Adjusting entries questions and answers pdf

European Union agency responsible for the protection of public and animal health through the scientific evaluation and supervision of medicines. Revised topics are marked ‘New’ or ‘Rev. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the adjusting entries questions and answers pdf sections of the text. MAH should provide additional data post-authorisation, as it is necessary from a public health perspective to complement the available data with additional data about the safety and, in certain cases, the efficacy or quality of authorised medicinal products.

The existence of such a system of PAMs does not aim at promoting premature approvals of marketing authorisations or post-authorisation procedures. The background and rationale for requesting PAMs will be described in the relevant assessment, which will present the context and nature of the PAM. PAMs are classified into their appropriate legal framework under which they will be enforced. What is a Specific Obligation?

PAMs other than specific obligations can be required for any type of authorisation and will be included in the opinion of an initial marketing authorisation or further to the committees’ assessment during post-authorisation. The wording of the PAM will describe the issue under investigation that has led to the request together with a clear outline of the studies or activities expected to address it and the deadline for its submission. Compliance with these measures is defined by both the submission of the requested data and adherence to the agreed timeframe. These codes relate to the Agency’s product and procedure tracking database called SIAMED and will be used, together with a numbering system, to identify each PAM of a medicinal product both in the database and in any correspondence of the Agency with the MAH.

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