Halal certification for pharmaceuticals
Audited against MS 2424:2019. The part most applicants underestimate is that your product must already be registered and your plant already licensed before JAKIM will look at it.
Halal is the last certificate, not the first
Pharmaceutical halal certification differs from food in one structural way: JAKIM is not the first regulator you deal with, it is close to the last. The manual makes product registration with the Drug Control Authority and an NPRA manufacturing licence with GMP compliance prerequisites of the application. If either is outstanding, the halal file cannot proceed regardless of how good your documentation is.
In practice this means the sequencing question matters more than the halal question. Businesses that come to us early usually need help ordering the work, not doing it.
| Requirement | What the manual says |
|---|---|
| PBKD product registration | Every pharmaceutical product must be registered with the Drug Control Authority |
| NPRA manufacturing licence and GMP | Processing premises must hold a Manufacturer's Licence from NPRA and meet GMP requirements |
Source: JAKIM, Manual Prosedur Pensijilan Halal Malaysia (Domestik) 2020, Prosedur 19, page 33 · edition of 2020
What you are audited against
The halal standard sits alongside the drug legislation rather than replacing it. Both apply.
| Instrument | Reference |
|---|---|
| Malaysian Standard | MS 2424:2019 — Halal Pharmaceuticals — General Requirements (First Revision) |
| Legislation | Sale of Drugs Act 1952 |
| Legislation | Control of Drugs and Cosmetics Regulations 1984 |
| Legislation | Drug Registration Guidance Document (DRGD) |
Source: JAKIM, Manual Prosedur Pensijilan Halal Malaysia (Domestik) 2020, Prosedur 19, page 33 · edition of 2020
Which products qualify
The manual names four eligible categories. Products outside them are not refused on halal grounds — they simply fall outside this scheme, and the right route may be the food, cosmetics or medical device scheme instead. Getting this wrong at application costs you the fee and the queue position.
| Eligible category |
|---|
| Scheduled poison products |
| Non-scheduled poison products (over-the-counter) |
| Health supplement products |
| Natural products (traditional and complementary medicines) |
Source: JAKIM, Manual Prosedur Pensijilan Halal Malaysia (Domestik) 2020, Prosedur 19, page 33 · edition of 2020
Where pharmaceutical applications actually fail
Rarely on the active ingredient. Almost always on excipients and processing aids, which is where the animal-derived and alcohol-derived inputs hide:
- Gelatin capsules. Bovine or porcine origin, and a supplier certificate that has lapsed or never covered the specific grade you buy.
- Magnesium stearate and lubricants. Frequently animal-derived, frequently documented only as "vegetable grade" with nothing behind the claim.
- Ethanol as a processing solvent. Its use, residual level and removal need to be documented rather than assumed away.
- Shared equipment. Lines that also run non-halal product, with cleaning validation written for cross-contamination rather than for halal status.
Staffing and system requirements
These are common to the product schemes and scale with company size. They are structural requirements, not paperwork — the named people have to exist and the records have to be real.
| Company size | Muslim employees | Appointment | Committee | System |
|---|---|---|---|---|
| Large and medium industry | Minimum two permanent Malaysian Muslim employees on duty in the processing area throughout every operating period or shift | Halal Executive at every branch premises | Internal Halal Committee for the premises and for each branch under separate operational management | HAS developed and implemented per the MHMS 2020 manual |
| Small industry | Minimum one permanent Malaysian Muslim employee on duty in the processing area throughout every operating period or shift | Halal Supervisor at the premises | Not separately required | IHCS developed and implemented per the MHMS 2020 manual |
| Micro industry | Minimum one permanent Malaysian Muslim employee on duty in the processing area throughout every operating period or shift | Not separately required | Not separately required | IHCS developed and implemented per the MHMS 2020 manual |
Source: JAKIM, Manual Prosedur Pensijilan Halal Malaysia (Domestik) 2020, Prosedur 19, page 31 · edition of 2020
Fees
Pharmaceuticals are charged on the same schedule as other product schemes, banded by annual turnover — RM100 a year for a micro business up to RM1,000 for the largest, plus a RM20 processing fee. See the full gazetted fee schedules.
Note: We are independent consultants, not JAKIM, NPRA or the Drug Control Authority. We prepare your documentation and your team; the registrations and the certificate are issued by those authorities.
Certifying a pharmaceutical product?
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For pharmaceuticals it usually finds excipient documentation, not doctrine.
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