Medical Information Services
Expert information on your medicinal products — with the reporting route into pharmacovigilance that can turn any enquiry into a case.
What are medical information services?
Medical Information is the scientific information service of a marketing authorisation holder. Physicians, pharmacists, patients and authorities ask questions about a medicinal product — about dosage, administration, interactions, availability. The answers must be scientifically correct, evidence-based and documented.
Why does it matter?
The real lever lies at the interface: enquiries to Medical Information regularly contain suspected cases without the caller describing them as such. “My patient isn’t tolerating this well, what can I do?” is an information request and, at the same time, the start of a reporting deadline. Where this handover is not regulated, cases are lost — and the clock keeps running regardless.
Who needs it?
Marketing authorisation holders that do not run their own scientific service. Companies with fluctuating enquiry volumes for whom dedicated staffing would not be economical. And all those who currently run their Medical Information alongside sales or office assistance and cannot properly document the reporting route.
What do the regulations require?
- Article 98 of Directive 2001/83/EC — scientific service of the marketing authorisation holder
- Section 74a AMG (German Medicines Act) — Information Officer for medicinal product information
- GVP Module VI — enquiries as a source of suspected adverse reactions, collection and start of the reporting clock
- GVP Module XV — safety communication to healthcare professionals and patients
How VigiPRO supports you
- Answering expert enquiries on the basis of the approved product information
- Documented handover to pharmacovigilance as soon as an enquiry contains a suspected case
- Setting up standard responses and escalation routes, aligned with your Information Officer
- Training your staff to recognise reportable matters
- Traceable filing of all enquiries and responses for audits and inspections
Why VigiPRO
At VigiPRO, medical information and pharmacovigilance come from a single source. This removes the interface between two service providers where cases would otherwise get stuck — and deadlines run correctly from the first contact.
Frequently asked questions
When does an information request become a reportable case?
As soon as four minimum criteria come together: an identifiable person, an identifiable reporter, a suspected adverse reaction and a medicinal product. A confirmed diagnosis or a proven causal relationship is not required — the suspicion is sufficient.
Can we simply let our sales team answer enquiries?
Expert information on a medicinal product belongs in the scientific service. Regardless of that: anyone in the company who learns of a suspected case triggers the reporting deadline. That is why every function with external contact needs a documented reporting route.
How is the service billed if volumes fluctuate?
The scope is tailored to your actual volume. Get in touch — we will look at the structure of your enquiries and make you an offer on that basis.
Tell us what it is about — you get a quote, not a brochure.