Market Vigilance and Oversight of Drugs

A deficiency which has produced, or leads to a significant risk of producing either a product which is harmful to the human or veterinary patient or a product which could result in a harmful residue in a food producing animal. 

A deficiency, which cannot be classified as either critical or major, but which indicates a departure from good manufacturing practice. 

Despite the extensive investigations that must be undertaken prior to placing a drug on the market, it is not possible to guarantee that all safety issues have been identified. Thus, market vigilance systems must be maintained after a dmg has been launched so as to detect safety issues that were not evident prior to commercialisation. For such systems to be effective requires the participation and cooperation of the medical profession, the pharmaceutical industry and the regulators, in order that critical safety information can be identified and acted on in a timely manner. In some 

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Market Vigilance and Oversight of Drugs 253 2. Definition of Significant Deficiencies... 

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