Our knowledge, experience, and expertise are now available on the go.
We are proud to announce the launch of My Tamimi App, a convenient new tool for anyone with an interest in the legal sector, from law students to General Counsel.Find out more
The main principle according to the above Law is to implement the registration of all medicines with the Ministry of Health (MOH) in order to be legally circulated in the UAE market. Article 65 of the Federal Law No. 4 of 1983 concerning the Profession of Pharmacy and Pharmaceutical institutions, states the following:
“No imported medicine, pharmaceutical preparation or children’s food should be put for circulation before being registered in the Ministry. Any medical company, which plans the marketing of its production in the country, should be registered in the Ministry”.
Based on the above article, it is clear that the general rule is not to allow the import of any medicine unless it is registered in the UAE. However, the question arises as to whether there are any exceptions and does the above rule apply in all situations? According to the Law there are no exceptions, as imported drugs are only permitted if they have been registered with the MOH.
However, practices by pharmaceutical companies have proven that there are indeed exceptions and in some cases, they have been able to import unregistered drugs. The MOH has enabled a process to import unregistered medicines in exceptional circumstances, namely:
Accordingly, some hospitals which are affiliated with Abu Dhabi Health Authority or Dubai Health Authority are allowed to import unregistered drugs into the UAE subject to approval from the MOH. The application to import unregistered drugs in such circumstances must be detailed and specific in order to gain approval. As such, the quantity of the imported medicines shall be limited to the hospital capacity and the number of existing and/or expected patients and under no circumstances are they able to supply non-registered medication outside the hospital. The MOH has the full authority to refuse an application to import unregistered drugs, amend the quantities, or issue a conditional or unconditional acceptance to such request and quantities.
The MOH have set a number of conditions with regards to the import of unregistered drugs:
Any hospital/entity which imports unregistered medicine is liable for such import and use of that medicine. This legal obligation is referenced by the condition above requiring a Letter of Undertaking from the hospital to use the product and bear all responsibility of such use. The sanctions stated in Law No. 4 of 1983 concerning the Profession of Pharmacy and Pharmaceutical Institutions shall be applied in case of any violation of the terms.
As with the general rule applying to all medicines, the law also prohibits importers of unregistered drugs from promoting any medicine in any way as per Article 92 of the Pharmacy Law which states: “Publication of pamphlets or books and advertising through newspapers, radio and TV for any medicine, pharmaceutical preparation or children’s food to be determined by the Minister shall not be permitted”. Conversely, the MOH welcomes medicine and disease awareness programs subject to their approval regardless of whether the drug is registered.
As with most rules, the above shows that whilst the law prohibits the importation of unregistered drugs, there are instances in which exceptions can be made.
Disclaimer: This chat service should not be relied upon as a substitute for professional advice which takes account of your specific circumstances and any changes in the law and practice. No warranty is made as to the accuracy or completeness of the information provided via this service and no liability is accepted by Al Tamimi & Company Limited, its affiliates, partners or employees for any loss arising as a result of reliance upon the information provided.
Kindly accept the disclaimer to proceed to a live chat.
Thank you for your inquiry. We will connect you to one of our agents now.
Thank you for your interest in working with Al Tamimi & Company. Please click here to view our latest job openings.