Member State [MS]« Back to Glossary Index
« Back to Glossary Index
- EMA Committees: Committee for Orphan Medicinal Products (COMP)The EMA Committee for Orphan Medicinal Products (COMP) reviews applications for orphan-medicinal-product designation.
- Information on medicinal productsInformation on medicinal products is provided to patients and healthcare providers in different, carefully regulated ways – including package labelling, package leaflets, and the Summary of Product Characteristics.
- More knowledge brings more benefit to patients!Doctors were not very clear in their communication about MS. I didn’t understand them. It was necessary to find easy and understandable Information. I focused on patient groups, looked for sites about patients’ rights. I started to collect all that know-how and started to sort out information, the good vs the bad. I realised how important patient information is. And I noticed that there was not much understandable and useful information for patients. Patient-level information is important for good decision-making.
- HTA systems in EuropeHTA systems in Europe differ, but usually involve assessment and appraisal steps.
- How are medicines regulated?A medicine can be marketed in the European Union (EU) until the company has obtained a Marketing Authorisation (MA) for that medicine from the relevant regulatory authority. MAs are granted for medicines that are proved to be safe, effective and of high quality.