Arquivos Life Sciences & Healthcare - Souto Correa Advogados

We have advised the first M&A of Pipo Saúde, a digital health and corporate benefits brokerage

marketing — Mon, 13 Feb 2023 14:38:05 +0000

We have advised the first M&A of Pipo Saúde, a digital health and corporate benefits brokerage. The company acquired the operation of HRTech Convenia, a benefits brokerage that serves more than 40 clients and covers more than 11,000 lives. The transaction sets Pipo to extend its portfolio to 80,000 lives covered and 220 corporate clients. Due to our full-service structure and multidisciplinary approach, we advised Pipo Saúde on all fronts of the deal: Corporate M&A with Gabriel Garibotti, Marília Bergamin, Martha Termignoni, and Mauricio Paschoal; and Life Sciences & Healthcare with Anderson Ribeiro and Gabriela Melani. For more information, click here.

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Anvisa’s Board of Directors approved the opening of a Public Consultation to propose authorization for the skinny label practice

marketing — Fri, 23 Dec 2022 14:27:34 +0000

At the last meeting of 2022, held on December 22, Anvisa’s Board of Directors approved a Public Consultation to amend Resolution-RDC 47/2009 – which sets forth rules for the elaboration, harmonization, updating, publication, and availability of labels of medicines for patients and health care professionals.

The proposed revision seeks to exclusively amend art. 14 of RDC 47/2009 to the following wording:

Art. 14.
§1 The labels for generic and branded generic drugs may differ from the respective label of the reference listed drug in the specific information for each product that must comply with the pharmacotechnical characteristics approved in the registration contained in the parts.
(…)
§3 In addition to the items mentioned in the previous paragraph, labels for generic and branded generic drugs may differ from the label of the reference listed drug (RLD) in relation to the therapeutic indications protected by patent.

The proposal aims to accept the skinny label practice. This exception already exists in other markets, which consists of the authorization for generic and branded drugs to enter the markets by excluding therapeutic indications under patent protection from their labels to avoid patent infringement.

A regulatory impact analysis did not precede the proposal mentioned above. The Reporting Director of the proposal informed that the legal opinions that analyzed the measure’s legality would also be disclosed with the public consultation.

Our Life Sciences & Healthcare team will monitor the publication of the draft submitted to Public Consultation and publish a new client alert on the subject. In the meantime, we are available via email: lifesciences@soutocorrea.com.br.

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Modification in the electronic submission system for Medical Devices

marketing — Thu, 01 Dec 2022 14:17:49 +0000

Anvisa has been working to centralize its routines in a single system – aka Solicita. In December, the action plan encompasses the transfer of procedures from the Health Products Technology Office (GGTPS) to Solicita.

All submissions for medical devices will be filed through Solicita, except for clinical trials and certificates, which remain under the current system.

The transfer will take place during December according to the calendar below:

Initial submissions of notification and registration will have a different form that must be filled in with all information. In this new form, the submission will be concluded only if all the required documents are attached.

All submissions will have electronic forms customized according to the submission scope and the inserted information will be used as the source for the Federal Register (DOU) publications of notifications and registrations.

Anvisa reported that some delays are to be expected during the transfer of procedures.

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New regulation on the chemicals controlled by Brazil’s Federal Police

marketing — Thu, 03 Nov 2022 13:12:31 +0000

The Brazilian Ministry of Justice and Public Security (MJPS) has issued Ordinance No. 204/2022 (Portuguese only) establishing the procedures to control and inspect chemical products as well as defining the chemicals that are to be controlled by the Federal Police.

The new regulation repeals Ordinance MJPS No. 240/2019 and modifies the list of controlled chemicals as follows:

Ordinance MJPS No. 204/2022 entered into force on 24 October 2022.

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The Legal 500 – Latin America 2023

marketing — Mon, 24 Oct 2022 13:33:25 +0000

A day after the Leaders League announcement, Souto Correa was once more featured in another international ranking: The Legal 500. In total, we had 55 recommended lawyers and 15 practice areas recognized for our legal services. Special mentions for the areas of Litigation and Corporate, which moved up in position, and the areas of Hydrocarbons, Life Sciences, Media and Entertainment, and Aviation entered the ranking for the first time. For more information, click here.

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Souto Correa strengthens life sciences team with in-house hire

marketing — Wed, 24 Aug 2022 00:27:49 +0000

The Latin Lawyer website reported that Paulo Rosito is the new hire of Souto Correa’s Life Sciences team. He has 25 years of experience in management and legal management positions in large pharmaceutical companies, such as Abbott, Merck Sharp & Dohme, Amgen, and Alexion, and other industries, including Embraer and Syngenta. Click here.

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