Thursday, 27 January 2022, 7:21 AM
Site: EUPATI Open Classroom
Course: EUPATI Open Classroom (EUPATI Open Classroom)
Glossary: Glossary
M

Magnetic Resonance Imaging

Magnetic Resonance Imaging

Malignant

A tumour is malignant if it is able to invade tissue other than where it originally grew (the primary site). Malignant tumours may spread (metastasise) to nearby tissues, or via the blood stream to other parts of the body quite distant from the primary site. New tumours can then form at those new sites. Benign tumours are not cancerous: their cells do not spread to other parts of the body.

Malta Medicines Authority

Maltese National Competent Authority. http://medicinesauthority.gov.mt/"

Market exclusivity

The 10-year period after the marketing authorisation of an orphan medicine, during which similar medicines for the same indication cannot be placed on the market. Market exclusivity should not be confused with market protection or data exclusivity, market exclusivity refers only to orphan medicines.

In this period, the EMA (the Agency™) and the member states shall not accept another application for a marketing authorisation, or grant a marketing authorisation or accept an application to extend an existing marketing authorisation, for the same therapeutic indication, in respect of a similar medicinal product. This protects the original marketing authorisation holder from market competition with similar medicines with similar indications once they are approved and is intended to encourage the development of medicines for rare diseases.

The period of market exclusivity is extended by two years for medicines that also have complied with an agreed paediatric investigation plan (PIP).

Marketing Authorisation

Marketing authorisation (MA) refers to the approval for a medicine to be marketed.

A system of marketing authorisation was put in place to protect public health. Marketing authorisations are granted only when a competent authority (or regulatory authority™) has conducted a scientific evaluation, and is satisfied that a medicine is sufficiently safe and effective, and of high enough quality.

Different procedures exist to obtain a MA. The EMA (the Agency™) is responsible for the centralised procedure™. A single application is submitted to the EMA for evaluation by the Agency™s Scientific committees. If the assessment is positive, a single marketing authorisation is issued by the European Commission. The Marketing Authorisation Holder can then legally begin to market the medicine in all EEA (European Economic Area) countries (EU member states and the three EEA EFTA States (Iceland, Liechtenstein, and Norway).

National Competent™ Authorities (NCAs) are responsible for evaluation of marketing authorisation applications and granting MAs for medicines that fall outside the scope of the centralised procedure. Companies can apply for authorisation of these medicines in several countries simultaneously, using the decentralised procedure™. Or, once a medicine is authorised in one EU member state, a company can apply for this authorisation to be recognised in other EU countries (the mutual recognition procedure™). These procedures result in national MAs for each member state involved.

Marketing Authorisation Application

Marketing Authorisation Application

Marketing Authorisation Holder

A Marketing Authorisation Holder (MAH) is a company, firm or non-profit organisation that has been granted a marketing authorisation. The marketing authorisation allows the holder to market a specific medicinal product, in one or more EU member states. Once a medicinal product is marketed and in use by patients, the MAH continues to be responsible for monitoring safety (pharmacovigilance). Any suspected adverse reactions must be reported to the body which granted the marketing authorisation, in the form of a periodic safety update report (PSUR).

Maximum Tolerated Dose

The maximum tolerated dose (MTD) is the highest dose of a medicine or treatment that will produce the desired effect without resulting in unacceptable side effects. It is determined in clinical trials by testing increasing doses on different groups of people until the highest dose with acceptable side effects is found. Establishing the maximum tolerated dose is the main objective of Phase I clinical trials.

Medical device

A medical device is an instrument, apparatus, implant, software or related article used to diagnose, prevent, or treat disease or other conditions. It must not achieve its primary intended action in or on the human body through pharmacological, immunological or metabolic means, but may be assisted in its function by such means.

Medical devices vary greatly in complexity and application. They are intended by the manufacturer to be used for:

  • Diagnosis, prevention, monitoring, treatment, or alleviation of disease.
  • Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap.
  • Investigation, replacement, or modification of the anatomy or of a physiological process.
  • Birth control.

Medical Products Agency

Swedish National Competent Authority. https://lakemedelsverket.se"