Get the free Guideline on core SmPC and Package Leaflet for 5 (99mTc) macrosalb
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1 2 3 412 October 2017 EMA/CHMP/745358/2016 Committee for Medicinal Products for Human Use (CHMP)6Guideline on core DMPC and package leaflet for (99mTc) macrosalb7Draft58 Draft Agreed by Radio pharmaceuticals
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What is guideline on core smpc?
Guideline on core smpc provides instructions and requirements for the submission of core Safety Management and Performance Checks (smpc) for a specific product.
Who is required to file guideline on core smpc?
The manufacturer or sponsor of the product is required to file guideline on core smpc.
How to fill out guideline on core smpc?
Guideline on core smpc can be filled out by following the specific instructions provided in the document and ensuring all required information is included.
What is the purpose of guideline on core smpc?
The purpose of guideline on core smpc is to ensure that safety management and performance checks are conducted according to regulatory requirements and standards.
What information must be reported on guideline on core smpc?
The guideline on core smpc must include information on the product, safety management procedures, performance checks, and any relevant data or findings.
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