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Proposal on Mandatory Fractioning of Medicines

By April 7, 2017 No Comments

Proposal Presented by the Brazilian Senator Would Introduce Mandatory Fractioning of Medicines through Specially Developed Fit-For-Purpose Packaging

A new Bill of Law PL 98/2017, recently presented to the Brazilian Congress by Senator Ms. Rose de Freitas, if adopted, would make mandatory for producers, pharmacies and drugstores to fractionate medicines through packaging specially developed for this purpose.

According to the justification of the Senator, the goal of this Proposal, which is imminently entering parliamentary procedure, is to enable the Brazilian consumers to purchase only the amount needed of the medicines, avoiding waste, ensuring the full treatment in time and quantity recommended by the doctor, and avoiding the risks of poisoning by taking leftover medicines stored at home.

The Bill stipulates a deadline of only 12 months for the pharmaceutical industry, producers and importers to comply with new regulations. This obligation is quite troubling, insofar the costs for compliance are massive, and there is no manner in which the industry and record-holders could know the demand for such fractionated products, which will surely generate vast uncertainties about the implementation of the legislation.

The Bill furthermore plans to force pharmacies to split the medicines, but makes it clear that the packaging should be specially developed for this purpose.

Holders of records, manufacturers or importers, would moreover have the responsibility to ensure and oversee the maintenance of the quality, safety and efficacy of the products object of this law every step of the way until the final consumer, in order to avoid risks and harmful effects.

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