A1 Active Ingredient

A1.1 Active Ingredient Name

A1.2 Salt Form

A1.3 Strength of Active Ingredient (Quantity unit/ dose)

A1.4 Strength Salt-Free

A1.5 Source of Active Ingredient (Animal – e.g. Bovine, Porcine, Ovine   or Others/ Plant/ Others)

A1.6 Form of Substance

A1.7 Remarks (if any)

A1.8 Status

A2 Excipients

A2.1 Excipient name

A2.2 Strength of Excipient (Quantity unit/ dose)

A2.3 Function of excipient (e.g. absorbent, diluents, bulking agent,

         coating agent, anti-caking agent etc.)

A2.4 Source of excipient

A2.5 Remarks (if any)

A3 Dosage

A3.1 Dosage Form

A3.2 Dosage Form Description

A3.3 Source of Capsule Shell

A3.4 Certificate to verify the Source of Capsule Shell

A3.5 Colouring Agent used in capsule shell

A3.6 Certificate of Analysis of Capsule Shell

Product Description

·   Please state, briefly on visual and physical characteristics of the product, including as in the following table (where applicable).

·   Shape, size, superficial markings for identification purposes, colour, odour, taste, consistency, type of tablet coating, type of capsule, etc.

·   When describing liquids, state clearly whether it is in the form of a solution (clear), suspension, emulsion, etc.

·   Please provide a concise and comprehensive summary of the pharmacological profile i.e. main and supplementary pharmacological effects (mechanism of action, actions other than the therapeutic effects).

  Note: If there is no information available for this section, please state as            ‘Not available’ (N/A).

·   Please provide a concise and comprehensive summary of the pharmacological profile i.e. relevant pharmacokinetics (absorption, plasma-protein binding, distribution, biotransformation, metabolism, excretion, etc);

Note: If there is no information available for this section, please state as            ‘Not available’ (N/A).

Health Supplements:

• The following indications are allowed:

-          Used as a Health Supplement; or Vitamins and mineral supplements for pregnant and lactating women.

·   Please state the dose (normal dose, dose range) and dosage schedule (frequency, duration) appropriate for each indication.

·   Dosage for adults, and, children (where appropriate) shall be stated.

· Ensure that dosage recommendation is relevant and appropriate for the product.

Please select route of administration from the drop-down list, e.g.  Oral, rectal, sublingual, topical etc.

·   Please state conditions for which or under which the product shall not be used.

·   Indicate clearly which conditions are :

-    absolutely contraindicated;

-    contraindicated but may be used under special circumstances and what precautions to be taken in such cases.

Warning and Precautions

• Please state briefly warnings and precautions, where necessary to ensure safe use of the product; (e.g. caution against giving to children and elderly; use in pregnancy and lactation; in infants; etc).

1. i) Animal part(s):

    - “This product contains animal part(s).”

1. ii) Animal origin(s): Example: for active ingredients such as pearl, shell of oyster (Concha), pearl, etc.

    -“This product contains substance(s) from animal origin.”

   iii) Porcine:

    -“This product contains animal part(s) (porcine/ pig).”

1. iv) Alcohol:

    - “This product contains alcohol.”

Health Supplements:

• Health supplement products with disease risk reduction claims (high) are encouraged to be dispensed under the supervision of pharmacists or medical practitioners. At such, the label and package insert of health supplement products with disease risk reduction claims (high) shall have the following statement:

“Please consult a doctor/ pharmacist before taking this product”.

• Product with dosage form of soft gel with tail (twist and squeeze) shall include the statement:

‘Under parent supervision’ in the label.

Reference National Pharmacy Regulatory Agency (formally known as National Pharmaceutical Control Bureau):

Drug Registration Guidance Document (DRGD) - Appendix 9 Labelling Requirement & Appendix 5 under 2.7.2 Specific Labelling Statements/ Warning & Precautions.

·   Please state interactions which are observed and/or for which there is potential clinical significance.

·   Interactions may occur with:

-    others medicinal products used;

-    other herbs/substance;

-    meals, or specific types of food.

Note: If there is no information available for this section, please state as            ‘Unknown’.

·   Please state any effect on pregnancy and lactation if applicable.

Reference National Pharmacy Regulatory Agency (formally known as National Pharmaceutical Control Bureau):

Drug Registration Guidance Document (DRGD) – Appendix 5 under 2.7.3 Table 10 & Table 11 List of Prohibited and Restricted Ingredients in Pregnancy.

·   Please state in order for severity and frequency, the side effects, adverse reactions, toxic effects, etc. (i.e. reactions, toxic effects, other than those desired therapeutically) including reactions such as allergy, hypersensitivity, drug dependence, addiction, carcinogenicity, tolerance, liver/ kidney toxicity etc.

·   Please indicate symptoms and sites of effects/ reactions:

1)  Reactions, whether minor or serious shall be stated.

2)  Severity, reversible, frequency of occurrence shall be indicated, wherever possible.

3) Clinical tests for detection of “sensitive” patients, measure for management of adverse reactions developed shall be described wherever possible.

Note: If there is no information available for this section, please state as             ‘Unknown’.

• ·   Please state briefly symptoms of overdose/ poisoning, and where possible, recommended treatment and antidotes for overdose/ poisoning.

   

  Note: If there is no information available for this section, please state as             ‘Unknown’.

·   Please state the recommended storage conditions (temperature, humidity, light etc.). To follow Zone IVB recommendation i.e. Store below 30^oC. Protect from light and moisture.

·   Information includes storage condition before first opening, after reconstitution and/or after opening and for all the listed pack types shall also be provided, where applicable. Stability data to support such storage condition shall be submitted.

·   Please provide justification/supporting data, if had different storage condition (e.g. 25 ^oC, 2 - 8 ^oC).

Reference ASEAN Guidelines:

-    ASEAN Guideline on Stability Study and Shelf-Life of Health Supplements.

-    ASEAN Guideline on Stability Study and Shelf-Life of Traditional Medicines.

• Shelf life for all the listed pack types shall be supported by stability data.
• Information includes shelf life before first opening, after reconstitution and/or after opening where applicable shall also be provided. Stability data to support such shelf life shall be submitted.
• Evidence is required to demonstrate that the product is stable which meets the finished product shelf life specifications throughout its proposed shelf-life and toxic decomposition products are not produced in significant amounts during this period; potency, sterility and efficacy of preservative, etc. are maintained.
• Effective from 27 Nov 2014, a shelf life of 2 years will be approved for both local and imported products. Proposed shelf life exceeding this period will have to be supported by stability study data conducted in Malaysia under zone IVb conditions (30±2 °C, 75±5%). For further information, please refer to the circular Bil (27).dlm BPFK/PPP/06/04Jld.7 Tempoh Hayat Simpanan (Shelf-Life) Bagi Produk Tradisional dan Suplemen Kesihatan (27 November 2014).

Please refer to the ASEAN Guidelines on Stability Study and Shelf Life of Traditional Medicines and Health Supplements for further details.

Please indicate WHO assigned ATC code for each distinct therapeutic indication proposed for a product, if such a code is available. Click button “click here to search” to search the code via database at http://www.whocc.no/atc_ddd_index/