4. Method of analysis.分析方法
5. Stability study稳定性实验
A-ACCELARTED 50-55℃, Relative Humidity 75% for 6 month 加速稳定性实验（温度50-55℃，湿度75%，6个月）
B-Real time of stability should be carried at minimum 30℃ and above and relative Humidity of 70%-75% for whole shelf life and frequency. Testing is 0.3.6.12.18.24 for product of tow years.长期稳定性实验（温度30℃或30℃以上，相对湿度70%-75%,取样日第0.3.6.12.18.24月）
6. Certificate of registration in other countries.在其它国家的注册证书
7. 20 leaflet 20 original samples. 20份说明书，20份样品
8. Pharmacological Toxicological studies/and clinical trials 药理毒理研究和临床研究.
9. Full description of any experimental research and investigations that had been carried out. 相关实验研究和调查的详细说明
Veterinary Drugs& Pharmaceuticals Directorate
Note:说明
The references material should be submitted if the nature of the Drug analysis& testing is required, or in case of the drug is not included in any of pharmacopeias.
如果药品需要进行分析或者该药品不包括在任何药典里，应提供参考资料。