Judgment;Summary — ECLI:EU:C:2023:50
Date: 2023-01-26
Language of the case: Spanish
Court formation: Seventh Chamber
Subject matter: Agriculture and Fisheries
Procedure: Reference for a preliminary ruling
Origin: Spain

Translation C-469/21 – 1 
Case C-469/21 
Request for a preliminary ruling 
Date lodged: 
29 July 2021 
Referring court: 
Tribunal Supremo (Spain) 
Date of the decision to refer: 
12 July 2021 
Applicant: 
Consejo General de Colegios Oficiales de Farmacéuticos de España 
Defendant: 
Administración General del Estado 
  
[…] [Domestic procedural issues] 
TRIBUNAL SUPREMO (Supreme Court, Spain) 
Sala de lo Contencioso-Administrativo (Chamber for Contentious 
Administrative Proceedings) 
[…] 
Order No / 
[…] [Composition of the court] 
Madrid, 12 July 2021. 
[…] [Reporting judge] 
FACTS 
FIRST.― […] administrative action […] [domestic procedural issues] against 
Real Decreto 717/2019, de 5 de diciembre, por el que se modifica el Real Decreto 
1345/2007, de 11 de octubre, por el que se regula el procedimiento de 
EN 
REQUEST FOR A PRELIMINARY RULING OF 12. 7. 2021 – CASE C-469/21 
 
2  
autorización, registro y condiciones de dispensación de los medicamentos de uso 
humano fabricados industrialmente (Royal Decree 717/2019 of 5 December 2019 
amending Royal Decree 1345/2007 of 11 October 2007 governing the procedure 
for authorisation, registration and conditions for the supply of medicinal products 
for human use manufactured industrially […] 
SECOND.― […] [Procedural formalities] 
LAW 
FIRST.- The Consejo General de Colegios Oficiales de Farmacéuticos (General 
Council of Official Colleges of Pharmacists, Spain) has lodged an administrative 
action against four provisions (Articles 84 to 86 and the sixth additional provision) 
of Royal Decree 717/2019. The latter amended Royal Decree 1345/2007 – which 
governs the procedure for authorisation, registration and conditions for the supply 
of medicinal products for human use manufactured industrially – to bring it into 
line with the EU legislation in this field. 
In so far as is important for these specific purposes, the legislative framework 
within which that direct challenge to a number of Spanish regulatory provisions 
has been brought is as follows. In regulating the distribution and supply of 
medicinal products, Directive 2001/83/EC, as partially amended by Directive 
2011/62/EU, lays down in Article 54a the duty to conduct verification procedures, 
referring for the purposes of the applicable rules to the provisions of a delegated 
regulation. Detailed rules governing those verification procedures were therefore 
adopted by means of Delegated Regulation (EU) 2016/61. Articles 31 to 35 
thereof lay down a number of rules: A) Actors in the medicinal products supply 
chain (manufacturers, distributors and pharmacies) are tasked with handling the 
verification procedures. B) The tool for storing all information about the supply of 
medicinal products is the ‘repository’, the existence of which is mandatory. There 
cannot be more than one repository in each Member State, although a number of 
States are permitted to share the same repository. C) The Member States’ 
repositories must be connected using a hub, such that they can function as a single 
system. That was achieved by the creation of the European Medicines Verification 
Organisation, a non-profit legal person governed by Belgian law. D) In addition 
to the repository, every Member State also has a number of ‘nodes’. Nodes are the 
management tools for carrying out verification. Verifiers use nodes to upload to 
the repository information regarding medicines supplied. 
The Spanish repository was set up on 21 July 2016 as a result of the creation of 
the legal person Sistema Español de Verificación de Medicamentos, S.L. The 
Consejo General de Colegios Oficiales de Farmacéuticos, applicant in this 
administrative action, is one of the shareholders. At the outset, the shareholders 
agreed that the Consejo General de Colegios Oficiales de Farmacéuticos would 
manage one node integrated into the repository. That node is called Nodofarma 
Verificación. 
CGCOF 
 
3 
That is the context in which Royal Decree 717/2019 takes effect, providing as it 
does for the existence of a new node under the responsibility of the Health 
Ministry, called Nodo SNSFarma. In accordance with Articles 84 to 86 and the 
sixth additional provision of Royal Decree 717/2019, which are the provisions 
contested in this administrative action, Nodo SNSFarma must be used by 
pharmacies when they dispense medicinal products financed by the National 
Health System. Those provisions also stipulate that Nodo SNSFarma is to be 
integrated into the national repository through the conclusion of an agreement 
between the Health Ministry and Sistema Español de Verificación de 
Medicamentos, S. L., and, in the event that no agreement is reached between the 
two parties, that integration is to take place by ministerial order. 
SECOND.- The Consejo General de Colegios Oficiales de Farmacéuticos bases 
its action challenging Articles 84 to 86 and the sixth additional provision of Royal 
Decree 717/2019 on four grounds. 
1. The applicant states that the contested provisions infringe Articles 31(1), 31(3), 
35(1)(b) and 44(5) of Delegated Regulation (EU) 2016/161. Article 44(5) 
provides that national authorities may contribute to the management of the 
repository and participate in the management board of the entity managing the 
repository, provided that their representation does not exceed one third. However, 
Articles 31(1), 31(3) and 35(1)(b) provide that the repository is to be set up and 
managed by manufacturers and marketing authorisation holders of medicinal 
products through a non-profit entity. In that connection, the applicant suggests, 
albeit in a way which is not totally clear, that the creation of a new node by the 
State Administration, together with the obligation imposed on pharmacies to use 
that node when dispensing medicinal products under the National Health System, 
goes beyond what is permitted in that regard by Article 44(5) of Delegated 
Regulation (EU) 2016/161. 
2. The applicant states that the contested provisions infringe Articles 25(3) and 
32(2) of Delegated Regulation (EU) 2016/161. In accordance with those articles, 
pharmacies must connect to the repositories system to carry out the verification 
procedures that are required of them when they supply medicinal products. Nodo 
SNSFarma does not satisfy that requirement since it is not legally integrated into 
the national repository managed by Sistema Español de Verificación de 
Medicamentos, S. L., and nor is it functionally integrated into that repository. Also 
in that regard, the applicant adds that the stipulation to the effect that integration 
can be decided on by ministerial order, in the event that no agreement is reached 
between Sistema Español de Verificación de Medicamentos, S. L. and the Health 
Ministry, breaches the abovementioned rule to the effect that management of the 
repository is the responsibility of manufacturers and marketing authorisation 
holders of medicinal products. 
3. The applicant states that the contested provisions infringe Articles 35(1)(g), 36 
and 44(1) of Delegated Regulation (EU) 2016/161. In accordance with those 
articles, there must be a complete record or ‘audit trail’ of all operations 
REQUEST FOR A PRELIMINARY RULING OF 12. 7. 2021 – CASE C-469/21 
 
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concerning each identifier, so that it is possible to track all medicinal products 
supplied. In the applicant’s submission, that is made difficult – if not impossible – 
by the imposition on pharmacies of the obligation to use Nodo SNSFarma when 
they dispense medicinal products under the National Health System; that is 
because the existence of two nodes in the same repository could lead to repetitions 
or omissions, which would harm the audit trail referred to. 
4. The applicant states that the contested provisions infringe Article 25(3) of 
Delegated Regulation (EU) 2016/161, and the principle of proportionality. As 
pointed out above, Article 25(3) provides that verification procedures must be 
carried out by connecting to the repositories system. However, the existence of 
two nodes, together with the obligation to use the node managed by the Health 
Ministry for certain operations, imposes an unnecessary complication on the 
running of pharmacies which have to date been able to carry out their tasks using 
a single node: the so-called Nodofarma Verificación, managed by the applicant, 
which was appointed by Sistema Español de Verificación de Medicamentos, S. L., 
the entity managing the national repository. The applicant further argues that the 
introduction of a new publicly owned node by Royal Decree 717/2019 happened 
more than two years after the period for transposition of Directive 2011/62/EU 
ended, without any difficulties having arisen in the meantime in relation to 
performance of the required verification operations. 
THIRD.- The Abogado del Estado (Counsel for the State), as defendant, argues 
that the contested provisions do not create new repository but rather only a new 
node for accessing the repository. This means, in his view, that Royal Decree 
717/2019 does not breach the principle that a single repository must exist in each 
Member State, as stipulated by Delegated Regulation (EU) 2016/161. 
The Abogado del Estado points out that Delegated Regulation (EU) 2016/161, 
particularly Article 44 thereof, grants national authorities supervisory powers in 
relation to the operation of the repository, including the right – mentioned above – 
to contribute to the management of the repository and also to participate in the 
management board of the entity managing the repository. 
Lastly, the Abogado del Estado stresses that the creation of a publicly owned 
node, like Nodo SNSFarma, is necessary for the proper operation of the National 
Health System. Given that the National Health System finances around 80% of the 
medicinal products supplied in Spain, it is, in the Abogado del Estado’s 
submission, necessary that there is a node which enables verification procedures 
to be performed at the same time as other procedures designed to account for 
pharmaceutical expenditure and facilitate reimbursements. It appears to follow 
from the Abogado del Estado’s line of argument as a whole that the principal 
reason for the creation of a new publicly owned node is to make it easier for the 
National Health Service to carry out its task, when acting as the administrative 
authority responsible for the funding of medicinal products. 
CGCOF 
 
5 
FOURTH.- This Chamber has certain questions concerning the compatibility of 
the contested provisions with Delegated Regulation (EU) 2016/61. In order to 
frame those questions properly, it is helpful to make a number of observations. 
First, as stated, the applicant’s line of argument is somewhat ambiguous or lacking 
in clarity: on occasions, it suggests that Royal Decree 717/2019 created a new 
repository, thereby breaching the rule that each Member State may have only one 
repository. Clearly, that is not the case: what Royal Decree 717/2019 does is to 
introduce a second node, this time under public ownership, which must be 
integrated into the national repository. And, in any event, the national repository 
continues to be managed by Sistema Español de Verificación de Medicamentos, 
S.L. 
Second, a reading of Delegated Regulation (EU) 2016/61 as a whole leads this 
Chamber to the view that the system it creates for verification procedures relating 
to medicinal products is based on a principle of self-administration by the actors 
involved in the medicinal product supply chain: manufacturers, distributors and 
pharmacies. That appears to exclude the possibility that the Public Administration 
would take on a major role in that area by directly managing the repository and its 
tools. It is true that a number of the provisions of Delegated Regulation (EU) 
2016/61, particularly Article 44 thereof, grant supervisory powers to the national 
authorities, to the extent that they even allow those authorities – within certain 
limits – to participate in the management body of the repository. However, that 
does not necessarily mean that those national authorities can create a node as a 
repository tool, let alone require the use of that node in certain situations. It should 
be recalled that, according to the information furnished by the Abogado del 
Estado, obligatory use of the new publicly owned node affects approximately 80% 
of all operations. 
Third, and closely connected with the above, there is a provision of Delegated 
Regulation (EU) 2016/61 which could be relevant to this case and which the 
parties have cited. That provision is Article 39, pursuant to which the entity 
managing the repository must permit the competent national authority to access 
the information contained in the repository for, inter alia, the purpose of 
reimbursement. It could be inferred from this that the objective pursued by Royal 
Decree 717/2019 in introducing a publicly owned node and the mandatory use of 
that node in connection with the supply of medicinal products financed by the 
National Health System could or should be achieved by other means. 
Fourth and lastly, even if it is found that Delegated Regulation (EU) 2016/61 does 
not preclude the creation of a second node by the national authorities, it is unlikely 
that, in the absence of an agreement with the entity managing the repository, that 
node can be integrated into the repository by a unilateral and authoritative act of 
the Administration. In this Chamber’s view, that is difficult to reconcile with the 
principle, referred to above, of self-administration of the repository by the actors 
involved. 
REQUEST FOR A PRELIMINARY RULING OF 12. 7. 2021 – CASE C-469/21 
 
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In the light of the foregoing considerations, there are essentially three questions 
concerning the compatibility of the contested provisions with Delegated 
Regulation (EU) 2016/61: A) Whether the national authority can set up a publicly 
owned and managed node. B) Whether the national authority can stipulate that 
pharmacies must use that node when supplying medicinal products financed by 
the National Health System. C) Whether, in the event that no agreement is reached 
between the State Administration and the entity managing the repository with a 
view to integrating that node into the repository, integration may be required 
unilaterally and authoritatively by ministerial order. 
On those grounds, 
THE CHAMBER DECIDES: 
FIRST.- To refer the following questions to the Court of Justice of the European 
Union for a preliminary ruling: 
1. Is a national provision that creates a node (as a tool for use with the repository), 
which is owned and managed by the State Administration, compatible with 
Delegated Regulation (EU) 2016/[1]61, in particular Articles 25, 31, 32, 35, 36 
and 44 thereof? 
2. If the answer to the previous question is in the affirmative, is a national 
provision that requires pharmacies to use that node when they supply medicinal 
products financed by the National Health System compatible with Delegated 
Regulation (EU) 2016/[1]61, in particular Articles 25, 31, 32, 35, 36 and 44 
thereof? 
3. If the answer to the previous question is in the affirmative, is a national 
provision that provides that, where no agreement is reached between the State 
Administration and the entity managing the national repository in relation to 
integrating the node concerned into the repository, integration may be required, 
unilaterally and authoritatively, by ministerial order compatible with Delegated 
Regulation (EU) 2016/[1]61, in particular Articles 25, 31, 32, 35, 36 and 44 
thereof? 
[…] [Repetition of domestic procedural issues, closing standard wording and 
signature of reporting judge]