Pharmacovigilance obligations for foreign MAHs in the UAE

Getting a medicine registered in the United Arab Emirates is only the start. Once a product is on the market, the Marketing Authorisation Holder carries continuing safety duties. This guide explains what pharmacovigilance (PV) means for a foreign Marketing Authorisation Holder in the UAE, covering the people, the documentation, and the reports the authority expects you to maintain.

Why pharmacovigilance matters for a MAH

A Marketing Authorisation Holder (MAH) must operate a pharmacovigilance system that collects and records all reports of suspected adverse drug reactions, whether those reports come from healthcare professionals or from consumers. This is not an optional add-on to registration. It is an ongoing legal responsibility that runs for as long as your product is authorised in the UAE market.

For a foreign manufacturer, the practical challenge is that these duties must be met locally, with people and processes that the authority can identify, contact, and inspect. A safety system that exists only at head office abroad is not enough on its own.

The people: QPPV and Local Contact Person

At the centre of the system is the Qualified Person for Pharmacovigilance (QPPV). The MAH must appoint a QPPV who is resident in the UAE. The QPPV is the individual accountable for the establishment and maintenance of the pharmacovigilance system, and the authority looks to this person as the responsible point of contact for product safety.

QPPV qualifications

The QPPV should hold suitable credentials and experience, namely:

• At least a bachelor's degree in pharmacy or medicine
• Basic training in epidemiology and biostatistics
• Relevant pharmacovigilance experience

When the QPPV sits abroad

Some foreign MAHs prefer to keep their QPPV at a central global office. If the QPPV is based outside the UAE, the MAH must designate a UAE-based Local Contact Person for Pharmacovigilance (LCPPV). The LCPPV gives the authority a local point of contact while the wider safety function continues to be led by the QPPV.

The documentation: the PV System Master File

The pharmacovigilance system is documented in a Pharmacovigilance System Master File (PSMF). The PSMF is the reference description of how your safety system is organised and how it operates. It is supported by:

• Standard operating procedures (SOPs) that define how safety tasks are carried out
• A risk-management system
• A signal-detection process
• An audit and inspection plan

Together these elements show that your system is not just a document but a working arrangement that can detect, assess, and act on safety information in a structured way.

Ongoing obligations after authorisation

Once your product is on the market, pharmacovigilance becomes a continuous cycle of collecting, assessing, and reporting safety information. Two ongoing duties sit at the core of this work.

Adverse-reaction reporting

The MAH reports suspected adverse reactions to the authority through Individual Case Safety Reports (ICSRs). These capture individual cases of suspected harm so that emerging safety issues can be tracked at a population level.

Periodic safety reports

Alongside case-level reporting, the MAH submits periodic safety reports (PSUR / PBRER). These pull together the accumulated safety experience of the product over a defined period, allowing the authority to review the overall benefit and risk profile rather than isolated cases.

The authority follows UAE Good Vigilance Practice (GVP) guidelines, which are now under the EDE / MOHAP. Because the structure and timing of these submissions are set by the authority, confirm the current requirements before you build your reporting calendar.

This guide is general information, not regulatory or legal advice. UAE requirements are actively changing during the MOHAP to EDE transition; confirm current rules with the relevant authority or your regulatory partner before acting. Related: pharmacovigilance services.