Get ready to rumble. Nadar and Team are coming out swinging. Enough of the garbage 13dud. Big Buys are going to hit this week, most likely today and from Brazilian investors. How about that 980%. Not good enough, lol.
Oh look how bout this. Anvisa "Non-registered medicines can be imported or used in Brazil in the following circumstances:
For experimental use: in case of pharmaceuticals the exemption is limited to three years. After this period, the product must be registered with Anvisa.
For certain special drug programmes (Anvisa's Resolution RDC No. 38/2013):
under the compassionate use programme, individual patients have access to unregistered pharmaceuticals under clinical development; and
under the expanded use programme, groups of patients have access to unregistered pharmaceuticals during a Phase III trial or after its completion.
Anvisa's reporting requirements apply to sponsors or clinical research organisations in connection with such programmes Neither of the above programmes applies for medical devices.
Direct import by the patient: Anvisa's regulation allows individuals with a medical prescription to import pharmaceuticals and medical devices directly where there is no alternative treatment available in Brazil. The importation must be made in the name of the patient and the prescriber is solely responsible on behalf of the patient for prescribing the non-approved product.
During the 2019 novel coronavirus disease (COVID-19) pandemic, Anvisa authorised the importation of non-registered medicines for the treatment of the disease, provided that the applicant company shows that the medicine has been registered with one of the following foreign authorities:
Food and Drug Administration (FDA) (US).
European Medicines Agency (EMA) (Europe).
Pharmaceuticals and Medical Devices Agency (PMDA) (Japan).
National Medical Products Administration (NMPA) (China).
Thanks for all the cheapies 13d. $CYDY$,the owner of Leronlimab, that 13dd is crying in their cheap beer about. No beer in jail though, that is chapter two coming SOON.
