UAE Drug Regulations Flashcards

Which UAE regulation covers the requirement for pharmacovigilance reporting by healthcare professionals?

Answer: MOHAP's National Pharmacovigilance Centre requires reporting of adverse drug reactions (ADRs)

MOHAP's National Pharmacovigilance Centre operates the UAE's ADR reporting system; healthcare professionals including pharmacists are required to report suspected adverse drug reactions.

What is the maximum legal supply for a prescription-only medicine dispensed in a UAE pharmacy without a repeat prescription?

Answer: A one-month supply unless specified otherwise by the prescriber for chronic conditions

UAE dispensing standards generally limit prescription-only medicine supply to one month per dispensing event unless the prescriber specifies otherwise for chronic disease management.

Which UAE legal requirement applies to the labelling of dispensed medications?

Answer: Labels must include patient name, drug name, dose, frequency, prescriber name, dispensing date, and pharmacy details

UAE MOHAP and DHA standards mandate comprehensive labelling of dispensed medications to ensure patient safety, traceability, and clear administration instructions.

Under UAE law, what is required for the import of personal medication quantities exceeding one month's supply?

Answer: Prior approval from MOHAP and documentation such as a medical certificate

Importing personal medications exceeding one month's supply into the UAE requires prior MOHAP approval and supporting documentation to prevent drug trafficking under the guise of personal use.

What is the role of the UAE Emirates Authority for Standardisation and Metrology (ESMA) in pharmaceuticals?

Answer: ESMA sets technical standards for pharmaceutical product quality, packaging, and labelling in the UAE

ESMA develops and enforces UAE national standards for pharmaceutical products including quality, safety, packaging, and labelling to complement MOHAP's registration requirements.

A pharmaceutical company wishes to conduct a clinical trial in the UAE. Which regulatory approval is required?

Answer: MOHAP approval and ethics committee approval from the research institution

Clinical trials in the UAE require both MOHAP regulatory approval and ethics committee clearance from the research institution to ensure participant protection and scientific integrity.