Harmonised Technical Guidance for Non-eCTD electronic ...
This Guidance Document is intended to assist pharmaceutical companies with the submission of regulatory information in electronic format to the National Competent Authorities in the EEA (hereafter referred to as NCAs).
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Guideline on the specifications for provision of an ...
esubmission.ema.europa.euGuideline on specification for veterinary e-submissions Page 5 of 18 Zipped files should not be used when sending CDs or DVDs. Applicants should provide the electronic submission on the smallest number of media components
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eCTD Guidance Document - Europa
esubmission.ema.europa.euPage 1 of 60 . Guidance for Industry on Providing Regulatory Information in Electronic Format . Harmonised Technical Guidance for . eCTD Submissions in the EU
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esubmission.ema.europa.euGuidance for Industry on Providing Regulatory Information in Electronic Format: eCTD Version: 2.0, August 2011 1 (46) Guidance for Industry on Providing Regulatory Information in Electronic Format
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Guideline on the specifications for provision of an ...
esubmission.ema.europa.euGuideline on specification for veterinary e-submissions Page 1 of 19 ... Version 2.45 December 20165 . Guideline on the specifications for provision of an electronic submission (e-submission) for a veterinary medicinal product. Adoption by Veterinary Harmonisation Group (version 2.45) December 20165 ... application form may accompany or follow ...
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