![]() 78 “On Rules for Registration and Examination of Medicines for Medical Use” ND is needed for laboratory examination during the drug registration and is also an instruction for quality assessment for laboratories in the post-registration period (for example, when the drug is brought into civil circulation).Ĭurrently, the requirements for the development of ND are regulated by the following main documents: Further in the body of the ND itself, each analytical technique used to determine a particular measure of quality is described in detail. As mentioned above, the ND includes a specification describing quality indicators, methods for their determination and acceptance criteria. The definition of the ND contains important information about the composition of this document. Transformation of normative documentation in the ND is accompanied by a more accurate and detailed definition of the term. normative documentation means a document containing a list of quality indicators of a drug for medical use determined by the results of relevant examinations, methods of control of its quality and established by its manufacturer.61 “On the circulation of medicines” as follows: Within the framework of national registration, the ND is determined according to Federal Law No. It’s worth noting that the normative document (ND) is not an invention of the Union and existed long before its formation. ![]() ![]() It is approved by the competent authority upon granting a marketing authorization for the medicinal product in the Union and is intended for post-marketing quality control of the medicinal product in the Union 78 “On the Rules for Registration and Examination of Medicines for Medical Use” ‘normative document’means a document establishing requirements for the quality control of a medicinal product ( it contains a specification and a description of analytical procedures and tests or references thereon, as well as appropriate acceptance criteria for the specified quality attributes, etc.) based on the assessment of the medicinal product. Normative document for the pharmaceuticals.Īccording to the definition of Decision No. ![]()
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