INFO LIFE SCIENCES | OCTOBER 2021

Anvisa publishes Resolution on requirements to import industrialised radiophermaceuticals

On 30 September 2021, the National Health Surveillance Agency (Anvisa) published Resolution RDC No 567/2021 (Portuguese language), establishing temporary and exceptional requirements for the import of industrialised radiopharmaceuticals listed in Normative Instruction No 81/2020 (Portuguese language).

The import of these products can be carried out by public bodies and entities, as well as legal private entities, including health establishments and services, providing they meet the Resolution’s requirements.

Products subject to the Resolution are exempt from sanitary registration with Anvisa. However, this does not exempt the importer from: (i) complying with the other applicable legal requirements and technical standards or (ii) carrying out post-marketing monitoring. Although registration is not mandatory, the products are subject to quality monitoring by the National Network of Health Surveillance Laboratories (RNLVIS)

The products must have undergone quality control tests by the manufacturer and will be exempt from quality control tests carried out in the Brazilian territory provided that the batches: (i) have undergone quality control tests and possess the necessary release certificate and (ii) are stored and transported in accordance with the conditions recommended by the manufacturer.

The importer must, among other obligations:

• Enable product traceability and allow the identification of those responsible for its distribution.
• Evaluate the benefit-risk profile arising from the use of the product.
• Monitor the conditions of the transportation chain, such as the storage and transportation temperature during international transit, in case of products that require refrigerated storage.
• Make public the information that the product has not been evaluated by Anvisa and has been approved by a foreign health surveillance agency.
• Comply with post-distribution and post-use surveillance actions, such as establishing monitoring mechanisms for technical complaints and adverse events and communicating recall actions to Anvisa.

The Resolution establishes mandatory documents for the import application, including a quality control analytical report, import licensing, operating permit (AFE), proof of the product registration in its country of origin or where its being marketed and proof of compliance with good manufacturing practices.

Anvisa will monitor technical complaints and adverse events, as well as adopt control, monitoring, and health inspection actions. In addition, Anvisa can suspend the import, distribution and use of the imported products.

Non-compliance with the Resolution is considered a sanitary infraction, under the terms of Law No 6,437/1973 without prejudice to civil, administrative, and criminal liability.

The Resolution entered into force on the date of its publication and will be valid until 31 December 2021.

 

 

Anvisa publishes FAQ on good distribuition, storage and transportation practices for drugs

Por Kestener & Vieira Advogados

 

On 28 September 2021, the National Health Surveillance Agency (Anvisa) published a frequently asked questions (FAQ) (Portuguese language) regarding Resolution RDC No 430/2020 (Portuguese language) (the RDC) which provides for good distribution, storage and transportation practices for drugs.

The material is intended for the pharmaceutical sector and for the National System of Health Surveillance (SNVS), which is responsible for inspecting the good practices of the companies.

The document aims to solve doubts raised by both the regulated sector and the SNVS inspectors, regarding the interpretation and application of the RDC, with the intent of clarifying its content and promoting better application of the RDC and greater quality control.

The FAQ document is available on Anvisa’s official website and addresses various aspects of the RDC.

 

 

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