Harmonisation

Harmonisation of SPCs of old antibiotics across the EU

In the EU, several possibilities for harmonisation and updating of the Summary of Product Characterisation (SPC) are provided in Directive 2001/82/EC. According to Article 30 or 31 referrals with a complete harmonisation as outcome purely national MAs have to be transferred into MRP (mutual recognition process) status and is organised by the Co-ordination Group for Mutual Recognition and Decentralised Procedures-Humans (CMDh). Most antibiotics are subject to Article 30 referrals. Due to the need of substantial re-assessment of efficacy and safety colistin is under review according to Article 31 referral. Only moxifloxacin has been reviewed recently according to Article 107i referral due to intensified safety concerns.

Harmonisation of SPCs in the European Union: indications, dosage

Complex Teicoplanin-dosing recommendation of teicoplanin

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