APPLICATION FOR LTO VARIATION

In the interest of delivering a fast and quality service, this Office
shall be issuing a Certification for those FDA licensed establishments
applying for minor variation during the validity of their Licenses to
Operate. This certification shall form an integral part of the LTO
attachment issued at the time its LTO is renewed. Consequently, all
minor variations shall be incorporated once LTO is re-issued for
renewal. Thus, previous LTO and certification related thereto shall be
surrendered to this Office.

Minor variations referred hereto shall include the following:

1. Inclusion of product (finished or raw material) and/or product line
2. Inclusion of sources (including toll manufacturer/repacker, trader)
3. Inclusion of activity e.g. from Manufacturer to Toll
   Manufacturer/ Repacker/ Importer/Exporter or Trader to Trader/Importer/
   Exporter (raw materials and bulk products)
4. Change in business name/address of the source
5. Change of key personnel for Quality Assurance, Quality Control, Production Manager, Authorized Person and Pharmacist
6. Deletion of product, source and/or activity

Major variations, as enumerated below, shall require re-issuance
of License to Operate as these are reflected in the LTO form itself:

1. Change of business name
2. Change of ownership
3. Transfer of location of the establishment
4. Re-classification of the establishment (e.g. from
   Distributor/Importer to Distributor/Wholesaler), except for those which
   were reclassified into another class of establishment (e.g. from
   Distributor/Importer/ Wholesaler to Trader).

Appropriate fee shall be collected for each variation as provided
under A.O. 50 s. 2001 or the Revised 2001 Schedule of Fees and Charges
for the Corresponding Services Rendered by the Bureau of Food and Drugs,
except transfer of location which shall be considered as initial
application. Multiple applications for minor variations may be issued
under one certification only. However payment shall be made for each
minor variation (e.g. Inclusion of source and deletion of source).

For partnership/corporation, change of business name and
corporate ownership may be applied under one major variation provided
that its incorporators/ shareholders as indicated in previous SEC
registration remain the same. A single payment shall be collected for
such variations.

Likewise, payment of one percent (1%) of the filing fee for the
Legal Research Fund (imposed by R.A. No. 3870, as amended by PD 200 and
further amended by PD 1856, otherwise known as “An Act Defining the
Functions of the U.P. Law Center, Providing for its Financing and for
other Purposes”) shall be made prior to receipt of the application.

The aforementioned fees are subject to change should there be
any revision on the existing rules and regulations implementing the
same.

The usual application process shall be strictly followed. All
variation applications received within the last quarter of the preceding
year shall be covered by this issuance.

This Circular shall take effect and implemented immediately.

(SGD) KENNETH Y. HARTIGAN-GO, MD
Acting Director-General