Headache? Perhaps you’d take 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. Although these conventional 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 products to ensure that the drugs we buy over the counter are compliant with UAE standards, thus ensuring our safe consumption. The present article discusses the law surrounding Registration and Importation of Pharmaceuticals in Dubai and the UAE.
So is the registration of over the counter drugs as simple as the process of procuring and consuming them? Under Federal Law Number 4 of 1983 (the Pharmacy Law), all drugs must be registered with the Ministry of Health 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 an application – and as the criteria on which such a decision arrives at is unavailable to the public, it appears as though any entity applying for the registration of a product shall have less guidance to follow 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 of medicines. Further regulations (such as the Dubai Health Authority’s Community Pharmacy Licensure and Pharmaceutical Practices Guide of February 2013) (the Pharmacy Guide) focuses 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 in the UAE must adhere without exception. Owing to the degree of discretion aﬀorded to the Ministry of Health, few hospitals that operated in conjunction with the Health Authorities of Dubai and Abu Dhabi can 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 employed 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 to eﬀect successful registration. This 'little guidance,' 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 under 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”. The Pharmacy Guide goes 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”. That said, any person who has spent considerable time browsing the drugstore shelves for a speciﬁc product will attest, today’s market consists of a huge variety of healthcare products – not just the standard medicines discussed earlier and prescription drugs. There are also 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 Sales List (the list consisting of all registered pharmaceutical substances in the UAE) includes “Dietary supplements, medicated cosmetics, antiseptic and disinfectants and miscellaneous products which contain 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 Health 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 applicant 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.
Continue reading other articles on Pharmaceuticals, Laws governing pharmaceuticals, medicines, medical devices, diagnostics, FDA and over the counter sale of drugs in Dubai and UAE, product liability, packaging and labeling requirements, import and export of medicines in UAE on this blog managed by STA's team of pharmaceutical lawyers in Dubai and rest of the UAE.
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