Berlin-Chemie AG — China drug registrations and re-registration deadlines
7 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2028-11-30.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20150563 | Priligy 盐酸达泊西汀片 | 2029-05-30 | 2028-11-30 |
| 国药准字HJ20150564 | Priligy 盐酸达泊西汀片 | 2029-05-30 | 2028-11-30 |
| 国药准字HJ20140208 | Zostex 溴夫定片 | 2029-06-16 | 2028-12-16 |
| 国药准字HJ20160184 | Espumisan 西甲硅油乳剂 | 2029-09-09 | 2029-03-09 |
| 国药准字HJ20160197 | Espumisan 西甲硅油乳剂 | 2029-09-09 | 2029-03-09 |
| 国药准字HJ20160235 | Letrox 左甲状腺素钠片 | 2029-12-12 | 2029-06-12 |
| 国药准字HJ20160236 | Letrox 左甲状腺素钠片 | 2029-12-12 | 2029-06-12 |
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.