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[Version 8, 10/2012]VIAUKI ISAMANTEKT EIGINLEIKUM LYFS 1. HEITI DRALYFS(Sr)heiti dralyfs styrkleiki lyfjaform drategundir.2. INNIHALDSLSINGVirk innihaldsefni:nmisglar:Hjlparefni:Sj lista yfir ll hjlparefni
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How to fill out application for marketing authorisation

01
Gather all necessary documents and information needed for the application, such as product details, manufacturing process, safety and efficacy data.
02
Complete the application form with accurate and detailed information about the product and its intended use.
03
Submit the application along with the required fees to the regulatory authority responsible for approving marketing authorisations.
04
Respond promptly to any requests for additional information or clarification from the regulatory authority.
05
Prepare for an inspection of the manufacturing facilities and quality control systems by the regulatory authority.
06
Await the decision on the application from the regulatory authority before marketing the product.

Who needs application for marketing authorisation?

01
Companies or individuals who wish to market a pharmaceutical or medical device product in a particular country or region.

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An application for marketing authorisation is a formal request submitted to a regulatory authority seeking permission to commercially distribute a product, typically a pharmaceutical drug or medical device, after it has met safety and efficacy standards.
The manufacturer or sponsor of the product seeking to market it is required to file the application for marketing authorisation, usually through a designated representative or legal entity in the relevant jurisdiction.
To fill out the application for marketing authorisation, one must gather and submit comprehensive data including product details, clinical trial results, safety and efficacy information, manufacturing processes, and labeling, in the specific format required by the regulatory body.
The purpose of the application for marketing authorisation is to ensure that a product is safe, effective, and of high quality before it can be made available to the public.
The application must include information such as the product's composition, pharmacology, toxicology, clinical data, proposed labeling, and manufacturing details.
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