Marketing authorisation

How it is used

The standard term in the UK and the EU, abbreviated MA; the company holding it is the marketing authorisation holder (MAH). In the US people usually talk about FDA approval instead. The approved product information sets out the licensed uses; prescribing outside them is called off-label or unlicensed use.

Example sentences

1. The company has applied for a marketing authorisation for the new vaccine.

2. Using the drug in children is outside its marketing authorisation.

Common collocations

• grant a marketing authorisation
• apply for a marketing authorisation
• marketing authorisation holder
• off-label use

Related terms

• generic drugA medicine with the same active ingredient, strength, dosage form and effect as an original branded medicine, usually sold after the original's patent has expired.
• pharmacovigilanceThe science and activities of detecting, assessing, understanding and preventing adverse effects and other safety problems of medicines once they are on the market.
• GMPShort for good manufacturing practice: the rules and quality systems that make sure medicines are produced and controlled consistently to the right quality standards.
• clinical trialA research study in people that tests whether a new medicine or treatment is safe and works, usually by comparing it with a placebo or an existing treatment.

More terms: Regulation and Medication Safety

• over-the-counter
• brand name
• controlled drug
• bioequivalence
• medication error
• formulary