Registration of Pharmaceutical Products in the UAE is a mandatory regulatory process overseen by the Ministry of Health and Prevention (MOHAP). It ensures that all pharmaceutical products meet UAE’s quality, safety, and efficacy standards before they can be imported, distributed, or sold in the local market. This process applies to all types of pharmaceutical products, including prescription medications, over-the-counter drugs, biologics, and vaccines.

Category of Registration of Pharma Products

The UAE has a comprehensive regulatory framework for the registration and regulation of pharmaceutical products to ensure their safety, efficacy, and quality. This framework governs the registration process for pharmaceutical products intended for general sale, export, import, and personal use. The Ministry of Health and Prevention (MOHAP) and other regulatory bodies oversee these processes to safeguard public health.

Registration for General Sale

Pharmaceutical products intended for general sale in the UAE must be registered with MOHAP to ensure compliance with local regulations. Ensure that pharmaceutical products meet safety, efficacy, and quality standards before they are marketed in the UAE.

Registration for Export

Facilitate the export of pharmaceutical products from the UAE to other countries, ensuring compliance with international standards. Pharmaceutical products intended for export from the UAE require registration to ensure they meet international standards and regulations.

Registration for Personal Use

Pharmaceutical products for personal use, such as those brought into the UAE by individuals for their own use, have specific registration and approval requirements. Allow individuals to bring in pharmaceutical products for personal use that are not commercially available in the UAE.

Registration for Import

Importing pharmaceutical products into the UAE requires registration to ensure they meet local safety and efficacy standards.

Types of Products which requires mandatory registration:

Prescription Drugs

Definition: These are medications that require a prescription from a licensed healthcare provider.
Examples: Antibiotics, antivirals, antifungals, cardiovascular drugs, oncology medications, and immunosuppressants.

Over-the-Counter (OTC) Drugs

Definition: Medications that do not require a prescription and can be purchased directly by consumers.
Examples: Pain relievers (e.g., ibuprofen, paracetamol), cough syrups, antihistamines, antacids, and skincare treatments.

Biopharmaceuticals

Definition: These are medications derived from biological sources, such as vaccines, blood products, gene therapies, and monoclonal antibodies.
Examples: Vaccines, insulin, monoclonal antibodies for cancer treatment.

Herbal and Traditional Medicines

Definition: These products are derived from natural sources and are often used in traditional medical systems, such as Ayurveda, Chinese medicine, or herbal remedies.
Examples: Herbal supplements, plant-based remedies, and traditional formulations for wellness and minor health conditions.

Homeopathic Medicines

Definition: Products that follow homeopathic principles of treatment, using highly diluted substances to trigger the body’s natural healing processes.
Examples: Diluted plant extracts, minerals, and animal-based remedies.

Dietary Supplements and Vitamins

Definition: Products that provide nutritional benefits, including vitamins, minerals, amino acids, and other dietary supplements.
Examples: Multivitamins, omega-3 supplements, protein powders, and probiotics.

Cosmeceuticals

Definition: Cosmetic products with medicinal properties that affect the skin or body.
Examples: Anti-aging creams, acne treatments, and skin whitening products with active ingredients.

Generic Drugs

Definition: Non-branded drugs that contain the same active ingredients as innovator drugs and are bioequivalent to the brand-name counterparts.
Examples: Generic versions of common medications like paracetamol, ibuprofen, or blood pressure medications.

Innovator Drugs (Patented Drugs)

Definition: New drugs that are developed and patented by a pharmaceutical company, typically before generic versions are available.
Examples: Breakthrough treatments for cancer, cardiovascular diseases, and rare diseases.

Controlled and Narcotic Drugs

Definition: Medications that are classified as controlled substances due to their potential for abuse or addiction.
Examples: Opioids (e.g., morphine, oxycodone), benzodiazepines, and ADHD medications (e.g., Ritalin).

Veterinary Medicines

Definition: Pharmaceuticals specifically designed for animals, including both prescription and over-the-counter treatments.
Examples: Antibiotics, antiparasitic drugs, and vaccines for animals.

Medical Devices Containing Pharmaceuticals

Definition: These are medical devices that include pharmaceutical substances, such as drug-eluting stents or medicated wound dressings.
Examples: Drug-coated stents for heart disease, medicated bandages.

Radiopharmaceuticals

Definition: Medications that contain radioactive substances used for diagnostic imaging or treatment of certain diseases.
Examples: Radioisotopes for cancer treatment or diagnostic scans (e.g., PET scans).

Biosimilars

Definition: Products that are similar to an existing biopharmaceutical but not identical. They are often developed after the patent of the original biologic drug expires.
Examples: Biosimilar versions of insulin, monoclonal antibodies.

Key Notes

All pharmaceutical products must comply with UAE’s health regulations.
Registration includes submitting a dossier, safety and efficacy data, and relevant certificates such as GMP and Free Sale Certificates.
Unregistered products cannot be legally sold or marketed in the UAE.

These types of products are subject to strict oversight to ensure public health and safety in the UAE.

Advantages of Registering Pharmaceutical Products in the UAE

Access to a Thriving Market

Growing Demand

The UAE has a dynamic healthcare sector driven by a growing population, an increasing prevalence of chronic diseases, and government initiatives to enhance healthcare services. Registering your pharmaceutical products in the UAE provides access to this expanding market.

Regional Hub

The UAE serves as a gateway to the Middle East and North Africa (MENA) region. Successful registration in the UAE can facilitate market entry into other Gulf Cooperation Council (GCC) countries, as the UAE’s regulatory standards are highly respected.

Legal Compliance and Credibility

Regulatory Approval

Obtaining MOHAP approval for your pharmaceutical products establishes compliance with the UAE’s stringent regulatory requirements. This boosts the credibility of your products and company in the region.

Consumer Confidence

Registered products that have passed the UAE’s rigorous evaluation process are trusted by healthcare professionals and consumers alike. This ensures greater confidence in the safety and efficacy of your products.

Competitive Edge

Exclusivity and Market Protection

Once a pharmaceutical product is registered, only the licensed distributor or local agent can import and market the product. This exclusivity protects your intellectual property and minimizes the risk of counterfeits or unauthorized sales.

Brand Recognition

Registered pharmaceutical products stand out in the UAE market, ensuring that your brand is associated with quality, safety, and regulatory compliance, giving you a competitive advantage over non-registered products.

Government Support and Initiatives

Investment in Healthcare

The UAE government is actively investing in healthcare infrastructure, which includes improving access to innovative medicines and treatments. By registering your pharmaceutical products, you can leverage these initiatives to expand your reach.

Healthcare Programs

The UAE’s focus on implementing world-class healthcare systems, such as universal health insurance and health digitalization, creates a demand for high-quality pharmaceuticals. Being a registered supplier allows you to participate in these programs.

Reduced Risk of Importation Issues

Smooth Import Process

Registered pharmaceutical products enjoy a streamlined import process through licensed distributors. MOHAP’s approval ensures that your products meet all regulatory requirements, avoiding customs delays or rejections at the border.

Fewer Legal Complications

Registration helps avoid legal complications related to unauthorized product entry into the UAE. By complying with MOHAP’s regulations, you can mitigate risks associated with fines, penalties, or product confiscation.

Long-Term Market Presence

Sustainable Growth

Registering pharmaceutical products in the UAE is not just about entering the market—it’s about maintaining a long-term presence. With a valid registration certificate, you can continually market and distribute your products, allowing for sustainable growth in a highly lucrative region.

Renewal and Expansion Opportunities

After successful registration, you have the option to renew the product’s registration and introduce new variants, fostering long-term expansion in the market.

Documents Required

Application Form

Completed product registration application form through MOHAP’s online portal.

Good Manufacturing Practice (GMP) Certificate

A GMP certificate issued by the health authority of the manufacturing country, ensuring that the product is produced according to international GMP standards.

Manufacturer’s ISO Certificates (if applicable)

Copies of any international standards certification, such as ISO 9001, that the manufacturer holds.

Certificate of Pharmaceutical Product (CPP)

Issued by the health authority in the product’s country of origin, certifying that the product is registered and marketed in that country. It should include information on the product’s safety, quality, and efficacy.

Free Sale Certificate (FSC)

A certificate proving that the product is freely sold in the country of origin. It must be issued by the relevant authorities.

Safety and Efficacy Data

Clinical Studies: Evidence from clinical trials showing the safety and efficacy of the product.
Pharmacovigilance Plan: A plan to monitor the product’s safety after it enters the UAE market.

Registration Certificate of Manufacturer

Certificate showing that the manufacturing company is authorized and registered by the health authority in the country of origin.

Product Samples

Samples for Testing: Provide physical samples of the pharmaceutical product for laboratory testing and analysis by MOHAP.

Power of Attorney (POA)

If the registration is being done through a local agent or distributor, a notarized and legalized Power of Attorney (POA) document authorizing the agent to act on behalf of the manufacturer.

Company Profile

A brief profile of the manufacturer or the company submitting the registration, including details about its experience, licenses, and other relevant qualifications.

Declaration of Conformity

A document declaring that the pharmaceutical product complies with all relevant health and safety standards.

Country Registration Evidence

Proof of registration and marketing approval in at least one other regulated market (e.g., USA, EU, Japan, etc.).

Patent Information (if applicable)

Details on whether the product is under patent protection, including patent certificates and expiration dates, if relevant.

Price List

A price list of the product in the country of origin and other countries where it is registered, for comparison purposes.

Batch Release Certificates (if applicable)

A batch release certificate issued by the manufacturing country’s health authority for the specific batches being submitted for registration.

Certificate of Analysis

A certificate of analysis for the active ingredients and the finished product, showing that it meets specified quality standards.

Cover Letter

A cover letter detailing the product being registered, its purpose, and any specific requests or declarations relevant to the registration process.

Product Dossier

A comprehensive dossier containing detailed information about the product, including:

Product Description: Full details of the pharmaceutical product, including its composition, dosage form, strength, and packaging.
Manufacturing Process: Detailed description of the manufacturing process, including production flowcharts, equipment used, and process validation.
Specifications: A list of the quality standards applied to raw materials, in-process materials, and finished products.
Stability Studies: Data from stability studies demonstrating the product’s shelf life under different storage conditions.
Bioequivalence Data (if applicable): Clinical data proving that the product has the same bioavailability as a reference product.

Labeling Information

Sample packaging and labels for the product that comply with UAE labeling standards, including:

- Brand Name and Generic Name
- Composition of Active Ingredients
- Usage Instructions and Dosage Information
- Warnings, Precautions, and Contraindications
- Expiry Date and Storage Conditions

Key Considerations

All documents should be submitted in either English or Arabic. If documents are in any other language, they must be accompanied by an official translation.
Accuracy and completeness are crucial; missing or incorrect information can lead to delays or rejection of the application.

Step-by-Step Process for Pharmaceutical Product Registration:

Validity of Pharmaceutical Product Registration in the UAE

Registration Validity Period

Once a pharmaceutical product is registered with the Ministry of Health and Prevention (MOHAP), the registration is typically valid for Three to five years depends upon type of product . This period starts from the date of issuance of the registration certificate.

Renewal Process

To continue marketing the pharmaceutical product in the UAE, companies must initiate the renewal process before the registration expires. The renewal application should be submitted at least six months prior to the expiration date to avoid any lapse in product availability.

Renewal Requirements

The renewal process involves:

Updating Documentation: Providing updated documentation, including recent Good Manufacturing Practice (GMP) certificates and clinical safety data if required.
Compliance Check: Ensuring that the product continues to meet all UAE regulatory standards and guidelines.
Fees: Paying the applicable renewal fees as prescribed by MOHAP.

Consequences of Non-Renewal

Failure to renew the registration on time can result in:

Suspension of Sales: The product may be suspended from sale in the UAE until the registration is renewed.
Regulatory Penalties: Companies may face penalties or fines for non-compliance.

Maintaining Compliance

To ensure the validity of your product registration:

Regular Updates: Keep abreast of any changes in UAE regulations and update your documentation accordingly.
Quality Control: Maintain stringent quality control measures and ensure that your product consistently adheres to UAE standards.

Government Fees

When registering pharmaceutical products in the UAE, it’s essential to understand the associated government fees. These fees are determined by the Ministry of Health and Prevention (MOHAP) and cover various aspects of the registration process. Here’s a breakdown of the typical fees involved:

Fees
Registration Application Fee
Product Evaluation Fee
Laboratory Testing Fee
GMP Certificate Verification Fee
Certificate Issuance Fee
Renewal Fee

Additional Considerations

Payment Methods

Fees are typically paid online via the MOHAP portal.

Fee Variations

Fees may vary depending on the product type, complexity, and specific requirements.

Refunds

Registration fees are generally non-refundable, even if the application is rejected or withdrawn.

Registration of Pharma Products