A Guide to Register Pharmaceutical Products Derived From Natural Sources in the UAE
Pharmaceutical products derived from natural sources are highly regulated in the UAE and hence require approval from the government for import in or sale out of the UAE. Importers, manufacturers of such products in the UAE should conduct product registration in the UAE for placing them in the local market. The Ministry of Health and Prevention (MOHAP) is the competent authority that regulates the certification of Pharmaceutical products derived from natural sources.
Approval by MOHAP ensures that the product doesn’t contain any ingredient that is harmful to the safety and health of the consumers. For a successful registration process, relevant businesses must understand the conditions and requirements stipulated by the MOHAP. Since the process involves a series of steps, it’s advisable to hire product registration agents in Dubai to meet the requirements. Read ahead to know the key conditions and requirements to register Pharmaceutical products derived from natural sources with MOHAP:
Target Applicants of MOHAP Product Registration Scheme
As per the rules of MOHAP product registration in the UAE, the applicant must be a medical warehouse licensed by the Ministry of Health possessing a valid trade license. Local manufacturers of pharmaceutical products can also apply for the MOHAP product registration scheme. Importers can authorise local distributors to register the products with the MOHAP on their behalf. Such Marketing Authorization Holders must be registered by MOHAP to be eligible to register the products. Consult with product registration agents in the UAE for further details.
Documents Required for Product Registration in the UAE
Applicants need to arrange, organise and draft all the mandatory documents to obtain quick approval from MOHAP. Most applicants fall short when it comes to documentation related product registration in the UAE. However, product registration agents in Dubai can help you navigate the challenges of paperwork. You need to gather and submit the following documents to register pharmaceutical products derived from natural sources with MOHAP:
- Application form signed and stamped by the company
- Certificate of pharmaceutical product or certificate of free sale issued by the competent authorities in the country of origin (to be certified by the Embassy of the UAE)
- Certificate of detailed product formulation showing active & inactive substances with their quantities and functions
- A certificate to prove the absence of pig derivatives/ hormones/ steroids
- Certificate of absence of mad cow disease and its causes in products containing dairy products
- Copy of certified contract from product agency signed between a marketing company and the local agent
- Copy of valid medical warehouse license issued by UAE MOHAP
- A valid certificate of registration of manufacturing firm issued by MOHAP, UAE
- Three samples of the product to be registered
- Applicants must submit product analysis requirements
- Study of the product stability and the study of bioequivalence
Key Steps of Product Registration in the UAE
Once the document drafting is completed, you must start the formal registration procedure. This process includes registration of details and submission of mandatory documents. The process must be executed diligently to avoid any misstep or non-compliance. Product registration agents in Dubai can help you properly navigate each step in the process. You must follow the below steps to register pharmaceutical products derived from natural sources with MOHAP:
- Register in the e-services of MOHAP (product registration agents in the UAE can help with this)
- Submit a request to register your product, make the payment
- Competent committees will deliberate the registration of the product and recommendations will be submitted to a competent ministerial committee
- Competent committees will deliberate the price of the product; recommendations will be submitted to a competent ministerial committee
- Letters will be sent to the companies on the decisions made by the committee
- Applicants need to follow up with the Analysis Section of the Drug Department
- Applicants must complete and submit all the mandatory requirements
- Issuance of pharmaceutical certificates
- Issuance of product registration certificate for products approved by the authority
How can Jitendra Intellectual Property Help You?
Suppliers of pharmaceutical products derived from natural sources must get approval from MOHAP before selling the products in the UAE. The process of product registration in the UAE helps the government to ensure that the products are free from harmful ingredients. The process helps importers and manufacturers to increase their brand value and loyalty among the consumers. However, it’s advisable to consult with product registration agents in Dubai such as Jitendra Intellectual Property (JIP) to ensure compliance.
JIP is an IP firm providing bespoke product registration services in Dubai and across the UAE. Our agents possess the qualifications and experience to get your products certified by relevant authorities in the UAE. Apart from MOHAP, we also assist companies to register their products with Dubai Montaji and Emirates Authority for Standardisation and Metrology (ESMA).