Примери за използване на Detailed grounds на Английски и техните преводи на Български
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The PRAC considered that a 2nd ad-hoc expert meeting was warranted to address some of the aspects that formed part of the detailed grounds submitted by Bracco and GE Healthcare.
The detailed grounds for the re-examination were submitted by Norbrook Laboratories Ltd on 14 April 2009.
Following the CHMP Opinion of 22 July 2010, one MAH submitted detailed grounds for the re-examination of the opinion.
The detailed grounds for the re-examination request were submitted by Vet-Agro Trading Sp. z o.o.
citing detailed grounds, for a re-examination of the opinion.
Notwithstanding this, and given the detailed grounds provided by the MAHs,
Given the detailed grounds provided by the MAH,
Based on the evaluation of the rapporteurs' assessment of the detailed grounds for the re-examination, on 11 November 2009, the CVMP considered the rapporteurs' proposal for amending the opinion adopted on 15 July 2009.
The scientific points of disagreement presented in the MAHs detailed grounds included efficacy aspects,
In its detailed grounds for re-examination, the MAH referred to a competitor product in which the release of oxycodone is accelerated in the presence of alcohol as an example of a potentially clinically meaningful interaction.
Having considered the detailed grounds submitted by the MAH, the PRAC confirmed
have requested the re-examination of the recommendation and submitted detailed grounds for the re-examination.
On 13 September 2006 the CVMP considered the detailed grounds for the re-examination of the opinion
submitted on 22 July 2014 its detailed grounds for the request for re-examination of the CHMP opinion recommending the refusal of the granting of the marketing authorisation.
including the information submitted during the original assessment procedure and the detailed grounds for re-examination put forward by the MAHs, the CHMP.
Having considered the detailed grounds for re-examination provided by the MAH in writing,
Having considered the detailed grounds for re-examination submitted by the MAH in writing,
a reassessment of existing information has detailed grounds for concluding that the use of a material
specific directives was adopted, has detailed grounds for establishing that the use of a material
The detailed grounds of the appeal must now be lodged with the FIA within 8 days of the stewards' decision.