The new Law admits the exceptional and temporary authorization to import and distribute, without prior registration in the National Health Surveillance Agency (ANVISA), of materials, drugs, equipment and supplies related to the health sector and subject to the sanitary surveillance, provided they are considered essential to combat the coronavirus pandemic and as long as registered by at least one of the following foreign health authorities:
(i) Food and Drug Administration (FDA);
(ii) European Medicines Agency (EMA);
(iii) Pharmaceuticals and Medical Devices Agency (PMDA); e
(iv) National Medical Products Administration (NMPA).
The law also establishes for the physician prescribing or applying drugs imported under this exceptional regime the obligation to inform the patient or his/her legal representant that that drug it is not registered by ANVISA, but it is by a foreign health authority.
The new Law should be well received by the regulated sector, considering that, usually, the registration of products within ANVISA may take from 30 up to 180 days, depending on the type and class.
The law came into force in its publication date.