Pharmacovigilance
Report a Safety Concern
If you wish to report a suspected adverse reaction or any other safety-related concern, please contact us:
Email: info@orelia-pharma.com
Phone: +31 (0) 6 2230 2083
Address: Industrieweg 1T, 4661 VN Halsteren, Netherlands
Download the Dutch reporting form
Download the English reporting form
Information to Include in Your Report
When submitting a report, please include the following information where available:
- Product name and batch number
- Description of the event or issue
- Patient information (age and sex – optional)
- Your contact details
All information will be treated confidentially and handled in accordance with applicable data protection legislation.
Contributing to Public Health
Reports from healthcare professionals, partners, and the public play an important role in improving the safety of medicines and protecting public health.
Professional Commitment
Orelia Pharma places the highest priority on patient safety. We support effective pharmacovigilance through continuous monitoring and evaluation of the safety of the medicinal products we distribute.
As a pharmaceutical wholesaler operating in accordance with EU Good Distribution Practice (GDP), we ensure that all products handled within our supply chain remain safe, effective, and fully traceable. Any suspected adverse reactions, product quality defects, or other safety-related concerns are carefully documented and forwarded to the appropriate Marketing Authorisation Holder (MAH) or competent authority when required.
Orelia Pharma is committed to maintaining the highest standards of safety and regulatory compliance through:
- Continuous monitoring of safety-related information
- Timely escalation of safety or quality concerns
- Cooperation with Marketing Authorisation Holders and competent authorities
- Full compliance with applicable pharmacovigilance requirements
- Transparent and responsible handling of safety information