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Home » Federal Departments » Registration & Drug Control Department » FAQ

Frequently Asking Question

 


 Is the “E-Dirham” used at the Ministry of Health?

Yes. Payment for any license or registration fee can only be made via the Cashier’s office using E-Dirhams.

  

 What are the requirements of personal import of medicines?

Individuals may bring medicine in to the country for their personal use. Up to three months supply of a prescription item can be brought in to the country.

Narcotic items should not be brought in to the country. In exceptional cases they can be brought in to the country but only with prior permission from the director of medicine and pharmacy control who will assess the individual case.

These guidelines relate to medicines brought in by an individual through an airport or border crossing and medicines arriving by post.

N.B: You can get more information about the requirements from the Import of personal medicines via travelers to UAE section at the website

 

What are the requirements to open a private pharmacy in UAE?

To open a private pharmacy in the UAE requires a license from the Registration and Drug Control Department. There are two stages stages:

  1. Preliminary approval of pharmacy establishing.
  2. Final approval of pharmacy establishing.

1. Requirements of Preliminary approval of pharmacy establishment.

  • Application form for establishing a pharmacy (Dhs.10 fees)
  • Report of preliminary approval from inspectorate Unit
  • Copy of rent contract of the Pharmacy to be established.
  • Architectural planning of Pharmacy location from municipality.
  • Authenticated architectural planning of inside pharmacy from the architect / consultants office.
  • Copy of passport of pharmacy owner. (He or she should be UAE citizen).
  • Copy o fnational family ID of Pharmacy owner.
  • Copy of Legal Signature of Pharmacy owner.
  • Three copies of Coloured photograph of Pharmacy owner.
  • Receipt of the Dhs. 100 fee for the preliminary inspection.

2. Requirements Final approval of pharmacy establishing:

  • Final approval report from inspectorate Unit.
  • Copy of Pharmacy location license from municipality.
  • Copy of Pharmacy license from Chamber of commerce and economic.
  • Approval report of civil defence certificate.
  • Detailed information of establishment and list of employees working at (name, Profession, license No.).
  • Attached requirements and certificates for pharmacist in- charge.
  • Receipt of fees (Dh 7,500) for pharmacy license.

 

 

How can I get my pharmacy MOH License?

The following documents must be provided when applying for a MOH Pharmacist or Pharmacy Assistant license (after passing the Pharmacy license exam):

  • Authenticated copy of Pharmacy B.Sc. certificate (4-5 years for pharmacist) or 2-year diploma certificate for Assistant pharmacist.
  • Authenticated copy of the experience certificate / record showing not less than 2 years experience in pharmacy.
  • Employment recommendation letter from pharmaceutical establishment signed and with company stamp.
  • Detailed information of intended place of work showing name of establishment and list of employees working there (name, profession, license No.).
  • Authenticated labour contract from labour office in UAE.
  • Copy of the intended establishment’s license from Chamber of Commerce.
  • Copy of the intended establishment’s license from municipality.
  • Receipt of fee payment (Dh300 for Pharmacist and Dh150 for Assistants- pharmacists)
    Copy of the applicant’s passport.
  • Photographs of the applicant (7).
  • Report of security section.

 

Where can I apply for MOH Pharmacy Exam?

The application for the MOH pharmacy exam is available in the Customer Service Center, M.O.H. Specific days are announced for acceptance of these applications. A schedule of pharmacy exams will be declared in Pharmacy Exam section of this site. (You can check this link to see the schedule of pharmacy exams). There is an exam registration fee of Dhs100 for pharmacist and Dh50 for Pharmacy Assistants.

 

 

What is the Arabic language exam?

As per Articles 2 and 3 of the of Pharmacy Federal Law No. (4) for (1983), fluency in Arabic is required for anyone receiving a license to practice in the private sector. The Arabic language exam is for non- Arabic speaking nationalities, it ensures that licensed pharmacist or assistant is fluent enough and having the basic communication skills to deal with Arabic customers in country. It is a written exam in which the candidate has to translate sentences from English to Arabic and Arabic to English.

 

 

Where can I find the requirements for the registration of medicines?

You can get detailed requirements for the registration of medicines along with criteria of Manufacturer registration from the Drug Registration Section at the website

 

 

How can I get the book of UAE Medicine Prices?

Each year the Registration and Drug Control Department issues the Products Price Book for UAE market, priced Dhs150. Prices are occasionally reviewed e.g. following exchange rate changes; and following the issue of a ministerial degree, the related manufactures are notified.

 

 

 What is a General Sale List product?

General Sale Products are medicinal products that can be sold direct to the public without prescription. However, because they claim to provide some form of therapeutic benefit they are registered. During the registration process the safety of the product is studied and the quality of manufacture and packaging is checked that it is in accordance with International and UAE requirements. General Sale List (GSL) products include dietary supplements, medicated cosmetics, antiseptics and disinfectants, and other products containing non-prescription ingredients but having a therapeutic claim such as many pharmacopoeial formulae.

 

Are there any criteria for Home opathic Product registration?

Yes. The Registration adn Drug Control Department with the office of complementary medicine in the MOH issued the criteria of homeopathic product registration in 2002.

 

 

I own a Veterinary products factory, how can I register this factory?

The Drug Registration Section, Registration and Drug Control Department, does the registration of Veterinary medicine manufactures and veterinary products; however, Ministry of Agriculture and Fisheries control the import of veterinary products. You can get the criteria from the Drug registration section at the website 

  

How can I get the latest UAE approved pharmaceutical products list?

In addition to the UAE price book, this list will be published on this web site in the near future. Please make sure to visit the website regularly.

 

 

 Where shall I report an Adverse Drug reaction (ADR)?

Many serious adverse reactions to medicines are quite rare. Many are not easily predicted and some are the result of unusual interactions with other medicines or food. An adverse reaction may also be due to a product defect. These types of reaction only becomes clear after a product has been approved for use in the market. Therefore, monitoring the safety of medicine in the market is essential. The Registration and Drug Control department believes it is the responsibility of all health professionals in UAE to report adverse drug reactions to the RDC department. This is especially true for “serious” ADR’s. These are classed as reactions that lead to hospital admission, require patient resuscitation or lead to death.

 

 

 Are there any UAE Guidelines of stability and bioequivalence for pharmaceutical products?

Yes. In 2001, the registration and Drug Control Department issued Guidelines of Bio-equivalence testing for generic Pharmaceutical Products and Guidelines of stability testing for Pharmaceutical Products. You can get it from the Good Practice Guidelines Section at the website

 

 

Are there any UAE Guidelines of Good Manufacturing Practice (GMP) for  pharmaceutical manufacturers?

Yes. The Registration and Drug Control Department has issued a UAE Guide to Good manufacturing practice (GMP) for manufacturing of medical products. It based upon the latest WHO, European and Pharmaceutical Inspection Convention guidelines and is consistent with the US FDA’s current GMP requirements.  You can get it from the Good Practice Guidelines Section at the website 

 

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