Monday, January 22, 2018

Section 3: Summary of product characteristics

SECTION 3: Summary of Product Characteristics

This Summary of Product characteristics must include the important information about the products that the applicant wishes to register. The DAH will check the information in the dossier, if it meets the requirement and the meet the professional and management requirements, the content of the Summary of Product characteristics will be accepted and included in the dossier.

In case the requirements are not satisfied, the DAH will request the applicant to correct the Summary of Product characteristics to be suitable for the national and international pharmaceutics dictionary.

The Summary of Product characteristics which is approved by the DAH will be the official document and will be attached with the Certificate on circulation of Save the veterinary products, the Summary will provide the main content for making the label and the kind of packaging of products.

3.1. Name of the products:
+ It must be the original name, it can not be imitated, copied from the name of other companies, it can not be the name of the other registration for exclusive use.
+ The name of the product must not cause the confusion of the nature, the ingredients and the treatment effect of the veterinary product.
+ The name of ingredient of the product, the main ingredients, excipients (adjuvant) must be the popular international name. For the ingredient originated from the plantation, animal, mineral, the popular name accompanied by the scientific name in the Latin language must be clearly written.

3.2. The preparation of products.
3.3. The instruction for use of veterinary products.
3.4. Component, content of the active ingredients contained in the formula of the products.
3.5. The pharmacological characteristics of the products.


3.6 The instruction of treatment and the dosage for the veterinary product.
The animal that can use the veterinary product (the name of animal must be specifically written. For example: buffalo, bull, pig, chicken...);
indication of which disease the veterinary products can treat;
Dosage of the veterinary products for each kind of animal.

3.7 The warning in use.

  • Attention in use;
  • Interaction with other drugs, other kinds of interaction;
  • The unwanted effect when the veterinary products are used according to the instruction and warned dosage in each product;
  • The unwanted effect in using overdose;
  • Information about the veterinary products for pregnant animal, animal giving milk and poultry giving eggs;
  • contraindication.
3.8. The warning for user of veterinary products for prevention and treatment for animal;
3.9. The time to stop using veterinary products (Withdraw time)
3.10. Information about using the veterinary products.

Expiry date:
+ Before opening the product for the first time;
+ After opening the product for the first time.
Notes about preservation of the products.
The guideline for removing the parts of the product that are not used.
3.11. The full name and address of the producer.

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