by NHMFIndustrial and commercial activity in Brazil affected by Coronavirus
Law No. 13,979/2020 will affect industrial and commercial activities due to the health restrictions to combat the Coronavirus. Among the measures there are the exceptional and temporary restriction on entering and leaving the country by highways, ports or airports; and exceptional and temporary authorization for the import of products subject to health surveillance without registration before ANVISA (National Health Surveillance Agency).
In industrial, commercial and provision service activities, the law provides for the isolation, quarantine and closure of ports, highways and airports for the entry and exit of Brazil of products, supplies and commodities subject to health surveillance with suspected contamination origin or without registration before ANVISA, as well as the separation of sick or suspected people from contamination, or luggage, means of transportation, goods or postal parcels affected.
Legally and technically, the Ministry of Health will define the conditions and terms of these restriction measures that may paralyze industrial, commercial and service provision activities, directly or indirectly, as the case may be.
There is also a waiver of bidding proceeding for the purchase of goods, services and supplies for these actions and restrictions. The law is in effect and already have immediate impacts on health protection and economic activity.
Dr. Renato Poltronieri and our Public and Regulatory Law sector monitor the developments of the subject and advise clients and interested parties on procedures for adapting or contesting this new rule, and are available to provide any assistance related to the matter.
by NHMFManufacturers and retailers of veterinary products must have a technical manager
Bill nº 5.306/19 proposes that establishments that industrialize, manufacture, sell or store products for veterinary use must have the presence of a veterinarian registered before the Regional Council of Veterinary Medicine.
The proposal lists the veterinary products subject to special control and determines that the sale will be conditioned to the prescription, in prescription form, by a veterinarian registered before the regional council of the category, under penalty of warning, fine and, when applicable, cancellation of product registration and/or cancellation of the establishment’s registration.
The Bill is being analyzed by the House of Representatives and awaits a conclusive opinion from the Economic Development, Industry, Commerce and Services Commission. If it becomes a law, all companies in this segment will have obligations and additional costs with hiring a veterinarian and registering operations.
Dr. Renato Poltronieri and the Public and Regulatory Law sector of NHM Advogados continue to monitor the matter and advise clients and interested parties on procedures for adapting or contesting the new rule, and are available to provide any assistance related to the subject.
by NHMFChemical sector impacted by the new rules of the Federal Police and Army
The new rules for control and inspection of chemical products by the Army and the Federal Police shook the chemical sector in January. Companies and their customers that previously did not need registration and certification of the product and/or mixture are now covered by the authority inspection, raising questions about the legislations in force.
This adaptation process must be closely monitored, and it is essential for the companies regularity to review internal procedures and, mainly, the technical and normative analysis to classify chemicals and/or mixtures as controlled or exempt.
The Ordinances of the Army and the Federal Police are in force and non-compliance occurrences subjects legal entities to the penalties of fine, interdiction of the establishment and even the revocation of registration, without prejudice to civil and/or penal sanctions.
The Public and Regulatory Law sector of NHM Advogados performs in the regularization of chemical sector`s companies and will be at your service to render any assistance related to the issue.
by NHMFChanges provided for in the Concessions Law will offer more legal certainty to companies
The Bill nº 7063/2017, which deals with the legal landmark for public-private concessions and partnerships (PPPs), entitled the General Concessions Law, consolidates in a single document the current rules of concessions, public-private partnerships and investment funds in infrastructure.
In order to ensure legal certainty for investors, the proposal establishes a maximum period for the Courts of Auditors to deliberate on the bidding notices and establishes the obligation of contractual provision of the granting authority’s response time for requesting economic-financial rebalancing.
In addition, there is the disciplining of the Expression of Interest (PMI) procedure and social and environmental sustainability will become part of the public service concession guidelines, so that feasibility studies and licensing for concession projects will have priority in the bodies. environmental
The report will be discussed and voted on in the special committee this Tuesday (11/26/2019), before attending the House of Representatives Plenary.
The Public Law and Regulatory Department of NHM Advogados will keep following up the developments of the matter and will be at your service to render any assistance related to the issue.
by NHMFLegal Entitites shall adapt to Zoning Law Changes
The Municipal Secretariat of Urban Development (SMDU) of the São Paulo City Hall is holding public hearings to promote adjustments to the Land Use and Occupation Law (Law 16,402 / 16), also known as the Zoning Law.
Real estate concepts and urban policy guidelines defined by the Strategic Master Plan will be reviewed and implemented in a final draft bill.
The adjustment process aims to improve the application of the established provisions, clarify recurring doubts in licensing processes and bring greater legal certainty in law enforcement.
The Public Law and Regulatory Department of NHM Advogados will keep following up the developments of the matter and will be at your service to render any assistance related to the issue.
by NHMFCompanies can contribute to elaboration of dispute settlement model for infrastructure contracts
The Special Secretariat of the Investment Partnership Program (SPPI) of the Civil Office of the Presidency of the Republic is promoting a Public Consultation (No. 1/2019/SPPI/CC/PR) to draft a resolution recommending the adoption of adequate dispute settlement mechanisms in partnership agreements of projects to be qualified under the Presidency of the Republic Investment Partnership Program (PPI).
Based on Technical Note No. 4/2019/STR/SPPI, the proposal aims at improving the regulatory framework for the development of the country’s infrastructure, promoting dialogue with the financial sector, private law practice specialized in regulatory law, concessionaires and entities of various sectors.
When allowed negotiation, mediation, arbitration and/or the creation of a dispute board as appropriate mechanisms for dispute settlement, the partnership agreements of ventures that may be qualified under the PPI will adopt the model clause provided for.
Once contributions are received and the appropriate answers and adjustments are made, the proposal will be able to be submitted to the Board of Directors of the Presidency of the Republic’s Investment Partnership Program (CPPI).
Interested individuals or legal entities may submit contributions until 12/01/2019.
The Public Law and Regulatory Department of NHM Advogados will keep following up the developments of the matter and will be at your service to render any assistance related to the issue.
by NHMFManufactres and Importers of Medicinal Products shall observe ANVISA’S New Regulation
On 10/23/2019 the National Health Surveillance Agency (ANVISA) published the Resolution of the Collegiate Board No. 317/2019, which provides for the expiration dates and the necessary documentation to maintain the regularization of medicines.
The regulation establishes new deadlines for medicines registration and defines rules regarding the notification and interest declaration for marketing continuity.
For registration renewal, petitions already received will be reviewed under the new terms and the new rules will be applied automatically, upon observance of the defined exceptions.
This normative will be effective on ninety (90) days from its publication.
The Public Law and Regulatory Department of NHM Advogados will keep following up the developments of the matter and will be at your service to render any assistance related to the issue.
by NHMFLegal entities and its collaborators must adapt to General Data Protection Law
Law n. 13.709/2018 (“General Data Protection Law”), sanctioned in August 2018, will soon enter into force.
The purpose of the regulation is to ensure data privacy (customers, collaborators, employees, partners, service providers, etc.), with certain rules for capturing, storing, processing and sharing personal information.
Companies, including startups, should be aware of their obligations to comply with the law, as the regulation applies regardless of the means and/or form of data processing, online or offline, whether or not using digital media.
The Public Law and Regulatory Department of NHM Advogados performs in data mapping and diagnosis for the adequacy of policies, contracts, procedures and other technical/operational activities to comply with the protection regime established by General Data Protection Law, and will be at your service to render any assistance related to the issue.
by NHMFManufacturers and food labeling are on the sight of ANVISA
Manufacturers and food labeling are on the sight of ANVISA
National Health Surveillance Agency (Anvisa) will require food manufacturers to change the labels of foods produced or imported/commercialized in the country.
Packaging will require even clearer information, such as a warning for products with high added sugar, saturated fat and sodium.
Anvisa proposes that this warning should appear on the front of the package, with a magnifying glass design.
The new regulation is in public consultation for 45 (forty five) days. Strictly speaking, to comply with legal formality, since the Anvisa Board is steady in this obligation and only a new technical fact or any judicial measure can avoid or postpone this new rules.
The Public Law and Regulatory Department of NHM Advogados will keep following up the initiatives by ANVISA, and it will be at your service to render any assistance related to the issue.
By Renato Poltronieri
by NHMF
Exported vegetable products shall meet additional sanitary requirements
Last Tuesday (13/Aug/2019), the Brazilian Ministry of Agriculture, Livestock and Supply (MAPA) published the Instrução Normativa nº 19, ruling on requirements, criteria and procedures for the issuance of the International Sanitary Certificate for vegetable products.
According to such ruling, the certificate, which can a digital one, will only be issued if, in addition to compliance the Brazilian laws, the requirements of the importing country or country blocs which were agreed upon or officially informed are observed.
Considering that meeting the qualitative and sanitary requirements is paramount for achieving competitiveness in the international Market, the exporting company shall comply with the new commercialization dynamics and adopt procedures to attest the product conformity.
The Instrução Normativa shall come into force ninety (90) days after is publication.
The Public Law and Regulatory Department of NHM Advogados will keep following up the initiatives for the easing and modernization of the inspection processes in the international trade, and it will be at your service to render any assistance related to the issue.