When it comes to getting your pharmaceutical and medical products into the UAE market, understanding the Dubai Health Authority (DHA) product registration process is crucial. This regulated procedure ensures that only safe, effective, and high-quality products are approved for sale in Dubai and the broader UAE market. If you’re a business looking to register a pharmaceutical product, medical device, or any other type of medical product, this guide will walk you through the essential steps and requirements.
What is DHA Product Registration?
DHA product registration is a process managed by the Ministry of Health and Prevention (MOHAP) in collaboration with the Dubai Health Authority. Its purpose is to ensure that all pharmaceutical, medical, and health-related products sold in Dubai meet stringent safety, efficacy, and quality standards. The registration process helps to maintain the integrity of healthcare in the UAE by regulating products ranging from conventional pharmaceuticals like tablets and syrups to more complex products like biologicals and medical devices.
Types of Products That Need DHA Registration
The product categories that require DHA registration include:
- Pharmaceutical Products: This includes conventional drugs like tablets, syrups, and injections.
- Biological Products: Vaccines and blood products fall into this category.
- Medical Devices: Diagnostic equipment, surgical tools, and other devices.
- Herbal and Natural Products: Including supplements and traditional remedies.
- Cosmeceuticals: Products that blend cosmetic and pharmaceutical properties.
- Controlled Medicines: Including narcotics and other controlled substances.
Each category has its own set of regulatory requirements, so it’s essential to understand what applies to your product before beginning the registration process.
The DHA Product Registration Process
The process to register pharmaceutical products with DHA can be divided into several key stages:
1. Company and Agent Registration
Before you can register your product, the company seeking registration must first be registered with MOHAP. Additionally, a licensed medical warehouse must be available, or a local agent must be authorized to handle the application process on behalf of the company.
2. Submission of Application
Once your company and agent are registered, you can submit your product registration application. This is done electronically through the MOHAP e-services portal. You’ll need to submit a variety of documents, including:
- Product Formula: A detailed breakdown of the ingredients used.
- Manufacturing Licenses: Certificates proving the manufacturing process complies with standards.
- GMP Certificates: Evidence that your product is manufactured following Good Manufacturing Practices.
- Free Sale Certificate: Proof that the product is available for sale in the country of origin.
3. Technical Review
After submitting the necessary documents, the product undergoes a technical review. The MOHAP technical committee reviews the product samples and documentation to ensure they meet the regulatory standards set by the UAE. This process verifies the product’s safety, quality, and effectiveness.
4. Ministerial Committee Evaluation
Once the technical review is complete, the product is forwarded to the ministerial committee for further evaluation and approval. This step may include additional testing or information requests if necessary.
5. Laboratory Testing and Sample Import
In some cases, the product may be required to undergo laboratory testing. Samples may be imported to official labs in the UAE to verify that the product complies with the necessary quality and safety standards.
6. Approval and Certificate Issuance
Upon successful evaluation, MOHAP issues a Certificate of Pharmaceutical Product (CPP). This certificate confirms that the product has met all regulatory requirements and is authorized for sale within Dubai and the UAE. The registration is typically valid for five years, after which a renewal is required.
7. Post-Registration Obligations
Once your product is registered, ongoing compliance is essential. Only MOHAP-licensed pharmaceutical warehouses can handle the distribution and sale of the product. It’s important to keep track of post-registration obligations, including safety monitoring and regular updates to ensure compliance.
Key Requirements for Product Registration
Here are some of the essential requirements to keep in mind when registering pharmaceutical and medical products with DHA:
- Required Documents: A full registration file must be submitted, including product samples, GMP certificates, free sale certificates, and any other documents specified by MOHAP.
- Compliance with UAE Regulations: Your product must comply with local standards, which may include special certifications like Halal certification or declarations regarding the absence of harmful substances.
- Registration Certificate: The registration certificate, issued by MOHAP, serves as proof of approval for your product. This certificate is valid for five years from the date of issuance, after which you’ll need to renew your registration.
- Product Testing: Depending on the type of product, laboratory testing may be required to ensure the product meets UAE’s health and safety standards.
- Local Representation: A local agent or office within the UAE is mandatory for foreign manufacturers wishing to register products in Dubai. This ensures accountability and ease of communication with regulatory authorities.
The Role of MOHAP and DHA in Registration
The Ministry of Health and Prevention (MOHAP) is the central authority responsible for overseeing product registration in the UAE. MOHAP collaborates with the Dubai Health Authority (DHA) to evaluate applications, perform technical reviews, and ensure that only safe and effective products are approved. The regulatory bodies maintain strict oversight over the entire process, ensuring that all products meet international standards of safety and quality.
If you’re ready to begin your product registration journey in Dubai, contact us today, and let’s ensure your product gets the approval it needs to thrive in the UAE market.