INFO KGV | LIFE SCIENCES OCTOBER 2020
RESOLUTION ON GOOD PRACTICES IN DRUG DISTRIBUTION, STORAGE AND TRANSPORTATION
Kestener & Vieira Advogados
On 9 October 2020, the National Health Surveillance Agency (ANVISA) published Resolution RDC No 430/2020 (Portuguese language), regarding good practices in distribution, warehousing and transportation of drugs.
The Resolution adjusts certain terms which were previously set forth by Resolution RDC No 304/2019 (Portuguese language) and Resolution RDC No 360/2020 (Portuguese language), and will bring into force, as well as consolidate, the regulations set forth by both Resolutions.
The main determinations of Resolution No 430/2020 are:
- It will enter into force on 16 March 2021, except for section 7 of the Resolution, which is already in force. Section 7 expressly allows the acquisition of drugs from distributors that are not the marketing authorisation (MA) holder, provided that the cargo traceability is guaranteed through the National Drugs Control System.
- In accordance with section 64, transporting agents will have a one-year time frame, beginning from 9 October 2020, to comply with certain obligations such as those related to the maintenance and control of the temperature and humidity described by the product’s MA.
It is expected that the new rules will enable full and more consolidated regulation on good practices in drug distribution, storage and transportation.
ANVISA INTRODUCES SIMPLER NOTIFICATION REGIME FOR CLASS II MEDICAL DEVICES
Beatriz M A Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Bruno Fontes Muniz, Kestener Granja and Vieira Advogados
On 5 October 2020, the National Health Surveillance Agency (ANVISA) published Resolution RDC No. 423/2020 (Portuguese language), replacing the registration system for medical devices in the risk class II category with a simpler notification regime.
In practical terms, the change to the notification regime means that a manufacturer of medical devices categorised as risk class II, a lower risk product, will be required only to communicate to ANVISA about its intention to manufacture, commercialise or import a medical device. Therefore, manufacturers will not be subject to ANVISA authorisation for the commercialisation of such products, provided that the company is compliant and maintains the licences required for the manufacturing, commercialisation and importation of those medical devices.
Risk class I products are already subject to the notification regime in accordance with Resolution RDC No 27/2011, Resolution RDC No 36/2015 and Resolution RDC No 40/2015 (Portuguese language).
“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”
