兽药原药生产许可证办理流程

兽药原药生产许可证办理流程
1.首先，申请人须向当地食品药品监督管理部门递交兽药原药生产许可证申请。

First, the applicant must submit an application for the production permit of animal drugs to the local food and drug administration department.
2.递交申请时，需要提供相关的申请表格和必要的材料。

When submitting the application, relevant application forms and necessary materials need to be provided.
3.材料包括但不限于生产工艺流程、场所布局图纸、质量管理体系文件等。

The materials include but are not limited to production process flow, site layout drawings, quality management system documents, etc.
4.食品药品监督管理部门将对提交的申请材料进行审核。

The food and drug administration department will review the submitted application materials.
5.审核通过后，申请人需要进行现场核查。

After the review is approved, the applicant needs to conduct on-site verification.
6.现场核查包括对生产场所、设备设施、卫生条件等的检查。

On-site verification includes inspections of production sites, equipment and facilities, hygiene conditions, etc.
7.核查合格后，食品药品监督管理部门将颁发兽药原药生产许可证。

After the verification is passed, the food and drug administration department will issue the production permit for animal drugs.
8.颁发许可证后，申请人可以开始兽药原药的生产。

After the permit is issued, the applicant can start the production of animal drugs.
9.申请人需严格按照许可证中规定的条件和要求进行生产。

The applicant must strictly follow the conditions and requirements specified in the permit for production.
10.同时，申请人还需要定期向监管部门提交生产和质量管理的报告。

At the same time, the applicant also needs to regularly submit reports on production and quality management to the regulatory department.
11.若生产过程中有任何改变，申请人需及时向监管部门进行备案。

If there are any changes in the production process, the applicant must record it with the regulatory department in a timely manner.
12.在许可证有效期内，申请人需要定期进行许可证核查和更新。

During the validity period of the permit, the applicant needs to regularly review and update the permit.
13.如需延续许可证有效期，申请人需提前向监管部门递交申请。

If it is necessary to extend the validity period of the permit, the applicant needs to submit an application to the regulatory department in advance.
14.监管部门将对申请进行审核，并根据情况决定是否延续许可证
有效期。

The regulatory department will review the application and decide whether to extend the validity period of the permit based on the situation.
15.若申请被批准，监管部门将颁发更新后的兽药原药生产许可证。

If the application is approved, the regulatory department will issue the updated production permit for animal drugs.
16.最终，申请人需要遵守监管部门的管理规定，确保符合兽药原
药生产的相关法规和标准。

Ultimately, the applicant needs to comply with the regulatory department's management regulations to ensure
compliance with relevant laws and standards for the production of animal drugs.。