Question & AnswerQ&A (FDA CIRCULAR NO. 2014-006)
The previous LTO and the related certification must be surrendered to the FDA Office.
Minor variations include addition of products (finished or raw materials), product lines, sources (such as toll manufacturers/repackers, traders), changes in activity (e.g., manufacturer to toll manufacturer, trader to importer), change of business name/address of the source, change of key personnel for Quality Assurance, Quality Control, Production Manager, Authorized Person and Pharmacist, and deletion of products, sources, or activities.
Major variations include change of business name, change of ownership, transfer of location of the establishment, and re-classification of the establishment (e.g., from distributor/importer to distributor/wholesaler) except when reclassified to another class such as trader.
Yes, multiple minor variation applications can be issued under one certification. However, payment must be made for each minor variation separately.
Transfer of location is considered as an initial application, and appropriate fees must be paid accordingly.
Yes, provided that the incorporators or shareholders as indicated in the previous SEC registration remain the same. One single payment shall be collected for such variations.
A payment of one percent (1%) of the filing fee for the Legal Research Fund is required, imposed by R.A. No. 3870, as amended by PD 200 and PD 1856.
The Circular takes effect and is implemented immediately upon issuance.
Applicants must follow the usual application process strictly. All variation applications received within the last quarter of the preceding year are covered by the issuance.