Marketing authorisation is the tool to release medicines to the market.
A medicine created through scientific research and clinical trials has a
long way to go before it reaches the consumer.
In order for a medicine to have the marketing authorisation, its benefits must exceed its risks.
In other words, the medicine must be both efficient for the treatment of a particular disease and sufficiently safe for its user. The pharmaceutical company must also demonstrate that the quality
of the medicine is impeccable.
In addition, the pharmaceutical company must produce a high-quality package for the medicine as well as the package leaflet that provides the medicine user with the necessary information. There are strict regulations covering these texts.
The marketing authorisation criteria are uniform all over the EU. The marketing authorisation is granted by the EU Commission or the Finnish Medicines Agency Fimea. In individual cases only and for particular therapeutic reasons, Fimea can grant a special authorisation for medicines with
no marketing authorisation.
An application for a centralised EU and EEA market authorisation of a medicine can be filed with the European Medicines Agency, EMA. In alternative, the application can be made for one Member State through the respective national procedure, or for several Member States through the mutual recognition or decentralised procedure.
It is partly up to the pharmaceutical company to decide for which countries it is going to apply the marketing authorisation. However, the EU legislation includes strict provisions on which medicines require a centralised authorisation. These include, for example, all novel innovative medicines.
The work to develop a medicine does not end with the granting of the marketing authorisation. Pharmaceutical companies continue the investigations on their medicinal products – they develop new indications for the medicine and gather information on their benefits and adverse features. The holder of the marketing authorisation is obliged to produce updated information for the authorities and the medicine users. If the medicine undergoes changes, an authorisation by the authorities is required.
Click here for more information:
Finnish Medical Agency Fimea
European Medicines Agency EMA