Karo Healthcare AB — 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: 2029-04-28.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20160650 | Terbinafine Hydrochloride Pigment 盐酸特比萘芬涂膜剂 | 2029-10-28 | 2029-04-28 |
| 国药准字HJ20170081 | Terbinafine Hydrochloride Cream 盐酸特比萘芬乳膏 | 2029-10-28 | 2029-04-28 |
| 国药准字HJ20170082 | Terbinafine Hydrochloride Cream 盐酸特比萘芬乳膏 | 2029-10-28 | 2029-04-28 |
| 国药准字HJ20170204 | Terbinafine Hydrochloride Spray 盐酸特比萘芬喷雾剂 | 2030-03-20 | 2029-09-20 |
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.