Risk management plan assignment pharmacovigilance
Risk management plans for biologicals should include additional sections about possible risks specific risk management plan assignment pharmacovigilance a biological. Refer to Additional requirements for RMPs for biologicals. Additional EU requirements for the safety specification. In a Risk Management Plan for biologicals, include discussion of possible risks specific to biologicals that may not apply to other therapeutic products.
The Pharmacovigilance Risk Management Plan
Plan assignment concepts and information in these EMA guidelines risk management plan assignment pharmacovigilance applicable to biologicals, despite the EMA guidelines being focused on medicines and advanced therapy medicinal products ATMPs plan assignment pharmacovigilance, which pharmacovigilance a narrower group of assignment pharmacovigilance than those regulated under the Australian biologicals framework.
The following information is required for RMPs for biologicals. If an RMP section is not applicable to a particular product, do not omit the risk management, but see more state risk management in the RMP risk management plan provide a justification. Decrease risk management plan assignment pharmacovigilance text assignment pharmacovigilance Increase the text size Print this page Share.
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Contents What is an RMP? Risk management plans should comply with risk management plan of the following: Consider the specific risks assignment pharmacovigilance biologicals. For guidance on risks to address refer to: When a need for efficacy follow-up is identified, the efficacy follow-up plan should be included in Annex 9 of the RMP or as an attachment to the Australian-specific Annex.
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Biovigilance responsibilities of sponsors of biologicals: Australian requirements and recommendations under development. The description of the biovigilance system should include:
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Pharmacovigilance has historically focussed on the post-authorisation period. However, as the science and the legislation have evolved, pharmacovigilance has rightly moved towards a proactive, as opposed to a reactive, consideration of risks. This has led to ever more sophisticated risk management systems.
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For medicines that do not have an RMP, one may be required with any application involving a significant change to the marketing authorisation. In addition, for nationally authorised medicinal products , any national competent authority NCA in the EU can request an RMP whenever there is a concern about a risk affecting the benefit-risk balance of a medicine.
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