TCI’s 2nd certificate of analysis following post-marketing surveillance.

TCI’s 2nd certificate of analysis following post-marketing surveillance.


The Pharmacy Unit, Ministry of Health and Human Services (MoHHS) is pleased to report that it is in receipt of the TCI’s 2nd certificate of analysis following testing and analysis of an antihypertensive medicine utilized within the country. The medicine that was tested and analysed met the required quality standard.

 

This is a continuation of the partnership formed with the Medicines Quality Control and Surveillance Department (MQCSD) of the Caribbean Public Health Agency (CARPHA) as a part of their risk-based Post- Market Surveillance (PMS) Programme for medicines. The MoHHS has since submitted a 3rd drug for testing and analysis.

 

A Certificate of Analysis is a legal document that certifies the quality of a medicine and/or its ingredients known as excipients. The certificate demonstrates that the batch/sample tested meets all the required quality control standards which confirms product quality and safety.

 

The Pharmacy Unit continues to strengthen the systems and capacities required to improve the effective monitoring of drug/patient safety. The Unit is committed to ensuring the utilization of good quality, effective, and safe medicines within the TCI.

 

The TCI’s involvement in the PMS Programme will continue to strengthen and support the effectiveness of its medicines regulatory system by:

  • Providing data and information that will better inform the government on the appropriate and effective regulatory actions and strategies to implement (that will improve the availability of safe and essential good quality medicines), and
  • Identifying in a timely manner, possible substandard and falsified products/medicines on the TCI market.

 

The MoHHS notes that it is essential to improve fair access to safe quality medicines which are hallmarks of effective disease management/treatment and will continue to actively monitor and regulate all medicines used within the TCI.

 

The MoHHS is committed to patient safety and will continue to ensure that the health and wellbeing of all TCI residents are positively impacted. Persons are encouraged to report any adverse events - suffered from    the    use    of    medicines    -    via    the    MoHHS'    Adverse    Drug    Reaction    Form     found   at https://gov.tc/docs/ADR.pdf. Consequently, suspected substandard and or falsified medicines can be flagged for testing and analysis.

 

For   further   information,   please   contact   André   Morgan,    National    Pharmacist    at:    338-3072 or amorgan@gov.tc

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