Normative document for the pharmaceuticals.

According to the definition of Decision No. 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.  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;

It’s worth noting that the normative document (ND) is not an invention of the Union and existed long before its formation. Within the framework of national registration, the ND is determined according to Federal Law No. 61 “On the circulation of medicines” as follows:

• 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.

Transformation of normative documentation in the ND is accompanied by a more accurate and detailed definition of the term. The definition of the ND contains important information about the composition of this document. As mentioned above, the ND includes a specification describing quality indicators, methods for their determination and acceptance criteria. Further in the body of the ND itself, each analytical technique used to determine a particular measure of quality is described in detail. 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).

Currently, the requirements for the development of ND are regulated by the following main documents:

• Decision No. 78 “On Rules for Registration and Examination of Medicines for Medical Use”
• Decision No. 151 “On Approval of the Guidelines for the Preparation of a Normative Document on the Quality of a Drug”

When drafting the ND, it is important to consider that it is based mainly on the documents of Module 3 of the dossier. Therefore, the information in the ND cannot contradict those in Module 3.

As you know, by the end of 2025 all drugs registered in the territory of the Russian Federation must undergo the procedure of bringing the dossier in line with the requirements of the EAEU. The ND is part of Module 1 dossier (1.5.7) and is attached to the dossier. Although at present, when passing this procedure in the Russian Federation, cases of ND request approved in the Russian Federation are known. This relates to the ND’s definition: “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” Procedure of bringing the dossier in line with the EAEU requirements is not a registration procedure, therefore it is impossible to change the ND.

Perhaps the situation will change soon, and a draft amending Decision No. 78 will be adopted, according to which the inclusion of the ND would not be considered a change in relation to the national dossier.

Learn more about the ND development service: info@beawire.com

References:

1. Decision of the Council of the Eurasian Economic Commission dated 03.11.2016 No. 78 (ed. 23.12.2020) “On the Rules of Registration and Expertise of Medicines for Medical Use.”
2. Decision of the Board of the Eurasian Economic Commission of 07.09.2018 No. 151 “On Approval of the Guidelines for Preparation of a Regulatory Document on the Quality of a Medicinal Products”
3. Federal law “On the circulation of medicines” of 12.04.2010 No. 61-FZ (last revision)