On June 3, two Public Consultations regarding the Simplified Notification of Low Risk Medicines were published in the DOU. These are:

• Public Consultation No. 818, of June 1, 2020, which brings a proposal for revision of the Resolution of the Collegiate Board – RDC No. 199, of 2006, which provides for the notification of low-risk drugs;

• Public Consultation No. 819, of June 1, 2020, which brings a proposal for revision of the Resolution of the Collegiate Board – RDC No. 107, of 2016, which approves the “List of low-risk drugs subject to simplified notification”.

According to the ANVISA, the revision of these resolutions was motivated due to the need to improve the standards, making them clearer, and favoring the quality of the notified drugs. In addition, there was a need to consolidate the changes made over the years in the original text and update some aspects to harmonize with the current rules applicable to medicines.

Check below the summary of the main changes brought about by Public Consultations.

Public Consultation No. 818, of June 1, 2020:

The revision of RDC No. 199/2006 was carried out to bringing greater clarity to the understanding of the notification through the electronic system, presents in a more direct way the documentation that must be prepared and maintained in the company, establishes the guidelines for the post-change process notification and also allows notification of medicines imported by importers, which was not previously possible. We detail below the main points of attention brought by the new CP.

Company Licence:

To qualify in the notification system, the manufacturer must have BPFC (Certificate of Good Practices in Manufacturing and Control of medicines) and the importing company must have a Certificate of Good Distribution and Storage Practices (BPDA). It is important to highlight that all companies involved in the drug manufacturing and notification process must be duly qualified in the notification system.

Documentation:

According to the new CP it will be necessary to send the following documents in the Notification of Low Risk Medicines:

I – Production descriptive report, containing: a) detailed description of the formula, designating the components according to the Brazilian Common Denomination (DCB). b) description of the quantity of each component per pharmacotechnical unit and per batch, indicating its function in the formula. c) size of the industrial batch. d) description of all stages of the production process, including the equipment used; and e) in-process controls.

II – Production orders and quality control reports of raw materials, packaging and finished product for each batch manufactured.

III – Quality control report, containing:

a) control of Transmissible Spongiform Encephalopathy (TSE) according to Resolution No. 305, of November 14, 2002, or its updates; and

b) specifications, methodologies, and the respective references used in the quality control of raw materials, packaging and finished product, as well as analytical validations.

IV – Stability studies:

a) studies of accelerated and long-term stability, photostability and stability in use under the terms of the Collegiate Board Resolution – RDC No. 318, of November 6, 2019, or its updates; and

b) technical rationale that supports the use of reduced stability study models when these are used. V – Model of package insert, if any, and labeling.

Labeling:

Regarding the labeling of Simplified Notification Drugs, we can highlight the change in the phrase that must be displayed on the packaging material, of “SIMPLIFIED NOTIFICATION DRUG RDC No. 199/2006. AFE nº: …………………….. (Authorization of Operation of the Notifying Company) ” to ” Notified Medication, according to RDC Nº xxx / 20xx “.

Post-Notification Change:

Also, according to the new CP, when there is a need for Post-Notification Change in any information provided, the company must perform a risk analysis before implementing the change in the previously notified drug. This Risk Analysis should include a detailed description of the intended changes and which tests or trials will be conducted in order to ensure that, even after the change, the drug remains in compliance with quality, safety and efficacy parameters.

Public Consultation No. 819, of June 1, 2020:

The RDC No. 107/2016 will be updated and transposed into a Normative Instruction, since the IN format is the model provided for periodic updates. This update was carried out based on the results of the evaluation of proposals for inclusion and alteration of the list submitted by the companies and arising from technical discussions within the Agency.

It is worth noting that 30 new drug presentations were included in the proposed IN, with some drugs being migrated from the new, generic and similar registration category, as is the case with paracetamol and ketoconazole, as they are classified as bio-free.

Also excluded were 10 products that did not fit as medicines, but as cosmetics, having as example cocoa butter, almond oil, talc and liquid petroleum jelly. In addition, changes were made to some indications, dosages and concentrations. These inclusions, exclusions and changes in the List of Low Risk drugs subject to notification (LMN) were the result of the analysis of requests from companies and technical areas of Anvisa.

According to the Agency, the increase in the number of medicines subject to notification, with a simplified rite of regularization, tends to increase the availability and variety of these medicines and facilitate access to the citizen. In addition, small businesses may also benefit, as notification is less costly than registration.

The estimated deadline for migration of the drugs registered for notification is 2 (two) years from the effective date of the standard..

The contribution starts on 11th June and the deadline is on 8th September. Access in full through the links:

• Public Consultation No. 818, of June 1, 2020: https://bit.ly/2Y8resm

• Public Consultation No. 819, of June 1, 2020: https://bit.ly/2UjUHOM

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