Definition of Minor Variations
- Inclusion of product (finished or raw material) and/or product line.
- Inclusion of sources such as toll manufacturer/repacker, trader.
- Inclusion of activities (e.g., change from Manufacturer to Toll Manufacturer/Repacker/Importer/Exporter or Trader to Trader/Importer/Exporter for raw materials and bulk products).
- Change in business name or address of the source.
- Change of key personnel, including Quality Assurance, Quality Control, Production Manager, Authorized Person, and Pharmacist.
- Deletion of product, source, and/or activity.
Definition and Requirements for Major Variations
- Major variations require re-issuance of License to Operate (LTO) as they affect the LTO form itself.
- Examples of major variations:
- Change of business name.
- Change of ownership.
- Transfer of establishment location.
- Re-classification of the establishment (e.g., Distributor/Importer to Distributor/Wholesaler), except reclassification into another class such as Trader.
Fees and Payment Procedures
- Appropriate fees collected for each variation as per A.O. 50 s. 2001 or the Revised 2001 Schedule of Fees.
- Transfer of location regarded as an initial application with respective fees.
- Multiple minor variations can be included in a single certification, but fees apply to each individual variation.
- For partnerships/corporations, business name and ownership changes can be combined as one major variation if incorporators/shareholders remain the same; single payment applies.
- Additional payment of 1% filing fee for the Legal Research Fund (mandated by R.A. No. 3870 as amended) is required before application receipt.
- Fees are subject to future revisions under applicable rules and regulations.
Application and Implementation Procedures
- Standard application processes must be strictly adhered to for variations.
- Variations applications received in the last quarter of the preceding year are covered by this Circular.
- Immediate effectivity and enforcement of this Circular upon issuance.
Compliance and Administrative Details
- Previous LTO and certifications must be surrendered to the FDA upon renewal.
- Minor variations are only incorporated during the re-issuance of LTO, not instantaneously.
- Clear differentiation between minor and major variations ensures proper licensing procedure and fee collection.
- Certification issuance aims to promote fast and quality service delivery by the FDA.
This Circular helps streamline the management of changes in FDA licensed establishments by categorizing variations, simplifying minor variation processing, ensuring proper fees collection, and defining clear administrative procedures.