Regulatory Updates

Distribution date: 05 April 2022

This resolution contains provision on sunscreens and multifunctional products in cosmetics and internalizes the GMC MERCOSUR Resolution nº 08/2011.

Products Covered: HS (3303, 3304, 3305, 3306, 3307, 340111, 340130, 9616, 9619) - Personal hygiene products, cosmetics, and perfumes

Regulation Type: Regular notification

Distribution date: 05 April 2022

This resolution contains provisions on the control by Anvisa of the importation of raw materials, manufacture, distribution, commercialization, medical prescription and application of ganglioside-based drugs.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 05 April 2022

This resolution contains provisions on the control by Anvisa of the importation of raw materials, manufacture, distribution, commercialization, medical prescription and application of ganglioside-based drugs.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 05 April 2022

This resolution contains provisions on the composition of seasonal influenza vaccines to be used in Brazil.These vaccines must conform to the composition recommended by the World Health Organization (WHO) for the use in the southern hemisphere in the corresponding season.

Products Covered: HS (3006) – Vaccines 

Regulation Type: Regular notification

Distribution date: 05 April 2022

This resolution contains provisions on the composition of seasonal influenza vaccines to be used in Brazil.These vaccines must conform to the composition recommended by the World Health Organization (WHO) for the use in the southern hemisphere in the corresponding season.

Products Covered: HS (3006) – Vaccines 

Regulation Type: Regular notification

Distribution date: 05 April 2022

This resolution contains provisions on the Certification of Good Practices for conducting Bioavailability/Bioequivalence studies of medicaments and defines which Bioavailability/Bioequivalence studies of medicines must be carried out in certified research centers.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 05 April 2022

This resolution contains provisions on the Certification of Good Practices for conducting Bioavailability/Bioequivalence studies of medicaments and defines which Bioavailability/Bioequivalence studies of medicines must be carried out in certified research centers.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 05 April 2022

This resolution contains provisions on the ban on the production and import of metered-dose inhalers that use chlorofluorocarbon-type propellant gas.

Products Covered: HS (3003-3004) – Medicaments

Regulation Type: Regular notification

Distribution date: 05 April 2022

This resolution contains provisions on the ban on the production and import of metered-dose inhalers that use chlorofluorocarbon-type propellant gas.

Products Covered: HS (3003-3004) – Medicaments

Regulation Type: Regular notification

Distribution date: 05 April 2022

This resolution contains provisions on minimum requirements related to the obligation, on the part of companies holding drug market authorizations, to communicate the implementation of the action of recalling drugs to the competent health authorities and consumers, in the event of sufficient evidence or proof of quality deviation that represent a risk, aggravation or health consequences, as well as in the event of deregistration related to safety and efficacy.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification