Regulatory Insights
Local cosmetic manufacturing: site requirements before product registration
Understand NMRA manufacturing acknowledgement, ISO 22716:2007 certification and individual cosmetic product registration in Sri Lanka.
A finished formula is not the same as a ready manufacturing site. Before a locally made cosmetic can move through product registration in Sri Lanka, the manufacturer needs to address the site requirements that sit behind every batch it produces.
The site and the product are different regulatory matters
The National Medicines Regulatory Authority (NMRA) describes the local cosmetic route in three steps: obtain acknowledgement from the Manufacturing Regulatory Division, obtain ISO 22716:2007 certification for the manufacturing site from an appropriately accredited body, and then apply for product registration.
The acknowledgement is an administrative stage in the site's process: under the NMRA's ISO 22716 notice, a new applicant submits a site master file, receives the acknowledgement and uses it to apply for certification. The ISO 22716 certificate addresses the relevant manufacturing practices and scope. Neither of these is a registration certificate for an individual cosmetic product.
The ISO 22716 requirement
In its published manufacturing-site notice, effective 1 May 2024, the NMRA moved to reliance on ISO 22716:2007 certification from the Sri Lanka Standards Institution (SLSI) or a body accredited by the Sri Lanka Accreditation Board (SLAB) for that standard. The notice provided a transitional grace period for existing approved sites ending on 31 May 2026. New applicants should follow the current acknowledgement and certification approach rather than assuming that a routine NMRA cosmetic GMP inspection can be substituted for certification.
Product documentation is still required
Once the applicable site requirements have been addressed, product dossiers must be prepared. The NMRA lists information such as quantitative formulation, finished-product analysis, labels and required declarations. For locally manufactured skincare products, the NMRA states that heavy metal test results for lead, mercury, arsenic and cadmium are mandatory.
The product's claims also matter. The NMRA states that scientific evidence supporting a product claim should relate to the finished product, not only to individual ingredients. Formula, claims, packaging and test evidence should therefore be reviewed together.
Where manufacturers should begin
Before investing in artwork or planning a large product range, identify the intended manufacturing categories, site activities, available quality records and whether the proposed certificate scope covers the actual work. Then prepare a realistic plan for the applicable site and product requirements.
How RAQ can assist
RAQ Consultation supports cosmetic manufacturers with gap assessments, SOP and documentation work, ingredient and claim review, product dossier preparation support and regulatory coordination. RAQ does not issue ISO certificates. Independent certification and NMRA product approval remain the responsibility of the respective competent bodies.
Official references
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