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Registration and Importation of Pharmaceuticals in UAE

Published on : 21 May 2015
Author(s):Sunil Thacker

xHeadache? Perhaps you’d take a paracetamol. Upset stomach? Maybe an indigestion pill. Cold or flu? You might consider anti-congestant medication. In the United Arab Emirates, such pharmaceuticals are easy to come by, with the majority of people likely to have a supply already to hand in their purses or bathroom cabinets. Yet although these common medications are not controlled in the same manner as prescription drugs, various approvals are required with regards to the importation, sale and marketing of such produce in order to ensure that the drugs we buy over the counter are compliant with UAE standards, thus ensuring our safe consumption.

So is the registration of over the counter drugs as simple as the process of procuring and consuming them? Pursuant to Federal Law Number 4 of 1983 (the Pharmacy Law), all drugs must be registered with the Ministry of Health in order to be lawfully sold within the UAE. Article 65 goes so far as to specify that this includes imported pharmaceuticals, whether or not they have been approved and registered in their country of origin. The decision as to whether to register such products shall be at the discretion of the Ministry of Health following application – and as the criteria on which such a decision will be made is unavailable to the public it appears as though any entity applying for the registration of a product shall have very little guidance to follow in order to increase the likelihood of success. The fact that only Articles 63-67 of the Pharmacy Law deal with the actual registration of pharmaceuticals further supports the view that manufacturers are largely unguided in their pursuit of registration, with supplementary regulations (such as the Dubai Health Authority’s Community Pharmacy Licensure and Pharmaceutical Practices Guide of February 2013) (the Pharmacy Guide) focusing primarily on the licensing and protocol of institutions and professionals as opposed to the industry’s products.

A reading of the applicable section of the Pharmacy Law would give the understanding that Ministry of Health registration is a strict condition to which all pharmaceutical products sold within the UAE must adhere without exception. Yet owing to the degree of discretion afforded to the Ministry of Health, certain hospitals operated in conjunction with the Health Authorities of Dubai and Abu Dhabi are able to apply for permission to import unregistered drugs in prescribed circumstances. These include emergency medicines used for the immediate preservation of life, drugs which are currently unavailable in hospitals (such as specific medicines used in the treatment of cancer) and those which have not yet been awarded Ministry approval, and specialist narcotic and psychotropic substances. However any approval granted with regards to an unregistered drug will be qualified with the condition that the product is not distributed outside of the institution in question, and will be quantified proportionally to the hospital capacity. The authority of the Ministry in this regards is such that permission may be withdrawn immediately in the event of a breach of any of the case-specific regulations and conditions by the licensed institute.

We have considered that there is little guidance available with regards to the content and scientific criteria a product must meet in order to effect successful registration. This, it would seem, gives rise to another question: what is a “medicine” within the meaning of the applicable law? How is a potential importer supposed to know whether or not his product will require registering pursuant to Article 65? The Pharmacy Law defines medicine as being “any medicine that contains one or more element for treatment or protection of human beings and animals”, with the Pharmacy Guide going further to specify “Medicine/medication/pharmaceutical drug shall mean or can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease”. But as any person who has spent considerable time browsing the drug store shelves for a specific product will attest, today’s market consists of a huge variety of healthcare products – not just the common medicines discussed earlier and prescription drugs, but various supplements, nutritional enhancements, and cosmetics which may not come under the definition of “medicine” per se. Do such items fall within the remit of the Pharmacy Law and its requirements?

To this effect the Ministry of Health produced Circular Number 20 of 2001 (the Circular), as issued by the Director of the Drug Control Department. Herein it is specified that the General Sale List (the list consisting of all registered pharmaceutical substances in the UAE) includes “Dietary supplements, medicated cosmetics, antiseptic and disinfectants and miscellaneous products which contains pharmaceutical ingredients and / or a medical claim and cannot be classified as medicines”. And despite the fact that it still does not suggest any composition criteria, the Circular goes some way towards laying out the various administrative requirements that a product should meet in order to obtain a successfully registered status. Most importantly, it is specified that the application form (available from the Technical Affairs Section or downloaded from the Ministry of Health website, in either the Arabic or English language) must be accompanied by the relevant Certificate of Pharmaceutical Product (CPP) as per the World Heath Organization Certification Scheme, or a Free Sale Certificate (FSC). This must have been issued by competent lawful authorities in the product’s country of origin, it must additionally have been authenticated by the Foreign Affairs section of the UAE or any GCC embassy in the country of origin. Moreover a successful application must be accompanied by 3 (three) samples of the pharmaceutical in its final packaging, along with a certificate of analysis for the given batch of samples

Further to this the application for registration will require the submission of various supporting documentation on the letterhead of the company requesting the registration of the product (complete with the company logo, stamp and authorized signature), which includes but is not limited to:

–A statement from the company declaring that the product is free from any hormones, heavy metals, antibiotics, steroids, derivatives of pork and any natural and  chemical ingredients with the potential to cause harmful effects to humans. When submitting a product containing an ingredient derived from animal source the    company must go so far as to specify the kind of animal and specifications of the part extracted from it, and must additionally clearly note the percentage of alcohol (if       any), together with an explanation as to why such ingredients were incorporated;

  • Halal certificate issued by recognizable organizations and authorities;
  • Details of a medical storage facility licensed by the Ministry of Health (as per the Circular Number 1 of 2006);
  • Samples of the outer label, inner label and insert of the product;
  • and CD containing artwork (outer, inner label and insert) of the product.

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