Exemption

 

EXEMPTION LIST APPLICATION FOR PHARMACEUTICAL COMPANIES

The exemption process has been discussed and aligned with the Department of Veterinary Services (DVS) and the Pharmacy Enforcement Division (Bahagian Penguatkuasa Farmasi) on 14 September 2026.

MAVMA is now tasked with conducting a preliminary screening of exemption applications to assess and verify the genuine needs of the veterinary industry before applicants proceed with submission to the BPF.

1. Eligibility Criteria

Applicants must ensure that their applications meet the following criteria:

  1. No registered alternative: No registered alternative containing the same active ingredient is available in Malaysia.
  2. Essential need: The product is required for emergency or life-saving purposes, animal welfare, public health, or food security, as determined by a licensed veterinarian.
  3. DVS endorsement: The active ingredient must be included in the DVS-endorsed list of active ingredients eligible for exemption.

 

2. Application Fee

The screening fee is RM300 per product, defined as one brand name and one concentration, regardless of the number of pack sizes.

 

3. Processing Time and Process Flow

The estimated processing time and application process are outlined in the attached presentation. These will be reviewed and updated from time to time based on operational requirements and further alignment with the relevant authorities.

Applicants are advised to refer to the latest version of the presentation before submitting their applications.

 

4. NPRA Lampiran A Checklist and Supporting Documents

Applicants must ensure that all requirements under the NPRA Lampiran A checklist are fulfilled and that the active ingredient is included in the DVS-endorsed list.

If the required active ingredient is not yet included in the endorsed list, applicants may submit a request for consideration through the following form:

https://docs.google.com/forms/d/1LrfUFBMWB19ZoKuDDLFx_T7BObM5_WIJkm8TPaiZlCc/edit

Requests for new active ingredients will be reviewed on a quarterly basis.

Applicants are encouraged to ensure that their submissions are complete and that the justification for exemption clearly demonstrates the genuine need for the product.

 

Application Commencement Date

The exemption application process is scheduled to commence on 2 January 2027 (to be confirmed). Meanwhile, applicants are encouraged to review the eligibility criteria and prepare the required supporting documents in advance.