INFO KGV | LIFE SCIENCES MARCH 2020

COVID-19: ANVISA PUBLISHES RESOLUTION ON GMP CERTIFICATION DURING PANDEMIC

Beatriz MA Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados

 

On 13 March 2020, the Brazilian Health Surveillance Agency (ANVISA) published Resolution RDC No 346/2020 (Portuguese language), which establishes transitory and extraordinary criteria for certification of Good Manufacturing Practices (GMP) for granting marketing authorisations for and post-registration alterations to drugs, active ingredients and medical devices during the COVID-19 pandemic.

ANVISA aims to maintain the supply of health products without interruption in face of the international public health emergency involving COVID-19. According to the new Resolution, since in loco health inspections are not currently feasible, they will be made through videoconferences and data transmission technology. Moreover, ANVISA will take into greater consideration information received from international regulatory authorities. This applies to all GMP certification requests, including those filed before the Resolution was published, except for new requests involving products developed to contain and treat patients infected with COVID-19 and essential products whose availability is threatened by shortages in the national market as a result of COVID-19.

This measure follows the actions taken by other internationally recognised health authorities such as the FDA and EMA.

The Resolution will initially be valid for 180 days from publication but may be renewed for an equal period depending on the evolution of the COVID-19 pandemic. The temporary certification model will be applicable for the duration that new Resolution is valid.

 

COVID-19: ANVISA PUBLISHES RULES REGARDING EXTRAORDINARY AND TEMPORARY MEASURES IN FACE OF PANDEMIC

Beatriz MA Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados

 

On 18 March 2020, the Brazilian Health Surveillance Agency (ANVISA) published the following rules regarding extraordinary and temporary measures in response to the COVID-19 pandemic:

• Resolution RDC No 347/2020 (Portuguese language), which defines extraordinary and temporary criteria and processes for marketing antiseptic preparations or sanitisers, due to the international public health emergency related to SARS-CoV-2 (the virus which causes COVID-19).

• Resolution RDC No 348/2020 (Portuguese language), which defines extraordinary and temporary criteria and processes to treat marketing authorisation requirements for and post registration alterations to drugs, biological products and products for in vitro diagnosis, due to the international public health emergency related to COVID-19.

According to Resolution RDC No 348/2020, all products developed to treat or prevent COVID-19 will be subject to the extraordinary and temporary registration processes established by the new rule.

The new Resolutions will initially be valid for 180 days from publication. Resolution RDC No 347/2020, however, establishes that its validity may be renewed for an equal period depending on the evolution of the COVID-19 pandemic.

 

 

COVID-19: ANVISA PRIORITISES ANALYSIS OF DIAGNOSTIC PRODUCTS

Beatriz MA Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados

 

On 12 March 2020, the Brazilian Health Surveillance Agency (ANVISA) established that it would prioritise the analysis of all processes relating to products developed for the diagnosis of COVID-19 and other respiratory infections.

According to ANVISA, the decision was motivated by the Ministry of Health and the World Health Organization declaration that the world is facing a public health emergency and pandemic. ANVISA aims to expand the population’s access to diagnostic products for respiratory infections such as COVID-19 and provide health professionals with better tools.

Companies interested in the prioritisation must comply with all requirements for the marketing authorisation of in vitro diagnostic products, established in Resolution RDC No 36/2015 (Portuguese language) and email gevit@anvisa.gov.br.

 

“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”