Veterinary Medicine Main Page

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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)

List of Registered Veterinary Products 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

25PPWG ANNEX 7 (iv) Final ASEAN Guideline on Stability Study Drug Product R2
published on 2019-02-12

MOPI Training - International Good Manufacturing Training Program 2019
published on 2019-02-04

The 27th ASEAN Consultative Committee for Standards and Quality
published on 2019-01-31

Verification of Translated Official Documents
published on 2019-01-23

List of Renewal Approved Veterinary Products
published on 2019-01-09

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

Pelaksanaan Produk Persediaan Parenteral yang telah dikelaskan sebagai Racun di bawah Akta Racun 1952
published on 2017-08-28

Arahan Pengarah Kanan Perkhidmatan Farmasi Bil. 11 Tahun 2016 - Penerimaan Pengesahan Pematuhan APB Bagi Tujuan Pendaftaran Semula Produk Farmaseutikal Berdaftar
published on 2016-07-01

Direktif Guideline on GMP for Veterinary Premixes (January 2015)
published on 2015-07-10

Keperluan Ahli Farmasi Berdaftar Sepenuh Masa untuk Mengetuai Bahagian Pengeluaran Premis Pengilang Produk Farmaseutikal, Radio Farmaseutikal dan Veterinar yang Berdaftar dengan Pihak Berkuasa Kawalan Dadah (PBKD) : Perlanjutan Tarikh Perlaksanaan
published on 2015-01-20

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, 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.

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Site Last Modified

Last Modified: Monday 18 February 2019, 12:11:14.