On October 23rd, ANVISA published the new RDC 317 drug renewal standard that totally changes the logic of drug renewal. But after all, what changes and what do I have to know about it?
The general rule is that the registration is valid for a period of ten years from the date of publication in the Federal Official Gazette.
For medicines granted with a commitment term where the company is pending with ANVISA, the first renewal will be in 3 years, the second in 5 years and thereafter the general rule applies where the renewal takes place every 10 years.
Medicines which are subject to notification are exempt from registration and will not need to be renewed. The regularization will be maintained in Anvisa's electronic system, in the last 6 (six) months of the regularization decade through the declaration of interest in the continuity of commercialization.
The validity of registration granted prior to the validity of RDC 317/19 is automatically extended from five to ten years, counted from the registration grant or the last renewal.
The new rule will only come into force on January 21st, 2020, therefore, only products whose validations must be filed as of 01/21/2010 (expiration of registration from 07/21/2020) will be able to take advantage of the new rule.
Registrations whose renewals must be filed between 10/23/19 to 1/21/2010 (registrations that expire between 04/20/2020 and 07/20/2020) must be renewed considering the current expiration date for the registration. Pay close attention as the absence of the protocol may result in the expiration of the drug registration.
The documents necessary to renew the medications are just Petition Forms, Proof of Payment of the Fee and the Proof of Marketing of the medication, by pharmaceutical form and concentration, for at least the final two thirds of the expired registration validity period.
ANVISA only managed to reach this level, where renewal started to be every 10 years, due to the fact that since 2009, companies are obliged to file annually the HMP (Product Change History), in which all updates and updates are informed. medication changes. With this, the Agency is able to monitor what is happening with the registered medicines and the renewal has become a purely bureaucratic act.
The objective of this measure is procedural savings, as it will save the time of technicians who may be focused on registration and post-registration processes and where there is a greater health risk.
On the side of companies, the measure is doubly positive, because in addition to saving labor to prepare the renewal processes, it will still save the renewal fees that reach up to R$ 113,339.52 for new medicines.