As of January 1, 2011, ASEAN harmonization registration of cosmetics has been fully implemented in Thailand. The Thai FDA now requires that the distributor or marketing authorization holder maintain a Product Information File (PIF) at their office. The PIF must be readily available for inspection by Thai FDA post-marketing inspection officers, who may visit companies in order to make on-the-spot decisions about product liability or product quality complaints. At a minimum, the PIF Part I regarding administrative documents and product summary must be kept at the office of the distributor or marketing authorization holder.
The FDA has recently announced that they will start conducting random audits on cosmetics companies to check whether their business place registration is in order and to check their PIF Part I compliance. Failure to comply could lead to imprisonment for a term of not more than one month and/or a fine of up to THB 10,000 (about USD 350).
If you have any questions about these potential FDA audits, please contact Alan Adcock, Partner and Deputy Director, Intellectual Property, at [email protected].
