Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring and prevention of adverse effects with pharmaceutical products.
In accordance with the ethical principles of the company, the requirements of international legislation and for the fulfilment of the commitments undertaken to our customers. AMAXA has developed and implemented the robust Pharmacovigilance System.
We have developed and implemented standard operating procedures that govern the processes of identifying, collecting, recording and transmitting information to the competent authorities with regard to:
- lack of effectiveness of the medicine
- suspected adverse reactions when using medicines provided by AMAXA
Our senior pharmacovigilance officials regularly attend pharmacovigilance related training courses to keep ahead of new developments.
In the case of suspected adverse reactions or suspected lack of efficacy of medicine delivered by our company, please complete the form on the right.
Key terms and concepts
Pharmacological Vigilance (Pharmacovigilance) is the scientific research and activities related to the identification, assessment, understanding and prevention of adverse effects or any other problems associated with the use of medicines.
Adverse reaction is any unwanted negative reaction that occurs when the medicines are used at usual doses recommended for the prevention, diagnosis and treatment of diseases.
Lack of efficacy of the medicine is the lack of therapeutic effect of the medicine on the course and duration of the disease.
Serial number (applied to all kinds of packaging) is a characteristic combination of numbers (five, six or seven figures) that specifically identifies the product series.