Question & AnswerQ&A (FDA Circular No. 2015-006)
The circular mandates the issuance of a new License to Operate (LTO) format for drug establishments following the implementation of Administrative Order No. 2014-0034, ensuring that only pertinent information is reflected on the LTO.
It covers establishments engaged in manufacture, conduct of clinical trials, distribution, importation, exportation, and retailing of drug products as well as the issuance of other related authorizations.
The new LTO format includes the name and address of the establishment, name of owner, LTO number and validity, and payment details.
Yes, names of pharmacists and/or key personnel such as production head, quality control and quality assurance manager, and authorized person to release the batch may be shown where applicable.
The list of sources, whether imported or locally manufactured finished pharmaceutical products and/or raw materials, will no longer be included as an attachment to the LTO but will be reflected only in the FDA database.
Activities include importation of raw materials for own production, importation of finished products for local packing/repacking, exportation of own products, and contracting activities as defined in Administrative Order No. 2014-0034.
No, this information shall no longer be included as an attachment but will be reflected solely in the FDA database.
The Certificate issued for the approved variation application shall be considered as an attachment to the LTO until it is renewed.
The establishment must submit a Notification Letter to the FDA through the Public Assistance, Information and Receiving (PAIR) or the respective Regional Office without a prior appointment.
A Document Tracking Slip (DTS) is issued as proof of receipt and that the FDA has been duly notified of the change.
Failure to inform the FDA of any changes may subject the establishment to appropriate regulatory action.
It supersedes FDA Memorandum Circular No. 2014-002.