Herbal Vigilance

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.

Applicants for, and holders of simplified registrations of traditional herbal medicinal products are not required to submit a pharmacovigilance system summary, however, each are required to operate a pharmacovigilance system and prepare, maintain and make available on request a pharmacovigilance system master file.

For other herbal medicinal products, not falling within the scope of the traditional use registration, the requirements to operate a pharmacovigilance system, to prepare, maintain and make available on request a pharmacovigilance system master file and to submit a summary of the pharmacovigilance system apply.

For homeopathic medicinal products registered via the simplified registration procedure the requirements to operate a pharmacovigilance system, to maintain and make available on request a pharmacovigilance system master file and to submit a summary of the pharmacovigilance system do not apply.

For other homeopathic medicinal products, not falling within the scope of the simplified registration, the requirements to operate a pharmacovigilance system, to prepare, maintain and make available on request a pharmacovigilance system master file and to submit a summary of the pharmacovigilance system apply.

As all THR registrations will be based on 30 years’ safe use, Marketing Authorisation Holders (MAHs) for the majority of registered herbal products will be requested to submit PSURs on a three-yearly cycle.

However, more frequent PSURs may be required for some registered products.

For more information please contact us at enquiries@pharmafile.ie