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European Medicines Agency
Postauthorisation Evaluation of Medicines for Human Use London, 23 February 2006
Doc. Ref. EMEA/180079/2005POSTAUTHORISATION GUIDANCE
Human Medicinal ProductsQUESTIONS AND
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What is post-authorisation guidance?
Post-authorisation guidance refers to the regulatory guidance provided by authorities after the approval of a medical product or medication. It provides additional instructions for the safe and effective use of the product.
Who is required to file post-authorisation guidance?
The marketing authorisation holder or any authorised party is responsible for filing post-authorisation guidance.
How to fill out post-authorisation guidance?
Post-authorisation guidance can be filled out through the submission of required forms and documents specified by the regulatory authorities. These forms typically require detailed information about the medical product and its intended use.
What is the purpose of post-authorisation guidance?
The purpose of post-authorisation guidance is to ensure continuous monitoring and evaluation of medical products after they have been approved. It helps identify any new risks, provide updated information, and improve patient safety.
What information must be reported on post-authorisation guidance?
Post-authorisation guidance requires reporting of any new safety concerns, changes in the product's indications, dosages, contraindications, interactions, and updates on its benefit-risk profile.
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