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EU Helps Firms To Prioritize Submission Of Data On ‘Critical’ Drugs

 
• By Ian Schofield

The submission of data for products on a new list of critical medicines is “a first step in achieving complete standardized product information for all medicines in the EU,” says the EMA.

Online documentation database and document management system concept
The EU is building a database of "critical medicines" • Source: Shutterstock

The European Medicines Agency has published a new list of “critical medicines” intended to help companies and national regulators map the drugs in its Product Management Service (PMS).

Manufacturing authorization holders (MAHs) can prioritize the medicines in the list for the submission of specific product information relating to pack sizes and manufacturing, while national competent authorities (NCAs) can...

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