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REGULATORY GUIDELINES

Republic Acts

  R. A. No. 3720

AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, DRUGS, AND COSMETICS BEING MADE AVAILABLE TO THE PUBLIC BY CREATING THE FOOD AND DRUG ADMINISTRATION WHICH SHALL ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO.

  R. A. No. 5921

AN ACT REGULATING THE PRACTICE OF PHARMACY AND SETTINGS STANDARDS OF PHARMACEUTICAL EDUCATION IN THE PHILIPPINES AND OF OTHER PURPOSES.

  R. A. No. 6675

AN ACT TO PROMOTE, REQUIRE AND ENSURE THE PRODUCTION OF AN ADEQUATE SUPPLY, DISTRIBUTION, USE AND ACCEPTANCE OF DRUGS AND MEDICINES IDENTIFIED BY THEIR GENERIC NAMES

  R. A. No. 7394 "THE CONSUMER ACT OF THE PHILIPPINES"
  R. A. No. 8203

AN ACT OF PROHIBITING COUNTERFEIT DRUGS, PROVIDING
PENALTIES FOR VIOLATIONS AND APPROPRIATING
FUNDS THEREFOR

Administrative Orders

 

SUBJECT

 A. O. No.104-A s. 2000

REVISED 2000 SCHEDULE OF FEES AND CHARGES FOR THE CORRESPONDING SERVICES RENDERED BY THE BUREAU OF LICENSING, BUREAU OF RESEARCH AND LABORATORIES, BUREAU OF FOOD AND DRUGS AND NATIONAL QUARANTINE OFFICE AMENDMENT TO A.O. 40 S. 2000

  A. O. No. 99 s. 2000

BANNING AND WITHDRAWAL OF THE FIXED - DOSE - COMBINATION DRUG PRODUCT LORATADINE + PSEUDOEPHEDRINE (CLARINASE) FROM THE MARKET

  A. O. No.  98 s. 2000

VOLUNTARY WITHDRAWAL OF ASTEMIZOLE (HISMANAL) FROM THE MARKET

  A. O. No.  97 s. 2000

BANNING AND WITHDRAWAL OF CISAPRIDE (PREPULSID) FROM THE MARKET

 A. O. No. 85 s. 2000

REGISTRATION, REQUIREMENTS FOR A GOVERNMENT AGENCY IMPORTING  A PHARMACEUTICAL PRODUCT WITH A REGISTERED COUNTERPART BRAND IN THE PHILIPPINES

  A. O. No. 23-C s. 2000

 

POLICIES AND GUIDELINES ON OVER-THE-COUNTER (OTC) DRUG PRODUCTS

 

A. O. No. 54 s. 1999

CHANGE OF MANUFACTURERS OF DRUG PRODUCTS IN COMPLIANCE WITH CGMP REQUIREMENTS

A. O. 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

A. O. No. 14 s. 1999

REGULATIONS FOR THE LICENSING OF SALT MANUFACTURERS

  A. O. No. 39 s. 1996

AMENDMENT TO DOH-ADMINISTRATIVE ORDER NO. 18-A S. 1993 OR THE STANDARDS OF QUALITY AND REQUIREMENTS FOR THE PROCESSING, PACKAGING AND LABELLING OF BOTTLED DRINKING WATER
A. O. No. 28 s. 1996 STANDARD MINIMUM ADVERTISING MESSAGE FOR ANTI-DIARRHEAL PREPARATIONS OR DRUG PRODUCTS
  A. O. No. 29-A s. 1994 REGULATION PART D-5 COSMETIC: LISTING OF COSMETICS SPECIALIST
  A. O. No. 18-A s. 1993

STANDARDS OF QUALITY AND REQUIREMENTS FOR THE PROCESSING, PACKAGING AND LABELING OF BOTTLED DRINKING WATER

A.O. No. 41 s. 1991 GUIDELINES ON ADVERTISEMENT AND PROMOTIONS OF VETERINARY DRUGS AND PRODUCTS
  A. O. No. 99 S. 1990 REQUIREMENTS FOR LABELLING MATERIALS OF CATEGORIES OF PHARMACEUTICAL PRODUCTS CONTAINING FOUR OR MORE ACTIVE INGREDIENTS OUTSIDE THE COVERAGE OF A.O. 85 S. 1990 
  A. O. No. 85 s. 1990 REQUIREMENTS FOR LABELLING MATERIALS OF CERTAIN
CATEGORIES OF PRODUCTS CONTAINING TWO OR MORE ACTIVE INGREDIENTS
  A. O. No. 56 s. 1989 REVISED REGULATIONS FOR THE LICENSING OF DRUG ESTABLISHMENTS AND OUTLETS
  A. O. No. 55 s. 1988

REQUIREMENTS FOR LABELLING MATERIALS OF PHARMACEUTICAL PRODUCTS

  A. O. No. 99-A s. 1984
 
REGULATION PART C-11: LISTING OF LOCAL HERBAL AND/OR TRADITIONAL DRUGS
  A. O. No. 88-A s.1984 REGULATORY GUIDELINES CONCERNING FOOD ADDITIVES

  A. O. No. 88-B s. 1984

RULES AND REGULATIONS GOVERNING THE LABELING OF PREPACKAGED FOOD PRODUCTS DISTRIBUTED IN THE PHILIPPINES

 

A. O. No. 42 s. 1982 REGULATION PART C-10: DRUGS REGISTRATION OF HEALTH AND OR TRADITIONAL DRUGS BOTH LOCAL AND IMPORTED
A. O. No. 208 s. 1974 HUMAN FOODS; CURRENT GOOD MANUFACTURING PRACTICE (SANITATION) IN MANUFACTURE, PROCESSING, PACKING OF HOLDING.
A. O. No. 150 s. 1971 REGULATION PART D-4 COSMETIC: REGISTRATION OF COSMETIC SPECIALTIES
B.C. 01 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
B.C. 02 s. 2001

ADVISORY ON VOLUNTARY RECALL OF PROCESSED MEAT PRODUCTS IMPORTED FROM EUROPEAN COUNTRIES

  B. C. 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 (MC NO. 10-A s. 1992)
  B.C. No. 3 s. 1999

ALCOHOL WITH DISINFECTANT AND ANTISEPTIC ACTIONS

  B. C. No. 01 s. 1997

ENFORCEMENT OF THE REQUIREMENT FOR BIO-AVAILABILITY
STUDIES FOR REGISTRATION OF PRODUCTS INCLUDED IN THE LIST B’ (PRIME) UNDER DOH-ADMINISTRATIVE ORDER 67 SERIES OF 1989.

B. O. No. 163 s. 1997

SPECIFIC REQUIREMENTS FOR THE REGISTRATION OF IMPORTED FOOD AND FOOD PRODUCTS

  M. C. No. 7 s. 1992

INCLUSION OF HEPATITIS C TESTING KITS IN LIST 1-B OF DIAGNOSTIC REAGENTS REQUIRED TO BE REGISTERED

FDA REG. No. 001-A s. 1982

GUIDELINES FOR THE OPEN-DATE MARKING OF LIQUID MILK PRODUCTS, PURSUANT TO ADMINISTRATIVE ORDER NO. 16 S. 1979

FDA REG. No. 001-B s. 1982

GUIDELINES FOR THE OPEN-DATE MARKING OF BAKERY PRODUCTS

FDA REG. No. 001-C s. 1982

GUIDELINES FOR THE OPEN-DATE MARKING OF INFANT FOOD

FDA REG. No. 001-D s. 1982

GUIDELINES FOR THE OPEN-DATE MARKING OF VITAMIN-C ENRICHED LIQUID FRUIT DRINKS

FDA REG. No. 001-E s. 1982

GUIDELINES FOR THE OPEN-DATE MARKING OF DRIED DAIRY MILK POWDER