Centralised procedure: The centralised procedure allows the marketing-authorisation holder to market the medicinal product and make it available to patients and healthcare professionals throughout the European Union on the basis of a single marketing authorisation delivered by the European Commission after a single scientific assessment and a single application to the European Medicines Agency (EMA).
Centrally authorised product: Referred as CAP for “Centrally Authorised medicinal Products” in EMA documents) A medicine with a single marketing authorisation issued by the European Commission and valid across the European Union. [Source: EMA Glossary of regulatory terms]
Clock stop: A period of time during which the evaluation of a medicine is officially stopped, while the applicant prepares responses to questions from the regulatory authority. The clock resumes when the applicant has sent its responses. [Source: Adapted from EMA Glossary of regulatory terms]
(Co-) rapporteur: One of the two members of EMA’s committee leading the assessment of an application. [Source: EMA Glossary of regulatory terms]
List of outstanding issues: A set of questions addressed to an applicant (generally a company) during a procedure, such as during the evaluation of a marketing authorisation application. [Source: Adapted from EMA Glossary of regulatory terms]
List of questions: A set of questions addressed to a company during a procedure, such as a marketing authorisation application. [Source: Adapted from EMA Glossary of regulatory terms]
Marketing authorisation: The approval to market a medicine in one, several or all European Union Member States. (Source: EMA Glossary of regulatory terms)
All medicinal products must have been granted a marketing authorisation prior to be placed legally on the market within the European Economic Area. The purpose of the marketing authorisation is to ensure safety, efficacy and high quality of authorised medicinal products. For Advanced Therapy Medicinal Products, a single application is submitted at the European Medicines Agency under the centralised procedure, and will be scientifically assessed by the Committee for Medicinal Products for Human Use (CHMP) as well as other relevant Committees, especially the Committee for Advanced Therapies (CAT). The marketing authorisation issued by the European Commission is valid in the European Union Member States, Iceland, Norway and Liechtenstein for a five-years period.
Marketing Authorisation Application: A Marketing Authorisation Application is an application submitted by a marketing authorisation applicant to the competent authority, i.e. the European Medicines Agency for the marketing authorisation of advanced therapy medicinal products within the European Union.
Marketing Authorisation Applicant: The people, company applying for a marketing authorisation for a medicinal product.
Marketing Authorisation holder: The company or the legal entity which has been granted a marketing authorisation to distribute and sell its medicinal product on a given market (for ATMPs, the market of European Union).
Marketing authorisation file: The file requested for marketing authorisation applications. The marketing authorisation file is based on the Common Technical Document (CTD), a document including five parts: Module 1 for regional administrative information (specific to each Member State), Module 2 for the CTD summary, Module 3 on quality (chemical, pharmaceutical, biological and biotechnological data), Module 4 on safety (toxico-pharmacological data) and Module 5 on efficacy (clinical data).
Oral explanation: A presentation and discussion in person between representatives of an applicant and an EMA committee. [Source: EMA Glossary of regulatory terms]
Risk-benefit balance: An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks, i.e. any risk relating to the quality, safety or efficacy of the medicinal product as regards patients' health or public health. (Articles 28a and 28 of Directive 2001/83/EC)
Variation (or ‘Variation to the terms of a marketing authorisation’): A change to the terms of a marketing authorisation. (Article 2.1 of Regulation (EC) n°1234/2008)
Extension of a marketing authorisation (or ‘extension’): a variation which is listed in Annex I of Regulation (EC) n°1234/2008 and fulfils the conditions laid down therein. (Article 2.4 of Regulation (EC) n°1234/2008) They are generally changes to the active substance or changes to strength, pharmaceutical form and route of administration.
Type IA variation (or ‘Minor variation of type IA’): a variation which has only a minimal impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned. (Article 2.2 of Regulation (EC) n°1234/2008)
Type II variation (or ‘Major variation of type II’): a variation which is not an extension and which may have a significant impact on the quality, safety or efficacy of the medicinal product concerned. (Article 2.3 of Regulation (EC) n°1234/2008)
Type IB variation (or ‘Minor variation of type IB’): a variation which is neither a minor variation of type IA nor a major variation of type II nor an extension. (Article 2.5 of Regulation (EC) n°1234/2008)
