Registration of Pharmaceutical Dossier Variations in Russia

Registration of dossier variations (type Ia, type Ib and type II) in Russia

is quite different from EU or US procedures. Before 2010 dossier variations were relatively simple procedure.

Currently Russian regulatory requirements for variations propose different types of variations, some of them can require quality control expertise, local clinical study or even both.

Our team has experience since 1999 in registration of pharmaceutical variations namely:

1. Changes in composition,
2. Adding new pharmaceutical form with similar composition
3. Adding new dosage
4. Adding new packaging,
5. Adding new indications,
6. SmPC text harmonization,
7. SmPC urgent safety updates,
8. Adding of new quality control methods,
9. Change of quality control methods,
10. Change of packaging or marking,
11. Addition of new manufacturer,
12. Change of storage conditions,
13. Extension of shelf life
14. Others

We provide full cycle service of timely registration of all kinds of pharmaceutical variations as well as consultation on optimal strategy of registration of a particular variation - whether it requires immediate registration in Russia or can be postponed and cumulated with upcoming dossier variations. MoH approval of some types of variations is not obligatory.