ANVISA New rules on drug labeling with RDC 768/22


Labeling rules and package leaflets serve to provide important information about the product, such as its composition, indications for use, dosage, contraindications, side effects, precautions, and storage instructions.

Pharmaceutical industries strictly comply with labeling and packaging standards to avoid failures that can result in administration errors or improper consumption of medicines, putting at risk the safety and health of patients.


As of July, the new regulatory framework for drug labeling, the RDC 768/22, from the National Health Surveillance Agency (Anvisa), comes into effect.

 The new regulatory framework is in line with several national and international guidelines and policies, such as: the National Program for Patient Safety (PNSP), which established that “the labels of medicines, drugs and related products must have characteristics that clearly differentiate them from each other and that inhibit dispensing and administration errors, unwanted exchanges or misuse”; and the recommendation of the World Health Organization (WHO) for the performance of regulatory agencies in cases of medication errors related to product design.

The new regulatory framework brings the determination to use a technique called Tall Man Lettering (TML)”.

TML is a technique that uses capital letters, colors, or boldface to draw attention to and help differentiate similar drug names. For the purposes of this standard, the TML will be applied to the similar generic name.

Compliance Verification

  • Is made through the specifications established by Anvisa, which include information such as product name, manufacturer, expiration date, batch number, composition, instructions for use, specific warnings, among others.
  • Compliance with good manufacturing practices for medicines, through periodic inspections and technical evaluations.
  • Medicines active ingredient antibiotics and regulated by Ordinance 344/98, some need to have the black stripe, a specific labeling statement, so, in this technical analysis, Anvisa does the verification of this information.
  • The inclusion of the Anvisa logo next to the registration number, which will be optional.
  • It is possible for the company to insert a QR code on the packaging of medicines, and through this code information related to the use of the product can be linked.

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GRP Brazil Office provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical, medical device, and life-consumers companies worldwide to register them product with ANVISA the local Health Authority (HA).

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Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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