General information.

Outsourcing of the registration services is a very interesting opportunity for manufacturers of the medicinal products, as for those who only taking course to Ukraine as well as for those who already established here a representative office.

Obtaining the marketing authorization for medicinal product in Ukraine – is the most complex and expensive part of market entry that requires much time, human resources and time to devote. If you have intentions to enter the market and open the representative office – the first several months you will have to pay fee for renting office and salaries to the stuff before your registration managers will finish the procedure and allow the products to be released on the market. Else, if you already have specialists responsible for registration procedure but not so many products that staff is working on the 100% of their efficiency – we can allow you not to make such additional expenses. Registration certificate is valid for 5 years and one product require not more than 4-6 month from that period.

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 (25%) 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, we send them with invoices of Bureau Cratia for second instalment (50%).

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). Technological Normative documentation (TND) is being directed to the State Service of the med. products for adoption.

Step 9. (simultaneously with step 7). You send us the samples of the finished product plus standards if they are needed for quality assurance*.

Step 10. We submit the samples to the local laboratory for quality assurance.

Step 11. We answer on the comments of the SPC if any.

Step 12. After adoption of TND, AND, leaflet and answers on the comments - dossier is being adopted on the session of the SPC (each last Thursday of the month).

Step 13. After adoption of the product original registration certificate is being issued during 2 weeks.

Step 14. We send you the original registration certificate (market autorisation), third installment (25%).

*Quality assurance - is the obligatory control procedure performed on samples to achive compliance with methods from AND. For example - Appearance, Micro Biological purity etc.