On December 25, 2016, ANVISA adopted new standards to allow the license transfer from a Brazilian Registration Holder (BRH) – generally corresponding to the importer/distributor on the territory – to another one.
As a matter of fact, in Brazil the BRH is the owner of the registration (both for registro and cadastro procedure), as well as the BGMP certificate.
The manufacturer plays a passive role in terms of device registration and marketing, he exclusively depends on the appointed BRH, therefore he is in an unfavorable position. This is also confirmed by the fact that it’s currently impossible to change the BRH, unless upon expiry of the product registration certificate (five years) or in more particular and limited cases.
But on December 25, when the RDC 102/2016 came into force, would this situation change the manufacturer dependence role? Will the manufacturer have the possibility to replace the appointed BRH with another one?
The answer to these questions is NO.
NO because:
- the outgoing BRH transfer approval will always be mandatory and formalized through a specific contract;
- the transfer will not require the manufacturer approval. The outgoing BRH may transfer the licenses ownership to any other subject selected, without even informing the manufacturer.
There is nothing new about it, except for the usual strengthening of the device market power belonging to the BRH and the manufacturer’s corresponding exclusion.
At these conditions, it is worth doubting once again that relying on a single importer in Brazil may be a winning choice.
Maybe relying on a third impartial and independent subject would be the best choice, someone who doesn’t affect the device marketing strategies on the territory decided by the manufacturer and doesn’t change the facts on the ground as he pleases.
This is exactly what Thema intends to guarantee to its own customers, using its own agency on the territory and through the registration service and License Holding in Brazil.
Do you want other information about Brazil? Go to the section Country Brazil
Would you like to be always updated about Thema’s activities? Sign up to our newsletter!
Marisa Testa
QA/RA Manager
