Republic of the Philippines Ministry of Health J) OFFICE OF THE SECRETARY zy Manila February 15, 1990 ADMINISTRATIVE ORDER No 85s 1690 ‘SUBJECT: REQUIREMENTS FOR LABELLING MATERIALS OF CERTAIN CATEGORIES OF PRODUCTS CONTAINING TWO OR MORE ACTIVE INGREDIENTS ‘Summary: This covered the requirements for generic labelling of products with 2 or more active ingredients in the following categories ‘SECTION 1: APPLICABILITY OF THE PROVISIONS OF AO 555. 1988 All pertinent provisions of AO. 55 s. 1988 on general requirements and specific requirements for labeling materials of pharmaceutical products shall apply to products containing two or more active ingredients covered by this A.O. SECTION 2; COVERAGE This A.0, covers only products containing two or more active Ingredients belonging to the categories below: 2.1, Products containing two or mare active ingredients with a single International Non-Proprietary Name (INN) 2.2, Products containing two and three active Ingredients but without a single INN 2.8. Fluid Replacement and Special Solution Produc's which follow the standard formulations contained in the current edition of the Philippine Nstional Drug Formulary (PNDF) 2.4. Multivitamin Products which follow the standard formulations contained in the current edition of the PNDF. 2.8. Multivitamin Products with non-vitamin components which follow the standard formulations contained in the current edition of the PNDF. All other products with two or mote active ingredients outside of the categories enumerated above are rot covered by this A. SECTION 3: GENERIC LABELLING Products inchided shall be generically labelled according tothe folowing 3.1, Ofcial Name of Products Coniaining Two or More Active Ingredients with 2 Single INN The INN name of the combination produet, eg. Cotimoxezale for the siandard formulation of Sulfamethoxszole + Trimethoprim shall be adopted as the Official Name end shall be used on the label as shown below:‘COTRIMOXAZOLE Terand Name, Trany) 3.2. Oficial Name of Products Containing Two and Three Active Ingracients but without @ Single NN For these products, the Genenc names of the two and three active ingredients shall bbe adopted as the Official name, and shall be used on the label es shown below FERROUS SALT + cin} FOLIC ACID. (Grand Name, ifany) (rand Name, any) PARACETAMOL, TRIPROLIDINE HCL PSEUDOEPHEDRINE HCL (Brand Name, ifany) 3.8 Offcial Name of Fluid Replacement and Spocial Solution Products which Follow the ‘Standard Formulations Contained in the Curreat Edition of the PNOF. ‘The nomenclature used by the PNOF for Fluid Replacement and Special Soluticn Products shall be adopted as the Official Name, and shall be used on the label 3s shown below Dextrose 5% in 0.9% Sodium Chionde (Brand Name, it any) Lactated Ringe’’s Solution (Brand Name, # any) ‘Oral Rehydralion Salts Replacement (Brand Name, if any) Peritoneel Dialysis Solution vith Dextrose 4.25% (Brand Name, if ny) 3.4 Offeial Name of Multvitamin Products For Multivitamin Products with standard formulations included in the current PNDF the official neme adopted shall be Multivitamins with the complete listing of the vitamin content using the standard abbreviated name ae showin below: Muit-Vtamins A,B Complex, C, D, & (Grand Name, Fany)3.5 Official Name of Products Containing Other Multivitamin Standard Formulations For other standard vitamin formulations, 6.9. Vtamin 81, 86 and B12, the Offcial Name shall be the complete listing of the vitamin content using the standard avbreviated names as shown below: Vitamins B1 + B6 + 812 (Brand Name, if any) 3.6 Official Name of Multivitamin Products with Non-Vitarnin Components For other standard formulations of Multivitamin Products with non-vitamin components, the Official Name shall be Mutivitemins with the name of the specife additional comporent(s) with the complete listing of the content using the standard abbreviated ames, as shown below: ~ Wali-Vitamins + Fe 7 AB Complex, CD. E+ Fe (Brand Name, ifany) Multivitamins + Minerals A, B Complex, C.D, E+ Fe, Ca, P, Mn, Zn (Brand Name, itany) SECTION 4: PROCEDURE FOR CHANGING OVER TO NEWLABELS 4.4. All drug establishments thet own registered drug products covered under this A.0, shall present thelr proposed generic labels in compliance with the above for review and approval by BFAD not later than Maren 31. 1980. 42 Ail satisfactory applications for new generic labele covered by this A.0, submitted within Merch 31, 1990 deadline shall be approved by BFAD no laler than April 30, 1930 43. Starting sixty (60) days after approval but nat later than June 39, 1990, only cuch approved generic labels shall be used for these products in new production. The drug establishment is required fo suiomit the last batch number bearing the old lebel and the frst batch number bearing the old label and the first tatch number bearing the new generic label betore the start of actual production with the new label 44, After September 30, 1990, all covered products with the old labels shall be deemed misbrandad and aubjoct o seisvre ky BFAD. 45, It shall be the responsibilty of the drug establishment ta ascertain the coverage of this 4.0. on its products, 46, Remedial generic laballing according to the provisions of A.O. 79s. 1988 is available to product covered by this 4.0.SECTION 5: SEPARAGILITY CLAUSE In case any provision of the A.O. is declared contrary to law or unconstitutional, other provisions which ara not affected thereby shall continue to be in force end in effect, SECTION 6: REPEALING CLAUSE All A.0.'s, Rules and Regulations, and other Administrative Issuances or parts thereof, inconsistent with the provisions of the AO. are thereby repealed and medified accordingly SECTION 7: EFFECTIVITY AND TIME-TABLE This A.O. shell take effect fiteen (15) days after its publication in two (2) newspapers of general circulation (Sad) ALFREDO R.A. BENGZON, M.D, Secretary of Healthti lv IMPLEMENTATION DETAILS OF A.0. 88 S. 1990: ‘The folowing pharmaceutical product categories are subjectto AO, 65s, 1990 Two-component products (2 Active ingredients) Three or more-component procucts ($ and more Active Ingredients) Multivitamins Fluic Replacement and Special Solution Products Oral Rehyaration Salts (ORS) ‘The general requirements, specific requirements and requirements for special products and on conteiners of A.O. 56s. 1988 as amended shall apply where relevant Requirements to be Submitted: ‘An application form properiyfillad up end duly certified Copy of current, valid License to Operate (LTO) Sopy of current, valid Certiicate of Product Registration (CPR) Copy of letter of registration application and BFAD offcial receipt. if product isin the process of being reaistered Two (2) copies of proposes labelling materials reflecting coler, typeface, font where applicable outer box >. Immectate label of bottle, ampule and vial ¢. blister pack and foil strip package insert ®. sample container —ampule, viel, plastic, ete z a b. ‘o small label (small container) in adaition to requirements 1-5: ‘Two (2) copies of actual labels ‘Two (2) copies of magnified facsimie (magnification - 100%) ‘Terminology for the Aciive Ingredient 1, The BFAD LIST of GENERIC NAMES of pharmaceutical products will be the basis of the name of the active ingredient 2. When the generic name of the active Ingredient is rot found in the above list ~the name as recommenced by the following references shall be used 1. Iimtemational Nonproprietary Names (INN) for Pharmaceutical Substances ~ Latest Ecition 2. Marlindale — Latest Edition (29) 3. Merck Index ~ Latest Edition (10°) 4. Other internationally Accepted Compedia 3. Where there is an intemationally accepted name for an FDC. such nomanclature shall be Used. The Generic Name af each of the active ingrediant and its corresponding salt and strength will spear on the formulation, Example COTRIMOXAZOLE 4. Where the product containing two (2) or more active ingredients does not nave one internationally accepted name, the Generic Name of each of the active ingredient shall appear on the principal display panelExample THIAMINE MONONITRATE PYRIDOXINE HYDROCHLORIDE HYDROXOCOBALAMIN, oR THIAMINE MONONITRATE + PYRIDOXINE HC! + HYDROXOCOBALAMIN | \Where the formulation of Fluld Replacement or Special Soluton Product conforms with the standard Philippine National Crug Formulary (PNOF) formulation. the PNOF Otel Name shall be edaplee. LACTATED RINGER'S SOLUTION Where the multivitamin product with standard formulation included in the current POF the Official Name adapted shall be Multivitamins with the complete listing of the vitarrin content using standard abbreviated names Exampie Exampie: MULTIVITAMINS, A, 0. E, 8 Complex, C For other standard vitamin formulations, the Offcial Name shail be the complete listing of the vitamin content using the standard abbreviated names or the Generic Neme of each of the active ingradient. Example. VITAMINS 81+ 88+ 812 | —] For Muttiviternin Products with non-vitemin components, the Oficial Name shall be MULTIVITAMINS plus the non-vitarin components with the complete listing of the vitamin ‘nd non-vitamin components using the standard abbreviated names where epplicable. Example MULTIVITAMINS + Fe A.D. E, 8 Complex, C oR MULTIVITAMINS + MINERALS AD, £, Complex, C+ Fe, CaP. hn, Znv. ML Products exempted irom Labelling Requirements (A.0. 85s. 1990) 4. Service lem Product is available on a limited basis upon physician's request, 2 Specialized Use 0.9. Anticancer drugs 2. Specially Packed ‘Special containers which cannet be made locally 4 Low Volume Importation of finished products not exceeding 500 urits/month or 6,000 units/year Other Requirements 4, The generic name and branc name must have common presentation in terms of a, Upperilower case b. Typeface, font and color PROVIDED THAT THE GENERIC NAME SHALL BE THE MOST PROMINENTLY PRINTED ELEMENT ON THE PRINCIPAL DISPLAY PANEL 2. Where the generic name and the pharmacologic category are the same, the pharmacologic category may bo omitted on the principal cispley panel. 3. For Fluld Replacements, Special Solutions, Multivitamins and two or more component producs, the dosage strengths may not be printed an the prncipal display panel, 4. For multivitamin preparations, the active ingredients must be enumerated in the following order: a. Fat-Soluble Vitamins ~ Vitamins A, 0, E, K b. Water-Soluble Vilamins — vitamin B Complex, Vitamin C Minerals 5. For two er mare component products, the active ingredients must be enumerated in the order of decreasing toxicity, pharmacologle activity ana strength 6 Graphics or Illustrations are not allowed to be printed on the principal display panel 7. In general, salts must appear in the box wth the acive ingredients, Exemptions ‘rom this, ‘tule willbe approaches on a case to case basis. Abbrevialions of Hydrechlorice to HCl and Hydrobromide to HBr are permitted, & In Fluic Replacements and Special Solutions the millagivalent strength must be represented in the formulaton,