Get the free Application to MHRA for Clinical Trials Authorisation
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Queen's University
BelfastResearch and EnterpriseStandard Operating Procedure
Research Governance
Title:Application to MARA for Clinical Trials Authorizations ReferenceQUBADREOlODate prepared21 July2008Version
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What is application to mhra for?
Application to MHRA is for seeking approval for the marketing of a new medicinal product in the UK.
Who is required to file application to mhra for?
Any pharmaceutical company looking to market a new medicinal product in the UK is required to file an application to MHRA.
How to fill out application to mhra for?
To fill out an application to MHRA, the pharmaceutical company needs to provide comprehensive information about the medicinal product, its safety, efficacy, and quality.
What is the purpose of application to mhra for?
The purpose of the application to MHRA is to ensure that the new medicinal product meets the necessary standards for safety, efficacy, and quality before it is marketed in the UK.
What information must be reported on application to mhra for?
The application to MHRA must include detailed information about the medicinal product, its formulation, manufacturing process, preclinical and clinical data, and proposed labeling and packaging.
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