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Pharmaceutical Registration UAE

Pharmaceutical Registration Services in UAE

The pharmaceutical market in the UAE is growing rapidly. Pharmaceutical companies wishing to import and distribute pharmaceutical products in the UAE must register their company. The Pharmaceuticals Act regulates the import, storage, distribution, sale, marketing and export of all drugs for humans and animals. In Dubai / UAE there is a full registration process for all types of products. Most of the products in Dubai are registered with the Dubai municipality, but all pharmaceutical products and devices are named by the United Arab Emirates Minister of Health and Prevention.

All companies must register before the production process. The authorities in Dubai are very concerned about public health and safety. Documentation and all legal proceedings may take longer. This is the reason for the rigorous and extensive registration process. Companies must pass every safety test. Once registered, the company produces pharmaceutical products and exports them to other countries.

The Requirement for Market Presence in the UAE

Companies must be legally registered in the UAE and registered with the Ministry of Health to import or distribute pharmaceutical products. The activities under a trade license must match with the products imported into the UAE.

Another option is to hire a local distributor or sales representative who is registered with the Ministry of Health to import medicines. The agent can then register the product on behalf of the importer. In both cases, the importer receives expert assistance from a product registration advisor in Dubai, United Arab Emirates, which eases the complexity of the whole process like us here at MAD Middle East. Our team of professional consultants will help you through this complicated process in a hassle-free manner.

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Requirements to Register Pharmaceutical Products in Dubai

Companies must meet all requirements to successfully register their products. If there are incomplete documents or requirements, your pharmaceutical product registration application will be rejected. Here are some of the requirements which are required for pharmaceutical product registration in Dubai:

  • Applications can be made in English or Arabic. Marketing Authorization for pharmaceutical products in the United Arab Emirates (UAE)
  • Product data must be registered with a trading name.
  • Applicants must have a medical business approved by the Ministry of Health.
  • Current company license from the Department of Drug Control.
  • Samples of the applicant's external labels, internal labels and product inserts are required.
  • Applicants must submit a CD with the product in JPEG format.
  • All the required documents must be finalized and submitted with the application.
  • Registration is valid for five years, after which the deadline must be renewed.
  • As we've already told you, getting approval from the Minister of Health can take some time.

This is the most important point to know if you are planning to register a pharmaceutical product in Dubai / UAE. MOH registered companies have the license to import pharmaceutical products in Dubai / UAE.

Process of Pharmaceutical Product Registration

The pharmaceutical product registration process must be carried out through the Ministry of Health's electronic service portal, where the UAE product registration advisor will create a company username and password for product registration. The following are the key steps in the process:

  • Applicant to follow up with Pharmacological Analysis Section of at the Drug Department
  • Pay the official fee
  • Deliberation by technical committees over the application
  • Submit the product registration application
  • The committee examines the applications and informs their decision to the companies
  • Complete the requirement and submit through e-services
  • A technical committee will approve registration after re-deliberating the submission
  • The application gets forward to the competent ministerial committee
  • Ministry issues certificates of registration of products if all the requirements and conditions are met

Product registration certificates issued by the Ministry are valid for five years from the date of approval by the Commission. For local pharmaceutical products, this certificate is valid for one year from the date of issue.

Why MAD Middlefor Pharmaceutical Product Registration in Dubai, UAE

All pharmaceutical products imported and manufactured in the UAE must be registered with the Ministry of Health before being generally sold. Product registration in the UAE is mandatory for all pharmaceutical companies to ensure that consumers receive products that are safe for consumption. The product registration process at the Ministry of Health ensures that pharmaceutical products do not contain harmful substances. To carry out the product registration process in the UAE, pharmaceutical companies must meet several legal requirements.

In practice, it is impossible for every company to fully understand the terms and conditions. Also, it is difficult for importers to walk around government departments to get approval for their products. This is where our business consultants at MAD Middle East comes into play for product registration in Dubai. Our professional business consultant effectively handles all processes related to product registration in the UAE, from registration to the issuance of certificates.