Guide to Reclassification (Switching) of Legal Supply Status of Human Medicinal Products
14 October 2010
The IMB has published this guide to assist marketing authorisation holders in making reclassification or ‘switching’ applications.
The guide provides an overview of the regulatory and administrative requirements for reclassification of the legal supply status of a medicinal product for human use which has been granted a marketing authorisation by the IMB, nationally, through mutual-recognition or decentralised procedures. For products authorised through the centralised procedure, the guide advises on specific national issues relating to their legal supply status.
To open the guide, please click on the link below:
Guide to Reclassification (Switching) of Legal Supply Status of Human Medicinal Products
For more information on legal supply status, visit the Legal Supply Status and Reclassification page under Medicines > Human Medicines > Licensing or click on the link below:
Legal Supply Status and Reclassification