On September 8, 2009, the Brazilian food and drug agency (ANVISA) enacted a new resolution on standardising medicine package inserts.
ANVISA claims that harmonising the formats and contents of package inserts will make access to drugs easier and safer for Brazilian consumers and medical professionals.
Among several other important matters, Section 18 of the resolution addresses how the package inserts of generic drugs and similar pharmaceutical products (branded copies without bioequivalence data and no interchangeability requirement) should harmonise with those of new drugs (reference drugs) developed by the research industry, and approved after lengthy and expensive trials.
The package inserts of generic and similar drugs should convey to their readers the same relevant technical information as the reference drugs, and in a similar manner.
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medicine packaging, copyright, ANVISA
