What Are The Requirements For Pharmaceutical Products To Be Registered In The UAE?
The UAE’s economy is vast and competitive. It is a dynamic market growing exponentially, and the government’s farsighted vision has improved the healthcare sector, with infrastructure being the main focus.
The UAE has taken center stage in the healthcare space, and the country’s pharmaceutical industry is rapidly evolving as one of the most robust globally. The UAE has become a regional pharma hub with government regulations and legal reforms.
Pharmaceuticals play a pivotal role in delivering effective patient care services. According to a report, the UAE’s pharma market is anticipated to grow by 27% between 2021 and 2025. The local pharma market is also expected to reach $4.7 billion by 2025.
Several pharma giants eye the UAE market to expand their services. However, like in any other country, there are specific rules and regulations that companies need to adhere to.
In addition, there are specific requirements that companies need to fulfill for pharmaceutical product registration in UAE.
Businesses need permission to sell, import, and market a product from the regulating bodies, which is, in this case, the Ministry of Health and Prevention.
Let’s understand it further.
The Prerequisites
- The Marketing Authorization Holder companies must be registered with the Ministry of Health and Prevention before registering their products.
- Companies must have a medical warehouse licensed by the Ministry of Health and need to have a valid license.
Steps To Follow
- Register your account on the Ministry of Health and Prevention (MOHAP).
- Fill in all the necessary details of the pharma product, pay the fees, proceed further, and submit the application.
- Technical committees deliberate and, after that, forward their recommendations to the competent ministerial committee.
- The company must follow up with the Pharmacological Analysis Section at the Drug Department.
- Company then needs to submit all the requirements after completion.
- The technical committee gives the go-ahead to the product registration after re-deliberating the submission.
- The Ministry issues certificates (5 years validity) for the registration of products once all the criteria/conditions are met.
- Certificates for locally manufactured pharma products are only valid for one year.
Conditions And Requirements For Pharmaceutical Product Registration In UAE
- A pharmaceutical product/ free sale certificate issued by the authority from the country of origin must have relevant information about the product’s brand name with a formulation containing active and inactive substances.
- Name and company address entitled with marketing/manufacturing rights.
- Information on the product’s shelf life and storage conditions
- A confirmation letter that the product has been sold for two years in the country of origin.
- Three authentic product samples.
- Approved internet leaflet certified by the competent authority.
- Leaflet stamped by the company and signed by the authority.
- A halal certificate issued by certified authorities/ organizations.
- Company confirmation that the product is free of hormones, heavy metals, antibiotics, steroids, pig derivatives and other natural or chemical substances that harm humans.
- In case the animal derivatives are used, the company must mention the animal type, the part extracted, and the percentage of alcohol (if it was used and why).
The UAE’s economy is vast and competitive. It is a dynamic market growing exponentially, and the government’s farsighted vision has improved the healthcare sector, with infrastructure being the main focus.
The UAE has taken center stage in the healthcare space, and the country’s pharmaceutical industry is rapidly evolving as one of the most robust globally. The UAE has become a regional pharma hub with government regulations and legal reforms.
Pharmaceuticals play a pivotal role in delivering effective patient care services. According to a report, the UAE’s pharma market is anticipated to grow by 27% between 2021 and 2025. The local pharma market is also expected to reach $4.7 billion by 2025.
Several pharma giants eye the UAE market to expand their services. However, like in any other country, there are specific rules and regulations that companies need to adhere to. In addition, there are specific requirements that companies need to fulfill for pharmaceutical product registration in the UAE.
Businesses need permission to sell, import, and market a product from the regulating bodies, which is, in this case, the Ministry of Health and Prevention.
Understanding the Regulatory Landscape
The UAE’s regulatory landscape for pharmaceuticals is designed to ensure the highest standards of safety, efficacy, and quality for all medicinal products. The Ministry of Health and Prevention (MOHAP) is the principal regulatory authority overseeing the registration, importation, and distribution of pharmaceuticals in the country.
The Prerequisites
Before registering their products, companies must ensure compliance with several prerequisites:
- Marketing Authorization Holder Registration: Companies must register as Marketing Authorization Holders with MOHAP.
- Medical Warehouse License: Companies must possess a medical warehouse licensed by MOHAP with a valid operating license.
Steps To Follow
To successfully register a pharmaceutical product in the UAE, companies need to follow these detailed steps:
- Account Registration: Register an account on the Ministry of Health and Prevention (MOHAP) portal.
- Application Submission: Fill in all necessary details of the pharmaceutical product, pay the required fees, and submit the application.
- Technical Committee Review: Technical committees review the application and forward their recommendations to the ministerial committee.
- Follow-Up: Companies must follow up with the Pharmacological Analysis Section at the Drug Department.
- Submission Completion: Submit all required documents and information to the technical committee.
- Approval: After re-deliberation, the technical committee approves the product registration.
- Certificate Issuance: MOHAP issues certificates valid for five years (one year for locally manufactured products).
Conditions And Requirements For Pharmaceutical Product Registration In UAE
To register a pharmaceutical product in the UAE, companies must meet several conditions and requirements:
- Pharmaceutical Product/Free Sale Certificate: Issued by the authority from the country of origin, detailing the product’s brand name and formulation.
- Company Information: Name and address of the company with marketing/manufacturing rights.
- Product Details: Information on the product’s shelf life and storage conditions.
- Sales Confirmation: A letter confirming that the product has been sold for two years in the country of origin.
- Product Samples: Three authentic product samples.
- Approved Leaflet: An internet leaflet certified by the competent authority and stamped by the company.
- Halal Certificate: Issued by certified authorities/organizations.
- Product Safety Confirmation: Company confirmation that the product is free from harmful substances such as hormones, heavy metals, antibiotics, steroids, pig derivatives, and other natural or chemical substances.
- Animal Derivatives Information: If animal derivatives are used, the company must specify the animal type, extracted part, and percentage of alcohol used.
Conclusion
Pharma Solutions is a leading UAE-based pharmaceutical platform, well-acquainted with the pharmaceutical products registration in UAE.
Pharma Solutions has a team of experienced professionals possessing extensive knowledge in facilitating licensing, commercialization, marketing, and the distribution of FDA/EMA-approved innovative pharmaceuticals in the UAE.
With commercial activities in 14+ countries of the GCC and MENA region, Pharma Solutions aims to provide effective solutions to businesses wanting to expand their reach and be a part of a rapidly growing economy.
Connect with us today and know more about our services.
