Registration of substances (APIs)

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In accordance with the Ukrainian legislation all substances, imported to the custom territory of Ukraine, have to pass the state registration procedure. Registration certificate is valid for 5 years from the date of State Registration. After expiration date the registration certificate can be renewed.

Registration procedure of substances is close to registration procedure of medicinal products, though it is easier, cheaper and faster.

Description of procedure

1. After you have decided to register the products with our help – we sign the Confidential Agreement.

2. You provide required documents to “Patern Ltd.”, and we perform the primary evaluation of the data provided. 

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

4. We inform you about the primary price and negotiate on terms of payment; if they are suitable for you – we start registration procedure (standard first installment is 60% of “Patern Ltd.” services), if not – we send you back all received documentation.

5. We perform the translation of the registration dossier, adopt it in accordance with local requirements and prepare the missing documentation. 

6. We submit the Application and package of documents for primary expertise to State Expert Center (SEC). SEC issues the invoices on state fee for expertise, which we send you with invoices of “Patern Ltd.” for second installment (20%). 

7. We form the registration materials according to the current legislation requirements. Every copy of registration dossier is provided to specialized commission for expertise. We do our best to speed up the process of registration dossier approval.

8. (Simultaneously with clause 7). You send us the samples of the substance for Quality Control Methods assurance*. 

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

10. We answer on every comment from SEC, conduct all the work with experts.

11. After Quality Control Methods assurance (QCM), elimination of all comments, SEC approves dossier at the Session (last Thursday of each month).

12. After signing the order of MOH for registration within two weeks the original registration certificate is issued, approved QCM.

13. We send you the original registration certificate, after you have carried out the third payment (20%) according to the Contract.

* Quality Control Methods assurance – is a necessary procedure for approval, based on the tests and inspections of quality control methods provided by the applicant.

This procedure includes:

- Quality control of all project indicators QCM;

- The check of reproducibility of QCM project analysis techniques.

doc-sub Registration dossier for substances