Marketing, Manufacturing, Packaging & Labeling Advertising
The key facts about marketing, manufacturing, packaging & labeling, advertising in the UAE. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
Under the Pharmaceutical Law, all applications for marketing authorization must be made through the Ministry of Health (MOH).
The authorization requirements include the submission of the company details including copies of trade licenses; lease agreement; and the license of the pharmacist in charge.
The key stages are: submission of the application process; inspection of the compounds contained in the drugs to be marketed; and compliance review. The MOH (and, as deemed appropriate, HAAD and DHA) conduct inspections of applicant pharmacies.
The initial response to an application is normally around one week.
2. What is the authorization process for the marketing of generic versions of these products?
Medical device approvals or clearances from a recognized regulatory authority can be used to abridge the evaluation process for generic medical products 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 1 devices (those devices which require the lowest level of regulation and pose the lowest level of risk to patients).
3. What are the typical fees for marketing approval?
The licensing fee is AED7,500, and the initial inspection fee is AED100. Other fees are contingent on the type of medication to be marketed, advertising guidelines, and media type.
4. What is the period of authorization and the renewal process?
The license is valid for one year, and must be submitted for renewal 90 days before its expiry.
5. What are the requirements, if any, for post-approval pharmacovigilance?
Doctors, pharmacists, and other healthcare providers must report any adverse effects they suspect may be caused by a medical product. A multi-disciplinary advisory committee reviews reported cases, and based on the recommendations made, the Ministry of Health (MOH) either takes disciplinary action against the manufacturer or seller of the medication or advises the manufacturer to change the information relating to its medication and its adverse effects.
In tandem with these rights, the MOH can implement track and trace and recall plans for medication.
6. Are foreign marketing authorizations recognized?
Market authorizations from foreign jurisdictions 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 Ministry of Health (MOH).
A foreign company hire a local distributor or agent already licensed by the MOH.
Furthermore, foreign applicants can have a maximum shareholding of 49% in a medical products factory.
7. Is parallel import of medicines or devices allowed?
Parallel imports are not allowed.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
There are no specific anti-bribery or anti-corruption laws in the UAE. However, the relevant part of Federal Law No. 3 of 1987 (Criminal Code) prohibits gifts or things of value to both public and non-public officials.
Under the Health Insurance Law and the Medical Liability Law, insurance companies, third-party administrators and healthcare providers are barred from paying or receiving commissions, financial or other incentives, or profiting from referring patients to medical testing.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
The Pharmaceuticals Law sets out the requirements for the manufacture of medicines. Without a license ordained by the Ministry of Health, no one is allowed to open such a factory.
Along with an application, the following documentation must also be submitted:
- The memorandum or articles of association of the factory including names of the shareholders;
- Details of the factory manager’s license to practice as a pharmacist and of all the licensed pharmacists who will work at the factory; and
- other documents as determined by the MOH.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?
The manufacturing requirements set out by law are certainly respectful of all available Ministry of Health, federal and international guidelines and best-practices such as the Good Manufacturing Practices published by the U.S. Food and Drug Administration, the European Medicines Agency, World Health Organization and the scientific committees attached to them.
11. What is the inspection regime for manufacturing facilities?
The UAE Ministry of Health and Prevention offers inspection to ensure compliance with GMPs as a business service – an applicant may file a request for an inspection of a pharmaceutical manufacturing establishment. This service is part of a quality assurance system that ensures the quality of pharmaceutical and medical products by controlling all activities associated with Good Storage Practices and Good Clinical Practices.
The procedural steps to invite inspection onto one’s manufacturing facilities are outlined below:
- an application for a field visit to the manufacturing site must be submitted
- the application will be referred to the inspector concerned
- the inspector will subsequently conduct a field visit and inspection of the manufacturing site and prepare the inspection report
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Yes, manufacturing facilities are open for inspection by foreign or third-party inspectors.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
The Pharmaceutical Law stipulates the requirements for packaging and labelling of medication and the various health authorities in the UAE implement and monitor these.
14. What information must be included in medicine and device labeling?
Under the Pharmaceutical Law, packaging and labelling must contain the:
Name of the medication or pharmaceutical preparation, as well as its registration number with the MOH.
- Components of the medication, and their amounts.
- Expiry date of the medication.
- Name of the factory producing the medication.
- Directions and methods for use of the medication, as well as warnings (including potential adverse effects and contraindications).
15. What additional information may be included in labeling and packaging?
The information must be made available in both Arabic and English.
16. What items may not be included in labeling and packaging?
The Pharmaceutical Law deals with this question in terms of what should be included in labelling or on packaging, rather than what should not be. Moreover, it can be discerned that the MOH’s guidance on labelling of medicines identifies the following as statements or wording that should not be used:
- promotional information;
- negative statements – the usage of solely positive statements are permitted to avoid ambiguity;
- medical terminology (unless there exists concrete evidence from user testing that it is understood); and
- abbreviations of the medicine’s name
The guidance also advises on the use of statements about conditions, indications, speed of action, formulation and population groups for OTC medicines, in order to prevent them from being misleading.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
All medical and pharmaceutical advertising must obtain governmental pre-approval before publication. Comparative-product advertising is not usually permitted and can result in criminal liability for defamation/harm to reputation under the laws of the UAE).
In general, advertisements cannot violate public morals, decency, UAE customs or Islamic values and traditions.
Medical advertising cannot be false, deceptive, or intentionally misrepresent the quality or type of medical treatment or product presented.
Additionally, advertising cannot mislead potential patients about the efficacy of certain medication treatments, therapies or protocols nor state that these will not have potential side effects.
Sales incentives to healthcare workers are not permitted by any medical or healthcare advertisement.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
The various regulatory authorities stipulate that medicine can only be dispensed in accordance with the applicable medical prescription, by a licensed and registered doctor or pharmacist.
An applicant can seek authorization from the Ministry of Health (MOH) and the applicable Emirate-level authority to sell medication online, and mail order medication may be regulated by both UAE Customs (under the GCC Common Customs Law, effective 2002) as well as the MOH (pursuant to the Pharmaceutical Law).
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?
Internet advertising of medical and pharmaceutical products requires prior governmental approval.
Advertising for telemedicine companies [must] clearly state what services they are authorized or licensed to provide. Advertisements geared towards children are prohibited.
20. May medicines and devices be advertised or sold directly to consumers?
Yes, OTC medicines and devices that fall under the minimal risk class can be advertised and sold directly to consumers.
21. How is compliance monitored?
Articles 77 to 88 of the Pharmaceuticals Law 1983 govern compliance powers with respect to all types of pharmaceutical establishments; this includes medical products factories.
As per Article 77 of the Pharmaceuticals Law, compliance inspectors are appointed by the Minister of Justice, Islamic Affairs and Awqaf in consultation with the Minister of Health and Prevention, with the pre-ordained roles of monitoring pharmaceutical establishments that are suspected of operating without a valid license or in breach of any other rules.
22. What are the potential penalties for noncompliance?
Inspectors are empowered to confiscate any substances found on the premises, and refer the case to the competent authority (in this case, the licensing committee of the Ministry of Health) to further investigations on suspected violations of the Pharmaceuticals Law.
Subsequently, a hearing might be held and the case shall be decided by the committee, irrespective of whether the alleged offender turns up. The licensing committee then decides on a penalty, with the approval of the UAE Ministry of Health.