The National Health of Surveillance Agency (“ANVISA”) published today the Resolution RDC No. 625/2022, which provides the minimum requirements related to the obligation of the marketing authorization holders to communicate the implementation of a drug recall to the competent authorities and consumers, in case there is sufficient evidence or proof of quality deviation resulting in risk or consequence to health, as well as due to the cancellation of registration related to safety and efficacy.
The new Resolution, which will come into force on April 1st 2022, will revoke current Resolution RDC No. 55/2005. Articles now provide for information that must be included (i) in each of the forms to be sent to ANVISA; (ii) in the messages to be transmitted to consumers; (iii) in the distribution map of the drug to be recalled, which must be sent to the registration holder by the distributors; as well as (iv) in the monitoring reports; being excluded the old forms attached to RDC No. 55/2005.
In addition, RDC No. 625/2022 now provides the possibility that the provisions related to a voluntary recall are be applied to the recalls determined by ANVISA.
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