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Public Assessment Report Decentralized Procedure 250 mg Film coated Tablets 500 mg Film coated Tablets 750 mg Film coated Tablets 1000 mg Film coated Tablets Procedure No: UK/H/3150/0014/DC UK License
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What is mhra public assessment report?
The MHRA (Medicines and Healthcare products Regulatory Agency) Public Assessment Report (PAR) provides information on the assessment of medicinal products that have been granted marketing authorization in the UK.
Who is required to file mhra public assessment report?
The marketing authorization holder (MAH) is required to file the MHRA Public Assessment Report (PAR) for their medicinal products.
How to fill out mhra public assessment report?
To fill out the MHRA Public Assessment Report (PAR), the marketing authorization holder (MAH) must provide detailed information on the quality, safety, and efficacy of their medicinal product, as well as any relevant clinical data and supporting documentation.
What is the purpose of mhra public assessment report?
The purpose of the MHRA Public Assessment Report (PAR) is to provide transparent and comprehensive information to healthcare professionals and the public about the evaluation and authorization process of medicinal products in the UK.
What information must be reported on mhra public assessment report?
The MHRA Public Assessment Report (PAR) requires the marketing authorization holder (MAH) to report information on the quality, safety, and efficacy of their medicinal product, including its composition, manufacturing process, clinical trial data, adverse reactions, and packaging details.
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