I. The content of one dossier for registration of veterinary products
The dossier for registration of veterinary products must be made in 03 sets, printed on the A4-sized papers, arranged in accordance with regulated order.
One dossier for registration of veterinary products includes:
- Section 1: The cover page of the dossier (Sample 1); index of the dossier (Sample 2);
- Section 2: Application for registration of veterinary products (Sample 3);
- Section 3: Summary of product characteristics;
- Section 4: Labels of veterinary products;
- Section 5: Technical information about the product quality;
- Section 6: Technical information about the safety level and the effects (validity) of the product;
- Section 7: Different kinds of Certificates GMP, ISO… If the Certificates are the copies, they must be certified by the competent authorities.
- Section 8: Other relating documents (The documents which has been analysed by the producers and the State Control Authorities of veterinary products, the testing results…).
Please note that the dossier for registration of imported products must be written in the Vietnamese languages or English. The summary of Product characteristics must be written in the English language.
SECTION 1: The cover page and the index of the dossier.
A. The cover page of the dossiers must include: ( As indicated in sample 1 )
- The purpose of registration of veterinary products;
- The name of the applicant;
- The names of veterinary products to be registered.
B. The index of the dossier ( As indicated in sample 2 )
- The dossier must be arranged in accordance with right order; each page must be numbered; the content must be written in accordance with the index.
SECTION 2: The application for veterinary products. (as indicated in sample 3)
The content of the application for veterinary products must contain the followings:
- The full name and address of the applicant, the producer;
- The name of the products;
- The preparation form of the products;
- The ingredient and content of the substances in the products;
- The different kinds of packaging of the products;
- The time to stop using the veterinary products on each kind of animal for exploitation of their meat, egg and milk (withdraw time) (if necessary);
- With regard to the imported products: the applicant must have the Marketing Authorization (Permit) in the producing countries, in other countries (if available) and Good Manufacturing Practice (If this document is the copy, it must be certified by the competent authority).
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.
SECTION 4: The label of veterinary products.
The proposed label must be contained in the dossier. For the imported veterinary products, the original label must be translated into the Vietnamese language. The information in the label must be suitable with the content of the Summary of product characteristics, including:
- Name of the veterinary products;
- The form of preparation;
- The component and the content of the active ingredient in the formula;
- Instruction for each kind of animal;
- Dosage for each kind of animal;
- Contraindication;
- Expiry date (calculated according to month and year);
- Withdraw time;
- Name and address of the producer.
SECTION 5: Technical information about the product quality.
5.1. Production process: The production process must be described fully, exactly and the factor that can pollute the product must be clearly indicated.
5.2. Criteria on the quality and testing method:
The standard quality of the components, active ingredients and the exipient (adjuvant) of the product must be suitable with the technical information promulgated in the national and international pharmaceutical dictionary. Without the evidences relating to those components, the producer must provide the evidence with the tantamount quality.
The producer must build up the quality for the finished products and must comply with the current criteria that are internationally accepted. On checking the quality of the products, the content of any active ingredient can be approximately 10% (≤ 10%) in comparison with the promulgated content. The tolerance about the volume (weight, volume) of the finished products must be within 5% (≤ 5%).
The applicant must provide the testing method with the following requirements:
+ In accordance with the science, technology in this field.
+ In accordance with the set of criteria of ISO
+ Describing clearly about the testing method so that the official of the Experiment Department can check the quality in accordance with the testing method of the applicant.
5.3. Analysing Certificate (testing sheet)
a. Testing from the producer: The producer must be responsible for the quality of veterinary products as well as testing the quality of the veterinary products. The testing of the quality of veterinary products can be executed by producer or the Testing Organisation of veterinary products in accordance with the contract between the applicant and this organisation.
b. Testing from the state body: The DAH request the applicant to send the sample products or the …………………….. relating to the products (if requested) to the State Testing Body so that this Body can proceed with testing the products. The testing result must be attached in the dossier.
5.4. Expiry date: The applicant must provide the DAH with information proving the stable period of the veterinary products in use and the proposed expiry date.
It is necessary to study the stability about the content of the main active ingredient containing in the formula. The standard quality of the products must be evaluated based on the fluctuation of the content of the active ingredient, the fluctuation must be within 10% (≤ 10%) in comparison with the promulgated content. The method used to study the stability of the finished products is required to provide the DAH.
SECTINON 6: Information about the safety and the effects (validity) of the product
The applicant must be completely responsible for:
– The safety of the product for the animal health, health of the consumers of the products that originate from animal, the user of veterinary products in prevention, treatment for animal and the environment.
– The effect (validity) of the products for the animals using the products.
The applicant must provide the technical information to prove the above two matters in the dossier.
For the products which are produced according to the copied formula from other producers, the producer does not need to provide information about the safety and the validity of those products.
II. Time frame:
1. The agency to which the registration document has been submitted shall, within fifteen (15) days from the receipt of the dossier, be responsible for answering the result, or notifying organizations or individuals whose dossiers are not satisfactory for supplementary information.
2. Within sixty (60) days from the date of receipt of legitimate document, the Department of Animal Health or the National Fisheries Quality Assurance and Veterinary Directorate shall be responsible for submitting results of document evaluation to the professional Scientific Committee set up by the Ministry of Agriculture and Rural Development and/or the Ministry of Fisheries. The Committee shall convene regularly or when required for approval of registration dossiers and request the Ministry of Agriculture and Rural Development or the Ministry of Fisheries to accredit and add the products registered into the List of Veterinary Drugs or the List of Biological Products, Microorganisms and Chemicals for veterinary used that are permitted for marketing and use in Vietnam.
For our previous cases, it took approximately 6-7months to obtain the registration for veterinary products.