What are Controlled Medicines?

Controlled medicines are administered to patients of acute and chronic diseases in accordance with modern medical practice.

Majority of medicines which are used worldwide are available in community pharmacies and hospitals in the UAE.

However, narcotic, psychotropic and other controlled drugs/medicines of class A or B are neither freely available in the UAE, nor can they be freely imported into the country. They fall under the controlled/restricted items’ category.

Non-Registered Medicines that come under the classification of controlled medicines cannot be imported into the UAE unless registered with MOH.

Rules on Importing of Controlled Medicines

Only importers with a Licence to Deal in Controlled Drugs, or a Licence to Possess Controlled Drugs, or an authorisation under the Act (e.g. a registered medical practitioner) are eligible to apply for import licences.

Licensing is statutorily required.

Importing Controlled Medicines (As an Organization)

To import controlled medicines in the UAE, you are required to receive a permit from Ministry of Health and Prevention. Ministry of Health is the main authority regulating the licensing of Pharmaceutical companies, medical devices and drugs within UAE.

Federal Law Number 4 of 1983 regarding the Pharmaceutical Profession and Institutions (the Pharmacy Law) provides that no medicine or pharmaceutical drug shall be circulated unless the product is registered with MOH.

Certain conditions and requirements must be met before an organization can begin filing an application for import:

  1. Product Analysis Certificate
  2. Product Registration Certificate
  3. Pharmacist License
  4. Institution License
  5. Local Purchase Request
  6. Medical clearance from customs authority and approval by inspectors
  7. License for Warehouse -MOH Approved & Inspected
  8. Letters of Regulatory Approval
  9. Clearance to manufacture, sell and distribute the product from exporting country

Once an organization meets all the above requirements and submits the application along with supporting documents and proof of inspection, the Ministry of Health and Prevention will review the concerned file and hold the sole discretion to accept or reject the application.

Importing Controlled Medicines (As an Individual)

Although there are restrictions to bringing controlled medicines into the UAE, the UAE has considered that expats are likely to bring controlled medicines inside the country if they have medical conditions. The country has made rules and regulations regarding this case.

The Pharmacy Federal Law No. 4 of 1983 and Narcotic Law 14 of 1995 are created to control the importation of medicines such as psychotropic drugs, narcotics and controlled medications.

Documentations required to bring controlled medications into the UAE:

  1. Authenticated permit or certificate from origin country health authority
  2. Valid Medical Prescriptions
  3. Custom Clearance

 

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