Life Sciences & Healthcare
The Brazilian National Sanitary Surveillance Agency (ANVISA) published on August 25, 2016 the Resolution No. 102 ("RDC 102/2016") issuing new rules for the transfer of marketing authorizations of cosmetic, drug, tobacco, agrochemicals and health products, as well as for the transfer of responsibility for clinical trials and the update of information relating to the operation and certification of companies as a result of corporate or business transactions.
Among the new rules is the authorization for the transfer of marketing authorizations and good practices certificates in business transactions involving the purchase and sale of assets, without necessarily occurring a corporate transaction between the companies.
Up to the moment, there was no legal protection for the transfer of marketing authorizations in transactions involving the purchase and sale of assets, but only in corporate transactions resulting in spin-off, merger or amalgamation of companies, as provided for in the RDC No. 22 of June 17, 2010 ("RDC 22/2010").
The new regulation will apply to all corporate and business transactions executed between companies carrying out ANVISA regulated activities, as well as corporate transactions concluded overseas, which have impact in companies and products in Brazil.
The discussions regarding the change in this regulation started back in 2011 and the Life Sciences sector waited with expectation for the conclusion of this process. RDC 102/2016 is an important milestone for the Life Sciences industry and for Brazilian economy, as it may cause an increase in the number of business transactions, allowing a smoother negotiation of product portfolios and a shorter timeframe between signing and closing in Life Sciences transactions.
RDC 102/2016 will enter into force on December 23, 2016 and will revoke RDC 22/2010.
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