ANVISA – New Public Consultation to change the rules for drug product labeling

On June 3, three Public Consultations regarding the Labeling of medicines were published in the Official Gazette (D.O.U). These are:

  • CP 815/2020: Proposes rules on the labeling of medicines in amendment to the current RDC 71/2009.

  • CP 816/2020: Proposes Normative Instruction (IN) that establishes specific requirements for the labeling of parenteral solutions of large and small volume, solutions for irrigation, dialysis, and plasma expanders.

  • CP 817/2020: Establishes warning phrases for substances and/or therapeutic classes in package inserts and medication packaging.

The proposals aim to define criteria in order to improve the form and content of the labels of regularized medicines in Brazil, also reducing the possibility of medication errors attributed to the visual characteristics of the packaging, as well as protecting and promoting the safe use of medicines for patients. intolerant or allergic to specific substances and classes of drugs.

About the Public Consultation Nº 815/2020, we can highlight the following changes:

  • Expansion of the scope of the Standard to cover all regularized drugs;

  • Clear definition of mandatory and optional information;

  • Creation of the rationale for information provision, considering the font size, space, alignment and highlighting of colors, to guarantee the readability of essential information;

  • Rules for expression of concentration, to standardize this information among medicines;

  • Harmonization to describe the DCB;

  • Use of indelible color contrast labels for small volume parenteral solutions (SPPV);

  • Prohibition of direct recording of information in ampoules;

  • Revocation of the MS identity manual, maintaining the MS identification logos.

Regarding Public Consultation Nº 816/2020, it is possible to observe that it presents a proposal in line with the guidelines of the World Health Organization (WHO) and seeks to define characteristics that clearly differentiate parenteral solutions from one another so that there is inhibition suspension and administration errors, unwanted exchanges or misuse.

To this end, it followed the recommendations and real-life evidence brought by the Brazilian Society of Anesthesiology, by the Institute of Safe Practices for the Use of Medicines (ISMP Brazil), as well as by the successful experience of the medication sector itself.

For Small Volume Parenteral Solutions (SPPV), the draft includes the use of indelible adhesive labels that allow color contrast, and the direct recording of information on glass ampoules is no longer allowed, as this technique may bring limitations for visual differentiation of the ampoules.

For Large Volume Parenteral Solutions (SPGV), among the proposals, it is worth mentioning that the information regarding the name of the solution and concentration must be highlighted in the bottom or side of the bag, vial or plastic ampoule, since the bags and the bottles start to collapse from top to bottom. Thus, the visualization of the information is facilitated if placed in these positions.

The Public Consultation Nº 817/2020, it is possible to observe that this draft contains some general rules for the application of objective phrases that convey the message in a safe and clear manner. In this sense, it proposes two annexes:

  • ANNEX I – List I: therapeutic substances or classes that require warning phrases.

  • ANNEX II List II: warning phrases that must appear on the package inserts and labeling of medications.

The proposal also makes it mandatory to include alerts for monosaccharide sugars: glucose, fructose and galactose and disaccharides: maltose, sucrose and lactose that accompany risks related to intolerance to these substances.

The deadline for the Public Consultations is until 9th September and can be accessed through the links:

– CP 815/2020:

– CP 816/2020:

– CP 817/2020:

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