The phrase "authorisation application" is correct and usable in written English.
It can be used in contexts where someone is submitting a request for permission or approval, often in legal, administrative, or regulatory settings.
Example: "The company submitted an authorisation application to the local government for the new construction project."
Alternatives: "permission request" or "approval application".
5 This period was further subdivided by the date of Marketing Authorisation Application (MAA, regulatory submission or 'filing') into periods representing clinical trials (prior to filing) and subsequent regulatory approval.
We used the nine main placebo controlled trials submitted to the European Medicines Agency in the marketing authorisation application of duloxetine for the treatment of major depressive disorder in adults.
Duration of clinical development (from initiation of studies in humans to receipt of Marketing Authorisation), subdivided into clinical trial and regulatory approval periods by the date of Marketing Authorisation Application.
11 12 13 In May 2011, before the EMA began to limit access to clinical study reports, we obtained such reports for the nine placebo controlled trials submitted in the marketing authorisation application of duloxetine for the treatment of major depressive disorder.
As part of the Regulatory Fitness and Performance Programme initiative, the Commission will streamline and simplify the authorisation application procedure under REACH in order to increase the predictability of the process for companies and reduce the administrative burden.
In negotiations, MEPs amended the draft to improve transparency, by requiring that detailed summaries be published in a publicly-accessible EU database, including full clinical study reports to be published once a decision on marketing authorisation has been taken or the marketing authorisation application has been withdrawn.
This amendment seeks to enhance the status of authorised economic operator by simplifying authorisation applications and procedural audits for authorised economic operators and speeding up processing operations.
The authors want to note that only the future will show whether applicants with either few or many resources will be treated equally upon authorisation applications.
This article addresses regulation of cell therapies in the European Union (EU), covering cell sourcing and applications for clinical trials and marketing authorisation applications.
Responsibility for this development in Germany lies with UBA, in parallel to the processing of authorisation applications.
In 2006, the European Medicines Agency (EMA) decided that all new marketing authorisation applications for human pharmaceuticals should be accompanied by an environmental risk assessment [1].
