Authorizations and GDP Compliance
EAST PHARMA holds an ANMDMR-issued Wholesale Distribution Authorisation and an active GDP certificate, both publicly verifiable through the EudraGMDP database maintained by the European Medicines Agency.
Romanian wholesale distribution authorization
EAST PHARMA holds a Wholesale Distribution Authorisation (WDA) issued by ANMDMR — the National Agency for Medicines and Medical Devices of Romania. This authorisation permits the wholesale sourcing, storage, and distribution of medicinal products within the applicable Romanian and EU regulatory framework.
Our WDA is maintained in active status and is subject to periodic inspection by ANMDMR in accordance with Romanian and EU pharmaceutical wholesale regulations.
GDP compliance in practice
EAST PHARMA holds an active GDP certificate alongside our WDA. Good Distribution Practice governs how we store, handle, document, and distribute medicinal products — covering storage conditions, temperature monitoring, documentation control, traceability, and qualified logistics arrangements.
We maintain controlled storage at ambient temperature (15–25°C) and cold chain (2–8°C) where required. All storage areas are continuously monitored and maintained in line with GDP requirements and manufacturer specifications.
ANMDMR oversight and inspection
Our wholesale distribution operations are subject to inspection and oversight by ANMDMR, the competent authority for medicines and medical devices in Romania. ANMDMR is the issuing authority for our WDA and GDP certificate within the applicable Romanian and European regulatory framework.
For procurement, QA, and regulatory teams, ANMDMR-issued authorizations form a core part of the qualification review typically carried out when assessing Romanian pharmaceutical wholesale partners.
EudraGMDP — public verification
Both our Wholesale Distribution Authorisation and GDP certificate are publicly registered in the EudraGMDP database maintained by the European Medicines Agency (EMA).
To verify our current authorization status, visit EudraGMDP database, select Romania, and search by company name. This public register is the standard verification tool for EU pharmaceutical wholesale qualification.
Quality Management System
EAST PHARMA maintains a Quality Management System aligned with EU GDP requirements. Our QMS covers 24 documented standard operating procedures across all GDP-critical areas, including:
Supplier and customer qualification
Deviation management and CAPA
Personnel training and competency
Product recall and complaint handling
Temperature monitoring and storage control
IT system validation and documentation control
FMD serialization and verification
The QMS is maintained and reviewed in line with current EU GDP guidelines and ANMDMR inspection requirements.
Qualification package available on request
For qualified inquiries, EAST PHARMA provides a standard documentation package to support partner onboarding, supplier qualification, and regulatory due diligence. This includes our WDA, GDP certificate, ANMDMR authorization documents, EudraGMDP registration reference, company registration details, standard questionnaires, and technical agreement templates.
Qualified partners may request our standard qualification package at info@east-pharma.com.