Pharmacovigilance Human & Veterinary
Complete pharmacovigilance management for human and veterinary medicinal products — in line with the GVP modules and national requirements.
What is pharmacovigilance?
Pharmacovigilance is the ongoing monitoring of medicinal products after they have been authorised. Reported suspected cases are collected, medically assessed, coded and submitted to the authorities within the deadlines. Around these cases sits a documented system of processes, roles and contracts — described in the Pharmacovigilance System Master File (PSMF).
Why does it matter?
The pharmacovigilance system is a prerequisite for marketing authorisation, not an add-on. If it is missing, or works only on paper, an inspection will result in findings and, in extreme cases, in conditions imposed on the marketing authorisation. In practice, the bottleneck is almost always in the same place: the intake of cases. If you learn too late that a suspected case exists, you can no longer meet the reporting deadline, however well everything else runs.
Who needs it?
Every marketing authorisation holder — from generics companies and parallel importers to manufacturers of veterinary medicinal products. Also companies that have taken over a marketing authorisation and inherit the previous holder’s system, as well as wholesalers and manufacturers entering the medicinal products sector for the first time.
What do the regulations require?
- Directive 2001/83/EC and Regulation (EC) No 726/2004 — core obligations of the marketing authorisation holder
- GVP Module I (pharmacovigilance systems), Module II (PSMF), Module VI (collection and reporting of suspected adverse reactions)
- Section 63a AMG (German Medicines Act) — Graduated Plan Officer (Stufenplanbeauftragter); Section 63b AMG — documentation and reporting obligations
- Regulation (EU) 2019/6 for veterinary medicinal products, including a separate PSMF
- ICH E2B(R3) for the reporting format, MedDRA for coding, submission to EudraVigilance
How VigiPRO supports you
- Creating or revising the PSMF, including annexes and change history
- Implementation of national and European requirements for human and veterinary medicinal products
- Medical single case assessment, data management and MedDRA coding
- Support during reorganisation: outsourcing, sale or acquisition of marketing authorisations, process optimisation
- Setting up and reviewing pharmacovigilance contracts and safety data exchange agreements (SDEA)
- Regulatory intelligence — identifying and assessing changes early
Why VigiPRO
VigiPRO covers the human and veterinary fields with the same team — from single case processing to the appointed responsible person. You have one contact person instead of a ticket number, and round-the-clock availability is guaranteed within the scope of the functions assumed.
Frequently asked questions
Can we outsource the pharmacovigilance system entirely?
The operational system, yes; the responsibility, no. The marketing authorisation holder remains responsible towards the authority. That is precisely why written pharmacovigilance contracts set out who performs which step and how handovers are documented.
What are the reporting deadlines for suspected cases?
Serious suspected cases must be reported within 15 days, non-serious ones within 90 days. The clock starts on the day on which anyone in the company becomes aware of the case — not only when the pharmacovigilance department receives it.
Do the same rules apply to veterinary medicinal products?
The approach is similar, but the legal basis is different: veterinary medicinal products are governed by Regulation (EU) 2019/6, with their own deadlines, their own PSMF and their own database. A human system cannot be transferred unchanged.
Tell us what it is about — you get a quote, not a brochure.
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