On July 3, Public Consultation No. 657/2019 (CP 657) providing for the criteria, deadlines and documents required for the renewal of drug registrations and notifications was launched. Contributions will be allowed until August 16.
According to the CP 657, the new regulation – once approved – will be applicable to all drugs that have been registered with or notified to the health surveillance agency Anvisa, including probiotics, except for those which are subject to special laws.
Drug registrations and drug notifications are valid for up to 10 years and are subject to renewal for equal periods – during which the original registration number will be kept.
In addition, CP 657 deals with the renewal of registration of drugs for rare, critical and high mortality diseases, which are to be approved through a commitment letter (under Public Consultation No. 652/2019, not yet converted into normative ruling).
In this case, registrations are valid for 3 years, after which the first renewal can occur. After the first renewal, registrations will be valid for 5 years, after which a second renewal can occur. After the second renewal, registrations will be valid for 10 years.
CP 657 compiles all deadlines for drug registrations and notifications and also simplifies the procedure for submitting the documents that will support the request for renewal, which must be made not less than 6 and not more than 12 months of the expiration date.
If no decision is rendered with respect to any request of renewal, the registration will be presumed automatically renewed as from the expiration date. Important to note, however, is that the administrative authority can reject any request for renewal and cancel any automatically renewed registration, or else ratify the automatic renewal.
If the deadline laid down in CP 657 for the request of registration renewal is missed, the registration will lose effect.
It should be noted that Anvisa may, at its own discretion and at any time during the registration validity period, request additional evidence and new studies to prove the drug quality, safety and efficiency. Such additional request must be duly justified.
