Sri Lanka Implements ISO 22716 Certification for Cosmetics Manufacturers

On May 29, 2024, the National Medicines Regulatory Authority (NMRA) of Sri Lanka issued a notice, necessitating cosmetic manufacturing sites to acquire ISO 22716 certification from the Sri Lanka Standards Institute (SLSI), effective May 1, 2024. Under this directive, Good Manufacturing Practice (GMP) Inspections for cosmetics plants by NMRA will cease, shifting to reliance on ISO 22716 GMP certification by SLSI.

The transition arrangement is as follows:

• Existing approved sites will have a two-year grace period until May 31, 2026, to comply with the ISO 22716 certification requirement. 

• Sites with pending applications will undergo GMP inspections by the NMRA, with a stipulation to acquire ISO 22716 certification within two years from May 1, 2024. 

• New applicants are required to submit a comprehensive site master file containing essential details about the site and the intended manufactured products. Upon acknowledgment from the NMRA, they can proceed with the ISO 22716 GMP certification application.