How to Apply for Variations with the Food and Drug Administration

How to Apply for Variations with the Food and Drug Administration

Do you want to add production lines or change your establishment’s business name? Do you want to transfer the location of your manufacturing plant or add additional floor in your building of production? Do you want to add additional activity of your business such as online ordering and delivery?

You can do these provided you must comply with the provisions of the law and existing regulations.

Reasonable variations are permitted, but requires prior FDA approval. Food and Drug Administration (“FDA”), formerly known as Bureau of Food and Drugs (BFAD) under the Department of Health (“DOH”), is the agency of the government which handles the registration of processed foods, drugs, medical devices, in vitro diagnostic reagents, cosmetics, and household hazardous substance products. It shall also approve variations made by establishments covered by the said office.

Variations may either be major or minor

Major variations cover changes in the operations of the establishment that may affect significantly and/or directly the aspects of safety and quality and when applicable, efficacy of products.  Major variation shall only be approved upon proper notification, compliance with requirements, and inspection by the FDA.

Minor variation covers changes in administrative matters and/or changes in the operations of the establishment but with minimal impact on the safety, quality and, when applicable, the efficacy of products.

What are the different types of variations and their corresponding documentary requirements?

Major Variation

Major variation refers to post-FDA approval changes in the status, condition or activity of a licensed establishment where inspection is required prior to approval of variation.

Major variations include the following:

Transfer of Location of Manufacturing Plant and Drug Retailers

It is the physical transfer of the establishment (and may entail changes in the previously approved address) and other variations (e.g. change of pharmacist or qualified personnel, and/or business name) may also be included in the application for variation provided that the same are included therein and the corresponding requirements for such changes are included.

The documentary requirements are the following:

  1. Application Form
  2. Business permit reflecting the new address
  3. Updated Site Master File
  4. Payment

Expansion of Manufacturer

It shall refer only to the expansion made which is adjacent to the existing location of the establishment and no additional product line is involved. Expansion shall also include additional floors for production.

The documentary requirements are the following:

  1. Application Form
  2. Updated Site Master File
  3. Payment

Additional Production Line

An additional production line is an added type or class of products produced within the same manufacturing site (e.g., sterile line, beverage line, etc.)

The documentary requirements are the following:

  1. Application Form
  2. Updated Site Master File
  3. Payment

Change of Manufacturing Activity

This shall refer to an additional activity that the manufacturer engages in (e.g., LTO as Manufacturer with additional activity as Repacker). It shall also refer to a change of previously licensed activity (e.g., LTO as Manufacturer-Repacker to Manufacturer-Packer).

The documentary requirements are the following:

  1. Application Form
  2. Updated Site Master File
  3. Payment

Transfer/Addition of Warehouse

It shall refer to the physical transfer of warehouse. It shall also refer to an addition of warehouse aside from the existing and previously inspected warehouse by FDA.

The documentary requirements are the following:

  1. Application Form
  2. Business permit reflecting new warehouse
  3. Payment

Minor Variations

Minor variation refers to changes in the status, condition or activity or a licensed establishment which are not critical to the safety or quality, or in the purity or efficacy, when applicable, of the health product.

Transfer of Location of Offices

It refers to the physical transfer of the office of the establishment (which may also entail changes in the previously approved address). Other variations (e.g., change of pharmacist or key personnel, and/or business name) may also be included in the application for variation provided that the same are indicated therein and the corresponding requirements for such changes are included.

The documentary requirements are the following:

  1. Application Form
  2. Business permit reflecting new address
  3. Payment

Change of Distributor Activity

It shall refer to an additional activity that the distributor engages in (e.g., LTO as Distributor-Importer with additional activity as Exporter) It shall also refer to a change from the initially licensed activity (e.g., LTO as Distributor-Importer to Distributor-Exporter).

The documentary requirements are the following:

  1. Application Form
  2. Contract Agreements to prove activity
  3. Payment

Expansion of Office Establishment and Drug Retailers

It shall refer to the expansion made which is adjacent to the existing locations of the establishment. Expansion shall also include additional floors where the building is occupied.

The documentary requirements are the following:

  1. Application Form
  2. Payment

Additional Drugstore Activity

Additional activity shall include online ordering and delivery, sterile compounding and non-sterile complex compounding, mobile pharmacy, carrying of medical devices, and other additional activities that may require appropriate regulation or may be handled on a case to case basis. These additional activities may already be included in the initial application.

The documentary requirements are the following:

  1. Application Form
  2. Additional Credentials of Pharmacist (e.g., Certificate of Training, where applicable)
  3. Documents related to activity with proof of validation (e.g., SOP, Masterlist of compounding recipes)
  4. Payment

Change of Ownership

There is a minor variation when there is a change of ownership of the licensed establishment.

The documentary requirements are the following:

  1. Application Form
  2. Any proof on the transfer of ownership such as any of the following: Deed of sale or assignment or transfer of rights/ownership, Memorandum of Agreement, or notarized Affidavit of the owner, proprietor, Chairman or CEO of the establishment validating the transfer.
  3. Payment

Change of Business Name

This refers to change only in the business name and no transfer of location or change of ownership.

The documentary requirements are the following:

  1. Application Form
  2. Proof of business name registration reflecting the new name.

Zonal Change in Address

This shall refer to change of the name/number of the street/building without physical transfer of the establishment.

The documentary requirements are the following:

  1. Application Form
  2. Payment

Change of Qualified Personnel

In this case, there is a change of the identified qualified person registered with FDA.

The documentary requirements are the following:

  1. Application Form
  2. Payment

Deletion of Activity

It shall refer to deletion of any approved/added activity.

The documentary requirements are the following:

  1. Application Form
  2. Payment

A Site Master File refers to a document prepared by the manufacturer and contains specific information about the quality management policies and activities of the site, the production and/or quality control of manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. It provides clear information on the manufacturer’s GMP related activities that are useful in general supervision and in the efficient planning and undertaking of GMP inspections.

About Nicolas and De Vega Law Offices

If you need assistance in registration with the Food and Drug Administration, applications for Licenses to Operate, drug, cosmetic, medical device or food registration, assistance in notifications filed under the ASEAN Harmonization Law, or have issues in corporate law, commercial law, corporate or commercial litigation, or civil or other criminal law-related issues,  we can help you. Nicolas and de Vega Law Offices is a full-service law firm in the Philippines.  You may visit us at the 16th Flr., Suite 1607 AIC Burgundy Empire Tower, ADB Ave., Ortigas Center, 1605 Pasig City, Metro Manila, Philippines.  You may also call us at +632 84706126, +632 84706130, +632 84016392 or e-mail us at [email protected]. Visit our website https://ndvlaw.com.

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