INFO KGV | LIFE SCIENCES JUNE 2020
COVID-19: IMPORT AND DISTRIBUTION OF PRODUCTS NOT YET REGISTERED WITH ANVISA
On 29 May 2020, the Brazilian President sanctioned Law No 14,006/2020 (Portuguese language), which alters Law No 13,979/2020 (Portuguese language), to permit the import and distribution of materials, drugs, equipment and health supplies related to COVID-19 that have not yet been registered with the Brazilian Health Surveillance Agency (ANVISA). Those products must be authorised by specified international sanitary authorities.
According to the new law, the importation of any product not yet registered with ANVISA and considered important for combating COVID-19 must be temporarily granted, provided that the product is registered with at least one of the following international sanitary authorities:
- Pharmaceuticals and Medical Devices Agency (Japan).
- National Medical Products Administration (China).
The law states that doctors have a duty to inform their patients about the authorisation process of the drug prescribed, so patients must be informed if the drug being prescribed to them is a product not yet registered by ANVISA, but approved by international sanitary authorities.
ANVISA has also issued a note (Portuguese language) on its position regarding the new law. ANVISA recognises that product approval processes may seem bureaucratic and slow, but states that careful procedures are necessary to ensure the quality and effectiveness of a product. In addition, ANVISA notes that the reality of healthcare is different in each country and for that reason the same product can be approved in one country and denied in others.
The authorisation to import and distribute products not yet registered with ANVISA is both extraordinary and temporary.
COVID-19: ANVISA PUBLISHES RESOLUTION EASING RULES OF GOOD MANUFACTURING AND IMPORTATION PRACTICES
Beatriz M. A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados
On 28 May 2020, the Brazilian Health Surveillance Agency (ANVISA) published Resolution RDC No 392/2020 (Portuguese language), which establishes extraordinary and temporary procedures for applying exceptions to specific requirements of good manufacturing and importation practices for drugs and active pharmaceutical ingredients.
According to the Resolution, companies that manufacture and import drugs and active pharmaceutical ingredients are authorised to request an exemption from complying with certain specified technical requirements of good manufacturing and importation practices, provided that:
- The exemption is necessary due the COVID-19 pandemic.
- A risk assessment is conducted, demonstrating that the effects of non-compliance with the technical requirements are controlled.
- The exemption will be documented in the company’s Management System of Pharmaceutical Quality.
Companies interested in requesting an exemption under the Resolution must file their petitions using related subject codes (Portuguese language) listed on ANVISA’s website.
ANVISA LAUNCHES PUBLIC CONSULTATIONS ON DRUG LABELLING AND LEAFLETS
Beatriz M. A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados
On 3 June 2020, the Brazilian Health Surveillance Agency (ANVISA) published three public consultations regarding rules for labelling and leaflets for drugs:
- Public Consultation No 816/2020 (Portuguese language), which proposes a normative ruling to establish specific requirements for the labelling of small and large volume parenteral solutions, irrigation solutions, dialysis and plasma expanders.
- Public Consultation No 817/2020 (Portuguese language), which proposes to revise warning phrases for substances and therapeutic classes in leaflets and drug packaging, currently established by Resolution RDC No 137/2003.
According to ANVISA, the public consultations comply with:
- The World Health Organization’s Third Global Patient Safety Challenge.
- Guidelines established by the National Patient Safety Program in Brazil.
- Law No 13,236/2015, which establishes that drug labelling must contain clear information to prevent dispensing and administration errors. In addition, the proposals consider the real-world environment with respect to the prescription and dispensation of drugs, as well as different education levels in Brazil.
Contributions to any of the three consultations may be submitted until 7 September 2020.
“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”
