Regulatory Affairs and Pharmacovigilance
The goal of Ednafarma is not only to expand the portfolio of its partner companies by offering a comprehensive and high-quality range of pharmaceutical products in the Albanian market, but also to ensure the safe and appropriate use of these medicines.
Our Pharmacovigilance and Regulatory Affairs professionals are responsible for assessing the causal relationship between exposure to a medicinal product and the occurrence of any adverse effects. They possess strong expertise in both Albanian and European legislation related to drug safety and provide support in the application process for new licenses.
The Regulatory Affairs service is also responsible for securing marketing authorizations for new medicines, managing renewals in accordance with established timelines, and handling various types of regulatory variations.
Adverse Event Reporting
If you contact Megapharm regarding your experience with one of our products, the information you provide may be used to report the case to the National Agency for Medicines and Medical Devices as required by law.
We may also use this information to contact the prescribing physician in order to follow up on any adverse effects related to the use of our product.
Pharmacovigilance and Regulatory Services
We are committed to ensuring the safety, quality, and compliance of all pharmaceutical products we manage. Below are answers to some common questions.
What is pharmacovigilance?
Pharmacovigilance is the process of monitoring, evaluating, and preventing adverse effects related to medicinal products, ensuring their safe use.
How can I report an adverse effect?
You can contact our team directly and provide details about your experience. All reports are handled with care and in accordance with regulatory requirements.
Is my information confidential?
Yes, all information you provide is treated with strict confidentiality and used only for safety monitoring and legal reporting purposes.
What happens after I submit a report?
Your report will be carefully evaluated by our specialists and, if required, submitted to the National Agency for Medicines and Medical Devices in compliance with legal obligations.
Do I need to contact my doctor as well?
Yes, we recommend informing your physician about any adverse effects to ensure proper medical guidance and follow-up.