The European self-medication industry is fully committed to protect the consumer against counterfeit medicines and therefore appreciates today's vote of the European Parliament on new legislation concerning falsified medicines.
"A good compromise has been found in the spirit of smart regulation" according to AESGP Director General Hubertus Cranz. The new law takes into account the particularities of non-prescription medicines which normally will not need to bear specific safety features. These will in principle be mandatory for prescription medicines only. A systematic inclusion of non-prescription medicines would have meant considerable additional costs to be paid at the end by the European citizens without any gain from a public health perspective.
"We are pleased to see that the European Parliament agreed on a rational and proportionate approach concerning the new system of safety features, and that this is supported by the other European institutions" Cranz stated.
An adequate compromise was also found with regard to active pharmaceutical ingredients taking into account the good functioning of current control systems. Inspections in countries outside the European Union will remain primarily in the hand of local inspectors. Better coordination of inspections and closer cooperation between EU and Non-EU authorities will be a helpful instrument.
Source:
Association Europ?©enne des Sp?©cialit?©s Pharmaceutiques Grand Public
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