What is classification?
Local regulatory authority (MOHAP in the United Arab Emirates, SFDA in the Kingdom of Saudi Arabia) classifies the product as a medicine, food supplement, or medical device. We highly recommend the classification procedure for borderline products and unique combinations. The classification decision is based on scientific grounds and regulations related to labeling, claims, and ingredients.
Why is classification so important?
It allows manufacturers and other stakeholders identify the category their product falls into in accordance with local standards, as well as plan further registration strategy according to the guidance. Some food supplements and topical skincare will fall into the medicines category due to the active ingredient and its dosage or specific therapeutic indications. Moreover, the medicines themselves are divided into the general sale, herbal, and conventional medicines categories. Each category has its own registration requirements. Classification helps identify the best registration path.
How can YallaRx help?
Our specialists will provide you with a list of documents required for classification and help you fix any gaps and misalignments. A well-crafted set of documents is essential for fast regulatory procedures with predictable results. We will submit the classification application to the regulatory body on your behalf and track the status until the official decision is received.
Timelines
SFDA (Saudi Arabia) review time - 2 to 10 working days.
MOHAP (UAE) review time - 10 working days.
YallaRx will require approximately 5 working days for the compilation and submission of documents.
Local regulatory authority (MOHAP in the United Arab Emirates, SFDA in the Kingdom of Saudi Arabia) classifies the product as a medicine, food supplement, or medical device. We highly recommend the classification procedure for borderline products and unique combinations. The classification decision is based on scientific grounds and regulations related to labeling, claims, and ingredients.
Why is classification so important?
It allows manufacturers and other stakeholders identify the category their product falls into in accordance with local standards, as well as plan further registration strategy according to the guidance. Some food supplements and topical skincare will fall into the medicines category due to the active ingredient and its dosage or specific therapeutic indications. Moreover, the medicines themselves are divided into the general sale, herbal, and conventional medicines categories. Each category has its own registration requirements. Classification helps identify the best registration path.
How can YallaRx help?
Our specialists will provide you with a list of documents required for classification and help you fix any gaps and misalignments. A well-crafted set of documents is essential for fast regulatory procedures with predictable results. We will submit the classification application to the regulatory body on your behalf and track the status until the official decision is received.
Timelines
SFDA (Saudi Arabia) review time - 2 to 10 working days.
MOHAP (UAE) review time - 10 working days.
YallaRx will require approximately 5 working days for the compilation and submission of documents.