The advertising and distribution of Medical Products in the UAE | LegaMart

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QuestionSep 1, 2021 - 5:58

The advertising and distribution of Medical Products in the UAE

The UAE is defined in its constitution as an independent, sovereign, federal state and is referred to thereunder as the ‘Union’. The constitution consists of four (4) parts and ten (10) chapters. To adequately separate the functions between each Emirate and the Union as a whole, the constitution does broadly distinguish between three (3) matters: 1.1 the exclusive Jurisdiction to the Union to issue legislation and to issue executive directive(s) (Category 1); 1.2 the exclusive Jurisdiction to the Union to issue legislating however, each emirate may issue its own implementing (executive) regulations (Category 2); and 1.3 matters that not assigned to the Union, in that case each Emirate is free to issue laws and also implement (Category 3). Accordingly, public health, medical services and UAE media-related matters fall under Category 1. Medical Products in the UAE Article 1 of the Federal Law no. 8 of 2019 on Medical Products, the Profession of Pharmacy and Pharmaceutical Facilities (“Medical Law”) defines the Medical Product as every Medicinal Product (drugs) or Medical Device or Healthcare Product (“Medical Product”). The Medical Law further defines the Medical Device as a medical product that contains any element, instrument, tool, machine, appliance, implant, in vitro reagent, calibrator or a system, including its accessories and operating software, which achieves the intended purpose to be applied in or on humans or animals, without pharmacological, immunological or metabolic effect, and which is manufactured, sold or offered in the following cases (the “Medical Device”): Diagnosis, treatment, cure, relief, monitoring or prevention of illness, injury or disability. Diagnosis, treatment, relief or compensation for anatomical position. Pregnancy control. As a Federal body, the Ministry of Health and Prevention (“MOHAP”) controls the distribution and importation of Medical Products in the UAE and regulates the same in all the Emirates. According to the governing laws and regulations, all Medical Products must be registered and licensed, whether including those registered in other jurisdictions, in order for the MOHAP to be aware of and has ensured that all medical devices which are available to be used and sold in the UAE are safe. The only exception to the above requirement is if a Medical Product is required in an emergency or on short notice, in which case only a health authority or hospital is permitted to order the device(s), and they must complete some formalities. Also, only Medical Products listed as permitted can be imported into the UAE. Therefore, a company wishes to enter the Emirati’s market have two options to import and sell medical devices into the UAE: First Option is to establish a trading company in one of the Emirates and appoint a distributor for the distribution of the products in the UAE. In such a case, it’s worth noting that the recent amendment of the commercial and industrial activities in the Emirate of Dubai, through Dubai Economic Development Department (mainland), allowed 100% foreign ownership of a company holding the following trading and manufacturing activities: Medical, Surgical Articles & Requisites Trading; Medical, Surgical Equipment & Instruments Trading; and Medical and Surgical Devices Manufacturing. However, the above activities are tied to the approval of the MOHAP. Depending on the company’s objectives, it may be worth to consider this option for a company entering the market for the first time, as different contractual legal arrangements can be done in this regard to protect the company’s interest and business. Also, such an option may save costs, labor liabilities, approvals and licensing process, warehouse, scientific office, and other essential requirements of MOHAP. If a company decides to explore this option, it is possible to get a preliminary approval (and reserve the name for such a company), pending an approval from the MOHAP. This preliminary approval and name reservation may last for up to six months. Depending on the company’s objectives, another alterative for this arrangement would be to establish an entity in a free zone. In this case, the company may be able to get a license (with 100% ownership) to import and export however, it may still require to appoint a distributor to distribute the products onshore. That said, it’s worth noting that there are 44 free zones in the UAE so it would be an option to consider which free zone works best for a company. The Second Option is to engage a third party, a local distribution agent or commercial agent, who is already registered with the Ministry of Health for the importation and distribution of medical products. As per the laws and regulations, some entities do have the license to import only and others have the license to both import and distribute. Promotion, marketing and advertising Companies are not permitted to circulate or advertise medical products without obtaining a marketing authorization or exclusive marketing authorization license and approval from the MOHAP as provided by the Medical Law. Also, under Federal Law No. 15/1980 (repealed yet some provisions may still be enforceable) regarding the Regulation of Publications, companies cannot distribute publications without the prior approval from the MOHAP or relevant health ministry. Additionally, the UAE Cabinet Resolution No. 7/2007 regarding Health Advertisement states that anyone that does not have MOHAP approval and an issued license is forbidden from advertising and promoting medical products in the UAE. Pursuant to the Medical Law, the Marketing Authorization Holder is the legal person authorized to market specific medical product within the country and is responsible of all marketing, promotion and follow up aspects of the product within the country, and who must ensure that medical product advertisements and promotions comply with the terms and conditions set out by the MOHAP. Once the approval is granted then that market authorization holder may grant the distributor the right to distribute or sell the Medical Product. As such and pursuant to Article 75 of the Medical Law, distributors in the UAE are prohibited from importing, storing, distributing or selling any Medical Product without getting such an approval from the market authorization holder. The Medical Law and the Ministerial Decision number 1412 of 2017lists the conditions which must be met in order for medical devices to be traded and marketed in the UAE, and which include the following: Local and foreign manufactures of medical devices must be registered with the MOHAP. The prior approval and authorization of the MOHAP must be obtained before announcing, advertising, or promoting a Medical Device. The information and data inserted on the inner and outer label and the leaflet of the medical device must be similar to the information mentioned on the MOH’s marketing authorization of the device. The leaflet must contain information in Arabic or English, except as/when otherwise approved by the MOH. The main laws regulating the advertising and promotion of medical products in the UAE are: Federal Law No. 15/1980 concerned with Publications and Public Matters. Federal Law No. 8/2019 On Medical Products, Profession of Pharmacy and Pharmaceutical Institutions. Federal Law No. 13/2020 concerning Public Health. Federal Decree Law No. 20/2020 on Standards and Specifications. Ministerial Cabinet Decision No. 7/2007 regarding Health Advertisement. Ministerial Cabinet Decision No. 35/2012 regarding Media Content in Businesses. Ministerial Cabinet Decision No. 22/2017 regarding Licensing of Media Activities. Ministerial Cabinet Decision N. 23/2017 regarding Media Content. Ministerial Decision No. 1412/2017 On the Approval of the Code of Practice of the Marketing and Trading of Medical Products. Ministerial Decision No. 430 of 2007 Regulating Health Advertisement. Advertising Guide by the National Media Council In addition, there are other local laws and regulation that apply in each Emirate. For example: Dubai Law Number 6 of 2018 Concerning Dubai Healthcare Authority. Dubai Guidelines for Medical Advertisement Content on Social Media. Abu Dhabi Directive for Health Advertisement. According to Article 39 (1) of the Medical Law, a medical product dispended by a medical prescription cannot be publicized or advertised to the public by any means. However, Article 39 (2) stated that the following are permitted by obtaining the approval of MOHP: Announcing, advertising or promoting a medical product in magazines or scientific resources intended for healthcare practitioners. Announcing, advertising or promoting to the public any non-prescription medicine or healthcare product that has marketing authorization. Failure to get the necessary authorizations for the above may impose a penalty which include, without limitation, a fine not less than One Hundred Thousand United Arab Emirates Dirham (AED100,000.00) and no more than Five Hundred Thousand United Arab Emirates Dirham (AED500,000.00) and imprisonment (up to one year), in addition to any criminal or civil liability that might also be imposed. Abridged Procedure Medical device approvals or clearances from a recognized regulatory authority (US, Canada, Japan, or Europe) can be used to abridge the evaluation process for medical devices to be marketed within the UAE. Evidence of regular approval or clearance of a medical device in the form of certification and relevant, authenticated documents must be submitted. For devices not certified in the US, Canada, Japan, or Europe, these will be examined, and if approved, will be exempted from recognized country certification for Class A devices (those devices which require the lowest level of regulation and pose the lowest level of risk to patients). The classification requirements of medical devices in the UAE are largely influenced by the US Food and Drug Administration’s Devices Regulation. The classification system in the UAE takes into account aspects, such as: the period of time for which a medical device is intended for use. the potential risk involved in its use. the degree of invasiveness on the body. Marketing Authorizations Foreign marketing authorizations are not recognized, and cannot be used, in the UAE. All entities which intend to sell or market their products must obtain the applicable licenses and authorizations from the MOHAP. According to Article 7 of the Medical Law, the medical product marketing authorization applicant must: Appoint one or more qualified persons residing in the country according to a resolution from the Minister. Provide a medical warehouse to carry out the import, storage, distribution and wholesale of marketing approved products. Monitor medical products through distribution channels. Provide the necessary capabilities and systems to comply with the requirements of the medical product marketing authorization. Monitor the performance of the licensed medical product and receive reports from pharmaceutical facilities about its effectiveness, safety, usage and quality. Inform the MOHAP and the concerned authority within 15 days of the date of noticing any unexpected side effects or adverse effects or critical side effects or adverse effects reported or monitored during circulation, or local or global clinical research conducted on the product(s). Monitor procedures of medical product withdrawal. Monitor product patent and manufacture right protection. Licensing and Advertisements’ Fees Regulation No. 430 of 2007 defined the advertisement as “any information about the Medical Product in written, photographic and broadcasting form, in the form of a design, in the form of a product packaging in any of the media whether audio, visual and printed, in the form of posters in public places or in promotional form through the means of personal, technical or electronic messages communication.” Additionally, the Cabinet Resolution No. 44 of 2016 which encompasses fees of the services provided by MOHAP, defines, in Article one, the Health Advertisement as “Any communication process that includes information, data or images that would promote health products, medical devices and health care products, or influence the public by encouraging them to purchase, use or benefit from those products or means, whatever the means or language used for that.” With reference to the Cabinet Resolution No. 44 with regards to licensing health advertisements for a company or an establishment that is not subject to the terms of medical licenses, the below listed fees shall apply on each product and for each language: Licensing health advertisements for a company or an establishment that is not subject to the terms of medical licenses Service Application Fee (AED) Service Fee 1. A printed health advertisement license, for a company or establishment that is not subject to the terms of medical licenses for a month 100 600 For each language and for each product. 2. Renewing the license of a printed health advertisement for a company or institution that is not subject to the conditions of medical licenses for a period of one month 100 600 For each language and for each product 3. A printed health advertisement license, for a company or establishment that is not subject to the terms of medical licenses for one year 100 6,000 For each language and for each product 4. Audible health advertisement license, for a company or institution that is not subject to the terms of medical licenses for a month 100 800 For each language and for each product 5. Renewing the license of an audible health advertisement for a company or institution that is not subject to the conditions of medical licenses for a period of one month 100 800 For each language and for each product 6. Audible health advertisement license, for a company or institution that is not subject to the terms of medical licenses for one year 100 8,000 For each language and for each product 7. An audiovisual health advertisement license for a company or institution that is not subject to the terms of medical licenses for a period of one month 100 900 For each language and for each product 8. Renewing the license of an audiovisual health advertisement for a company or institution that is not subject to the conditions of medical licenses for a period of one month. 100 900 For each language and for each product 9. An audiovisual health advertisement license for a company or institution that is not subject to the terms of medical licenses for a period of one year. 100 9,000 For each language and for each product 10. Certificate to add a price to the Medical Product (if any). — 500 Each time 11. Advertising on websites for one month. 100 1000 For each language and for each content 12. Advertising on websites for one year. 100 3000 For each language and for each content 13. Advertising on social media for one month. 100 1000 For each language, each account and for each content 14. Advertising on social media for one year 100 3000 For each language and for each content 15. Amending the wording of a marketing product 100 500 For each language and for each product Conditions and requirements The advertising license from the MOHAP does not exempt the institution from complying with the requirements imposed by other parties in terms of services and products contained in the material. Documentation must be provided for each product included in the licensed advertisement. Advertisements in languages other than Arabic or English must be legally translated into Arabic or English. One account must be opened for each healthcare institution holding a license from one of the licensing authorities to practice in the healthcare professions in the UAE. One account must be opened for each commercial organization licensed by one of the economic departments in the UAE, provided that their activities are healthcare related Every healthcare institution is permitted to open one account. If more than one account is opened for the same institution, all of its accounts on the program will be freezed. Procedures and steps As listed in the official website of MOHAP, the below steps shall be taken in order to obtain an advertisement authorization Registers in e-services, creates a username and password (if not already done so), and accesses the e-system. Registers (for the first time) in the advertising licensing services program. Logs into the service, completes the online form and attaches the required documents. Pay the application fee (non-refundable). The relevant department shall thereafter the advertisement content and all supportive documents. If no additional documents or amendments are needed, then it shall issue its approval; once approval is granted and received, the company shall proceed with making the payment online, or through the Customer Happiness Centre at the MOHAP. The company can thereafter print the ad design, including the MOHAP approval, along with the start and end dates of the permission/license. Documents required There is no one rule as to which documents that are required in order to evaluate and obtain the license however, in practice, the MOHAP rely heavily on recognized regulatory authorities in developed jurisdictions to decide whether to grant the license. As such, in addition to the below documents that usually the MOHAP require, the company shall consider the ‘Abridged Procedure’ above: valid licenses for services providers/facility. valid registration or classification certificates for any products mentioned in the advertisement. additional documents may be requested depending on the format of the advertising material (such as design, text, image or storyboard). classification certificate for products that do not need registration for which case FDA or CE certificate, and user manual (in Arabic or English) should be submitted. Suspension or Annulment of the Health Advertisement License Following to the approval of the MOHAP and based on the recommendation of the Health Advertisement Department by virtue of a justified report, the advertisement license may be suspended or annulled after it is being issued or becoming in force, in in any or more of the following conditions: if cases or violations were found to be filed against the advertised health product. expiry of the original license of the health product during the advertisement term. if the product is proved to be harmful to the health after the advertisement publishing. if it was discovered that the approval was based on incorrect documents or information. If a report is received from the competent department or the technical committee member(s), confirming that the approval is given by mistake. Further: the advertiser or the advertisement agency shall refrain from publishing the advertisement as soon as they receive the undersecretary’s decision of suspension or annulment. The license number shall be cancelled in case the annulment is final with the word (cancelled) written. For temporary suspension, the expiry date of license shall be changed. The charge shall not be refunded in the following cases: If the suspension or annulment decision is taken due to the applicant’s acts. If the suspension or annulment is done with the knowledge of the applicant or the advertisement agency for reasons related to them. Medical Devices Samples In interpreting Article 42 and 43 of the Medical law, samples of the Medical Devices may be presented to healthcare professionals, provided that the samples are in reasonable quantities, clearly indicated that they are samples, and such samples may not be sold/circulated. Samples must have the phrase “Medical sample free – not for sale” written on it in both Arabic and English. As said above, to avoid most of the hard and costly work, as a company with no experience in the UAE market, its recommended to engage a distribution company. Through the deep experience of Clout’s team members in such a field, strong connections with well-known reliable distributors in the market have been built. As such, we will be able to find the right partner and represent our client in all levels of communications, products profit’s percentage negotiations and contracting with such distributing companies.

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