A foreign manufacturer cannot hold a Malaysian product registration - a locally incorporated Marketing Authorisation Holder (MAH) must. RHMI acts as that holder as an independent party: we carry the holder's legal duties (pharmacovigilance, variations, renewals, recalls, shortage reporting), while the manufacturer keeps ownership of the dossier and contractually guaranteed transfer rights. The registration is not tied to any distributor, so the commercial partner can be changed without losing market access.
A note on terms: NPRA officially calls the holder the Product Registration Holder (PRH). Throughout RHMI's guides we use the equivalent international term, Marketing Authorisation Holder (MAH) - they mean the same party.
Why the holder role decides everything
The MAH is the legal face of your product in Malaysia. NPRA deals with the holder, not with you. The holder files variations, renews the registration, answers safety queries, executes recalls and - since 1 July 2026 - reports shortages and discontinuations. Whoever holds the registration controls your route to the market.
That is why the common shortcut - letting your distributor take the role - is the single most consequential decision in a Malaysian market entry. It works while the relationship works. When it does not, your market access is in your former partner's name, and moving it requires their consent. This is the lock-in risk in detail.
What RHMI's MAH service includes
| Area | What we do |
|---|---|
| Holding the registration | RHMI is named as the Product Registration Holder for your MAL number |
| NPRA liaison | All correspondence, queries and inspections related to the holder role |
| Pharmacovigilance | Safety reporting and the holder's PV obligations |
| Variations | Preparing and filing changes to the registration as your product evolves |
| Renewals | Tracking renewal deadlines and filing on schedule |
| Shortage reporting | The mandatory reporting of shortages and discontinuations in force since 1 July 2026 |
| Recall management | Coordinating a recall if one is ever required |
The contractual control framework
The lock-in problem is not caused by one partner holding the registration. It is caused by holding it without the right contract. Every RHMI MAH agreement fixes, in writing, before anything is filed:
- Dossier ownership. The registration dossier and all data in it remain your property.
- Transfer rights. You hold a contractual right to move the registration - to another holder or your own future subsidiary. Our consent and cooperation are a contractual obligation, not a favour; the transfer itself then goes through NPRA's formal change-of-holder procedure.
- Renewal terms. Renewals happen on schedule regardless of the state of commercial negotiations.
- Exit process. What happens at the end of the engagement is agreed at the beginning of it.
How the engagement runs
- Scoping call - product, approving regulator, approval date.
- Route and structure assessment - which registration route applies, and how holder, import and distribution should be split for your case.
- MAH agreement - the control framework above, fixed in the contract.
- Registration - we file and carry the application to the MAL number. How the registration itself works.
- Life as the holder - pharmacovigilance, variations, renewals, reporting, with a named contact and regular updates.
Already registered - with the wrong holder?
A Malaysian registration can be moved without losing the MAL number. NPRA's change-of-holder procedure is a formal route: the application is filed in QUEST3+, and the product keeps its registration while the holder changes. The application is filed by the outgoing holder, so the transfer depends on their cooperation - one more reason exit terms should be in the distribution contract before they are needed. If your registration currently sits with a distributor, we manage the change of holder and the contractual control framework applies from the day of transfer. How the transfer works, step by step.
Frequently asked questions
Can RHMI be our MAH if we already have a distributor?
Yes - that is the recommended structure. RHMI holds the registration; your distributor distributes. The two roles stay separate, so changing the distributor never puts the registration at risk.
Who owns the dossier if RHMI is the holder?
You do. Dossier ownership stays with the manufacturer in the agreement, and RHMI's consent to a future transfer of the registration is a contractual obligation.
What are the holder's legal duties?
Pharmacovigilance, variations, renewals, recall execution, and mandatory reporting of shortages and discontinuations (in force since 1 July 2026). These sit with RHMI as the holder - with your visibility into each of them.
Can we move the registration away from RHMI later?
Yes. The transfer right is written into the agreement. Malaysia's change-of-holder procedure keeps your MAL number through the move.
You might also find useful
- Marketing Authorisation Holder (MAH) in Malaysia: What It Is and How to Appoint One
- Change of MAH in Malaysia: How to Transfer Your Drug Registration
- Can a Foreign Manufacturer Hold a Drug Registration in Malaysia?
- Editorial note: This page describes RHMI's MAH service. Regulatory timelines, fees and eligibility are administrative details that change; we confirm them against NPRA's current guidance in every engagement. Last reviewed: 1 September 2026.