Opinion of the Advocate General — ECLI:EU:C:2023:225
Date: 2023-03-16
Language of the case: German
Subject matter: Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: Austria

Summary C-47/22 – 1 
Case C-47/22 
Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged: 
21 January 2022 
Referring court: 
Bundesverwaltungsgericht (Austria) 
Date of the decision to refer: 
20 January 2022 
Appellant: 
Apotheke B. 
Respondent authority: 
Bundesamt für Sicherheit im Gesundheitswesen (BASG) 
  
Subject matter of the main proceedings 
Interpretation of provisions of EU law on medicinal products for human use; 
conditions for obtaining distribution authorisation; requirements in respect of the 
holder of such authorisation 
Subject matter and legal basis of the request 
Interpretation of EU law, in particular Article 267 TFEU 
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. 6) as amended by Regulation (EU) 2020/1043 of 
the European Parliament and of the Council of 15 July 2020 (OJ 2020 L 231, 
p. 12) (‘Directive 2001/83’) 
Guidelines of 5 November 2013 on Good Distribution Practice of medicinal 
products for human use (OJ 2013 C 343, p. 1) (‘GDP Guidelines’) 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-47/22 
 
2  
Questions referred for a preliminary ruling 
1. (a) Must Article 80(b) 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 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 distribution authorisation or who are 
exempt from the obligation to obtain such distribution authorisation under 
the terms of 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 Article 80(b) 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 distribution 
authorisation? 
2. (a) Must Articles 79(b) and 80(g) of that directive, in conjunction with 
point 2.2 of the GDP Guidelines, be interpreted as meaning that the staffing 
requirements are fulfilled 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 Articles 79 and 80(g) thereof, 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 themselves on the written procedures relating to their respective 
areas of responsibility? 
(c) Must Directive 2001/83, and in particular Articles 79 and 80(g) thereof, 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 Articles 77(6) and 79 thereof, be 
interpreted as meaning that the authorisation to engage in activity as a 
APOTHEKE B. 
 
3 
wholesaler in medicinal products must also be revoked where it is 
established that a requirement under Article 80 of that directive is not 
fulfilled – for example, medicinal products are obtained in a manner 
contrary to Article 80(b) 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? 
Provisions of EU law relied on 
Directive 2001/83, in particular recitals 2, 3, 35 and 36 and Articles 1, 77, 79, 80 
and 84 
GDP Guidelines, in particular subchapters 1.1, 1.2, 2.1, 2.2, 2.3, 4.1, 4.2 and 5.2 
thereof, and the annex thereto 
TFEU, in particular Articles 114 and 168 
TEU, in particular Article 5 
Provisions of national law relied on 
Bundesgesetz vom 2. März 1983 über die Herstellung und das Inverkehrbringen 
von Arzneimitteln (Arzneimittelgesetz) [Federal Law of 2 March 1983 on the 
production and placing on the market of medicinal products (Law on medicinal 
products)] (BGBl. No 185/1983 in the version published in BGBl. I No 23/2020) 
(‘the AMG’), in particular Paragraphs 1, 2, 57, 62, 63 and 66a 
Gesetz vom 18. Dezember 1906, betreffend die Regelung des Apothekenwesens 
(Apothekengesetz) [Law of 18 December 1906 regulating pharmacies (Law on 
pharmacies)] (RGBl. No 5/1907 in the version published in BGBl. No 50/2021) 
(‘the ApG’), in particular Paragraphs 1, 4, 7 and 9 
Verordnung des Bundesministers für Gesundheit über Betriebe, die Arzneimittel 
oder Wirkstoffe herstellen, kontrollieren oder in Verkehr bringen und über die 
Vermittlung von Arzneimitteln (Arzneimittelbetriebsordnung 2009) [Regulation 
of the Federal Minister for Health on businesses which manufacture, control or 
place on the market medicinal products or active substances and on the brokering 
of medicinal products (2009 Regulation on medicinal product businesses)] (BGBl. 
II No 324/2008 in the version published in BGBl II. No 41/2019 (‘the AMBO’), in 
particular Paragraphs 1, 2, 4, 5, 6 and 10 
Verordnung der Bundesministerin für Gesundheit und Frauen über den Betrieb 
von Apotheken und ärztlichen und tierärztlichen Hausapotheken 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-47/22 
 
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(Apothekenbetriebsordnung 2005) [Regulation of the Federal Minister for Health 
and Women on the operation of pharmacies and doctors’ and veterinarians’ 
dispensaries (2005 Regulation on the operation of pharmacies)] (BGBl. II 
No 65/2005 in the version published in BGBl. No 354/2019) (‘the ABO’), in 
particular Paragraph 1 
Facts and procedure 
1 The present appeal proceedings concern the lawfulness of the revocation of a 
licence granted under the provisions of the Austrian AMG by the Bundesamt für 
Sicherheit im Gesundheitswesen (Federal Office for Safety in Healthcare; ‘the 
authority’) to the appellant for the activity of wholesale distribution of medicinal 
products. 
2 The parties are in dispute concerning one of the conditions for such revocation, 
namely non-compliance with the requirements which are contained in the 
AMBO –adopted in implementation of the AMG – and which concern wholesale 
operations. They are also in dispute concerning the lawfulness of the revocation 
itself. 
3 The Republic of Austria has transposed Directive 2001/83 and its provisions on 
the wholesale distribution of medicinal products by, inter alia, the AMG and the 
AMBO. 
4 On the basis of the investigative work by the authority and its own investigations, 
the referring court provisionally proceeds on the basis of the following facts: 
5 The appellant is a limited partnership established under Austrian law. It operates a 
public pharmacy in respect of which the general partner of that company holds a 
licence – granted to her as a person – under the Austrian legislation on 
pharmacies. The appellant also holds a licence as a wholesaler of medicinal 
products, which was granted to it in accordance with the AMG, by decision of 
XXX. 
6 The appellant – as the holder of authorisation to engage in the wholesale 
distribution of medicinal products – purchased medicinal products on several 
occasions from other public pharmacies, which do not hold wholesale 
authorisation under the AMG, and subsequently resold them to authorised 
wholesalers established in Austria. The medicinal products purchased in that 
manner were transported by carriers, commissioned by the appellant, from the 
respective pharmacies selling those medicinal products to the appellant or, on the 
latter’s instructions, to a third party. 
7 The authority carried out an inspection of the appellant’s premises on XXX. The 
person identified as the ‘qualified person’ (‘VP’) in the description for the 
appellant’s establishment was not present on the premises during that inspection. 
APOTHEKE B. 
 
5 
She was on leave that day and was in XXX, 30 minutes away, to attend a 
hairdresser’s appointment. 
8 In the course of several telephone conversations between the authority and VP, the 
latter offered to send to the premises an employee who was not her deputy but was 
responsible for the areas of ‘personnel’, ‘marketing’ and ‘law’. That person was 
not able to provide all the documents required by the authority, with the result that 
the inspection was discontinued and then resumed on XXX in the presence of VP. 
9 The appellant maintained a business relationship with XXX in the period from 
XXX to XXX. That company provided logistics services to the appellant under a 
‘logistics contract’ that they had concluded with one another. 
10 The services included checking the authenticity of the medicinal products, 
monitoring expiry dates and batch numbers and ensuring that medicinal products 
were packaged in the appropriate product packaging. In that context, the 
appellant’s medicinal products were temporarily stored in the storage facilities of 
XXX for a few days. 
11 According to an expert assessment carried out for the referring court, all persons 
engaged in wholesale distribution must be fully trained and have constant access 
to standard operating procedures. In the event of the qualified person being absent, 
supporting documents must be made available to the inspectors to enable them to 
evaluate whether all aspects of the legal framework have been complied with. 
12 Following its inspections and after having received observations from the 
appellant, the authority, by decision of XXX (‘the decision’), revoked the 
marketing authorisation for medicinal products which was granted to the appellant 
by decision of XXX. 
13 The authority justified the revocation by citing certain failures to fulfil the 
applicable legal requirements under the AMG and the AMBO. It also stated that 
the appellant failed to comply with the regulations adopted on the basis of Section 
VI of the AMG or with the operating licence and failed to operate according to the 
principles of good distribution practice (see Paragraphs 2 and 4 of the AMBO, in 
conjunction with the GDP Guidelines). It also revoked the certificate pursuant to 
Paragraph 68(5) of the AMG. 
14 It stated that the suppliers were not qualified in accordance with the legal 
requirements and the business’ internal specifications at the time when the 
medicinal products were purchased. Moreover, medicinal products were not 
obtained exclusively from (duly licensed) medicinal product wholesalers, 
manufacturers or importers fulfilling the requirements under Paragraph 3(9) and 
(10) of the AMBO, but were also purchased from public pharmacies. 
15 The authority found that the appellant was not in a position to comply with and 
implement the requirements under Paragraph 3(9) and (10) of the AMBO and the 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-47/22 
 
6  
GDP Guidelines in its business. In the appellant’s business, there is a risk of 
potentially falsified medicinal products entering the legal supply chain. 
16 Furthermore, the appellant’s business did not have a sufficient number of 
competent and sufficiently qualified staff. The authority stated that, according to 
the provisions of the AMBO, all areas of the pharmaceutical quality assurance 
system must be adequately staffed with competent and sufficiently qualified 
personnel. The ‘qualified person’ plays a special role in that respect, and is 
required to ensure that a quality assurance system is introduced and maintained. 
The authority found that, on the basis of the failures identified and the appellant’s 
observations, it is apparent that the persons working in the business do not have 
sufficient knowledge and/or understanding of good distribution practice. 
17 The appellant brought an appeal against the decision of XXX. The appellant 
submits that the safety of the medicinal products has not been specifically 
jeopardised. With regard to staffing, the appellant argued that the AMBO provides 
for only one qualified person and that that person could not be at his or her 
workplace continuously. Although the qualified person in question was not 
present for the first inspection, she was for the second. 
18 As a result of the appeal, the Bundesverwaltungsgericht (Federal Administrative 
Court, Austria) subsequently held hearings and took evidence, the preliminary 
result of which is presented in the present order. 
Reasoning in the request for a preliminary ruling 
19 The success of the appeal turns on a decision of the Court of Justice of the 
European Union (‘the Court’) on the interpretation of the Treaties. 
20 In connection with the legal dispute described above, questions concerning the 
interpretation of Directive 2001/83 arise on which the Court has, to date, not made 
a relevant ruling. 
21 The answers to the questions referred are relevant to the resolution of the case 
because, in accordance with Article 77(6) of Directive 2001/83, a Member State 
which has granted an authorisation must suspend or revoke that authorisation if 
the conditions of authorisation cease to be met. 
Question 1(a)  
22 The appellant is a holder of distribution authorisation as provided for in 
Article 77(1) of Directive 2001/83. Marketing authorisation was granted to it in 
accordance with Paragraph 63(1) of the AMG, since it is a ‘business’ as provided 
for in Paragraph 62(1) of the AMG. 
APOTHEKE B. 
 
7 
23 In accordance with Article 80(b) of Directive 2001/83, holders of distribution 
authorisation must fulfil the requirement to 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 in accordance 
with Article 77(3). 
24 According to the facts established on a provisional basis, the appellant procured – 
and also ‘obtained’ – medicinal products from other public pharmacies, which, 
however, were not in possession of distribution authorisation or exempt from 
obtaining such authorisation. Directive 2001/83 does not define the term 
‘obtaining’ *. The referring court takes the view that it must be interpreted as 
defined in the glossary to the GDP Guidelines and as distinct from the concepts of 
‘transport’ and ‘supplying’ (see subchapter 5.2 of the GDP Guidelines, the first 
paragraphs of which refers to the requirement under Article 80(b) of Directive 
2001/83). According to that glossary, ‘procuring’ means ‘obtaining, acquiring, 
purchasing or buying’ medicinal products from manufacturers, importers or other 
wholesale distributors. A purchase or acquisition is already apparent from the 
respective delivery notes that are the subject of the proceedings. 
25 In its judgment of 28 June 2012, Caronna (C-7/11, EU:C:2012:396), the Court 
stated that Article 77(2) of Directive 2001/83/EC, as amended by Commission 
Directive 2009/120/EC of 14 September 2009, must be interpreted as meaning 
that the requirement to obtain authorisation for the wholesale distribution of 
medicinal products is applicable to a pharmacist who, as a natural person, is also 
authorised under domestic law to operate as a wholesaler in medicinal products. 
The Court also stated that a pharmacist who is also authorised under domestic law 
to operate as a wholesaler in medicinal products must satisfy all the requirements 
imposed on applicants for and holders of authorisation for the wholesale 
distribution of medicinal products in Articles 79 to 82 of Directive 2001/83, as 
amended by Directive 2009/120 (see paragraph 50 of the judgment). 
26 Under the national legislation, a wholesaler in medicinal products may obtain 
medicinal products only from a wholesaler, manufacturer or importer of medicinal 
products, in accordance with Paragraph 3(8) of the AMBO. In that respect, it must 
verify, in accordance with Paragraph 3(9) of the AMBO, whether the supplying 
wholesaler in medicinal products complies with ‘good distribution practice’ and 
 
*  Translator’s note: The German source text refers to the term ‘beschaffen’ which is used 
consistently in the German language version of Directive 2001/83. This term appears to be 
important for the questions referred. However, Directive 2001/83 contains no consistent English 
language equivalent for DE ‘beschaffen’, which is most often rendered as ‘obtain’, for example 
in Article 80(b) of Directive 2001/83, but is also rendered as ‘procure’ or ‘receive’ elsewhere in 
that directive. The German language version of the glossary in the GDP Guidelines defines the 
term ‘Beschaffung’, which is rendered in the English language version as ‘Procuring’. As noted 
above, Article 80(b) uses ‘obtain’ rather than ‘procure’. For DE ‘beschaffen’, this translation 
uses ‘obtain’ or ‘procure’ as used in the Articles of Directive 2001/83 referenced, and where 
there is no specific reference, ‘obtain’ is used. This translation uses ‘procure’ for DE ‘besorgen’ 
(which term is not used in the directive itself, nor in the GDP Guidelines). 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-47/22 
 
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also whether it is in possession of the relevant authorisation under the AMG or 
from an authority of another contracting party to the EEA. Possession of an 
authorisation must also be verified in the case of a supplying manufacturer or 
importer (see Paragraph 3(10) of the AMBO). 
27 Compliance with the AMBO is a condition for granting authorisation under the 
AMG. An infringement of the AMBO in the course of business may form the 
basis for an order suspending or even revoking the authorisation. 
28 However, the appellant also operates a pharmacy intended for the general public 
(a ‘public pharmacy’) pursuant to Paragraph 1 of the ApG. Its general partner 
holds a licence pursuant to Paragraph 9 of the ApG. Under the provisions of the 
Austrian legislation on pharmacies, pharmacy businesses may also be operated in 
the form of a partnership. 
29 The tasks of a public pharmacy in connection with the supply of medicinal 
products to the population also include the ‘occasional supply’ of medicinal 
products to other pharmacies, by virtue of the express provision laid down in 
Paragraph 1(2) of the ABO – which was adopted in implementation of the ApG. 
30  In accordance with Paragraph 62(1) of the AMG, ‘public pharmacies’ are not 
considered to be ‘businesses’ within the meaning of that provision where they 
place medicinal products on the market ‘as part of the normal operation of the 
pharmacy’ in accordance with the ABO. However, the first sentence of 
Paragraph 62(2a) of the AMG stipulates that, where public pharmacies ‘supply’ 
medicinal products to other public pharmacies – a form of ‘placing on the 
market’ – in a manner going beyond the normal operation of the pharmacy, they 
require authorisation to that effect pursuant to Paragraph 63(1) of the AMG. 
31 The referring court takes the view that the provision of Article 80(b) of Directive 
2001/83 must be interpreted as meaning that persons who are in possession of a 
distribution authorisation under that directive may procure medicinal products 
exclusively from persons who are in possession of the distribution authorisation or 
who are exempt from the obligation to obtain such authorisation, failing which 
they no longer fulfil the requirement laid down in Article 80(b) of that directive, 
as a result of having obtained them from other persons. However, this also applies 
if that person is also otherwise authorised to supply medicinal products to the 
public (at retail level) and – in accordance with the national rules outlined above – 
obtains medicinal products from other public pharmacies which are not, however, 
in possession of a distribution authorisation or exempt from the obligation to 
obtain such authorisation. 
32 Nevertheless, the Federal Administrative Court has doubts as to whether that 
interpretation is correct, for the reasons set out below. There does not appear to be 
any case-law of the Court relating specifically to Question 1(a), even if its 
judgment referred to above is taken into account. Nor is there any relevant 
national case-law. 
APOTHEKE B. 
 
9 
33 The appellant submits, in essence, that Article 80(b) must be interpreted as not 
precluding supply via a public pharmacy as an ‘intermediate carrier’ (or 
‘intermediate supplier’). The appellant argues, referring in particular to recitals 2 
and 3 of Directive 2001/83, that this applies as long as it can be ensured, in respect 
of each individual medicinal product (at the level of each individual package), that 
the product in question comes from a wholesaler or manufacturer of medicinal 
products which is authorised to supply it, and, in respect of each partial step, all 
provisions guaranteeing the protection and usability of the medicinal product are 
complied with. According to the appellant, such pharmacies assume transport and 
logistics functions, and the quantities of medicinal products involved are 
extremely small. It claims that the same level of hygiene and protection is 
provided as in the case where a (pure and simple) transport company is used. The 
only difference is that the public pharmacy (from which products are obtained) 
continues to place orders independently. The appellant submits that Articles 28 to 
37 TFEU preclude the exclusion of pharmacies from supply chains (including in 
the form of ‘intermediate carriers’). It takes the view that no restrictions on trade 
and supply chains can be derived from Article 80(b) of the directive, as also 
follows from the preparatory work relating to Commission Directive 2001/62/EC 
of 9 August 2001 amending Directive 90/128/EEC relating to plastic materials 
and articles intended to come into contact with foodstuffs (OJ 2001 L 221, p. 18). 
34 However, taking into account the preparatory work which is relevant in the 
present case, together with the associated documents, opinions, recitals, etc – 
which include , on the one hand, Council Directive 92/25/EEC of 31 March 1992 
on the wholesale distribution of medicinal products for human use (OJ 1992 
L 113, p. 1), Directive 2001/83, together with recitals 2, 3 and 35 thereof, and 
Directive 2001/62 and , on the other hand, the preparatory materials relating to the 
above directives, Articles 114 and 168(4) TFEU, relating to the level of human 
health protection to be guaranteed in achieving harmonisation, and the principle of 
proportionality enshrined in Article 5 TEU – the referring court is unable to share 
the appellant’s view on the interpretation of the requirement under Article 80(b) of 
Directive 2001/83. 
35 Through subparagraphs 2 and 3, which were added to Article 80 of Directive 
2001/83, additional protective measures for the distribution chain were also taken 
in the internal market, with the result that the holder of a distribution authorisation 
obtaining supplies must (now additionally) verify whether the supplying 
wholesaler, manufacturer or importer holds a distribution or manufacturing 
licence. 
36 If it is assumed, as the referring court does, that the concepts of 
‘obtaining’/‘procuring’ and ‘supplying’ are to be understood as defined in the 
glossary ** in the annex to the GDP Guidelines, the appellant’s transactions with 
other public pharmacies in relation to medicinal products in the main proceedings 
 
**  As noted above, ‘Beschaffung’ is rendered in the GDP Guidelines as ‘Procuring’, despite 
Article 80(b) using ‘obtain’ for ‘beschaffen’ rather than ‘procure’. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-47/22 
 
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constitute ‘obtaining’‘ from the point of view of the appellant and ‘supplying’ 
from the point of view of the respective pharmacies (that is to say, those other 
pharmacies are to be regarded as ‘suppliers’). They would in any event be mere 
‘carriers’ only if the transactions were not to be categorised as ‘obtaining’ or 
‘supplying’. 
37 However, the interpretation considered to be correct by the referring court might 
be regarded as being contrary to the principle of proportionality because, despite 
the objective of ensuring a high level of environmental protection, it would entail 
an excessive restriction of the supply chain. 
Question 1(b)  
38 The appellant purchased medicinal products from persons who, although 
authorised or entitled to supply medicinal products to the public, were not 
themselves in possession of a distribution authorisation, and the appellant (re)sold 
the medicinal products thus obtained to persons who were themselves in 
possession of a distribution authorisation. 
39 In view of the wording of Article 80(b) of Directive 2001/83, the referring court 
proceeds on the assumption that, in the case of a person who holds a distribution 
authorisation, compliance with the requirement under that provision does not 
depend on to whom the medicinal products obtained are supplied (or whether they 
in fact merely enter the retail [pharmacy] business) of the person obtaining them). 
40 It is precisely the objective of ensuring a high level of human health protection 
pursued by the requirements of Article 80 of Directive 2001/83 which precludes 
an interpretation according to which a person who (also) holds authorisation for 
the wholesale distribution of medicinal products may also obtain medicinal 
products from other pharmacies which themselves neither hold such authorisation 
nor are to be regarded as manufacturers, as long as only the medicinal products 
obtained in that manner are not supplied to other holders of wholesale distribution 
authorisations. Accordingly, it is precisely the special requirements for 
wholesalers – including, in particular, compliance with the principles and 
guidelines of good distribution practices – which should be extensively applied in 
the supply chain. 
41 However, that interpretation might also contradict the principle of proportionality 
belonging to the legal order of the European Union. 
Questions 2(a) and 2(b)  
42 According to Article 79 of Directive 2001/83, in order to obtain the distribution 
authorisation, applicants 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. They must undertake to comply with the 
obligations incumbent on them under the terms of Article 80 of that directive, 
APOTHEKE B. 
 
11 
which include compliance with the GDP Guidelines published by the European 
Commission in accordance with the procedure laid down in Article 84 of 
Directive 2001/83. 
43 Chapter 2 of the GDP Guidelines concerns the staffing of wholesale 
establishments with suitable personnel. Subchapter 2.1 of the GDP Guidelines 
states, as a principle, that the correct distribution of medicinal products relies upon 
people, and there must be sufficient trained personnel to carry out all the tasks for 
which the wholesale distributor is responsible. As a concrete guideline, subchapter 
2.2 of the GDP Guidelines states that the responsible person should fulfil their 
responsibilities personally and should be continuously contactable, which also 
includes duties relating to a fully documented quality system. 
44 According to subchapter 2.3 of the GDP Guidelines, there should be an adequate 
number of competent personnel involved in all stages of the wholesale distribution 
activities of medicinal products. In accordance with subchapter 4.2 of the GDP 
Guidelines, documentation comprises all written procedures or instructions, in 
paper or in electronic form. In addition, the documentation should also be readily 
available/retrievable, and each employee should have ready access to all 
documentation necessary for his or her duties. 
45 In the present case, the staff who were present at the establishment were not able 
to produce the requested documents during the first inspection. As regards the 
details in that respect, reference is made to the above findings of fact. On the basis 
of those circumstances, the authority took the view that the appellant’s staffing 
was not sufficient. 
46 The referring court takes the view that Question 2(a) must be answered to the 
effect that the requirements of Articles 79(b) and 80(g) of the directive, in 
conjunction with the GDP Guidelines, continue to be met even where the 
responsible person is absent for a period of time, as was the case in the main 
proceedings, and even where that absence lasts for a period of approximately four 
hours. This is the case, in particular, where it is ensured that the responsible 
person can be reached by telephone at any time. 
47 With regard to the answer to Question 2(b), the referring court takes the view that 
Articles 79(b) and 80(g) of Directive 2001/83, in conjunction with the GDP 
Guidelines, must be interpreted as meaning that the requirements deriving from 
those provisions, in particular the adequate provision of competent staff, are no 
longer fulfilled where the (‘other’) staff present during day-to-day operations are 
not able to provide access, at all times, to the standard operating procedures which 
are applicable to them and have been established for them on the basis of their 
responsibilities. That is not altered by the fact that the responsible person can be 
reached by telephone. Conversely, however, the rules are complied with by virtue 
of the availability of the responsible person by telephone where, as in the case in 
the main proceedings, the staff present at the premises are not responsible for the 
area in respect of which the standard operating procedures are to be provided. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-47/22 
 
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48 Nevertheless, the referring court continues to have doubts as to whether that 
interpretation is correct in the light of the facts established (see, regarding the 
assessment of the application to the facts of the present case, judgment of the 
Court of 8 November 2016, Lesoochranárske zoskupenie VLK, C-243/15, 
EU:C:2016:838, paragraph 64). In accordance with subchapter 2.2 of the GDP 
Guidelines, the responsible person should fulfil their responsibilities personally 
and should be continuously contactable, and may delegate duties but not 
responsibilities. 
Question 2(c)  
49 There should be an adequate number of competent personnel involved in all stages 
of the wholesale distribution activities of medicinal products. In accordance with 
the second sentence of the first paragraph of subchapter 2.3 of the GDP 
Guidelines, the number of personnel required will depend on the volume and 
scope of activities. The GDP Guidelines also contain guidelines and a principle on 
outsourced activities (see, inter alia, Chapter 7 of the GDP Guidelines). 
50 In the absence of further rules in the EU legal order on the determination of the 
required number of employees (and also the determination of whether that number 
is adequate and the employees are competent), the principle of procedural 
autonomy of the Member States must be observed. Accordingly, they must 
determine the respective procedural arrangements in such a manner that (at the 
least) they are not less favourable than those governing similar domestic situations 
and do not render impossible in practice or excessively difficult the exercise of 
rights conferred by the EU legal order (see, inter alia, judgment of the Court of 
7 November 2019, Flausch and Others, C-280/18, EU:C:2019:928, paragraph 27). 
Those arrangements also include arrangements of the competent authority (and, 
above all, of a court subsequently before which an appeal against a decision of 
that authority is brought) for the ways in which evidence is to be elicited, what 
evidence is to be admissible, or the principles governing the assessment of the 
probative value of evidence adduced and also the level of proof required (see 
judgment of the Court of 21 June 2017, W and Others, C-621/15, EU:C:2017:484, 
paragraph 25). 
51 The referring court proceeds on the assumption that, in determining the number of 
employees required in wholesale distribution activities, account can (or must) also 
be taken of whether, and if so to what extent, the holder of distribution 
authorisation outsources activities to a third party. When assessing the required 
number of employees, a report from a suitable expert can or must be obtained, 
where necessary. 
52 However, the referring court continues to have doubts as to whether what it 
considers to be the appropriate answer to Question 2(c) is also correct with regard 
to the facts established in the main proceedings. 
APOTHEKE B. 
 
13 
Question 3 
53 According to Article 77(6) of Directive 2001/83, the Member State which granted 
the authorisation referred to in paragraph 1 of that provision is to suspend or 
revoke that authorisation if the conditions of authorisation cease to be met. 
54 The minimum requirements to be fulfilled in order for a Member State to grant an 
authorisation for the wholesale distribution of medicinal products are set out in 
Article 79(a) to (c) of Directive 2001/83. They include, in particular, the 
obligations set out in Article 80 of the directive, which in turn include, for 
example, the requirement that wholesalers in medicinal products 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) of Directive 2001/83 (as 
provided for in Article 80(b)). 
55 It is unclear in which cases authorisation must merely be suspended and when it 
must (even) be revoked. 
56 Austrian law provides, in the first sentence of Paragraph 66a of the AMG, that the 
authorisation granted is to be revoked if the requirements are no longer met. 
According to the second sentence of that provision, instead of revocation, the total 
or partial suspension of the authorisation may also be ordered where the holder of 
the operating authorisation may be able to eliminate the reason for the revocation 
within a reasonable period of time. In accordance with the preparatory work, the 
decision as to whether to order revocation or suspension is left to the discretion of 
the authority. There does not appear to be any national case-law on that provision. 
57 In the main proceedings, the authority took the view – in connection with the 
obligation under Article 80(c) and the second paragraph of Article 80of the 
directive – that the extent to which the holder of the authorisation has an 
understanding of the necessity and importance of compliance with the legal 
requirements, in particular in relation to the supply chain as a whole and to full 
documentation of such compliance, must also be taken into account in assessing 
whether a distribution authorisation may be revoked. According to the authority, if 
an authorisation holder ceases to be non-compliant only after repeated instances of 
non-compliance, it must be concluded that it is not capable of complying with its 
legal obligations. 
58 Against that background, the referring court proceeds on the assumption that the 
authorisation must be revoked only if, at the time of the decision, there are 
indications in the individual case that compliance with all the obligations and 
requirements under Article 80 of the directive continues not to be expected. Such 
indications may arise from the nature and duration of the infringement of such an 
obligation, or from the fact of whether the authorisation holder has taken 
appropriate measures at the time of the decision by a competent authority. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-47/22 
 
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59 The referring court also proceeds on the assumption that the nature and gravity of 
the infringement determines whether the authority will decide to suspend the 
authorisation instead of revoking it. Furthermore, the competent authority must 
observe the principle of proportionality when taking such action, that is to say, 
revocation is lawful only if it is appropriate and necessary in order to achieve the 
objectives legitimately pursued by the legislation. When there is a choice between 
several measures, recourse must be had to the least onerous. 
60 The referring court continues to have doubts also as regards whether that 
interpretation of the directive is correct in the light of the facts established.