On August 25, 2016, Brazil’s National Health Surveillance Agency (“ANVISA”) granted a new resolution (“RDC”) to improve a bordering field of the product registration process.
This new procedure aims to address reported problems concerning red tape slow process of ownership transfer of registered products before Health Surveillance Agencies.
Moving forward with the redesign of its regulatory framework, ANVISA also delimited adjacent subjects to the ownership transfer, such as (i) the global transfer of liability about ongoing clinical trials; and (ii) updating of data registered on the Company’s licenses (i.e. AFE; and AE) and certifications (i.e. GMP; GDP; and GCP) before Health Surveillance Agencies.
Until the old RDC, the ownership transfer of registered products before the Health Surveillance Agencies was possible only in the case of mergers, consolidations or corporate spin offs of one or more companies. Now, under the new rules, the simple sale of assets and / or financial assets transfer between companies will promptly enable the ownership transfer of these registrations before ANVISA, thereby fulfilling the rights and obligations under the provisions of the agreed upon transaction.
New guidelines under RDC No. 102/2016 requires that conditions and technical and health characteristics of the products and ongoing clinical trials continue unimpeded by the M&A transaction.
Addressing innovation and R&D, the RDC sets forth that after the completed transaction, all rights and obligations by the seller company will be subrogated to the buying company that includes but it not limited to: (i) meeting deadlines and adequacy determinations on health legislation; and (ii) compliance with any restrictive measures imposed on the marketing of products.
Note that for the acts committed prior to the M&A transaction there is joint liability of the seller company in relation to the buying company before Health Surveillance Agencies.
The RDC also improved companies’ reported concerns about timing of filling the requests of (i) updating of data; (ii) cancellation of the previous registration on behalf of the seller company before ANVISA; and (iii) ownership transfer of registrations. Hence, the deadline for providing such requests was set on a case by case basis by RDC No. 102/2016, in order to meet the peculiarities of each sector.
For pesticide products, their components and similar, as well as tobacco products or derived, the time limit is sixty (60) days from the date of the registration of the corporate documents before the Board of Trade or, if just an commercial transaction, from the date of the effecting of the Closing AoA Amendment.
On the other hand, the ownership transfer of registered products and the cancellation of the previous registration of drugs, active pharmaceutical ingredients (“API”), cosmetics, cleaning products, foods, and among others health products in general, the period is one hundred and eighty days (180) per the rule detailed above.
Meanwhile, the updating of data registered on the Company’s licenses and certifications before Health Surveillance Agencies should be applied as soon as the M&A transaction is consummated.
All-in-all, the transfer requests – conducted by the buying company – and the cancellation requests – carried out by the seller company – should be performed at the same time by the parties, as these also will be presented together to ANVISA.
Regarding specifically the pharmaceutical sphere, careful attention should be focused on the determination contained in article 34 of the RDC No. 102/2016. Such rule has confirmed understanding recommended by the Agency since mid-2015, allowing that as a result of the ownership transfer of registered products, a single company holds different names for drugs with the same API.
This is different from the Brazilian Public Prosecutor perspective that the maintenance of different names for identical drugs causes undue consumer confusion in the marketplace and, for that reason, could present a high health risk to the public at large.
Finally, article 34 and RDC No. 102/2016 were enacted to settle a legal gap in relation to imports which are carried out after the M&A transaction but before the approval of the data amendments of the Company’s licenses and certifications by ANVISA. For this purpose, the ANVISA created the document called “Statement on practiced transaction”, wherewith the buying company can import goods affected by the deal, using the licenses held by the seller company, even before the publication of the granting decision by ANVISA.
The same rationale was applied in the provision to permit the importation of products of which the transfer of ownership is still pending before ANVISA. In this case, the document for such reference is on RDC No. 81/2008.
The validity of the cancellation of the previous registration and of the ownership transfer of registered products will begin only after ninety (90) days from publication of the decision through a specific ANVISA Resolution.
It is possible to secure that this period of vacancy, plus the term of Article 40 of RDC No. 102/2016, will benefit the management of the strategic plan of the company to stock depletion of residual products, packages, and labels, without causing damage to stakeholders.
Despite its advances, as well as of the streamlining of procedures imposed to companies operating in the Life Sciences sector in Brazil, some relevant points to private entities remain uncovered by the RDC, especially with regard to the predictability of the granting decision of the ownership transfer and its implications, either in trade scope (e.g. manufacture and marketing of products by the buying company), or in the surveillance sphere (e.g. traceability and assessment of health risks).
As ANVISA adopts an increasingly system to the Food and Drug Administration (“FDA”) in United States, the country continues to try to make business-friendly regulatory decisions.
The RDC No. 102/2016 shall enter into force at the end of December, 2016, covering companies operating in the pesticide market, its components and similar, as well as tobacco, drugs, API, cosmetics, cleaning products, foods, and among others health markets in general.
It is undeniable that ANVISA’s regulatory framework again meets the needs of today’s globalized market and, thus, enhances the attractiveness of Brazil to investors.
Fabiano Gallo, Terence Trennepohl and Bruna Rocha