How to Transfer Your Malaysian MAL to a New Product Registration Holder
C. Y. Chin, Business Development Director | Infinity Pharmacare | September 2026
The application to move a Malaysian marketing authorisation to a new holder is filed by the company you want to remove. Appendix 31 of the Drug Registration Guidance Document puts it in one sentence: “An application to transfer the marketing authorization of a registered product shall be submitted by the existing PRH.”
Everything else follows from that line. If the underlying position is new to you, why a foreign manufacturer cannot hold its own MAL and what the holder controls, start with what a Product Registration Holder actually is. This article assumes your product is registered and that you now want it moved. Three provisions decide whether it moves.
Who files a change of Product Registration Holder?
The existing PRH files it, and the guidance names no alternative applicant. That is Appendix 31, Section 2(1), quoted above. Section 3 puts the mechanics in the same hands: submission through QUEST, with hard copy original documents delivered to NPRA.
A change of holder sits at DRGD Section 20.3, described there as “a transfer of marketing authorization from the existing PRH to another proposed new holder” which “allows for the same registration number of the registered product to be maintained”. It sits outside Section 20.1, so it carries no variation category, code or condition number, which is where it parts company with an ordinary post approval variation.
One note on vocabulary before the detail. NPRA writes Product Registration Holder throughout Appendix 31, while the DRGD glossary uses marketing authorization holder in the same document. Some advisers write MAH. The terms name the same office, and this article uses NPRA’s own.
Why does the existing PRH’s board resolution decide the outcome?
Because it is the document on the list with no omission condition and no foreign entity carve out. Item (iv) reads: “Resolution by the Company Board of Directors of existing PRH verifying that ALL the Board of Directors/ Partners have given their consent to the Change of PRH. This resolution must be signed by ALL the Board of Directors/ Partners.”
Set that against item (ii), the equivalent resolution from the Product Owner, which ends: “This requirement can be omitted if the Product Owner is not a local entity.” A foreign manufacturer is excused from producing its own board consent. The party it wants to replace is not.
The wording sets no quorum, no majority and no substitute signatory. Every director or partner signs, or the file is short a required document.
| # | Document | Issued or signed by | Omission condition |
|---|---|---|---|
| i | Letter of Authorization (LOA) | Product Owner, on its own letterhead | None |
| ii | Board resolution consenting to the COH, signed by ALL directors or partners | Local Product Owner | Omitted if the Product Owner is not a local entity |
| iii | Latest SSM corporate information showing directors and shareholders, certified by Commissioner for Oaths as a statutory declaration | Local Product Owner | Omitted if the Product Owner is not a local entity |
| iv | Board resolution consenting to the COH, signed by ALL directors or partners | Existing PRH | None |
| v | Latest SSM corporate information showing directors and shareholders, certified by Commissioner for Oaths | Existing PRH | None |
| vi | Company or Business Registration Certificate, certified true copy by a MAICSA accredited company secretary or by SSM | Proposed new PRH | None |
| vii | Statement of Acceptance as Product Registration Holder, form NPRA-430.5(3) | Proposed new PRH | None |
How does an application fail without anyone refusing it?
Through silence. Section 2(9) states that the application may be rejected if the applicant fails to provide satisfactory required documents within thirty working days from the first date of correspondence by the evaluator. Section 5.5 adds that the Secretariat may request further information or documentation, and that failure to provide it results in rejection.
The applicant in both provisions is the existing PRH. The clock runs against the party holding the file, and the fee is non refundable if the application is rejected.
What is NPRA’s position when the holder and the product owner disagree?
It stays out, and says so in the DRGD itself. Section 5.2(l): “NPRA shall only correspond with the existing PRH and not with any other third party (including product owner and the law firm hired by any of the party) regarding product registration.” Retaining counsel does not open a channel. The exclusion is written to cover it.
Section 5.2(m) uses a change of holder as its own worked example: “NPRA shall not be involved in any dispute between the existing PRH and other third parties. The existing PRH is responsible for solving the dispute. For example, disputes between the PRH and the product owner in matters of COH or any contractual agreement between the two parties.”
The regulator is not unaware of you. Its glossary defines Product Owner as “A person, company or entity who is the legal/ registered owner of the product formulation and/or process with whom the marketing authorization holder has a contract”. The document that recognises the contract places one of its parties outside the correspondence channel.
What does the guidance not address?
Most of the situations a manufacturer in difficulty is actually in. The text does not address a transfer where the registration is under suspension, where the product is conditionally registered, where a variation is pending on the same product, or where the existing PRH has been dissolved, wound up or has ceased to exist. It does not say whether GMP status is reassessed, expires or carries over, nor whether an import or wholesaler licence held by the existing PRH transfers, lapses or must be reapplied for. It states no consequence where the existing PRH declines to apply or to consent, and provides no mechanism for a transfer without it. Unaddressed is the accurate word. None of it is prohibited and none of it is permitted.
What does the procedure require when both parties cooperate?
A Letter of Authorization from the Product Owner, on its own letterhead, and then a sequence running on two six month clocks. The LOA carries the registered name and registration number of the products, the name, business registration number and address of both the existing PRH and the proposed new PRH exactly as registered in QUEST, the effective date of the appointment and of the termination, and the Product Owner’s own name, address, email, telephone and fax as registered in QUEST. It is signed by the Managing Director, Director, President, Chief Executive Officer or General Manager with overall responsibility for the company. If no effective date is stated, the date of issuance applies. A Product Owner registered outside Malaysia has the LOA certified by a Notary Public in its country of origin, a Malaysian registered one by a local Commissioner for Oaths.
Paragraph 4 of the template answers the question most manufacturers ask next. The Product Owner confirms that the entire dossier of the listed products, including all data supporting the original application and all correspondence with the DCA and NPRA, transfers from the existing PRH to the proposed new PRH upon DCA approval. The template also directs that the proposed new PRH, the existing PRH and the Product Manufacturer are copied.
The first clock starts on the LOA date. Against that date field the template states that the existing PRH shall submit an application within 6 months from this date. The second is a recency rule under Section 5.3, where document dates, including the stamps and signatures of certifying bodies, must not exceed six months from the date of application. Each page of an attachment such as a product list must be endorsed by the signatory.
Two eligibility conditions sit on either side of the file. The proposed new PRH must be a registered company or business with SSM and a registered QUEST user with NPRA, tested against PRH eligibility under the 12th Revision. The product must have at least six months of registration validity remaining, failing which the existing PRH applies for renewal first. Nothing else changes: Section 2(4) bars any change to the technical data or the approved pharmaceutical and pharmacological information, including the texts of the product label and leaflet, other than the name and address of the approved PRH.
- The existing PRH completes and submits the application online through QUEST.
- The fee is paid through QUEST immediately after submission: RM1,000.00 for a pharmaceutical product including a health supplement, non refundable.
- Original supporting documents go to the Centre of Product and Cosmetic Evaluation once payment is made. Photocopies are not accepted.
- The Secretariat receives and evaluates the application with the originals, and may request further information.
- Satisfactory applications are tabled to a DCA meeting for approval. Non satisfactory applications are tabled for rejection, fee non refundable.
- The Secretariat notifies the proposed new PRH of the approval and sends a termination notification to the existing PRH. A rejection goes to the existing PRH.
The forty five working day decision period does not begin at submission. Appendix 31 runs it from the point NPRA deems the application complete, which puts the thirty working day document window ahead of it rather than inside it. A holder who answers the evaluator slowly delays the start of the clock, not just the end of it.
Appendix 31 also cross refers to Directive No. 2, 2025, NPRA.600-1/9/13(49)Jld.1 of 18 February 2025.
Who carries the product while the file sits with the DCA?
The existing PRH does, in full. Section 2(5) keeps marketing authorisation responsibility with it in the interim, and Section 2(7) keeps it liable for pharmacovigilance issues or quality defects associated with the product during that period, while allowing it to deplete remaining stocks. Under Section 2(6) the transfer takes effect on the day the DCA decides, the previous holder’s authorisation is cancelled because the product cannot be marketed simultaneously by two different PRHs, and the new PRH takes over.
Stock depletion after approval is worth reading twice. Section 2(8) allows either the existing or the newly approved PRH to submit a written request to deplete existing stocks, and whichever one submits it is held responsible for those batches and quantities in the event of pharmacovigilance issues or quality defects. Liability follows the signature on the request. That is a supply agreement question wearing regulatory clothing.
What should be settled before a local partner is appointed?
Every requirement above that sits with the existing PRH, because none of them can be produced later by the manufacturer alone. The procedure needs that company to file, to pass a board resolution signed by all of its directors or partners, to produce certified SSM corporate information, and to answer the evaluator within thirty working days. It also keeps NPRA’s correspondence channel pointed at that company, whatever the contract says.
The RM1,000 is the processing fee, not the cost of a transfer. The cost is the time a product spends unmoved while a party with no remaining commercial interest decides whether to sign. Read the document list again, note who issues each line, then look at the agreement that appointed your current holder and count how many of those lines it obliges them to produce. The device side raises the same question in its own form, covered in who controls your Malaysian device registration. Both are answered at appointment, not at exit.
This briefing is for general information only. It does not constitute legal, regulatory or medical advice. Regulatory requirements change. Verify all details against current official NPRA guidance before making filing or commercial decisions.