National Council for Drugs and Poisons

The National Council for Drugs and Poisons is the national authority competent to regulate medicines and oversee them in Sudan. Regulatory work on pharmaceutical preparations actually began after independence, since the sixties of the last century, when the first pharmacy and poisons law was prepared in 1963, and its enforcement was entrusted to the Federal Ministry of Health, represented by the General Directorate of Pharmacy and its directorates in the regions, to undertake oversight and the licensing of pharmaceutical establishments.

In 2001, the Federal Council for Pharmacy and Poisons was established under the Pharmacy and Poisons Act of that year, and it continued to work under the umbrella of the Federal General Directorate of Pharmacy until 2007, then from that year it came under the supervision of the Federal Minister of Health. In 2009, the law was amended to become the Drugs and Poisons Act of 2009, which is currently in force, and under it the Council was established in its current form, with a legal personality and its headquarters in the national capital.

According to Article Six of the 2009 Act, the Council is competent to set the specifications, controls and conditions for importing medicines, manufacturing them, overseeing them, storing them, pricing them, transporting them and using them, and its competence extends to cosmetics, medical supplies and pharmaceutical preparations. Among its tasks are registering medicines and the products subject to its oversight, accrediting reference laboratories, setting the bases for licensing medicine warehouses, laboratories, medicine factories and veterinary serum and vaccine laboratories, regulating the work of pharmaceutical establishments and their management, approving the export of medicines, and licensing the conduct of drug trials in accordance with the legal controls.

The Council includes in its membership representatives of the institutions and bodies relevant to oversight of human and veterinary medicines and other medical products, and a general secretariat undertakes its direct executive tasks with independent technical, administrative and financial powers, and follows up the implementation of its decisions.

(Sources: Official website of the National Council for Drugs and Poisons nmpb.gov.sd — the Council's introductory page; the Drugs and Poisons Act of 2009, Articles 4 and 6)

— Editorial Team