MAH Representation & Product Management
Your products. A coordinated Main role.
An applicable Main Pharmaceutical Establishment appointment for manufacturers, MAHs and product owners, supporting product registration, regulatory maintenance, pharmacovigilance and ongoing product lifecycle responsibilities in the UAE.
Discuss this serviceWho it is for
For manufacturers, MAHs and product owners assessing a formal Main Pharmaceutical Establishment arrangement and the division of regulatory, operational and commercial responsibilities around their products.
Two commercial operating approaches
Customer-Led Commercial Operations
The customer leads its commercial team, customer relationships and purchase orders. HubPharma performs the agreed formal Main role and any separately agreed fulfilment or delivery activities.
HubPharma-Supported Commercial Operations
The customer may request broader order coordination and operational execution alongside the Main role. Commercial authority, invoice issuance, collections and credit risk are defined case by case in the agreement.
Coordinate the product lifecycle
Registration & appointment
Clarify the applicable establishment appointment, responsible parties and product-registration work needed for the agreed arrangement.
Regulatory maintenance
Coordinate relevant renewals, minor variations, regulatory correspondence and product-information maintenance within the appointed scope.
Pharmacovigilance & lifecycle
Define the Main role’s applicable safety and lifecycle responsibilities, information flows and interfaces with the manufacturer or MAH.
Agreed operating services
Storage, import, distribution, fulfilment and delivery may be included where permitted and contracted. They are defined expressly rather than assumed to be part of every appointment.
What this helps you do
- Bring registration and ongoing regulatory work into a defined Main arrangement.
- Choose a commercial operating approach without obscuring formal regulatory responsibilities.
- Agree ownership of tasks, information and operational handovers before work begins.
Important scope qualifications
A Main Pharmaceutical Establishment appointment does not make HubPharma the MAH or product owner and does not transfer product ownership or create an equity interest. Responsibilities, permitted activities, commercial participation and any storage, import or distribution services depend on the applicable appointment and written agreement.
Discuss this service
Discuss your products, existing representation and the Main-role support you are considering.
Discuss this service