bfad laws and regulations

39
OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER Inventory of Administrative Issuances 93 Date Filed Ref. No. Subject No. Subject Title Date Adopted 26-Jul-10 10-290 Memo Cir. No. 2010-012 Republic Act No. 9442 and Its Implementing Rules and Regulations 8-Jul-10 26-Jul-10 10-290 Circular No. 2010-011 Declaring the Products Identified Below to be Imminently Injurious, Unsafe or Dangerous and Authorizing the FDA Inspectors to Seize Said Products from Public Sale or Distribution 16-Jun-10 26-Jul-10 10-290 Circular No. 2010-010 Cut-Off Time for Receiving of Applications and Payments of Fees in FDA 24-May-10 26-Jul-10 10-290 Circular No. 2010-009 Amendment to Memorandum Circular No. 5, s. 1994 Dated April 20, 1994 Regarding Reports on Adverse Drug Reaction 16-Apr-10 26-Jul-10 10-290 Circular No. 2010-008 Adoption of the CODEX Standards on Food Contaminants in Processed Food 29-Mar-10 26-Jul-10 10-290 Circular No. 2010-007 Automatic Renewal of License to Operate (LTO) 15-Mar-10 26-Jul-10 10-290 Circular No. 2010-006 Automatic Revalidation of License to Operate (LTO) 9-Mar-10 26-Feb-10 10-085 Circular No. 2010-005 Submission of Process Flow in Handling Adverse Events from Drugs, Medical Devices, Food Supplements, Milk Products, Herbals, etc. 17-Feb-10 26-Feb-10 10-085 Circular No. 2010-004 Declaring the Products Identified Below to be Imminently Injurious, Unsafe or Dangerous and Authorizing the FDA Inspectors to Seize Said Products from Public Sale or Distribution 18-Feb-10 26-Feb-10 10-085 Circular No. 2010-003 Revised Fees for Seminar on Licensing of Drug Establishments 20-Jan-10 21-Jan-10 10-038 Circular No. 2010-002 Declaring the Products Identified Below to be Imminently Injurious, Unsafe or Dangerous and Authorizing the FDA Inspectors to Seize Said Products from Public Sale or Distribution 8-Jan-10 DEPARTMENT OF HEALTH FOOD AND DRUGS ADMINISTRATION

Upload: maaaackiiiieeee

Post on 26-Dec-2015

658 views

Category:

Documents


13 download

DESCRIPTION

BFAD Laws and Regulations

TRANSCRIPT

Page 1: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

93

Date Filed Ref. No. Subject No. Subject Title Date Adopted

26-Jul-10 10-290 Memo Cir. No. 2010-012 Republic Act No. 9442 and Its Implementing Rules and Regulations 8-Jul-10

26-Jul-10 10-290 Circular No. 2010-011

Declaring the Products Identified Below to be Imminently Injurious, Unsafe or Dangerous and

Authorizing the FDA Inspectors to Seize Said Products from Public Sale or Distribution

16-Jun-10

26-Jul-10 10-290 Circular No. 2010-010 Cut-Off Time for Receiving of Applications and Payments of Fees in FDA 24-May-10

26-Jul-10 10-290 Circular No. 2010-009Amendment to Memorandum Circular No. 5, s.

1994 Dated April 20, 1994 Regarding Reports on Adverse Drug Reaction

16-Apr-10

26-Jul-10 10-290 Circular No. 2010-008 Adoption of the CODEX Standards on Food Contaminants in Processed Food 29-Mar-10

26-Jul-10 10-290 Circular No. 2010-007 Automatic Renewal of License to Operate (LTO) 15-Mar-10

26-Jul-10 10-290 Circular No. 2010-006 Automatic Revalidation of License to Operate (LTO) 9-Mar-10

26-Feb-10 10-085 Circular No. 2010-005Submission of Process Flow in Handling Adverse

Events from Drugs, Medical Devices, Food Supplements, Milk Products, Herbals, etc.

17-Feb-10

26-Feb-10 10-085 Circular No. 2010-004

Declaring the Products Identified Below to be Imminently Injurious, Unsafe or Dangerous and

Authorizing the FDA Inspectors to Seize Said Products from Public Sale or Distribution

18-Feb-10

26-Feb-10 10-085 Circular No. 2010-003 Revised Fees for Seminar on Licensing of Drug Establishments 20-Jan-10

21-Jan-10 10-038 Circular No. 2010-002

Declaring the Products Identified Below to be Imminently Injurious, Unsafe or Dangerous and

Authorizing the FDA Inspectors to Seize Said Products from Public Sale or Distribution

8-Jan-10

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

Page 2: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

94

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

21-Jan-10 10-038 Circular No. 2010-001

Declaring the Products Identified Below to be Imminently Injurious, Unsafe or Dangerous and

Authorizing the FDA Inspectors to Seize Said Products from Public Sale or Distribution

8-Jan-10

24-Nov-09 09-440 Circular No. 2009-004End Dates in the Importation and Distribution of

Metered Dose Inhalers Containing Chlorofluorocarbon (CFC)

5-Nov-09

6-Nov-09 09-413 Circular No. 2009-003Grace Period for the 4th Updates and

Amendments of the Asean Cosmetic Directive (ACD)

2-Jul-09

6-Nov-09 09-413 Circular No. 2009-002

Specific Operational Instructions Implementing Administrative Order No. 2008-0033 Dated

December 2, 2008, Subject: Rules and Conditions in Exempting Antibiotic Drug Products

from the Batch Certification Requirement Amending for this Purpose Item III (C) and (D) of Administrative Order No. 103 s. 2002 "Batch

Certification of Antibiotics", and for Other Purposes

19-Jan-09

6-Nov-09 09-413 Circular No. 2009-001Rules on the Pilot Implementation of the Bureau

of Food and Drugs Integrated Information System (BIIS)

21-Jan-09

6-Nov-09 09-413 Memo Cir. No. 2009-001 Department of Health's Reiteration of the Policy on Donation of Milk Products 2-Oct-09

6-Nov-09 09-413 Circular No. 2008-005Grace Period for the 3rd Updates and

Amendments of the Asean Cosmetic Directive (ACD)

9-Dec-08

Page 3: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

95

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

6-Nov-08 08-403 Joint DOH-DTI-IPO-BFAD Adm. Ord. No. 2008

The Implementing Rules and Regulations of Republic Act No. 9502 Otherwise Known as the

"Universally Accessible Cheaper and Quality Medicines Act of 2008"

4-Nov-08

14-Oct-08 08-377 Circular No. 2008-004 Testing of Infant Formula and Other Milk Product for the Presence of Melamine 29-Sep-08

14-Oct-08 08-377 Circular No. 2008-003Grace Period for the 2nd Updates and

Amendments of the ASEAN Cosmetic Directive (ACD)

7-Aug-08

14-Oct-08 08-377 Circular No. 2008-002Seminar Fees for the Participants of Seminars on

Licensing of Establishments and Product Registration

10-Jun-08

14-Oct-08 08-377 Circular No. 2008-001Grace Period for the New Updates and

Amendments of the ASEAN Cosmetic Directive (ACD)

2-May-08

14-Oct-08 08-377 Circular No. 2007-013-A

Amendment to Bureau Circular No. 2007-013 "Updated Guidelines for the Implementation of

the Association of South East Asian Nation (ASEAN) Cosmetic Directive and the Association of South East Asian Nation (ASEAN) Common

Technical Documents"

21-Jan-08

14-Oct-08 08-377 Circular No. 2007-013

Updated Guidelines for the Implementation of the Association of South East Asian (ASEAN)

Cosmetic Directive and Association of South East Asian Nation (ASEAN) Common Technical

Documents

21-Dec-07

14-Oct-08 08-377 Circular No. 2007-012 Updates on Site Information File 28-Nov-07

Page 4: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

96

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

14-Oct-08 08-377 Circular No. 2007-006-A

Amendment to Bureau Circular No. 2007-006 Providing for the "Additional Requirement for Importation of Processed Food Products for

Distribution in the Philippines."

24-Mar-08

7-Dec-07 07-415 Circular No. 2007-011

Adoption of the Association of Southeast Asian Nations Common Technical Documents (ACTD)

and Common Technical Requirements (ACTR) on the Pharmaceutical Product Registration for

Human Use

1-Oct-07

7-Dec-07 07-415 Circular No. 2007-010

Guidelines in the Initial Issuance and Renewal of License to Operate for Iron Rice Premix

Manufacturer/Repacker/Importer and Setting Forth the Standards for Iron Rice Premix

10-Oct-07

7-Dec-07 07-415 Circular No. 2007-009 Updated Standards for Iodine Level of Salts 10-Oct-07

7-Dec-07 07-415 Circular No. 2007-008-B Amendment of Bureau Circular No. 2007-008 Dated 1 August 2007 27-Sep-07

7-Dec-07 07-415 Circular No. 2007-008-A Amendment of Bureau Circular No. 2007-008 Dated 1 August 2007 9-Aug-07

7-Dec-07 07-415 Circular No. 2007-008 Creation of Sub-Committee Task Force for Pharmaceuticals 1-Aug-07

7-Dec-07 07-415 Circular No. 2007-007 Products Imported from China 27-Jul-07

7-Dec-07 07-415 Circular No. 2007-006Additional Requirement for Importation of

Processed Food Products for Distribution in the Philippines

12-Jul-07

7-Dec-07 07-415 Circular No. 2007-005Supplemental Guidelines for the Processing of

Principal Certificate of Product Registration (CPR)

2-Apr-07

Page 5: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

97

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

7-Dec-07 07-415 Circular No. 2007-004

Guidelines for the Implementation of Administrative Order No. 2007-006 (Amendment

of Administrative Order No. 46 s. 1988 Re: Organizational Arrangements to Implement the

National Drug Policy)

23-Feb-07

7-Dec-07 07-415 Circular No. 2007-003 Cold Chain Management Requirements 1-Feb-07

7-Dec-07 07-415 Circular No. 2007-002 Guidelines in the Use of Nutrition and Health Claims in Food 23-Jan-07

7-Dec-07 07-415 Circular No. 2007-001 Mandatory Submission of List of Products Being Handled 29-Jan-07

7-Dec-07 07-415 Circular No. 2006-018 Additional Requirements in the Registration of Virgin Coconut Oil Food Supplement with Flavor 28-Dec-06

7-Dec-07 07-415 Circular No. 2006-017

Amendment to Bureau Circular 2006-001 "Updated Guidelines for the Submission of

Application for Notification, Registration and Export of Cosmetic Products"

18-Dec-06

7-Dec-07 07-415 Circular No. 2006-016 Updated List of Food Additives 18-Oct-06

7-Dec-07 07-415 Circular No. 2006-008-A

Amendment to Bureau Circular No. 008 s. 2006, The Subject of Which is the "Lifting of

Moratorium on the Conduct of Bioavailability/Bioequivalence Studies for

Selected Pharmaceutical Products and Bureau Circular No. 2007-005 or the "Supplemental

Guidelines for the Processing of Principal Certificate of Product Registration", and

Providing for the Procedures and/or Guidelines Thereof

8-Oct-07

7-Dec-07 07-415 Circular No. 06-2005 List of Recognized Laboratories 10-Feb-05

Page 6: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

98

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

9-Nov-06 06-437 Circular No. 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-06

9-Nov-06 06-437 Circular No. 2006-014 Licensing of Veterinary Establishments 4-Oct-06

9-Nov-06 06-437 Circular No. 2006-013Amendment to Bureau Circular No. 17 S. 2005

Further Updating the Accepted Whitening Agents for Cosmetics

5-Sep-06

9-Nov-06 06-437 Circular No. 2006-012 Maximum Allowable Limits of Heavy Metals for Cosmetic Products 4-Sep-06

9-Nov-06 06-437 Circular No. 011, s. 2006

Specific Operational Instructions Implementing Administrative Order No. 2005-0031 Dated December 7, 2005, Subject: 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

26-Jun-06

9-Nov-06 06-437 Circular No. 10, s. 2006Good Manufacturing Practices Seminar for Food Establishments Based on A.O. 153, s. 2004 and

Other Related Regulations19-Jun-06

9-Nov-06 06-437 Circular No. 09, s. 2006 Amendment to Bureau Circular No. 06 s. 2005 - List of Recognized Laboratories 22-May-06

9-Nov-06 06-437 Circular No. 008, s. 2006Lifting of Moratorium on the Conduct of

Bioavailability/Bioequivalence Studies for Selected Pharmaceutical Products

27-Apr-06

Page 7: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

99

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

9-Nov-06 06-437 Circular No. 2006-007

Amendment to Bureau Circular No. 2006-005 re: Guidelines for the Submission of Application for

Automatic Renewal Registration of Pharmaceutical Products, Medical Devices, Prepackaged Food and Food Products, and

Household Hazardous Substances

21-Mar-06

9-Nov-06 06-437 Circular No. 006, s. 2006 Creation of BFAD Food Fortification Data Management System Team 28-Feb-06

9-Nov-06 06-437 Circular No. 2006-005

Guidelines for the Submission of Application for Automatic Renewal Registration of

Pharmaceutical Products, Medical Devices, Prepackaged Food and Food Products, and

Household Hazardous Substances

22-Feb-06

9-Nov-06 06-437 Circular No. 004, s. 2006 Mandatory Fortification of Flour 28-Feb-06

9-Nov-06 06-437 Circular No. 003, s. 2006Mandatory Attendance to the Cosmetic Seminar

Covering the 13 ASEAN Training Modules on Good Manufacturing Practice

10-Feb-06

9-Nov-06 06-437 Circular No. 002, s. 2006Implementation of Bureau of Food and Drugs

Quality Seal Program in Line with the FOURmula ONE for Health Initiative

9-Feb-06

9-Nov-06 06-437 Circular No. 2006-001Updated Guidelines for the Submission of

Application for Notification, Registration and Export of Cosmetic Products

3-Jan-06

9-Nov-06 06-437 Circular No. 21, s. 2005 Cut-Off Time for the Receiving of Payments of Fees in BFAD 11-Nov-05

10-Nov-05 05-433 Circular No. 20, s. 2005 Revised Assessment Slips 24-Oct-05

10-Nov-05 05-433 Circular No. 19,s. 2005 Extension of Submission of Site Information File" (SIF) 21-Oct-05

Page 8: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

100

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

10-Nov-05 05-433 Circular No. 18, s. 2005New Advisory on Labeling Selective

Cycloxygenase-2 (COX-2) Inhibitors and Non-Steroidal Anti-Inflammatory Drugs (NSAIDS)

12-Oct-05

10-Nov-05 05-433 Circular No. 17, s. 2005 Update of Accepted Whitening Agents for Cosmetics 22-Sep-05

26-Aug-05 05-353 Circular No. 16, s. 2005 Adopting the 2002 Recommended Energy and Nutrient Intakes as the New Dietary Standard 9-Aug-05

26-Aug-05 05-353 Circular No. 15, s. 2005 PARECOXIB (DYNASTAT) 14-Jul-0526-Aug-05 05-353 Circular No. 14, s. 2005 Re: GENE THERAPY 6-Jul-05

26-Aug-05 05-353 Circular No. 13-A, s. 2005 Reconstitution of the BFAD-Cosmetics Industry Joint Committee 29-Jun-05

26-Aug-05 05-353 Circulr No. 13, s. 2005 Submission of Site Information File (SIF) 22-Jun-0529-Jun-05 05-266 Circular No. 12, s. 2005 BFAD Quality Seal 20-Jun-05

29-Jun-05 05-266 Circular No. 11, s. 2005 Revised Labeling of Selective COX-2 Inhibitor Drugs and NSAIDS 7-Jun-05

29-Jun-05 05-266 Circular No. 10, s. 2005 Creation of the Joint BFAD Inspectorate Team 5-May-054-May-05 05-189 Circular No. 09, s. 2005 Submission of Site Information File 7-Apr-054-May-05 05-189 Circular No. 8, s. 2005 Selective COX-2 Inhibitors 4-Apr-05

16-Mar-05 05-121 Circular No. 7, s. 2005 Full Implementation of the Lot or Batch Release Certification Requirement 2-Mar-05

16-Mar-05 05-121 Circular No. 06, s. 2005 List of Recognized Laboratories 10-Feb-0516-Mar-05 05-121 Circular No. 05, s. 2005 Black Box Warning for All Antidepressant Drugs 3-Jan-05

16-Mar-05 05-121 Circular No. 4, s. 2005 Revised Fees for Seminar on Licensing of Drug Establishments 1-Feb-05

16-Mar-05 05-121 Circular No. 3, s. 2005 Submission of Site Information File 19-Jan-05

19-Jan-05 05-032 Circular No. 2, s. 2005 Revised Fees for Seminar on Licensing of Drug Establishments 10-Jan-05

19-Jan-05 05-032 Circular No. 1, s. 2005 Classification of All Injectable Hyaluronic Acid as Device 4-Jan-05

Page 9: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

101

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

19-Jan-05 05-032 Circular No. 20, s. 2004Submission of Application for Registration in

Accordance with the ASEAN Common Technical Document (ACTD) Format

13-Dec-04

19-Jan-05 05-032 Circular No. 19, s. 2004 Delisting of ROFECOXIB from Bureau of Food and Drugs Registry of Drug Products 26-Nov-04

19-Jan-05 05-032 Circular No. 18, s. 2004 Mandating the Use of Vitamin A and Iron Fortified Flour 17-Nov-04

19-Jan-05 05-032 Circular No. 17, s. 2004 TAHEEBO / Pau d' arco / Lapacho 28-Oct-0419-Jan-05 05-032 Circular No. 16, s. 2004 Guideline on Probiotics 26-Oct-04

27-Oct-04 04-355 Circular No. 15, s. 2004

Guidelines in Advertising, Promotion and Other Marketing Materials of Breastmilk Substitutes,

Breastmilk Supplement and Other Related Products

20-Oct-04

27-Oct-04 04-355 Circular No. 14, a. 2004 Submission of Adverse Drug Reaction Reports on COX-2 Inhibitors as Part of Safety Monitoring 12-Oct-04

27-Oct-04 04-355 Circular No. 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-04

27-Oct-04 04-355 Circular No. 12, s. 2004 Entry of Meat-Based Food Products into the EU 14-Sep-04

27-Oct-04 04-355 Circular No. 11, s. 2004

Food and Drugs (Composition and Labeling Amendment) Regulation 2004 Issued by

Hongkong Food and Environmental Hygiene Department

2-Aug-04

27-Oct-04 04-355 Circular No. 10, s. 2004Information on the Exportation of Fresh/Frozen Marine Products and Fresh, Frozen and Chilled

Chicken Meat from the Philippines27-Jul-04

Page 10: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

102

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

3-Sep-04 04-293 Circular No. 09, s. 2004Articles Regarding the Bioterrorism Act

Published/Released by the US Food and Drug Administration

1-Jul-04

3-Sep-04 04-293 Circular No. 08, s. 2004

Regulation and Monitoring of the Mandatory Fortification of Staples (Rice, Sugar, Flour and

Cooking Oil) and Their Utilization by Food Processors as Ingredients

10-Jun-04

3-Sep-04 04-293 Circular No. 07, s. 2004 Registration of Veterinary Products 3-Jun-04

3-Sep-04 04-293 Circular No. 06, s. 2004Office of the President Memorandum Order No. 136: Approving the 2004 Investment Priorities

Plan18-May-04

3-Sep-04 04-293 Circular No. 05, s. 2004 Consolidation and Update of Permissible Cosmetic Claims 6-Apr-04

3-Sep-04 04-293 Circular No. 4-B, s. 2004 Whitening Agents in Cosmetics Preparations 3-Apr-04

3-Sep-04 04-293 Circular No. 4-A, s. 2004 Different Brand Names for Narcotic/Opioid Analgesic Drugs for Cancer Pain 31-Mar-04

3-Sep-04 04-293 Circular No. 4, s. 2004Reiterating Memorandum Circular No. 008, s.

1988 (RE: Drug and Medical Devices Registration)

30-Mar-04

3-Sep-04 04-293 Circular No. 03, s. 2004

Guidelines for the Registration and Performance Validation of Methamphetamine

(MET)/Tetrahydrocannabinol (THC) Drug Screening Test Kits

26-Mar-04

3-Sep-04 04-293 Circular No. 02, s. 2004 Re: GINKGO BILOBA 10-Feb-04

3-Sep-04 04-293 Circular No. 01-A, s. 2004 Guidelines for the Assessment of Microbiological Quality of Processed Foods 4-Feb-04

26-Jan-04 04-027 Circular No. 01, s. 2004 Sale of BFAD:ICR Mice and BFAD:SD Rat 8-Jan-04

26-Jan-04 04-027 Circular No. 10, s. 2003 Addendum to Bureau Circular No. 7, s. 2000 Dated 29 August 2000 3-Dec-03

Page 11: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

103

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

26-Jan-04 04-027 Circular No. 09, s. 2003 Re: GINGKO BILOBA 20-Nov-03

26-Jan-04 04-027 Circular No. 08, s. 2003 Clarification of Guidelines on the Use of BFAD Registered Brand Names 18-Nov-03

26-Jan-04 04-027 Circular No. 07, s. 2003

DOH Administrative Order No. 51 Dated 30 May 2003, Subject: Amendment to Administrative Order No. 154 Dated 16 November 2003 re:

Revised Guidelines for Designation of Authority for Certain Administrative Transactions in the Central Office, Department of Health (DOH)

27-Jun-03

12-Jun-03 03-284 Circular No.06, s. 2003 Accreditation of Liaison Officers to BFAD 20-May-03

12-Jun-03 03-284 Circular No. 05-B, s. 2003

Attendance in Licensing Seminar as a Requirement in the Application for A License to Operate of a Drug Establishment/Drug Outlet

(AO 56 s. 1989)

10-Apr-03

12-Jun-03 03-284 Circular No. 05-A, s. 2003Lifting of Moratorium on the Acceptance of

Application for Initial Registration of Pharmaceutical Products

10-Apr-03

12-Jun-03 03-284 Circular No. 05, s. 2003 Classification of Hemodialysis Products as Drugs 10-Apr-03

12-Jun-03 03-284 Circular No. 04, s. 2003 Establishment of the BFAD Medical Clinic 27-Mar-03

12-Jun-03 03-284 Circular No. 03-A, s. 2003Mandatory Dissemination of Information

Regarding the Precaution/Warning of Drug Products Containing Phenylpropanolamine (PPA)

17-Mar-03

12-Jun-03 03-284 Circular No. 03, s. 2003Mandatory Printing of Boxed Warning on All

Phenylpropanolamine (PPA) Containing Products (OTC and Rx).

17-Mar-03

12-Jun-03 03-284 Circular No. 02, s. 2003 Classification of Paracetamol Syrup/Suspension 120mg/5ml and 125mg/5ml 13-Feb-03

Page 12: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

104

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

12-Jun-03 03-284 Circular No. 01, s. 2003Pattern in Writing of Date in All

Communications/Documents Addressed to BFAD and Emanating from BFAD

12-Feb-03

19-Sep-02 02-422 Circular No. 10, s. 2002 Revised List of Permissible Cosmetics Claims that Require Justification 11-Sep-02

19-Sep-02 02-422 Circular No. 9, s. 2002 Customs Memorandum Circular No. 218-2000 Dated 18 July-2002 15-Aug-02

19-Sep-02 02-422 Circular No. 8, s. 2002 Guidelines for Monitoring Iodized Salt 19-Sep-02

19-Sep-02 02-422 Circular No. 7, s. 2002

Upgrading of Manufacturing Facilities in Harmony with A.O. No. 90 s. 2002, Current

Good Manufacturing Practice (cGMP) Guidelines for Cosmetic Products

29-Apr-02

19-Sep-02 02-422 Circular No. 6, s. 2002

Amending Bureau Circular No. 02, s. 2002 Setting the Deadline for Compliance on the Labeling and Advertisement of Cigarettes

Mandated Under DOH-Administrative Order No. 10, s. 1993 and Bureau Circular No. 16-A s,

2001

4-Apr-02

19-Sep-02 02-422 Circular No. 5, s. 2002Extension of the Validity Period of Initial and Renewal Registration of In-Vitro Diagnostic

Reagents/Kits4-Apr-02

19-Sep-02 02-422 Memo Cir. No. 4, s. 2002Certificate of Analysis on 3-MCPD in Soy Sauce

and Related Food Products Containing Acid Hydrolyzed Vegetable Protein

19-Feb-02

19-Sep-02 02-422 Circular No. 03, s. 2002 Reclassification of Sambong 250mg Tablet From Over-The-Counter (OTC) to Household Remedy 31-Jan-02

19-Sep-02 02-422 Circular No. 02, s. 2002Setting the Deadline for Compliance with Bureau Circular No. 16-A s. 2001 on the Labeling and

Advertisement of Cigarettes22-Jan-02

Page 13: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

105

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

19-Sep-02 02-422 Circular No. 01, s. 2002 Notarized Application Forms for Product Registration 18-Jan-02

19-Sep-02 02-422 Adm. Ord. No. 134, s. 2002Amendment to the Revised 2001 Schedule of

Fees and Charges of BFAD for Food Manufacturers

16-Jul-02

19-Sep-02 02-422 Adm. Ord. No. 90, s. 2002 Current Good Manufacturing Practice Guidelines for Cosmetic Products 18-Mar-02

19-Sep-02 02-422 Adm. Ord. No. 70, s. 2002 Licensing of Botika ng Barangays (BnB) in Various Local Government Units 3-Jan-02

19-Sep-02 02-422 Adm. Ord. No. 56, s. 2001Guideline on Labeling and Advertisement of

Cigarettes and Designating the Bureau of Food and Drugs as Its Regulating Agency

24-Oct-01

19-Sep-02 02-422 Adm. Ord. No. 50, s. 2001Revised 2001 Schedule of Fees and Charges for

the Corresponding Services Rendered by the Bureau of Food and Drugs

17-Sep-01

19-Sep-02 02-422 Circular No. 18, s. 2001Delisting of LEVENORGESTREL 750 mcg

(POSTINOR) from Bureau of Food and Drugs Registry of Drug Products

7-Dec-01

19-Sep-02 02-422 Circular No. 17, s. 2001Classification of Oral Rehydration Salts, Lagundi 300mg Tablet, Multivitamins Oral Formulations

and Pyrantel Embonate29-Nov-01

5-Dec-01 01-474 Circular No. 16-A, s. 2001 Labeling and Advertisement of Cigarettes 20-Nov-01

5-Dec-01 01-474 Circular No. 16, s. 2001Guidelines for the Immediate Processing of

Applications for Initial Registration of Pharmaceutical Products

20-Nov-01

5-Dec-01 01-474 Circular No. 15-A, s. 2001 Amendment to BFAD Circular No. 23 Dated 16 September 1994 13-Nov-01

Page 14: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

106

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

5-Dec-01 01-474 Circular No. 15, s. 2001Guidelines for the Immediate Processing of

Pending Applications for Renewal Registration of Pharmaceutical Products

26-Oct-01

5-Dec-01 01-474 Circular No. 14, s. 2001Amendment to Bureau Circular No. 13-A s. 2001 "Over-The-Counter (OTC) Drugs Reclassified as

Household Remedies"26-Oct-01

5-Dec-01 01-474 Circular No. 13-A, s. 2001Amendment to Bureau Circular No. 11 s., 2001 "Over-the-Counter (OTC) Drugs Reclassified as

Houshold Remedies"17-Oct-01

5-Dec-01 01-474 Circular No. 13, s. 2001 Erratum to Bureau Circular No. 9, s. 2001 17-Oct-01

5-Dec-01 01-474 Circular No. 12, s. 2001 Addendum to Bureau Circular No. 6-A s. 2001 Dated June 11, 2001 5-Oct-01

5-Dec-01 01-474 Circular No. 11, s. 2001 Re: Over-the-Counter (OTC) Drugs Reclassified as Household Remedies 20-Aug-01

5-Dec-01 01-474 Circular No. 10, s. 2001 Submission of Site Information File and Updating 10-Aug-01

5-Dec-01 01-474 Circular No. 9, s. 20011. Glass Ionomers of Automatic Restorative

Treatment (ART) 2. Fit and Fissure Sealant 3. Hand Instruments with Kits for ART

7-Aug-01

5-Dec-01 01-474 Circular No. 6-A, s. 2001 Revised Minimum Required Samples for Laboratory Analysis 11-Jun-01

26-Jul-01 01-294 Circular No. 8, s. 2001 Guidelines to be Observed on the Implementation of Product Recall System 6-Jul-01

26-Jul-01 01-294 Circular No. 7, s. 2001 Proposed Guidelines for the Assessment of Microbiological Quality of Processed Foods 22-Jun-01

26-Jul-01 01-294 Circular No. 6, s. 2001 Aflatoxin M1 in Milk 30-May-0126-Jul-01 01-294 Circular No. 5, s. 2001 Acute Toxicity of Tin 30-May-01

17-May-01 01-205 Circular No. 4, s. 2001 Extension of the Validity of Monitored Release Study 20-Apr-01

Page 15: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

107

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

17-May-01 01-205 Circular No. 3, s. 2001

Cancellation of the Certificates of Product Registration, Seizure and Confiscation of BFAD Registered Products, which do not Conform to

their Registered Specifications

5-Apr-01

17-May-01 01-205 Circular No. 2, s. 2001 Advisory on Voluntary Recall of Processed Meat Products Imported from European Countries 8-Mar-01

17-May-01 01-205 Circular No. 1, s. 2001

Guidelines on the Temporary Ban on the Importation of Processed Meat Products from

Cattle, Sheep and Goat, and Other Food Ingredients Containing Substances Derived from

these Animals

8-Mar-01

2-Feb-01 01-062 Adm. Ord. No. 104-A, s. 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

Drugs and National Quarantine Office (Amendment to Administrative Order No. 40 s.

2000)

21-Aug-00

2-Feb-01 01-062 Adm. Ord. No. 86, s. 2000 The Need and Role of A Medical Director in the Phamaceutical Industry 18-Jul-00

2-Feb-01 01-062 Adm. Ord. No. 40, s. 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

Drugs and National Quarantine Office

17-Apr-00

2-Feb-01 01-062 Circular No. 9, s. 2000 Records Filing, Retrieval/Borrowing and Disposal 12-Dec-00

2-Feb-01 01-062 Circular No. 8, s. 2000 Confiscation of Unregistered CLARIDEM Astringent No.3 21-Nov-00

Page 16: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

108

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

2-Feb-01 01-062 Circular No. 7, s. 2000 Creation of a BFAD-Cosmetics Industry Joint Committee 29-Aug-00

7-Sep-00 00-346 Adm. Ord. No. 99, s. 2000Banning and Withdrawal of the Fixed-Dose-

Combination Drug Product loratadine + Pseudoephedrine (Clarinase) from the Market

9-Aug-00

7-Sep-00 00-346 Adm. Ord. No. 98, s. 2000 Voluntary Withdrawal of Astemizole (Hismanal) from the Market 9-Aug-00

7-Sep-00 00-346 Adm. Ord. No. 97, s. 2000 Banning and Withdrawal of Cisapride (Prepulsid) from the Market 9-Aug-00

7-Sep-00 00-346 Adm. Ord. No. 85, s. 2000

Registration Requirements for A Government Agency Importing A Pharmaceutical Product with

a Registered Counterpart Brand in the Philippines

14-Jul-00

7-Sep-00 00-346 Adm. Ord. No. 23-C, s. 2000

Policies and Guidelines on Over the Counter (OTC) Drug Products 9-Mar-00

7-Sep-00 00-346 Circular No. 6, s. 2000 Authentication of Documents 16-Aug-00

7-Sep-00 00-346 Circular No. 5-B, s. 2000 Standard Policy on Labeled Potency of Phamaceutical Products 3-Aug-00

25-Jul-00 00-264 DOH Adm. Ord. No. 4-A, s. 2000

Banning and Withdrawal of Olaquindox and Carbadox from the Market 11-Jan-00

25-Jul-00 00-264 Memorandum No. 8, s. 2000

Revised Permissible Claims for Cosmetic Preparations 7-Jul-00

25-Jul-00 00-264 Circular No. 03-A, s. 2000 Amendment to FDA Circular No. 2 s. of 1982 on the Importation of Semi-Synthetic Antibiotics 8-Jun-00

29-Jun-00 00-239 Circular No. 5-A, s. 2000

Provision of Speakers for the Joint Bureau of Food and Drugs - Philippine Pharmaceutical

Association Sponsored Continuing Professional Education Programs

23-Jun-00

Page 17: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

109

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

29-Jun-00 00-239 Circular No. 5, s. 2000

Attendance to the Joint Bureau of Food and Drugs - Philippine Pharmaceutical Association Sponsored Continuing Professional Education

Program

23-Jun-00

29-Jun-00 00-239 Circular No. 4, a. 2000Implementation of Administrative Order No. 13, s. 1999, "Use of Hydroquinone and/or Tretinoin

(Retinoic Acid)14-Jun-00

29-Jun-00 00-239

Amendment to the Rules and Regulations Implementing Republic Act No. 8203 Otherwise

Known as the "Special Law on Counterfeit Drugs"

31-Jan-00

29-Jun-00 00-239 Adm. Ord. No. 13, s. 1999 Use of Hydroquinone and/or Tretinoin (Retinoic Acid) 6-Apr-99

6-Mar-00 00-085 Circular No. 03, s. 2000Submission of Test Procedures and Test

Specifications for Products to be Included in the Philippine Pharmacopeia

28-Feb-00

6-Mar-00 00-085 Circular No. 02, s. 2000Submission of List of All Pending Applications for

Registration/Listing of Cosmetic Products and Household Hazardous Substances

24-Jan-00

6-Mar-00 00-085 Adm. Ord. No. 1, s. 2000 Banning and Withdrawal of Trovafloxacin (Trovan) from the Market 3-Jan-00

6-Mar-00 00-085 Adm. Ord. No. 54, s. 1999 Change of Manufacturers of Drug Products in Compliance with the CGMP Requirements 22-Dec-99

6-Mar-00 00-085 Adm. Ord. No. 48-C, s. 1999

Submission of Suggested Retail Price of Pharmaceutical Product as Additional Requirement for Product Registration

21-Nov-99

Page 18: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

110

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

6-Mar-00 00-085 Adm. Ord. No. 41-A, s. 1999

Fee for Re-Submission of Application for Initial or Renewal Registration of Pharmaceutical

Products Previously Disapproved Pursuant to Bureau of Food and Drugs (BFAD) Bureau

Circular No. 6, s. 1999

29-Sep-99

6-Mar-00 00-085Rules and Regulations Implementing Republic Act No. 8203 Otherwise Known as the Special

Law on Counterfeit Drug19-Nov-96

17-Jan-00 00-023 Circular No. 1, s. 2000 Moratorium on the Acceptance of Application for Initial Registration of Pharmaceutical Products 13-Jan-00

17-Jan-00 00-023 Circular No. 23, s. 1999 Expoliant and Expoliate as Permissible Claims for Cosmetic Preparations 24-Nov-99

17-Jan-00 00-023 Circular No. 22, s. 1999Deletion of the Requirement for a Certificate of Brand Name Clearance in Filing an Application

for Registration of Branded Products27-Oct-99

17-Jan-00 00-023 Circular No. 21, s. 1999Guidelines for the Evaluation of Brand Names for

Products to be Registered with the Bureau of Food and Drugs

27-Oct-99

17-Jan-00 00-023 Circular No. 20, s. 1999 Amended Criteria for Selection of Employees for Filling of Vacant Position 14-Oct-99

17-Jan-00 00-023 Circular No. 19, s. 1999Re-Iterating Section 20 (b)(1))B) of R.A. 3720

as Amended by Section 12 of E.O. 175 and Section 29-A of E.O. 175

no date

17-Jan-00 00-023 Circular No. 18, s. 1999 Importation and Registration of Imported Pre-packed Food Products 16-Aug-99

17-Jan-00 00-023 Circular No. 17-A, s. 1999Resumption of Acceptance of Application for Registration of Branded Ethical/Prescription

Pharmaceutical Products23-Jul-99

Page 19: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

111

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

17-Jan-00 00-023 Circular No. 17, s. 1999Transfer of Processing of Brand Name Clearance for Pharmaceutical Products to the Intellectual

Property Office (IPO)_23-Jul-99

22-Jun-99 99-211 Circular No. 13-A, s. 1999

Moratorium on the Conduct of Bioavailability/Bioequivalence Studies for

Pharmaceutical Products Included in the List B' (Products with Reported Problems on

Bioavailability/Bioequivalence)

14-Jun-99

22-Jun-99 99-211 Circular No. 13, s. 1999 Dioxin Contaminated Food Products Monitored by BFAD 14-Jun-99

22-Jun-99 99-211 Circular No. 12-B, s. 1999

Phasing-Out the Registration of Branded Version of Registered Unbranded Drug Product and

Unbranded Version of Registered Branded Drug Product (Memorandum Circular No. 10-A s.

1992)

11-Jun-99

22-Jun-99 99-211 Circular No. 12-A, s. 1999Withdrawal from the Market of Products

Suspected to be Tainted with Meat and Other Materials Containing Dioxin

11-Jun-99

22-Jun-99 99-211 Circular No. 12, s. 1999Inventory and Temporary Cessation of

Distribution of Certain Food Products Produced in Belgium and Other Suspected Countries

11-Jun-99

22-Jun-99 99-211 Circular No. 11-A, s. 1999 Submission of List of Products Validly Registered and in the Market 9-Jun-99

22-Jun-99 99-211 Circular No. 11, s. 1999

Certification of Registrations' Annotation of Suspension/Cancellation of Drug or Drug Product

Combination found to be Adulterated/Misbranded

1-Jun-99

22-Jun-99 99-211 Circular No. 10,. S.1999 Criteria for Selection of Employees for Filling of Vacant Position 31-May-99

Page 20: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

112

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

22-Jun-99 99-211 Circular No. 9, s. 1999 Labeling of Prepackaged Processed Meat Products 22-Apr-99

22-Jun-99 99-211 Circular No. 8-A, s. 1999Guidelines in the Collection and Submission of

Samples of Food, Drugs, Cosmetics, and Medical Devices for Physico-Chemical Analysis

19-Apr-99

22-Jun-99 99-211 Adm. Ord. No. 16, s. 1999Delisting Oral Proteolytic Enzyme-Containing

Drug Products in the Registry of Drugs with the Bureau of Food and Drugs (BFAD)

13-May-99

22-Jun-99 99-211 Adm. Ord. No. 14, s. 1999 Regulations for the Licensing of Salt Manufacturers 3-May-99

22-Jun-99 99-211 Adm. Ord. No. 13, s. 1999 Use of Hydroquinone and/or Tretinoin (Retinoic Acid) 6-Apr-99

16-Apr-99 99-129 Adm. Ord. No. 13, s. 1999 Use of Hydroquinone and/or Tretinoin (Retinoic Acid) 6-Apr-99

16-Apr-99 99-129 Circular No. 8, s. 1999

Amendment to Bureau Circular No. 8, s. 1998 "Registration of Imported Food Products Covered

by An Exlusive Distributorship Agreement and Sale or Offer for Sale of the Same Products

Whose Registration Papers are Still In-Process"

13-Apr-99

16-Apr-99 99-129 Circular No. 7, s. 1999 Re-Iterating Article IV, Section 30 of Republic Act 5921 18-Feb-99

16-Apr-99 99-129 Circular No. 6, s. 1999Revised Bureau Circular No. 4, s. 1999 "New

Protocol for Registration of Drugs, Foods, Cosmetics and Medical Devices

15-Feb-99

16-Apr-99 99-129 Circular No. 5, s. 1999 Revised Process of Submission of Application for Product Registration 10-Feb-99

16-Apr-99 99-129 Circular No. 4, s. 1999 New Protocol for Registration of Drugs, Foods, Cosmetics and Medical Devices 3-Feb-99

Page 21: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

113

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

16-Apr-99 99-129 Circular No. 3, s. 1999 Alcohol with Disinfectant and Antiseptic Actions 2-Feb-99

16-Apr-99 99-129 Circular No. 2, s. 1999Amendment to BFAD M.C. No. 25, s. 1992 Otherwise Known as "Additional Labeling

Requirement for Food Supplements"15-Jan-99

16-Apr-99 99-129 Circular No. 1, s. 1999 Revised BFAD's Receipt of Renewal Application Stamp 14-Jan-99

25-Nov-98 98-349 Circular No. 8, s. 1998

Registration of Imported Food Products Covered by An Exclusive Distributorship Agreement;

and Sale or Offer for Sale of the Same Products Whose Registration Papers are Still In-Process

27-Oct-98

25-Nov-98 98-349 Circular No. 7, s. 1998Adoption of the Guiding Principles for Good

Manufaturing Practice (GMP) Guidelines in the Manufacture of Cosmetic Products

23-Oct-98

25-Nov-98 98-349 Circular No.6-A, s. 1998 Permissible Net Content Variation in Pre-Packaged Food 20-Oct-98

25-Nov-98 98-349 Circular No. 6, s. 1998 Fictitious, or Impostors Food and Drug Regulation Officers (FDROs) 13-Oct-98

25-Nov-98 98-349 Circular No. 5, s. 1998 Extension of the Validity Period of Renewal Registration of Medical and Dental Devices 3-Aug-98

25-Nov-98 98-349 Circular No. 4, s. 1998Deadline for the Final Phase-Out of Potassium

Bromate as a Flour Treatment Agent set in A.O. 25, s. 1996

30-Jul-98

29-Jul-98 98-215 Circular No. 3, s. 1998Upgrading of Manufacturing Facilities in

Consonance with CGMP Requirements Beginning 1996 up to Year-End 1999

14-May-98

29-Jul-98 98-215 Circular No. 2, s. 1998 Amended Criteria for Promotion 7-May-9829-Jul-98 98-215 Circular No. 1, s. 1998 Criteria for Promotion 3-Mar-9830-Oct-97 97-300 Circular No. 13, s. 1997 Submission of the List of Winners 5-Sep-9730-Oct-97 97-300 Circular No. 12, s. 1997 1997 Updated Listing of Cosmetic Ingredients 4-Sep-97

Page 22: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

114

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

30-Oct-97 97-300 Circular No. 11, s. 1997Extension of the Period to Declare Unregistered Imported Food Products Under Bureau Circular

No. 4, s. 19972-Sep-97

30-Oct-97 97-300 Circular No. 10, s. 1997Calendars/Posters and Other Form of

Advertisement Using Picture of Women that are Perceived as Vulgar and Obscene

21-Aug-97

30-Oct-97 97-300 Circular No. 09, s. 1997

Specific Guidelines for Preparation of Order of Payment and Collection of Fees for Certificate of

Authentication for Copies of BFAD Official Document(s)

10-Jul-97

30-Oct-97 97-300 Circular No. 08, s. 1997 Implementation Details of BFAD Circular No. 1, s. 1997 30-Apr-97

30-Oct-97 97-300 Circular No. 07, s. 1997Batch Recall of Dexamethasone Sodium

Phosphate Injection (Dextrapin Injection) 8mg/2ml vial, Batch No. 1296, 2/99

14-Apr-97

30-Oct-97 97-300 Circular No. 06, s. 1997Extension of the Period to Declare Unregistered Imported Food Products Under Bureau Circular

No. 4, s. 199731-Mar-97

30-Oct-97 97-300 Circular No. 5-A, s. 1997Amendment of Office Circular No. 1, s. 1994 Subject: Employee Suggestion and Incentive

Awards System20-Mar-97

30-Oct-97 97-300 Circular No. 5, s. 1997Revised Checklist of Requirements and the 1997 Guidelines for the Registration of Pharmaceutical

Products19-Mar-97

11-Mar-97 97-081 Circular No. 04, s. 1997

Declaration of Unregistered Imported Food Products in the Market and Allowing These

Declared Products on Certain Conditions Upon Payment of Administrative Fine

14-Feb-97

Page 23: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

115

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

11-Mar-97 97-081 Circular No. 03, 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

3-Feb-97

11-Mar-97 97-081 Circular No. 02, s. 1997 Accreditation of Drug Liaison Officers to BFAD 4-Feb-97

11-Mar-97 97-081 Circular No. 01, s. 1997

Enforcement of the Requirement for Bioavailability Studies for Registration of

Products Included in the List B' (Prime) Under DOH-Administrative Order 67 Series of 1989

21-Jan-97

11-Mar-97 97-081 Circular No. 6, s. 1996Exclusion of Quinolone Derivatives and

Veterinary Antibiotic Products from the BFAD Batch Certification Requirement

1-Oct-96

11-Mar-97 97-081 Circular No. 5, s. 1996 Iterating Article IV, Section 25 of Republic Act 5921 7-Aug-96

3-Sep-96 96-221 Circular No. 5, s. 1996 Iterating Article IV, Section 25 of Republic Act 5921, as Amended 7-Aug-96

3-Sep-96 96-221 Circular No. 4, s. 1996 Pertinent Provisions of Republic Act (R.A.) 7581 Otherwise Known as the Price Act 30-Jul-96

25-Jul-96 96-183 Bureau Order No.67-B, s. 1996

Requiring the Inclusion of Warning Statement for Products Containing Sodium Metabisulfite

and Other Derivatives of this Sodium Salt5-Jun-96

25-Jul-96 96-183 Adm. Order No. 20-A, s. 1996

Authority of the Bureau of Food and Drugs and DOH-Integrated Regional Field Offices to Levy, Assess, Collect and Retain Fees to Cover the

Certification of Supervision Issued in the Sales Promotion Activities Involving Raffles, Seedings,

and Contests, Pursuant to the Provisions of Consumer Act of the Philippines (RA 7394)

24-May-96

Page 24: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

116

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

14-Jun-96 96-141 Bureau Order No. 59-B, s. 1996

Provisional Permit to Market Food Products Pending Approval of the Application for Product

Registration21-May-96

14-Jun-96 96-141 Circular No. 3, s. 1996 Selling of Drugs or Medicines to the Public 22-Apr-96

14-Jun-96 96-141 Circular No. 2, s. 1996 Ban Against Importation of UK Beef and Beef Products Effective Immediately 11-Apr-96

11-Apr-96 96-083 Circular No. 1, s. 1996 Revised Fees for Seminar on Licensing of Drug Establishments 1-Mar-96

11-Apr-96 96-083 Circular No. 4, s. 1995 Period Within Which An Initial Conditional Registration Shall be Processed and Issued 17-Oct-95

11-Apr-96 96-083 Circular No. 3-A, s. 1995

Revised and/or Updated Lists of Ingredients or Substances in Cosmetics Recommended After A

Series of Review and Studies by the BFAD-Industry Joint Study Group

9-Oct-95

11-Apr-96 96-083 Circular No. 3, s. 1995 BFAD Posters for Consumers of Drug Products 12-Sep-95

11-Apr-96 96-083 Bureau Order No. 101-H, s. 1995

Amending Sections Three (III) Four (IV), Five (V) and Six (VI) of Memorandum Circular No. 19-

A, s. 19929-Oct-95

11-Apr-96 96-083 Bureau Memo. No. 21, s. 1995

Lists of Permissible Claims for Cosmetic Preparations, etc. 25-Sep-95

20-Jun-95 95-139 Circular No. 2, s. 1995 Cancellation of 1988-1989-1990 Inactive Applications for Product Registrations 15-May-95

20-Jun-95 95-139 Circular No. 1, s. 1995 Phase-Out of Potassium Bromate as Flour Treatment Agent in Bread-Making 16-Feb-95

20-Jun-95 95-139 Circular No. 2, s. 1994 Amendment of MC No. 4, s. 1994 18-Nov-94

20-Jun-95 95-139 Circular No. 1, s. 1994 Memorandum Circular No. 18, Series 1994 Dated August 11, 1994 and September 20, 1994 24-Oct-94

Page 25: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

117

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

20-Jun-95 95-139 Adm. Order No. 33, s. 1994

Supplementary Instructions to DOH Adminstrative Order No. 32 s. 1994 to Cover

Administrative Issuances to be Issued by Other Major Offices and Organizational Units of the Department of Health to Take Effect July 15,

1994

8-Jul-94

20-Jun-95 95-139 Adm. Order No. 32, s. 1994

Instructions Governing the Preparation, Classification, Review, Approval, Dissemination, Use and Monitoring of Administrative Issuances and Amending DOH Administrative Order No.

111, s. 1963, to Take Effect July 15, 1994

4-Jul-94

25-May-95 95-120 Circular No. 23, s. 1994Amending Memo Circular No. 4, s. 1994

Compliance with the IRR of the Senior Citizens Act

16-Sep-94

25-May-95 95-120 Circular No. 22, s. 1994 Inventory, Proper Disposal and/or Destruction of Used Vials or Bottles 8-Sep-94

25-May-95 95-120 Circular No. 21, s. 1994 Creation of BFAD/Industry Joint Committee on Management Systems and Procedures 6-Sep-94

25-May-95 95-120 Circular No. 20, s. 1994 Minimum Required Samples for Laboratory Analysis 7-Sep-94

26-Aug-94 94-260 Memo Cir. No. 19, s. 1994 Reclassification of Hydroquinone 1-2% from Cosmetics to Drugs 15-Aug-94

26-Aug-94 94-260 Memo Cir. No. 18, s. 1994 Additional Labelling Requirement for Pre-Packaged Food Products 11-Aug-94

26-Aug-94 94-260 Memo Cir. No. 17, s. 1994System and Procedure for Application of

Certificate of Product Listing as Per Administrative Order No. 29-A, s. 1994

21-Jul-94

Page 26: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

118

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

26-Aug-94 94-260 Memo Cir. No. 16-A, s. 1994

Limiting the Number of Proposed Brandname for Brandname Clearance for a Single Drug Product

or Pharmaceutical Specialty15-Jul-94

26-Aug-94 94-260 Memo Cir. No. 16, s. 1994 Clarification on Administrative Order No. 29-A s. 1994 15-Jul-94

26-Aug-94 94-260 Memo Cir. No. 15, s. 1994 Change of Capsule Color of A Registered Drug Product or Pharmaceutical Preparations 1-Jul-94

26-Aug-94 94-260 Memo Cir. No. 14, s. 1994 Sales Promotion of Foods, Drugs, Cosmetics and Household Hazardous Substances Products 14-Jun-94

26-Aug-94 94-260 Memo Cir. No. 13, s. 1994 Revised Seminar Fees for the Participants to the Series of Seminar on Licensing of Establishments 17-Jun-94

26-Aug-94 94-260 Memo Cir. No. 12, s. 1994 Addendum to BFAD Memo Circular No. 4 s. 1994 7-Jun-94

26-Aug-94 94-260 Memo Cir. No. 11, s. 1994 Joint BFAD-RITM Operational Procedure for Registration of HIV Test Systems 23-May-94

26-Aug-94 94-260 Memo Cir. No. 10, s. 1994Revocation of Office Memo No. 5, s. 1990, Use

of Universal Product Code (UPC) on Locally Manufactured Products

10-May-94

26-Aug-94 94-260 Memo Cir. No. 9, s. 1994 Restriction of Sale and Distribution of Misoprostol (Cytotec) 6-May-94

26-Aug-94 94-260 Adm. Ord. No. 29-A, s. 1994

Regulation Part D-5 Cosmetic: Listing of Cosmetics Specialists 18-May-94

12-May-94 94-155 Memo Cir. No. 8, s. 1994 Allowing the Use of Butylated Hydroxytoluene (BHT) on Both Rinse-Off and Leave-On Products 28-Apr-94

12-May-94 94-155 Memo Cir. No. 7, s. 1994 Implementing Guidelines for Certain Cosmetic Registration Requirements 12-Apr-94

12-May-94 94-155 Memo Cir. No. 6, s. 1994 Limiting the Sale of OTC Cough Preparations to One (1) Bottle of 120 ml. per Customer 19-Apr-94

12-May-94 94-155 Memo Cir. No. 5, s. 1994 Reports on Adverse Drug Reaction 20-Apr-94

Page 27: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

119

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

12-May-94 94-155 Memo Cir. No. 4, s. 1994 Amendment of MC No. 1, s. 1994: Compliance with the IRR of the Senior Citizens Act. 11-Apr-94

12-May-94 94-155 Memo Cir. No. 3, s. 1994 Drug Store Personnel Development Program 4-Apr-94

12-May-94 94-155 Memo Cir. No. 2, s. 1994

Amendment of Memorandum Circular No. 5 and 9 s. 1993 and Updating the List of Drug Outlets

Authorized to Dispense Nalbuphine Hydrochloride 10mg/5ml. (Nubain Injection)

11-Mar-94

12-May-94 94-155 Memo Cir. No. 1, s. 1994 Compliance with the IRR of the Senior Citizens Act. 14-Feb-94

12-May-94 94-155 Memo Cir. No. 12, s. 1993Confirmation of the Expansion of the Joint Study Group of the Cosmetic Industry and BFAD (JSG-

CIB)22-Oct-93

7-Oct-93 93-229 Memo Cir. No. 11, s. 1993 Supplementary Labelling Guidelines for Cosmetic Products 20-Sep-93

7-Oct-93 93-229 Memo Cir. No. 10, s. 1993 Amendment of Certain Cosmetic Registration Guidelines and Requirements 7-Sep-93

7-Oct-93 93-229 Memo Cir. No. 9, s. 1993

Amendment of MC No 20 s. 1992, MC No. 5 s. 1993 and Updating the List of Drug Outlets

Authorized to Dispense Nalbuphine Hydrochloride 10mg/5ml. (Nubain Injection)

16-Aug-93

7-Oct-93 93-229 Memo Cir. No. 8, s. 1993 Validity Period of Provisional Registration of Fixed-Dosed Combinations (FDCs) 12-Aug-93

7-Oct-93 93-229 Memo Cir. No. 7, s. 1993

Applications for Initial Registration Filed on July 16, 1993 re: Products Undergoing Renewal

Registration are Allowed in the Market Until the Application for Renewal Registration is Finally

Acted by BFAD.

28-Jul-93

7-Oct-93 93-229 Memo Cir. No. 6, s. 1993 Monitoring of Food Products Requiring an Open Date Marking 9-Jun-93

Page 28: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

120

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

7-Oct-93 93-229 Memo Cir. No. 5, s. 1993

Amendment of MC No. 20 s. 1992 and Updating the List of Drug Outlets Authorized to Dispense

Nalbuphine Hydrochloride 10mg/ml (Nubain Injection)

4-May-93

11-May-93 93-110 Memo Cir. No. 4, s. 1993Phasing Out of the Process of Extending the

Effectivity of CPR or Memorandum of Extension (MOE)

15-Apr-93

11-May-93 93-110 Memo Cir. No. 3, s. 1993 Maximum Allowable Concentration of BORIC ACID in Cosmetics 12-Apr-93

24-Feb-93 93-055 Memo Cir. No. 2, s. 1993 Cough Syrup Containing Dextromethorphan 9-Feb-9324-Feb-93 93-055 Memo Cir. No. 1, s. 1993 Unregistered Methergin Ampoule 2-Feb-93

24-Feb-93 93-055 Office Order No. 8-A, s. 1993

Prescribing Procedures for the Speedy Disposition of Administrative Cases in BFAD 10-Feb-93

24-Feb-93 93-055 Memo Cir. No. 28, s. 1992Sale of ASEAN Reference Substance Produced by the Bureau of Food and Drugs (ASEAN Reference

Substance Project).12-Nov-92

24-Feb-93 93-055 Memo Cir. No. 27, s. 1992 Confiscation of Lily's Peanut Butter 3-Nov-92

6-Nov-92 IPD-605 Memo Cir. No. 26, s. 1992 Extension of the Deadline for the Listing of Unregistered Cosmetic Products 30-Oct-92

6-Nov-92 IPD-605 Memo Cir. No. 25, s. 1992 Additional Labelling Requirement for Food Supplements 15-Oct-92

6-Nov-92 IPD-605 Memo Cir. No. 24, s. 1992 Sale of Official Publication of BFAD Operational Manual on Drug Evaluation and Control 19-Oct-92

6-Nov-92 IPD-605 Memo Cir. No. 23, s. 1992 Confiscation of RX Supercandy 14-Oct-926-Nov-92 IPD-605 Memo Cir. No. 22, s. 1992 Aqua Babe Infant Formula Water 8-Oct-926-Nov-92 IPD-605 Memo Cir. No. 21, s. 1992 Peanut Butter with High Aflatoxin Content 14-Sep-92

6-Nov-92 IPD-605 Memo Cir. No. 20, s. 1992 Authorized Outlets of Nalbuphine Hydrochloride 10mg/ml (Nubain Injection) 11-Sep-92

Page 29: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

121

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

6-Nov-92 IPD-605 Memo Cir. No. 19-A, s. 1992 Specific Standards and Requirements 30-Jul-92

6-Nov-92 IPD-605 Memo Cir. No. 19, s. 1992 Clarificatory Guidelines on Administrative Order 150 s. 1971 30-Jul-92

6-Nov-92 IPD-605 Memo Cir. No. 18, s. 1992Confirmation of the Policy Not to Require Patent

Clearance for the Registration of the Drug Products

28-Jul-92

6-Nov-92 IPD-605 Memo Cir. No. 17, s. 1992 Registration of Household Remedies 27-Jul-92

28-Jul-92 IPD-549 Memo Cir. No. 16, s. 1992 Declaration of Amnesty for Unregistered Cosmetics in the Market 17-Jul-92

28-Jul-92 IPD-549 Memo Cir. No. 15, s. 1992 Measures of Establishment's Compliance with Good Manufacturing Practices 7-Jul-92

28-Jul-92 IPD-549 Memo Cir. No. 14, s. 1992 Substandard Golden Sun Vinegar Processed by Golden Sun Food Products 19-Jun-92

28-Jul-92 IPD-549 Memo Cir. No. 13, s. 1992 Dimehydrinate B.P. Ampoule mfd. By: Maripharm Pharmaceuticals 18-Jun-92

28-Jul-92 IPD-549 Memo Cir. No. 12, s. 1992 Unregistered Musamycetin/Chloramphenicol 125 mg/5ml 17-Jun-92

10-Jun-92 IPD-516 Memo Cir. No. 11, s. 1992 Samples Requirement for the Purpose of Registration of Drugs and Devices 30-May-92

10-Jun-92 IPD-516 Memo Cir. No. 10-A, s. 1992

Registration of Branded Version of Registered Unbranded Generic Drug Product, and Generic Version of Registered Branded Drug Products

27-May-92

10-Jun-92 IPD-516 Memo Cir. No. 10, s. 1992Clarifying FDA (BFAD) Memorandum Circular No. 001 s. 1983, Sec. 4.2.2 of Chapter 1 and Section

4.2.1, Chapter 11 of A.O. 56 s. 198927-May-92

10-Jun-92 IPD-516 Memo Cir. No. 9-A, s. 1992 Information on Counterfeit Pharmaceutical Products 18-May-92

Page 30: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

122

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

10-Jun-92 IPD-516 Memo Cir. No. 9, s. 1992Chemesco Dicycloverine Hydrochloride

10mg/5ml Syrup Mfd. By: Drugmaker's Labs., Inc. For: Chemesco, Ic.

18-May-92

10-Jun-92 IPD-516 Memo Cir. No. 8, s. 1992Multivitamins and Minerals (Leginsol Vita) Drops

Manufactured by; Phil-Genetics Laboratories For: Dyna Drug Corp. DR-XY12413

28-Apr-92

10-Jun-92 IPD-516 Memo Cir. No. 7, s. 1992 Inclusion of Hepatitis C Testing Kits in List 1-B of Diagnostic Reagents Required to be Registered 24-Apr-92

10-Jun-92 IPD-516 Memo Cir. No. 6, s. 1992 Amendment of Categories of Drug Products to Qualify Under Special Lane 22-Apr-92

14-Apr-92 IPD-492 Memo Cir. No. 5-D, s. 1992 Medifortan Capsule - DR-XY2203 Mfd. By: Biodrug Medical Labs., Inc. For: Medi Rx. Inc. 31-Mar-92

14-Apr-92 IPD-492 Memo Cir. No. 5-C, s. 1992 Paracetamol 500 mg Tablet Manufactured by: Sydenham Labs., Inc. 31-Mar-92

14-Apr-92 IPD-492 Memo Cir. No. 5-B, s. 1992 Aminogesic Forte 500 mg. Tablet Mfg. By: Sydenham Labs., Inc. 31-Mar-92

14-Apr-92 IPD-492 Memo Cir. No. 5-A, s. 1992Quinine Sulfate Film Coated 325 mg. Tablet Mfd.

By: Labatec Pharma S.A. - DR-XY1201 Impt. By: Medecor Phils., Inc.

31-Mar-92

14-Apr-92 IPD-492 Memo Cir. No. 5, s. 1992Aspirin (Pedia) 100 mg. Tablet - DR - 901 Mfd.

By: United Labs., Inc. For: Myra Pharmaceuticals

31-Mar-92

14-Apr-92 IPD-492 Memo Cir. No. 4, s. 1992 Hemo K Tablet - DR-X4030 Manufactured by: Am-Europharma Corp. 19-Mar-92

28-Feb-92 IPD-467 Memo Cir. No. 2, s. 1992Clarification of Section 3.4 of A.O. 96 s. 90 on the Exemption from the Criteria Prescribed for

Fixed-Dose-Combination28-Jan-92

Page 31: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

123

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

28-Feb-92 IPD-467 Memo Cir. No. 1, s. 1992

Creation of A Joint Study Group of the Cosmetic Industry and BFAD to Compile, Publish, Review

and Study Rules and Regulations Governing Cosmetic Preparations

21-Jan-92

28-Feb-92 IPD-467 Regulation No. 2, s. 1986Assignment of Brand Name and/or Generic

Names for a Formulation of a Drug or Pharmaceutical Specialty

17-Nov-86

28-Feb-92 IPD-467 Regulation No. 1, s. 1986 New Labeling Requirements of Preparations Containing Salicylates 1-Aug-86

19-Nov-91 IPD-240 Regulation No. 5, s. 1987 Guidelines on Advertisement and Promotions of Prescription Pharmaceutical Products 8-Dec-87

16-Oct-91 IPD-240-A Memo Cir. No. 001, s. 1983Procurement or Buying of Stocks Only from Legitimate or Authorized Manufacturers or

Distributors10-Mar-83

16-Oct-91 IPD-240-A Memo Cir. No. 17, s. 1991 Re-Issuance of BFAD Circulars, Rules and Regulations 7-Oct-91

21-Aug-91 IPD-359 Memo Cir. No. 13, s. 1991 Fake/Imitation Consumer Products in Plastic Bottles or Containers 24-Jul-91

21-Aug-91 IPD-359 Memo Cir. No. 12, s. 1991 Clarification of New Registration When There is a Change of Manufacturer 28-Jun-91

21-Aug-91 IPD-359 Memo Cir. No. 11, s. 1991Modification of Memorandum Circular No. 6 s. 1991: Implementation Details of A.O. 99 s.

199018-Jun-91

21-Aug-91 IPD-359 Memo Cir. No. 10, s. 1991 Unregistered Epogen 13-Jun-91

21-Aug-91 IPD-359 Memo Cir. No. 9, s. 1991Inclusion of Abdominal Pads in List 1 A Medical

Devices Required to be Registered and Correction of No. 30 of the Same List

11-Jun-91

21-Aug-91 IPD-359 Memo Cir. No. 8, s. 1991 Special Cases of Drug Products Eligible for Memorandum of Extension (MOE) 15-May-91

Page 32: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

124

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

21-Aug-91 IPD-359 Memo Cir. No. 7, s. 1991Clarification of Prescribed Periods for Renewal of

Registration and Compliance to Letter of Abeyance

27-Mar-91

21-Aug-91 IPD-359 Memo Cir. No. 6, s. 1991 Implementation Details of A.O. 99 s. 1990 26-Mar-91

21-Aug-91 IPD-359 Memo Cir. No. 5, s. 1991 The Designation and Registration of An Official Liaison Officer 4-Feb-91

21-Aug-91 IPD-359 Memo Cir. No. 4-A, s. 1991

Amending List 1-A and List II of Memorandum Circular No. 1 s. 1991 Dated 03 January 1991 Subject: Registration of Medical Devices and

Diagnostic Reagents

23-Jan-91

21-Aug-91 IPD-359 Memo Cir. No. 4, s. 1991Requirements for Application for Drug

Registration Extension Pursuant to Memo Circular No. 18, s. 1989

23-Jan-91

21-Aug-91 IPD-359 Memo Cir. No. 3, s. 1991

Procedure in the Processing of Certificate of Good Manufacturing Practice (GMP), Certificate of Free Sale and Certificate of GMP and the Free

Sale

10-Jan-91

21-Aug-91 IPD-359 Memo Cir. No. 2, s. 1991 Clarification of "Packing" and 'Repacking" in the Definition of Drug Manufacturer 7-Jan-91

21-Aug-91 IPD-359 Memo Cir. No. 1, s. 1991 Registration of Medical Devices and Diagnostic Reagents 3-Jan-91

8-Feb-91 IPD-240 Memo Cir. No. 16, s. 1990

Exemption of Certified Countryside and Barangay Business Enterprises (CCBE) from

BFAD License to Operate (LTO) and Compliance to Technical Requirement (CRT) Fees

28-Dec-90

8-Feb-91 IPD-240 Memo Cir. No. 15, s. 1990 Exemption from the Requirement Providing One Pharmacist for Each Licensed Activity 6-Dec-90

Page 33: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

125

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

8-Feb-91 IPD-240 Memo Cir. No. 14, s. 1990

Submission of the First and Last Batch Number of Products Complying with Generic Labelling

Requirements and Using the Old Labels Respectively

2-Nov-90

8-Feb-91 IPD-240 Memo Cir. No. 13, s. 1990

Provisional Requirement for Licensing of Establishments to Engage in the Manufacture,

Distribution and Sale of Diagnostic Reagents for Laboratory Use

31-Oct-90

8-Feb-91 IPD-240 Memo Cir. No. 12, s. 1990 Signatures Required in Reports of Laboratory Analysis 26-Oct-90

8-Feb-91 IPD-240 Memo Cir. No. 11, s. 1990Information From World Health Organization

Headquarters Regarding A Batch of Mislabelled Diethylene Glycol Used in Paracetamol Syrup

15-Oct.90

8-Feb-91 IPD-240 Memo Cir. No. 10, s. 1990Bureau of Patents, Trademarks and Technology Transfer (BPTTT) Clearance in the Processing of

BFAD Brand Name Clearance5-Sep-90

8-Feb-91 IPD-240 Memo Cir. No. 9, s. 1990Revised Implementing Guidelines for the

Effective Implementation of A.O. No. 151 s. 1971 Re: Certification of Antibiotics

17-Aug-90

8-Feb-91 IPD-240 Memo Cir. No. 8, s. 1990Clarification on the Rules and Regulations Governing Dispensing and Drug Outlets

Licensing Requirements6-Jun-90

8-Feb-91 IPD-240 Memo Cir. No. 7, s. 1990 Classification of Cough Syrups 23-May-90

8-Feb-91 IPD-240 Memo Cir. No. 6, s. 1990Confirmation of the Resolution During the

Conference with Food Importers at the BFAD on April 2, 1990

16-May-90

8-Feb-91 IPD-240 Memo Cir. No. 5, s. 1990. Facilitating Action on Registration of Certain Pharmaceutical Products 15-May-90

8-Feb-91 IPD-240 Memo Cir. No. 4, s. 1990 Batch Certification of Antibiotics 7-May-90

Page 34: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

126

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

8-Feb-91 IPD-240 Memo Cir. No. 3, s. 1990 Fake Products of Colgate-Palmolive Phils., Inc. 19-Apr-90

8-Feb-91 IPD-240 Memo Cir. No. 2, s. 1990 Compliance with Administrative Order No. 56 s. 1989 20-Mar-90

8-Feb-91 IPD-240 Memo Cir. No. 25, s. 1989 Public Information About the Generics Act of 1988 5-Dec-89

8-Feb-91 IPD-240 Memo Cir. No. 24-B, s. 1989 Confiscation of SHENYUNG (Growth) Balls 29-Nov-89

8-Feb-91 IPD-240 Memo Cir. No. 24-A, s. 1989

Adulterated and Unregistered Imported Food Products 27-Nov-89

8-Feb-91 IPD-240 Memo Cir. No. 24, s. 1989 Guidelines to Implement A.O. 79, s. 1989 27-Oct-89

8-Feb-91 IPD-240 Memo Cir. No. 23, s. 1989 US-FDA Ban on Methylene Chloride in Hair Sprays 16-Oct-89

8-Feb-91 IPD-240 Memo Cir. No. 22, s. 1989 USFDA Revised Policy on Country of Origin Labelling for Imported Food 12-Oct-89

8-Feb-91 IPD-240 Memo Cir. No. 21, s. 1989 Solicitation of Advertisement by Quest Publications 15-Sep-89

8-Feb-91 IPD-240 Memo Cir. No. 20, s. 1989 Registration of Imported Food Products 4-Sep-898-Feb-91 IPD-240 Memo Cir. No. 19, s. 1989 Requirement for Tablet Hardness 21-Aug-898-Feb-91 IPD-240 Memo Cir. No. 18, s. 1989 Drug Registration Extension 16-Aug-89

8-Feb-91 IPD-240 Memo Cir. No. 17, s. 1989 Monitoring of Drugstore Pharmacist's Office Hours 15-Aug-89

8-Feb-91 IPD-240 Memo Cir. No. 16, s. 1989 Monitoring of Voluntary Compliance with the Generics Act of 1988 7-Aug-89

8-Feb-91 IPD-240 Memo Cir. No. 15, s. 1989Final Deadline for Generic Labelling and Generic Advertising of Drug Products Containing Single

Active Ingredients19-Jul-89

8-Feb-91 IPD-240 Memo Cir. No. 14, s. 1989 Batch Certification of Antibiotic and Antibiotic Containing Products 18-Jul-89

Page 35: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

127

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

8-Feb-91 IPD-240 Memo Cir. No. 13, s. 1989 Methanol Content in Alcohol Beverages as Defined by Memo Circular No. 88-003 15-Jun-89

8-Feb-91 IPD-240 Memo Cir. No. 12, s. 1989 Fake Efficascent Oil 6-Jun-898-Feb-91 IPD-240 Memo Cir. No. 11, s. 1989 Fake Drug Products 30-May-89

8-Feb-91 IPD-240 Memo Cir. No. 10, s. 1989

Administrative Order No. 70, s. 1989 Re-Classifying Pseudoephedrine and Drug Products

Containing Pseudoephedrine as Prescription Drugs

29-May-89

8-Feb-91 IPD-240 Memo Cir. No. 009-A, s. 1989

Specification of Quality Control Equipment/Facilities for Repacking of

Pharmaceutical Products18-May-89

8-Feb-91 IPD-240 Memo Cir. No. 009, s. 1989Clarification on the Period of Time

Pharmaceutical Products with Old Label shall be Allowed to Remain in the Market

18-May-89

8-Feb-91 IPD-240 Memo Cir. No. 008, s. 1989

Implementation of Schedule of Cost of Laboratory Analysis for Registration of Drug

Products in Relation to Section 6 of Administrative Order No. 67 s. 1989

9-May-89

8-Feb-91 IPD-240 Memo Cir. No. 007. S. 1989 DEPO-PROVERA 20-Apr-89

8-Feb-91 IPD-240 Memo Cir. No. 006, s. 1989 Garamycin Injection 80mg. Lot No. PH5AMKZ-1 ED 01/89 27-Mar-89

8-Feb-91 IPD-240 Memo Cir. No. 005, s. 1989 BFAD Program on Inspection of Drug Establishment 3-Apr-89

8-Feb-91 IPD-240 Memo Cir. No. 004, s. 1989Quality Control Facilities and Equipment as A

Requirement in the Repacking of Finished Pharmaceutical Products Including Raw Materials

3-Mar-89

Page 36: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

128

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

8-Feb-91 IPD-240 Memo Cir. No. 003-A, s. 1989

Drugs Validly Registered and Active in the Market 14-Feb-89

8-Feb-91 IPD-240 Memo Cir. No. 003, s. 1989 Bronchopen Vial and Bronchopen Ampoule 14-Feb-89

8-Feb-91 IPD-240 Memo Cir. No. 002-A, s. 1989 Submission of Prototype Labels, etc. 13-Feb-89

8-Feb-91 IPD-240 Memo Cir. No. 002, s. 1989

Applications for License to Operate Filed Directly at the Bureau of Food and Drugs or Offering to Pay the Fees Therefor Directly with the Same

Office

25-Jan-89

8-Feb-91 IPD-240 Memo Cir. No. 001, s. 1989Netromycin 150 mg/ampoule LN-PH7UWHAZ -ED - 3/92 Manufactured by Interphil Lab. Inc.

for Schering Corporation (Phil.) Inc.16-Jan-89

8-Feb-91 IPD-240 Memo Cir. No. 019, s. 1988 Sensitive Eye Effervescent Cleansing Tablet Manufactured by Bausch and Lomb 19-Dec-88

8-Feb-91 IPD-240 Memo Cir. No. 018, s. 1988 Dairy Meadow Full Cream Powdered Milk 14-Dec-888-Feb-91 IPD-240 Memo Cir. No. 017, s. 1988 Medicycline 250 mg. 19-Oct-88

8-Feb-91 IPD-240 Memo Cir. No. 016, s. 1988 Birch Tree Milk Powder with Expiry Date of May 1989 and June 1989 6-Sep-88

8-Feb-91 IPD-240 Memo Cir. No. 015, s. 1988 Banned Alaska Products 30-Aug-88

8-Feb-91 IPD-240 Memo Cir. No. 014, s. 1988Fake Pentrexyl 500mg. Capsule; PL 734;

11/90 Purportedly Manufactured by Bristol Lab. Inc.

23-Aug-88

8-Feb-91 IPD-240 Memo Cir. No. 013, s. 1988 "Muscle Pain"/Methyl Salicyclate Manufactured by Breagh Food Products 23-Aug-88

8-Feb-91 IPD-240 Memo Cir. No. 012, s. 1988 Fenix Capsules of Ethegal Laboratories 19-Aug-88

8-Feb-91 IPD-240 Memo Cir. No. 011, s. 1988Amplipen 250mg. Lot No. 041021 Expiration Date October 1989 Manufactured by Sigjohn

Pharmaceuticals, Quezon City19-Aug-88

8-Feb-91 IPD-240 Memo Cir. No. 010, s. 1988 Submission of Samples for Analysis 19-Aug-88

Page 37: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

129

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

8-Feb-91 IPD-240 Memo Cir. No. 009, s. 1988 Confirmation of the Phase Out Action on Mercury Containing Preparations for Antiseptic Use 18-Jul-88

8-Feb-91 IPD-240 Memo Cir. No. 008, s. 1988 Drug & Medical Device Registration 14-Jul-88

8-Feb-91 IPD-240 Memo Cir. No. 007-88, s. 1988 "Mommy's Like" Baby Oil 5-Jul-88

8-Feb-91 IPD-240 Memo Cir. No. 005-88, s. 1988

Registration of Diagnostic Reagents and Test Kits for AIDS 2-Jun-88

8-Feb-91 IPD-240 Memo Cir. No. 004-88 BFAD General Guidelines on Donation of Pharmaceutical Products 2-May-88

8-Feb-91 IPD-240 Memo Cir. No. 88-003 Methanol Content in Alcoholic Beverages 19-May-88

8-Feb-91 IPD-240 Memo Cir. No. 88-002Provisions of Section 4 of Board Regulation No. 2 s. 1988 Dated March 17, 1988 of the Dangerous

Drugs Board4-Apr-88

8-Feb-91 IPD-240 Memo Cir. No. 88-001 Implementation of the Provisions of Administrative Order No.134 s. 1970 9-Mar-88

8-Feb-91 IPD-240 Regulation No. 1, s. 1988 Amended General Regulations for the Licensing of Drug Establishments 4-Jan-88

8-Feb-91 IPD-240 Regulation No. 4, s. 1987

Deferment of Implementation of BFAD Regulation No. 2 s. 1987 Regarding Guidelines on Evaluation and Registration of Fixed-Dose

Combination Drugs and BFAD Regulation No. 3 s. 1987 Regarding Dipyrone and Related

Compounds

9-Nov-87

8-Feb-91 IPD-240 Memo Cir. No. 1-D, s. 1987Further Amendments to BFAD Memorandum

Circulars Relative to Guidelines for Monitoring of Imported Foodstuffs

2-Feb-87

8-Feb-91 IPD-240 Regulation No. 3, s. 1987 Dipyrone and Related Compounds 19-Oct-87

Page 38: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

130

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

8-Feb-91 IPD-240 Regulation No. 2, s. 1987Amending A.O. No. 7, s. 1986 Re: Guidelines on

the Evaluation and Registration of Fixed-Dose Combination Drugs

7-Oct-87

8-Feb-91 IPD-240 Regulation No. 1-A, s. 1987 Addendum to BFAD Regulation No. 1 Dated April 1, 1987 10-Apr-87

8-Feb-91 IPD-240 Regulation No. 1, s. 1987 Withdrawing Approval of Drug Registration for Oral Anti-Inflammatory Proteolytic Enzymes 1-Apr-87

8-Feb-91 IPD-240 Memo Cir. No. 2, s. 1986 Birch Tree Milk Powder 20-Oct-86

8-Feb-91 IPD-240 Memo Cir. No.1-C, s. 1986Amendments to BFAD Memorandum Circulars

Relative to Guidelines for Monitoring of Imported Foodstuffs

27-Nov-86

8-Feb-91 IPD-240 Memo Cir. No.1-B, s. 1986 Modified Guidelines for Monitoring of Foodstuffs 27-Oct-86

8-Feb-91 IPD-240 Memo Cir. No. 1-A, s. 1986

Amendments to BFAD Memorandum Circular Dated 01 July 1986 Concerning the Guidelines

for Monitoring of Foodstuffs Imported from Europe and China for Contamination with

Radioactive Substances

19-Sep-86

8-Feb-91 IPD-240 Regulation No. 2, s. 1986Assignment of Brand Name and/or Generic

Names for a Formulation of a Drug or Pharmaceutical Specialty

17-Nov-86

8-Feb-91 IPD-240 Regulation No. 1, s. 1986 New Labeling Requirements of Preparations Containing Salicylates 1-Aug-86

8-Feb-91 IPD-240 Memo Ord. No. 1, s. 1985 Sale and Distribution of Glacial Acetic Acid as Vinegar or for Vinegar Manufacture 27-Sep-85

8-Feb-91 IPD-240 Regulation No. 001-E, s. 1982

Guidelines for the Open-Date Marking of Dried Dairy Milk Powder 8-Nov-82

8-Feb-91 IPD-240 Regulation No. 001-D, s. 1982

Guidelines for the Open-Date Marking of Vitamin C - Enriched Liquid Fruit Drinks 8-Nov-82

Page 39: BFAD Laws and Regulations

OFFICE OF THE NATIONAL ADMINISTRATIVE REGISTER

Inventory of Administrative Issuances

131

Date Filed Ref. No. Subject No. Subject Title Date Adopted

DEPARTMENT OF HEALTHFOOD AND DRUGS ADMINISTRATION

8-Feb-91 IPD-240 Regulation No. 001-C, s. 1982

Guidelines for the Open-Date Marking of Infant Food 1-Oct-82

8-Feb-91 IPD-240 Regulation No. 001-B, s. 1982

Guidelines for the Open-Date Marking of Bakery Products 7-Sep-82

8-Feb-91 IPD-240 Regulation No. 001-A, s. 1982

Guidelines for the Open-Date Marking of Liquid Milk Products, Pursuant to Administrative Order

No. 16, s. 197930-Aug-82

8-Feb-91 IPD-240 Regulation No. 001, s. 1982 Guidelines for Open-Date Marking of Prepackaged Foods 23-Aug-82

2-Feb-91 IPD-240 Memo Cir. No. 1, s. 1990 Compliance with the DOH - Administrative Order No. 55, s. 1989 or the Generic Labelling 12-Feb-90