INFO LIFE SCIENCES | SEPTEMBER 2021

COVID-19: Anvisa publishes resolution on exceptional and temporary import of vaccines and inputs

On 24 August 2021, the National Health Surveillance Agency (Anvisa) published Resolution RDC No 533/2021 (Portuguese language), which establishes the exceptional and temporary procedure for the import of vaccines and vaccine supplies registered before the Agency to combat the COVID-19 pandemic.

The Resolution applies to: (i) vaccines that have market authorisation (MA) or authorisation for emergency use granted by Anvisa and are intended for exclusive use for public health programme, and (ii) supplies for the manufacture of the vaccines which are the active pharmaceutical ingredient and semi-finished products.

The Resolution lists the various documents required for the import of the drugs, that is:

• Electronic import petition, under the terms of Chapter III, section I of Resolution RDC No 81/2008, which provides for the import of goods and products under health surveillance.
• Description of the goods in the Import Licence with the due disclaimers regarding the specific purpose for COVID-19.
• Commercial invoice.
• Declaration stating that it is an import of COVID-19 vaccine or vaccine supply regulated by Anvisa for use by a public health programme.
• Analytical report on quality control of the imported product (supply or finished product) and of the diluent, if any, by batch, issued by the manufacturer.
• Import Licence registered in SISCOMEX (Brazil’s Integrated Foreign Trade System).
• The importer’s authorisation to operate (AFE), when applicable.
• Declaration by the importer that it will follow the complete procedure of the Electronic Import Petition, carrying out all the formalities until the import process is generated at Anvisa, even after the approval of the Import Licence.
• Declaration of the Registration Holder (DDR) in cases of vaccine importation by third parties.
• Document issued by Anvisa authorising the emergency use of the vaccine, where applicable.

The importer is exempt from presenting other documents provided for in Resolution RDC No 81/2008.

The Resolution entered into force on the date of its publication and will be automatically revoked at the end of the National Public Health Emergency that was declared by Ordinance No 188/2020.

Anvisa concludes fourth stage of “Revision Decree”

By Kestener & Vieira Advogados

On 31 August 2021, the National Health Surveillance Agency (Anvisa) announced (Portuguese language) that it had concluded the fourth stage of the regulatory acts revision and consolidation programme established by Decree No 10,139/2019 (Portuguese language) (the Revision Decree).

The revision programme has five stages and is expected to be concluded by March 2022. It does not include technical changes to the content of the rules, but rather improves the legislative procedure and wording, as well as organising and consolidating the normative acts. To this end, the Revision Decree eliminates ambiguities, unifies repetitive articles, updates outdated terms and language, and eliminates obsolete sections, among other measures.

In the fourth stage, Anvisa approved 25 Resolutions and one Normative Instruction. These were published in the Federal Gazette on 31 May 2021 and entered into force on 1 October 2021. They include:

• Resolution RDC No 546/2021 (Portuguese language), which revokes Resolution RDC No 56/2001 and determines the essential requirements for safety and efficacy of medical devices, internalising Mercosur/GMC Resolution No 72/1998 (Portuguese language).
• Resolution RDC No 548/2021 (Portuguese language), which revokes Resolution RDC No 10/2015 and regulates clinical trials involving medical devices in Brazil.
• Resolution RDC No 549/2021 (Portuguese language), which revokes Resolution RDC No 27/2011 and determines the procedure for mandatory certification for equipment subject to health surveillance, such as (i) equipment for medical, dental, laboratory or physical therapy purposes aimed at diagnosis, treatment, rehabilitation, and monitoring in human beings; and (ii) equipment for aesthetic purposes.
• Resolution RDC No 556/2021 (Portuguese language), which revokes Resolution RDC No 14/2011 and determines the requirements for the gathering of health materials, such as stents, defibrillators and prostheses, for the purpose of registering these materials with Anvisa.

As the fourth stage has concluded, Anvisa is moving forward with the revision programme and expects to evaluate more than 600 rules in total regarding ports, airports and borders, medicines, food, cosmetics, sanitation and pesticides.

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