How to Register Pharmaceutical Products in UAE

Some medicines like paracetamol, panadol, antibiotics or anti-allergies are types you see in general stores and medical stores. The medicines need approvals from the Ministry of Health and Prevention before importing, selling or marketing in the United Arab Emirates.

The pharmaceutical industry is profitable which means there has been a lot of interest from local and multinational companies. Ensuring that these companies adhere to the right protocols and sell approved medications. The Ministry of Health and Prevention vets in the companies and products priority. Products on markets are registered with the Ministry of Health and Prevention first or you would get hefty fines and license suspension.

Federal Law Number 4 of 1983 related to Pharmaceutical Profession and Institutions are referred to as the Pharmacy Law claiming that no pharmaceutical drug shall be circulated until the product gets registered with the Ministry of Health. Various prerequisites are involved to import registered and unregistered drugs in the country to sell or to market in clinics or hospitals.

The prerequisites of the pharmaceutical market in the UAE

To start the business you have to get prior permission from the regulating bodies. The governing bodies ensure several factors including quality. To sell, import and market a pharmaceutical medicine you have to get approval from the Ministry of Health and Prevention.

To get eligible for the process, the company applying must be legally incorporated in the UAE. They also need to be registered with the Ministry of Health. When you are not planning on registering the company, the other option is to engage a commercial agent or a local distributor as they are already registered with the Ministry of Health to import the pharmaceutical products.

Agents then need to register the products on your behalf and save your time. The agents get a nominal fee for doing this.

The Ministry of Health and Prevention claims the following conditions to be met before applying.

1. The marketing authorization holder companies need to be registered with the Ministry of Health and Prevention as they could register their products.

2. Applicants should have the medical warehouse licensed by the Ministry of Health and require a valid license.

The Pharmaceutical Product Registration in the UAE

The pharmaceutical product registration in the United Arab Emirates can be done online through the Ministry of Health and Prevention website.

The website implements a registration process that needs you to insert your email address and password. This enables you to access the electronic portal of registration of the pharmaceutical products as well in future.

The Process

• You have to register your account on the Ministry of Health and Prevention Website.
• Then open the document with the pharmaceutical product registration and fill in the necessary details.
• You have to pay the dues to meet all needs of the application.
• After the application submission, technical committees will deliberate and forward their recommendations to the competent ministerial committee.
• Applicants can follow up with the Pharmacological Analysis Section at the Drug Department.
• The company then completes all needs and submit them on e-portal.
• The technical committee approves the registration after re-deliberating the submission.
• When the conditions are met the Ministry issues the registration of products.

The registration certificate issued by the Ministry is valid for five years. Starting date of the certificate will be from the date of the committee approval. The manufactured pharmaceutical products certificate is valid only for a year and has to be renewed.

Need for the Registration of Pharmaceutical Products in UAE

As the pharma business impacts the health of citizens, countries have a rigorous process to register the products. Most often people outsource the registration work to reputable consultants and that’s how the successful approval has been exponentially increased. Blackswan Business Setup Services provide the registration of several products in the United Arab Emirates.

Documents needed to successfully register the products

• The certificate of the product or the certificate of free sales is issued by the competent authority of the origin country.
• The certificate should include the brand name and the formulation of the product.
• The company address must attain rights for marketing and manufacturing.
• Precise information of products like shelf life and storage conditions are to be met.
• Letter confirming the product has been sold for two years in the country of origin.
• The three authentic samples of the product with the Certificate of Product Analysis of them.
• Have the approved internet leaflet certified by the competent authority.
• The product should be Halal, the Halal certificate is needed from the regulated authority.

These are the official requirements but the regulating body may need additional documents and certificates to complete the registration process. The products should be free from heavy metals, hormones, antibiotics, steroids, pig derivatives and substances that prove harmful to health. These minute details can make a difference in having your product registered or not.

We are aware of the complete process of registering pharmaceutical products because of their experience in the United Arab Emirates market. We have registered a large number of products successfully in Dubai and UAE. You can fill up the form below and get a quote.