by NHMF
Pharmaceutical manufacturers must comply with new sanitary guidelines
On Tuesday (08/20/2019) the Board of Directors of the National Health Surveillance Agency (ANVISA) approved the new regulatory framework for Good Manufacturing Practice (GMP) of medicines in Brazil.
The new rules will meet international standards to ensure the quality, effectiveness and safety of medicines, enabling the increased competitiveness of national companies and expansion of products exportation to international markets.
Furthermore, from this update, it is expected that Brazil will be integrated to the international inspection cooperation scheme that takes place between countries and pharmaceutical inspection authorities, called Pharmaceutical Inspection Co-operation Scheme (PIC/s).
The Collegiate Board Resolution No. 17/2010 and other related Normative Instructions will soon be updated by the authority and published in the Brazilian Official Gazette.
Our Public and Regulatory Law sector will continue to monitor legislative developments and is available to provide further information or clarification related to the matter.
by NHMFTHE DEADLINE FOR UPDATING THE CORPORATE STRUCTURE AND FINAL BENEFICIARY IS JUNE 26, 2019.
As per the Normative Instruction No. 1,863/2018, issued by the Brazilian Federal Revenue, national or foreign entities registered with the CNPJ (National Registry of Legal Entities) on or before December 28, 2018, have until June 26, 2019 to update its enrollment, identifying its corporate structure and the existence (or not) of an individual considered/classified as the final beneficiary, regardless of the corporate structure and origin of capital (exceptions apply). For entities enrolled with the CNPJ after December 28, 2018, the deadline to provide such information is 90 days from the date of its enrollment.
This is a mandatory procedure, except if otherwise provided for in the above-mentioned Normative Instruction, and the failure to comply with its terms, depending on the situation, could expose the entities subject to it to have their tax registry (CNPJ) suspended and face restrictions on transacting with financial institutions, among other impairments.
Our Corporate and Regulatory teams are monitoring the evolution of the matter and are available to provide any assistance related to the topic.
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by NHMFAdministrators and technical functions can be heldresponsible
Administrators and technical functions can be heldresponsible
As widely publicized by national and international media, after several tragedies involving technical facts or actions, with or without procedural shortcomings, administrators, managers and professionals in technical functions can be held responsible for the acts performed or results/effects related to their competencies or in the exercise of their activities, even if practiced in accordance to the company interest.
The legal repercussions of acts or events may involve administrators, directors, managers, attorneys, accountants, responsible technicians, engineers etc. For the determination of culpability the factual situation shall be analyzed in details, once the responsibility is not limited to the administrative and/or business spheres. In the case of company managers, for example, these may be responsible for the crime of fraudulent management practices.
Thus, it is increasingly common for legal entities to take steps to prevent risks and avoid responsibility for the irregular, reckless or inappropriate performance of its managers and technical professionals. Compliance with specific legislation, rigorous operational procedures in the operational structure and a (re)evaluation of the risks involved in each operation, according to the field of activity, are the keys to minimizing the implications that may occur. Our Public, Regulatory Law, M&A, Criminal, Compliance and Banking sectors will continue to monitor the legislative evolution and are available to provide further information or clarification related to the matter.
To obtaining this file, click here.