Dear Professionals
When we are filing the DCP & CEP when queries will come. Day 70, Day 100 Like this how many types are there and what are the timelines for responding to these queries. How much fees we have to file for these DMFs. To file the DMF how much stability data is required. How to file the variations for these DMFs.
At present i am in QA i want to move to regulatory. Pl suggest
Regards
Ramakrishna
[quote=rmk_19]Dear Professionals
When we are filing the DCP & CEP when queries will come. Day 70, Day 100 Like this how many types are there and what are the timelines for responding to these queries. How much fees we have to file for these DMFs. To file the DMF how much stability data is required. How to file the variations for these DMFs.
At present i am in QA i want to move to regulatory. Pl suggest
Regards
Ramakrishna[/quote]
Hi Ramakrishna,
when the active substance is officiallised in Ph.Eur monograph then we can submit the CEP based subsequantly we can respond requested for additional information received from EDQM. this case we have to submit around 3000 EU dollers for submissions.
When the monograph is not officalised in the Ph.EUr we have to move through DCP-Decentralised, MRP-Mutual recognisation procedures and NP-National Procedures these submissions we will performed by drug product manufacturers however we can submit tthe ASMF to EU countries based on the Drug product manufacturers suggestions.