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NEW FEDERAL DECREE REGULATES THE TAKE-BACK SYSTEM FOR MEDICINES

09/06/2020

The Federal Decree No. 10,388/2020, which regulates the take-back system for medicines nationwide, was published last Friday (June 5th, 2020) on an extra edition of the Federal Official Gazette. The regulation will come into force a hundred and eighty (180) days after its publication.

The system will cover the structuring, implementation and operationalization of the take-back system for disused or expired household medicines, exclusively of human use, either industrialized or compounded, and their packages, after the consumers’ disposal. The system will be developed in two (2) phases:

Phase 01 – begins with the publication of the Federal Decree and covers:

a) the creation, within ninety (90) days after the Decree comes into force, of a performance monitoring group composed of the sector’s representative entities, which will monitor the implementation of the system;

b) the structuring of a mechanism towards rendering annual information about the amount of disused and/or expired household medicines collected by the take-back system.

Phase 02 – will come into force a hundred and twenty (120) days after Phase 01,  covering:

a) the qualification of service providers that may act in the system;

b) the preparation of a communication plan to publicize the implementation of the system;

c) the installation of fixed points to receive disused and/or expired household medicines and their packages after consumers’ disposal, which shall be managed as non-hazardous waste during the stages of disposal, temporary storage, transportation and sorting, until transfer to a unit for treatment and final proper destination.

The obligations of each player in the system

Producers, importers, distributors, sellers and consumers are all responsible for the effectiveness of the system, each of whom within their own specific roles.

Consumers must dispose the medicines at pharmacies, drugstores or other receiving points.

Sellers must install in their stores, at their own expenses, fixed points to receive and store the medicines collected directly from the consumers. During the first two (2) years of Phase 02, the fixed points must be installed at pharmacies and drugstores in Capitals and Municipalities with a population of over 500,000 inhabitants. During the three (3) following years, such installation must also occur in the Municipalities with a population of over 100,000 inhabitants.

Distributors must collect, at their own expenses, medicines subject to the Decree after consumers’ disposal and accommodate them at a secondary storage place. The transportation of disused and/or expired household medicines can be made through the same modals used for distributing new medicines.

Producers and importers, in their turn, must transport, at their own expenses, disused and/or expired household medicines from the secondary storage place to the unit of treatment, where they will receive final proper destination.

The final proper destination of the medicines object of this Decree must be performed by incinerators, coprocessors and Class I landfills, respecting this order of priority, and shall be funded by producers and importers.

A report containing information about the amount of medicines received by the system, the number of Municipalities attended, fixed points installed and the weight, in kilograms, of the medicines returned by the consumers, must be presented annually.

The Decree also establishes that, within five (5) years, the Ministry of Environment shall reassess the need for its review.

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