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EEC-1992 OTC DRUG REGISTRATION SYSTEM WILL NOT BE COMPLETELY HARMONIZED BUT "MORE RESTRICTIVE COMMON DENOMINATOR" LIKELY, EUROPEAN P-A PREDICTS

Executive Summary

The adoption of non-prescription drug standards from those European Economic Community (EEC) countries having the least experience with self-medication is possible after the 1992 trade unification, AESGP Director Hubertus Cranz predicted at a Nonprescription Drug Manufacturers Association EEC-1992 update May 16. The European Proprietary Association representative said his group's analysis shows that the EEC might decide to establish "a binding European list of prescription/nonprescription active substances" before the deadline for harmonization. "However, it is far more probable," Cranz noted, "that a harmonization on a lower, which means a more restrictive, common denominator would take place" after the 1992 deadline, "reducing the range of self-medication products." As an example of the broad differences in existing national OTC regulations, Cranz pointed to Greece, where he said "no nonprescription list at all really exists up to now" and there is little history of self-medication. He contrasted Greece and other southern European countries with Northern Europe "where you have a developed role of self-medication proved to be safe and efficient for the health insurance system" and noted that the differences become "far more difficult when you look at dosages and indications." The AESGP is involved in ongoing negotiations with the EC's governing commission on the subject of patient package information and may bring up the issue of advertising in the future, Cranz said. The group's consultations "up to now have already shown that detailed requirements obligatory for all medicines far beyond the current requirements . . . . could cause significant problems for certain product groups," Cranz commented, adding: "It will try to be our effort to build as much flexibility as necessary in the requirements for package information."(ITEM 190)Symbol, no caption
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