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Pharmacy and Poisons (Pharmacovigilance and Post Market Surveillance) Rules, 2022 🇰🇪


REPUBLIC OF KENYA

Pharmacy and Poisons Act, 1956

Legal Notice No. 96

Pharmacy and Poisons (Pharmacovigilance and Post Market Surveillance) Rules, 2022

  • Commenced on (exact date unavailable)
  • [This is the version of this document from (exact date unavailable).]
  • [Note: The original publication document is not available and this content could not be verified.]

Part I – PRELIMINARY

1. Citation

These Rules may be cited as the Pharmacy and Poisons (Pharmacovigilance and Post Market Surveillance) Rules.

2. Application

These Rules shall apply to health products and technologies manufactured, imported, distributed, marketed, licensed or used in healthcare practice in Kenya.

3. Interpretation

In these Rules, unless the context otherwise requires ─"Act" means the Pharmacy and Poisons Act;"active surveillance" means prospective measures taken to detect adverse drug reactions and adverse events and involves active follow-up during and after treatment of patients where the events may be detected by asking the pat…

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