Drugs and Poisons Act of 2009.

This Act consisting of 40 articles provides for the operations of import, manufacture, control, storage, pricing, transport and use of drugs, cosmetic preparations, all medical requisites and pharmaceutical preparations. Responsible body is the National Drugs and Poisons Board, established according to article 4 of this Act. Main tasks of the Board are as follows (i) lay down conditions necessary to license drugs stores, pharmaceutical laboratories, drugs factories, veterinary vaccines, serums and drugs information bureau; (ii) procedures pertaining to registration; (iii) lay down rules for practice and management by the pharmaceutical facility; (iv) register foreign drugs; (v) license the conduct of drugs experiments both on animals and human beings; (vi) establish requisites of pharmaceutical and cosmetic preparations regarding safety, effectiveness, price, quality and protection of the consumer; (vii) approve exportation of drugs and pharmaceutical preparation; (viii) control the quality and distribution of the drugs; and (ix) prepare a list of poisons (divided in dangerous anesthetic substances, non-dangerous drugs, and poisons other than drugs) and publish the same in the Gazette. The National Reference Laboratory, together with other validated laboratories, is responsible for issuing the certificates related to both imported and locally manufactured drugs and pharmaceutical preparations.
In relation to the pharmaceutical facilities, the Law establishes that (i) it is prohibited to manufacture, prepare, synthesize, import, distribute, sell, offer for sale, transfer or circulate any pharmaceutical preparation without a license and registration (exemptions are indicated in art.16.2); and (ii) foreign drugs and pharmaceutical preparation can only be imported by companies listed in the Board's register. Furthermore, (i) for dispensing anesthetic drugs is requested a medical prescription (art.30); (ii) approval of the Board is requested for advertisement of drugs and pharmaceutical preparations; (iii) packages shall bear a tag, bearing the prescribed data; (iv) no adulterated drugs (containing less quantity of effective substance or substances or not identical to the specifications) can be manufactured, imported, sold, offered for sale, distributed or circulated.