New regulation for registration and posterior modifications of name of drugs and biological products before ANVISA

On 22 December 2017 came into force the National Sanitary Surveillance Agency’s (ANVISA) Service Orientation no. 43/2017 (OS 43/17), establishing objective and detailed criteria for evaluation and analysis of the registration and posterior modifications of name of drugs and
biological products before ANVISA, to be executed by the General Drugs and Biological Products Management (GGMED). Such Service Orientation complements the prior Board of Directors’ Resolution RDC no. 59/2014 – that establishes the criteria for drug name creation.

According to OS 43/17, ANVISA’s analysis for granting new drug names shall gradually adopt the following procedures: (i) research in the POCA system, which comprises the ANVISA’s database, and identifies graphic and phonetic similarities with previous marketing approvals; (ii)
research in drugs database (Datavisa); (iii) research in the Brazilian Trademark Office’s database, to verify the application/registration of the trade mark; (iv) evaluation, by the examiner, of graphic and phonetic conflict with prior marketing approvals in ANVISA’s database; (v) search for eventual mistakes and (vi) evaluation of the safety of the proposed name, taking
into consideration the risk of error in its prescription, distribution, administration or use.

The analysis will be performed in Portuguese and, in case of conflict, the following elements shall be considered: (i) intended use; (ii) directions on how to use; (iii) how it works; (iv) its benefits; (v) risks associated to its use; (vi) measures to ensure its safe use; (vii) its technical
features, such as: name, Active Pharmaceutical Ingredient (API), indication, how to administer, frequency and quantity, target, restrictions, history of similar cases, previous orientations from the Board of Directors, among others.

If a conflict between drug names is identified, and based on the abovementioned criteria, GGMED will analyze the risk of error or misleading prescriptions, with the help of a flowchart
and a risk matrix. The flowchart helps in identifying the name availability and registrability, while the risk matrix provides a detailed analysis of the graphic and phonetic elements of the intended name  and the potential conflicts with other already registered names. These tools aim
to reduce subjectivity on the drug name analysis. If the possibility of confusion is confirmed, the comparative analysis will also take into consideration the distribution, administration and/or how to use it.

According to the OS 43/17, the registration of the name will be rejected only if there is risk of confusion, even if there is similarity between two names. The risk of confusion is the leading and predominant element in ANVISA’s analysis.

It is possible to file the application form presenting more than one name option for registration. The analysis will follow the priority established by the applicant and the alternative name is analysed only after the final decision concerning the rejection of the first name option is rendered and sent, with its grounds, to the applicant. If the applicant identifies possible conflicts
before filing its application, it is possible to present relevant information to the examiner, to increase the chances of registration.

On 27 February 2018, GGMED hosted a meeting with trade associations to clarify several aspects regarding the application of the OS 43/17, the flowchart and the risk matrix.

Lastly, it is important to point out that the registration of the drug name before ANVISA does not substitute registration before the Brazilian Trademark Office, which is still needed to grant exclusive rights to the owner, as well as to prevent third parties from using and exploring
identical or similar trade marks.


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