CRED NPM

05/11/2024

Switch application – Data package

Application (independent from MAA)

Application form active substance and limitations e.g. to specific dosage form, indication,… → pre defined product profile

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• Information if central application concerned

• Patients treated (per country, including Rx/OTC status)

• As MAH: Reference to licenses affected

• Switch rationale (Clinical overview, publications, safety data...)

• Proposed labelling for OTC use

The Organisation for Professionals in Regulatory Affairs

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Substance based switch procedure

German switch procedure

Pharmaceutical Company

Federal Council

Variation submission for MAs to change to OTC status & labelling

Amendment of the Ordinance on Prescription-Only Medicinal Products

Expert Advisory Committee for

Prescription Only Issues

2x per year

YouTube Video on German switch process

The Organisation for Professionals in Regulatory Affairs

Source: Sträter Rechtsanwälte, Pharma Deutschland

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