Examples of using Documentation submitted in English and their translations into Croatian
{-}
-
Colloquial
-
Ecclesiastic
-
Computer
The certification shall be based on documentation submitted by the railway undertaking as described in Annex IV.
Documentation submitted to the Authority as part of the application shall be published immediately on the website referred to in Article 32.
According to Brussels, the most serious problem is poorly prepared documentation, submitted without the necessary explanations and projections.
Any documentation submitted with the request shall conform to the requirements of Administrative and Financial Regulation 30.
The protection arrangements prevent applicants for a generic product from referring to the documentation submitted for the reference product.
Verify that the documentation submitted complies with the requirements laid down in Article 7(1) and is satisfactory for granting a marketing authorisation;
Within 90 days of its appointment, the joint assessment team shall review the documentation submitted with the application in accordance with Article 38.
Only information and documentation submitted before the interview to determine which state is responsible for examining their application is taken into account.
Within 90 days of its appointment, the joint assessment team shall review the documentation submitted with the application in accordance with Article 38.
For the documentation submitted in written, eAF should be submitted in addition on CD, as well as the summary of product characteristics, package leaflet and labelling.
Such an application for approval shall refer to the application(including documentation submitted) and authorisation under Directive 2011/61/EU.
The documentation submitted with the application for a permanent residence shall be submitted in the original copy or a certified copy, and documents in a foreign language shall be submitted with a translation into one of the official languages in Bosnia and Herzegovina.
We are concerned for example,whether there was sufficient time for a comprehensive review of the thousands of pages of technical documentation submitted only in English.
In order to ensure additional consistency in opinion,the assessment of documentation submitted alongside the majority of applications(all marketing authorisations, renewals and variations depending on the need) are confirmed by the Committee for medicinal products, HALMED's body gathering internal and when needed external experts with different expertise.
Working days(if the other party does not provide documentary evidence within 10 working days,ECHA will assess the dispute based only on the documentation submitted by the claimant).
This part also regulates the‘protection period' applying to technical documentation submitted in order to obtain or amend a marketing authorisation.
Member States shall ensure that when determined in accordance with Article 38(2)(f), the retrospective assessment shall be carried out by thecompetent authority which shall, on the basis of the necessary documentation submitted by the user, evaluate the following.
Within 90 days after designation of the joint assessment team, the national authority responsible for notified bodies andthe joint assessment team shall review the documentation submitted with the application in accordance with Article 29 and conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or sub-contractor, located inside or outside the Union, to be involved in the conformity assessment process.
Article 49(2) to(4) shall apply to the coordinating Member State in relation to the verification that the clinical performance study falls within the scope of this Regulation andthat the application is complete, except for the documentation submitted in accordance with Sections 4.2, 4.3 and 4.4 of Chapter I of Annex XIII.
Such disclosure should cover a number of elements, which are not covered by the usual documentation submitted to customs, such as shipping documents and customs declarations.
(40) In order to facilitate the functioning of the authorisation and mutual recognition procedures, it is appropriate to establish a system for the mutual exchange of information, and Member States,the Commission and the Agency should make available to each other on request the particulars and scientific documentation submitted in connection with applications for authorisation of biocidal products.
Member States should make available to each other,the Commission and the Authority the particulars and scientific documentation submitted in connection with applications for authorisation of plant protection products.
Documentation for dossier upgrading is comprised from the previously submitted documentation and the additional documentation submitted with the application according to these Instructions.
The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions,as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate.
The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions,as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate.
The notified body shall keep a copy of the EC-type examination certificate, its annexes and additions,as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.
The notified body shall keep a copy of the EU type-examination certificate, its annexes and additions,as well as the technical file including the documentation submitted by the manufacturer, until 5 years after the expiry of the validity of that certificate.
The notified body shall keep a copy of the EU type-examination certificate, its annexes and additions,as well as the technical file including the documentation submitted by the manufacturer, for a period of five years after the expiry of the validity of that certificate.
Under the direction of the coordinating Member State referred to in paragraph 2, the Member States concerned shall coordinate their assessment of the application,in particular of the documentation submitted in accordance with Chapter I of Annex XIII, except for Sections 4.2, 4.3 and 4.4 thereof which shall be assessed separately by each Member State concerned.
(a) within 6 days of receipt of the single application notify the sponsor whether the clinical investigation falls within the scope of this Regulation andwhether the application is complete, except for the documentation submitted in accordance with Sections 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XIV for which each Member State shall verify the completeness.