Medicinal Product Regulation and Product Liability in the United Arab Emirates: An Overview
Federal Law No. 4 of 1983 (Pharmaceuticals Law 1983) governs and applies to:
· Pharmaceutical establishments.
· Import, manufacture, and distribution of pharmaceutical products.
Federal Law No. 14 of 1995 (Counter Measures against Narcotic Drugs and Psychotropic substances) regulates the import of medicines into the UAE.
Federal Law No. 5 of 1984 deals with regulating the licensing and registration of physicians, pharmacists and other healthcare specialists within both public and private healthcare establishments.
Federal Laws No. 7 of 1975 and No. 2 of 1996 define the specific requirements for the establishment and licensing of public and private medical laboratories, clinics and hospitals in the UAE.
The regulatory authorities for pharmaceuticals in UAE are the:
· UAE Ministry of Health (MOH).
· Health Authority-Abu Dhabi (HAAD).
· Dubai Health Authority (DHA).
· Emirates Health Authority (EHA).
These authorities monitor the licensing of pharmacists and pharmacies, the registration of pharmaceuticals and advertising guidelines for drugs.
The MOH formulates nationwide health policies and regulates the healthcare market in the Northern Emirates. The healthcare system of the country’s two largest Emirates, Dubai and Abu Dhabi, are governed by DHA and HAAD respectively.
There did not exist a separate entity to regulate the healthcare system in the Northern Emirates prior to 2009. Therefore, the healthcare system of these Emirates fell under the ambit of the MOH before the formation of the Emirates Health Authority vide the Federal Law Number 13 of 2009. This institution was primarily organized with the view to facilitate inter-departmental co-operation between the authorities. EHA is based in Sharjah.
2. Briefly, outline how biologicals and combination products are regulated in your jurisdiction.
All biological and combination products (therapeutic and diagnostic products that combine drugs, devices, and/or biological products) are heavily regulated by the UAE Ministry of Health (MOH).
A drug must be registered by the Ministry of Health before importing the same within the UAE market (Pharmaceuticals Law 1983).
The Pharmaceuticals Law 1983 also prohibits anyone from engaging in the pharmaceutical profession without a valid license. "Pharmaceutical profession" is defined as the preparation, composition, separation, manufacturing, packaging, selling or distribution of any medicine or pharmaceutical preparation for the prevention or cure of illnesses in human beings or animals (Article 1, Pharmaceuticals Law 1983).
Pharmacists who practice without a valid license or in breach of its conditions face disciplinary measures (Refer Question 8).
Imprisonment of up to one year and/or a fine may be imposed on anyone submitting false documents or data to gain a license; or otherwise practicing as a pharmacist illegally (Articles 83 and 84, Pharmaceuticals Law 1983).
Other offence(s) including adulterating or imitating substances attract imprisonment of up to three years and/or fines of up to AED10,000 (Article 86, Pharmaceuticals Law 1983).
Pharmacies, medical store(s) and pharmaceuticals factories require registration and a valid license issued by the Ministry of Health (the MOH).
Only licensed medical stores and pharmacies are permitted to import and distribute pharmaceutical products. Applicants for a pharmacy or a medical store licence must be UAE nationals.
The Pharmaceuticals law requires any medical company planning to market its products in the UAE to register with the MOH on the recommendation of the Medicine Companies and Pricing Committee. (see Question 9).
Registration requirements vary based on the types of products being marketed; and are determined by the classification committee of the MOH on the basis of the information submitted by the applicant.
See Question 8 for compliance powers in relation to all types of pharmaceutical establishments as well as the penalties for non-compliance.
The Registration Guidelines issued by the MOH govern the registration and regulation of medical devices. The Registration Guidelines are modelled on international standards for rules and regulations, in particular, those issued by the US Food and Drug Administration and contained in the EU Medical Device Directive (Directive 93/42/EEC concerning medical devices).
Medical device companies intending to export their products into the UAE must appoint a local representative or distributor who has a licensed medical store.
The Registration Guidelines provide for four different classes of medical device for the purposes of registration, based on risk factors including, for example, how long the device is intended to be used for and how invasive it will be.
The appointed local representative or distributor must submit a medical device registration application form to the MOH's drug control department along with the prescribed documents, including ,(http://www.cpd-pharma.ae/downloads/4-Medical%20Device/check.pdf) :
- Regulatory Approval (certificates of regulatory approval and clearance to manufacture, import or export the device from the export country);
- risk assessment reports;
- regulatory status of the device in other countries;
- details of the device including instructions, warnings, and contraindications;
- labeling information;
- declaration of conformity to safety standards and other data on safety and clinical studies;
- manufacturing process; and
- other miscellaneous requirements
If the application is approved, a registration number authorising the import and sale of the device is given, which is valid for five years.
Diagnostics services must submit an application to the Health Regulation Department (HRD) for a licence to establish a new diagnostic centre.
There is currently no specific regulation of health IT issues and mobile medical applications.
The national healthcare system in the UAE is divided into public and private healthcare providers.
Public healthcare services are operated and regulated by government regulatory authorities such as the:
- Ministry of Health (MOH).
- Dubai Health Authority.
- Health Authority Abu Dhabi.
- Abu Dhabi Health Services Company (SEHA).
These authorities work in partnership with foreign healthcare organisations for the day to day running of hospitals and clinics throughout the UAE.
Private healthcare providers are non-government run hospitals and clinics providing specialty or multi-speciality healthcare.
A mandatory health insurance model funds the national healthcare system in the UAE.
The main sources of funding in Abu Dhabi are:
· Employers or sponsors: employers are responsible for insuring their staff. Those who are not in employment must be funded by a sponsor.
· Government: the single-payer health insurance scheme for nationals is funded by the government, administered by the national health insurance company and regulated by the MOH.
· Individuals: individuals pay out-of-pocket payments and insurance premiums.
- Persons under 65 years of age;
- UAE Nationals;
- UAE Residents;
- Direct family members who are listed as the dependants;
- Unmarried children under 18 years of age and children under 23 years of age who are on a student visa.
7. What is the process for this? How do the health providers/insurers claim back the costs? Is there a maximum cost which will be reimbursed? Is it limited to citizens or available to any user? Is there an equivalent to the prescription charge?
The cost of a medical product may be funded by the state in public healthcare facilities or on grounds of charity.
Process and Procedures followed by Health Providers and Insurers, Maximum Costs that can be Reimbursed, Circumstances where such costs can be reimbursed, Products that will be paid and allowable v/s products that will not be allowed
- Legal and ethical requirement: pharmacies must adhere to Pharmacies Law 1983 and MOH code of conduct.
- Guidelines on Personnel:
- Guidelines on Environment and Equipment
- Documents Required
- Dispensary requirements
The Pharmaceuticals Law 1983 sets out the requirements for establishing factories for the manufacture of medicines. No-one is allowed to open such a factory a without obtaining a licence.
Applications for a medical products factory licence must be made to the licensing committee of the UAE Ministry of Health (MOH) along with (www.haad.ae/HAAD/LinkClick.aspx?fileticket=SDq8N_2802s%3D&tabid=1159):
· The memorandum or articles of association of the factory including names of the shareholders.
· Details of the factory manager's licence to practise as a pharmacist and of all the licensed pharmacists who will work at the factory.
· Other documents as determined by the MOH.
Conditions imposed on licences include those relating to (Articles 47 to 57, Pharmaceuticals Law 1983):
· Site location and premises.
· Mandatory requirements and maintenance.
· Supervision of the factory and laboratories.
· Storage of raw or dangerous materials and manufactured preparations.
Restrictions on foreign applicants
Foreign applicants can have a maximum shareholding of 49% in a medical products factory.
The MOH can collect the fees for licences and registration made on condition that the fees collected do not exceed AED10,000 for the factory licence and AED 2,000 for other licences and records.
The level of fees is determined by the MOH at the recommendation of the licensing committee.
Monitoring compliance and imposing penalties
Articles 77 to 88 of the Pharmaceuticals Law 1983 govern compliance powers in relation to all types of pharmaceutical establishments including medical products factories.
Inspectors are appointed by the Minister of Justice, Islamic Affairs and Awqaf in consultation with the Minister of Health and Prevention, MOH (Article 77, Pharmaceuticals Law 1983), to monitor pharmaceutical establishments that are suspected of operating without a valid licence or in breach of any other rules.
Inspectors can confiscate any substances found on the premises and refer the case to the competent authority (in this case, the licensing committee of the MOH) to investigate suspected violations of the Pharmaceuticals Law 1983 or other relevant rules.
A hearing is held and the case decided by the committee whether or not the alleged offender turns up. The licensing committee then decides on the penalty, with the approval of the UAE Ministry of Health (MOH).
The Licensing Committee of the MOH can impose disciplinary measures on licensed pharmacists who commit offences as follows (Article 79, Pharmaceuticals Law 1983):
· Suspension for up to one year.
· Withdrawal of the licence.
The Licensing Committee can impose similar measures on owners (Article 79, Pharmaceuticals Law 1983):
· Closure of the pharmaceutical establishment for up to 60 days.
· If the offence is repeated, the establishment can be closed for several periods not exceeding six months in total in the same year.
· The licence can be withdrawn.
The offender can appeal the decision within 15 days from notification to the Minister of Health and Prevention, who must decide on the appeal within 30 days. In all cases, punishments involving suspension from work, withdrawal of a licence or closure of a facility cannot be imposed before the expiry of the period prescribed for submitting the appeal or deciding on it.
Further punishments of fines or imprisonment can be imposed on factory managers, owners or practitioners (Articles 83 to 87, Pharmaceuticals Law 1983) (see Question 2).]
11. Marketing: Regulatory, Compliance and Authorization Process involved in Marketing of Medicinal Products in Dubai and UAE
Any medical company planning to market its products in the UAE must be registered by the UAE Ministry of Health (MOH). The process is covered in Chapter 10 of the Pharmaceuticals Law 1983. Both, the company and the drug must be authorised. Only entities that are themselves registered with the Ministry of Health can apply for product registration.
Article 1 (9) of the Pharmaceuticals Law 1983 defines ‘medicine’ as ‘any medicine that contains one or more element for treatment or protection of human beings and animals.
Authorisation conditions are governed by Chapter 6 of the Pharmaceutical Law 1983.
To register a medical store or pharmacy with the MOH, the following must be submitted online at the MOH website:
· A valid copy of the commercial licence and/or tenancy agreement.
· Details of all commercial and medical pharmacies owned by the marketing group and a table showing the entire group structure.
· Licence of the pharmacist who would manage the pharmacy with their issue and expiry dates, and contact details of the marketing group.
· Owner’s passport/other ID.
· Internal layout of the proposed location.
· Initial inspection fees of AED 100.
· Engineering drawing of the location.
· Planning map for the pharmacy location approved by the municipality plus photos.
· Details of the pharmacist appointed or transferred from another firm to be in-charge of the pharmacy.
· Licensing fees of AED 7500.
Key stages and timing
The key stages and timing are:
· Submission of the application online with the required documents.
· Inspection of the composition and ingredients of drugs to be marketed.
· Compliance checking.
The MOH generally conducts inspections in pharmacies. However, the DHA and HAAD also has the jurisdiction to conduct such inspections in the Emirate of Dubai and Abu Dhabi, respectively.
The initial response time for licence applications is about one week.
Fees depend on the type and composition of the medicine to be marketed, advertising guidelines and media type.
Period of authorisation and renewals
The authorisation is valid for one year and must be renewed 90 days before expiry.
The licence is renewed for a period of one year after fulfilling the renewal requirements for the re-licensing assessment
The licence is automatically cancelled in these circumstances (Article 25):
· Transfer of the ownership of the pharmacy to another person.
· Closure of the pharmacy for six consecutive months without excuse acceptable to the Licensing Committee.
· Failure to commence work in the pharmacy within six months from the date of issue of licence.
Monitoring compliance and imposing penalties
Imported medicines and pharmaceutical products cannot be put into circulation without being registered by the MOH (Article 65, Pharmaceuticals law 1983).
In order for a company to import pharmaceuticals and medical devices into the UAE, a company must:
· Both incorporate in the UAE and obtain a medical importation and distribution licence from the Ministry.
· Engage a local agent or distributor, who is already registered with the Ministry, to import the pharmaceuticals and medical devices on their behalf.
Any medicine or pharmaceutical preparation which undergoes a change to its constituents must be re-registered (Article 66, Pharmaceuticals law 1983).
Medical products must also comply with strict packaging requirements (see Question 18).
Inspectors appointed by the MOH to the Medical Empowerment and Compliance Department are authorized to inspect any pharmaceutical establishment or store suspected to be dealing in drugs, medicines, and poisons without a
““Неправильное лечение является обычно следствием недостаточных профессиональных знаний практикующего врача, вследствие небрежности или недостаточных усилий”.”
На пути становления, когда Объединенные Арабские Эмираты начали превращаться в страну потрясающих небоскребов, разнообразных бизнес…
Medicinal Product Regulation and Product Liability in the United Arab Emirates: An Overview (Part II of II)
In Part I, we discussed technical aspects pertaining to Pharmaceutical Product Regulations applicable in…
Статьи по Теме
Врачебная халатность в Дубае ОАЭ
Medicinal Product Regulation and Product Liability in the United Arab Emirates: An Overview (Part II of II)
““Неправильное лечение является обычно следствием недостаточных профессиональных знаний практикующего врача, вследствие небрежности или недостаточных усилий”.” На пути становления, когда Объединенные Арабские Эмираты начали превращаться в страну потрясающих небоскребов, разнообразных бизнес…
Medicinal Product Regulation and Product Liability in the United Arab Emirates: An Overview (Part II of II) In Part I, we discussed technical aspects pertaining to Pharmaceutical Product Regulations applicable in…