Leyes y reglamentos en el marco del párrafo 2 del artículo 63 del Acuerdo sobre los ADPIC - Ver detalles del documento

European Union
Regulation No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Regulates clinical trials in regards to authorization requirements and procedure, implementation as well as the creation of an electronic database for safety reporting. The Regulation further deals with the manufacture and import of investigational medici
On the 20th day following that of its publication in the Official Journal of the European Union (publication date - 27.5.2014) It shall apply as from six months after the publication of the notice referred to in Article 82(3), but in any event no earlier