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European Coalition on Homeopathic & Anthroposophic Medicinal Products

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Homeopathic medicinal products exempt from safety features: significant saving for the sector

10 Feb 2016

Homeopathic medicinal products subject to prescription are exempt from obligatory ‘safety features’ required for other prescription medicinal products under new EU legislation against falsified medicines. Nor are homeopathic medicinal products not subject to prescription included on the list of those required to bear the safety features, which include a unique identifier and an anti-tampering device.

This exemption is confirmed by the publication of a delegated regulation which supplements the Falsified Medicines Directive (2011/62/EU) by laying down detailed rules for safety features to appear on the packaging of medicinal products for human use. It was published on Tuesday 9 February in the Official Journal and enters into force in three years’ time. Such safety features are intended to protect European citizens against the health threat of falsified medicines, which may contain ingredients of low quality or in the wrong dosage, ensuring that only high quality ingredients are used for medicines in the EU.

ECHAMP very much welcomes the confirmation of the exemption for these products, since the implementation of safety features would have been disproportionate to the sales figures for  homeopathic medicinal products subject to prescription. This exemption will save ECHAMP members between €700,000 and €1.4m in up-front investment costs for new anti-counterfeiting technologies, such as the installation of data matrix printing and reading equipment, line data collection, and a products serialisation database. Other savings vary according to production levels and turnover but include incremental annual costs such as the cost per tag and the costs of registration or authorisation.

In addition, if the obligation is imposed in Spain, significant additional investment would be needed by homeopathic companies in this market.

This exemption would appear to be in part as a result of the advocacy work ECHAMP undertook on this issue.