INFO KGV | LIFE SCIENCES FEBRUARY 2019
ANVISA TO AUTOMATICALLY GRANT IMPORT LICENCE FOR DRUGS INTENDED FOR COMPLIANCE WITH JUDICIAL INJUNCTIONS
On 4 February 2019, the Brazilian Health Surveillance Agency (ANVISA) published Resolution RDC No 262/2019 (Portuguese language). The Resolution simplifies the procedure before ANVISA for importing drugs without a marketing authorisation (MA) that are necessary for compliance with judicial injunctions upon request from public institutions of the Brazilian Public Health System.
The new Resolution amends regulations concerning the import procedures of health products set forth in Resolution RDC No 81/2008 (Portuguese language), according to which, as a general rule, ANVISA must technically evaluate all import requests. The Resolution enables such import requests to be granted automatically without ANVISA being required to technically evaluate the requests.
“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”
ANVISA ESTABLISHES NEW PROCEDURES FOR ADMINISTRATIVE APPEALS AGAINST TECHNICAL DECISIONS
Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno, César Santos Borlina and Giovanna Pasquini Malfatti
On 11 February 2019, the Brazilian Health Surveillance Agency (ANVISA) published Resolution RDC No 266/2019 (Portuguese language), which provides new rules on the procedure to present administrative appeals against technical decisions issued by ANVISA.
In accordance with the Resolution, administrative appeals must be analysed by the General Office of Appeals (GGREC), a second instance body recently created by Resolution RDC No 255/2018 (Portuguese language), published on 11 December 2018. The GGREC comprises three specialised coordinators and one processing unit. Interested parties must pass through the GGREC before being permitted to appeal before ANVISA’s Board of Directors in the final and last instance.
The new Resolution entered into force on 11 February 2019, and revokes Resolution RDC No 25/2008, which previously set forth the main rules for presenting administrative appeals. All eventual lack of provisions or doubts on the application of the Resolution shall be decided by ANVISA’s Board of Directors.
“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”
BRAZILIAN FEDERAL MEDICINE COUNCIL REVOKES NEW REGULATION ON TELEMEDICINE
Beatriz M.A. Camargo Kestener, Rubens Granja, César Santos Borlina and Leonardo Barboni Rosa
On 22 February 2019, the councillors of the Brazilian Federal Medicine Council (CFM) revoked Resolution No 2,227/2018 (Portuguese language), which permitted the wider practice of telemedicine and which was only published on 6 February 2019, keeping in force the current CFM Resolution No 1,643/2002 (Portuguese language). There is no estimated date for the presentation of a new proposal of regulation.
Resolution No 2,227/2018 was introduced to address technological advances in medicine and electronic communications. Its publication prompted concerns from the medical profession, relating mostly to the eventual impact on the quality of patient treatment. In response, CFM published on 8 February 2019, a public consultation (Portuguese language) which was open for comments until 7 April 2019. However, given the negative response voiced by the medical profession, on 22 February 2019, the CFM decided to revoke Resolution No 2,227/2018.
“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”
ANVISA ANNOUNCES PUBLIC MEETING TO REVIEW GOOD STORAGE, DISTRIBUTION AND TRANSPORTATION OF DRUGS
Beatriz M.A. Camargo Kestener, Rubens Granja, César Santos Borlina and Leonardo Barboni Rosa
On 25 February 2019, the Brazilian Health Surveillance Agency (ANVISA) scheduled a public meeting to discuss the results obtained from Public Consultation No 343/2017 (Portuguese language), which aims to review the good practice parameters for storage, distribution and transportation of drugs established by Ordinance No 802/1998.
The proposed resolution’s goals are to increase control over the production and supply chain and to safeguard quality control during the storage, distribution and transportation of drugs.
