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 

A2.1 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)

A3.1 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

State, briefly on visual and physical characteristics of the product, including (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).

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

• Please state the dose (normal dose, dose range) and dosage schedule (frequency, duration); and route of administration appropriate for each therapeutic indication.

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

• Dosage adjustments for special conditions, e.g. renal, hepatic, cardiac, nutritional insufficiencies (where relevant) shall be stated.

• Where appropriate, diluents and instructions for dilution, reconstitution and use or administration of the product shall be clearly stated.

• Distinction shall be made between therapeutic and prophylactic doses, and between dosages for different clinical uses, where applicable.

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

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

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

• Indicate clearly which conditions are :

o absolutely contraindicated

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

• Where there is likelihood that additives are added, especially for intravenous solutions, foreseeable contraindicated additives shall be mentioned (where applicable).

• Concurrent drug therapy which are contraindicated shall also be included where possible (where applicable)

Please state briefly on warnings and precautions, where necessary to ensure safe use; and efficacious (where applicable) of the product; (e.g. caution against giving to children and elderly; against driving motor vehicles or manning heavy machinery after intake of product; use in pregnancy and lactation; in infants; etc.)

Please state interactions which are observed and/or for which there is potential clinical significance. Interactions may occur with:

• medicinal products used for the same indication;

• medicinal products used for other indications;

• meals, or specific types of food

Use in Pregnancy:

• The following shall be stated i.e. information on the possibility of using the medical product in fertile and pregnant women.

Use in Lactation:

• When the active substance(s) or its metabolites are excreted in milk, recommendations as to whether to stop or continue breast feeding, and the likelihood and degree of adverse reaction in infant shall be stated.

• 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

• Indicate also symptoms and sites of effects/ reactions.

• Reactions, whether minor or serious shall be stated.

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

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

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

Please state briefly precautions and warnings necessary to ensure safe and efficacious use of the drug, e.g. caution against driving motor vehicles or manning heavy machinery after intake of product.

Please state the pre-clinical safety data.

• Please state the recommended storage conditions (temperature, humidity, light etc.). 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 refer:

ICH Q5C: Stability Testing of Biotechnological/ Biological Products

Please state the instructions for use.

• 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.

1. 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/

   Please refer:

   ATC/ DDD index