Guangdong Simplifies Record-Filing of Drug Package Inserts and Labels

On 13 March, the General Office of the Guangdong Provincial Medical Products Administration issued a notice relating to record-filing of drug package inserts and labels (Yue Yao Jian Ban Xu No. 95 [2020]). It states that, in accordance with Announcement No. 103 [2019] of the National Medical Products Administration, all enterprises or drug development institutions holding a drug registration certificate will become drug marketing licence holders, with effect from 1 December 2019. The licence holder shall, in accordance with the provisions of Article 49 of the Drug Administration Law, indicate on the drug package insert sheet, or label, its name and address, the manufacturer’s name and address, and other relevant information. If the licence holder and manufacturer are the same entity, the licence holder may revise such information on the package insert sheet or label at its own discretion without having to submit a record-filing application to the provincial medical products administration.

Source: Guangdong Provincial Medical Products Administration