Veterinary Medicine Main Page

Directory | Public | QUEST3+ System

Increase size

Reset to Default

Decrease size

Veterinary Medicine

This section of the website provides information on the regulation of medicines for veterinary use in Malaysia. It particularly concerns the marketing authorization and post-authorization regulations involving veterinary medicines under the purview of the Drug Control Authority (DCA).

Products containing feed additives in combination with scheduled poisons will be regulated by the DCA.

Products containing pesticide ingredients in combination with scheduled poisons will be regulated by the DCA.

Guidelines Circulars & Directives Application Forms Frequently Asked Questions (FAQs)

Product Search List of Renewal Approved Veterinary Products Veterinary Useful Links

Recent Updates, Directives & Circulars for Veterinary Medicine

Recent Updates for Guidelines, Circulars, Directives, FAQ & Announcements for Veterinary Medicine
Directives & Circulars Related to Veterinary Medicine

Recent Updates
Directives & Circulars

New Products Approved
published on 2022-04-14

Direktif untuk semua produk (termasuk kombinasi) yang mengandungi hydrochlorothiazide, indapamide, chlorthalidone dan acetazolamide: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko choroidal effusion, acute myopia dan acute angle-closure glaucoma
published on 2022-04-12

Direktif untuk semua produk yang mengandungi warfarin : Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko anticoagulant-related nephropathy (ARN)
published on 2022-04-12

Direktif untuk semua produk yang mengandungi co-trimoxazole (sulfamethoxazole, trimethoprim): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko acute respiratory distress syndrome (ARDS)
published on 2022-04-12

Malaysian Guidance Document on Voluntary Good Pharmacovigilance Practices (GVP) Inspection (1st Edition, March 2022)
published on 2022-03-29

Pekeliling berkenaan perubahan prosedur kerja beberapa kategori variasi Minor Variation (Prior Approval) kepada Minor Variation (Notification) “Do & Tell” bagi produk farmaseutikal veterinar
published on 2020-07-21

Pekeliling berkenaan pelaksanaan Guidelines on Abridged Registration Pathway for Veterinary Products
published on 2020-07-21

Direktif untuk mengehadkan penggunaan colistin dalam keluaran ubat veterinar
published on 2019-04-18

Direktif Kaji Semula Pendaftaran Produk untuk tujuan eksport sahaja/ For Export Only (FEO).
published on 2018-03-06

Pekeliling Keperluan Penghantaran Permohonan Pendaftaran Produk Vet
published on 2017-10-30

Product Registration Process

Step I : Preparation

Product classification, Token Configuration, Payment Mode and Key Documents

Pre-submission of Application (Preparation)

Step I : Preparation

Step 2 : Submission

Key-in, upload documents and submission of online application forms (Part I, Part II, Part III & Part IV)

Product Validation, Part I, Part II, Part III & Part IV

Step 2 : Submission

Step 3 : Regulatory Outcome

Evaluation of Application & Drug Control Authority (DCA) decision.

Evaluation of Application & Drug Control Authority (DCA) decision.

Step 3 : Regulatory Outcome

Step 4 : Post-registration Process

Maintenance of Registration, Withdrawal of Product Registration, Amendment to the particulars of the product, Post marketing activities

Maintenance of Registration, Withdrawal of Product Registration, Amendment to the particulars of the product, Post marketing activities

Step 4 : Post-registration Process

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

Email: npra@npra.gov.my
Phone: +603-7883 5400
Fax: +603-7956 2924, +603-7956 7075

More Links

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Mobile Web :

Site Last Modified

Last Modified: Wednesday 18 May 2022, 18:46:01.