Przykłady użycia Documentation submitted w języku Angielski i ich tłumaczenia na język Polski
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Medicine
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Colloquial
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Official
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Ecclesiastic
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Ecclesiastic
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Financial
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Official/political
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Programming
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Computer
The Commission shall examine documentation submitted by Member States.
Based on the documentation submitted by the Marketing Authorisation Holder
The Commission shall examine documentation submitted by Member States.
Any documentation submitted with the request shall conform to the requirements of Administrative
The applicant may refer to other documentation submitted alone or with a simplified IMPD.
The documentation submitted by the sponsor shall include data on all costs that the sponsor has incurred in the course of developing the medicinal product;
Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee.
verification of conformity with the description provided in the documentation submitted by the holder.
The certification shall be based on documentation submitted by the railway undertaking as described in Annex IV.
The protection arrangements prevent applicants for a generic product from referring to the documentation submitted for the reference product.
To dothis, it will review the documentation submitted for compliance and maintain aregister of European crowdfunding platforms.
The competent authority or the Agency to which the application has been submitted in accordance with Article 6 shall inform the applicant if the documentation submitted in support of the application is insufficient.
To do this, it will review the documentation submitted for compliance and maintain a register of European crowdfunding platforms.
package leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee.
For this purpose the Commission shall examine documentation submitted by Member States
speed ranges it is necessary to have additional specifications then these shall be declared in the format of Annex 1 and attached to the documentation submitted.
Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee.
The documentation submitted by the sponsor shall include
The competent authorities of the UCITS home Member State shall verify whether the documentation submitted by the UCITS according to paragraphs 1
Benefit/ Risk considerations Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CPMP considered
on the basis of the protocols and the documentation submitted by the applicant, a certificate attesting to this fact.Â.
Based on the documentation submitted by the MAH and the scientific discussion within the Committee,
as well as the technical file including the documentation submitted by the manufacturer for a period up to the end of the validity of the certificate27.
Based on the documentation submitted by the MAH and the scientific discussion within the Committee,
The competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries are able to manufacture the veterinary medicinal product concerned and/or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with Article 71.
The documentation submitted with this application consists of literature referring to the use of the originator product Eqvalan,
package leaflet proposed by the applicant has been assessed based on the documentation submitted and the scientific discussion within the Committee.
Applicant has been assessed based on the documentation submitted, the scientific discussion within the Committee
The scope of the referral was the harmonisation of the Summaries of Products Characteristics,• the Summary of Products Characteristic proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,• Important new information on interactions with several medicinal products was included in the SPC.
Shall check that the documentation submitted in support of the application complies with Articles 12