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Section C: Body of Data. To attach the Print Form (Section P – Product Information) once all the documents are completed prior to submission. P1 : Description & Composition of Finished Product. P2 : Pharmaceutical Development. P2.1 : Information on Development Studies. P2.2 : Components of the Drug Product. P2.3 : Finished Products.
a) Crinis Carbonisatus (Carbonised human hair) b) Human Placenta. For new active ingredients or new combination products, the following information shall be required: a) Product containing new single ingredient: i) Extract form. - Information on the taxonomy of the ingredient; - Techniques and methods in preparing/ processing the extract and ...
Regulation Basics. NPRA was given the task of ensuring the quality, efficacy and safety of pharmaceuticals through the registration and licensing scheme. This is achieved through evaluation of scientific data and laboratory tests on all products before they are marketed. A system to monitor products in the market was set-up.
Information from other available registered products in Malaysia. A1 - A3. Details of the following as entered under Product Validation will appear automatically in the application form: 1. Product name; 2. Name and Strength of Active Ingredients, Name and Strength of Excipients; and. 3. Dosage form.
Product Name : N/A. Registration No : N/A. Holder : N/A. Holder Address : N/A. Phone No : N/A. Manufacturer : LANDRATSAMT ROSENHEIM. Manufacturer Address ...
Dec 9, 2022 · The CNH is responsible to notify the DPS prior to manufacture, sell, supply, import or possess any cosmetic product. 2.2 Responsibility of the CNH. CNH is responsible to ensure that: All transactions with NPRA shall be carried out by CNH’s appointed person (s). Notified product meets all stipulated regulations and guidelines for cosmetic ...
Jun 13, 2024 · National Pharmaceutical Regulatory Agency (NPRA) Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia. Phone: +603-7883 5400
