The famhp has updated the e-Submission guidelines in order to underline the required use of the electronic application form starting from the 1st of January 2016.
To the attention of the holders of Mas for medicinal products for human use : update of the document ‘New definition of the approval date in SmPC and leaflet’
The document ‘New definition of the approval date in SmPC and leaflet’ was recently subject to adjustments.
To the attention of the holders of Mas for medicinal products : update of the document "Exemptions: procedure to be followed for medicines for human use"
The document “Exemptions: procedure to be followed for medicines for human use” concerning the exemptions for the obligations for packaging and patient leaflet was recently updated.
To the attention of the holders of MA for medicinal products for human use : update of the FAQ on Variations.
A new version (3) of the document ‘National FAQ on variations’ is available.
To ensure that marketing autorisation holders are kept informed about the progress of their submitted files (obtaining a new licence, as well as variations, notifications and renewals), our IT-system sends out automatic mails. It seems, based on several notifications errors that we received, that certain e-mail addresses are no longer valid. An update of these addresses is necessary.
To the attention of holders of MA’s: new definition for the approval date mentioned in SmPC and PIL.
When the administratively closing of a variation or renewal leads to an update of the marketing authorization (MA), a new methodology to determine the approval date mentioned in the summary of product characteristics (SmPC) and patient leaflet (PIL) will be used from 15/6/15.
The new edition of the electronic newsletter "VIG-NEWS" of the federal agency for medicines and health products (famhp) is now available. The VIG-NEWS is a selection of recent news concerning pharmacovigilance from different sources.
Due to a reduction in the manufacturing capacity for the vaccines HAVRIX 1440 and HAVRIX JUNIOR 720 (GSK), used to protect adults and children against hepatitis A, and in order to limit the impact of these supply shortages, alternatives are being proposed The Superior Health Council (SHC) details the correct use of the proposed alternatives in advice number 9260: Recommendation concerning the risk on the shortage supply for hepatitis A vaccine.