Tenders Are Invited For hiring a specialized company to supply ethical, generic and similar drugs of Tale CMEDANVISA, according to conditions, quantities and requirements estalished in this Notice and its attachments

1 Formula Manipulation Medicines Cosmetics Pharmaceuticals iological medicine: complex molecules of high molecular weight otained from iological fluids, animal tissues or iotechnological procedures through manipulation or insertion of another genetic material (technology of Recominant DNA) or alteration of genes that occurs due to irradiation, chemicals or forced selection currently, iological drug registration legislation covers: allergens, monoclonal antiodies, iomedies, hemoderivates, proiotics, differentiated vaccination: Applicaility Decree 7174: non applicaility margin Preferaly: Non Quantity: 1 UNIT UNIT: UNIT2 Formula Manipulation Medicines Cosmetics Pharmaceuticals Specific Medicine: Pharmaceutical products, technically otained or elaorate, with finished Prophylactic, curative or palliative not framed in the categories of new, generic, similar, iological, heral or notified medicine and whose active sustance (s), regardless of nature or origin, is not suject to ioequivalence test , Faced with a comparative product Differentiated: Applicaility Decree 7174: Non Applicaility Preference Margin: Non QUANTITY: 1 UNIT: UNIT3 Formula Manipulation Medicines Cosmetic Pharmaceuticals Pharmaceuticals Medicine: Otained with exclusive employment of active raw materials Vegetales do not consider heral medicine that includes in its composition isolated, synthetic or natural sustances, nor their associations with plant extracts her heral medicines, as well as all medications, are characterized y knowledge of the efficacy and risks of their use, as well as reproducile Effectiveness and safety should e validated through ethnopharmacological surveys, use, technoscientific documentation in iliography andor indexed pulications andor pharmacological and toxicological studies preclinical and clinical to quality should e achieved through the Control of raw materials, finished product, packaging materials and staility studies Differentiated Treatment: Applicaility Decree 7174: Non Applicaility Preference Margin: Non Quantity: 1 UNIT: UNIT4 Formula Manipulation Medicines Cosmetics Pharmaceuticals Principle Active, in the same dose and pharmaceutical form, is administered y the same way and with the same dosage and therapeutic indication of the reference drug, presenting effectiveness and safety equivalent to that of the reference medicine and may, with it, e interchangeale to interchange, ie, at Egura replacement of the reference drug with its generic, is ensured y therapeutic equivalence tests, which include in vitro comparison, through pharmaceutical and in vivo equivalence studies, with ioequivalence studies presented to the National Health Surveillance Agency, generic drugs may eing identified y the yellow stripe generic gender In addition, the packaging should e included in the phrase generic drug Law No 978799 Differentiated Treatment: Applicaility Decree 7174: non applicaility Preference margin: Non Quantity: 1 UNIT UNIT: Unit5 Formula Manipulation Drugs Cosmetics Pharmaceuticals New Medicine: With synthetic and semisynthetic active ingredients, associated or not when the term new drug is used without another complement is not referring to, therefore, iological, heral, homeopathic, drug products, Specific itos, registration drugs, nor copies (generic and similar) Differentiated Treatment: Applicaility Decree 7174: Non Applicaility Preference Margin: Non Quantity: 1 Supply Unit: Unit