Who is a holder of registration certificate?
This is is very popular question from our customers – which company name must be written in hard copy of registration certificate as a holder of registration certificate?
What is the reason of this question: before 2013 year in Russia old regulation law was in action, according to this law company who is written as owner of current certificate have had all rights to this certificate. So only this company could initiate and provide all actions with certificate if this was required.
Today situation quite different – Order of Russian Government 1416 speaks about manufacturer’s responsibility and only manufacturer has all rights for registration certificate – more information here.
What is the difference of holder and AR (local authorized representative company):
- holder – just company who is appointed by manufacturer to be a holder and be listed in registration certificate (Manufacturer appoints this company in PoA),
- AR – company is in charge of product circulation, compliance issues and post-market surveillance.
What is it PoA? Power of attorney – the same as legalization letter from manufacturer to authorized representative in Russia. Which information PoA contains: manufacturer, AR, holder, factory site names (very often), dates of validity and list of activities under this PoA.