|
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) |
|
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 |