Order 959n dated December 13, 2016
"On approval of the classification of changes to be introduced to the documents contained in the Registration Dossier for the registered medicinal products for human use"

No.;Type (character) of changes;Section of the Registration Dossier for the medicinal product for human use containing documents that are subject to changes introduction

1.;Change in the name, type of business entity and (or) address, contact information of the holder or owner of the Registration certificate;Administrative documentation 2.;Change in the name, type of business entity, contact information of the manufacturer of the medicinal product that is not associated with the change of the production site of the medicinal product and (or) pharmaceutical substance, which is included in the composition of the medicinal product (hereinafter respectively - medicinal product, pharmaceutical substance);Administrative documentation. Chemical, pharmaceutical and biological documentation 3.;Deletion of one or more stakeholders of the manufacturing process of the medicinal product (production site);Administrative documentation 4.;Replacement or addition of one or more participants of the manufacturing process of the medicinal product (production site), that perform quality control of the medicinal product and its packaging into the secondary (consumer) packages;Administrative documentation 5.;Change in the name and (or) address of the organization authorized by the holder or owner of the Registration certificate for the medicinal product to accept consumer complaints;Administrative documentation 6.;Changes to correct typos and errors;Administrative documentation. Chemical, pharmaceutical and biological documentation 7.;Changes in the labeling design of the medicinal product;Administrative documentation 8.;Change in the name and (or) address of the manufacturer or supplier of any raw material, reagent, intermediate substance of the pharmaceutical substance not associated with the change of their production site;Chemical, pharmaceutical and biological documentation 9.;Change in the characteristics and properties of the packaging materials and container closure systems which do not come into contact with the medicinal product;Chemical, pharmaceutical and biological documentation 10.;Change in the pharmacovigilance system of the holder or owner of the Registration certificate for the medicinal product;Administrative documentation 11.;Deletion of the primary packages of the medicinal product that do not affect the dosing regimen;Administrative documentation

No.;Type (character) of changes;Section of the Registration Dossier for the medicinal product for human use containing documents that are subject to changes introduction;Expert examination of the methods proposed for the quality control of the medicinal products and quality control of the submitted samples of the medicinal products with the use of such methods;Expert examination of the expected risk/benefit ratio for the use of the medicinal product

1.;Change in the trade name of the medicinal product;Administrative documentation;-;+ 2.;Change in the International nonproprietary, group or chemical name of the medicinal product;Administrative documentation;+;+ 3.;Change in the name of the pharmaceutical substance (International nonproprietary name or group name or chemical and trade names);Administrative documentation;+;- 4.;Changes related to the change of the name or code of the medicinal product in accordance with the Anatomical Therapeutic Chemical Classification System, recommended by the World Health Organization;Administrative documentation;-;+ 5.;Change in the pharmaceutical form of the medicinal product without changes in the qualitative composition and (or) quantitative composition of the active substances and (or) qualitative composition of the excipients of the medicinal product;Administrative documentation;+;+ 6.;Change in the appearance of the finished pharmaceutical form, caused by the addition, modification or removal of imprints, bossing or other markings not affecting the strengths of the medicinal product, as well as the shape of tablets, capsules or suppositories;Administrative documentation;+;+ 7.;Change in the information on pharmacodynamics and pharmacokinetics of the medicinal product (except for pharmacokinetics of homeopathic and herbal medicinal products);Administrative documentation Pharmacological and toxicological documentation;-;+ 8.;Change and (or) addition of the therapeutic indications for the use of the medicinal product;Administrative documentation;-;+ 9.;Change and (or) addition of the contraindications for the use of the medicinal product;Administrative documentation;-;+ 10.;Change and (or) addition of new safety precautions measures for the use of the medicinal product;Administrative documentation;-;+ 11.;Changes in the instructions on possibility and peculiarities of the use of the medicinal product in pregnant or breast-feeding women, children and adults with chronic diseases;Administrative documentation;-;+ 12.;Change in the posology, methods of administration and, where necessary, time of administration of the medicinal product and duration of the treatment, including those in children under and over one year of age;Administrative documentation;-;+ 13.;Change and (or) addition of the information about potential side effects and adverse reactions associated with the use of the medicinal product;Administrative documentation;-;+ 14;Change in the information about the symptoms of overdose, medical assistance measures in cases of overdose;Administrative documentation;-;+ 15.;Change in the information about interactions with other medicinal products and (or) food;Administrative documentation;-;+ 16.;Change in the pharmaceutical forms of the medicinal product, addition or replacement of measuring device for the metered pharmaceutical forms;Administrative documentation;+;+ 17.;Change in the specific effect of the medicinal product at its initial dosing or withdrawal;Administrative documentation;-;+ 18.;Change in the information on potential influence of the medicinal product on the ability to drive and use machines;Administrative documentation;-;+ 19.;Change in the shelf life of the medicinal product;Administrative documentation;+;+ 20.;Change in the storage conditions of the medicinal product;Administrative documentation;+;+ 21.;Change in the pharmacy terms of sale of the medicinal product;Administrative documentation;-;+ 22.;Change in the information contained in the Instructions for medical use of the medicinal product or Summary of Product Characteristics of the medicinal product approved in the country of origin;Administrative documentation;-;+ 23.;Change and (or) addition, and (or) removal of the quality indicators, methods for determination of quality parameters and (or) addition and (or) removal of an alternative test method;Administrative documentation;+;- 24.;Changes introduced with the purpose to bring the Normative documentation for the medicinal product in line with the State Pharmacopoeia requirements;Administrative documentation;+;- 25.;Deletion of the strength of the medicinal product;Administrative documentation;+;+ 26.;Changes in the Risk Management Plan for biological medicinal products;Administrative documentation;-;+ 27.;Change or addition of one or more stakeholders of the manufacturing process of the medicinal product associated with the change of the production site of the medicinal product;Administrative documentation;Chemical, pharmaceutical and biological documentation;+;+ 28.;Change in the manufacturing process and (or) technological process and (or) change in the control methods at one or several stages of the manufacturing process of the medicinal product, provided that there are no changes introduced to the specification of the medicinal product;Chemical, pharmaceutical and biological documentation;+ ;+ Only for biological medicinal products 29.;Change in the manufacturing process of the herbal medicinal product relating to change in geographical source, method of manufacture or production of this herbal medicinal product;Chemical, pharmaceutical and biological documentation;+;+ 30.;Change in the Specification of the pharmaceutical substance;Chemical, pharmaceutical and biological documentation;+;+ Only for biological medicinal products 31.;Change in the analytical methods used for quality control of the medicinal product;Chemical, pharmaceutical and biological documentation;+;- 32.;Change in the standard samples or substances used in quality control of the medicinal products;Chemical, pharmaceutical and biological documentation;+;- 33.;Change in the characteristics and properties of the packaging materials and container closure systems of the primary packaging of the pharmaceutical substance;Chemical, pharmaceutical and biological documentation;+;- 34.;Change in the stability data on the medicinal product;Chemical, pharmaceutical and biological documentation;+;- 35.;Change in the shelf life of the pharmaceutical substance;Chemical, pharmaceutical and biological documentation;+;- 36.;Change in the appearance and (or) composition of the excipients included in the composition of the medicinal product;Chemical, pharmaceutical and biological documentation;+;+ 37.;Change in the microbiological characteristics of the medicinal product;Chemical, pharmaceutical and biological documentation;+;- 38.;Change in the primary packaging with regard to the inclusion of additional primary packaging;Chemical, pharmaceutical and biological documentation;+;+ 39.;Change in the data on toxicological properties of the medicinal product;Pharmacological and toxicological documentation;-;+ 40.;Change in the data on bioavailability and bioequivalence of the medicinal product;Clinical documentation;-;+ 41.;Change in the data on clinical efficiency and safety of the medicinal product;Clinical documentation;-;+ 42.;Change in the data on post-marketing experience of the use of the medicinal product;Clinical documentation;-;+