Pharmacovigilance (PV) is the science relating to the detection, assessment, understanding and prevention of adverse effects particularly long term and short term side effects of medicinal products. The legal status of medicinal products is part of the marketing authorisation (MA) and products may be available either on prescription (prescription only medicines POMs) or available in a pharmacy without prescription under the supervision of a pharmacist (P) or on general sale (GSL).
At Ceuta we ensure all personnel involved in the selling and marketing of our clients' products are trained in pharmacovigilance requirements.
All serious and non-serious adverse reaction reports, overdoses, pregnancy exposure or lack of efficacy involving products reported to Ceuta personnel, are recorded and passed on to our clients' pharmacovigilance departments.
Further to this, all department heads responsible for pharmacovigilance have also completed an intensive two day certified course in Adverse Event Reporting conducted by Pharmacy Training International.
Ceuta has been audited routinely both by its clients and by the MHRA. By conducting inspections at the sites of (MA) holders and their third party representatives, pharmacovigilance inspectors assess compliance with the requirements of legislation and guidelines relating to the monitoring of the safety of medicines used in clinical practice.
If you are outsourcing licensed medicines you should select a partner who has the PV accreditation from the MHRA.
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