E-Notivisa will now register notifications of adverse events and technical problems related to food
The new system module will be launched during a webinar on 9/23, at 10 am. Join in! Next Monday, September 23, at 10 am, Anvisa will hold an online seminar (webinar) to present the new e-Notivisa module. From now on, the …
How to Import Dental Products
The import of dental products is a growing market, especially for high-demand materials such as zirconia blocks and lithium disilicate. These products, essential for state-of-the-art dental procedures, require a specific import process that involves strict regulations. In this article, we will explore how …
Anvisa extends the period of validity of the Certificate of Good Manufacturing Practices to four years.
This measure is valid for companies participating in the MDSAP program. The Brazilian Health Surveillance Agency (Anvisa) decided to extend the validity period of the Certificate of Good Manufacturing Practices (CBPF) for manufacturers of medical devices that participate in the Medical Device …
Anatel authorizes the experimental phase of the provision of mobile telephone services via satellite.
The Brazilian Telecommunications Agency (Anatel) used a mechanism called Regulatory Sandbox, an approach that makes regulations more flexible for telecommunications projects considered to be of great relevance to the country. Anatel’s Board of Directors decided, during a virtual meeting held on Thursday …
https://www.licempre.com.br/anvisa-na-46a-reuniao-do-ich-avancos-em-produtos-farmaceuticos/
The Brazilian Health Regulatory Agency (Anvisa) will be present at the 46th meeting of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The event took place in Vancouver, Canada, from June 9th to 14th. With 17 …
Low-impact pesticides to control diseases and pests are new alternatives for farmers.
Published on December 7th, in the Diário Oficial da União [Federal Official Gazette], Act No. 57 of the Department of Plant Health and Agricultural Inputs of the Secretary for Agricultural Defense, presents the registration of 45 new agricultural pesticides formulated, which will …
Anvisa publishes guidelines on microbiological control of cosmetics.
Last Monday, October 3, the Resolution of the Collegiate Board of Directors (RCBD) [Resolução da Diretoria Colegiada – RDC] 752/2022 came into force, which provides for the regularization of personal hygiene products, cosmetics, and perfumes. This is the first in a series …
Anvisa optimizes clinical research through new regulation
On February 16, Anvisa published in the Official Journal of the Union, the Collegiate Board Resolution (RDC) 601/2022, which deals with the simplified analysis, in an exceptional and temporary way, of clinical research petitions. This Resolution aims to optimize the release of …
Anvisa updates the codes of its Contingency Plan
Recently, Anvisa announced that it identified the need to include and change the subject codes for the Import Licensing petition, through the Request System, originating from the registration of LPCO – Licenses, Permissions, Certificates and Other Documents, in the Single Foreign Trade …
Norm on imports of medicines and medical devices reaches the end of its validity, according to Anvisa
With the emergence of the pandemic, Brazil needed to supply itself with essential products to face Covid-19 in hospital environments. For this, the RDC 483/2021 was created as an emergency, which aimed to supply the national market in order to meet all …
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