Public consultation open on guideline on the acceptability of names for human medicines
NewsCorporateRegulatory and procedural guidance
The European Medicines Agency has released the sixth revision of the Draft guideline on the acceptability of names for human medicinal products processed through the centralised procedure for public consultation.
The current update of this guideline provides further recommendations on the requirements for acceptability and submission of proposed (invented) names.
It also clarifies:
- specific aspects of the criteria applied to address safety and public-health concerns;
- international-non-proprietary-name issues;
- product-specific concerns;
- the procedure for submission of proposed (invented) name requests.
The updated guideline is open for comments until 30 August 2013. Comments should be sent to nrg@ema.europa.eu using the.