Guidelines on Importing Medical Devices and Drugs in UAE

Panadol, paracetamol, antibiotics or anti-allergies are some medicines which 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 importing registered and unregistered drugs in the country to sell or market it 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 a detailed FAQs as below:

1. What are the legislation governing the importation of medical devices and drugs? Also, which governmental authority overlooks the registration process of medical devices and drugs and pharmaceutical companies?

The principal legislation governing the imports, sale and manufacturing of pharmaceuticals and medical devices in UAE is Pharmacy Law. There are several other legislations which 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:

• • Federal Law Number 14 of 1995 concerning the counter-measures and combatting the Narcotics and Psychotropic Substances and its recent amendment under Federal Law Number 8 of 2016;
  • Federal Law Number 5 of 1984 regulating the licensing and registration requirements of professionals of pharmaceuticals such as pharmacists or physicians;
  • Federal Law Number 1 of 1979 regarding the organisation of industrial affairs where mainland Pharmaceuticals companies must appoint a local service agent;
  • Federal Law Number 2 of 2015 on the Commercial Companies Law
  • Dubai Health Authority Community Pharmacy License and Pharmaceuticals practices Guide 2013.

Ministry of Health is the main authority regulating the licensing of Pharmaceutical companies, medical devices and drugs within 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 issue guidelines specifically for concerned Emirate on the detailed procedure for registering and licensing the medical devices and pharmaceuticals.

1. What are different alternatives available to import medical devices and drugs?

There are two alternatives available wherein the desired can import, sell and market medical devices and drugs within UAE. These alternatives are as follows:

1. • Incorporate a company: companies who are willing to import medical devices and drugs within UAE can establish a mainland company with a UAE national shareholder holding 51% of the shareholding. The companies should, at all times, ensure that the trade license and permits to perform such activities are in place and should be associated with the importation of pharmaceuticals products. It is pertinent to note that the activities undertaken by the company should be properly highlighted on the trade license. Otherwise, the company will not be allowed to perform such activity;
   • Enter into agreement with distributor or agent: under this article, the companies who are not willing to establish their presence can sign an agency agreement with the local agent and register the pharmaceuticals and devices within the country. The agent will act on the behalf of company to import, distribute and market the pharmacy products.

1. Is there a process to register the company importing medical devices and pharmaceutical drugs?

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 warehouse 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 Ministry. The foregoing committee reviews the file and all other applications and determines which companies must be given license for warehouse 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.

1. What procedure must be followed to register the medical devices and pharmaceuticals?

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 are 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 regards 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 fulfil 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 which must be submitted irrespective of the classification which is as follows:

1. Letters of regulatory approval;
2. Clearance certificate to manufacture, sell and distribute the product from exporting country;
3. Certified free sale certificate.

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 labelling. 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.

1. Is it necessary to import only registered medical devices and pharmaceuticals in UAE? If not, what is the procedure to import unregistered medical devices and pharmaceuticals?

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:

1. Medicines required in emergency situation necessary for the patient’s life;
2. Drugs which are not readily available in the market and used for treating rare medical conditions such as heart or cancer patients;

• Drugs not yet regulated by the Ministry;

1. Any drug which is required by any health institutions or government or semi-government hospital registered with HAAD or DHA or even Ministry of Interior;
2. Any registered pharmaceutical which is not easily available officially;
3. Drugs whose registration was cancelled by the Ministry due to lack of demand;

• Demand raised by any health institution or government or semi-government hospital for an unregistered narcotic or psychotropic drug.

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:

1. Trade License of the company (importer);
2. A purchase order from the hospital;
3. Justification letter from the medical consultant;
4. Declaration from the hospital;
5. The license of the distributor or importer.

Further, the Ministry imposes certain restrictions regarding the importation of such medicines as follow:

• Only the registered agent can submit the application, or it can be submitted by a licensed medical store or licensed distributor;
• It is important that the medicine being imported in UAE must be registered in the country of origin. The process will be fairly simpler if the medicine is registered in any GCC countries, the US or Europe;
• An application should be submitted by the head of the hospital or medical director of the hospital, who require such medicine;
• An undertaking letter to bear the responsibility of such medicine.

Awatif Mohammad Shoqi Advocates & Legal Consultancy is a full-service law firm in UAE committed to delivering sound judgment to its clients on their most difficult and important matters.