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Laws and Regulations

GENERAL

FDA CIRCULARS
Number Subject Date Posted
FDAC 2010-010 Cut-Off Time for Receiving of Applications and Payments of Fees in FDA 24 May 2010 28 May 2010
FDAC 2010-007 Automatic Renewal of License to Operate (LTO) 15 Mar 2010 19 Mar 2010
FDAC 2010-003 Revised Fees for Seminar on Licensing of Drug Establishments 20 Jan 2010 02 Feb 2010
BC 2009-001 Rules on the Pilot Implementation of the BFAD Integrated Informstion System (BIIS) 21 Jan 2009 21 Jan 2009
BC 2008-002 Seminar Fees for the Participants of Seminars on Licensing of Establishments and Product Registration 10 Jun 2008 11 Jul 2008
BC 2007-007 Products Imported from China 27 Jul 2007 06 Aug 2007
BC 2007-005 Supplemental Guidelines for the Processing of Principal Certificate of Product Registration (CPR) 02 Apr 2007  
BC 2007-004 Guidelines for the Implementation of Administrative Order No. 2007-006 (Amendment to Administrative Order No. 46 s. 1988 Re: Organizational Arrangements to Implement the National Drug Policy) 23 Feb 2007 05 Mar 2007
BC 2007-001 Mandatory Submission of List of Products Being Handled 29 Jan 2007  
BC 2006-015 Guidelines for the issuance of a Conditional Certificate of Product Registration for Veterinary Products with Initial Registration with the Bureau of Food and Drugs 18 Oct 2006 26 Oct 2006
xBC 2006-014 Licensing of Veterinary Establishments 04 Oct 2006 18 Oct 2006
BC 9 s. 2006 Amendment to Bureau Circular No. 06 s. 2005 - List of Recognized Laboratories 22 May 2006  
BC 2 s. 2006 Implementation of Bureau of Food and Drugs Quality Seal Program in line with the FOURmula ONE for Health Initiative 09 Feb 2006  
BC 21 s. 2005 Cut-off Time for the Receiving of Payments of Fees in BFAD 11 Nov 2005  
BC 20 s. 2005 Revised Assessment Slips 24 Oct 2005  
BC 10 s. 2005 Creation of the Joint BFAD Inspectorate Team 5 May 2005  
BO 133-d s. 2004 Amendment of B.O. No. 35-g s. 2004 RE: Creation of BFAD-Industry Implementation Working Group on the Harmonization for Pharmaceuticals 12 Nov 2004  
BC 13 s. 2004 Clarification of par. a, Bureau Circular No. 6 s. 1999 (Revised B.C. No. 4 s. 1999 "New Protocol for Registration of Drugs, Foods, Cosmetics and Medical Devices) 27 Sep 2004  
BC 11 s. 2004 Food and Drugs (Composition and Labeling Amendment) Regulation 2004 issued by Hongkong Food and Environmental Hygiene Department 02 Aug 2004  
DM 67 s. 2004 Authority of Food Drug Regulatory Officers to Perform Inspection and Other Regulation Duties on Weekends (Saturdays and Sundays) Relative to the Expansion of Botika ng Barangays (BnBs) 16 Jun 2004  
BC 06 s. 2004 Office of the President Memorandum Order No. 136: Approving the 2004 Investment Priorities Plan 18 May 2004  
BO 35-g s. 2004 Creation of BFAD-Industry Implementation Working Group on the Harmonization for Pharmaceuticals 29 Mar 2004  
BC 01 s. 2004 Sale of BFAD: ICR Mice and BFAD: SD Rat 08 Jan 2004  
BC 08 s. 2001 Guidelines to be Observed on the Implementation of Product Recall System 06 Jul 2001  
BC 6-A s. 2001 Revised Minimum Required Samples for Laboratory Analysis 11 Jun 2001  
BC 3 s. 2001 Cancellation of the Certificates of Product Registration, Seizure and Confiscation of BFAD registered products, which do not conform to their registered specification. 05 Apr 2001  
BC 6 s. 2000 Authentication of Documents 16 Aug 2000  
BC 21 s. 1999 Guidelines for the Evaluation of Brand Names for Products to be Registered with the Bureau of Food and Drugs 27 Oct 1999  
BC 22 s. 1999 Deletion of the Requirement for a Certificate of Brand Name Clearance in Filing an Application for Registration of Branded Product 27 Oct 1999  
BC 8-A s. 1999 Guidelines in the Collection and Submission of Samples of Food, Drugs, Cosmetics, and Medical Devices for Physico-Chemical Analysis 19 Apr 1999  
BC 6 s. 1999 Revised Bureau Circular No. 4 s. 1999 “New Protocol for Registration of Drugs, Foods, Cosmetics and Medical Devices" 15 Feb 1999  
BC 5 s. 1999 Revised Process of Submission of Application for Product Registration 10 Feb 1999  
BC 4 s. 1999 New Protocol for Registration of Drugs, Foods, Cosmetic and Medical Devices 03 Feb 1999  
BC 3 s. 1998 Upgrading of Manufacturing Facilities in Consonance with CGMP Requirements Beginning 1996 Up to Year-End 1999 14 May 1998  
BC 13 s. 1997 Submission of the List of Winners 05 Sep 1997  
BM 24 s. 1997 Steps/Procedure in the Unsealing of Boxes Containing Seized Products for Collection of Samples for Examination 14 Aug 1997  
BC 2 s. 1997 Accreditation of Drug Liaison Officers to BFAD 04 Feb 1997  
BC 3 s. 1997 Guidelines for the Processing of Requests for Authentication for Copies of BFAD Official Documents by Parties other than the Department of Health or any of Its Agencies 03 Feb 1997  
BFAD CIRCULAR 12 s. 1991 Clarification of New Registration when there is a Change of Manufacturer 28 Jun 1991