ANVISA places restrictions on outsourcing quality control and drug storage

The Brazilian Health Regulatory Agency (ANVISA) has published a Directory Board Resolution (RDC) 257/2018, confining the outsourcing of drug storage and quality control analyses. The resolution, which came into effect on 20 December 2018 means that drug import companies cannot outsource quality control assays and must have their own quality control laboratory and a storage location for drugs. In addition, only companies with their own storage facilities are able to outsource surplus drug storage. This will only be in effect until December 2020, the aim being to analyse its impact before making a final decision.

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Published 9. January 2019 in News, News Brazil