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Decree-Law No. 12/2004, Pharmaceutical Activities (Timor-Leste)

The Law-Decree requires that activities relating to import, storage, sales in bulk, sales in retail and export of medicines for human use only be exercised by entities duly registered in accordance with the applicable law for registration of businesses, as well as duly licensed by the Regulating Commission of Pharmaceutical Activities. 

It further specifies the procedure with respect to the application, dismissal, suspension and revocation of licenses and lays down the regulations on sale of medicine and prescription of medicines, among others.

Translation