Scribd
Upload
46 views2 pages

Fda Memorandum On CPR

Uploaded by

J Velasco Peralta
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF or read online on Scribd
46 views2 pages

Fda Memorandum On CPR

Uploaded by

J Velasco Peralta
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF or read online on Scribd
You are on page 1/ 2
Republic ofthe Philippines Department of Health: Fl FOOD AND DRUG ADMINISTRATION #., MEMORANDUM FOR: GERARDO V. BAYUGO, MD, MP} Undersecretary of Health Chairperson, COBAC-C FROM: BENJAMIN G. CO, MD, FPPS, FPSECP Director IV Center for Drug Regulation and Research Food and Drug Administration SUBJECT: | Reply_to Memorandum dated 10 November 2016, regardin; Requirement for the Submission of GMP Certificate and License to Operate (LTO) during Procurement DATE: 10 February 2017 This refers to the memorandum received by this Office regarding your request for a written position of the Food and Drug Administration (FDA) on whether or not current Good Manufacturing Practice (CGMP) Certificate and License to Operate (LTO) must be required during the bidding of pharmaceutical products. Our position remains that the pre-requisites for the submission of applications for drug registration include: 1) all local establishments involved in the distribution of product is licensed with FDA: and 2) all drug manufacturers involved in the production (both local and abroad) have passed the requirements of cGMP. Any non-compliance, whether at the point of registration or during the validity of the Certificate of Product Registration (CPR) issued shall be grounds for disapproval of the application, cancellation of the CPR, issuance of product recall order for the concerned product together with a public health advisory by the FDA. In order to reduce the documentary review of the Central Office - Bids and Awards Committee-C (COBAC-C), we recommend that only a valid CPR be the requirement during biddings, with subsequent checking of any FDA Advisory on the concerned product for any issue on the safety, efficacy, and quality. Should you have inquiries on the status of cGMP and LTO of a drug product, you may coordinate with the FDA representative to the COBAC-C Technical Working Group (TWG), Givie Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines —— Trunk Line 463 2.857 1900 Fax +632.807 0751 on Website: wwrw-fda.gov.ph Email: [email protected] & = a0 ( Mr. Kenneth Ramdolf M. Manzano, at +63 2 857 1986 to 87 or via email at [email protected]. For your information and guidance. Thank you. LAI in 201612071 12603 Department of Heaith Office for Technical Services Document Coder, | Date:_2/2 [It Time: 0:0 | “ecelved by: PHChe |

You might also like