Drug – any substance or combination of substances (one or more APIs and excipients), that has properties and is intended for the treatment or prevention of humans’ diseases, any substance or combination of substances (one or more APIs and excipients), which can be designed for pregnancy prevention, restoring, correcting or modifying physiological functions of human through pharmacological, immunological or metabolic action, or to establish a medical diagnosis.
Outsourcing of registration services is a great opportunity for foreign manufacturers of drugs to get professional service.
The registration procedure of medicines required for product import into the market is a complex and costly process that requires a lot of time-consuming and expenses. The transfer of work to register your products to our company avoids the necessity to look for registration managers and greatly facilitate the work of your company. The registration certificate is valid for 5 years after the expiration date the renewal procedure must be done.
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 20% 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 (60%).
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 finished product plus standards if they are needed 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), approved leaflet and instructions for medical use, 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 and instructions for medical use.
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.
|New registration of medicines|
|Amendments to the registration dossier|
|Dossier for the registration of medicines|