ORDER OF THE MINISTRY OF HEALTH OF UKRAINE 26.08.2005 No. 426 (as amended) On Approval of the Procedure for Conducting Expert Evaluation of Registration Materials for Medicinal Products Submitted for State Registration (Re-registration), as well as Expert Evaluation of Materials on Amendments to Registration Materials during the Validity of the Registration Certificate
06.05.2021
20557
MoH order No. 426 of 26.08.2005 approves the Procedure for the expert evaluation of registration materials for medicinal products for state registration, re-registration, and variations during the validity of the registration certificate. The document contains forms, the dossier structure in CTD format, requirements for instructions, product characteristics, and labeling, and lists of documents for different categories of products. compiled automatically
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