Examples of using Documentation submitted in English and their translations into Greek
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Medicine
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Colloquial
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Official
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Ecclesiastic
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Financial
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Official/political
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Computer
Any documentation submitted by doctors, and mental health professionals are reviewed at this point.
In addition, the CHMP had concerns about the documentation submitted in support of the effectiveness and safety of the medicine.
The documentation submitted by physicians and mental health professionals is reviewed in this point.
The protection arrangements prevent applicants for a generic product from referring to the documentation submitted for the reference product.
If the documentation submitted is incomplete, the judge may allow a single period of five days to complete it.
The information on conflicts of interests will also constitute a part of the documentation submitted during the formal consultation process.
Documentation submitted to the Authority as part of the application shall be published immediately on the website referred to in Article 32.
Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee.
The documentation submitted to the regulatory authorities contains the results of these studies and a comprehensive benefit-risk assessment.
Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee.
The documentation submitted to the regulatory authorities contains the results of these studies and comprehensive information on the product's benefit-risk assessment.
Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee.
Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CHMP considered that the benefit/ risk ratio of neurontin and associated names is favourable relating to.
Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee.
Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CHMP considered that the benefit/risk ratio of STAMARIL and associated names is favourable for use relating to.
The product information proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee.
In addition, the Committee reviewed the documentation submitted by the MAH in support of the proposed harmonised Quality documentation(Module 3);
The Summary of Products Characteristic, labelling andpackage leaflet proposed by the applicant has been assessed based on the documentation submitted and the scientific discussion within the Committee.
The Health andSafety File is an integral part of the documentation submitted in accordance with the applicable provisions for the issuance of a building permit, as required.
The Summary of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee.
The Health andSafety Plan is an integral part of the documentation submitted in accordance with the applicable provisions for the issuance of the Building Permit of the project, as required.
The Committee reviewed the data submitted by the MAH in support of the proposed harmonisation of the Product Information,including based on the documentation submitted and the scientific discussion within the Committee;
The CTO reserves the right to further examine the documentation submitted and to request any additional information and/or the submission of additional documentation and data.
The Summary of Products Characteristic, labelling andpackage leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee.
The CTO reserves the right to further examine the documentation submitted and to request additional clarifications and/or the submission of additional data and documentation. .
The Summary of Products Characteristic,labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee.
Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CHMP considered that the benefit/risk ratio of Agopton and associated names is favourable for use relating to.
The Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee.
Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CPMP considered that the benefit/ risk ratio of Prograf and associated names is favourable for use relating to.
Whereas, the scope of the referral was that the safety and efficacy in long-term treatment of ropinirole in restless legs syndrome should be demonstrated, based on the documentation submitted and the scientific discussion within the Committee, the Summary of Products Characteristic proposed by the applicant has been amended as set out in Annexe III.
