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[]
[null,null,null,null,null,null,"Anexa 1 (engleza)"]
["DEFECTIVE PRODUCT REPORT"]
[]
["Medicine Type",null,null,null,null,null,"Date of submission:"]
["human use",null,null,null,null,null,{"$f":"TODAY()","v":"2018-10-15"}]
[]
["1. REPORTER DETAILS"]
["Reporter",null,null,"Company",null,null,"Representing"]
[]
[null,null,null,null,null,null,"Other (if applicable):"]
["Address",null,null,"E-mail",null,null,"Direct phone number"]
[]
[]
[]
["2. Product details"]
[]
[1,"Product",null,"INN",null,"MA type","MA no.","Strength"]
[]
["Pharmaceutical form",null,null,"Route of administration",null,null,"Presentation/packaging"]
[]
["Manufacturer of the batch",null,null,"Site of batch release",null,null,"MA holder"]
["Name ",null,null,"Name ",null,null,"Name "]
["Address",null,null,"Address",null,null,"Address"]
[]
["1.1","Batch size","Units affected","Batch no","Expiry date","Manufacturing date","Product distribution","Pack langauges(s)"]
[]
[]
[]
["3. DEFECT DETAILS"]
["Defect description"]
[]
[]
[]
[]
["Defect category",null,null,null,"Defect descriptor"]
[]
["Site where the defect occurred"]
["Name",null,null,null,"Address"]
[]
["4. INVESTIGATION AND ACTION DETAILS"]
["Summary of the investigation"]
[]
[]
[]
[]
["Competent Authority(ies) contacted"]
[]
[]
[]
["Adverse reaction/evence and reoccurrence identified (report according to applicable pharmacovigilance requirements)  "]
[]
[]
[]
[]
["Proposed action",null,null,null,null,"Justification of the proposed action"]
[]
["Other (if applicable):"]
["Proposed depth of the recall",null,null,null,null,"Consequences of proposed action on the market"]
[]
["In the event that the agreed action intended to take is leading to disruption in product supply, please notify NAMMD"]
[]
[]
["Description of the root cause identified/expected",null,"Expected root cause details"]
[]
[]
[]
[]
[]
[1,"Proposed/taken CAPA to prevent reoccurence",null,null,null,"CAPA implementation timeline"]
[]
["Please provide in timely fashion: investigation report including CAPAs, health hazard risk assessment report, photos, test results and any other documentation, if needed"]
[]
[]
[null,"Attach files",null,"Please attach the investigation and any other relevant documentation"]

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[]
[]
[]
[null,"Categorie companie"]
[null,"manufacturer",null,"Tip APP",null,null,"Categorie defect"]
[null,"MAH",null,"NAP",null,null,"1.    Manufacturing laboratory controls issue",null,null,"descrierea cauzei"]
[null,"parallel distributor/parallel importer",null,"DCP",null,null,"2. Product contamination and sterility issues",null,null,"environmental"]
[null,"wholesaler",null,"MRP",null,null,"3. Product label issues",null,null,"equipment"]
[null,"other (please specify)",null,null,null,null,"4.  Product packaging issues",null,null,"human error"]
[null,null,null,null,null,null,"5. Product physical issues",null,null,"materials"]
[null,null,null,null,null,null,null,null,null,"method"]
[null,null,null,null,null,null,null,null,null,"not determined"]
[null,"Tip defect",null,"Actiune propusa",null,null,null,null,null,"others"]
[null,"1.1 Manufacturing laboratory controls issue",null,"Market suspension",null,null,"Nivelul retragerii"]
[null,"1.2 Out of specification test results",null,"No recall",null,null,"company warehouse",null,null,"Consecinte retragere"]
[null,"2.1 Product contamination chemical",null,"Quarantine",null,null,"wholesaler",null,null,"none, other batches/presentations available"]
[null,"2.2 Product contamination microbial",null,"Recall Class I",null,null,"patient",null,null,"possible shortage"]
[null,"2.3 Product contamination physical",null,"Recall Class II",null,null,"pharmacy/hospital",null,null,"others, please specify"]
[null,"2.4 Product contamination with body fluid",null,"Recall Class III",null,null,"none"]
[null,"2.5 Product sterility lacking",null,"Others (please specify below)."]
[null,"2.6 Suspected transmission of an infectious agent via product"]
[null,"3.1 Physical product label issue"]
[null,"3.2 Product barcode issue"]
[null,"3.3 Product expiration date issue"]
[null,"3.4 Product identification number issue"]
[null,"3.5 Product label issue"]
[null,"3.6 Product label on wrong product"]
[null,"3.7 Product lot number issue"]
[null,"4.1 Product blister packaging issue"]
[null,"4.2 Product closure issue"]
[null,"4.3 Product commingling"]
[null,"4.4  Product container issue"]
[null,"4.5 Product container seal issue"]
[null,"4.6 Product dropper issue"]
[null,"4.7 Product outer packaging issue"]
[null,"4.8 Product packaging issue"]
[null,"4.9 Product packaging quantity issue "]
[null,"5.1 Product coating issue"]
[null,"5.2 Product deposit"]
[null,"5.3 Product dosage form issue"]
[null,"5.4 Product gel formation"]
[null,"5.5 Product physical issue"]