Module 6

04/10/2024

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EU: Changing the classification for supply…

• Until 2008, switches were by EU NATIONAL procedures only

● First centralised switch approval 2008

Rx to OTC (Pharmacy) switch

❑ GSK Alli (Orlistat) ❑ Rx = Roche Xenical

The Organisation for Professionals in Regulatory Affairs

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38

Directive 2001/83/EC – Title VI Articles 70-75

Article 71: Prescription control is required for medicines where:

● A direct or indirect danger exists to human health, even when used correctly.

● There is frequently incorrect use ❑ Which could lead to direct or indirect danger…

● Further investigation of activity and / or side effects is required

● Normally prescribed by a doctor to be administered parenterally

The Organisation for Professionals in Regulatory Affairs

38

19