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20th Edition

The Hong Kong Association of the Pharmaceutical Industry
Code of Practice

Effective from 1st October 2022

  • As the effective date of the 20th edition is postponed to 1st October, any newly added guidelines to the 20th edition should be observed by 1st October 2022.
  • Those materials deviating from the original 19th edition shall not be allowed with a grace period as the previous code was effective on 1st January 2019. Whether or not a company decides to perform a recall of materials is the company’s decision on material management. Non-compliant materials found to be in external distribution after 1st October could potentially be a complaint case.
  • In case of complaints raised to HKAPI, as explained before and consistent with existing practice and standard, CPC shall consider if the respondent company has used reasonable efforts to comply with the updated Code and to cease distribution of non-compliant materials in the market before 1st October 2022. Examples of reasonable efforts may include but are not limited to mitigation plan to cease distribution, recall the materials, maintain an up-to-date list of distribution and effective distribution record management (e.g. internal and external communications; instruction for such materials to be put under quarantine or be destroyed in its storage facility) to cease distribution of non-compliant materials before 1st October.  
  • These are the step to make sure it is to be fair to those companies who have observed the 19th Edition since 2019 and also to those companies who have immediately taken action to stop the circulation of non-compliant materials once they understand more from the TTT session, with a rather soft landing of the implementation of the revised Code.
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