Registration of Pharmaceutical Products in the UAE
The United Arab Emirates has a well-regulated pharmaceutical market. They ensure that only safe and effective products reach consumers. For companies planning to enter this sector, understanding the official guidelines for registration is essential.
The process involves meeting regulatory standards, submitting the required documentation, and obtaining approvals from the Ministry of Health and Prevention (MOHAP). This guides walks you through everything you should know register your products successfully.
Table of Contents
What is Pharmaceutical Product Registration in UAE?
Pharmaceutical product registration in the UAE is a legal requirement. It makes sure that all medicines and healthcare products are safe, effective, and meet quality standards. The Ministry of Health and Prevention (MOHAP) is the main authority that oversees this process.
After the completion of registration, the company receives the Certificate of Pharmaceutical Product (CPP). It usually consists of a registration number (unique for the product), validity period (often 5 years, after which renewal is required), conditions of approval (if any).
Key Points to Know:
- Why register? Registration protects public health and ensures only approved products are sold in the market.
- Who needs to register? Local companies, manufacturers, and international firms that want to sell medicines in the UAE.
- What is checked? Product safety, effectiveness, and compliance with UAE regulations.
- Main authority: The Ministry of Health and Prevention (MOHAP).
In short, registration is not just a formality. It is the first step for companies that want to enter the UAE’s growing pharmaceutical market.
Benefits of Registration of Pharmaceutical Products
- Legal Approval: Only registered/approved products can be sold legally in the UAE.
- Market Access: Opens doors to the UAE’s strong and growing healthcare market.
- Regional Expansion: Registration helps in entering other GCC countries more easily.
- Trust and Credibility: Builds confidence with doctors, pharmacies, and patients.
- Quality Assurance: Confirms the product meets strict safety and quality standards.
- Brand Recognition: Approved products gain higher acceptance in the market.
- Long-Term Growth: Supports business expansion and stable operations.
- Regulatory Protection: Protects the product against counterfeit or unregistered competition.
Categories of Pharmaceutical Products in UAE
The UAE classifies these products into different categories. Each category has its own rules and approval process.
Conventional Medicines: These include common drugs like tablets, capsules, syrups, and injections. They are used to treat everyday health problems and long-term diseases.
Biological Products: This group covers vaccines, blood products, and medicines made using biotechnology. They often need more detailed testing and safety data.
Herbal and Natural Products: Herbal medicines, natural supplements, and traditional remedies fall under this category. They must be proven safe before they are sold.
Medical Devices: Items like diagnostic kits, surgical tools, and healthcare equipment are registered separately but still go through MOHAP review.
Cosmeceuticals: These are cosmetic products that also claim health benefits, such as medicated creams or anti-acne lotions. They are checked for both safety and effectiveness.
Controlled Medicines: Narcotic and psychotropic medicines are in this category. They have strict regulations because of their high risk of misuse.
Conditions and Requirements for MOHAP Certificate
Marketing Authorization Holder (MAH)
The company that owns the product must be registered with MOHAP before it can apply for product registration.
Licensed Local Agent
A licensed medical warehouse or local distributor in the UAE is needed to submit the application and handle the product in the market.
Technical File Submission
All documents must be submitted in the eCTD format (Electronic Common Technical Document). This makes the review process faster and organized.
Product Safety and Quality Data
Companies must provide details on safety, effectiveness, and quality. This may include stability studies, bioequivalence reports, and a pharmacovigilance plan if required.
Pricing Approval
After the product is registered, The Health and Prevention Ministry also checks and approves the selling price before it enters the market.
Laboratory Testing
Samples of the product are tested in MOHAP’s quality control labs to confirm the claims and quality.
Fees and Charges
An application fee and a registration fee are required. Other fees may apply for extra services like lab testing or evaluation.
Validity of Certificate
The CCP is usually valid for five years. Locally manufactured pharmaceutical license may be valid for one year.
Renewal Process
To renew the registration of products, the company must submit updated documents, product samples, a license of pharmaceutical product from the origin country, and proof of any changes made to the product.
Manufacturing Site Approval
If the product is made outside the UAE, the factory must have a valid GMP license, legalized by the UAE Embassy to register their products. For local factories, The Health and Prevention Ministry site registration is required.
Required Documents for Registration Process
- Application form from the Ministry of Health and Prevention.
- Product formula and composition details.
- Manufacturing license and Good Manufacturing Practice (GMP) license.
- Stability studies and clinical data (if required).
- Free-Sale-License from the country of origin.
- Copy of the trade license of the local agent.
- Labels, packaging, and product information leaflets.
Steps to Obtain Pharmaceutical Product Registration Certificate
Step 1: Company and Agent Registration
Marketing authorization holder companies must first be registered with MOHAP to be able to register pharmaceutical products. They also need a medical warehouse licensed by the ministry or a local agent with a valid license to act on their behalf.
Step 2: Submit Applications
The company should submit applications for the registration of medical products to the MOHAP Drug Department. The application includes documents like product details, GMP certificate, and Free Sale Certificate from the country of origin.
Step 3: Technical Review
The Drug Department reviews the application and forwards it to the Technical Committee. This committee checks product safety, quality, and effectiveness.
Step 4: Ministerial Committee Evaluation
If the product passes the technical review, it goes to the Competent Ministerial Committee. The committee provides the committee approval needed before the final stage.
Step 5: Laboratory Testing and Import of Samples
Product samples are imported and tested in official labs to confirm compliance with UAE standards.
Step 6: Committee Approval and Certificate Issued
Once approved by the competent authority, the CCP is issued to the company. This confirms the marketing authorization of the product in the UAE.
Step 7: Validity of Registration
The CCP is usually valid for five years. After this period, companies must apply for renewal through MOHAP to continue marketing their products.
Frequently Asked Questions (FAQs)
1. What is medical product registration in the UAE?
Medical product registration in the UAE is the official process that allows a medical product to be legally marketed and sold in the country. This ensures safety, quality, and compliance with health regulations.
2. Who can file applications to register a pharmaceutical product?
Only marketing authorization holder companies have to be registered with the Ministry of Health and Prevention (MOHAP). They can file applications to register their products through a licensed local agent.
3. What types of products require registration?
The process covers human medical products, biological or other human pharmaceutical formulations, as well as products that have been approved for registration in other countries.
4. What documents are required for medical product registration?
Required documents may include details of the medical product, a free sale certificate, manufacturing licenses, product composition, and health and safety test results.
5. What is a Certificate of Pharmaceutical Product (CPP)?
A CCP confirms that the product is free from harmful substances, complies with international standards, and has been issued by the competent authorities for global recognition.
6. How long are registration certificates valid?
Product registration certificates are valid for five years in most cases. However, certain temporary certificates, such as those valid for one year, may be issued depending on the conditions and requirements.
7. Does the UAE require locally manufactured products to go through registration?
Yes, both imported and locally manufactured medical products must go through the drug registration process to ensure compliance before sale in the UAE market.
8. Which committees review the applications?
Relevant technical and ministerial committees examine applications, deliberate on health and safety compliance, and decide whether products should be approved for registration.
9. What happens if a product does not meet conditions and requirements?
If products fail to meet the registration to ensure safety standards, it may lead to product confiscation, rejection of the application, or denial of certificates of registration of products.
10. Can companies get support with submitting the registration?
Yes, product registration consultants in the pharmaceutical industry can guide companies through the process to register, ensuring all conditions are met for successful registration in the United Arab Emirates.