PR3 Type of product and service information required by procedures, and percentage of significant products and services subject to such information requirements

Pharmaceutical products can be sold and used only under a product-specific marketing authorisation granted by a pharmaceutical regulatory authority. A marketing authorisation is granted for products which are safe to use for their indicated purpose, proven to be therapeutically effective, appropriate as drugs, meet the quality requirements set and are appropriately manufactured and labelled.

Pharmaceutical legislation and regulatory authorities provide that for products classified as drugs, the pharmaceutical company may only provide information contained in the Summary of Product Characteristics (SPC) and exclusively that. The product information leaflet in the package contains the main facts about the drug and its use in the form approved by authorities. The drug and health authorities maintain national and international drug databases which contain up-to-date information for each product with a valid marketing authorisation.

In EU countries, pharmaceutical companies cannot provide information about prescription drugs directly to consumers. Instead, it is the responsibility of healthcare professionals like doctors and pharmacies to do so. Marketing self-medication products directly to consumers is allowed, although under strict conditions.

Orion aims to look after patient safety also by sharing accurate up-to-date information about the use, storage and safety of its products via its own marketing and corporate communications channels, in the extent permitted by law.

Regulations related to diagnostic products require that the product packages contain all essential information about the product, manufacturer, purpose of product, storage and validity. The package contains appropriate warnings. The end user will always receive detailed user instructions with the package. When required, an analysis certificate, information on product calibration traceability and a safety data sheet is provided for each batch.

PR4 Total number of incidents on non-compliance with regulations and voluntary codes concerning product and service information and labelling, by type of outcomes

Orion is not aware of any non-compliance with regulations and voluntary codes concerning product and service information during the reporting period.