3.5 Patient / consumer safety

The safety of our patients / consumers is very important.

The pharmacovigilance / nutrivigilance activity is carried out uninterruptedly throughout the life cycle of the products marketed by the company.

The Company undertakes to continuously assess the benefits and risks of the products it markets by detecting, evaluating, understanding, preventing the occurrence of adverse effects, side effects, serious side effects, unexpected side effects or any other drug problems. The process of collecting & reporting these events will preserve the confidentiality of the personal data of all those involved (patient, healthcare professional, etc.) in accordance with the legislation in force.

All of the company’s employees are regularly trained with regard to reporting within 24 hours any adverse events caused by the medicines to the company’s pharmacovigilance officers and to the email address roregaff (at) prisum.ro or to use the telephone number 021 322 01 18.

The company also encourages its employees to report to the company’s quality officers, without delay any deficiencies signalled by them for any product marketed by the company. These notices will be forwarded to the e-mail address calitate (at) prisum.ro.

The company undertakes to deliver quality products to its patients / consumers by complying with the codes of best practice on medicines, food supplements and cosmetics (GDP, ISO 9001, ISO 22000), and with the applicable legislation specific to the marketed products.

We are regularly audited by specific certification and accreditation bodies. At the same time, the company makes every effort to periodically audit all partners (sub-distributors, customers, etc.) with whom it conducts business relationships, ensuring that they meet all the conditions stipulated in commercial contracts.