BRH mediates between the company and the ANVISA. The fee charged by the BRH includes ANVISA fee + BRH service charges.
A BRH, by definition of the regulations, do not "mediate" anything. It?s the fully responsible registration holder for the product in Brazil, even if the product is manufactured abroad.
When a company provides a letter of authorization to the BRH, this letter will include the committment of BGMP fee as well, and its associated BRH service fee.
This depends on the agreement. There?s no rule for that. I?m not sure what you mean by "BRH service fee" (probably an additional fee the BHR service requires for handling the BGMP certification process - BRh services did not include this in the past, for example).
When a company opts for the MDSAP then obviously the BRH will lose on their revenue. Hence a BRH will never encourage company to take up MDSAP.
Depends on how much we are talking about. As mentioned above, in the past there was no "revenue" related to BGMP certification. If the services are requiring a fee right now - and I know some are - it will depend on how much they are getting out of it. As I mentioned on the last, post, historically BRH services did not profit from this, but from having a device registered in Brazil.
Also, as I mentioned before too, those services do what they are paid to do. If you, as the original manufacturer, conclude that you want to use MDSAP, you simply do that. There?s not need to "encourage a company to take up MDSAP", it?s the company decision, not theirs.
Their ABIMED comes in handy to speeden up the process. Perhaps the BRH never know the parallel MDSAP process now exists as a pilot on a 3 year trial period.
Well BRH services have already profited for years from the lack of knowledge of their clients. There?s nothing new in this case.
Now comes the next catch. When a company takes up the MDSAP, they pay the AO. If the company waits for FDA, its free. But when FDA inspection is applicable to the company, and the company wants to expand the market, then MDSAP may help. They therefore land up paying the AO and eventually cover the FDA inspection also at a cost.
Yes, as I mentioned, it was created as an alternative. That?s also why it?s optional.
So how popular is this MDSAP after 16 months of pilot out of the 36 months which included the AO recognition period as well ... ??
Well, it?s a question participating the regulatory authorities should be asking, right? Although I think they should have asked and answered that before beginning the program.