Authority Issues Temporary Licenses for Sanitizer, Mask Makers

The Food & Drug Authority drafted a new temporary directive that gives an exclusive license to manufacturers, enabling them to make hand sanitizer, disinfectant and face masks.

Drafted as a response to the ongoing effort of the country to ward off the potential outbreak of Novel Coronavirus (COVID-19), the directive was enacted last week. The Authority issued the six-month directive in a speedy process.

The seven-page directive is applicable to newly formed manufacturers as well as for those who are already in the business.

To secure a license, applicants should prepare a designated space for the production of these products and a place to store the manufactured products. They should also have a technical officer who holds a first degree in biology, chemistry or chemical engineering. Once the applicants fulfill all the requirements set by the directive, they will get the license within two days.

They are also compelled to specify the manufacturer's name and the location of the plant on product labeling.

So far, 56 manufacturers have fulfilled the requirements and secured accreditation to start producing hand sanitizer and alcohol, antiseptics and disinfectant. Twenty-six of the manufacturers were already engaged in making these and other products, while the remaining 30 requested new applications. Ethio Asian, Ethiopian Pharmaceuticals Manufacturing Factory (EPHARM), Taflen Industry & Trading, Gastrock, Sheba Pharmaceutical are among the companies that secured the license.

The directive also applies to companies that import these products. Importers of masks, hand sanitizer and gloves must also have a technical staff member that will monitor the operation. Gloves and face mask importers are required to produce a CE Marking, an international health certification, or are expected to have quality assurance documents. Hand sanitizer importers are also asked to provide the quality assurance certificates.

Face mask manufacturers, which use cloth, are expected to prove the masks can filter out bacteria and viruses. These companies are also asked to come up with an assurance certification, according to the directive.