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Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil BJPS
Gamboa,Maryelle Moreira Lima; Roesch,Heveline Rayane Moura; Lemos,Vanessa Pinheiro Amaral; Rocha,Bruna Oliveira; Santos-Oliveira,Ralph.
Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ) or positrons emitter (β+), linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased,...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Radiopharmaceuticals/regulation; Radiopharmaceuticals/ surveillance; Radiopharmaceuticals/pharmacovigilance; Pharmacovigilance/practice in radiopharmaceuticals drugs; Brazilian legislation/radiopharmaceuticals control.
Ano: 2014 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502014000200285
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