Glossary

An unexpected adverse reaction is a harmful and unintended response to a medication which is not consistent with applicable product information or characteristics of the medicinal product.

The Unique Device Identification (UDI) is a unique number, or combination of numbers and letters, given to a medical device. It is in two parts: one part identifies the device the other part identifies the producer. The aim of the UDI system is to improve patient safety: it means devices can be traced and recalled more easily, and it makes counterfeiting (production of fake copies) more difficult. The UDI is given to medical devices in addition to other labelling requirements.

United Kingdom Ethics Committee Authority (UKECA) http://www.hra.nhs.uk/resources/research-legislation-and-governance/four-nations/"

The Universal Declaration of Human Rights is an international document that states the basic rights and fundamental freedoms to which all human beings are entitled. It was adopted by the General Assembly of the United Nations in 1948, as a result of the experience and atrocities of the Second World War. It represented the first global expression of rights to which all human beings are entitled “ regardless of nationality, place of residence, gender, national or ethnic origin, colour, religion, language, or any other status.

The Declaration consists of 30 articles, and a number of key principles including:

• Universality
  
• Interdependence and indivisibility
  
• Equality and non-discrimination
  

The declaration has been translated into law in various forms and has inspired more than 80 international human rights treaties and declarations, which together constitute a comprehensive, legally binding system for the promotion and protection of human rights.

The full text of the Declaration is published by the United Nations on its website.

Polish National Competent Authority. http://www.urpl.gov.pl/"

Utility, or usefulness, is the (perceived) ability of something to satisfy needs or wants. In health economics, utilities measure the strength of patient preferences. For example, how important various factors are to patients, such as symptoms, pain, and psychological health. The impact of new treatments on those factors, and therefore on quality of life (QoL), can then be calculated. This is a common approach used by health technology assessment (HTA) bodies, which advise on whether treatments should be funded by (for example) government health departments.