GENERAL

ADMINISTRATIVE ORDERS | BUREAU CIRCULARS | MEMORANDUM CIRCULARS

GENERAL

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BFAD ISSUANCE	Date Issued	Date Posted	SUBJECT
AO 2007-0006	26 Jan 2007		Amendment to Administrative Order No. 46 s. 1988 Re: Organizational Arrangements to Implement the National Drug Policy
AO 0158 (Malacañang)	22 Aug 2006		Ordering the Fast-Tracking of the Computerization of Export-Related Processes of Government Agencies
AO 2006-0009	14 Feb 2006		Guidelines Institutionalizing and Strengthening the Essential Drug Price Monitoring System (EDPMS)
AO 2005-31	07 Dec 2005		Guidelines and Procedure for the Issuance of the Principal Certificate of Product Registration and the Listing of Identical Drug Products based on the Identity of Manufacturer and Pharmaceutical Formulation
AO 2005-30	07 Dec 2005		Guidelines and Procedure for the Automatic Renewal of the Certificate of Product Registration issued by the Bureau of Food and Drugs
AO 16 s 2005	21 June 2005		General Policies and Guidelines Governing Brand Names of Products for Registration with the Bureau of Food and Drugs
AO 163 s. 2002	16 Oct 2002		Implementing Guidelines and Procedures in the Procurement and Requisition of Drugs and Medicines by the Department of Health Pursuant to Executive Order No. 49 dated January 21, 1993
AO 50 s. 2001	17 Sept 2001		Revised 2001 Schedule of Fees and Charge for the Corresponding Services Rendered by the Bureau of Food and Drugs.
DO 47-E s. 2001	01 Mar 2001		Renaming the National Drug Committee into the National Formulary Committee and Defining its Structure and Functions
AO 104 s. 2000	21 Aug 2000		Revised 2000 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Licensing and Regulation, Bureau of Research and Laboratories, Bureau of Food and National Quarantine Office Amendment to A.O. No. 40, s. 2000
AO 18 s. 1999	30 May 1999		Amendment of Administrative Order No. 2-Adated February 23,1997 Re: Prescribing Fees for Certificate of Authentication for Copies of BFAD Official Document, and Amended Certificate of Product Registration
AO 32 s. 1997	22 Dec 1997		Prescribing Fees for Certificates Clearance, Permits And Licenses Issued by the BFAD in Accordance with the Consumer Act of the Philippines, Republic Act 7394
AO 2-A s. 1997	23 Feb 1997		Prescribing Fees for Certificate of Authentication for Copies of BFAD Official Documents, and Amended Certificate of Product Registration
AO 118 s. 1992	27 Jan 1992		Approval of Resolution of BFAD Administrative Cases Recommending Certain Administrative Sanction for Violations of R.A. 3720 as Amended and BFAD Rules and Regulations
AO 117 s. 1992	17 Jan 1992		Providing for the Classification of Household Remedies
AO 104 s. 1991	08 Apr 1991		Importation and Donation of Relief Commodities for use in the Relief and Rehabilitation Programs of the Government for Calamity-Affected Areas
AO 46 s. 1988	07 Jun 1988		Organizational Arrangements to Implement the National Drug Policy (NDP)
AO 116-B s. 1985	27 May 1985		Implementation of Sections 4, and 8, of Executive Order No. 851, Creating the Bureau of Food and Drugs which Shall Assume the Functions of the Abolished Food and Drug Administration
AO 76 s. 1984	24 Jan 1984		Guidelines to be Observed by FDA (BFAD) in Clearance of Name Relative to Food, Drugs and Cosmetics
AO 71 s. 1983	06 Sep 1983		Revised Schedule of Fees and Charges Enforced and Collected by Agencies of the Ministry of Health
AO 72 s. 1983	06 Sep 1983		Seizure and Confiscation of Violative Food, Drug and Cosmetics, for the Protection of the Interest of the Consumers
AO 66 s. 1983	18 Jul 1983		Amending Ministry Order No. 35-A s. 1980, Relative to the Guidelines in the Supervision and Issuance of Results of Analysis of all Drugs & Pharmaceutical Products including Antibiotics, Food and Food Products as well as its Certification for Export performed in the Food and Drug Administration for Laboratory Examination and Assay
AO 015-A s. 1981	14 Oct 1981		FDA Guidelines Governing Simplified Export Procedures Under Presidential Decree No. 930
AO 250 s. 1975	18 Jul 1975		Amending Section 1, Par VII of Administrative Order No. 241 s. 1975 re: Regulations Governing the Revised Fees for Operation of Food, Drug & Cosmetic Establishments and the Registration, Analysis, Examination and Testing of Products
AO 60 s. 1968	05 Mar 1968		General Regulation for the Enforcement of the Food, Drugs & Cosmetic Act-(A-7 Operation of Drug Establishments & A-8 Requirements for Cosmetic Laboratory)
AO 62 s. 1968	05 Mar 1968		General Regulation for the Enforcement of the Food, Drugs & Cosmetic Act-(B-5 Special Dietary Foods)
AO 61 s. 1968	05 Mar 1968		General Regulations for the Enforcement of the Food, Drug & Cosmetic Act-(C-3 Misbranding-Drugs & Devices)
AO 52 s. 1967	13 Dec 1967		General Organization and Delegation of Functions of the Food and Drug Administration

BUREAU CIRCULARS

BFAD ISSUANCE	Date Issued	Date Posted	SUBJECT
BC 2007-007	27 July 2007	06 Aug 2007	Products Imported from China
BC 2007-005	02 Apr 2007		Supplemental Guidelines for the Processing of Principal Certificate of Product Registration (CPR)
BC 2007-004 FLOWCHART (14 March 2007)	23 Feb 2007	05 Mar 2007	Guidelines for the Implementation of Administrative Order No. 2007-0006 (Amendment to Administrative Order No. 46 s. 1988 Re: Organizational Arrangements to Implement the National Drug Policy)
BC 2007-001	29 Jan 2007		Mandatory Submission of List of Products Being Handled
BC 2006-015	18 Oct 2006		Guidelines for the issuance of a Conditional Certificate of Product Registration for Veterinary Products with Initial Registration with the Bureau of Food and Drugs
BC 2006-014	04 Oct 2006		Licensing of Veterinary Establishments
BC 8 s 2001	6 July 2001		Guidelines to be Observed on the Implementation of Product Recall System
BC 9 s. 2006	22 May 2006		Amendment to Bureau Circular No. 06 s. 2005 - List of Recognized Laboratories
BC 2 s. 2006	09 Feb 2006		Implementation of Bureau of Food and Drugs Quality Seal Program in line with The FOURmula ONE for Health Initiative
BC 21 s. 2005	11 Nov 2005		Cut-off Time for the Receiving of Payments of Fees in BFAD
BC 20 s. 2005	24 Oct 2005		Revised Assessment Slips
BC 15 s 2005	14 July 2005		Parecoxib (Dynastat)
BC 10 s. 2005	5 May 2005		Creation of the Joint BFAD Inspectorate Team
BO 133-d s. 2004	12 Nov 2004		Amendment of B.O. No. 35-g s. 2004 RE: Creation of BFAD-Industry Implementation Working Group on the Harmonization for Pharmaceuticals
BC 13 s. 2004	27 Sep 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)
BC 11 s. 2004	02 Aug 2004		Food and Drugs (Composition and Labeling Amendment) Regulation 2004 issued by Hongkong Food and Environmental Hygiene Department
DM 67 s. 2004	16 Jun 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)
BC 06 s. 2004	18 May 2004		Office of the President Memorandum Order No. 136: Approving the 2004 Investment Priorities Plan
BO 35-g s. 2004	29 Mar 2004		Creation of BFAD-Industry Implementation Working Group on the Harmonization for Pharmaceuticals
BC 01 s. 2004	08 Jan 2004		Sale of BFAD: ICR Mice and BFAD: SD Rat
BC 9 s. 2002	15 Aug 2002		Customs Memorandum Circular No. 218-2002 dated 18 July 2002
BC 8 s. 2001	06 Jul 2001		Guidelines to be Observed on the Implementation of Product Recall System
BC 6-A s. 2001	11 Jun 2001		Revised Minimum Required Samples for Laboratory Analysis
BC 3 s. 2001	05 Apr 2001		Cancellation of the Certificates of Product Registration, Seizure and Confiscation of BFAD registered products, which do not conform to their registered specification.
BO 27-A s. 2001	14 Feb 2001		Confidentiality of Documents
BC 6 s. 2000	16 Aug 2000		Authentication of Documents
BC 21 s. 1999	27 Oct 1999		Guidelines for the Evaluation of Brand Names for Products to be Registered with the Bureau of Food and Drugs
BC 22 s. 1999	27 Oct 1999		Deletion of the Requirement for a Certificate of Brand Name Clearance in Filing an Application for Registration of Branded Product
BC 8-A s. 1999	19 Apr 1999		Guidelines in the Collection and Submission of Samples of Food, Drugs, Cosmetics, and Medical Devices for Physico-Chemical Analysis
BC 6 s. 1999	15 Feb 1999		Revised Bureau Circular No. 4 s. 1999 “New Protocol for Registration of Drugs, Foods, Cosmetics and Medical Devices"
BC 5 s. 1999	10 Feb 1999		Revised Process of Submission of Application for Product Registration
BC 4 s. 1999	03 Feb 1999		New Protocol for Registration of Drugs, Foods, Cosmetic and Medical Devices
BC 3 s. 1998	14 May 1998		Upgrading of Manufacturing Facilities in Consonance with CGMP Requirements Beginning 1996 Up to Year-End 1999
BC 13 s. 1997	05 Sep 1997		Submission of the List of Winners
BM 24 s. 1997	14 Aug 1997		Steps/Procedure in the Unsealing of Boxes Containing Seized Products for Collection of Samples for Examination
BC 2 s. 1997	04 Feb 1997		Accreditation of Drug Liaison Officers to BFAD
BC 3 s. 1997	03 Feb 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
BFAD CIRCULAR 12 s. 1991	28 Jun 1991		Clarification of New Registration when there is a Change of Manufacturer

MEMORANDUM CIRCULARS

BFAD ISSUANCE	Date Issued	Date Posted	SUBJECT
DM 2007-0026	22 Jan 2007		Prohibition on the creation of Technical Working Group (TWGs)/Committees with regulated entities
Customs MC 218-2002	18 Jul 2002		Monitoring of Salt Importation
MC 20 s. 1994	07 Sep 1994		Minimum Required Samples for Laboratory Analysis
MC 16-A s. 1994	15 Jul 1994		Limiting the Number of Proposed Brand Name for Brand Name Clearance for a Single Drug Product or Pharmaceutical Specialty
MC 14 s. 1994	14 Jun 1994		Sales Promotion of Foods, Drugs, Cosmetics and Household Hazardous Substances Products
MC 4 s. 1993	15 Apr 1993		Phasing Out of the Process of Extending the Effectivity of CPR or Memorandum of Extension (MOE)
MC 3 s. 1991	10 Jan 1991		Procedure in the Processing of Certificate of Good Manufacturing Practice (GMP), Certificate of Free Sale and Certificate of GMP and the Free Sale
MC 10 s. 1990	05 Sep 1990		Bureau of Patents Trademarks and Technology Transfer (BPTTT) Clearance in the Processing of BFAD Brand Name Clearance
MC 1 s. 1990	12 Feb 1990		Compliance with the DOH – Administrative Order No. 55 s. 1989 or the Generic Labeling
MC 2 s. 1989	25 Jan 1989		Application for License to Operate Filed Directly at the Bureau of Food and Drugs or Offering to Pay the Fees Therefore Directly with the Same Office.