An element of drug marketing applications, which provides a substantially condensed summary of the quality-related data provided within the submission.
An element of drug marketing applications, which provides a substantially condensed summary of the quality-related data provided within the submission.
As defined in ICH E6 “A standard for the design, conduct, performance, monitoring, auditing, recording,…
View definitionThe date of the first marketing authorization for any product containing the active substance granted…
View definitionThis website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this site, you will need to enable or disable cookies again.
This site uses Google Analytics to collect anonymous information such as the number of visitors to the site and the most popular pages.
Keeping this cookie activated helps us to improve our website.
Please first enable strictly necessary cookies so that we can save your preferences !
This site uses Google Analytics to collect anonymous information such as the number of visitors to the site and the most popular pages.
Keeping this cookie activated helps us to improve our website.
Please first enable strictly necessary cookies so that we can save your preferences !
More information about our Privacy Policy