According to Brazilian legislation, what are the minimum requirements for generic drugs? The generic drugs must be registered by Anvisa, proving t...

According to Brazilian legislation, what are the minimum requirements for generic drugs?

The generic drugs must be registered by Anvisa, proving their bioavailability.
The generic drugs must undergo bioequivalence testing only if they are prescription drugs.
The generic drugs must have the same physical characteristics, composition of substances, time of action in the body, and absorption by the bloodstream as the reference product.
The generic drugs are innovative (unprecedented in the market) drugs developed by pharmaceutical laboratories.
The generic drugs have the same active ingredient but may contain other substances in their formula, such as dyes and excipients (substances used to give shape to the drug but without pharmacological effect) and may have a different presentation form.
The generic drugs will have their patent granted for up to 20 years; they need to undergo efficacy, safety, and quality tests.
a) The generic drugs must be registered by Anvisa, proving their bioavailability.
b) The generic drugs must undergo bioequivalence testing only if they are prescription drugs.
c) The generic drugs must have the same physical characteristics, composition of substances, time of action in the body, and absorption by the bloodstream as the reference product.
d) The generic drugs are innovative (unprecedented in the market) drugs developed by pharmaceutical laboratories.
e) The generic drugs have the same active ingredient but may contain other substances in their formula, such as dyes and excipients (substances used to give shape to the drug but without pharmacological effect) and may have a different presentation form.
f) The generic drugs will have their patent granted for up to 20 years; they need to undergo efficacy, safety, and quality tests.