Regulatory Open Forum

Hello Priya, There is no guidance on the time interval to update the Plant Master File (PMF).  Since this document is included ...

Saschka,  There has definitely been some great discussion especially regarding reprocessing/useful life.  Here are a few resources ...

Anne,  For the UK:  For Devices: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1137842/Device_Registration_Reference_Guide_Feb_2023_Final_v1.pdf ...

Hi All Does anyone has any recent experience with the Market Authorization Application submission requirements in the UK and ...

Or maybe that would qualify as a 1X dilution. Some examples:  https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=arnica ...

It is pretty quick. Do you have any specific question relating to Establishment Registration?  ------------------------------ ...

The last one I did about 8 months ago only took a little over 7 business days.  ------------------------------ Stephanie Christianson, ...

Usha,  To follow-up on Anne's response. If this is for EU MDR compliance, ensure that you notify your authorized representative ...

Hi Anon Five percent sounds more like an active ingredient than a homeopathic dilution? You may already have seen the draft ...

Hello Usha It depends on what countries you're doing business in. The term "PRRC" is usually associated with the European ...