The Brazilian Health Surveillance Agency (ANVISA) published new RDC rule, concerning all procedures for transferring ownerships of health surveillance registries for regulated products, as well as the general transfer of liability for clinical trials, and the updating of registry data regarding the companies’ health surveillance licenses and certifications, whenever a corporate or commercial operation occur.
The new rule was positively received by the regulated market, since it now allows the transfer of regulated products’ regulations not only in corporate operations (such as restructurings, mergers and acquisitions, as the previous rule defined) but also in other commercial operations.
Henceforth, not only in corporate but also commercial operations, companies will be able to (i) update its registries regarding its health surveillance related business licenses and certifications; (ii) transfer the global liabilities for its clinical trials; and (iii) transfer the ownership of its registries regarding its health regulated products, through a single petition for each performed corporate or commercial operation.
The change also includes the transferring of the certifications regarding Good Practices for manufacturing, distribution and storage, and drug bioequivalence, as well as its business licenses granted by the agency.
It is also important to point out that the procedure transfers to the successor, whether due to corporate or commercial operations, all the rights and obligations of the previous holder, such as the compliance of deadlines and health surveillance rules.
The rule establishes the procedures for submitting such petitions, according to each regulated product category, and seems to promise a great improvement for the commercial operations of the regulated market.
Flávio C. Fujita – Pharmaco-Chemical Task-Force Team – Zilveti Advogados