Module 18 2021

07/02/2021

MDs incorporating ancillary medicinal substances

1. Notified body consultation

2. Consultation with EU Medicines CA • NB and manufacturer choose CA • consultation on • drug substance aspects alone and • as incorporated into the device • variable procedures and timelines 3. Consultation with EMA • mandatory • human blood derivatives (human albumin, thrombin) • products derived from biotechnology • voluntary • drug substance authorised via centralised procedure

The Organisation for Professionals in Regulatory Affairs

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MDs incorporating ancillary medicinal substances Two connected regulatory procedures  Regulation of medicines ● Scientific advice ● Clinical trials Authorisations (CTAs) ● Marketing Authorisations ● Post marketing safety monitoring ● Inspections ● Enforcement and prosecution

The Organisation for Professionals in Regulatory Affairs

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12