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Country: Malta
Title: 126a Notification of Variation (Malta Medicines Authority)
Description: Following the issue of the 126a authorisation, the Authorisation holder must notify the Medicines Authority of any changes to the authorised product, which have been approved in the Member State (EU/EEA country of source) that will affect the details on the authorisation document and/or the product information.
Link: https://eforms.gov.mt/pdfforms.aspx?fid=HCC065E
Category: Healthcare

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