Full cycle of registration and re-registration of medical and other products |
Type of service |
Cost of services |
* Consultation on registration related to state duties and other paid questions |
* Primary consultation – $200, secondary and further – $100. |
Registration of medicines |
$2000 for one drug with one dosage (additionally for each dose, variety of flavors and aromatics, additionally for each medicinal product in a single primary packaging or in separate primary packaging contained in a single secondary packaging – $500). |
Registration of the medical device / medical equipment |
$1500 for one medical device / medical equipment (for each additional volume, variety – $400). |
Re-registration of medicines |
$1800 for one drug with one dosage (additionally for each dose, variety of flavors and aromatics, additionally for each medicinal product in a single primary packaging or in separate primary packaging contained in a single secondary packaging – $500) |
Re-registration of the medical device / medical equipment |
$1300 for one medical device / medical equipment (for each additional volume, variety – $400). |
Registration of dietary supplements (BAA) |
$1500 for one product (for each additional volume, variety – $500). |
Re-registration of dietary supplements (BAA) |
$1300 for one product (for each additional volume, variety – $500). |
Registration of perfumery and cosmetic products |
$1300 for one product (for each additional volume, variety – $500). |
Registration of veterinary products |
$1500 for one product (for each additional volume, variety – $500). |
Re-registration of veterinary products |
$1300 for one product (for each additional volume, variety – $500). |
Making changes to the dossier (ND, instructions, color models, etc.) |
Depending on the amount of work from $300 to $1000. |
Conducting clinical / preclinical trials (if necessary) |
As agreed. |
Translation and / or making of instructions for use (professional translation into the state language). |
Translation – $15 per page / making and translation – $25 per page. |
Note:
* After signing a contract with us, all types of consulting are free.
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Pharmacopoeia CommitteeTasks 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... Read more |
Department of RegistrationTasks 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... Read more |
Pharmacological CommitteeTasks 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... Read more |