On November 8, 2021, the NMPA (National Medical Products Administration) published a Q&A article to respond to frequently asked questions in relation to the new CSAR framework for cosmetics filing and registration in China.
Q1. Can the registration applicant, filing person and entrusted manufacturer appoint the same person to be in charge of product quality and safety?
Answer: If the registration applicant, filing person and entrusted manufacturer belongs to the same corporate group and also uses the same quality management system, the three parties can appoint the same person in charge of quality and safety, otherwise, they can only appoint a different person in charge.
Q2. Can the person in charge of quality and safety authorize others to perform their duties on their behalf?
Answer: With the written consent of the legal representative or the main person in charge, the person in charge of quality and safety can authorize others to perform their duties on their behalf. The authorized person shall have corresponding qualifications and ability to perform duties. The time period, personnel and matters shall be truthfully recorded to ensure that the authorized actions can be traced back. The person in charge of quality and safety shall supervise the performance of the authorized person, and bear the legal responsibility instead of transferring it to the authorized person.
Q3. Should businesses in the cosmetic industry establish and implement sales record system?
Answer: Yes, but only required for the registration applicants, filing persons and entrusted manufacturers. Shopping malls and supermarkets are not required to have a sales record system, but they should ensure that the products are traceable. If the sales transaction occurs between businesses, they are encouraged to establish and implement a sales record system.
Cosmetics filing and registration continues to mature with the CSAR framework. Cisema has supported many cosmetics companies with their product filings and registration under the new framework. Hear what you’ve been missing and contact us today.
By Jeff Jiang. Contact Cisema if you would like to learn more.