VARIANTS HAVE NO THERAPEUTIC EFFECT .

THAT CHECK MUST HOWEVER EXTEND ONLY TO VERIFYING WHETHER THE PRODUCTS SO CONFORM AND THE MEMBER STATE IN QUESTION MUST HAVE REQUIRED THE MANUFACTURER OR AUTHORIZED IMPORTER TO PROVIDE FULL INFORMATION REGARDING THE DIFFERENT FORMS IN WHICH THE MEDICINAL PRODUCTS IN QUESTION ARE MANUFACTURED OR MARKETED IN THE VARIOUS MEMBER STATES BY EITHER THE MANUFACTURER HIMSELF , SUBSIDIARY OR RELATED UNDERTAKINGS , OR UNDERTAKINGS MANUFACTURING SUCH PRODUCTS UNDER LICENCE .

2 . A MONITORING PROCEDURE WHICH IS IN ACCORDANCE WITH THE REQUIREMENTS OF ARTICLE 36 OF THE EEC TREATY IS NOT DEPRIVED OF ITS JUSTIFICATION , WITHIN THE MEANING OF THAT PROVISION , BY VIRTUE OF THE FACT THAT IT GIVES RISE TO THE COLLECTION OF FEES . ON THE OTHER HAND SUCH FEES MAY NOT BE CONSIDERED COMPATIBLE WITH THE TREATY ON THE SOLE GROUND THAT THEY ARE CHARGED IN CONSEQUENCE OF A MEASURE ADOPTED BY THE STATE WHICH IS JUSTIFIED WITHIN THE MEANING OF ARTICLE 36 . THE EXEMPTION PROVIDED FOR IN ARTICLE 36 IN FACT RELATES EXCLUSIVELY TO QUANTITATIVE RESTRICTIONS ON IMPORTS OR EXPORTS OR MEASURES HAVING EQUIVALENT EFFECT . IT MAY NOT BE EXTENDED TO CUSTOMS DUTIES OR TO CHARGES HAVING EQUIVALENT EFFECT WHICH , AS SUCH , FALL OUTSIDE THE COMPASS OF ARTICLE 36 .

3 . FEES DEMANDED OF A PARALLEL IMPORTER OF PHARMACEUTICAL PRODUCTS EITHER IN THE FORM OF A SINGLE FEE ON THE OCCASION OF THE REGISTRATION OF THE PHARMACEUTICAL PRODUCTS WHICH HE PROPOSES TO IMPORT OR IN THE FORM OF AN ANNUAL FEE CHARGED IN ORDER TO MEET THE COSTS OF PROCEDURES INTENDED TO CHECK WHETHER THE PRODUCTS SUBSEQUENTLY MARKETED ARE IDENTICAL TO THE REGISTERED PRODUCT DO NOT CONSTITUTE CHARGES HAVING AN EFFECT EQUIVALENT TO CUSTOMS DUTIES WHERE THOSE FEES FORM PART OF A GENERAL SYSTEM OF INTERNAL FEES CHARGED BOTH ON OCCASION OF THE REGISTRATION OF MEDICINAL PRODUCTS PRODUCED IN THE MEMBER STATE IN QUESTION AND ON THE OCCASION OF THE REGISTRATION OF MEDICINAL PRODUCTS IMPORTED EITHER DIRECTLY BY THE MANUFACTURER OF HIS APPOINTED IMPORTER OR AS WHAT ARE KNOWN AS PARALLEL IMPORTS AND WHERE SUCH FEES ARE CHARGED , IN THE CASE OF PARALLEL IMPORTS , IN ACCORDANCE WITH CRITERIA IDENTICAL OR COMPARABLE TO THE CRITERIA EMPLOYED IN DETERMINING THE FEES ON DOMESTIC PRODUCTS .

4 . A DISCRIMINATORY INTERNAL TAX DOES NOT AUTOMATICALLY CONSTITUTE A CHARGE HAVING AN EFFECT EQUIVALENT TO A CUSTOMS DUTY . A CHARGE IN THE FORM OF AN INTERNAL TAX MAY NOT BE CONSIDERED AS A CHARGE HAVING AN EFFECT EQUIVALENT TO A CUSTOMS DUTY UNLESS THE DETAILED RULES GOVERNING THE LEVYING OF THE CHARGE , OR ITS USE IF THE CHARGE IN QUESTION IS ALLOCATED TO A PARTICULAR USE , ARE SUCH THAT IN FACT IT IS IMPOSED SOLELY ON IMPORTED PRODUCTS TO THE EXCLUSION OF DOMESTIC PRODUCTS .

5 . ARTICLE 95 OF THE EEC TREATY IS COMPLIED WITH WHERE AN INTERNAL TAX APPLIES IN ACCORDANCE WITH THE SAME CRITERIA , OBJECTIVELY JUSTIFIED BY THE PURPOSE FOR WHICH THE TAX WAS INTRODUCED , TO DOMESTIC PRODUCTS AND IMPORTED PRODUCTS SO THAT IT DOES NOT RESULT IN THE IMPORTED PRODUCT ' S BEARING A HEAVIER CHARGE THAN THAT BORNE BY THE SIMILAR DOMESTIC PRODUCT . THE FACT THAT A CHARGE WHICH MEETS THOSE CRITERIA HAS DIFFERENT EFFECTS ON THE COST PRICES OF THE VARIOUS UNDERTAKINGS BY REASON OF PARTICULAR FEATURES OF THE ECONOMIC STRUCTURE OF SUCH UNDERTAKINGS WHICH MANUFACTURE OR MARKET SUCH PRODUCTS IS IRRELEVANT TO THE APPLICATION OF THAT PROVISION .