CHANGE OF MANUFACTURERS OF DRUG PRODUCTS IN COMPLIANCE WITH THE CGMP REQUIREMENTS
mandating manufacturing facilities to strictly comply with CGMP
Requirements beginning January 1, 2000 and in order to provide
transitory measures for drug establishments whose products will be
affected thereby, the following rules and regulations are promulgated
for the information, guidance and compliance of all concerned.
1. Issuances of a new Certificate of Product Registration
(CPR) is required if there is a change in the manufacturer as
contemplated above and provided that the following conditions are met:
1.1 The LTO of the current manufacturer shall be cancelled due to non-compliance with the A.O. on CGMP.
1.2 The new manufacturer has already been certified as CGMP Compliant.
1.3 The drug product is validly registered with the BFAD.
1.4 There shall be no change in the formulation, and manufacturing process of the product.
2. Application for CPR shall be supported by the following documents:
2.1 Copy of the LTO of applicant and the new manufacturer
2.2 Agreement between the applicant and the new manufacturer for product accountability.
2.3 Complete set of documents in accordance with the 1997
Guidelines for Registration of Pharmaceutical Products reflecting the
name of the new manufacturer.2.4 Process validation data such as Certificate of Analysis of
product as manufactured by the new manufacturer for three production
batches.2.5 Multi-point dissolution profile done on the product, when
applicable, as produced by the current and the new manufacturer using
compendial or application requirements.2.6 Transitional labeling materials reflecting the complete name and address of the new manufacturer.
A CPR valid for six (6) months shall be issued for applications that
could not immediately supported by document Nos. 2.4 and 2.5 as stated
above, on the condition that the necessary tests shall be conducted with
the results submitted to BFAD within the six-month period.
Upon compliance with all of the above requirements, a new CPR shall
be issued with the same validity as the product’s previous CPR.
A fee of one thousand pesos (P1,000.00) shall be charged per
application for CPR of product complying with the conditions set forth
in this Order.
Any product whose manufacturer has been changed for any other reason
other than that contemplated herein shall be filed and processed as
initial registration.
This Order shall take effect fifteen (15) days after publication in two newspaper of general circulation.
Adopted: 22 Dec. 1999
(SGD.) ALBERTO G. ROMUALDEZ, JR. M.D.
Secretary of Health