Saudi Arabia · Saudi Food and Drug Authority · Over-the-counter
Review target
100 working days
official guidance
Legal time limit
-
Not published
Steps
4
5 requirements
Application fee
-
There is no separate OTC registration route. An OTC medicine is registered like other medicines, and the Registration Committee sets its legal status (prescription only, controlled, pharmacist only or over the counter) and where it may be sold. A registered medicine can later be switched to OTC through a variation. Medicines safe to use without medical supervision, either at first registration or as a later switch.
The official review target is 100 working days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Propose the legal status in the application; 2. Committee sets legal and distribution status; 3. Reclassification request; 4. Variation review (100 days).
Outcome: Legal status of over the counter, with a distribution site such as community pharmacies.
Legal basis: Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and their Products, Article 14
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 100 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetofficial guidance. Official total target for a variation application that includes a type II change. Actual times can differ. | 100 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (15 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.