Brazil proposed requests for registration and post-registration of medicines for sale under medical prescription

Brazilian Health Regulatory Agency (Anvisa) proposed Resolution provides for the classification in the priority category, of registration petitions, post-registration and prior consent in clinical research of medications.

The criteria and procedures for framing an application for registration, post-registration and prior consent in clinical research for drugs in the priority category are stablished under the terms of this Resolution, according to public relevance, in order to guarantee or expand access to pharmaceutical assistance,.

ANVISA may classify as priority the requests for registration and post-registration of medicines for sale under medical prescription, which are under risk of market shortages that have an impact on public health.

Medications prioritized and registered according to the criteria of this Resolution should be marketed within a period of up to 120 days from the date of publication of the registration. New drugs in the priority category, as a result of the criteria established in this Resolution, will have a period of 30 days to submit the price proposal to ANVISA, counted from the first business day after the protocol of the priority petition.

The classification in the priority category should be done at the moment of the protocol of the petition (registration, post registration alteration and previous consent in clinical research), which will be the object of prioritization. The deadline for final decision regarding the analysis of registration and post-registration requests for medicines classified as priority will be:

I - 120 days for applications for registration of medication;

II - 60 days for post-registration requests.

In order to apply the criteria set forth in this Resolution, the priority petition for registration, post-registration and prior consent in clinical drug research must be instructed with all documentation required by current legislation and regulations.

Products covered: Pharmaceutical products

Proposed date of adoption: NA

Proposed date of entry into force: NA

Final date for comments: 08-10-2017

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.