2.2 Type (e.g.: from purified “live attenuated,” “manufactured inactivated (...) obtained from human plasma or manufactured using etc.). recombinant DNA technology,” 2.3 Administration (e.g.: for “intended intramuscular injection,” etc.). 2.4 Description of intended use (e.g.: of newborn “immunization etc.). infants,” 2.5 Dosage size (if not restrictive), or expected immunogenic reaction (e.g.: each dose shall contain that amount of Hbsag protein with micrograms/ml specified by the manufacturer for newborn dosage, that when given as part of a primary immunization series [3 doses] is capable of producing specific humoral antibody [anti HBs] at a level of at least 10 milli international units in >-90 percent of etc.). recipients,” 2.6 Dose package (e.g.: dose sterile etc.). “5 infant glass vials,” 2.7 Filling volume (e.g.: product should contain 15% “final etc.). overfill,” 2.8 Closures (e.g.: shall be fitted with closures that “vaccine vials conform to ISO standard 8362-2”). 2.9 Storage temperature (e.g.: degrees C. Do not or “2–8 freeze,” as appropriate, etc.). 2.10 The product should remain stable up to the indicated test expiry date if kept according to the required storage temperature. 2.11 Standards (e.g.: vaccine should conform to standards “The established by the country or, where no standard Purchaser’s has been adopted, meet current requirements published by the WHO Expert Committee on Biological Standardization, or requirements of an established body of equivalent stature such as the U.S. Pharmacopoeia, the British Pharmacopoeia, the French Pharmacopoeia, or the International Pharmacopoeia”). 3.1 Each vial or ampoule shall carry the standard 3. Labeling manufacturer’s Requirements label in the language of country, if available at no Purchaser’s extra charge; otherwise, the label shall be in English. 3.2 Each vial or ampoule label shall state the following: name of the vaccine;
2.2 Type (e.g.: “live attenuated,” “manufactured from purified inactivated (...) obtained from human plasma or manufactured using recombinant DNA technology,” etc.). 2.3 Administration (e.g.: “intended for intramuscular injection,” etc.). 2.4 Description of intended use (e.g.: “immunization of newborn infants,” etc.). 2.5 Dosage size (if not restrictive), or expected immunogenic reaction (e.g.: each dose shall contain that amount of Hbsag protein with micrograms/ml specified by the manufacturer for newborn dosage, that when given as part of a primary immunization series [3 doses] is capable of producing specific humoral antibody [anti HBs] at a level of at least 10 milli international units in >-90 percent of recipients,” etc.). 2.6 Dose package (e.g.: “5 infant dose sterile glass vials,” etc.). 2.7 Filling volume (e.g.: “final product should contain 15% overfill,” etc.). 2.8 Closures (e.g.: “vaccine vials shall be fitted with closures that conform to ISO standard 8362-2”). 2.9 Storage temperature (e.g.: “2–8 degrees C. Do not freeze,” or as appropriate, etc.). 2.10 The product should remain stable up to the indicated test expiry date if kept according to the required storage temperature. 2.11 Standards (e.g.: “The vaccine should conform to standards established by the Purchaser’s country or, where no standard has been adopted, meet current requirements published by the WHO Expert Committee on Biological Standardization, or requirements of an established body of equivalent stature such as the U.S. Pharmacopoeia, the British Pharmacopoeia, the French Pharmacopoeia, or the International Pharmacopoeia”). 3. Labeling Requirements 3.1 Each vial or ampoule shall carry the manufacturer’s standard label in the language of Purchaser’s country, if available at no extra charge; otherwise, the label shall be in English. 3.2 Each vial or ampoule label shall state the following: name of the vaccine;
Health-Sector-Goods-EN-April2015.docx