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56 TECHNICAL AND REGULATORY AFFAIRS 2018 YEARBOOK
Annual ICCR Meeting, Brazil edition spection model (document and paper analysis) to
implement a post-market control (the product
REGISTRATION TIMES in the aisle, even avoiding falsification), as it is
already done in reference countries, such as the
As the country mover toward its international United States and European Countries.
technical and regulatory positioning, in the do-
mestic market the industry still feels the effects A breakthrough had already been made
of the political crisis that begun in 2014, facing in 2015 when only five categories (30% of the
arbitrary and often unconstitutional decisions. market) were subject to registration: insect
Most of the activities are, therefore, placed to repellent, sun- screen, children's personal
minimize economic impacts in face of regulato- care products, hair straighteners and hand
ry changes as indicated in previous yearbooks. sanitizers - other prod ucts should only carry
out the communication before the update
One of the aspects that must be stressed out because they are of low health risk. However,
was the activities for the facilitation of admin- the decrease in the number of notifications -
istrative and regulatory procedures. This mac- which should make the analysis process within
ro-theme aims to get closer to the premarket in- ANVISA easier – continues to be a barrier
in the way of requiring a lot of time (labels
changes take up to 159 days to get an approval,
for example).
Some major problems impacted the evo-
lution through times: the political instability
that prevented the preservation of qualified
technical teams to meet the sanitary authori-
ties regulatory demands; problems in the
op-eration of the electronic communication
sys- tems (operation of the SGAS - Automa-
tion System for Registration of personal care
products, fragrances and cosmetics and Data-
visa), among others. This lack of predictability
has a huge negative impact, especially for in-
ternational companies that often leave Brazil
out of their global launches, reducing invest-
ment and hence job offer.
REGULATORY UPDATES
LABELING
In 2017, public consultation was enabled for
coexisting labels, seeking to accelerate the
