Pharmaceutical /Medicine/Drug/OTC registration in South Sudan

 MOH- Ministry of Health

 MOH Website-https://moh.gov.ss/

 Regulatory Authority-DRUGS & FOOD CONTROL AUTHORITY

 Regulatory Website-https://moh.gov.ss/drugs_&_food_control_authority.php

 Local Authorized Representative Required-Yes

Drug Approval Process

Application For Marketing Authorization

A request for marketing authorization must be made in the required format and be accompanied by the required payment to the Secretary-General.

Within a given time frame, the Authority may ask for more information from the applicant, collect samples, or request samples in order tofinish the dossier or address any questions regardingthe medication, poison, chemical, cosmetic, medical device, or food. When such a request is made, the applicant has an obligation to provide the Authority with information demonstratingthat efficacy, quality, and safety are guaranteed.

An authorized or registered medication, poison, chemical, cosmetic, medical device, or food may not be eligible for marketing authorization at any point following examination, according to the Authority.

Foods, medicines, cosmetics, chemicals, or other items cannot be produced, imported, distributed, sold, or exported, either immediately or as of a date indicated in a Board order. The Inventory and/or Registry of Authorized Drugs, Poisons, Chemicals, Cosmetics, Medical Devices, or Foods shall be changed appropriately with respect to the entry in relation to the specific product following an order made in accordance with the provisions of subsection (3) above.

Any producer, importer, or exporter who, without good cause, neglects to provide these details within the allotted time frame or within an extended time frame that the Authority may have given, will not be eligible to produce, import, distribute, sell, or export any medication, poison, chemical, cosmetic, medical device, or food starting on the date that the Board specifies in a notification sent to the relevant importer, manufacturer, or exporter.

The Board may consider international organization statements and regulatory data from other nations when deciding whether to provide a product Marketing Authorization license. The Board will first confer with pertinent authorities, such as medical professionals.

Evaluation and Issuance of Marketing Authorizations

After taking into account the product’s efficacy, safety, and quality, the Board will issue an order determining whether a food, medicine, chemical, poison, cosmetic, medical device, or otherwise unlisted product is permitted or registered the Inventory, provided, however, that a marketing authorization license has been applied for and filed for its manufacture, import, export, or sale in South Sudan after the Appointed Date.

The Authority may, at any time, request information from any manufacturer, importer, or exporter toevaluate and assess any drug, poison, chemical, cosmetic, medical device, food, or regulated product that is intended to be manufactured, imported, or exported after the Appointed Date.

If the Board determines that a drug, poison, chemical, cosmetic, medical device, or food can only be registered if it is distributed, advertised, or promoted in a specific way or under specific conditions, it will impose any requirements that it deemsappropriate or necessary when approving the registration of that medication.

License validity – 5 Years