62022CJ0047_SUM
Case C‑47/22
Apotheke B.
v
Bundesamt für Sicherheit im Gesundheitswesen (BASG)
(Request for a preliminary ruling from the Bundesverwaltungsgericht)
Judgment of the Court (Fifth Chamber) of 21 September 2023
(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)
Approximation of laws – Medicinal products for human use – Directive 2001/83 – Wholesale distribution of medicinal products – Obligation to have a distribution authorisation – Requirements imposed on applicants for and holders of such an authorisation – Possibility of obtaining supplies from persons who do not hold a wholesale distribution authorisation – Not permissible – Acquisition concerning a minimal quantity or concerning medicinal products intended for resale to persons authorised to supply them to the public – Irrelevant
(European Parliament and Council Directive 2001/83, Art. 80, first para., point (b))
(see paragraphs 26, 27, 31, 34, 35, operative part 1)
Approximation of laws – Medicinal products for human use – Directive 2001/83 – Wholesale distribution of medicinal products – Obligation to have a distribution authorisation – Requirements imposed on applicants for and holders of such an authorisation – Personnel requirements – Absence of the responsible person from the premises during an inspection – Whether permissible – Conditions – Sufficient competent staff – Concept – Criteria for assessment
(European Parliament and Council Directive 2001/83, Art. 79(b) and (c))
(see paragraphs 38, 39, 42, 44, 46-50, operative part 2)
Approximation of laws – Medicinal products for human use – Directive 2001/83 – Wholesale distribution of medicinal products – Obligation to have a distribution authorisation – Requirements imposed on applicants for and holders of such an authorisation – Penalties for failure to comply – Requirement that those penalties be proportionate – Assessment by the national court
(European Parliament and Council Directive 2001/83, Art. 77(6))
(see paragraphs 56, 57, 59, operative part 3)
See the text of the decision.