Variations to registered medicines and medical devices

A new manufacturer, pack, composition or patient leaflet.

Related procedures

VariationsFiled through the system with documents and, if needed, samples. Term is at most 50% of the registration term; the rule does not apply to recognition products. The Ministry of Health sets the fee. For 180 calendar days after the decision, production and import under the old data are allowed. A new contract or transfer site is added after testing and GMP inspection.Постановление КМ № 738, прил. 1, п. 29-31
Certificate reissueAfter a reorganisation or name change with the same site and technology, apply within 1 month. The Center reissues within 5 working days, free of charge.Постановление КМ № 738, прил. 1, п. 32-33

Certificate reissueAfter a reorganisation or a name change, with the same manufacturing site and technology, the application is filed within one month. Reissue takes up to 5 working days; no fee is charged.Постановление КМ № 738, прил. 2, п. 26-27

Consultation
We review the product and documents and give a timeline and price.
Contract
We fix the scope, schedule and people responsible.
Dossier
We collect documents, translate them and build the dossier to the rules.
Submission and review
We submit the dossier, answer queries and follow the testing.
Certificate
We hand over the certificate and remind you about renewal in advance.

The exact list depends on the product. We check your documents at the consultation.

Acts from the knowledge base for this product type.