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 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.

 

Category	Description
Tablet	Shape, size, colour, odour, taste, marking, embosss, type of tablet (e.g. coated, uncoated, film, sugar etc)
Capsule	Shape, size, colour, odour, taste, marking, embosss, coating, content of capsule, type of capsule (e.g. soft, hard, chewable etc)
Softgel	Size, liquid color, emboss, shape
Liquid	Clarity, type (e.g. suspension/ emulsion/ solution etc), taste, odour, color
Pill	colour, odour, taste, size etc
Powder/ Granules	colour, odour, taste, size etc

 

Pharmacodynamics

• 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).

Pharmacokinetics

• 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).

Indication

 

Traditional Medicines:

·   Indication of traditional medicine should be started with the following sentence: Traditionally used for / as / to ....).·   Please refer to DRGD to check the approved indications by DCA for traditional products. 

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

Drug Registration Guidance Document (DRGD) – Appendix 5 under 2.3.1 Indications Acceptable for Natural Products & Appendix 5 under 2.3.2 Table 6 Non- Permissible Indication.

 

·   For products with active ingredients that have never been registered, please submit reference / literature information to support the therapeutic effect / indication of the product.·   Indication in Chinese not exactly similar to English/Malay due to difficulty in translation, is allowable for formulary product provided that the product is for physician use only and the indication is almost similar to DRGD·   Indication can be either for health maintenance or symptom relief, not combination.

• Some products need specific requirements as stated in DRGD:

1. Foot patches

• Traditionally used for general health, promoting blood circulation and relieve fatigue.
• If there are other indications other than those mentioned above, applicant is required to submit clinical study data to support the proposed indication.

1. Herbal Tea

• Please refer to Circular Ref: (19) dlm . BPFK/ PPP /01/03 Jld.3. Product classification Food-Drug Interphase (FDI).

III. Homeopathic Products

• Indications allowed for homeopathic product is the same as those allowed for traditional products in the DRGD.

 

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

Drug Registration Guidance Document (DRGD) – Appendix 5 under 3 Product Specific Requirements.

· 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.

 

Traditional Medicines:

· Dosage for medicines, for example:

 

A) ADULT

· Please state as below:

i. How many capsules / tablet each meal.

ii. How many capsule/ tablet per day. Frequency need to be specific.

iii. Before or after eating.

iv. Specify dose and age range for children, adults and the elderly (if applicable).

v. Liquid: need to specify the volume every meal and how to measure (teaspoon / spoon / measuring spoon / measuring cup etc).

vi. Powder: need to mention weight every meal and also how to measure. Measuring spoon / cup / scoop must be supplied with the product. Tea spoon / spoon are not allowed because the density of the powder is not the same. Spoon supplies / measuring equipment can be excluded for products for physician use only (Pharmacy Regulatory Policy Meeting 1/2016).

 

B) CHILDREN

· Dosage for children under a year is not allowed.

·  Dosage for camphor for children under the age of 2 is not allowed.

· Dosage for products containing Ginseng is not allowed for children (under 12 YEARS).

· All children dose should be supported with formulary / journal (same formulation and active ingredient) or confirmation of association.

· Please submit reliable supporting reference (e.g. pharmacopoeia/ compendium/ materia medica) or get the endorsement of the formulation for the children dosing from one of the associations below;

Chinese Medicine:

i)Federation of Chinese Physicians and Medicine-Dealers Associations of Malaysia (FCPMDAM)

ii) Federation of Chinese Physicians & Acupuncturists Association of Malaysia (FCPAAM)

iii) Malaysia Chinese Medical Association (MCMA).

 Malay Medicine:

i) Gabungan Pertubuhan Pengamal Perubatan Melayu Malaysia (Gapera)

Indian Medicine:

i)Malaysian Association of Traditional Indian Medicine (PEPTIM)

· Please attach the reference or endorsement letter under section F12. If applicants fail to submit reference or endorsement letter, please remove the children dose accordingly.

Route of Administration

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

Contraindication

·   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.

 

Traditional Medicines:

·   For products containing the ingredients listed in the 'List of Prohibited Ingredients in Pregnancy' in DRGD, please state:

-          'Contraindicated in pregnant. Insufficient reliable data in lactating women '

·   For product with indication “To regulate menstruation/ To improve menstrual flow”, please state:

-          “Contraindicated in pregnant women.”

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

 

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 List of Prohibited Ingredients in Pregnancy.

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).

·   For products containing ingredients as specified below, please add the required statements:

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.”

·   Some health supplements and traditional medicines required specific labelling requirement as listed in the 'Drug Registration Guidance Document' and the circular issued by the DCA.

 

 

Traditional Medicines:

• Please enter statements:

 

“This is a traditional medicine/Ini adalah ubat tradisional.” OR “This is a homeopathy medicine/Ini adalah ubat homeopati.”

• The following statements shall also be stated on the product label, where applicable:

1. i) For product with an indication “For general health/ well being” or “Untuk kesihatan umum”, please state:

     - “Please consult your pharmacist / doctor before taking this product or Sila merujuk kepada ahli farmasi/ doktor sebelum mengambil produk ini.”

1. ii) For product with an indication “To relieve symptoms for…. (any illness)” or “untuk mengurangkan tanda-tanda/ simptom….”, please state:

-“Please consult your pharmacist/ doctor if symptoms persist/ worsen or Sila merujuk kepada ahli farmasi/ doktor jika simptom berlarutan/ bertambah teruk.”

    iii) For product with indication ‘To reduce body weight’, please state these statements, (unless proven otherwise):

       - “Balanced diet and regular exercise are essential.”

       - “Safety on long term use has not been established.”

• Unless otherwise supported, all herbal/ traditional products label shall state the following general cautionary statement, EXCEPT for product with indication for men’s health or product for children use only:

    - “Pregnancy and breastfeeding: Insufficient reliable data”

·   Please ensure that the 'Keep out of reach of children & Jauhkan daripada capaian kanak-kanak' statement is written in both English and B. Malaysia. 

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.

Interaction with Other Medicaments

• 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’.

Pregnancy and Lactation

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

 

Traditional Medicines:

• For all herbal/ traditional products label shall state the following general cautionary statement, unless otherwise supported.

 

“Pregnancy and breastfeeding: Insufficient reliable data”

 

• Products containing any ingredients as listed in the following lists, i.e. List of Prohibited Ingredients in Pregnancy and List of Restricted Ingredients in Pregnancy, the following cautionary statement shall be stated in the product label:

 

1. Prohibited Ingredients in Pregnancy:

“Contraindicated in pregnant women. Insufficient reliable data in breastfeeding women”

 

II       Restricted ingredients in pregnancy:

           “To be used with caution in pregnancy. Insufficient reliable data in breastfeeding women”

 

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.

Side Effects

• 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’.

Symptoms & Treatment of Overdose

• 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’.

Storage Condition

• Please state the recommended storage conditions (temperature, humidity, light etc.). To follow Zone IVB recommendation i.e. Store below 30^o 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 Traditional Medicines.

Shelf life

• 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.

Therapeutical Code/ATC Code (If any)

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/