Category - Regulatory Affairs

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Medicines regulation in Europe

Medicines regulation is the basis for ensuring that only medicines of a high quality are marketed. In Europe, the European Commission proposes high-level legislation in the form of regulations...

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How are medicines regulated?

A medicine can be marketed in the European Union (EU) until the company has obtained a Marketing Authorisation (MA) for that medicine from the relevant regulatory authority. MAs are...

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Off-label use

Off-label use of a medicine is the use of an authorised medicine by a healthcare professional to treat a patient in a way not covered by the Marketing Authorisation...

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Marketing authorisation

Before a medicinal product can be marketed and sold, a marketing authorisation must be obtained from the relevent National Competent Authorities. The marketing authorisation application process can take one...

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Information on medicinal products

Information on medicinal products is provided to patients and healthcare providers in different, carefully regulated ways – including package labelling, package leaflets, and the Summary of Product Characteristics.

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Prescribing medicines for special populations

Special considerations are necessary when prescribing medicines in special populations, such as children, the elderly, pregnant and breastfeeding women, and patients with renal (kidney) or hepatic (liver) impairment.

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