Patern Ltd

In accordance with the Ukrainian legislative system all substances, imported to the custom territory of Ukraine, have to pass the registration procedure. Average registration period is 2-3 months. Registration certificate is valid for 5 years from the date of State Registration. After expiry registration certificate can be renewed (re-registration).

Registration procedure of substances is close to medicinal products, though it is easier, cheaper and faster. Substances are also divided to herbal and non-herbal products, herbal substances are being registered even cheaper and quicker.

Description of the procedure.

1. After you decided to register the products with our help - we sign the CDA (Confidential Agreement).
2. You transfer the dossier(s) to our office, so we can perform the primary control of the information.
3. We carefully look through the dossier, prepare the list of missing documents and define the amount of work that have to be done.
4. We announce the primary price and negotiate on discounts and terms of payment; if they are suitable for you - we start registration procedure, if not - we send you back all received documentation. First installment (50%) for services of "Patern ltd."
5. We perform the translation of the dossier, combine it in accordance with local requirements, and prepare the missing documentation.
6. We submit the Application and 3 copies of the final version of dossier to the State Pharmacological Center (StPhC) for expertise. StPhC issue the invoices for State Fee and Expertise.
7. Each copy of the dossier is being transferred to specialized commissions. We do our best to speed up the adoption procedure.
8. (simultaneously with step 7). You send us the samples of substance(s) for quality assurance*.
9. We submit the samples to the local laboratory for quality assurance.
10. After positive conclusion from expertise and quality assurance product is being adopted on the session of the SPC (each last Thursday of the month).
11. After adoption of the product original registration certificate is being issued during 2 weeks.
12. We send you the original registration certificate (market authorization), second installment (50%).

*Quality assurance - is the obligatory control procedure performed on samples to achieve compliance with methods from Drug Master File (DMF).

It is possible to perform state registration of medicinal product and its active substance simultaneously in a case of submitting the registration materials in CTD-format.

Commercial offer you can download here