MOHAP ( Ministry of Health and Prevention)
Product Classification - MOHAP
The classification letter identifies the product classification if the product needs or does not need registration by MOHAP. If it is determined that it needs registration by MOHAP, it must be registered in MOHAP according to the class identified in the classification letter.
Documents Required
- Emirates ID or Passport or Trade License or Drug Store License (Depends on the user type).
- Product Catalog for Medical Devices.
- Product Picture.
- Certificate from the authorities in the country of origin related to the product (CPP/Free Sale Certificate/CE/ISO).
- Registration and marketing status in other countries (Attach copies of certificates) if applicable.
- Leaflet/Product Information in English/ Arabic.
- Inner Pack Label with Clear and Readable Product Name and Information (Artwork).
- Outer Pack Label with Clear and Readable Product Name and Information (Artwork).
- Composition Certificate (Active/ Inactive ingredient list with each ingredient quantity)/ MSDS (applicable for products containing medicinal/chemical ingredients).
Service completion duration: 10 working days
Service fees: AED 500
Validity: Three Years
MOHAP- Products Registration
Conventional, Biological or other human pharmaceutical products
To register conventional, biological or other human pharmaceutical products for importation and trading within the UAE are required registration by the Ministry of health and prevention, UAE and all modules must be submitted in eCTD format.
Documents Required
The required documents are to be submitted in accordance to the requirements of the standard technical file (eCTD).
Service Fee:
Application : AED100
Registration of Conventional pharmaceutical product: AED 7,000
Analysis or re-analysis of a medical product: AED 3,500
Pricing certificate after committee approval: AED 500
For PV plan evaluation: AED 1,000
General sale/OTC Products:
All the pharmaceutical products with limited medicinal usage, which cannot be considered medicines and are intended for general sale/OTC. These include products such as dietary supplements,medical cosmetics and medical disinfectants are required registration by the Ministry of health and prevention, UAE.
Documents Required
- Certificate of pharmaceutical product (in accordance with the WHO system) or a certificate of free sale of the product issued by the competent authorities in the country of origin and certified by the Embassy of the United Arab Emirates.
- The certificate of the pharmaceutical product or free sale certificate should contain the following information:
- Product Brand Name: If the brand name required to be registered in UAE is different from the name in the country of origin, this shall be made clear in the certificate, besides stating the reason for that and making both names clear with an emphasis on their conformity in terms of formulation and other specifications.
- The detailed formulation of the product contains active and inactive substances with their quantities and functions of inactive substances.
- Name of the company entitled to marketing/ manufacturing/ manufacturing sites/ subcontract manufacturers along with their addresses.
- One sample of the product.
- A valid registration certificate of the manufacturing company issued by MOHAP-UAE with the intended production line.
- Halal certificate issued by certified authorities and organizations.
- A valid registration certificate of the manufacturing company issued by MOHAP-UAE with the intended production line.
- The following information must be provided on letterhead papers and stamped by the company and signed by the authorized person:
- A statement issued by the company confirming that the product to be registered is free of hormones, heavy metals, antibiotics, steroids, pig derivatives and any other natural or chemical substances that have a harmful impact on human beings biologically and behaviorally.
- If the product contains animal derived substances, the animal type and the part extracted from it should be mentioned with the percentage of alcohol used “if any and why it is used”.
- A copy of the certified contract signed between the marketing company and local agent indicating the products for which the agent will be responsible.
- A certified certificate from the competent authorities of the country of origin stating that the materials used in manufacturing the product is free from mad cow disease and its causes (if the product contains substances classified as potential substances for transmitting the disease) (BSE/TSE free certificate).
- A copy of the outer and inner cover and the leaflet printed on letterhead paper stamped by the company and signed by the authorized person.
- Detailed Composition Certificate (active & inactive ingredients with their quantities).
- Summary of Product Characteristics (SPC).
Service Fee:
Application: AED 100
Registration of a pharmaceutical product for general sale & OTC Products: AED 5,000
Service completion duration: 45 Working Days
Validity: Five Years after that renewal required.
Pharmaceutical products derived from natural sources
Registration of pharmaceutical products derived from natural sources such as medicinal plants and animals are required registration by the Ministry of health and prevention, UAE.
Documents Required
- Filling out the application form for registering pharmaceutical products derived from natural sources completely signed and stamped by the company.
- Certificate of pharmaceutical product or certificate of free sale of the product issued by the competent authorities in the country of origin certified by the Embassy of the United Arab Emirates.
- Detailed product formulation certificate which includes active and inactive substances along with their quantities and functions of inactive substances.
- A certificate of absence of pig derivatives/ hormones/ steroids.
- Certificate of absence of mad cow disease and its causes in products containing dairy products.
- A copy of the certified contract of the product agency signed between the marketing company and the local agent.
- A valid certificate of registration of the manufacturing company issued by MOHAP-UAE.
- One sample of the product.
- Provide product analysis requirements.
Service Fee:
Application: AED 100
Registration of a pharmaceutical product derived from natural sources: AED 5,000
Service completion duration: 45 Working Days
Validity: Five Years after that renewal required
The time of the registration process can be reduced if the desired products have already been registered by any other recognized regulatory authority (US FDA, EU, TGA, Australia, Japan, MHLW etc.)
Medical Devices Registration
Medical devices should be approved by the Ministry of Health Drug Registration and Control Department in the UAE. Imported medical devices require a pre-approval from the importation of the consignment that is given by the Ministry of health and prevention.
Products also include the accessories that are used in healthcare for the diagnosis, monitoring, prevention, or for the treatment of the illness or handicap excluding drugs. Medical devices can be dental products, consumables, diagnostic imaging, orthopedic and prosthetic products as well as patient aids.
Documents Required
- Filling out the application form of registration completely and to be signed and stamped by the company.
- A copy of the valid registration certificate of the factory.
- A valid certificate of free sale/ registration issued by the competent authorities in the country of origin certified by the Embassy of the United Arab Emirates.
- A copy of the product agency contract signed between the company and the agent.
- Certificate of quality conformity/ marketing authorization, such as EC, 510 (K), PMA as per the classification of the equipment, i.e. Class I, II, III, IV.
- Post-marketing monitoring requirements.
- Product’s information, including: description, formulation, types, sizes, models, accessories, usages, side effects, contradictions, warnings, precautions, usage guidelines, photos of packaging covers, brochures and usage manuals.
- Provide laboratory requirements and analysis, as well as pricing for certain medical equipment.
- Providing one sample, certificate of analysis (as per equipment type), external and internal covers and brochures.
- Acknowledgment of the company that equipment conforms to the specifications as per the Medical Equipment Manual (EC-Declaration of Conformity).
- Safety and efficacy data (for products classified as Class III, IV).
- Special requirements: Certificate of conformity to equipment manufactured from animal products.
Service completion duration: 45 working days
Service fees:
Application: AED 100
Registration of a medical device: 5,000 AED
Validity: Five Years after that renewal required
