According to Volume 9A of The Rules Governing the Medicinal Products in the EU, the Marketing Authorisation Holder (MAH) of a medicinal product (including herbal medicines and strong vitamins/minerals) should:
- have a Qualified Person for Pharmacovigilance (QPPV)
- be able to report adverse events electronically via Eudravigilance and keep records of presumed adverse drug reactions
- prepare and submit Periodic Safety Update Reports (PSURs) to the national competent authorities
- perform weekly literature searches in order to identify publications, which include possible adverse drug reactions of which the MAH is expected to be aware of.
Jacobsen Pharma offers a complete pharmacovigilance solution in order to meet the increasing demands from the medicines agencies. We can help ensure that all of your pharmacovigilance requirements are fulfilled and that your systems are streamlined to your regulatory affairs needs.
Pharmacovigilance System
- Qualified Person for Pharmacovigilance
- Quality management system
- Registration of adverse drug reactions
- Inspections and internal audits
Eudravigilance registration
- MedDRA coding of adverse drug reactions
- Expedited electronic reporting of adverse drug reactions
- Third party provider
Risk Detection
- Weekly literature searches
- Signal detection
Risk Assessment
- Medical evaluation
- Periodic safety update reports
- Risk management plans
Jacobsen Pharma AS can implement a complete pharmacovigilance system into your company and act as QPPV with access to medical evaluation. Alternatively we can offer to be responsible for parts of the above mentioned activities.
With these services Jacobsen Pharma AS can help your company to fulfil the obligations for pharmacovigilance.
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