WHEREAS, it is necessary to ensure the
safety, quality, efficacy of active
pharmaceutical ingredient and input during
their importation, storage, distribution,
transportation, and handling;
it is necessary to protect public
health through the regulation of Medicine
Manufacturers engaged in the processing of
active and inactive ingredients for further
processing and distribution of medicines
manufactured ...
The following definitions are provided to facilitate understanding of the Guideline; they apply
only to the words and phrases used in this Guideline. Although every effort has been made to use
standard definitions, the ...
Any substance or mixture of substances intended to be used in the manufacture of a
medicinal product and that, when used in its production, becomes an active ingredient of that
product intended to exert a pharmacological, ...
Ethiopia, similar to numerous developing nations, heavily depends on the importation of medicines
and medical products. Although local pharmaceutical manufacturers are expanding their capabilities,
it is essential for ...
The Ethiopian Food and Drug Authority (EFDA) is mandated by the Proclamation No.
1112/2019 to ensure safety, efficacy and quality as well as rational use of medicines. Article 19
sub-article 1 of the proclamation decrees ...
The Ethiopia Food and Drug Authority (EFDA) is responsible for ensuring the safety, efficacy,
and quality of medicines in Ethiopia, as mandated by the Food and Medicine Administration
Proclamation No. 1112/2019. Article ...
Medicinal gases play a critical role in modern healthcare, serving as essential therapeutic agents for
various medical conditions. They comprise of medicinal products / drugs that are supplied as a gas or gas
mixtures. ...
The Ethiopian Food and Drug Authority (EFDA), under Proclamation 1112/2019, regulates all
medicinal products, including plasma-derived biological products. Article 30(3) of the
proclamation mandates that blood and blood ...
Marketing authorization (MA) of pharmaceutical products is one of the crucial regulatory
requirements to ensure safety, quality and efficacy of medicines. The Ethiopian Food and Drug
Authority has categorized finished ...
WHEREAS, to ensure production, import, export,
storage, distribution, transport, prescribing, dispensing,
and use of narcotic and psychotropic medicine is
carried out in accordance with the law;
Surveillance activities that occur following market approval of a
medicine, including: maintenance of product authorization and/or
registration of variations or renewals; regular inspections of
manufacturers, wholesalers, ...