INFO KGV | LIFE SCIENCES MAY 2019
ANVISA WORK GROUP PROPOSES NEW REGULATION FOR API
The Work Group created in 2018 by the Brazilian Health Surveillance Agency (ANVISA) and regulated health sector associations has concluded discussions on the new regulatory framework regarding registration of active pharmaceutical ingredients (APIs).
The proposed regulatory framework is intended to simplify the requirements for registration of APIs, which are currently set forth in Resolution RDC No. 57/2009 (Portuguese Language). The requirements for all synthetic and semi-synthetic API’s are now expected to be unified and harmonized with international standards, such as those set out by the International Council for Harmonisation of Technical Requirements for Pharmaceutical for Human Use.
The new regulation proposed by the Work Group will soon be submitted for analysis and public consultation.
“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”
ORDINANCE TO FACILITATE THE IMPORT OF PRODUCTS UNDER SANITARY SURVEILLANCE
Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno, César Santos Borlina and Leonardo Barboni Rosa, Kestener Granja and Vieira Advogados
On 7 May 2019, the Brazilian Health Surveillance Agency (“ANVISA”) and the Brazilian Federal Revenue (RFB) signed Ordinance No. 1/2019 (Portuguese Language), intended to improve the importation of products under sanitary surveillance. The Ordinance implements a process for registering companies that present a low risk of freight security and logistics issues or of contract breach in international trade affairs. These companies would be certified as Authorized Economic Operators (AEOs), capable of properly managing the risks to which they are exposed when dealing with international trade logistics.
An AEO is an internationally recognized status marker created by the World Customs Organization (WCO), and regulated in Brazil by RFB Normative Instruction No. 1.598/2015 (Portuguese Language). Admission is voluntary, and acceptance is subject to compliance with the programme’s requirements in terms of tax, customs, and logistics policies.
The heads of both government bodies stated that this is a measure intended to make international trade with Brazil more streamlined and predictable by modernising customs policies and implementing a more robust risk management programme.
“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”
