Examples of using Update reports in English and their translations into German
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Medicine
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Colloquial
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Official
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Ecclesiastic
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Financial
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Ecclesiastic
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Political
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Computer
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Programming
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Official/political
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Political
Update reports, list of IVV marathons.
Periodic Safety Update Reports.
Update reports as regularly as daily.
Periodic Safety Update Reports.
We update reports and upcoming events once a week.
Periodic Safety Update Reports.
Periodic safety update reports, follow-up measures and specific obligations 1999-2001 75.
The Marketing Authorisation Holder willcontinue to submit annual Periodic Safety Update Reports.
To provide the Periodic Safety Update Reports for the last 3 years.
All further safety data have tobe presented annually in Development Safety Update Reports DSUR.
Periodic safety update reports: The periodical reports containing the records referred to in Article 75.
The Marketing Authorisation Holderwill continue to submit Periodic Safety Update Reports on a 2 years basis.
Create and update reports from a large number of parameterized simulations according to specific routines to grant the best possible reproducibility and quality.
The marketing Authorisation holderwill continue to submit periodic safety update reports on a 2-year cycle.
Currently, periodic safety update reports are line listings of adverse reactions and, as for adverse reactions reports, are submitted for all medicinal products.
Developing andemerging countries are expected to submit Biennial Update Reports(BURs) to the UNFCCC every two years.
Periodic safety update reports shall also be submitted immediately upon request or at least every six months during the first two years following the initial placing on the Community market and once a year for the following two years.
The general volume of activity in terms of periodic safety update reports(PSURs) increased only slightly compared to 2001 levels.
Marketing authorisation holders shall be required to submit to the Agency periodic safety update reports containing.
However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates(EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
At the time of granting the marketing authorisation,the submission of periodic safety update reports is not required for this medicinal product.
In connection with the proposal to abolish the five-yearly renewal requirement, and to increase the efficacy of the system,it is proposed that the deadlines for the compulsory submission of periodic safety update reports be shortened Article 104.
The List of Union reference dates andfrequency of submission of periodic safety update reports(EURD- list) is now a binding list since the 1th of April 2013.
There is still much to do after successful approval: imposed conditions have to be fulfilled, extension deadlines met,periodic safety update reports(PSUR) initiated and submitted on time.
In addition, duration a pandemic,resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
Evaluation of the effectiveness of any risk management system and the results of any studies performedshall be included in the periodic safety update reports referred to in Article 24(3) of Regulation(EC) No 726/2004.
PSURs The MAH will continue tosubmit 3 yearly Periodic Safety Update Reports, unless otherwise specified by the CHMP.
The Council has rejected amendment120 counting the intervals for periodic safety update reports from the time of first marketing instead of marketing authorisation.
This is acceptable, in particular as the Council has agreed on a new Article 104(6a)whereby amendments to the arrangements concerning the periodic safety update reports can be adopted through a Committee procedure in the light of experience gained.