General information.

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, cheper and faster. Substances are also divided to herbal and non-herbal products, herbal substances are being registered even more cheaper and quicker.

Description of procedure.

Step 1. After you decided to register the products with our help - we sign the CDA (Confidential Agreement).

Step 2. You transfer the dossier(s) to our office, so we can perform the primary control of the information.

Step 3. We carefully look through the dossier, prepare the list of missing documents and define the amount of work that have to be done.

Step 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 instalment (50%) for services of Bureau Cratia.

Step 5. We perform the translation of the dossier, combine it in accordance with local requirements, prepare the missing documentation.

Step 6. We submit the Application and 3 copies of the final version of dossier to the State Pharmacological Center (SPC) for expertise. SPC issue the invoices for State Fee and Expertise.

Step 7. Each copy of the dossier is being transferred to specialized commissions. We do our best to speed up the adoption procedure.

Step 8 . (simultaneously with step 7). You send us the samples of substance(s) for quality assurance*.

Step 9 . We submit the samples to the local laboratory for quality assurance.

Step 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).

Step 11. After adoption of the product original registration certificate is being issued during 2 weeks.

Step 12. We send you the original registration certificate (market autorisation), second installment (50%).

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