Proposal for a decree on medicines take-back schemes

The Ministry of Environment has started a public consultation process on a proposal for a decree to regulate the take-back of old/unused medicines, as authorised by the Brazilian National Solid Waste Policy (Federal Law No. 12.305/2010).

The proposed decree imposes obligations on manufacturers, importers, distributors, sellers, and consumers of medicines, as follows:

  • CONSUMERS must take expired or unused medicines back to the drugstores and pharmacies appointed by sellers, distributors, manufacturers, and importers;
  • DRUGSTORES AND PHARMACIES are required to acquire and maintain drop-off containers inside their business establishments (collection points) as well as to ensure the availability of at least one fixed (i.e. permanent) collection point for every 30 thousand inhabitants; they must also provide a safe place inside their businesses establishments for the primary storage of the medicines discarded by consumers;
  • DISTRIBUTORS are required to arrange the collection of the medicines discarded by consumers from the primary to the secondary storage points;
  • MANUFACTURERS AND IMPORTERS are required not only to arrange or finance the transport of the discarded medicines from the secondary storage points to treatment and disposal facilities but also to finance treatment and final disposal.

The business sector is also required to disclose the existence and location of collection points as well as information about collection campaigns (place, date, and duration). They must also create a computerised system for reporting results to the federal government.

Please click here to access the proposed decree on medicine take-back schemes. Public consultation ends on 19 December 2018 and contributions can be made electronically at <>.


This article is intended exclusively to provide information and does not contain any opinion, recommendation or legal advice from Felsberg Advogados in relation to the issues addressed.