Court of Justice, Fifth Chamber
21 September 2023, Case C‑47/22
(Apotheke B. v Bundesamt für Sicherheit im Gesundheitswesen (BASG))
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 authorised to supply medicinal products to the public without holding a distribution authorisation or being exempted from the obligation to have such an authorisation – Definitions of ‘sufficiently qualified personnel’ and ‘responsible person’ – Suspension or withdrawal of wholesale distribution authorisation
1. Subparagraph (b) of the first paragraph of Article 80 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011,
must be interpreted as meaning that the holder of an authorisation for the wholesale distribution of medicinal products may not obtain medicinal products from other persons who, under national legislation, are authorised or entitled to supply medicinal products to the public, but who are themselves neither holders of such a distribution authorisation nor exempt from the requirement to obtain such an authorisation under Article 77(3) of Directive 2001/83, as amended, even if the acquisition concerns only a minimal quantity, or if the medicinal products thus acquired are intended to be resold only to persons authorised or entitled to supply medicinal products to the public or to persons who themselves hold a wholesale distribution authorisation.
2. Article 79(b) of Directive 2001/83, as amended by Directive 2011/62,
must be interpreted as meaning that the personnel requirements laid down by that provision are fulfilled where, during an inspection, the responsible person designated by the wholesaler is not present on the premises, provided that he or she is contactable by telephone and that the members of staff present on the premises are able to provide directly to the inspection service the information requested by the latter about the procedures which fall within their sphere of competence. In order to assess whether a wholesaler has sufficient competent staff, it is necessary to take into account the activities that that wholesaler has, where applicable, outsourced and the number of staff members involved in those activities.
3. Article 77(6) of Directive 2001/83, as amended by Directive 2011/62,
must be interpreted as meaning that the competent authority of a Member State called upon to decide whether the authorisation for the distribution of wholesale medicinal products must be suspended or withdrawn following infringements of the obligations laid down in Articles 79 and 80 of Directive 2001/83, as amended, is to base its examination on the nature and seriousness of those infringements, while paying particular attention to the high level of security of supply of medicinal products laid down in that directive. In order for the measure that may be taken to be proportionate, it shall also take into account, where appropriate, the fact that those deficiencies have been remedied as quickly as possible and that the deficiencies were repetitive or systematic.
categoria:European Case Law