Примери за използване на An assessment report на Английски и техните преводи на Български
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Shall be certified by an assessment report.
An assessment report with further details about the review has been published on EMA's website.
Each Assessment is published in an Assessment report.
An assessment report of the reference Member State containing information on the evaluation and decision on the plant protection product.
The evidence supporting the PRAC review will be published in an assessment report following the CHMP opinion.
Хората също превеждат
The same applies to an assessment report relating to the management capabilities of a member of the temporary staff which is drawn up under provisions internal to a Union agency.
The Commission should take this information into account when submitting an assessment report in order to identify possible needs for amending this Regulation.
In accordance with Article 15(4) of Regulation(EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 22 February 2008, in an assessment report.
The applicant shall request one Member State to act as“reference Member State” and to prepare an assessment report on the medicinal product in accordance with paragraphs 2 or 3.
The competent authorities shall draw up an assessment report and comments on the dossier as regards the results of the analytical and pharmacotoxicological tests and the clinical trials of the medicinal product concerned.
Submits to the Commission a description of the management and control systems accompanied by an assessment report on their compliance with Articles 101 and 105 of Commission Regulation(EC) No.
The competent authorities shall draw up an assessment report and comments on the dossier as regards the results of the analytical and pharmacotoxicological tests and the clinical trials of the veterinary medicinal product concerned.
In accordance with Article 15(4) of Regulation(EC) No 1451/2007, the findings of the review were incorporated in an assessment report reviewed within the Standing Committee on Biocidal Products on 13 March 2014.
This condition is satisfied in the case of an assessment report on management capabilities, as such a report is based on value judgments which are subjective and thus, by their nature, susceptible to change.
And 3, respectively, of the FDA,the rapporteur Republic of Bulgaria within 60 days from the date of receipt of the periodic safety update report shall draw up an assessment report and send it electronically to the European Medicines Agency and the regulatory authorities of the Member States.
The rapporteur shall prepare an assessment report within 60 days of receipt of the periodic safety update report and send it to the Agency and to the members of the Pharmacovigilance Risk Assessment Committee.
The applicant shall request one Member State to act as reference Member State and to prepare an assessment report in respect of the veterinary medicinal product in accordance with paragraphs 2 or 3.
The competent authority shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical, safety and residue tests and the pre-clinical and clinical trials of the veterinary medicinal product concerned.
The applicant shall request one Member State to act as reference Member State and to prepare an assessment report in respect of the veterinary medicinal product in accordance with paragraphs 2 or 3.
The reporting Member State shall assess the application with regard to an aspect covered by Part I of the assessment report, including whether the clinical trial will remain a low-intervention clinical trial after its substantial modification,and draw up an assessment report.
Submits to the Commission a description of the management andcontrol systems accompanied by an assessment report on their compliance with Articles 101 and 105 of Commission Regulation(EC) No. 718/2007 of 12 June 2007.
The technical services which have presented an assessment report issued by a national authority of another European Union Member State shall provide the Automobile Administration Executive Agency with information concerning all changes in the notification and the reports from the surveillance checks performed, within one week after their issuance.
To this end, the marketing authorisation holder shall request the reference Member State either to prepare an assessment report on the medicinal product or, if necessary, to update any existing assessment report. .
The designating approval authority shall draw up an assessment report demonstrating that the candidate technical service has been assessed for its compliance with the requirements of this Regulation and the delegated acts adopted pursuant to this Regulation.
To this end, the marketing authorisation holder shall request the reference Member State either to prepare an assessment report on the medicinal product or, if necessary, to update any existing assessment report. .
The designating approval authority shall draw up an assessment report demonstrating that the candidate technical service has been assessed for its compliance with this Regulation and the delegated acts adopted pursuant to it.
Whereas concern in terms of transparency andconflicts of interest has furthermore been raised by several stakeholders over the fact that the RMS given responsibility by the Commission for the renewal of an assessment report may be the same one which did the initial draft assessment report; .
To this end, the marketing authorisation holder shall request the reference Member State either to prepare an assessment report on the medicinal product or, if necessary, to update any existing assessment report. .
Assess the quality, safety andefficacy of the medicinal product and shall draw up an assessment report with comments on the results of the pharmaceutical and pre-clinical tests and clinical trials, the risk management system and the system for monitoring the safety of the medicinal product concerned.