Businesses in the pharmaceutical sector in Ethiopia will now be required to go through regulatory processes before they can use promotional materials for their medical products, according to a new rule introduced by the Ethiopian Food and Drug Administration (FDA).
Last Monday, the FDA issued a circular instructing manufacturers, importers, and wholesalers of pharmaceutical products that they “should not employ and disseminate promotional materials without clearance from the Authority.”
The companies must submit an application to the Authority for approval to use their promotional materials before they advertise their pharmaceutical products, according to a letter signed by Seyoum Wolde, the Authority’s deputy director general for the medicine sector.
The Authority has produced a guideline for the regulation of advertising and promotion of medicines as part of the process of revising its rule covering the promotional activities of medicines. Ajema Bekele, who is in charge of pharmaceutical registration at the Authority, says that mass media ads for medicines aren’t allowed unless they are for items like condoms and contraceptives that need to be known more about.
Nonetheless, he claims that the company’s medical personnel are free to work on advertising materials for pharmaceutical drugs. He said that in order to promote their medicines, pharmaceutical corporations send out professionals who meet with physicians and clinics in person. The Authority’s prior permission is now required for advertisements of this kind.
Under the new plan, the Authority will have the last say on all advertisements and other forms of marketing. This change, as explained by Ajema, occurred when the Ethiopian Media Authority transferred responsibility for regulating advertisements for medical products to the Food and Drug Administration.
The circular instructed pharmaceutical product manufacturers, importers, and distributors to inform the Authority of any health workers who are licensed and authorized to market the medicines.
The Authority estimates that the application procedure for the promotion and advertising permit approval might take up to two weeks, provided the applicant firm presents all relevant information throughout the application process.
When seeking approval for promotional materials, the company is required to provide certain information, including the brand and generic names of the medicine, information about the manufacturer and distributor of the medicine, information about the advertising company, and the advertising company’s credentials.
