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Classification of changes (variations) to the registration dossier of a medicinal product for medical use (under the national regulations in Russia)

(As per the Order of the Ministry of Health of the Russian Federation dated Dec 13th, 2016 № 959n, amended by the Order of the Ministry of Health of Russia of Mar 06th, 2023, № 95N).

The changes apply to variation applications to documents of the registration dossier for registered medicinal products for medical use submitted to the Russian Ministry of Health after April 25, 2023.

I. Changes of the registration dossier for registered medicinal product that do not require expert examination (expertise) of proposed methods of quality control of the medicinal product and quality of samples of the medicinal product and (or) expert examination of expected benefit to risk ratio of the medicinal product use (non-significant variations)

N p/p

Type (nature) of changes

Section of the registration dossier of medicinal product, containing the documents to be modified

1.

Change of name, legal form and (or) address, contact information of the holder or owner of the registration certificate

Administrative documentation

2.

Change in the name, legal form, contact information of the manufacturer of a medicinal product not related to a change in the place of manufacture of the medicinal product and (or) API and (or) excipients of the medicinal product

Administrative documentation;

Chemical, pharmaceutical and biological documentation

3.

Exclusion of one or more participants of the manufacturing process of a medicinal product (manufacturing sites)

Administrative documentation

4.

Replacement or addition of one or more participants in the manufacturing process of a medicinal product (manufacturing sites) that perform quality control of the medicinal product and secondary (consumer) packaging

Administrative documentation

5.

Change of name and (or) address of the organization authorized by the holder or owner of the registration certificate of the medicinal product to accept claims from consumers

Administrative documentation

6.

Amendments to correct typographical errors and mistakes 

Administrative documentation;

Chemical, pharmaceutical and biological documentation

7.

Changes in the design of the labeling of a medicinal product 

(packaging artworks) 

Administrative documentation

8.

Change of the name and (or) address of the manufacturer or supplier of any starting material, reagent, intermediate substance of the API not related to a change in the place of their production

Chemical, pharmaceutical and biological documentation

9.

Changes in the characteristics and properties of packaging materials and closures that do not come into contact with the medicinal product

(i.e. not applicable for any primary packaging)

Chemical, pharmaceutical and biological documentation

10.

Change in the pharmacovigilance system of the holder or owner of the registration certificate of a medicinal product

Administrative documentation

11.

Removal of primary packaging of a medicinal product that does not affect the dosage regimen

Administrative documentation

12.

Exclusion of the manufacturer or supplier (manufacturing sites) of any starting material, reagent, intermediate substance of the API as parts of a medicinal product 

Chemical, pharmaceutical and biological documentation

13.

Replacement and (or) addition of the API manufacturer (including change of the site of the API production stage) provided that such API is included in the state register of medicines

Administrative documentation

14.

Replacement and (or) addition of manufacturers and (or) supplier of starting and excipient materials and (or) the same starting and excipient materials used in the process of production of the API or medicinal product (reagents, intermediates, culture media and their components, filters, sorbents, consumables, bags, hoses and other materials)

Administrative documentation

15.

Replacement and (or) addition of manufacturers and (or) suppliers of equipment and (or) similar equipment used in the manufacturing process of the API or the medicinal product, as well as changes in the manufacturing process associated with the use of alternative equipment

Chemical, pharmaceutical and biological documentation

16.

Replacement and (or) addition of manufacturers and (or) supplier of reference materials and (or) similar reference materials certified in accordance with the state pharmacopoeia, as well as reagents, materials, equipment used in the processes of analytical control of intermediates, API or medicinal product, as well as changes in analytical methods associated with the inclusion, change or addition of alternative materials, reagents, equipment and reference materials used in analytical methods

Chemical, pharmaceutical and biological documentation

17.

Replacement and/or addition of manufacturers of primary packaging of the API

Chemical, pharmaceutical and biological documentation

18.

Replacement of ethyl alcohol used in the production of medicines as an excipient by the API ethyl alcohol (ethanol)

Administrative documentation;

Chemical, pharmaceutical and biological documentation

 

II. Changes of the registration dossier for a registered medicinal product that require expert examination of proposed methods of quality control of the medicinal product and quality of submitted samples of the drug product using and (or) expert examination of the expected benefit to the possible risk ratio of the medicinal product use

N

n/a

Type (nature) of changes

Sections of the registration dossier for a medicinal product containing the documents to be modified

Examination of the proposed methods of quality control of the medicinal product and the quality of submitted samples of the medicinal product using these methods

Examination of the ratio of the expected benefit to the possible risk of use of the medicinal product

Evaluation of documents and information submitted by the applicant

Examination of the quality of drug product samples

1.

Change of the trade name of a medicinal product

Administrative documentation

-

-

+

2.

Change of the INN or grouping name or chemical name of a medicinal product

Administrative documentation

+

-

+

3.

Change of the name of the API (international nonproprietary name, or grouping name, or chemical and trade name)

Administrative documentation

+

-

-

4.

Changes related to modifications in the name or code of the medicinal product according to the anatomical-therapeutic-chemical (ATC) classification recommended by the World Health Organization

Administrative documentation

-

-

+

5.

Change of the dosage form of the medicinal product without change of qualitative and (or) quantitative composition of active ingredients and (or) qualitative composition of excipients of the medicinal product

Administrative documentation

+

-

+

6.

Change in the description of the finished dosage form caused by addition, change or removal of engravings, thickenings or other markings that do not affect the dosing of the medicinal product, as well as change in the form of tablets, capsules, suppositories

Administrative documentation;

Chemical, pharmaceutical and biological documentation

+

-

+

7.

Changes in information on pharmacodynamics and pharmacokinetics of the medicinal product

(excluding pharmacokinetics of homeopathic and herbal drug products)

Administrative documentation;

Pharmacological, toxicological, clinical documentation

-

-

+

8.

Change and (or) addition of indications for use of the medicinal product

Administrative documentation;

Pharmacological, toxicological, clinical documentation

-

-

+

9.

Change and (or) addition of contraindications for use of the medicinal product

Administrative documentation

Pharmacological, toxicological, clinical documentation

-

-

+

10.

Change and/or adding new precautions for use of the medicinal product

Administrative documentation

Pharmacological, toxicological, clinical documentation

-

-

+

11.

Change of instructions on the possibility of use and special warnings for use of the medicinal product in pregnant and/or breastfeeding women, children and  adults with chronic diseases

Administrative documentation

Pharmacological, toxicological, clinical documentation

-

-

+

12.

Change in dosing regimen, routes of administration and posology, administration

timing, treatment duration, including for children under and after one year of age

Administrative documentation

Pharmacological, toxicological, clinical documentation

-

-

+

13.

Change and (or) addition of the information on possible side effects and adverse reactions when using the medicinal product

Administrative documentation;

Pharmacological, toxicological, clinical documentation

   

+

14.

Change of the information on symptoms of the overdose, measures to treat overdosing

Administrative documentation;

Pharmacological, toxicological, clinical documentation

-

-

+

15.

Change of the information on interaction with other medicinal products and (or) food

Administrative documentation;

Pharmacological, toxicological, clinical documentation

-

-

+

16.

Change of the release forms of the medicinal product

Administrative documentation;

Pharmacological, toxicological, clinical documentation

+

-

+

17.

Adding or replacing of a measuring device for dosage forms

Administrative documentation;

Chemical, pharmaceutical and biological documentation

+

+

(if the change is likely to have significant impact on quality, efficiency and safety of the drug product)

+

18.

Change of the features of the effects on the first take or after stop taking the medicinal product

Administrative documentation;

Pharmacological, toxicological, clinical documentation

-

-

+

19.

Changes of the information about the possible effects of the medicinal product on the ability to drive vehicles and operate mechanisms

Administrative documentation;

Pharmacological, toxicological, clinical documentation

-

-

+

20.

Change of the shelf life of the medicinal product

Administrative documentation;

Chemical, pharmaceutical and biological documentation

+

-

-

21.

Change of the storage conditions of medicinal drugs

(i.e. either API or drug product)

Administrative documentation;

Chemical, pharmaceutical and biological documentation

+

-

-

22.

Change of the dispensing conditions for the medicinal product

Administrative documentation

-

-

+

23.

Changing and/or adding quality control parameters, quality control methods and/or adding of alternative quality control method

(i.e. either API or drug product)

Administrative documentation;

Chemical, pharmaceutical and biological documentation

+

+

(with respect to changed or added parameters of quality and corresponding analytical methods)

-

24.

Removal of quality control parameters, quality control methods and/or deletion of an alternative quality control method

(i.e. either API or drug product)

Administrative documentation;

Chemical, pharmaceutical and biological documentation

+

-

-

25.

Changes to bring the normative documentation of the medicinal drug in compliance with the requirements of the State Pharmacopoeia

Administrative documentation;

Chemical, pharmaceutical and biological documentation

+

+

(in the case of changes of the analytical methods or addition of new quality parameters)

 

26.

Removal of a dosage of the medicinal product

Administrative documentation

+

-

+

27.

Changes to the Risk Management Plan for a biologic drug product

Administrative documentation

-

-

+

28.

Change or addition of one or more participants in the manufacturing process of the medicinal product associated with the change in the place of manufacturing of the medicinal product

Administrative documentation;

Chemical, pharmaceutical and biological documentation

+

+

(except for secondary packaging and releasing quality control sites)

(for sites, where manufacturing operations are performed for biological, immunological medicinal products or medicinal products anufctured by complex manufacturing processes, according to the tests specified by the request of the expert institutions (if available)

+

29.

Change of the manufacturing process and (or) manufacturing technology and (or) change of QC methods at one or several stages of production of a medicinal drug

(i.e. either API or the drug product)

Chemical, pharmaceutical and biological documentation

+

-

(in case of absence of changes in the specification of the medicinal drug)

+

only for biological drug  products

30.

Change in the manufacturing process of herbal medicinal product relating to change in the geographic source, method of production or manufacture of the herbal medicinal product

Chemical, pharmaceutical and biological documentation

+

+

+

31.

Changes in the specification of the API

Chemical, pharmaceutical and biological documentation

+

+

only for biological drug  products

+

only for biological drug  products

32.

Change in the quality control methods used in the quality control of medicinal drugs

(i.e. either API or drug product)

Administrative documentation;

Chemical, pharmaceutical and biological documentation

+

+

-

33.

Change of the characteristics and properties of packaging materials and closure system of the  API primary packaging

Chemical, pharmaceutical and biological documentation

+

-

-

34.

Change in the stability data on the medicinal drug

(i.e. either API or drug product)

Chemical, pharmaceutical and biological documentation

+

-

-

35.

Change in the shelf life of the API

Chemical, pharmaceutical and biological documentation

+

-

-

36.

Change in the description and (or) composition of excipients included to the medicinal product

Administrative documentation;

Chemical, pharmaceutical and biological documentation

+

+

(except for changes of references to specifications of excipients, included to the composition of the medicinal product)

+

37.

Changes in the microbiological characteristics of the drug product

Chemical, pharmaceutical and biological documentation

+

+

-

38.

Change of the primary packaging of medicinal products in terms of inclusion of additional packaging or replacement of primary packaging

Administrative documentation;

Chemical, pharmaceutical and biological documentation

+

+

(if the change of primary packaging can render substantial impact on quality, efficiency and safety of medicinal drug)

+

39.

Changes in toxicological properties data of the medicinal product

Pharmacological, toxicological, clinical documentation

-

-

+

40.

Changes in data on bioavailability and bioequivalence of the medicinal product

Clinical documentation

-

-

+

41.

Changes in data on clinical efficacy and safety of the medicinal product

Pharmacological, toxicological, clinical documentation

-

-

+

42.

Change of data on post-registration study(es) experience of the medicinal product

Clinical documentation

-

-

+

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