Примери за използване на Authorisation application на Английски и техните преводи на Български
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Medicine
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Colloquial
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Official
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Ecclesiastic
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Ecclesiastic
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Computer
The harmonization of the pharmacokinetic section in the teicoplanin SmPC is based on the data first provided in the initial marketing authorisation application, and more recent data retrieved from a literature research.
presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
conducted to support the marketing authorisation application in the United States
of the marketing authorisation application dossier.
Developing your translation strategy as early as possible will allow adequate time for a Language Service Provider to familiarise itself with the needs of your company, your authorisation application, and any modifications that need to occur in the application while the process is in its initial English-only stages.
In conclusion, the MAH was of the opinion that the results from the pivotal bioequivalence study supporting the marketing authorisation application are confirmed by the other studies not conducted at,
presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
usage instructions are appropriate for the intended use specified in the marketing authorisation application dossier.
presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Deadlines for Union authorisation applications National authorisation and mutual recognition renewal.
Deadlines for Union authorisation applications.
The table below lists the deadlines for Union authorisation applications, which are necessary to keep existing products on the market.
The Committee concluded that the particulars supporting the marketing authorisations and marketing authorisation applications are incorrect
This is also the deadline for submitting EU product authorisation applications to keep existing products on the market.
The CHMP reviewed the bio-analytical studies performed at Texas-based Cetero Research facility that had been submitted as part of the marketing authorisation applications of the medicines concerned.
were considered not reliable to support marketing authorisation applications(MAAs).
consulting companies are welcome to use the partners service for applicants to find a suitable partner for their authorisation applications.
To ensure effective examination of authorisation applications and to enhance the competitiveness of Community research and industry,