The Marketing Authorisation Holder’s should ensure that it has an appropriate system of pharmacovigilance in place in order to assume responsibility and liability for its medicinal products for veterinary use (VMPs) on the market and to ensure that appropriate action may be taken, when necessary.
The MAHs should ensure that they have an appropriate system of pharmacovigilance in place, in accordance with Article 74 of Directive 2001/82/EC and Article 48 of Regulation (EC) No. 726/2004.
Cosmetovigilance is defined by the collection, evaluation and monitoring of spontaneous reports of undesirable events observed during or after normal or reasonably foreseeable use of a cosmetic product. Together with other tools, cosmetovigilance contributes to post market surveillance.
This task falls to the Responsible Person (RP) to continuously monitor and record such effects and regularly re-assess the risk associated with them.
New regulation places an obligation on distributors to notify serious undesirable effects occurring in Europe to the local competent authority.
The marketing authorisation holder for a medicinal product (herbal medicinal products, certain medicinal products for external use or natural remedies) or the registration holder for a traditional herbal medicinal product must operate a pharmacovigilance system.
The Medical Devices Directives provide that adverse incidents are evaluated and, where appropriate, information is disseminated in the form of a National Competent Authority Report (NCAR) with the objective of preventing repetition of such incidents through the adoption of appropriate field safety corrective actions.
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