Traditional Medicines and OTC Products
The ins and outs of traditional medicines and OTC products in the UAE. Prepared in association with STA, a leading law firm in the UAE, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
As per Article 1 of the Pharmacy Law of 1983, medicines are defined as “any medicine that contains one or more element for treatment or protection of human beings and animals”. Traditional, herbal, complementary, and alternative medicine all fall under the purview of the aforementioned definition.
All these medical products must be registered with the MOH, before they are distributed. A new drug application must be submitted to the MOH before importing or manufacturing any pharmaceutical product.
The pharmaceuticals will be classified by the MOH depending on the purpose of the products. In addition, registration and/or certification may also be required from the Dubai Health Authority or the Health Authority Abu Dhabi for these products.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Yes, as long as they obtain marketing approval from the MOH before distribution, because the packaging will need to reflect the manufacturer’s logo, together with the medical specifications. There will likely also be axillary marketing, such as flyers, posters, videos and websites, that must also be submitted to the MOH before implementation.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
Advertising and marketing of any medical products, to medical professionals is strictly bound by the rules outlined in Ministerial Resolution No. 430 of 2007 and Ministerial Decision No. 1412 of 2017. Any content that does not comply with those guidelines shall be deemed illegal, and will be subject to a penalty.
Generally, any advertising and marketing attached to medical products must be accurate, equivocal in tone, and objective to a sufficient standard so that the individual being directed by the advertising/marketing can form their own opinion on the value of the product. To that end, any advertising/marketing must be free from exaggerated statements or promises. There are a plethora of other rules that attach to advertising and marketing, and can be found in the aforementioned instruments.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
The government of Dubai has set out exhaustive pharmacy standards, and in its elaboration on the accepted dispensation modes, delineates between OTC-P, and OTC-G. OTC-P, Over the Counter Pharmacy Medicine, refers to those medicinal products that may be dispensed without a prescription and sold only in pharmacies. Such products may be stored in direct access to the consumers. On the other hand, OTC-G refers to medicines sold in pharmacies and non-pharmaceutical outlets. These medicinal products may be sold in pharmacies and outlets such as supermarkets with controlled storage conditions; the acquisition must be made through a licensed medical store only.
5. Are there any limitations on locations or channels through which OTC products may be sold?
Over the Counter Pharmacy Medicine, OTC-P products, that may be dispensed without a prescription, can be sold only in pharmacies.
6. What health, advertising, and marketing claims may be made for OTC products?
Please refer to question 3.
7. Can OTC products be marketed or advertised directly to the public?
Yes, these may be advertised directly to the public. The Ministry of Health and Prevention is the authority responsible for regulating advertising and marketing materials connected to pharmaceuticals or medical products.
It must be noted that is of the essence to obtain marketing authorization from the MOH, before commencing any advertising/marketing for medical products or pharmaceuticals within the UAE. The application for advertising/marketing approval can be made online once an entity has been established in the UAE. Once the marketing authorization has been granted by the MOH, it shall then review all the intended advertising/marketing tools prior to implementation. The proposed advertising/marketing tools can be uploaded on the MOH website electronically, once an account has been registered with the MOH.
In addition to the above, the Dubai Health Authority or the Health Authority Abu Dhabi can request a review the contents of the advertising/marketing of medical products/pharmaceuticals before they are implemented on a case-by-case basis.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
At present, there exists no established procedure to cater to the conversion of a prescription-only product to an over-the-counter product.
Changes such as those of the medicinal form, dosage, etc., which bear the potentiality to affect the status of the medicinal product, shall require fresh registration. In the event of such changes to the product, that might warrant changing its status from prescription to over-the-counter, its owner should apply for changes to the registration materials. Expert examination of such changes will accordingly be made, as per the set procedure for the registration of any new medicinal product. Consequently, the owner shall receive the new registration certificate.
9. What are the requirements for the importation of either traditional medicines or OTC products?
In accordance with Article 65 of UAE Federal Law No. 4 of 1983, all pharmaceutical products imported into the UAE, need to be mandatorily registered with the Ministry of Health. At the time of registration, a committee at the Ministry of Health will undertake a review of the pharmaceutical product and then determine the “CIF” (cost, insurance, and freight) price for the particular pharmaceutical product. Pursuant to Incoterms, CIF generally refers to all of the costs incurred to get the relevant product from the place of origin to the named port of destination.
In accordance with Ministerial Resolution 140 of 2013 (the Pricing Resolution), once the CIF price for a pharmaceutical product has been set by the Ministry of Health, the agent or distributor of the pharmaceutical products, and the pharmacy or private hospitals shall be paid a fixed margin of the aforementioned CIF price.