The National Health Surveillance Agency published Resolution RDC No. 625/2022, which provides the minimum requirements related to the marketing authorization holders’ obligation to communicate the implementation of a drug recall to the competent authorities and consumers. This is in case there is sufficient evidence or proof of quality deviation resulting in risks or consequences to health, as well as due to the cancellation of registration related to safety and efficacy.
With the annual J.P. Morgan Healthcare Conference pivoting to a virtual format again in 2022, we will be hosting a lineup of virtual events and reports aligned with the industry’s biggest conference.
How do life sciences companies intend to leverage new and existing sources of growth? Explore the trajectory of life sciences transactions in our latest report.
As digital transformation reshapes business models with different emphases across regions, digitally enabled strategies are helping companies transition from product-only offerings to product-service hybrids, orient to patient mapping, pre-diagnostics solutions and enhancing treatment administration.
The Brazilian National Health Surveillance Agency (“Anvisa”) published Resolution RDC No. 497/2021 (“RDC 497/2021”) setting forth the new administrative procedure for obtaining the Good Manufacturing Practices Certificate, as well as the Good Distribution and/or Storage Practices Certificate. RDC 497/2021 modifies the general conditions for certification, as provided for in its Chapter II, to facilitate the certification process.
On 1 April 2021, Law nº 14,133/2021 or the New Public Procurement General Law (“New Public Procurement Law”) was published, substituting Law nº 8,666/1993. The Brazilian president, however, has vetoed 26 items of the bill approved by the National Congress.
The Brazilian Senate approved last week the final text of the bill for a new public procurement general law (“New Public Procurement Law”), which will substitute Law nº 8,666/1993. The final document will now be submitted to the Brazilian president for signature and/or vetoes.
The Brazilian Senate approved last week the final text of the bill for a new public procurement general law (“New Public Procurement Law”), which will substitute Law nº 8,666/1993. The final document will now be submitted to the Brazilian president for signature and/or vetoes.
The Brazilian federal government published on 10 March: (a) Federal Law No. 14,124/2021, for providing for exceptional measures related to the acquisition of vaccines and other services related to COVID-19; and (b) Federal Law No. 14,125/2021, for providing for liability and adverse events of post-vaccination against COVID-19, and for the acquisition and distribution of vaccines by private entities and federative entities (state or municipality).
As the energy, mining and infrastructure industry in Latin America looks ahead to the new year, we present the Latin America EMI Hot Topics Guides for 2021 to facilitate discussions about the key trends we see in each sector. We invite you to read the guides to learn more about…