CRED NPM

05/11/2024

Non-prescription medicines ID card

Name:

Non-Prescription medicines (NPM) defined by default in Article 72 of Dir.2001/83/EC

Synonym:

Over the counter medicine (OTC)

Antonym:

Prescription medicine (Rx) Four criteria defined in Article 71 of Dir.2001/83/EC

Family:

Self-care

Medicinal Product

Regulatory Category:

The Organisation for Professionals in Regulatory Affairs

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Change of legal status

Directive 2001/83/EC

MA needed

None of the Rx criteria of article 71 • Direct or indirect danger

Art. 72 - definition by default

• Abuse-misuse • New substance • Injectable

The Organisation for Professionals in Regulatory Affairs

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2