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September 5, 2012

Client Alert: New Requirements for First-Time Overseas Pharmaceutical Manufacturers

Tilleke & Gibbins

Starting October 1, 2012, overseas pharmaceutical manufacturers that have never before been recorded in the Drug Product Registry of Thailand will need to be accredited by the Thai Food and Drug Administration (FDA) before marketing authorization can be obtained. Otherwise, the FDA will not allow the business operator to submit an Application for Importation of Drug Product Sample, which is a required document for drug product registration.

To comply with the recent “Notification of the Thai FDA Regarding the GMP Accreditation of an Overseas Manufacturer,” business operators who import drug products from new overseas manufacturers must submit all of the following additional documents:

  • A Plant Master File, complying with the requirements stated in the Notification of the Ministry of Public Health re: Good Manufacturing Practices (GMP) and Requirements for Manufacturing of Modern Drugs in accordance with the Drug Act B.E. 2555 (2012).
  • A flow chart and other relevant information indicating all manufacturing processes, including premises and equipment involved in the manufacturing of such pharmaceutical product.
  • A GMP inspection report, issued by the authorized government agency of the country of origin or the International Certificate Organizations (if applicable).
  • A current Certificate of GMP, issued by the authorized government agency of the country of origin.

If there is any issue regarding the accreditation for an overseas manufacturer, the FDA may request to conduct an inspection of the overseas manufacturer. Alternatively, the inspection may be requested by the Marketing Authorization Holder or the business operator. All relevant expenses regarding the inspection must be covered by the Marketing Authorization Holder or business operator.

It is therefore essential that from October 1, 2012, importers and distributors of drug products manufactured by new overseas manufacturers take action to submit the required documents to the FDA.