C-47/22Apotheke B. v Bundesamt für Sicherheit im Gesundheitswesen (BASG)

Domstolens egne nøkkelord

Reference for a preliminary ruling – Pharmaceutical and cosmetic products – Medicinal products for human use – Directive 2001/83/EC – Article 77(6) – Article 79(b) – Article 80(b) – Guidelines on Good Distribution Practice of medicinal products for human use (GDP) – Pharmaceutical distribution chain – Holder of a wholesale distribution authorisation obtaining medicinal products from persons who are authorised to supply medicinal products to the public but who do not hold a distribution authorisation and are not exempted from the obligation to have such an authorisation – Concepts of ‘sufficient competent staff’ and ‘responsible person’ – Suspension or withdrawal of the wholesale distribution authorisation.

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