INFO KGV | LIFE SCIENCES JULY 2020
COVID-19: PROPOSED RESOLUTION EXEMPTING DRUG LABELLING AND LEAFLET REQUIREMENTS
On 3 July 2020, the COVID Discussion Group, composed of members of the Brazilian Health Surveillance Agency (ANVISA) and representatives of the regulated sector, discussed a proposed resolution that would establish extraordinary and temporary exceptions to specific drug labelling and leaflet requirements as a result of the COVID-19 pandemic.
According to the proposed resolution, companies that manufacture drugs will be exempt from complying with the technical requirements relating to labelling and leaflets established by Resolution RDC No. 47/2009 (Portuguese language) and Resolution RDC No. 71/2009 (Portuguese language), provided that:
- They hold a certificate of Good Manufacturing Practice.
- They notify ANVISA about the exemption and present all required documents.
- The exemption is necessary due to the COVID-19 pandemic.
- A risk assessment is conducted, demonstrating that the effects of non-compliance with the technical requirements are controlled.
- The exemption is documented in the company’s Management System of Pharmaceutical Quality, allowing for the drug to be tracked.
Voting on the proposed resolution is expected to take place on 27 July 2020. There will be no public consultation on the resolution due to the high degree of urgency and significance of the matter.
ANVISA ISSUES SERVICE ORIENTATION TO SIMPLIFY CLINICAL TRIAL DOCUMENT ANALYSIS PROCEDURES
Beatriz M. A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados
On 13 July 2020, the Brazilian Health Surveillance Agency (ANVISA) issued Service Orientation No. 88/2020 (Portuguese language), which establishes procedures for analysing documents that are required for the submission of a Clinical Drug Development Dossier (CDDD), as well as for assessing alterations that potentially impact the quality or safety of an experimental drug, active comparator or placebo.
The service orientation simplifying the analysis procedure for a CDDD, is applicable to:
- Drugs that have at least one clinical trial, at any stage, approved by at least one regulatory authority of a member country of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
- Experimental drugs already registered in at least one of the ICH member countries.
- CDDD assessment of substantial quality alterations.
According to ANVISA, the aim of the service orientation is to provide clarity and predictability for the approval process of new clinical trials in Brazil, while maintaining and observing good clinical practices and clinical trial safety and quality.
The service orientation entered into force on the date of its publication.
ANVISA LAUNCHES PUBLIC CONSULTATION ON INVENTORY DEPLETION
Beatriz M. A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados
On 15 July 2020, the Brazilian Health Surveillance Agency (ANVISA) published Public Consultation No. 869/2020 (Portuguese language), which introduces a rule that would simplify the procedure for the inventory depletion of products subject to sanitary surveillance. The consultation relates to depletions that occur as a result of certain specified events, including the following:
- Expiration of registration.
- Cancellation of registration upon request or by transfer of ownership.
- Expiration or rejection of Good Manufacturing Practice certificates.
- Post-registration changes.
Currently, inventory depletion is not specifically regulated. Companies interested in inventory depletion must file a request with ANVISA. The proposed rule would simplify the inventory depletion process by eliminating the requirement for companies to request authorisation from ANVISA. Inventory depletion would be limited, however, and the new process would only be applicable to products meeting certain criteria:
- Only products with valid expiration dates that are regularly manufactured, distributed and commercialised.
- Products with cancelled or expired registrations, provided they were manufactured during the valid registration period.
- All post-registration alteration requests must have been approved.
According to ANVISA, the proposed rule will benefit both the regulated sector and ANVISA, as it will provide a positive regulatory impact and simplify the inventory depletion procedure.
Contributions to the public consultation may be submitted until 4 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.”
