How to Register Herbal Medicine Products in Dubai, UAE?
The import and sale of herbal medicine products in the UAE remain largely unregulated in the past (till 2009, to be precise). Herbal medicines, by definition, should be made out of natural sources, but many products sold in the market contained harmful ingredients. In view of such instances of adulteration, the government made it mandatory for herbal medicine importers and distributors to perform product registration in the UAE.
Importers, distributors and manufacturers of all herbal products must register the products with the Ministry of Health and Prevention (MOHAP). The Ministry performs all the mandatory tests to confirm that the product in question is devoid of any harmful ingredients and safe for public consumption. Since public safety is the prime concern of the government, the process of herbal product registration in Dubai, UAE, involves a series of highly streamlined steps. Businesses dealing with herbal products can enlist the help of product registration consultants in Dubai to pass through each of these steps.
Read ahead to know more about the process, requirements and conditions of registering herbal medicines with MOHAP.
Who Can Apply for Herbal Product Registration in Dubai?
As per the Ministry of Health guidelines, a drug warehouse or a local manufacturer with a valid trade license can apply for UAE product registration. Companies operating both mainland and free zones are allowed to register herbal medicines with the MOHAP. However, a local distributor with a valid trade license can also apply for product registration in Dubai on behalf of companies operating abroad. The manufacturers or distributors can hire product registration agents in Dubai to make the process easier.
Requirements for Registering Herbal Medicines with MOHAP
The manufacturers and importers need to submit all mandatory information and documents required to register a product with the UAE Ministry of Health. The information supplied should be accurate, and the documents should be proper for the speedy completion of product registration in Dubai. The following information/documents are mandatory,
- Certificate free sale issued by the competent authorities in the country of origin certified by the UAE Embassy
- Detailed product formulation certificate (active & inactive substances should be mentioned along with their quantities and functions)
- A certificate substantiating the absence of pig derivatives/ hormones/ steroids
- Certificate to confirm the absence of mad cow disease if it contains any dairy product
- Copy of contract signed between the marketing company and the local agent
- Copy of a valid license of a medical warehouse issued by MOHAP-UAE
- A valid certificate of registration of the manufacturing company issued by MOHAP-UAE
- Three samples of the product in question
- Information/documents related to product analysis
- Provide the study of the product stability and the study of bioequivalence (by-product).
Process of Registering Herbal Products with the UAE Ministry of Health
All applications for herbal product registration in the UAE should be made through the dedicated online portal of the MOHAP. The steps for registering a herbal product in Dubai, UAE is as follows,
- Fill out the application for product registration (product registration agents in Dubai will assist)
- Submit the request for product registration
- Competent Committees will review the registration, and they will redirect it to the competent ministerial committee with their recommendations
- The committee will send letters to the companies stating their decision
- The applicant should follow up with the Analysis Section at the Drug Department
- Applicants should complete the requirements and submit them online
- The relevant committees will re-deliberate the registration after the applicants meet the requirements
- The committee will issue a certificate of product registration after all conditions and requirements are met. The product registration certificate in the UAE is valid for five years effective the date of committee approval
- Certificate for locally manufactured products are valid for one year effective the date of issuance
How Can Jitendra Intellectual Property Help?
The UAE is an interesting mix of people from diverse cultural and ethnic backgrounds, which makes it a perfect place for selling herbal medicines. People who prefer natural sources of healing go for buying herbal medicines. Considering the high risk of adulteration in this particular sector, the government has made product registration in the UAE mandatory for manufacturing or importing herbal medicines. The sale of unregistered products will be considered an offence, and such products will be rejected during shipment or seized.
The mandatory requirement of herbal product registration in the UAE involves a series of intricate steps that the businessmen may struggle to meet effectively. However, the support of product registration consultants in the UAE, such as Jitendra Intellectual Property (JIP), minimises the struggles of the manufacturers and importers. JIP acts as the local representative of the companies and helps them fulfil all the requirements at minimum costs. JIP has sufficient legal knowledge and industry experience in helping businessmen register their herbal products with MOHAP.