INFO KGV | LIFE SCIENCES FEBRUARY 2021

ANVISA’S RESOLUTION RDC NO 430/2020 WILL COME INTO FORCE IN MARCH 2021

On 9 October 2020, the Brazilian Health Surveillance Agency (ANVISA), published Resolution RDC No 430/2020 (Portuguese language) regarding good practices in distribution, warehousing and transportation of drugs.

The majority of the Resolution’s provisions will enter into force on 16 March 2021, altering and consolidating two previous Resolutions: Resolution RDC No 304/2019 and Resolution RDC No 360/2020 (Portuguese language).

Section 7 of the Resolution, which has already been in effect since its date of publication in the Federal Official Gazette, 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.

Once the new Resolution comes into force, Ordinance No 802/1998 (Portuguese language) and Resolution RDC No 320/2002 (Portuguese language), which currently provide rules on the matter, will be revoked.

Once the new rules enter in force, there will be a more consolidated regulatory regime regarding distribution, warehousing and transportation of drugs. However, it is important to note that certain obligations, such as those related to the maintenance and control of temperature and humidity, as set forth by the product’s MA, will only enter in force on 9 October 2021 (Resolution No 430/2020 Section 64).

“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”