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National Pharmaceutical Regulatory Agency announced an update to the application form used for the Certificate of Indication and Declaration Certificate for products registered with the Drug Control Authority.
Applicants are requested to use the latest version of the form, N1-FR-06/4 (April 2026 version), for all related applications.
Updated Application Form
The revised form applies to applications for:
- Certificate of Indication
- Declaration Certificate
The updated version replaces previous forms for these submissions.
Product Categories Covered
The updated application form is available for the following product categories:
- Generic Medicines https://www.npra.gov.my/index.php/en/application-forms
- Natural Products https://www.npra.gov.my/index.php/en/component/content/article/161-english/application-form-traditional/1768-application-forms-health-supplements-2.html?Itemid=1391
- Health Supplements https://www.npra.gov.my/index.php/en/application-forms-for-health-supplements.html
- Veterinary Medicines https://www.npra.gov.my/index.php/en/application-forms-veterinary-medicine.html
Applicants should access and use the relevant updated form for their product category.
Effective Update
NPRA advises applicants to use only the latest version of the form for all new submissions related to these certificates.
For More information: https://www.npra.gov.my/index.php/en/industry-news-announcements/1527844-update-of-borang-permohonan-sijil-indikasi-sijil-deklarasi-bagi-produk-berdaftar-dengan-pihak-berkuasa-kawalan-dadah.html
Supporting Regulatory Processes (Different Style)
Changes in application forms and certificate requirements can impact submission workflows and documentation accuracy.
Baupharma’s Regulatory Affairs services support companies with regulatory submissions, dossier preparation, and evolving registration requirements:https://www.baupharma.com/services-categories/regulatory-affairs/#Regulatory-affairs-services
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