How to Register Pharmaceutical Products With UAE Ministry of Health?
The UAE is a significant market for the sale of pharmaceutical drugs where imports outnumber local manufacturing. Numerous foreign pharmaceutical companies have been reaping the benefits of the lucrative UAE market, which warrants the need for ensuring strict safety standards for the benefit of the consumers. In the UAE, the import and distribution of pharmaceutical products are regulated by the Ministry of Health and Prevention (MOHAP). Importers and manufacturers of pharmaceutical products, therefore, are required to register with MOHAP to sell their products anywhere in the UAE.
In this article, we will look at the process and requirements of registering pharmaceutical products with MOHAP, to permit their importation into and sale within the UAE.
The Requirement for Market Presence in the UAE
The companies must be legally incorporated in the UAE and registered with the Ministry of Health to import or distribute pharmaceutical products. The activities in the trade license must match with the products that are being imported into the UAE.
Alternatively, the company can engage a local distributor or commercial agent who has already registered with the Ministry of Health for importing pharmaceutical products. The agent can then register the products on behalf of the importer. In either case, the importers get expert assistance from product registration consultants in Dubai, UAE who will ease the complexities of the entire procedure.
Process of Pharmaceutical Product Registration
The process of registering pharmaceutical products must be performed through the e-services portal of the Ministry of Health, where the UAE product registration consultants will create user name and password for the companies. The following are the essential steps involved in the process:
- Submit the product registration application
- Pay the official fee
- Deliberation by technical committees over the application
- The application gets forwarded to the competent ministerial committee
- The committee examines the applications and informs their decision to the companies
- Applicant to follow up with Pharmacological Analysis Section of at the Drug Department
- Complete the requirements and submit through e-services
- A technical committee will approve registration after re-deliberating the submission
- Ministry issues certificates of registration of products if all the conditions and requirements are met
The product registration certificates issued by the Ministry is valid for five years effective from the date of committee approval. For locally manufactured pharmaceutical products, the certificate is valid for one year effective from the date of issuance.
Conditions and Requirements for Registration
Registering pharmaceutical products in the UAE is not an easy task. It requires extensive documentation and several requirements to be met by the companies. The procedure can be simplified with the assistance of reputed product registration consultants in Dubai, UAE. The consultants will guide the companies about the conditions and requirements of pharmaceutical product registration with the Ministry of Health. The following is a list of information required:
- Certificate of the product or certificate of free sales issued by the competent authority in the country of origin
- The certificate should contain the product brand name and formulation of the product containing active and inactive substances
- Name and address of the company that has the right to marketing/ manufacturing
- Information on the product’s shelf life and storage conditions
- Confirmation that the product is marketed in the country of origin for at least two years
- Three Samples of the product
- Copy of internal leaflet certified by competent authorities in the country of origin
- Certificate of Product analysis of the samples
- Halal certificate issued by certified authorities and organizations
In addition to these documents, the companies should provide a statement confirming that the product is free from hormones, heavy metals, antibiotics, steroids, pig derivatives or any other substances that have a harmful impact on human beings biologically and behaviourally. If the product contains any animal-derived substances, the companies should mention the animal type. If alcohol is used mention the percentage of alcohol and state why it is used.
Hire the Best Product Registration Consultants in Dubai, UAE
All the pharmaceutical products imported into and manufactured in the UAE must be registered with the Ministry of health before its general sale. Performing product registration in the UAE is mandatory for all pharmaceutical companies to ensure that consumers receive safe products for consumption. The product registration process with the Ministry of Health makes sure that pharmaceutical products do not contain any harmful substance. Conducting the process of product registration in the UAE requires pharmaceutical companies to go through a series of legal requirements.
It is not practically possible for every company to get a full grasp of the conditions and requirements. Also, it is hard for the importers to run around the government departments for getting approval for their products. This is where product registration consultants in Dubai, such as Jitendra Intellectual Property (JIP) becomes relevant for the businesses. JIP effectively handles all the processes related to UAE product registration, right from the application to the certificate issuance.