Transcription of IMPLEMENTING INDIA’S DRUG SERIALIZATION AND TRACEABILITY ...
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IMPLEMENTING INDIA S DRUG SERIALIZATION AND TRACEABILITY REQUIREMENTS TO ADVANCE PATIENT SAFETY AND SUPPORT GLOBAL TRADE MAY 2017 SUM M ARY OF P RINCIP L ES AND RECOM M END ATIONS PRINCIPLES Principle 1: Regulators should solicit stakeholder input early in the regulatory process ( , before the laws and regulations are developed) and throughout its implementation. Stakeholder input, both in policy formulation and in the subsequent adaptation after implementation, is critical to success. (Page 5) Principle 2: A phased implementation schedule supports successful implementation of new regulatory requirements. (Page 6) Principle 3: All regulatory requirements and systems should promote compliance and information integrity.
implementation of a track and trace system incorporating serialization for all pharmaceutical products exported from India. The stated purpose of the requirement is to “address counterfeit and ineffective
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