Recommendations of the CHMP* Pharmacovigilance Working Party on implementation of new safety-related information in the product information of medicines
Safety concerns may emerge with any medicines that may necessitate modifications in the product information so that a positive benefit-risk balance is continuously maintained. Some of these safety-related updates are agreed on and recommended by the Pharmacovigilance Working Party of the CHMP (PhVWP) and should be implemented by all concerned marketing authorization holders in a uniform and harmonized manner. This way, relevant new safety information becomes available for healthcare professionals and patients at the same time in all concerned member states of the European Economic Area.
In order to facilitate timely implementation, recommended changes to product information agreed by the PhVWP and made public by the Heads of Medicines Agencies are published on the website of the National Institute of Pharmacy (NIP) as well. This publication includes:
1. SPC (Summary of Product Characteristics) and PIL (Patient Information Leaflet) wordings to be implemented in English and Hungarian, and
2. timeline of implementation as approved by the coordination group (CMDh).
Timelines to be observed by the marketing authorization holders concerning implementation of PhVWP wording recommendations are published by NIP beginning from January 2012. Timelines that has already been expired are not displayed retroactively.
Marketing authorization holders that hold an authorization for a medicine valid on the territory of Hungary containing the concerned active substance(s), are requested to submit a variation application to modify the product information in accordance with the agreed PhVWP wording observing the published timelines.
