Philippines: Automatic Renewals of Licenses to Operate

In March 2010, the Philippine Bureau of Food and Drugs (BFAD) announced that it will be issuing Automatic Renewals for Licenses to Operate (LTO) that are set to expire within the end of this year. These LTOs are those belonging to registered drug and medical device manufacturers under Regulation Division II. These renewals will be issued without any required inspection.

The Application for Automatic Renewal will be accepted 3 months before the LTO expiry date. The entity that is seeking this Automatic Renewal must fulfill the following:

  • Be operational for at least one year
  • Have no violative products reported for the past year
  • Have latest issuance of LTO not earlier than 2008
  • Have valid contracts of the following as required:
  • Manufacturing Agreements with toll manufacturers (for traders only)
  • Contract of Lease for plant site/office site
  • Warehouse (if located separately)
  • Have a pharmacist of good standing (rendering full time service) for the past year, if applicable
  • No previous noted deficiencies
  • Have systemized distribution records (whether manual or computerized recording)
  • Have compilation of relevant SOPs

Additional criteria for manufacturers:

  • Must have been inspected last year (2009) with no deficiencies or CAPA has been verified satisfactorily
  • Must have no changes in its updated Site Information File (SIF)

Those applying for renewal should pay renewal fees and submit the following supplemental documents:

  • An application letter for renewal of LTO and photocopy of Official Receipt for renewal payment
  • An affidavit attesting that the company has no changes in its operation and set-up, in order to avail of the said automatic renewal