Starting on January 21, 2020, the term of validity of drug registrations will be changed, from 5 to 10 years (Plenary Board Resolution – RDC – No. 317, published on October 23, 2019).
Under the new Resolution, an exception is made for the terms of validity of drugs for rare diseases. In this case, the initial term of validity will be 3 years, extended to 5 years after the first renewal and then to 10 years upon the second renewal.
The new Resolution does not change the deadline for applying for renewal of drug registration. Applications must be made no earlier than 12 months and no later than 6 months of the expiration date.
For drugs which are not subject to registration, but which are required to be notified to the Brazilian authority, a declaration of interest in continuing marketing will be needed. Every 10 years, a declaration of interest in continuing to market such drugs will have to be submitted within the last six months of the 10-year period. Otherwise, marketing of these drugs will have to be discontinued.
The new Resolution also requires that those applying for renewal of drug registration proves marketing of the drug for at least the last two-thirds of the registration validity period.
Important to note is that any request for registration renewal to be made prior to the new Resolution effective date must observe the expiration date as in force now. Until the new regulation comes into force, manufacturers must submit their requests for renewal of drug registration within the term originally granted upon registration. In case no such renewal request is timely submitted, registration will lose effect.
All renewal requests already made and pending the authority’s review will be analyzed according to the terms and conditions of the new Resolution.
The Brazilian authority will make all necessary adjustments in the system to update expiration dates. Thus, when the new regulation comes into force, all valid registrations – except for drugs for rare diseases – will have their expiration dates automatically set in 10 years as from the effective date of registration or last renewal.
Regardless of such extension of validity term, the Brazilian authority may at any time request additional information and documents to prove the quality, safety and efficacy of the drug.
