№ |
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 |
