Examples of using Validation date in English and their translations into Slovak
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Validation date will be displayed on your ad.
(a) within 10 days from the validation date for low-intervention clinical trials;
Notification shall bedone by way of one single decision within ten days from the validation date.
The reference MSCA has 90 days from the validation date to assess whether a full evaluation of the dossier is required.
Each Member Stateconcerned shall complete its assessment within ten days from the validation date.
Where the sponsor is not notified, the validation date shall be the last day of the time periods referred to in paragraphs 1 and 3.
An initial assessment phase performed by thereporting Member State within 26 days from the validation date;
Where the sponsor is not notified, the validation date shall be the last day of the periods referred to in paragraphs 1, 3 and 4 respectively.
The Member State shallnotify the sponsor of the authorisation within 45 days of the validation date referred to in paragraph 5.
Between the validation date and the reporting date, only the reporting Member State may request additional information from the sponsor, taking into account the considerations referred to in paragraph 5.
The Member State shallnotify the sponsor of the authorisation within 45 days of the validation date referred to in paragraph 5.
The reporting Member State, and only the reporting Member State, may, between the validation date and the assessment date, request additional explanations from the sponsor, taking into account the considerations referred to in paragraph 4.
Establish the results of its assessment in a draft assessmentreport to be transmitted within 26 days of the validation date to the Member States concerned.
(c) after the expiry of 35 days after the validation date referred to in paragraph 4, unless the Member State concerned has notified the sponsor within that period of its refusal based on considerations of public health, patient safety or public policy.
For the purpose of this Article, the date on which the sponsor is notified in accordance with paragraph 1 shall be the validation date of the application.
Each Member State concernedshall complete its assessment within 45 days from the validation date and submit, through the EU portal, Part II of the assessment report, including its conclusion, to the sponsor.
For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 2 shall be the validation date of the application.
By day 38 after the validation date, the other Member States concerned shall transmit their comments and proposals on the draft assessment report and the underlying application to the coordinating Member State which shall take due account of those comments and proposals in its finalisation of the final assessment report, to be transmitted within 45 days of the validation date to the sponsor and the other Member States concerned.
For the purposes of Articles 18, 19 and 22, the date on which the sponsor is notified in accordance with paragraph 2 shall be the validation date of the application.
In the case of investigational class I devices or in the case of non-invasive class IIa and class IIb devices, unless otherwise stated by national law,immediately after the validation date of the application pursuant to paragraph 5, and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the clinical investigation;
For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 1 or 3 shall be the validation date of the application.
The sponsor may at its owninitiative change the content of the application only between the validation date and the assessment date and only for duly justified reasons.
The reporting Member State shall submit Part I of the assessment report, including its conclusion, to the sponsor andto the other Member States concerned within 15 days from the validation date.
Each Member State concerned shall assess, for its territory, the aspects of the substantial modification which are covered byPart II of the assessment report within ten days from the validation date.
The reporting Member State shall submit, through the EU portal, the final assessment report including its conclusion, to the sponsor andto the other Member States concerned within 38 days from the validation date.
Each Member State concerned shall assess, for its own territory, the aspects of the substantial modification which are covered by Part II of the assessment report and submit, through the EU portal, that report, including its conclusion,to the sponsor within 38 days from the validation date.
To avoid lengthy clinical trial authorisation procedures that would delay patients' access to clinical trials the EESC proposes the following amendment in Article 7(2) first sentence:"Each Member State shall complete its assessment, including the opinion of thenational ethics committee, within 10 days from the validation date pursuant to Article 6(4).".
Date- data validation.