Part I, Section A: Product Particulars

Please refer to the Glossary developed for the ACTD and ACTR. The definitions used in the glossary have been developed for the ASEAN Common Technical Dossier (ACTD) and Common Technical Requirements (ACTR). They are not necessarily meaningful outside the scope of the specific parts of ACTD and ACTR to which they refer.
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.
A4 : Product Description
A5 : Pharmacodynamic
A6 : Pharmacokinetics
A7 : Environmental Properties (for product used directly in the environment e.g medicine for fish)?
A8 : Indication
A9 : Target Species
A10 : Recommended Dose
A11 : Route of Administration
A12 : Contraindication
A13 : Warnings and Precautions
A14 : Interactions with Other Medicaments
A15 : Pregnancy and Lactation
A16 : Side Effects
A17 : Symptoms & Treatment of Overdose
A18 : Instructions For Use
A19 : Storage Condition
A20 : Shelf life as packaged for sale
A21 : Shelf Life after first opening of container (where relevant)
A22 : Shelf life after reconstitution or dilution (where relevant)
A23: ATCVet Code
A24: Is the product for food-producing animal?

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

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  • Last Modified: Rabu 17 Julai 2019, 16:23:30.
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