ANVISA Publishes Service Guidelines: New Rules Should Expedite Importation Procedures

Author:TozziniFreire Advogados
Profession:TozziniFreire Advogados

With the publication of Service Guideline No. 47, dated April 9, 2018, ANVISA updated sanitary control procedures for imported products and how such procedures will be internally administered by the Agency.

With the changes in the rules for distribution, analysis, physical inspection, request for interdiction and review of denial appeals, ANVISA expects to reduce delays in the release of goods. Some importers reported considerable delays, especially after the publication of Service Guideline No. 34/2017, which was revoked by the new regulation.

Under the new rules, the approval process will be divided according to the nature of the imported product - the Health Surveillance Posts will be allocated to (i) Health Products, (ii) Medicines, (iii) Food, and (iv) Cosmetics, Sanitation, Hygiene and others. In addition, the distribution of the approval processes will be defined not only by the chronological order of the requests but also according to new criteria set out in the annex to the new Service Guideline No. 47/2018.

Such criteria establishes a priority for, among others: (i) processes previously analyzed, (ii) direct importation by the Ministry of Health or Health Department, (iii)...

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