How to Register Pharmaceutical Products in Dubai?
UAE’s pharmaceutical market is growing at a fast pace. The UAE presently imports 85% and 90% of its pharmaceutical products. Pharmaceutical companies seeking to import and distribute pharmaceutical products in the UAE to register their firms.
There is a complete process of registration of all types of products in Dubai/UAE. Most of the products in Dubai are registered by the Dubai municipality, but all pharmaceutical products and devices by the Minister of Health and Prevention, UAE. All the companies have to register themselves before even the manufacturing process. Dubai authority is very concerned with the health and safety of the people. It may take more time in documentation and all the legal processes. That is the reason behind the strict and vast procedure of registration. The companies have to go to every safety test.
Process of Pharmaceutical Product Registration
Pharmaceutical product registration in the UAE involves a systematic process facilitated through the Ministry of Health’s e-services portal. Initially, UAE product registration consultants will assist companies in creating login credentials for the portal. The following steps outline the essential procedure:
- Submission of the product registration application.
- Payment of the official fee.
- Review by technical committees.
- Forwarding of the application to the competent ministerial committee.
- Examination of applications by the committee, with decisions communicated to the companies.
- Follow-up with the Pharmacological Analysis Section of the Drug Department by the applicant.
- Completion of requirements and submission through e-services.
- Approval of registration by a technical committee upon re-deliberation of the submission.
- Issuance of product registration certificates by the Ministry if all conditions and requirements.
It’s important to note that the Ministry-issued product registration certificates are valid for five years from the date of committee approval. However, for locally manufactured pharmaceutical products, the certificate validity is one year from the date of issuance.
What are the requirements to Register Pharmaceutical Products in Dubai?
The companies have to fulfill all the requirements to register their products successfully. If any documents or requirements are incomplete, their request for the registration of the pharmaceutical products. Let’s see some of the essential requirements:
These are the important points you need to know if you are planning to register pharmaceutical products in Dubai/UAE. A registered company by MOH will have the permit to import pharmaceutical products into Dubai/UAE.
- The application can in English or Arabic. Marketing authorization for pharmaceutical Products in the United Arab Emirates (UAE)
- All the documents must do and submitted with the application.
- The registration will be valid for five years, after completing the period.
- As we have told it you, it is a long process, it may take a lot of time to get approval by the Minister of Health.
- The product details and registered with a trade name.
- Shelf-life of the product with Storage conditions.
- Food Labeling and Packaging Regulations
- The applicant should have a medical store licensed by the Ministry of Health.
- A valid company permit from the drug control department.
- The applicant’s Samples of the outer label, inner label, and insert of the products.
- The applicants must submit a CD of the product in JPEG format.
Our experienced team is well acquainted with the whole process of registration of the products in Dubai/UAE. We can handle the complete procedure from beginning to end. Our trustworthy consultancy team will manage it, so you need not go anywhere else. We are available 24/7 at your service. Feel free to contact us on Contact Us or drop us a mail at info@msz.ae