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.
Description of 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 (20%) 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 issues the invoices for State Fee and Expertise; we send them with invoices of "Patern Ltd." for second installment (60%).
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). Technological Normative documentation (TND) is being directed to the State Service of the med. products for adoption.
9. (Simultaneously with step 7). You send us the samples of the finished product plus standards if they are needed for quality assurance*.
10. We submit the samples to the local laboratory for quality assurance.
11. We answer on the comments of the StPhC if any.
12. After adoption of TND, AND leaflet and answers on the comments - dossier is being adopted on the session of the StPhC (each last Thursday of the month).
13. After adoption of the product original registration certificate is being issued during 2 weeks.
14. We send you the original registration certificate (market authorization), third installment (20%).
*Quality assurance - is the obligatory control procedure performed on samples to achieve compliance with methods from AND. For example - Appearance, Micro Biological purity etc.
You can also see the graphical description of procedure here
Commercial offer you can download here
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