8 December 2018

Ethiopia: Authority Eases Registration, Licensing for Medicine

The Food & Drug Authority, the nation's food and medicine regulator, has issued a circular to ease the registration and licensing requirements for medical supply equipment importers.

The Authority's circular, dated November 6, 2018, lifted the restriction that allowed only one agent to register a product and only two others to import and distribute specific medical equipment and medicine from a manufacturer.

This new circular is intended to reduce the amount of time it takes to register drugs and medical equipment and allow manufacturers to directly register their products in the country. The regulations put in place prior to the circular imposed limitations on the sector by allowing only a few industry players that impacted market competition negatively, the circular reads.

The circular was issued as an interim directive until a draft proclamation was established, which has already been approved by the Council of Ministers and adopted by parliament on November 24, 2018.

Under the new circular that came into effect on November 10, 2018, registration, import and distribution of any drug or medical equipment by the manufacturer, importer and agents are permitted.

In the same token, any firm can now import and register any medical equipment or drug and import already registered supplies by other agents operating in the country.

"The advantage of this new proclamation is to open opportunities for new businesses who want to engage in the industry," Abdela Kasso, product registration and licensing acting-director of the Authority, told Fortune. "This will increase the supply of medicine and medical equipment and improve competition in the market."

The Authority, established in 2009 to ensure the safety and quality of products and health services, requires all businesses to present certificates of competency, hire medical consultants and obtain a business license to operate in the sector. The Authority is mandated to register, license and inspect health professionals, pharmaceuticals, restaurants and health institutions.

Current importers argue that the Authority's decision is counterproductive.

"Registering a product takes a long time and many resources," says Meseret Yimam, technical manager of Agmas Medical Equipment Importer & Distributor, one of 287 drug and medical equipment importers in the country. "Now that everyone can import a product once it is registered, the company which registered the brand will be disadvantaged."

The nation, which prioritises the import of medical goods in foreign currency allocation, spends over 300 million dollars annually to import pharmaceuticals and medical equipment. Most medical supplies and drugs imported are from manufacturers in India, the United States and Italy.

Experts believe that this decision discourages local manufacturers of drugs by encouraging imports.

"The new arrangement discourages local manufacturers as the market may be flooded by imported products from foreign manufacturers," says Ephraim Berhanu, a lecturer at Addis Abeba University's Department of Law with a decade of experience.

Currently, there are 28 manufacturers of drugs in Ethiopia.

Ethiopia

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