• 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.

Pharmacodynamic

Concise and comprehensive summary of the pharmacological profile:

• Main and supplementary pharmacological effects (mechanism of action, actions other than the therapeutic effects

• Relevant pharmacokinetics (absorption, plasma-protein binding, distribution, biotransformation, metabolism, excretion, etc)

• For product used directly in the environment e.g. medicine or fish, provide general information on environmental effect.
• Information must be supported with reliable references.

• State briefly on the recommended clinical use(s) of product, indicating clearly whether it is curative, palliative, adjunctive, diagnostic, etc.
• Indications should be specific; phrases such as “associated conditions” or “allied diseases” would not normally be considered appropriate.
• Indications other than those specified and accepted at the time of registration must not be included in any product literature, data sheets, package inserts, labels, etc, without prior permission from the DCA.
• Should it be desired to include new indications, an application shall be filed with the DCA together with supporting clinical documentation on evidence of efficacy and safety for the additional uses (indications).

• Select the targeted animal species for the product (may select more than one target species, if relevant).
• State the target species and sub-group, when appropriate.
• If the species is not listed, key-in the species the box provided.

• State the dose (normal dose, dose range) and dosage schedule (frequency, duration); and route of administration appropriate for each therapeutic indication and target species, including direction for proper use of the product by the veterinarian, farmer or owner. Any special equipment needed for administration of the product should be mentioned. Where the product is to be administered via the feed or water, any dosage adjustment for inappetent animals should be specified, if justified from the data available.
• 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.
• In the case of premixes for inclusion in the feeding-stuffs: any restriction on the range or type of feed which may be used for the preparation should be indicated. If specific mixing instructions are needed, it should be clearly stated.

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

• State conditions for which or under which the product shall not be used.
• Indicate clearly which conditions are:

• State briefly precautions and warnings necessary to ensure safe and efficacious use of the drug, including special precautions for use, special warnings for each target species, and special precautions to be taken by the person administering the products to animals.
• Where necessary, recommendations to minimise exposure of the product user during administration and, where relevant, during preparation of the product for administration should also be given in this section.
• Guidance on remedial action to be taken following accidental contact should also be given, where necessary.
• Any measures which can be taken to identify animals at risk and prevent the occurrence or detect early the onset or worsening of conditions should be stated. If there is a need for awareness of clinical signs representing early warning of a serious ADR, a statement should be included. Any need for specific clinical or laboratory monitoring should be stated.

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

Pregnancy and Lactation

• In order to ensure the safe use of the product, the practitioner must be informed of the recommendations regarding the use of the product in pregnant/ lactating animals or laying birds.
• The following should be mentioned;     

1. Conclusions from the animal reproductive toxicity/ fertility study;
2. The risk in animals at different times of pregnancy, as assessed from a);
3. Information on the possibility of using the product in breeding animals/ laying birds.

• Use in lactation: When the active substance(s) or its metabolites are excreted in the milk, a recommendation as to whether to stop or continue to feed (new-born) animals, and the likelihood and degree of adverse reaction should be given.

• 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. In addition, it should be indicated whether certain species or breeds or types of individual are more susceptible to the undesirable effect concerned, or whether it is more frequent under certain types of husbandry conditions.
• 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

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

• Specific instruction for use, application and administration of the product

• State the recommended storage conditions (temperature, humidity, light etc.).
• 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.

• Shelf life for all the listed pack types shall be supported by stability data.

Shelf Life after first opening of container

Shelf Life after first opening of container must be supported with the in-use stability data unless the in-use shelf life is 24 hours or less

Mandatory for

• Products in Oral Solution (must be supported with the in-use stability data unless the in-use shelf life is 24 hours or less)
• Injectable solution packaged in multi-dose container (must be supported with the in-use stability data unless the in-use shelf life is 24 hours or less)
• Sterile eye and ear prep packaged in multi-dose container (in use stability data is required if the product is not used within 4 weeks after opening the container)

Mandatory for

• Soluble powder to be added with drinking water (must be supported with the stability data after dilution unless the shelf life is 24 hours or less)
• Powder for Injection (must be supported with the stability data after reconstitution unless the shelf life is 24 hours or less)
• For Oral Powder to be mixed with feed, in-use shelf life is not mandatory. (If it is stated more than 24 hrs, in-use stability data must be submitted to support the shelf life claimed).

• Search for the ATCVet Code for each active substance.
• If the code is not in the database, click NOT LISTED upon which, the particulars of the new ATCVet Code should be provided by the applicant, along with the supporting document.

• A24.1 Withdrawal Period(s)

• A24.2 Maximum Residual Limit (MRL).

• Appendix 11 to see Allowable Maximum Residual Limit food,Registration Guideline of Veterinary Products (REGOVP).For substances not in the list, source of reference for the limit has to be provided.