Conditions for applying for a Certificate of eligibility to produce veterinary drugs

Issue Certificate of eligibility to produce veterinary drugs is an administrative procedure that veterinary medicine manufacturing establishments in Vietnam need to carry out to ensure their production and business activities are legal and continuous. The following article will introduce to customers the conditions to apply for a Certificate of eligibility to produce veterinary drugs production issued by the Department of Animal Health as well as the related administrative procedures. Please refer to customers!

Where to submit an application for a certificate of eligibility to produce veterinary drugs?

Pursuant to the provisions of Clause 2, Article 44 of Circular 13/2016/TT-BNNPTNT, the Department of Animal Health is the agency with authority to appraise documents, evaluate and recognize establishments qualified to produce and import veterinary medicine.

Conditions for the Department of Animal Health to issue a Certificate of eligibility to produce veterinary drugs

According to Article 90 of the Law on Veterinary Medicine 2015, the conditions for the Department of Animal Health to issue a Certificate of eligibility to produce veterinary drugs are:

• Have a Business Registration Certificate;
• Have locations, factories, and drug warehouses that ensure safe area and distance for people, pets, and the environment;
• Have equipment suitable for production scale and quality inspection for each type of veterinary medicine;
• Have a wastewater and waste treatment system that meets veterinary hygiene requirements and according to the law on environmental protection;
• The person directly managing the production and testing of veterinary drugs must have a Veterinary Practice Certificate in producing and testing veterinary drugs;
• People directly producing veterinary drugs must be trained and fostered in appropriate expertise;
• Have a Certificate of eligibility to produce veterinary drugs.

This condition is guided by Article 12 of Decree 35/2016/ND-CP effective from July 1, 2016, amended by Clause 1, Article 2 of Decree 123/2018/ND-CP effective from July 1, 2016. September 17, 2018 as follows:

For location:

• There must be a safe distance from residential areas, public buildings, hospitals, veterinary clinics, animal disease diagnostic facilities, and sources of pollution.

For factories:

• There must be a design appropriate to the scale and type of drug produced, avoiding the intrusion of insects and other animals; have a location that separates sources of infection from outside;
• The floor is waterproof, easy to clean, disinfect and disinfect; Walls and ceilings are made of durable, sturdy, easy-to-clean materials;
• Have a water and gas supply and treatment system to ensure production; There is a drainage system, water treatment, exhaust gas, and waste;

For warehouses storing raw materials, auxiliary materials, and finished drugs, have an area appropriate to the scale of production and ensure the following conditions:

• There is a separate warehouse to preserve raw materials, auxiliary materials, and finished drugs;
• There is a separate warehouse outside to store solvents and flammable materials;
• Avoid intrusion by insects and other animals;
• Floor, walls, ceiling as prescribed for factories;
• There are shelves and racks for raw materials, auxiliary materials, packaging, and finished drugs; have equipment and means to ensure storage conditions.

Equipment and tools must be arranged and installed in accordance with the scale and type of medicine produced; Has operating instructions; have a maintenance plan; Have cleaning procedures and ensure hygiene requirements are met, without causing contamination or cross-contamination between products.

Checking the quality of veterinary drugs:

• The quality control area must be separate from the production area; arranged appropriately to avoid cross-contamination; areas where biological and microbiological tests are conducted;
• Samples and standards must be stored in a separate area, ensuring storage conditions;
• Must have appropriate equipment.

Application for a Certificate of eligibility to produce veterinary drugs

According to Article 20 of Circular No. 13/2016/TT-BNNPTNT, the application for a Certificate of eligibility for veterinary drug production needs to be prepared:

• Application for issuance of certificate of eligibility to produce veterinary drugs according to the form specified in Appendix XIX issued together with the Circular 13/2016/TT-BNNPTNT amended and supplemented by Clause 17, Article 1 of Circular 18/2018/TT-BNNPTNT.
• A detailed explanation of the facilities and techniques for producing veterinary drugs according to the sample.

In addition, establishments applying for a Certificate of eligibility to produce veterinary drugs by the Department of Animal Health also need to prepare:

• List of veterinary drugs and raw materials for production;
• Business registration certificate (original or copy with confirmation stamp of the registered enterprise;
• Veterinary medicine production practice certificate for people directly managing production (original or copy with confirmation stamp of the registered enterprise).

Number of documents: 01 set

Procedure for applying for a Certificate of eligibility to produce veterinary drugs

How to do it

According to Point b, Section 6, Appendix issued with Decision No. 4014/QD-BNN-TY dated October 24, 2022 of the Minister of Agriculture and Rural Development, how to apply for a Certificate of eligibility for production Exporting veterinary drugs issued by the Department of Animal Health is a direct form.

Implementation steps and costs

Regarding implementation procedures:

According to Clause 2, Article 96 of the Law on Animal Health 2015 (amended and supplemented in 2017), Point b, Section 6, Appendix issued with Decision No. 4014/QD-BNN-TY dated October 24, 2022 of the Minister of Agriculture Industry and Rural Development, steps to apply for a Certificate of eligibility for veterinary drug production issued by the Department of Animal Health:

Step 1: Organizations and individuals producing veterinary drugs submit application dossiers for issuance of Certificate of eligibility to produce veterinary drugs to the Department of Animal Health.

Step 2: Within 15 days from the date of receipt of valid documents, the Department of Animal Health checks the conditions of the production facility. If qualified, within 05 working days from the date of completion of the inspection. must issue a Certificate of eligibility to produce veterinary drugs; In case of refusal, a written response must be made clearly stating the reason.

About cost

According to Point g, Section 6, Appendix issued with Decision No. 4014/QD-BNN-TY dated October 24, 2022 of the Minister of Agriculture and Rural Development, when applying for a Certificate of eligibility for production Veterinary drugs are issued by the Department of Animal Health. You must pay a fee to check the conditions for producing veterinary drugs and aquatic veterinary drugs, specifically:

• 1,025,000 VND/time for newly established establishments with 1 production line (or 1 workshop); Or an operating facility with 2 lines (or 2 workshops) or more
• 1,300,000 VND/time for newly established establishments with 2 lines (or 2 workshops) or more
• 700,000 VND/time for an operating facility with 1 line (or 1 workshop).

Support service for applying for a Certificate of eligibility to produce veterinary drugs issued by the Department of Animal Health

The process of granting a Certificate of eligibility for veterinary drug production requires strict compliance with legal regulations. At Long Phan, we are proud of our support and consulting services for applying for a Certificate of eligibility to produce veterinary drugs by the Department of Animal Health, including the following activities:

• Detailed and specific advice on procedures and conditions for applying for a Certificate of eligibility to produce veterinary drugs;
• Support in drafting and preparing necessary documents and records for applying for a Certificate of eligibility to produce veterinary drugs;
• On behalf of customers, submit documents and fees to apply for a Certificate of eligibility to produce veterinary drugs;
• Monitor the progress of processing applications for Certificate of eligibility for veterinary drug production and overcome arising risks;
• Receive results and hand over to customers.

Above is the entire content of the conditions for applying for a Certificate of eligibility to produce veterinary drugs. If you need detailed support or advice about this process, please contact the hotline 0906735386. Long Phan is ready to provide information and support customers in applying for a Certificate of eligibility to produce veterinary drugs.