On August 25 2016 the Health Surveillance Agency (ANVISA) published Resolution 102/2016, issuing new rules regarding the transfer of:

  • marketing authorisations for cosmetic, drug, tobacco, agrochemical and health products; and
  • responsibility for clinical trials and updating information regarding the operation and certification of companies as a result of corporate or business transactions.

Among other things, the rules enable the transfer of marketing authorisations and good practice certificates in business transactions involving the sale and purchase of assets, without requiring the companies involved to complete a corporate transaction.

Previously, the transfer of marketing authorisations in transactions involving the sale and purchase of assets had no legal protection. Rather, such protection existed only in corporate transactions resulting from company spin-offs, mergers or amalgamations, as provided for in Resolution 22/2010 of June 17 2010.

Resolution 102/2016 will apply to all corporate and business transactions executed between companies carrying out ANVISA-regulated activities – as well as corporate transactions concluded overseas – that impact companies and products marketed in Brazil.

Further, RDC 102/2016 provides the procedures for updating manufacturing, distribution and storage and drug bioavailability and bioequivalence good practice certificates as a result of business or corporate transactions involving the sale and purchase of assets. This is a key change, as it allows acquiring companies to be assigned the existing certification instead of having to pursue new certification, as was previously required.

Discussions regarding these regulatory changes began in 2011 and the life sciences sector has waited patiently for the process to be concluded. Resolution 102/2016 is an important milestone for the sector and the Brazilian economy, as it may lead to an increase in the number of business transactions by allowing the smoother negotiation of product portfolios and a shorter timeframe between signing and finalising life sciences transactions.

Resolution 102/2016 will take effect on December 23 2016 and will revoke Resolution 22/2010.

For further information on this topic please contact Elysangela de Oliveira Rabelo at TozziniFreire Advogados by telephone (+55 11 50 86 50 00) or email (erabelo@tozzinifreire.com.br). The TozziniFreire Advogados website can be accessed at www.tozzinifreire.com.br.