ADMINISTRATIVE ORDERS | BUREAU CIRCULARS | MEMORANDUM CIRCULARS

 

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ADMINISTRATIVE ORDERS          

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BFAD ISSUANCE

Date Issued

Date Posted

SUBJECT

AO 2006-0021

10 Aug 2006

  Supplemental Guidelines to Administrative Order (AO) 67 s. 1987, Revised Rules and Regulations on Registration of Pharmaceutical Products and Bureau Circular 05 s. 1997 in evaluating New Drug Applications
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 11 s. 2005

4 Apr 2005

  Supplemental Guidelines to Administrative Order No. 144 series 2004, entitled: "Guidelines for the Establishment and Operations of Botika ng Barangays (BnB) and Pharmaceutical Distribution Networks (PDNs)" relative to the inclusion of other drugs which are classified as Prescription Drugs and Other Related Matters
AO 8 s 2005

18 April 2005

  Policy and Requirements for Availing of Special Permit for Restricted Use of Unregistered Drug and Test Kits for Human Immune Deficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS)
AO 7 s 2005

31 March 2005

  Amending AO No. 142 s 2004 by providing exemption from the requirement of Certificate of Product Registration for all goods procured through UNICEF, UNDP, WHO and GDF
AO 1 s 2005

3 Jan 2005

  Revised Polices and Guidelines Governing Patent and Trade Secret Rights in relation to the Registration of Pharmaceutical Products
AO 184 s 2004

28 Dec 2004

  Guidelines on the Registration of Traditionally-Used Herbal Products
AO 177 s. 2004

12 Nov 2004

  Amendment to AO No. 171 s. 2004 on the Policies and Guidelines to Implement the Relevant Provisions of Republic Act 9257, otherwise known as the "Expanded Senior Citizen Act of 2003"
AO  172 s. 2004

16 Sep 2004

  Guidelines on the Registration of Herbal Medicines
AO 171 s 2004

1 Oct 2004

  Policies and Guidelines to Implement the Relevant Provisions of Republic Act 9257, otherwise known as the "Expanded Senior Citizens Act of 2003"
AO 170 s 2004

30 Sep 2004

  Policies and Guidelines Governing Intellectual Property Rights in relation to Registration of Pharmaceutical Products
AO 169 s 2004

6 Sep 2004

  Implementing Guidelines for the Exclusive Use of Generic Names and Generic Terminology in all Prescriptions and Orders in all DOH Facilities
AO  144 s. 2004

7 May 2004

  Guidelines (Establishment & Operation of Botika ng Barangays (BnB) & Pharmaceutical Distribution Networks (PDNs)
AO  142 s. 2004

31 Mar 2004

  Bureau of Food and Drugs (BFAD)'s issuance of Certificate of Product Registration for Foreign Assisted Projects Procurement and Laboratory Testing of Pharmaceutical and biological Products Procured by and/or delivered to the Department of Health (DOH)

AO 134 s. 2004

9 Jan 2004

  Guidelines Governing the Registration and Performance Evaluation of Drug Screening Test Kits and Reagents

AO  90 s. 2003

18 Sep 2003

  Reclassification and revision in the use of Hydroquinone and / or Tretinoin  (RETINOIC ACID) preparations

AO  64 s. 2003

1 Jul 2003

  Policy Guidelines on the Operationalization of Botika ng Barangays  (BnBs) by the Center for  health Development (CHD)
AO 54-A s. 2003

6 Jun 2003

  Guidelines on the Processing and Clearance of Importations through Donations by the Department of Health
AO 34 s 2003

2 Apr 2003

  Guidelines in the operationalization of Botika ng Barangay at CHD III Pilot Areas
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 103 s. 2002

23 Apr 2002

 

Batch Certification of Antibiotics

AO 70 s. 2002

03 Jan 2002

 

Licensing of Botika ng Barangay (BnB) in Various Local Government Units

AO 53 s. 2001

09 Oct 2001

 

Recalling Administrative Order No. 40 s. 2001

AO 50 s 2001

17 Sep 2001

  Revised 2001 Schedule of Fees and Charges for the Corresponding Services rendered by the Bureau of Food and Drugs

AO  47-A  s. 2001

30 Aug 2001

 

Rules and Regulations on the Registration, Including Approval and Conduct of Clinical Trials, and Lot or Batch Release Certification of Vaccines and Biologic Product

AO 40 s. 2001

27 Aug 2001

 

Allowing Drug Manufacturers and Supplies Without CPR’s to Participate in the Bidding of the DOH Central Office.

AO 34 s. 2001

10 Jul 2001

 

Provisional Accreditation of DOH Drugs and Medical Supplies

AO 27 s. 2001

19 Jun 2001

 

Rules and Regulations for Licensing Local Manufacturers of Vaccines and Biologic Products 

AO 3 s 2001

6 Mar 2001

  Recalling AO No, 99 s 2000 Providing for the banning and Withdrawal of the Fixed Dose Combination drug product Loratidine+Pseudoephedrine (Clarinase) from the marker

AO 1 s. 2001

26 Feb 2001

 

Granting of Provisional Accreditation Pharmaceutical Suppliers

AO 177 s. 2001

24 Jan 2001

 

Amendment to Administrative Order No. 117s. 2000 Relative to the Guidelines on the Accreditation of Suppliers of Medical Equipment, Parts, Accessories and Medical Equipment Repair Shop

AO 163b s 2000

11 Dec 2000

  Revised Schedule of Fees and Charges for the services rendered by the Bureau of Food and Drugs

AO 163 s. 2000

04 Dec 2000

 

Reclassifying All Pharmaceutical Products Containing More Than 25mg To 50mg Of Phenylpropanolamine To Prescription Drugs And Prohibiting the Registration of those Containing More than 50mg

AO 119 s. 2000

25 Sept 2000

 

Additional Guidelines on the Promotion of Over-The-Counter Drugs  OTC to the Public 

AO 107 s 2000

04 Sep 2000

 

Amendment/Addendum to AO 51 Sec. 9.1, 9.3, 9.4 and 10.2 s 1988. Reconstitution and Strengthening of the Membership of the Therapeutics Committee at the Centers for Health Development, Special Hospitals, National Medical Centers, Regional Medical Centers, Regional Hospitals and Sanitaria

AO 85 s. 2000

14 Jul 2000

 

Registration Requirement for a Government Agency Importing a Pharmaceutical Product with a Registered Counterpart Brand in the Philippines

AO 82 s. 2000

13 Jul 2000

 

Policies and Guidelines Governing Sale by Drug Outlets of Generic Alternative at Discounted Price

AO 49a s 2000 9 May 2000   Policy Guidelines in the Implementation/Operations of the DOH Botica in all DOH Retained Hospitals

AO  23-C s. 2000

09 Mar 2000

 

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

AO 23 s 2000 2 Mar 2000   Implementing Rules and Regulations of RA NO. 8423 otherwise known as The Traditional and Alternative Medicine Act of 1997

AO 54 s. 1999

22 Dec 1999

 

Change of Manufacturers of Drug Products in Compliance with the CGMP Requirements

AO  48-C  s. 1999

21 Nov 1999

 

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

AO  43-A  s. 1999

11 Oct 1999

 

Amendment of Administrative Order No. 220 s. 1974 Current Good Manufacturing Practice.

AO 43 s. 1999

29 Sep 1999    Current Good Manufacturing Practice Guidelines For Drugs

AO  41-A  s. 1999

29 Sep 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

AO 10 s. 1997

29 May 1997

 

Waiver of Test Analysis on Antibiotics Preparations and List B Prime Drugs

AO 31 s 1996

26 Aug 1996

  Guidelines in the Strengthening of the Implementation of the "Project Murang Gamot Presyong DOH"
AO 28 s 1996

31 Jul 1996

  Standard Minimum Advertising Message for Anti-Diarrheal Preparations of Drug Products

AO  23-A s. 1996

05 Jul 1996

 

Guidelines on the Development and Establishment of Botica ng Barangay

AO 38 s. 1994

18 Oct 1994

 

Recording of Non-Prescription Cough Preparations Subject to Abuse

AO 4 s. 1992

03 Nov 1992

 

Policy and Requirements for Availing of Compassionate Special Permit (CSP) for Restricted Use of  Unregistered Drug and Device Product/Preparation

AO 42 s. 1992

19 Aug 1992

  Regulation Part C-10: Drug Registration Of Herbal and/or Traditional Drugs Both Local And Imported

AO 117 s. 1992

17 Jan 1992

 

Providing for the Classification of Household Remedies

AO 115 s. 1991

08 Nov 1991

 

Providing for the Classification of Household Remedies

AO 111b s 1991

15 Oct 1991

  Rules and Regulations on Registrations to Implement Prescribing Requirements for the Veterinary Drugs and Products
AO 111a s 1991 7 Oct 1991   Rules and Regulations on Registration of Veterinary Drugs and Products

AO 110 s. 1991

19 Jun 1991

 

Re-scheduling of Mandatory Use of Generic Labels for Pharmaceutical Products Containing Four of More Active Ingredients under the Coverage of Administrative Order No. 99 s. 1990

AO 106 s. 1991

16 May 1991

 

Guidelines on Prescribing of Multiactive-Ingredient Fixed-Dose Combination Drug Products

AO 107 s. 1991

16 May 1991

 

Guidelines on Dispensing of Multiactive-Ingredient Fixed-Dose Combination Drug Products

AO 105 s. 1991

15 Apr 1991

 

Requirement for Labeling Materials of Veterinary Drug products 

AO 99 s 1990

3 Dec 1990

  Requirements for Labelling Materials of Categories of Pharmaceutical Products containing four or more active ingredients outside the coverage of AO 85 s 1990.
AO 96 s 1990

19 Dec 1990

  Guidelines on the Registration of Fixed-Dose Combination Drug Products
AO 90 s 1990

23 April 1990

  Amendment to AO 62 s 1989 re: Rules and Regulations to Impalement Prescribing Requirements
AO 85 s 1990

15 Feb 1990

  Requirements for Labelling Materials of Certain Categories of Products containing two or more active ingredients

AO 79 s. 1989

18 Sep 1989

 

Transitional Remedial Labeling in Compliance with R.A. 6675

AO 67 s. 1989

15 Sep 1989

 

Revised Rules and Regulations on Registration of Pharmaceutical Products

AO 66 s 1989

15 Mar 1989

  Rules and Regulation on the Process of Review and Evaluation of Questioned Drug or Drug Products
AO 65 s. 1989

13 Mar 1989

  Guidelines on Advertisement and Promotions to Implement The Generics Act of 1988
AO 63 s 1989

13 Mar 1989

  Rules and Regulations to Implement Dispensing Requirements under the Generic Act of 1988 (RA No 6675)
AO 62 s 1989

9 Mar 1989

  Rules and Regulations to Implement Prescribing Requirements under the Generic Act of 1988 (RA No 6675)

AO 56 s. 1989

03 Jan 1989

 

Revised Regulations for the Licensing of Drug Establishments and Outlets

AO 55 s. 1988

17 Dec 1988

  Requirements for Labelling Materials of Pharmaceutical Products
AO 51 s 1988

16 Nov 1988

  Implementing Guidelines for Department of Health Compliance with Republic Act 6675 (Generic Act of 1988)
AO 32 s 1987

23 Nov 1987

  Further Amending AO No. 101 s 1969 Relative to Registration of Drugs and Pharmaceutical Specialties
AO 7 s 1986

30 Jan 1986

  Amending AO No. 133 s 196 s 1985 Re: Guidelines on the evaluation and registration of Fixed Dose Combination
AO 133 s 1985

9 Oct 1985

  Guidelines on the evaluation and registration of Fixed Dose Combination Drugs
AO 106a s 1985

25 Jan 1985

  amendments to AO No. 60 s 1968 on Regulations Governing the Operation of Drug Establishments
AO 99a s 1984

14 Aug 1984

  Regulation Part C-11: Listing of Local Herbal and/or Traditional Drugs
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 72 s 1983

6 Sep 1983

  Seizure and Confiscation of Violative Food, Drug and Cosmetics, for the protection of the interest of consumers
AO 42 s 1982

19 Aug 1992

  Regulation Part C-10: Drug Registration of Herbal and/or Traditional Drugs Both Local and Importer
AO 42 s 1979

19 Jul 1979

  Clarification on AO 38 s 1979 restricting the use of Several brand names for a formulation

AO 39 s. 1979

15 Jun 1979

 

Delisting of Fertilizer, Pesticide, Insecticide and other Economic Poison as Household Hazardous Substances

AO 38 s. 1979

15 June 1979

 

Restriction on the Use of Several Brand Names for a Formulation of a Drug or Pharmaceutical Specialty

AO 34 s 1979

11 Jun 1979

  The Need and Role of a Medical Director in the Pharmaceutical Industry

AO 312 s. 1977

17 Jan 1977

 

Household Hazardous Substances 

AO 311 s. 1977

17 Jan 1977

 

Labeling Requirements of Hazardous Substances

AO 303 s. 1976

03 Sep 1976

 

Registration of Hazardous Substances and Manufacturer of Hazardous Substances

AO 220 s. 1974

13 Jun 1974

 

Drugs: Current Good Manufacturing Practice in Manufacture, Processing, Packaging or Holding

AO 151 s. 1971

18 Aug 1971

 

Regulation Part C-7 Drug and Devices: Certification of Antibiotics

AO 149 s. 1971

19 Jul 1971

 

Unauthorized Purchase, Possession, Display or Sale of Government-Owned Drugs, Medicines or any Other Medicinal Items

AO 131 s. 1970

15 Oct 1970

 

Regulation Part C-3.2:  Drugs Prohibition of Use of More Than One Name for a Given Formulation

AO 126 s. 1970

06 Aug 1970

 

Regulation Part C-10: Drugs; Statement of Lot Number, Expiration Date, Registration Number and Storage Conditions of Pharmaceutical Specialties

AO 109 s. 1969

15 August 1969

 

Regulation Part C-1: Drugs Labeling: Prescription Drugs Label Symbol

AO 101 s. 1969

25 April 1969

 

Regulation Part C-9: Drugs: Registration of Drugs and Pharmaceutical Specialties

AO 92 s. 1968

03 December 1968

 

Rules and Regulations Covering the Sale, Distribution, Dispensing, Importation, Manufacture of Depressant and Stimulant Drugs

AO 89 s. 1968

03 October 1968

 

Exemption of Certain Drugs from Prescription Requirements

AO 61 s 1968

5 Mar 1968

  General Regulations for the Enforcement of the Food, Drug & Cosmetic Act (C-3 Misbranding-Drugs & Devices)

 

BUREAU CIRCULARS

 

BFAD ISSUANCE

Date Issued

Date Posted

SUBJECT

BC 2007-011 01 Oct 2007 19 Oct 2007 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
BC 2006-008A 08 Oct 2007 16 Oct 2007 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.
BC 2006-011 26 June 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
BC 2006-009 22 May 2006   Amendment to Bureau Circular No. 06 s. 2005 - List of Recognized Laboratories
BC 2006-008 27 Apr 2006   Lifting of Moratorium on the Conduct of Bioavailability/ Bioequivalence Studies for Selected Pharmaceutical Products
BC 2006-007 21 Mar 2006   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
BC 2006-005

22 Feb 2006

  Guidelines for the Submission of Application for Automatic Renewal Registration of Pharmaceutical Products, Medical Devices, Prepackaged Food and Food Products, and Household Hazardous Substances
BC 18 s. 2005

12 Oct 2005

  New Advisory on Labeling Selective Cycloxygenase-2 (COX-2) Inhibitors and Non-steroidal Anti-inflammatory Drugs (NSAIDS)
BC 15 s 2005

14 July 2005

  Parecoxib (Dynastat)
BC 14 s 2005

6 July 2005

  Gene Therapy
BC 12 s 2005

20 June 2005

  BFAD Quality Seal
BC 11 s 2005

7 June 2005

  Revised Labeling of Selective COX-2 Inhibitor Drugs and NSAIDS
BC 8 s 2005

4 April 2005

  Selective COX-2 Inhibitors
BC 7 s. 2005

02 Mar 2005

  Full Implementation of the Lot or Batch Release Certification Requirement
BC 6 s 2005

10 Feb 2005

  List of Recognized Laboratories
BC 5 s 2005

03 Jan 2005

  Black box warning for all antidepressant drugs
BC 4 s. 2005

01 Feb 2005

  Revised Fees for Seminar on Licensing of Drug Establishments
BC 3 s 2005

19 Jan 2004

  Submission of Site Information File
BC 2 s. 2005

10 Jan 2005

  Revised Fees for Seminar on Licensing of Drug Establishments
BC 1 s 2005

4 Jan 2005

  Classification of all Injectable Hyaluronic Acid as Device
BC 20 s. 2004

13 Dec 2004

  Submission of Application for Registration in Accordance with the Asean Common Technical Document (ACTD) Format
BC 19 s 2004

26 Nov 2004

  Delisting of ROFECOXIB from Bureau of Food and Drugs REGISTRY OF DRUG PRODUCTS
BC 14 s 2004

12 Oct 2004

  Submission of adverse drug reaction reports of COX-2 inhibitors as part of safety monitoring
BC 07 s. 2004

3 Jun 2004

 

Registration of Veterinary Products

BC No. 4-a s. 2004

31 Mar 2004

  Different Brand Names for Narcotic/Opioid Analgesic Drugs for Cancer Pain

BC No. 04 s. 2004

30 Mar2004

 

 Reiterating Memorandum Circular No. 008 s. 1988) (RE: DRUG AND MEDICAL DEVICE REGISTRATION)

BC No. 03 s. 2004

26 Mar  2004

 

Guidelines for the Registration and Performance Validation of Methamphetamine (MET)/Tetrahydrocannobinol (THC) Drug Screening Test Kits

BC No. 02 s. 2004

10 Feb 2004

 

Classification of GINKGO BILOBA as drugs

BC No. 05-b s. 2003

10 Apr 2003

  Attendance in Licensing seminars as a requirement in the application for a license to operate of a drug establishment / drug outlet (A.O. 56 S 1989)

BC No. 05-a s. 2003

 

10 April 2003   Lifting of Moratorium on the Acceptance of Application for Initial Registration of Pharmaceutical Products

BC No. 05 s. 2003

10 April 2003

  Classification of Hemodialysis Products as Drugs

BC No. 02 s. 2003

 

13 Feb 2003

 

Classification of Paracetamol syrup / suspension 120 mg/5mL and 125 mg/5mL

BC No. 03 s. 2003

17 Mar 2003

  Mandatory printing of boxed warning on all Phenylpropanloamine (PPA) containing products (OTC and RX)

BC No. 03-a s. 2003

17 Mar 2003

  Mandatory dissemination of information regarding the precaution/warning of drug products containing PHENYLPROPANOLAMINE (PPA)

BC No. 05-a s. 2003

10 Apr 2003

  Lifting of Moratorium on the Acceptance of Application for Initial Registration of Pharmaceutical Products

BC 3-a s 2003

17 Mar 2003

  Mandatory Dissemination of Information Regarding the Precaution/Warning of Drug Products containing Phenylpropanolamine (PPA)

BC 12 s. 2002

25 Oct 2002

  Reiterating the Ban on the Use of Chloramphenicol in Food Producing Animals

BC 5 s. 2002

04 Apr 2002

 

Extension of the Validity Period of Initial and Renewal Registration of In-Vitro Diagnostic Reagents/Kits 

BC 3 s. 2002

31 Jan 2002

 

Reclassification of Sambong 250mg Tablet from Over-The-Counter (OTC) to Household Remedy

BC 1 s. 2002

18 Jan 2002

  Notarized Application Forms for Product Registration

BC 17 s. 2001

29 Nov 2001

 

Classification of Certain Drug Products

BC 16 s. 2001

20 Nov 2001

 

Guidelines for the Immediate Processing of Applications for Initial Registration of Pharmaceutical Products

BC 15-A  s. 2001

13 Nov 2001

 

Amendment to BFAD Circular No. 23 Dated 16 September 1994

BC 15 s. 2001

26 Oct 2001

 

Guidelines for the Immediate Processing of Pending Applications for Renewal Registration of Pharmaceutical Products

BC 14 s. 2001

26 Oct 2001

 

Amendment to Bureau Circular No. 13-A s. 2001 “Over-The-Counter (OTC) Drugs Reclassified as Household Remedies"

BC 13-A  s. 2001

17 Oct 2001

 

Amendment To Bureau Circular No. 11 s. 2001 “Over-The Counter (OTC) Drugs Reclassified as Household Remedies

BC 12 s. 2001

05 Oct 2001

  Addendum to Bureau Circular No. 6-A s. 2001Dated June 11, 2001

BC 11 s. 2001

20 Aug 2001

 

Over-the-Counter (OTC) Drug Reclassified as Household Remedies

BC 10 s. 2001

10 Aug 2001

 

Submission of Site Information File and updating

BM 10 s. 2001

25 Jun 2001

Reduction on the Required Number of Antibiotic Samples for Analysis for Batch Certification.

BC 6-A s. 2001

11 Jun 2001

  Revised Minimum Required Samples for Laboratory Analysis

BC 4 s. 2001

20 Apr 2001

 

Extension of the Validity of Monitored Release Study

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 28-A  s. 2001

15 Feb 2001

 

Requirements and Fees for Review of Pharmaceutical Products by the Advisory Committee to BFAD (ACB)

BC   5-B s. 2000

03 Aug 2000

 

Standard Policy on Labeled Potency of Pharmaceutical Products

BC 4 s. 2000

14 Jun 2000

 

Implementation of Administrative Order No. 13 s. 1999 “Use of Hydroquinone and/or Tretinoin (Retinoic Acid)

BC   3-A s. 2000

08 Jun 2000

 

Amendment to FDA Circular No. 2. s. of 1982 on the Importation of Semi-Synthetic Antibiotics

BC 3 s. 2000

28 Feb 2000

 

Submission of Test Procedures and Test Specifications for Products to be Included in the Philippine Pharmacopoeia 

BC 1 s. 2000

13 Jan 2000

 

Moratorium on the Acceptance of Application for Initial Registration of Pharmaceutical Products

BC 19 s. 1999

 

Re-Iterating Section 20 (b)(1)(B) of R.A. 3720 as Amended Section 12 of E.O. 175 and Section 29-A of E.O. 175

BC 17 s. 1999

23 Jul 1999

 

Transfer of Processing of Brand Name Clearance for Pharmaceutical Products to the Intellectual Property Office (IPO) 

BC   17-A s. 1999

23 Jul 1999

 

Resumption of Acceptance of Application for Registration of Branded Ethical/Prescription Pharmaceutical Products

BC 16 s. 1999

06 Jul 1999

 

Amending BFAD MC # 22 Date September 8, 1994 Regarding Inventory, Proper Disposal and/or Destruction of Used Vials or Bottles

BC   13-A s. 1999

14 Jun 1999

 

Moratorium on the Conduct of Bioavailability/ Bioequivalence Studies for Pharmaceutical Products Included in the List B’ (Products with Reported Problems on Bioavailability/ Bioequivalence)

BC   12-B s. 1999

11 Jun 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)

BC 11 s. 1999

01 Jun 1999

 

Certification of Registrations' Annotation of Suspension/Cancellation of Drug or Drug Product Combination Found to be Adulterated/Misbranded

BC 7 s. 1999

18 Feb 1999

 

Re-iterating Article IV, Section 30 of Republic Act 5921

BC 5 s. 1998

03 Aug 1998

 

Extension of the Validity Period of Renewal Registration of Medical and Dental Devices

BC 8 s. 1997

30 Apr 1997

 

Implementation Details of BFAD Circular No.1. s. 1997

BC 5 s. 1997

19 Mar 1997

 

Revised Checklist of Requirements and the 1997 Guidelines for the Registration of Pharmaceutical Products

BC 1 s. 1997

21 Jan 1997

 

Enforcement of the Requirement for Bioavailability Studies for Registration of Products Included in the List B’ (Prime) Under DOH-Administrative Order 67 s. 1989

BC 5 s. 1996

07 Aug 1996

 

Iterating Article IV, Section 25 of Republic Act 5921, as Amended.

BC 4 s. 1996

30 Jul 1996

 

Pertinent Provision of Republic Act (R.A.) 7581 Otherwise Known as the Price Act.

BO 67-B s. 1996

05 Jun 1996

 

Requiring the Inclusion of Warning Statement for Products Containing Sodium Metabisulfite  and other Derivatives of this Sodium Salt

BC 3 s. 1996

22 Apr 1996

 

Selling of Drugs or Medicines to the Public

BC 4 s. 1995

17 Oct 1995

 

Period within which an Initial Conditional Registration shall be Processed and Issued

OO 22 s. 1991

18 Oct 1991

 

Guidelines for the Classification of Vitamins and Minerals as Drug or as Food

BC 12 s 1991

28 Jun 1991

  Clarification of New Registration when there is a change of manufacturer
BFAD REG 1 s 1988

4 Jan 1988

  Amended General Regulations for the Licensing of Drug Establishments

BFAD REG 5 s. 198