Viatris Healthcare GmbH — China drug registrations and re-registration deadlines
4 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2027-12-29.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20230090 | Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray 氮䓬斯汀氟替卡松鼻喷雾剂 | 2028-06-29 | 2027-12-29 |
| 国药准字HJ20150201 | AZEP 盐酸氮䓬斯汀鼻喷雾剂 | 2030-05-14 | 2029-11-14 |
| 国药准字HJ20181067 | Legalon 水飞蓟素胶囊 | 2031-03-24 | 2030-09-24 |
| 国药准字HJ20171048 | AZEP 盐酸氮䓬斯汀滴眼液 | 2031-04-20 | 2030-10-20 |
Under the Provisions for Drug Registration (药品注册管理办法) Art. 82, an application to renew an overseas-manufactured drug registration is filed with the Center for Drug Evaluation no later than 6 months before the certificate expires; the filing line column is that arithmetic applied to the expiry cell. Art. 84(1): a certificate with no application by expiry is not re-registered and is cancelled at expiry. Every figure is taken from the public NMPA database as of 2026-06-28, or computed from it. Registration data changes; the NMPA portal governs. This page states no view on whether any of these products' Domestic Responsible Person (境内责任人) arrangements meet NMPA Announcement No. 137 — that cannot be determined from a public entry.