Price list for medicine registration services and issuance of Registration Certificate (State Duty)




Name of registration services and extension of validity of registration certificate
Cost of services
(including VAT 15%)
in US dollars
1
Registration of one dosage form
9798
1.1
additionally for each dose, variety of flavors and aromatics
980.25
1.2
additionally for each medicinal product in a single primary packaging or in separate primary packaging contained in a single secondary packaging
980.25
2
Introduction of amendments and additions to registration documents
 
2.1
Without laboratory testing of drug samples, in particular:
 
2.1.1
change of name of the medicine and / or manufacturer
2898
2.1.2
change of name and / or applicant company ownership / registration certificate holder
1638.75
2.1.3
changes in the registration dossier of medicinal product (changes in the manufacturing process of the medicinal product that don't affect a specification on finished product: change in production batch, amendment or supplement of the manufacturer of active substance, excipients, packaging materials, change in the manufacturing process or control methods of active substance, updating the quality certificate for the active substance, changing the production of excipients)
1253.5
2.1.4
changes in the normative document (specification) of the medicinal product that are not related to changes in the analytical quality control and standardization of indicators
1035
2.1.5
package design (change of parameters, design, font, graphic design, etc.)
718.75
2.1.6
amending the instructions for medical use
718.75
2.1.7
amending the registration documents of the substance
184
2.2
With laboratory testing of drug samples, in particular:
 
2.2.1
the introduction of an additional type of packaging of the registered dosage form (additional packaging size, packing set, changing a dosing spoon, syringe, glass, cap); making changes to the analytical quality control and standardization of indicators, additional methods of analysis in the normative document (specification), changing the composition of the registered medicinal product, without changing the dose of active substance
2351.75
2.2.2
amending the registration documents of the substance
615.25
3
Reissuance of Registration Certificate
235.75
4
Extension of validity of the Registration Certificate
5612
5
Issue of duplicate Registration Certificate
143.75

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Pharmacopoeia Committee

Tasks of the Pharmacopoeia Committee:

- examination of normative documents for medicines subject to registration and extension of the term of registration;
- systematic revision of normative documents for medicines with a view to improving their quality and improving the methods of control;
- examination and preparation for approval of additions and amendments of the...

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Department of Registration

Tasks of the Registration Department:

- after the adoption of the application for registration, conducts the initial (preliminary) examination of the application and attached registration documents and samples of medicines, medical devices and medical equipment;
- conducts appropriate correspondence with the applicant on the...

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Pharmacological Committee

Tasks of the Pharmacological Committee:

- conducts examination of administrative, pharmacological, toxicological and clinical parts of registration documents of pharmacological and (or) medicinal products;
- conducts examines and re-examines documents of pharmacological and (or) medicinal products with the involvement of independent experts;
- decides on the use of the medicines without clinical trials in the...

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