Situations of Ampoules, Vials, and Syringes Containing Cosmetic Products in Chiang Mai Province and Regulatory Measures for Pre and Post-marketing

Abstract

Background: Cosmetic products packaged in vials were typically classified in the low-risk group (auto-submission) rather than the high-risk group. However, there exists a regulatory gap between pre- and post-marketing stage in Chiang Mai.

Objectives:This study aimed to explore the regulatory situation for cosmetics packaged in ampoules, vials, and syringes, as well as identify regulatory gaps and propose regulatory measures for pre- and post-marketing stage in Chiang Mai.

Methods: The study employed methodology (quantitative and qualitative research) and was conducted in Chiang Mai from August to December 2023.

Results: Pre-marketing registration yielded nine importation licences for ampoules, vials, and syringes containing cosmetic products. Within this group, a problem related to misuse in aesthetic clinics was identified, which could potentially harm consumers. To address pre- and post-marketing regulatory gaps in Chiang Mai, this research proposes the following measures. Conduct post-audits after automatic registration approval within 7 days, with a specific focus on facial skin care cosmetics packaged in glass or plastic bottles. This measure aligns with Thai food and drug administration procedures and aims to prevent incorrect group submissions. Regularly inspect cosmetic production and import locations every 6 months post-approval to prevent unrelated production or imports without proper registration. Collaborate with post-marketing and health service staff to monitor and inspect mis-indication use, ensuring efficient regulation and enforcement. Scrutinise ampoules, vials, and syringes containing cosmetic products based on importation licence details and actual product labels.

Conclusion: This research illuminates the regulatory gaps associated with ampoules, vials, and syringes containing cosmetic products in Chiang Mai. During the pre-marketing stage, discrepancies between filed registrations and actual products were rectified. Additionally, misuse was addressed during the post-marketing stage. Policy suggestions and regulatory measures have been systematically integrated and developed in the Chiang Mai Provincial Public Health Office to safeguard consumer health.