INFO LIFE SCIENCES | JULY 2021

COVID-19: Anvisa extends validity of Resolutions on exceptional procedures for manufacture and importation of drugs

On 8 July 2021, the National Health Surveillance Agency (Anvisa) extended the validity of Resolution RDC No 483/2021 (Portuguese language) and Resolution RDC No 484/2021 (Portuguese language), which aim to combat the COVID-19 pandemic, by providing exceptional and temporary measures to ease requirements related to the market authorisation (MA) approval and importation of drugs and products essential in tackling COVID-19.

Resolution RDC No 483/2021, which sets forth requirements for importing medical devices and drugs that are identified as public health priorities but do not have an MA from Anvisa, has had its validity extended until 14 September 2021.

Resolution RDC No 484/2021, which sets forth procedures for emergency manufacture approval for drugs used to treat patients with COVID-19, has had its validity extended until 31 December 2021. The manufacture of these drugs must be approved under the notification regime, enabling the manufacturer to promptly produce the drugs and make them available to Brazil’s hospitals and clinics.

Both Resolutions were extended due to the current national pandemic situation, to maintain the supply of such products in the light of high consumption and to prevent shortages.

 

Anvisa publishes public consultation on Unique Device Identification

By Kestener & Vieira Advogados

 

On 30 June 2021, the National Health Surveillance Agency (Anvisa) published Public Consultation No 1,051/2021 (Portuguese language) regarding a proposed Resolution to regulate identification of medical devices through the Unique Device Identification (UDI).

The UDI corresponds to an international standard defined by a numeric or alphanumeric series, in accordance with International Medical Device Regulators Forum (IMDRF) guidelines. The series allow the unequivocal identification of a product in the market, thereby simplifying the traceability of devices.

The proposed Resolution (Portuguese language) applies to all medical devices that are regulated by Anvisa, including in vitro diagnostic products, except those that are custom-made or under clinical investigation. If approved, the Resolution will compel manufacturers to implement mechanisms in their quality control systems to ensure that every medical device has its own UDI series.

Moreover, the proposed Resolution establishes deadlines, following its approval, for assigning the UDI in accordance with the medical device’s risk class or function. The Resolution sets out:

• A two-year period for risk class IV.
• A three-year period for risk class III.
• A four-year period for risk class II.
• A six-year period for risk class I.
• Immediate application of traceability tags for unique identification of coronary artery stents, drug-eluting stents for coronary arteries and implants for hip and knee arthroplasty.

Contributions to the consultation on the proposed Resolution must be submitted via the form available on Anvisa’s website by 6 September 2021.

 

COVID-19: provisional pricing for drugs and vaccines

By Kestener & Vieira Advogados

 

On 5 July 2021, the Drug Market Regulation Chamber (CMED) published Resolution CMED No 8/2021 (Portuguese language) revoking Resolution CMED No 5/2021 (Portuguese language) and Resolution CMED No 6/2020 (Portuguese language) which until then had regulated the procedure for determining the price of new COVID-19 drugs and vaccines.

Resolution CMED No 8/2021 maintains the previous Resolutions’ provisions, which are:

• Products without marketing authorisation and with temporary authorisation for emergency use are not subject to CMED’s price analysis.
• CMED’s Technical Executive Committee has the authority to analyse and decide price registration requests for COVID-19 drugs and vaccines, considering that this case is categorised as an “omitted case”.
• CMED’s Technical Executive Committee has a term of 90 days to decide on the above-mentioned price registration, according to Communication CMED No 10/2016 (Portuguese language).
• While awaiting CMED’s final decision, the applicant company may commercialise the product at the proposed price.

However, Resolution CMED No 8/2021 includes a new provision determining that the above-mentioned price registration will be valid only while the COVID-19 pandemic continues. The Resolution entered into force on its publication date.

 

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