Guideline on names of medicinal products

The guideline has been produced to support the companies naming medicinal products. It is based on the Guideline on the acceptability of names for human medicinal products processed through the centralised procedure used by the EMA.

The guideline is intended to increase the understanding of the Swedish Medical Products Agency's assessment of product names in accordance with the Medical Products Agency's provisions (LVFS 2005:11) on labelling and package leaflets for medicinal products, the Medical Products Agency's provisions (LVFS 2012:19) on parallel imported medicinal products, the Medical Products Agency's provisions (HSLF-FS 2017:75) on homeopathic medicinal products and the Medical Products Agency's provisions (LVFS 2006:3) on traditional herbal medicinal products for human use in regard to the naming of products. 

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The guideline of EMEA is found at
https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf

 
 

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Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information