This page is intended to provide advice to Marketing Authorisation Holders of centrally authorised medicinal products about procedural and regulatory aspects to the Risk Management Plan RMP lifecycle during the post authorisation phase. It addresses the classification of changes to the RMP, submission requirements and aspects to be considered in the management of parallel procedures affecting RMP. Revised topics are marked 'New' or 'Rev. MAHs must in all cases comply with the requirements of Community legislation. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text. It should be noted, however, that for these products without RMP there are situations e.
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RMP INFOTEC PVT. LTD. ~ NETWORK MARKETING INDIA
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11+ Risk Management Plan Templates – Samples, Examples
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