Panadol, paracetamol, antibiotics, or anti-allergies are some medicines that are often lying around your house in case of emergencies or are readily available over the counter in any nearby pharmacy.
Even though these medicines are not controlled, yet require several approvals from the Ministry of Health (MOH) prior to importing, selling, and marketing them in UAE. MOH governs the importation of controlled drugs and medical devices for all the Emirates. The Top Lawyers in Dubai through this article will discuss the procedure by which a company can import medical devices or drugs in the UAE with an intention to sell the same to hospitals or clinics.
Federal Law Number 4 of 1983 regarding the Pharmaceutical Profession and Institutions (the Pharmacy Law) provides that no medicine or pharmaceutical drug shall be circulated unless the product is registered with MOH. There are several prerequisites to be considered prior to import registered and unregistered drugs in the country to sell or market them in hospitals or clinics. Best Lawyers in Dubai have simplified the procedure of introducing drugs and medical devices, registering the pharmaceutical company and the drug through detailed FAQs as below:
The principal legislation governing the imports, sale, and manufacturing of pharmaceuticals and medical devices in UAE is Pharmacy Law. There are several other legislations that simultaneously govern the procedure of licensing the pharmaceutical companies, registration of medical devices and drugs, importation procedure for registered drugs, and others. The legislation are as follows:
The Ministry of Health is the main authority regulating the licensing of Pharmaceutical companies, medical devices, and drugs within the UAE. MOH also lays down rules and regulations for the implementation of health care facilities. In addition to this, each Emirate has established local health regulators who supervise the healthcare and pharmaceutical sector within the specific jurisdiction. For instance, Dubai Health Authority (DHA) regulates within the Emirate of Dubai, where, Health Authority Abu Dhabi (HAAD) governs in Abu Dhabi.
The regulators above monitor the registration of pharmaceutical companies, medical devices, and drugs. MOH promulgate Federal laws, whereas, the regulator’s issued guidelines specifically for concerned Emirate on the detailed procedure for registering and licensing the medical devices and pharmaceuticals.
There are two alternatives available wherein the desired can import, sell and market medical devices and drugs within UAE. These alternatives are as follows:
Article 1 of the Pharmacy Law, prohibits anyone from manufacturing, packaging, selling, distributing any medical device or drug without a proper license from the Ministry of Health. The law obliges the company importing pharmaceuticals and medical devices to establish their company within UAE and obtain a pharmaceutical importation license.
According to the Pharmacy Law, the first step in order to import pharmaceuticals and medical devices within UAE is to obtain a license for warehouses in the country, as mentioned under Article 47 of the Law. MOH has laid down certain prerequisites for specific conditions of the warehouse including the size, location, storage of pharmaceuticals and devices, and appointment of a licensed pharmacist who will oversee the goods being imported.
Upon receiving the license application for the warehouse, the MOH will inspect the place in order to ensure that the warehouse meets the requirements set out by the law and the guidelines laid down by the competent authority. The license will be granted to the facility if the MOH is satisfied with the warehouse. The Ministry offers a service where they inspect the warehouse prior to the lease agreement being signed as this will allow the company to wait and understand if the Ministry approves the warehouse.
Once the inspection is completed, and the entity has received MOH approval, the next step for the company is to submit a file along with all relevant supporting documents including, proof of inspection, details pertaining to the licensed pharmacist, and information about the categories of pharmaceuticals and medicals devices that will be imported by the company. Ministry will review the concerned file and holds the sole discretion to accept or reject the application. If accepted, the file will be transferred to the final committee of the Ministry. The foregoing committee reviews the file and all other applications and determines which companies must be given licenses for warehouses for importing pharmaceuticals and medical devices. The committee sits four times a year to review all the applications. The permits so granted by the Committee make ask for several amendments in the warehouse of the pharmaceuticals or devices that will be imported.
Article 65 of the Pharmacy Law, restricts the importation of any medicine, Medical device or children’s food without proper registration from the Ministry. Therefore, even if the company has importing license from the Ministry, they are not allowed to sell or distribute the medical devices or drugs unless the same is registered with the Ministry.
The company in order to register the medical devices or drugs must submit an application either for the medical device or for the drug as the case may be, to the Ministry for their perusal and approval. The Pharmacy Law obliges the manufacturer from his country of origin along with the local authorized representative to submit the application. The foreign manufacturer must explicitly authorize the local representative to act on his behalf in the UAE or with regard to his obligations and responsibilities. In such a case, the local authorized representative can act as the distributor, or there can be a separate authorized representative. However, if the distributor is the local authorized representative as well, the distributor must produce evidence stating his abilities to fulfill the responsibilities required by the Ministry. The representative is completely responsible for the product being distributed and the market plan for managing the complaints if registered. The representative is obliged to adhere to the guidelines mentioned by the Ministry post distributing the product in the market.
The law requires the application for registration of a product in a certain format that is the application must entail information pertaining to the medical device or the drug along with the details of the manufacturer, the local representative, and the distributor of the product. There are certain classifications in which a medical device may be registered that is class I, II, III or IV, depending upon its use. The requisite documents for each classification are different. However, there are several documents that must be submitted irrespective of the classification which is as follows:
Apart from the aforementioned documents, the applicant must submit an audit plan, details concerning the site for manufacturing products, information regarding the usage of the product, precautions while using the product, post-marketing strategies, safety information, and labeling. Upon receiving the application, the Ministry will review the application and the documents attached therein. They may further seek additional documents from the applicant if required.
Although the Pharmacy Law obliges the company willing to import medical devices or drugs within the country to register the products prior to selling or distributing, however, there is an exception to the general rule. The exception allows the importation of unregistered medical products to seek specific approvals from the competent Ministry. Nevertheless, under the following exceptional cases the importer can import unregistered medicines:
Thus, the procedure for registration of such medicine will be costly considering its rare consumption. Through this system, the distributors and patients can seek medical treatment regardless of non-registration.
Since these medicines are used for rare medical conditions, a justification letter from a medical consultant or a professional is utmost. The letter must entail the reasons for importing such medicine and using the same instead of an alternative. Importantly, the importation of an unregistered medical device or a product can only be through a licensed medical store. For seeking Ministry’s approval to import unregistered medicine, the applicant must submit the following documents along with the application form:
Further, the Ministry imposes certain restrictions regarding the importation of such medicines as follow:
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