Traditional Medicines and OTC Products
The ins and outs of traditional medicines and OTC products in Saudi Arabia. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: Saudi Arabia, available to purchase here for GBP 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
This presentation comprised a briefing on the current situation of the practice of traditional medicine (TRM) and complementary and alternative medicine (CAM), the availability of two kinds of herbal products, from local and imported crude medicinal plants, and the history of traditional medicine in Saudi Arabian culture.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Yes, but the national authorities responsible for the regulation of herbal medicinal, traditional, complementary products and practices should authorize every advertisement before it reaches the public.
The regulatory authority should issue an advertising permit after a satisfactory evaluation of the contents of the advert to ensure that the public gets the correct information about the product, devoid of ambiguous or false claims. The print and electronic media should be notified to ensure that every advertiser of herbal medicinal products obtains the advertising permit from the national authority before such advertisements are circulated.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
Medical claims: Medical claims are here defined as those claims specified to treat, cure or prevent a disease or restore, correct or modify physiological functions. Frequently, products with medical claims have to be registered by the medical products agency before being allowed onto the market.
Health claims: Health claims could, for instance, include “any statement, suggestion, or implication in labelling or advertising that a product carries a specific health benefit, but not nutritional claims nor medical claims. The term “health claims” further includes claims which refer to nutrient function and recommended dietary practice.
Nutrient content claims: Nutrient content claims, for instance, indicate that a certain product is particularly rich or low in a nutritional component such as fibre or fat.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
Pharmacies in Saudi Arabia are easily accessible to the public. Antibiotics, as well as many other non-prescription medications, are available OTC. Another study examined the behaviour of parents with regards to OTC medication and found that, out of 750 parents from different cities across Saudi Arabia, 80% self medicate their children. This correlates with the findings of the present study, which indicated that the majority of respondents (67.2%) practice self-medication with OTC drugs.
This is not surprising as many patients in Saudi Arabia can buy any OTC drug without any prescription. The current study revealed that the majority of patients use the OTC drugs without the advice of a health professional, as customers felt shy and reluctant, there was a lack of confidentiality, the pharmacist was felt to be impatient, there was a queue, or the customer did not trust the pharmacist.
5. Are there any limitations on locations or channels through which OTC products may be sold?
Please refer to Question 4 above.
6. What health, advertising, and marketing claims may be made for OTC products?
The medical advertisements must contain the generic name, a statement of “Please purchase and use following the drug instructions or under the guidance of pharmacist”, its medical advertisement approval number and its manufacturing approval number. Meanwhile, a special label (OTC) for OTC drugs should be indicated in the advertisements for such non-prescription drugs.
7. Can OTC products be marketed or advertised directly to the public?
It is permitted to advertise OTC medication to the general public in Saudi Arabia. However, it is subject to the prior approval of the SFDA. The content of advertisements is examined by the SFDA and after obtaining approval, the SFDA approval number must be displayed in the advertising.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
The SFDA has the authority to revise and publish the list of OTC drugs. Alternatively, the marketing authorization holders can apply to the SFDA for the conversion between prescription drugs and OTC drugs.
9. What are the requirements for the importation of either traditional medicines or OTC products?
The requirements for the importation of either traditional medicines or OTC products are generally the same as those for chemical drugs or prescription drugs.