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15 November 2021 EMA/679405/2021 Veterinary Medicines Division It is strongly recommended referring to the GPV module on collection and recording of suspected adverse events for veterinary medicinal
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How to fill out extensions of marketing authorisations
01
Obtain the necessary application form for the extension of marketing authorisations.
02
Fill out the application form with accurate and up-to-date information regarding the product and its use.
03
Provide any required supporting documentation, such as updated clinical trial data or safety information.
04
Submit the completed application form and supporting documentation to the regulatory authority for review.
05
Respond promptly to any requests for additional information or clarifications from the regulatory authority.
06
Await the decision from the regulatory authority regarding the approval or rejection of the extension of marketing authorisations.
Who needs extensions of marketing authorisations?
01
Pharmaceutical companies seeking to extend the marketing authorisations for their products.
02
Manufacturers looking to introduce new indications or dosages for existing products.
03
Companies aiming to expand the geographical scope of their marketing authorisations.
04
Any entity wishing to modify the conditions of an existing marketing authorisation.
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What is extensions of marketing authorisations?
Extensions of marketing authorisations are requests made to regulatory authorities to extend the marketing approval period for a specific product or indication.
Who is required to file extensions of marketing authorisations?
Manufacturers or sponsors of pharmaceutical products are required to file extensions of marketing authorisations.
How to fill out extensions of marketing authorisations?
Extensions of marketing authorisations are typically filled out using specific forms provided by the regulatory authorities, with detailed information about the product, indication, safety data, etc.
What is the purpose of extensions of marketing authorisations?
The purpose of extensions of marketing authorisations is to allow continued marketing of a product beyond its initial approval period, based on updated data and information.
What information must be reported on extensions of marketing authorisations?
Information required on extensions of marketing authorisations typically includes updated safety data, efficacy data, labeling information, etc.
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