Other Guidelines for Generic Medicine

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Guidelines - Generic Medicine

: Posted By Jauze; 05 October 2018; Hits: 14094

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2021
2020
- Guideline For Registration of Drug-Medical Device And Medical Device-Drug Combination Products 3rd Edition, 2020 2020-09-23
2019
- 4.4 : Post-Marketing Activities 2019-03-13
2018
- Product Validation 3.1 - 3.8 : Active Ingredients 2018-08-29
- Product Validation PV5 - PV18 : Other Information 2018-08-29
- Product Validation 4.1 - 4.5 : Excipients 2018-08-29
- Garispanduan Pelaksanaan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) 2018-08-01
2016
- Malaysian Guidelines on Good Pharmacovigilance Pratices (GVP) for Product Registration Holders (1st Edition, August 2021) 2016-09-08

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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

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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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