MARKETING AUTHORISATION (MA)
In order to be placed on the market, a pharmaceutical product must first obtain a marketing authorisation (MA). The MA is requested by a pharmaceutical company for its product and on the basis of an application providing safety, efficiency and pharmaceutical quality data for the claimed indication.
The pharmaceutical quality, safety and efficiency data included in the MA application stem from experiments conducted on animals and from clinical trials conducted on humans and abide by international norms, harmonised on a European level.
The evaluation of the medicine’s therapeutic effects must outweigh the risks to the patient’s health (positive benefit/ risk balance).
The benefit/ risk balance must be at least identical to that of products already commercialised for the same indication.
The MA comprises:
- a Summary of Product Characteristics (SmPCs)
- A leaflet presenting the information of the SmPCs in more accessible terms, intended for the patient’s use
- Labelling including the information required to identify the medicine
Our generic medicines
Cevidra has recently decided to acquire the marketing authorisation of high value-added generic products. The commercialisation of the two specialties is expected in 2022.
- Treatment of acute pains
- Pharmaceutical form initially unavailable in France
- Uncovered medical need
- Multiple myeloma treatment
- A molecule at the heart of the development of multiple myeloma therapeutic solutions
- Health professional support in the form of educational material in prescribing or delivering this medicine