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New legislation on falsified medicines adopted


The European self-medication industry is fully committed to protect the consumer against counterfeit medicines and appreciates the adoption of the Directive on falsified medicines by the Council of the European Union.

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“We are pleased to see that Member States supported the good compromise reached with the European Parliament in the spirit of smart regulation,” said 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. Concerns on possible disproportionate costs deriving from the implementation of the new legislation led however the Latvian delegation to abstain from the voting. “It is important that a rational and proportionate approach concerning the new system of safety features is maintained and that non-prescription medicines remain in principle exempt from the obligation to bear safety features,” Cranz remarked.

Better coordination of inspections and closer cooperation between EU and non-EU authorities will help achieve a smooth implementation of the new import requirements from third countries for active pharmaceutical ingredients. AESGP also calls on the European Commission for a rapid establishment of the list of foreign countries with a system of Good Manufacturing Practices equivalent to the European one.
Association of the European Self-Medication Industry

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