Agent 25Online

DOCTOR PHARMA

Pharma & Biotech

Medicines, side effects, generics, reimbursement — DOCTOR PHARMA guides you through the Belgian pharmaceutical world.

FAMHP/FAGGMAPharmacovigilanceClinical trialsBiotechNIHDI reimbursementMedical devices

Personality & Approach

Belgian pharmaceutical, biotech and medicines regulation expert. Tone: scientific, rigorous, accessible. Masters FAMHP regulation, marketing authorizations (MA), pharmacovigilance, clinical trials, medical devices, NIHDI reimbursement and biotech specifics. Deep knowledge of Belgian federal framework and European regulation (EMA).

// SOUL.md

Ultra-specialized agent in pharma & biotech · 13 sub-domains of expertise · Tailored for individuals · Exclusive Belgian market · Available in French, Dutch, English and German

Expertise

13 areas of expertise

DOCTOR PHARMA masters every aspect of their domain to provide you with precise advice tailored to the Belgian framework.

MA & registration

Marketing authorization (national, MRP, DCP, EMA centralized), CTD/eCTD dossier, variations, renewals, generics (bioequivalence)

FAMHP regulation

Federal Agency for Medicines and Health Products, GMP inspections, manufacturing/distribution authorizations, import/export, narcotics/psychotropics

Pharmacovigilance

QPPV, adverse reaction reporting, PSMF, PSUR/PBRER, safety signals, risk management plans (RMP)

Clinical trials

EU Regulation 536/2014, CTIS, Ethics Committee, informed consent, GCP, SUSAR, clinical trial insurance

Medical devices

MDR 2017/745, IVDR 2017/746, CE marking, classification (I/IIa/IIb/III), notified body, EUDAMED, post-market surveillance

NIHDI reimbursement

Drug Reimbursement Committee (CRM), chapter IV, forms, maximum price, article 81 conventions, managed entry agreements

Pharmacy & dispensing

Pharmacy opening/transfer (moratorium), GPP (Good Pharmaceutical Practices), magistral/officinal preparations, hospital pharmacy, duty

Biotech & biological medicines

Biosimilars, advanced therapies (ATMP), orphan drugs, biological production, cold chain, GDP

Pharmaceutical advertising

Medicine advertising (Book V ELC + RD 07/04/1995), medical visits, samples, MDEON (mandatory visa), transparency of advantages

Medical cannabis & controlled substances

Legal framework for medical cannabis in Belgium, special FAMHP authorizations, narcotics (1961 convention), psychotropics

Cosmetics & food supplements

EC Regulation 1223/2009 cosmetics, CPNP notification, food supplements (RD 03/03/1992), novel food, health claims

Pharma intellectual property

Pharma patents, SPC (Supplementary Protection Certificate), data exclusivity (8+2+1), Bolar exemption, generics litigation

Patient rights & reimbursements

BIM/OMNIO status, maximum billing (MAF), third-party payment, NIHDI reimbursement categories (A/B/C/Cs), co-payment, global medical record, Belgian patient rights

Use cases

How DOCTOR PHARMA helps you

Practical solutions for individuals

Medicine side effects

Understand and report an adverse drug reaction

Generic vs brand medicine

Understand the difference and bioequivalence of generics

Medicine reimbursement

Check if a medicine is reimbursed by the health fund/NIHDI

Safe self-medication

Rules for buying over-the-counter medicines in Belgium

Medical cannabis

Legal framework for medical cannabis in Belgium

Duty pharmacy

Find the duty pharmacy and understand the on-call system

Ask DOCTOR PHARMA your question

FAQ

Frequently asked questions about DOCTOR PHARMA

What can DOCTOR PHARMA do for me?

DOCTOR PHARMA is an AI consultant specialized in pharma & biotech for the Belgian market. It masters 13 sub-domains of expertise and can help you with: ma & registration, famhp regulation, pharmacovigilance, clinical trials, medical devices, and much more.

Does DOCTOR PHARMA replace a professional?

No, DOCTOR PHARMA is a decision-support tool. It provides analyses, template documents and advice based on Belgian law, but always recommends validation by a certified professional for important decisions.

How do I use DOCTOR PHARMA?

Create a free account on KonsultIA.be, select DOCTOR PHARMA from the dashboard, and ask your question. The agent responds with precise information tailored to the Belgian context.

Does DOCTOR PHARMA know Belgian law?

Yes, DOCTOR PHARMA is specifically trained on the Belgian legal and regulatory framework. It knows the specificities of the three regions (Brussels, Wallonia, Flanders) and cites reference texts.

Discover