1 This request for a preliminary ruling concerns the interpretation of Article 77(6), Article 79(b) and point (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 (OJ 2001 L 311, p. 67), as amended by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 (OJ 2011 L 174, p. 74) (‘Directive 2001/83’).
2 The request has been made in proceedings between Apotheke B., a limited partnership operating a pharmacy in Austria, and the Bundesamt für Sicherheit im Gesundheitswesen (BASG) (Federal Office for Safety in Healthcare, Austria) (‘the Federal Office’) concerning the revocation of the authorisation to engage in activity as a wholesaler in medicinal products.
3 Title VII of Directive 2001/83, entitled ‘Wholesale distribution and brokering of medicinal products’, provides in Article 77(1), (3), (5) and (6): ‘1. Member States shall take all appropriate measures to ensure that the wholesale distribution of medicinal products is subject to the possession of an authorisation to engage in activity as a wholesaler in medicinal products, stating the premises located on their territory for which it is valid. … 3. Possession of a manufacturing authorisation shall include authorisation to distribute by wholesale the medicinal products covered by that authorisation. Possession of an authorisation to engage in activity as a wholesaler in medicinal products shall not give dispensation from the obligation to possess a manufacturing authorisation and to comply with the conditions set out in that respect, even where the manufacturing or import business is secondary. … 5. Checks on the persons authorised to engage in activity as a wholesaler in medicinal products, and the inspection of their premises, shall be carried out under the responsibility of the Member State which granted the authorisation for premises located on its territory. 6. The Member State which granted the authorisation referred to in paragraph 1 shall suspend or revoke that authorisation if the conditions of authorisation cease to be met. …’
4 Article 79 of that directive provides: ‘In order to obtain the distribution authorisation, applicants must fulfil the following minimum requirements: … (b) they must have staff, and in particular, a qualified person designated as responsible, meeting the conditions provided for by the legislation of the Member State concerned; (c) they must undertake to fulfil the obligations incumbent on them under the terms of Article 80.’
5 The first paragraph of Article 80 of Directive 2001/83 is worded as follows: ‘Holders of the distribution authorisation must fulfil the following minimum requirements: … (b) they must obtain their supplies of medicinal products only from persons who are themselves in possession of the distribution authorisation or who are exempt from obtaining such authorisation under the terms of Article 77(3); … (g) they must comply with the principles and guidelines of good distribution practice for medicinal products as laid down in Article 84; (h) they must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities; …’
6 Article 84 of that directive provides: ‘The Commission shall publish guidelines on good distribution practice. To this end, it shall consult the Committee for Medicinal Products for Human Use and the Pharmaceutical Committee established by Council Decision 75/320/EEC [of 20 May 1975 setting up a pharmaceutical committee (OJ 1975 L 147, p. 23)].’
7 Chapter 2 of the Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (OJ 2013 C 343, p. 1; ‘the GDP Guidelines’), entitled ‘Personnel’, states, in the second paragraph of point 2.2: ‘The responsible person should fulfil their responsibilities personally and should be continuously contactable. The responsible person may delegate duties but not responsibilities.’
8 Chapter 4 of the GDP Guidelines, entitled ‘Documentation’, provides, in the first and seventh paragraphs of point 4.2: ‘Documentation comprises all written procedures, instructions, contracts, records and data, in paper or in electronic form. Documentation should be readily available/retrievable. … Each employee should have ready access to all necessary documentation for the tasks executed.’
9 The Arzneimittelgesetz (Law on Medicinal Products) of 2 March 1983 (BGBl. 185/1983), as amended by the law of 15 December 2020 (BGBl. I, 135/2020) (‘the AMG’), provides, in Article 2(2): ‘A “wholesaler in medicinal products” is a professional who, under the Gewerbeordnung 1994 [(Code governing the industrial, commercial and craft professions 1994), BGBl. 194/1994], is entitled to engage in the wholesale distribution of medicinal products and holds the corresponding authorisation referred to in Paragraph 63(1) and a pharmaceutical undertaking of another party to the Agreement on the European Economic Area who is entitled to engage in activities relating to the wholesale distribution of medicinal products.’
10 Paragraph 57 of that law, entitled ‘Issue of medicinal products’, provides in subparagraph 1: ‘Medicinal products may be dispensed by the manufacturer, depositary or wholesaler in medicinal products only to 1. pharmacy dispensaries, hospital pharmacies and veterinary personal pharmacies, … 4. wholesalers of medicinal products, …’
11 Paragraph 62 of that law, entitled ‘Operating regulations’, provides in subparagraph 1: ‘In so far as this is necessary in order to guarantee the quality of medicinal products or active substances necessary for the health and life of humans or animals and the supply of medicinal products or active substances, the Federal Minister for Health is required to lay down, by means of a regulation, operating rules for establishments which manufacture, control or place on the market medicinal products or active substances.’
12 Paragraph 63 of the AMG, entitled ‘Authorisation’, provides in subparagraph 1: ‘In the establishments referred to in Paragraph 62(1), the manufacture, placing on the market and control of medicinal products or medicinal products and active substances shall be subject to an authorisation issued by the [Federal Office].’
13 Under Paragraph 66a of the AMG: ‘The authorisation referred to in Paragraph 63(1) or Paragraph 65(1) must be revoked if it subsequently transpires that the conditions were not met. It must be revoked if the conditions are no longer met. Revocation may be replaced by the total or partial suspension of the authorisation if the holder of the operating authorisation is able to remedy the cause of the revocation within a reasonable period. [The Federal Office] shall immediately inform the other parties to the Agreement on the European Economic Area, Switzerland and the Commission thereof.’
14 Apotheke B. is a limited partnership, established in Austria, which operates a pharmacy and held an authorisation to engage in activity as a wholesaler in medicinal products granted in accordance with the AMG.
15 On 8 March 2021, following an inspection carried out at Apotheke B.’s premises on 30 July 2020, and a subsequent investigation, the Federal Office adopted a decision to revoke that authorisation.
16 The Federal Office took that revocation decision after finding that the applicant in the main proceedings had purchased, on several occasions, medicinal products from other pharmacies which did not have any wholesale distribution authorisation and that it then resold them to wholesalers who had such an authorisation.
17 The Federal Office also noted that Apotheke B. did not have sufficient specialised and qualified staff, as the only person present during the inspection was not able to provide the relevant documents required by national law.
18 During the inspection carried out on 30 July 2020 by the Federal Office, it became apparent that the ‘responsible person’ was not present on the premises but was contactable by telephone. She was on leave on that day and was informed of the inspection by the employees of the Federal Office approximately 15 minutes before they arrived at the premises.
19 It is also apparent from the order for reference that, between 2019 and 2020, the applicant in the main proceedings entrusted certain logistics services, such as preparing orders for medicinal products, packaging products or monitoring expiration dates, to a third-party company.
20 Apotheke B. has brought an action before the Bundesverwaltungsgericht (Federal Administrative Court, Austria) against the decision of the Federal Office of 8 March 2021 to revoke its authorisation to operate as a wholesaler in medicinal products.
21 In support of its action, it submits, first, that the fact that it purchased medicinal products from persons who did not have a wholesale distribution authorisation did not specifically jeopardise the objective of safety of medicinal products. Secondly, it takes the view that the national legislation requires only one competent person to be present on the premises, that person not being required to remain there continuously.
22 In those circumstances, the Bundesverwaltungsgericht (Federal Administrative Court) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling: ‘(1) (a) Must [point (b) of the first paragraph of Article 80] of Directive 2001/83 be interpreted as meaning that the requirement deriving from that provision is fulfilled even where, as in the main proceedings, a holder of [a] distribution authorisation obtains medicinal products from other persons who are also authorised or entitled to supply medicinal products to the public under national law, but who are not themselves in possession of such [a] distribution authorisation or who are exempt from the obligation to obtain such [a] distribution authorisation under Article 77(3) of that directive, and only small quantities are supplied? (b) If Question 1(a) is answered in the negative, is it relevant to compliance with the requirement laid down in [point (b) of the first paragraph of] Article 80 of Directive 2001/83 whether a supply of medicinal products obtained in the manner described in the main proceedings and in Question 1(a) is made only to persons authorised or entitled to supply medicinal products to the public under Article 77(2) of that directive or also to those who are themselves holders of [a] distribution authorisation? (2) (a) Must [Article 79(b) and point (g) of the first paragraph of Article 80 of Directive 2001/83], [read] in conjunction with point 2.2 of the GDP Guidelines, be interpreted as meaning that the staffing requirements are [met] even where, as in the main proceedings, the responsible person is (physically) absent from the premises for a period of four hours but can be contacted by telephone during that time? (b) Must Directive 2001/83, in particular [Article 79 and point (g) of the first paragraph of Article 80] thereof, [read] in conjunction with the first paragraph of point 2.3 of the GDP Guidelines, be interpreted as meaning that the staffing requirements provided for in those provisions and guidelines are met where, as in the main proceedings, in the event that the responsible person is absent as described in Question 2(a), the staff present on the premises are not able, in particular in the event of an inspection by the competent authority of the Member State, to provide information on the written procedures [falling within] their respective areas of responsibility? (c) Must Directive 2001/83, in particular [Article 79 and point (g) of the first paragraph of Article 80] thereof, [read] in conjunction with point 2.3 of the GDP Guidelines, be interpreted as meaning that, in assessing whether an adequate number of competent personnel is involved in all stages of the wholesale distribution activities, account must also be taken of activities outsourced to third parties (or activities carried out by third parties on behalf of the establishment), as occurred in the case in the main proceedings, and does that directive preclude or even require the obtaining of an expert report for the purposes of that assessment? (3) Must Directive 2001/83, in particular [Article 77(6) and Article 79] thereof, be interpreted as meaning that the authorisation to engage in activity as a wholesaler in medicinal products must also be revoked where it is established that a requirement under Article 80 of that directive is not [met] - for example, medicinal products are obtained in a manner contrary to [point (g) of the first paragraph of Article 80] of that directive, as may be the case in the main proceedings - but that requirement is then once more complied with, in any event[,] at the time of the decision by the competent authority of the Member State or the court before which the matter is brought? If not[,] what other requirements for that assessment exist under EU law, and, in particular, when must the authorisation be (merely) suspended instead of revoked?’
23 By its first question, the referring court asks, in essence, whether point (b) of the first paragraph of Article 80 of Directive 2001/83 is to be interpreted as meaning that a person holding an authorisation for the wholesale distribution of medicinal products may 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 obligation to obtain such an authorisation under Article 77(3) of that directive, if the acquisition concerns only a minimal quantity, and whether the fact that the medicinal products acquired by a wholesaler from such persons will be resold only to persons authorised or entitled to supply medicinal products to the public or to persons who are themselves holders of a wholesale distribution authorisation is capable of justifying a different answer to that question.
24 As a preliminary point, it should be recalled that the EU legislature chose to harmonise, by Articles 79 to 82 of Directive 2001/83, the minimum requirements to be satisfied by applicants for and holders of an authorisation for the wholesale distribution of medicinal products (judgment of 28 June 2012, Caronna, C‑7/11, EU:C:2012:396, paragraph 44).
25 Article 79 of Directive 2001/83 provides that the granting of an authorisation to operate as a wholesaler in medicinal products is contingent on the existence of suitable premises, installations and equipment and qualified staff, so as to ensure proper conservation and distribution of the medicinal products. There are further requirements, set out in Articles 80 to 82 of that directive, with which the holder of the authorisation must comply, including those relating to the documentation of transactions, the supply of medicinal products and compliance with the principles and guidelines relating to good distribution practice. Fulfilment of the conditions required for the issue of that authorisation is subject to supervision during the period in which it is held (judgment of 28 June 2012, Caronna, C‑7/11, EU:C:2012:396, paragraphs 45 and 46).
26 As regards, more specifically, the obtaining of medicinal products by wholesalers, it follows from the wording of point (b) of the first paragraph of Article 80 of Directive 2001/83 that the holder of a distribution authorisation may obtain medicinal products only from persons who either themselves hold the wholesale distribution authorisation or are exempted from that authorisation under Article 77(3) of that directive, by virtue of holding a manufacturing authorisation.
27 The wording of that provision therefore excludes any possibility of obtaining supplies from other persons, such as persons authorised or entitled under national legislation to supply medicinal products to the public.
28 According to the Court’s case-law, an interpretation of a provision of EU law cannot have the result of depriving the clear and precise wording of that provision of all effectiveness. Thus, where the meaning of a provision of EU law is absolutely plain from its very wording, the Court cannot depart from that interpretation (judgment of 20 September 2022, VDandSR, C‑339/20 and C‑397/20, EU:C:2022:703, paragraph 71 and the case-law cited).
29 The interpretation arising from paragraphs 26 and 27 of the present judgment is supported by the objectives of Directive 2001/83, in particular the protection of public health, the removal of barriers to trade in medicinal products within the European Union and the need to exercise control over the entire chain of distribution of medicinal products. The Court has held that, in order to achieve those objectives, the minimum requirements for the wholesale distribution of medicinal products must be met in a uniform and effective manner by all persons who engage in that activity in all Member States (see, to that effect, judgment of 28 June 2012, Caronna, C‑7/11, EU:C:2012:396, paragraph 48).
30 Furthermore, given that the retail of medicinal products has different characteristics from the wholesale distribution of such products, it cannot be presumed from the simple fact that pharmacists satisfy the conditions governing retail supply in their respective Member States that they also satisfy the conditions laid down by harmonised rules at European Union level for wholesale distribution (judgment of 28 June 2012, Caronna, C‑7/11, EU:C:2012:396, paragraph 47).
31 The fact that the supply to the holder of a wholesale distribution authorisation by a person not covered by point (b) of the first paragraph of Article 80 of Directive 2001/83 concerns only an extremely small quantity of medicinal products is irrelevant, since that provision does not provide for any exception, even in respect of minimal quantities, to the obligation to obtain supplies from persons who themselves hold such an authorisation or who are exempt from that authorisation because they hold a manufacturing authorisation for medicinal products.
32 It is clear from the case-law of the Court that the laying down, by Directive 2001/83, of minimum requirements for the wholesale distribution of medicinal products which must be met in a uniform and effective manner by all persons who engage in that activity in all Member States is intended to ensure the attainment of the objectives of that directive, in particular that of protecting public health (see, to that effect, judgment of 28 June 2012, Caronna, C‑7/11, EU:C:2012:396, paragraph 48).
33 Failure to comply with the minimum requirements for the wholesale distribution of a small quantity of medicinal products is liable to endanger the health of at least one person and, in that sense, cannot be reconciled with the objectives pursued by Directive 2001/83.
34 Lastly, it is also irrelevant that medicinal products acquired by a wholesaler from a person other than those referred to in point (b) of the first paragraph of Article 80 of Directive 2001/83 are intended for resale to persons who are authorised or entitled to supply medicinal products to the public or who themselves hold a wholesale distribution authorisation. That provision does not provide for any exception on the basis of the capacity of the persons to whom the wholesaler intends to resell the medicinal products which it acquires. Furthermore, persons authorised or entitled to supply medicinal products to the public and persons holding a wholesale distribution authorisation are likely to constitute the majority of the customers of a wholesaler, with the result that, if it were to be considered that that provision does not apply to medicinal products acquired by a wholesaler for resale to such persons, that provision would be rendered largely meaningless.
35 Consequently, the answer to the first question is that point (b) of the first paragraph of Article 80 of Directive 2001/83 must be interpreted as meaning that a person holding 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 obligation to obtain such an authorisation under Article 77(3) of that directive, even if the acquisition concerns only a minimal quantity, or if the medicinal products thus acquired are intended for resale only to persons authorised or entitled to supply medicinal products to the public or to persons who are themselves holders of a wholesale distribution authorisation.
36 By its second question, the referring court asks, in essence, whether Article 79(b) of Directive 2001/83 is to be interpreted as meaning that the personnel requirements laid down in that provision are met where, during an inspection, the responsible person designated by the wholesaler is not present on the premises but is contactable by telephone, and the members of staff present on the premises are not in a position to provide the inspection service with the information requested about the procedures which fall within their sphere of competence. It also asks whether that provision is to be interpreted as meaning that, in order to assess whether a wholesaler has sufficient competent staff, it is necessary to take into account the activities which that wholesaler has, as the case may be, outsourced.
37 It should be borne in mind that, under Article 79(b) of Directive 2001/83, the wholesale distributor must have staff, and in particular, a qualified person designated as responsible, under the conditions laid down by the law of the Member State concerned.
38 As regards, in the first place, the absence of the person designated as responsible by the wholesaler from the premises at the time of the inspection, it should be noted that the reference, in the wording of that provision, to ‘a’ responsible person, in that it involves the designation of a single person and not several, one of whom could replace another in the absence of the latter’s absence, is difficult to reconcile with an interpretation of that provision according to which the responsible person must always be present on the premises during an inspection. In so far as such inspections could take place without prior notice, or be announced shortly before they were carried out, to require the responsible person always to be present during an inspection would mean, in practice, that that person could never be absent from his or her workplace for any reason whatsoever.
39 Thus, there is nothing to prevent urgent questions relating to the implementation and maintenance of a quality system from being settled by telephone with the responsible person, in the event of that person being temporarily absent.
40 Moreover, that interpretation is supported by the GDP Guidelines, which Article 84 of Directive 2001/83 empowers the European Commission to publish, and with which the holder of a distribution authorisation must comply, as provided for in point (g) of the first paragraph of Article 80 of that directive.
41 It follows from the second paragraph of point 2.2 of those guidelines that the responsible person should fulfil his or her responsibilities personally and should be continuously contactable. The responsible person may delegate duties but not responsibilities.
42 On the other hand, the fact that the responsible person does not necessarily have to be present on the premises at the time of an inspection cannot justify the fact that the members of staff present on the premises during such an inspection are not in a position to provide the inspection service with the information requested by it concerning the procedures which fall within their sphere of competence.
43 Article 79(c) of Directive 2001/83 requires applicants for a distribution authorisation to undertake to fulfil the obligations incumbent on them under the terms of Article 80 of that directive, including the obligation, laid down in point (h) of the first paragraph of that article, to maintain a quality scheme establishing the responsibilities, procedures and risk management measures for the activities of the holders of such an authorisation.
44 It is therefore for any holder of a distribution authorisation to put in place the necessary procedures in order to ensure that, in the absence of the responsible person from the premises during an inspection, another member of staff is in a position to provide the inspection service with the information requested by it, thereby guaranteeing the effectiveness of the review exercised during such an inspection.
45 That interpretation is, moreover, supported by the first and seventh paragraphs of point 4.2 of the GDP Guidelines, from which it is apparent that the documentation to be kept by the holder of a distribution authorisation must be available and accessible directly and that every employee must have easy access to all the documentation necessary for the performance of his or her tasks.
46 It follows that the personnel requirements laid down in Article 79(b) of Directive 2001/83 are met even if, 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 a member of staff present on the premises is in a position to provide the inspection service directly with the information requested by it.
47 As regards, in the second place, the question whether it is necessary to take into account the activities which that wholesaler has, as the case may be, outsourced in order to determine whether it has sufficient competent staff, it should be noted that, in order for a wholesaler to be able to carry out all the tasks for which it is responsible at all stages of wholesale distribution activities, it must necessarily have sufficient competent staff in the light of the volume and scale of its activities.
48 Directive 2001/83 does not prohibit wholesale distributors from outsourcing certain tasks. Moreover, neither that directive nor the GDP Guidelines provide a method for assessing whether a wholesale distributor has sufficient staff.
49 Therefore, in order to assess whether there is a sufficient number of competent staff, it is necessary to take into account all the activities of the wholesaler, including those which have, as the case may be, been outsourced.
50 Consequently, the answer to the second question is that Article 79(b) of Directive 2001/83 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 in a position 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, as the case may be, outsourced and the number of staff members involved in those activities.
51 By its third question, the referring court seeks to ascertain, in essence, whether Article 77(6) of Directive 2001/83 is to be interpreted as meaning that the authorisation for the wholesale distribution of medicinal products must be revoked, in the event of infringement of a requirement laid down in Article 80 of that directive, which has been remedied by the holder of the authorisation at the time of adoption of the decision of the competent authority of the Member State concerned or, as the case may be, of a court hearing an appeal against the decision of that authority.
52 Under Article 77(6) of that directive, Member States are required to suspend or revoke the authorisation to engage in activity as a wholesaler in medicinal products where the conditions set out in Articles 79 and 80 cease to be met by the holder of that authorisation.
53 By that provision, the EU legislature has effected only a minimum harmonisation limited to the determination of the measures which may be taken where the conditions laid down in Articles 79 and 80 of Directive 2001/83 cease to be met.
54 It is in no way apparent from the wording of Article 77(6) of Directive 2001/83 that the EU legislature intended to define the criteria governing the implementation of those measures and to specify the way in which those criteria are to be applied by the national authorities.
55 That said, it should be borne in mind that observance of the principle of proportionality, which constitutes a general principle of EU law, is binding on Member States when they are implementing EU law (judgment of 8 March 2022, Bezirkshauptmannschaft Hartberg-Fürstenfeld (Direct effect), C‑205/20, EU:C:2022:168, paragraph 31 and the case-law cited).
56 Therefore, in order to determine whether the infringement, by the holder, of the conditions to which authorisation to engage in activity as a wholesaler in medicinal products is subject must result in the revocation or suspension of that authorisation, Member States are required to comply with the principle of proportionality and, in order to do so, to take account of the nature and seriousness of the infringement found, while paying particular attention to the high level of security of supply of medicinal products enshrined in Directive 2001/83, and to the possibility for the holder to remedy the deficiencies within a reasonable period.
57 Thus, if the deficiencies found have already been remedied prior to the adoption of the competent authority’s decision, that authority need not necessarily revoke or suspend the authorisation to engage in activity as a wholesaler in medicinal products. Furthermore, Article 77(6) of Directive 2001/83 does not preclude a national court hearing an appeal against a decision of the competent national authority revoking or suspending such an authorisation from taking into consideration, if it is permitted to do so under national procedural rules, the fact that the holder of that authorisation has, in the meantime, remedied the deficiencies found after the adoption of the decision of the competent authority, in order to annul or reconstruct the contested decision.
58 The foregoing considerations are without prejudice to the possibility for the competent national authority to impose, where appropriate, the penalties provided for by national law for the deficiencies found.
59 Consequently, the answer to the third question is that Article 77(6) of Directive 2001/83 must be interpreted as meaning that the competent authority of a Member State called upon to decide whether the authorisation for the wholesale distribution of medicinal products must be suspended or revoked following infringements of the obligations laid down in Articles 79 and 80 of that directive 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 enshrined in that directive. In order for the measure that may be taken to be proportionate, that authority is also to 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.
60 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.