Examples of using Documentation submitted in English and their translations into Bulgarian
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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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Computer
The CMDh considered the documentation submitted by one MAH(KRKA d.d.,
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 7(1).
manages qualification equivalence requests by checking the documentation submitted(declarations of value
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 7(1).
that Member States should make available to each other on request the particulars and scientific documentation submitted in connection with applications for authorization of plant protection products;
that Member States and the Commission should make available to each other on request the particulars and scientific documentation submitted in connection with applications for authorisation of biocidal products;
The documentation submitted by the applicant should cover all aspects of the safety and/or efficacy assessment and must include or refer to a
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 7(1)
Consequently, in cases where the documentation submitted by the Member State gave rise to observations being sent by the Commission,
the joint assessment team shall review the documentation submitted with the application in accordance with Article 29
After reviewing all the documentation submitted by the marketing authorisation holders, the CVMP concluded
The documentation submitted by the applicant should cover all aspects of the safety and/or efficacy assessment
(b) The documentation submitted by the applicant should cover all aspects of the efficacy assessment and must include
The Commission shall examine documentation submitted by Member States.
The applicant may refer to other documentation submitted alone or with a simplified IMPD.
Based upon the documentation submitted, the Committee will approve
Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee.
The certification shall be based on documentation submitted by the railway undertaking as described in Annex IV.
The certification shall be based on documentation submitted by the railway undertaking as described in Annex IV.
The information on conflicts of interests will also constitute a part of the documentation submitted during the formal consultation process.