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ECHAMP Position Paper – Illegal pharmcovigilance requirements for registered homeopathic medicinal products

21 Sep 2018

A new position paper from ECHAMP outlines an irregular, inconsistent and illegal change in the pharmacovigilance obligations for manufacturers of homeopathic medicinal products in the EU.

Article 16(3) of EU Directive 2001/83/EC confirms that homeopathic medicinal products registered under the special, simplified registration procedure (Article 14) are exempt from pharmacovigilance requirements. According to this legislation, there are no EU reporting obligations for suspected adverse reactions for these registered products. In some Member States, certain obligations do exist based on national rules.

However, this legal basis has been challenged over the past six months by the full implementation of EudraVIgilance, the European Medicines Agency’s centralised European database of suspected adverse reactions to medicines. As a result, new processes have been introduced in some Member States which now nevertheless require licence holders to submit data on registered medicinal products and their substances using the extended EudraVigilance medicinal product dictionary (XEVMPD), also known as the Article 57 database.

There is no legal basis for this obligation. Companies are challenged by the additional workload and the inconsistency of the requirement between Member States. ECHAMP calls on the European Medicines Agency and the Member States to seek a more pragmatic solution.

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