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 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 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
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.