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 ANNEX C  
 
LIST OF REQUIREMENTS FOR SPECIFIC VARIATION IN THE LTO  
 
1. Major Variation for Local Manufacturers  
 
Type of Variation  Requirement  
Transfer of Location of 
Manufacturing/Packing/Repacking 
Plant  
 
Physical transfer of the establishment 
(and may entail changes in the 
previously approved address)  
 1. Application Form  
2. Proof of business address 
reflecting the new plant location:   
a. For Single Proprietorship:  
Business Permit/Mayor’s 
Permit or Barangay Business 
Permit/Clearance reflecting the 
new plant location;   
b. For SEC -registered  
establishments:   
- Amended Articles 
of Incorporation (if transferred 
from one  city/municipality/ 
province); or   
- Updated General Information 
Sheet (GIS) from SEC (if 
transferred from one  city/ 
municipality/province)   
  
If the establishment address is different 
from the address indicated in the SEC 
Registration, provide Business 
Permit/Mayor’s Permit or Barangay 
Business Permit/Clearance reflecting 
the new plant location.  
 
3. Updated Site Master File  
4. Updated floor plan or plant lay -out 
5. Payment of appropriate fees.  
Expansion of 
Manufacturer/Packer/Repacker and/or 
Additional Product Line; or Change of 
Manufacturing Activity  
 
 Expansion shall refer to expansion 
made which is adjacent to the 
existing location of the 
establishment  
 Additi onal product line refers to 
additional type or class of products 
produced within the same 
manufacturing site (e.g., sterile line, 
beverage line, etc.)  1. Application Form  
2. Updated Site Master File and Floor 
Plan showing the expansion made 
to be presented upon inspection  
3. Payment of appropriate fees.  
 
For drug and food products, 
satisfactory laborato ry analysis of not 
more than one (1) year from the 
issuance shall also be presented  Page 2 of 5 
  Change in manufacturing activity 
shall refer to an additional activity 
that a manufacturer engages in (e.g., 
LTO as Manufacturer -Repacker to 
Manufacturer -Packer)  
 
 
2. Minor Variation  
 
Transfer of Location of Offices  
 
Physical transfer of the office of the 
establishment  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Proof of business address reflecting the 
new office location:  
 
1. Application Form  
2. For Single Proprietorship  
Business Permit/Mayor’s Permit or 
Barangay Business 
Permit/Clearance reflecting the new 
office location;  
3. For SEC -registered 
establishments  
b. Amended Articles of 
Incorporation (if transferred 
from one 
city/municipality/province); 
or 
c. Updated General 
Information Sheet (GIS) 
from SEC (if transferred 
within the same 
city/municipality)  
4. PEZA Certificate reflecting the new 
office address, if applicable  
5. Notarized Contract of Lease or any 
proof of ownership of the new 
office location  
6. Payment of appropriate fees.  
 
If the establishment address is different from 
the address indicated in the SEC 
Registration, provide LGU/Mayor’s Permit 
or Barangay Business Permit/Clearance 
reflecting the new office location . 
Transfer of Location of Drug 
Retailers  
 
Physical transfer of the drug retailer 
establishment  
 Proof of business address reflecting the 
new location of drug retailer:  
 
1. Application Form  
2. For Single Proprietorship  
Business Permit/Mayor’s Permit or 
Barangay Business Page 3 of 5 
 Permit/Clearance reflecting the new 
location of drug retailer;  
3. For SEC -registered 
establishments  
d. Amended Articles of 
Incorporation (if transferred 
from one 
city/municipality/province); 
or 
e. Updated General 
Information Sheet (GIS) 
from SEC (if transferred 
within the same 
city/municipality)  
4. Payment of appropriate fees.  
 
If the establishment address is different from 
the address indicated in the SEC 
Registration, provide LGU/Mayor’s Permit 
or Barangay Business Permit/Clearance 
reflecting the new location of drug retailer . 
Change of Distributor Activity  
 
Shall refer to an additional/deletion 
of/change in activity that the 
distributor engages in.  1. Application Form  
2. Contract Agreements showing 
change in activity  
3. Payment of appropriate fees.  
Transfer/Addition of Warehouse  
 
Physical transfer and addition of the 
warehouse of the establishment  
 1. Application form  
2. Business permit/Mayor’s 
permit/Barangay Clearance 
reflecting the new address  
3. Contract of Lease including the 
warehouse address  
4. PEZA certificate reflecting the new 
warehouse address, if applicable  
5. Payment of appropriate fees  
 
Additional Drugstore Activities  1. Application Form  
2. Additional Credentials of Pharmacist, 
as applicable  
3. Other documents related or specifi c to 
the additional activity, such as but not 
limited to:  
a. Adult vaccination  
i. Standard Operating Procedure 
(SOP) for the cold chain 
management following FDA 
Circular 2021 -003 (Revised 
Guidelines on the Cold Chain 
Management for Page 4 of 5 
 Pharmaceutical Products and 
Establishments)  
ii. SOP for the vaccination/ 
immunization activities  
iii. Certification as a Certified 
Immunizing Pharmacist  
b. Dispense Vaccines and Biologicals  
i. SOP for the cold chain 
management following FDA 
Circular 2021 -003 
c. Mobile Pharmacy  
i. SOP for the conduct of m obile 
pharmacy activities  
ii. Image/Picture with 
description of the mobile 
pharmacy vehicle  
iii. Credentials of the supervising 
pharmacist of the mobile 
pharmacy  
d. Online Ordering and Delivery  
i. SOP for the online ordering 
and delivery activities  
ii. Website link  
iii. Website screenshot showing 
the ordering system and the 
placement of LTO details  
iv. Other documents as required 
in separate issuance for e -
Pharmacy  
e. Sterile Compounding and Non -
Sterile Complex Compounding  
i. SOP for the compounding 
activities.  
4. Payment of appropria te fees.  
 
NOTE: The establishment shall be inspected 
for GMP clearance prior approval of the 
variation.  
Expansion of Office Establishments 
and Drug Retailers  
 
Shall refer to expansion made which 
is adjacent to the existing location of 
the establishment  1. Application Form  
2. Current floor plan  
3. Expansion floor plan  
4. Payment of appropriate fees  
 
Change in ownership of the 
establishment  
 
Change only in the business name of 
the establishment  1. Business name registration reflecting 
new ownership;  
2. Any proof of the transfer of 
ownership such as any of the 
following;  Page 5 of 5 
  i. Deed of Sale or Assignment or 
Transfer of Rights/Ownership;  
 ii. Memorandum of Agreement 
(MOA);  
iii. Notarized Affidavit of the owner, 
proprietor, chairman or CEO of the 
establishment  validating the transfer.  
3. Payment of appropriate fees  
Zonal Change in Address  
 
Change of the name/number of the 
street/building without physical 
transfer of the establishment  1. Application Form  
2. Certificate of Zonal Change from the 
Local Government Unit or Business 
Permit/Mayor’s Permit/Barangay 
Clearance stating that there is no 
actual transfer of the establishment  
3. Payment of appropriate fees  
Change of Qualified Person  
 
Change in the identified qualified 
person initially registered with the 
FDA  1. Application Form  
2. Valid PRC ID  
3. Proof of termination of employment, 
if previously connected with another 
pharmacy/establishment or 
Notarized Waiver of Liability/ 
Sworn Statement stating the QP is 
effectively  resigned from the 
previous employer.  
 
For Pharmacists handling multiple 
RONPDs: List of all RONPDs handled by 
the Pharmacist (to include, Name of 
establishment, Address, Day and Time of 
shift and LTO Number)  
 
4. Payment of appropriate fees.  
Change of Author ized Person  
 
Change in the authorized person 
initially registered with the FDA  1. Application Form  
2. Valid government issued ID  
3. Payment of appropriate fees.  
Addition/Deletion of Sources and 
Products  
 
Addition/deletion of source(s) and 
product(s) in the previous/existing 
list 
 
 1. Application Form  
2. Notarized Valid Contract 
Agreement; For foreign source(s), a 
copy of the contract agreement duly 
authenticated by the host 
government of the country of origin 
(legalized by the Philippine 
Embassy/Consulate if from a non -
Apostille country  
3. Payment of appropriate fees.