Pharmacovigilance and quality assurance system
The mission of the company is to take care of the health of every person.
That is why collecting information related to the safety, efficacy and quality of the company’s medicines and medical devices is an important part of our work. To achieve this goal, the quality assurance and pharmacovigilance system’s have been created, which allows us to identify adverse events\lack of efficacy and quality complaints of our products on time.If you want to report an adverse event\lack of efficacy and quality problems after using our product, you can choose any way of reporting convenient for you:
- By phones: +36 30 643 6850
- By email: safety-hungary@alpenpharma.com, safety@regsana.eu.
What can you report:
1. Adverse event – any undesirable and unforeseen manifestation, symptom or disease that coincides in time with taking a product, regardless of whether it is related to taking the product or not.
2. Misuse – situations where a medicinal product is intentionally and inappropriately used not in accordance with the authorized product information.
3. Off-label use – situations where a medicinal product is intentionally used for a medical purpose not in accordance with the authorized product information.
4. Abuse – persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful physical or psychological effects.
5. Lack of efficacy – failure to produce the expected pharmacological action for an approved indication. Example for vaccines: Occurrence of the specific vaccine-preventable disease in a person who is appropriately and fully vaccinated.
6. Occupational exposure – exposure to a product during as a result of one’s professional or non-professional occupation.
7. Overdose – administration of a quantity of a medicinal product given per administration or cumulatively which is above the maximum recommended dose according to the authorized product information.
8. Unanticipated beneficial effects – any unanticipated beneficial effect occurring after a product administration and bringing an improvement or cure of a disease or a symptom. This improvement or cure are not waited or this effect has not been proven by validated studies.
9. Medication Error – refers to any unintentional error in the prescribing, dispensing, or administration of a medicinal product while in the control of the healthcare professional, patient or consumer.
10. Suspected transmission of an infectious agent- transmission of an infectious agent via a medicinal product associated or non-associated to an adverse event.
11. Exposure during pregnancy or whilst breastfeeding – any product taken during pregnancy or whilst breastfeeding. Exposure can take place just before pregnancy, at the time of conception, at the mother or the father.
If you have questions and / or complaints regarding the quality of products, please send us an email:
safety-hungary@alpenpharma.com, quality@alpenpharma.com
All information that you provide is confidential and not subject to disclosure, except as otherwise provided by law.