One of the many responsibilities of the marketing authorization holder is to systematically collect experience from the product’s benefits and causes of concern immediately after the first launch, and this responsibility continues until the product is no longer available.
Orion is committed to continuously monitoring and assessing the benefits and risks of its products to ensure and secure patient safety using purposeful procedures and methods. This includes, for example, product specific risk management plans, detection of signals of safety concern, periodic reviews of the product’s benefit-risk balance and up-to-date educational materials. Also, timely and appropriate risk minimization actions, such as e.g. amendment of the summary of product characteristics with new information concerning safety, communication of safety issues to patients and healthcare professionals are important. Safety and benefit studies can also be conducted after the launch of a product.
We report adverse events and quality deviations to the healthcare authorities and the relevant healthcare professionals using officially adopted systems and channels. When there is a reason, we take the necessary actions without undue delay.
Orion is committed to maintaining efficient pharmacovigilance systems and continuously monitoring their applicability, compliance, and performance. Pharmacovigilance means the comprehensive and complex process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines.
As a responsible company, it is also in Orion’s interest to fight by all applicable means against the increasing availability of fake drugs. All our employees are anticipated to take rapid initiative for action if alerted by any signal of counterfeit versions of Orion’s products.
Pharmaceutical companies have a legal responsibility to share information on their medicinal products to healthcare professionals and patients to ensure their safe and proper use. Communication concerning prescription medicines is subject to strict regulation, which emphasizes that the arguments and information must be in accordance with the product information leaflet confirmed for the product by the authorities. Orion’s sales and marketing organizations follow a broad range of instruction and guidelines. These comprise the locally valid legislation and other requirements concerning medicinal products, marketing and communication, consumers and competition and the International Code on Advertising and Marketing Communication Practice. Equally important are our internal guidelines which adhere to the principles of pharma industry ethical codes, as well as the Orion Group’s Code of Conduct and corporate policies.
We arrange regular and continued training and testing to ensure that the persons engaged in our sales and marketing operations have adopted and follow the required principles and guidelines, and that they possess the needed knowledge and skills to provide the right information on Orion’s products.
References:
EU Commission’s website ec.europa.eu/health/human-use: Medicinal Products for Human use
Ethics in the marketing phase
After a new product has been approved for marketing and for clinical use in patients based on the results of a years long, thorough, and strictly controlled research and development process, the monitoring of safety and efficacy continues until the product is no longer available.