The referring court refers to several persons, namely, at the level of the Land, the Minister-President and the Minister for the Environment and <mask>, and at the level of the administrative region of Upper Bavaria, the President and Vice-President of the government. It adds that, as a precaution, it would be appropriate to extend the measure to include managerial staff of the Land and the administrative region of Upper Bavaria, as the responsible organs of the Land have parliamentary immunity and this, unless it was withdrawn, would defeat a committal order.


In addition, in the judgment of 24 March 2011, Commission v Spain (C‑400/08, EU:C:2011:172, paragraphs 110 and 111), the Court held, in the context of the assessment of a potential justification of an infringement of the freedom of establishment by the national legislation at issue, that the establishment of a committee comprising, inter alia, representatives of the trade sector, responsible for drawing up a report before any decision on the issuing or refusal of a permit was taken, was not such as to achieve the objectives relating to town and country planning, environmental protection or <mask>. The only sectoral interest represented in that committee was that of the existing local trade and, therefore, potential competitors of the applicant for a commercial operating permit.


See the successive versions of Paragraph 165a of the VersVG cited in points 8 and 9 above. Paragraph 165a of the VersVG was repealed on 31 December 2018 by the Gesetz zur Änderung des Versicherungsvertragsgesetzes, des Konsumentenschutzgesetzes und des Versicherungsaufsichtsgesetzes 2018 (Law amending the Law on insurance contracts, the Law on <mask> and the Law on insurance supervision 2018; BGBl. I No 51/2018). Since 1 January 2019, Paragraph 5c(4) of the VersVG now provides that cancellation is to be declared ‘in written form’.


142. If that is so, it must be recalled that the purpose of Directive 1999/44 is, as recital 1 thereof states, to ensure a high level of <mask>. In particular, Article 2(1) of that directive obliges the seller to deliver goods to the consumer which are in conformity with the contract of sale. (74) Recital 8 of the directive explains that, in order to facilitate the application of the principle of conformity with the contract, it is useful to introduce a rebuttable presumption of conformity with the contract covering the most common situations, and that, in the absence of specific contractual terms, as well as where the minimum protection clause is applied, the elements mentioned in that presumption may be used to determine the lack of conformity of the goods with the contract.


As regards the new part of the reasons contained in the 2020 maintaining acts, it is apparent from the articles from the websites ‘Eqtsad News’ and ‘Aliqtisadi’ taken from document WK 3600/2020 REV 1, that the applicant is, respectively, a founding member and a member of the board of Assas lil-Hadid. In that regard, it should be noted that, as the applicant submits, the summaries of the articles from those websites produced by the Council indicate the name ‘Asas Iron Company’ instead of ‘Assas lil-Hadid’. It is, however, the same company. The first name is the English translation of the second name, which corresponds to the entity’s Arabic name. Asas Iron Company’s articles of association, ratified by the representative of its founders and by the Syrian Ministry of Internal Trade and <mask>, as well as its registration certificate of 6 November 2019, produced by the applicant, confirm that the two names correspond.


Regarding the context, since Article 4(2) of Directive 93/13 lays down exceptions to the assessment of unfair terms, such as that provided for in the system of <mask> put in place by that directive, that provision must be strictly interpreted.   Since the wording of Article 4(2) draws no distinction as to whether the price or the remuneration for the service in question was expressed as either a fixed charge or interest, such an interpretation would not justify the exclusion of contractual clauses providing for the payment of charges other than interest from the scope of that provision.


Only when the legislation on food labelling was simplified and codified in a single instrument, namely Regulation No 1169/2011,   did the EU legislature assert that that legislation ‘both serve[d] the interests of the internal market by simplifying the law, ensuring legal certainty and reducing administrative burden, and benefit[ed] citizens by requiring clear, comprehensible and legible labelling of foods’.   The subject matter of that regulation was defined as, inter alia, the provision of ‘the basis for the assurance of a high level of <mask> in relation to food information …’ and the establishment of ‘the means to guarantee the right of consumers to information and procedures for the provision of food information’.   In that context, Article 3(1) of the regulation states that one of the ‘general objectives’ of the legislation is to ensure ‘a high level of protection of consumers’ health and interests by providing a basis for final consumers to make informed choices and to make safe use of food, with particular regard to health, economic, environmental, social and ethical considerations’.


It will therefore be for the national court to ascertain whether there are overriding reasons relating to the public interest justifying the authorisation scheme for taxi dispatching services. I would only point out that that scheme concerns an intermediation service on a market which is already subject to an authorisation scheme, namely that for the provision of taxi transport services.   It therefore appears that, for example, the public interest in <mask> is already satisfied. Thus, the task of the national court will be to ascertain what other overriding reasons are capable of justifying that additional authorisation scheme.


76 As the Advocate General observed in point 76 of his Opinion, the preventive function of actions brought by <mask> associations, such as the Federal Union, could not be guaranteed if the representative action provided for in Article 80(2) of the GDPR allowed only the infringement of the rights of a person individually and specifically affected by that infringement to be invoked.


46 First, such information is, as regards <mask>, necessary for consumers not to be misled by unclear, ambiguous or incomplete information on the various guarantees which exist and their relationship, and to ensure, in particular, that they are able to understand that the manufacturer’s commercial guarantee does not originate from the trader and whether it may, where appropriate, be exercised through the trader. Secondly, such an information requirement cannot be regarded as constituting a disproportionate burden for the trader, since the trader itself decides, in full knowledge of the facts, to draw the consumer’s attention to the guarantee and intends to derive a competitive advantage from it.


63. However, the conclusion must be different if national time bars or limitation periods lead to an asymmetry of the possibilities for bringing an action, that is to say if a creditor can assert his payment claims for longer than the consumer can assert the invalidity of the contract. Thus, a court must examine the unfairness of a term of its own motion despite the expiry of the time limit, as otherwise the seller or supplier may circumvent the <mask> intended by the Unfair Contract Terms Directive by simply waiting for the time limit to expire before bringing an action to enforce his unfair terms. (45)


Paragraph 106(2) of the Electricity Market Law provides that the Energiavirasto is responsible for monitoring compliance with that law and the legal and administrative provisions issued on the basis thereof, as well as compliance with the approval decisions issued on the basis of that law. Under that provision, supervision is regulated separately in the Supervision Law. Pursuant to Paragraph 106(4) of the Electricity Market Law, the Kuluttaja-asiamies (Consumer Ombudsman, Finland) monitors the legality of clauses of the contracts referred to in Chapter 13 of the Electricity Market Law (electricity contracts) from the perspective of <mask>.


By its fourth question, the referring court asks, in essence, whether Article 3 and Article 8 of Directive 93/13, read in conjunction with Article 6 and Article 7 of that directive, must be interpreted as meaning that, in the context of the examination of its own motion of the possible unfairness of the terms in a contract concluded between a seller or supplier and a consumer, which the national court carries out in order to determine whether there is a significant imbalance in the parties’ obligations under that contract, that court may also take into account national provisions ensuring a higher level of <mask> than that provided for by that directive.


The referring court considers that it is possible to adopt an interpretation which makes it possible to balance the principle of a high level of <mask> and the principle of legal certainty. In its view, the date on which the contract at issue comes to an end, that is to say, when the consumer is released from any obligation vis-à-vis the seller or supplier and should therefore no longer be regarded as being in a weak position vis-à-vis that seller or supplier, is a date, determined objectively, on which the consumer must or should have been aware of the unfairness of the term or terms of that contract and from which the three-year limitation period to bring an action of a pecuniary nature, including an action for reimbursement, starts to run.


Under point 13 of the first subparagraph of Paragraph 6 of the Supervision Law, the Energiavirasto has the task of contributing, in its activity as the national regulatory authority within the meaning of the EU legal provisions concerning the electricity and natural gas sectors, to ensuring efficiency and enforcement of <mask> measures concerning the electricity and natural gas markets.


Zürich, on the other hand, takes the view that, in the present case, the policy holder was correctly informed of its right of cancellation and that merely citing a requirement for that right to be exercised in writing – which, moreover, is beneficial to the policy holder itself and serves the principle of legal certainty – does not make the information incorrect. In any event, where the policy holder is a trader, the cancellation period expires entirely irrespective of whether information has been provided in that respect. The spirit and purpose of the right of cancellation provided for by EU law relate only to <mask>.


The ACPR, the French and Polish Governments and the EBA take the opposite view. According to the ACPR, the French Government and the EBA, the EBA is entitled to adopt guidelines beyond the strict scope of the legislative acts referred to in Article 1(2) of Regulation No 1093/2010 because Article 1(3) thereof extends the EBA’s powers to issues not covered by those acts. In any case, product governance and corporate governance are interrelated so that the contested guidelines cannot be considered to be outside the scope of the EBA’s competence. According to the same intervening parties, as well as the Polish Government, the EBA’s action is also lawful because Regulation No 1093/2010 expressly aims to provide <mask>. The EBA had the power to adopt the contested guidelines in as much as they serve that objective. Thus, according to the ACPR and the EBA, there should simply be a general assessment of the EBA’s power to adopt guidelines. Such a general assessment would lead to the conclusion that the EBA had the power to issue the contested guidelines.


Lastly, in order to guarantee extensive <mask>, in Article 3(g) of that directive the EU legislature broadly defines the ‘total cost of the credit to the consumer’ as covering all the costs, including interest, commissions, taxes and any other kind of fees which the consumer is required to pay in connection with the credit agreement and which are known to the creditor, except for notarial costs (judgment of 26 March 2020, Mikrokasa and Revenue Niestandaryzowany Sekurytyzacyjny Fundusz Inwestycyjny Zamknięty, C‑779/18, EU:C:2020:236, paragraph 39 and the case-law cited).


On the other hand, according to the settled case-law of the Court, the right to property, which is guaranteed by Article 17 of the Charter, is not an absolute right, but must be considered in relation to its function in society (see, to that effect, judgment of 10 July 2003, Booker Aquaculture and Hydro Seafood, C‑20/00 and C‑64/00, EU:C:2003:397, paragraph 68). In the context of the case in the main proceedings, the right to property must be reconciled with Article 38 of the Charter, which, like Article 168(4)(b) TFEU, seeks to ensure a high level of <mask> in EU policies, including the protection of public health.


47 In that regard, the Court has held that, in the absence of specific EU legislation in this area, the rules implementing <mask>, provided for in Article 6(1) and Article 7(1) of Directive 93/13, are a matter for the domestic legal order of the Member States, in accordance with the principle of the procedural autonomy of the latter. However, those rules must not be less favourable than those governing similar domestic actions (principle of equivalence) nor may they be framed in such a way as to make it in practice impossible or excessively difficult to exercise the rights conferred by EU law (principle of effectiveness). It follows that the award of the costs of judicial proceedings before the national courts falls within the procedural autonomy of the Member States, subject to compliance with the principles of equivalence and effectiveness (see judgment of 16 July 2020, Caixabank and Banco Bilbao Vizcaya Argentaria, C‑224/19 and C‑259/19, EU:C:2020:578, paragraphs 83 and 95 and the case-law cited).


33 Moreover, the Court has recognised that <mask> is not absolute. In particular, it has held that EU law does not require a national court to disapply domestic rules of procedure conferring finality on a decision, even if to do so would make it possible to remedy an infringement of a provision, regardless of its nature, contained in Directive 93/13 (see, to that effect, judgments of 6 October 2009, Asturcom Telecomunicaciones, C‑40/08, EU:C:2009:615, paragraph 37, and of 21 December 2016, Gutiérrez Naranjo and Others, C‑154/15, C‑307/15 and C‑308/15, EU:C:2016:980, paragraph 68), subject, however, in accordance with the case-law recalled in paragraph 22 above, to compliance with the principles of equivalence and effectiveness.


(Reference for a preliminary ruling — <mask> — Directive 2008/48/EC — Pre-contractual obligations — Article 5(6) — Obligation on the creditor to seek to establish the credit most suitable — Article 8(1) — Obligation on the creditor to refrain from concluding the loan agreement if there are doubts over the creditworthiness of the consumer — Obligation on the creditor to assess the expediency of the credit)


50. The KBA also states that that regulation is based on Article 95 EC (now Article 114 TFEU), which concerns measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market. However, Article 95(3) EC provides that the Commission, in its proposals concerning health, safety, environmental protection and <mask>, will take as a base a high level of protection, taking account in particular of any new development based on scientific facts. Consequently, the fact that that regulation is not founded on a specific legal basis relating to the environment, namely Article 175 EC, is not such as to exclude the link between that regulation and environmental law.


In that connection, first, I would point out that, from the perspective of the informative purpose, given the arbitrary and variable nature of the calculation of the abovementioned nutritional values, it is difficult to determine how, in the present case, the presentation of repeated nutrition information relating to the food after preparation would be useful to the consumer, particularly since the mandatory nutrition declaration would in fact be relegated to of secondary significance visually. Furthermore, in order to ensure a high level of <mask> in relation to information, taking into account the differences in the perception of consumers,   as the Court has observed, food information must be correct, neutral and objective.   That would not, however, be the case if the manufacturers of foods which can be prepared in different ways were to choose the way which best suits them, in particular that which gives the lowest energy value. Adopting such an approach would be neither neutral nor objective.


(Reference for a preliminary ruling – <mask> – Directive 93/13/EEC – Unfair terms in consumer contracts – Articles 3(1), 4(1) and 6(1) – Assessment of the unfairness of contractual terms – Term fixing in advance the creditor’s potential advantage in the event of termination of the contract – Significant imbalance in the parties’ rights and obligations under the contract – Date on which the imbalance must be assessed – Finding that a term is unfair – Consequences – Replacement of an unfair term with a supplementary provision of national law)


Second, as the Directive is a minimum harmonisation measure and leaves some leeway to Member States, the latter may in their national provisions determine the place where goods must be made available to be brought into conformity, bearing in mind the requirements posed by Article 3(3). Moreover, in accordance with Article 8(2) of the Directive, Member States may always adopt or maintain in force more stringent provisions to ensure a higher level of <mask>. Thus, in the interest of legal certainty, Member States may enact specific rules for certain categories of goods.


As noted by the Advocate General in point 59 of his Opinion, to hold that proceedings brought by a public authority are outside the scope of Regulation No 1215/2012 merely because of the use by that authority of evidence gathered by virtue of its public powers would undermine the practical effectiveness of one of the models of implementation of <mask> envisaged by the EU legislature. In that model, in contrast to the one in which it is the administrative authority itself that determines the consequences that are to follow from an infringement, in circumstances such as those in the main proceedings the public authority is assigned the task of defending the interests of consumers before the courts.


Consumer interests should be at the heart of this Directive and quality of service should be a central responsibility of electricity undertakings. Existing rights of consumers need to be strengthened and guaranteed, and should include greater transparency. <mask> should ensure that all consumers in the wider remit of the Community benefit from a competitive market. Consumer rights should be enforced by Member States or, where a Member State has so provided, the regulatory authorities.


48 As a preliminary point, it should be noted that, as is apparent, in particular, from paragraph 36 and from paragraphs 41 to 44 above, the dispute in the main proceedings is between a <mask> association, such as the Federal Union, and Meta Platforms Ireland and concerns the question whether such an association may bring proceedings against that company in the absence of a mandate granted to it for that purpose and independently of the infringement of specific rights of the data subjects.


First, he argues that, by its questions, the referring court is seeking to ascertain whether or not the time limit laid down by the national legislation for bringing proceedings before that court has been complied with. A question referred for a preliminary ruling must concern the interpretation of EU law rather than aspects relating to national law. Secondly, the applicant states that to limit the effects of restitution following a finding that a contractual term is unfair would be contrary to the rationale on which <mask> is based.


It should be stated, by way of preliminary point, that by that question that court is referring to the participation in the abovementioned procedures of representatives of the Ministry of the Economy and the Ministry of the Environment of the Slovak Republic. Subject to the verifications to be carried out by the referring court, it is apparent from the request for a preliminary ruling that the participation of the Ministry of the Environment relates only to tariff regulation procedures in connection with the production and supply of drinking water. Thus, in such a case, the provisions of Directive 2009/72, which apply, in particular, to the common rules on the generation, transmission, distribution and supply of electricity, and also to provisions relating to <mask>, with the aim of improving and integrating competitive markets for electricity in the European Union, should not apply to such participation.


It should also be pointed out that it follows from Article 4 of Directive 2011/83 that the level of <mask> ensured by national provisions as provided for by Member States cannot diverge from the level laid down in that directive unless otherwise provided for by that directive. In that regard, the Court has held that Article 21 of that directive does not constitute an exception to the Member States’ obligation not to deviate from the level of protection laid down by that directive (judgment of 13 September 2018, Starman, C‑332/17, EU:C:2018:721, paragraph 28).


According to the referring court, those national provisions are intended to ensure <mask>, in that the consumer cannot be required, in the event of early termination of the term of a loan agreement which he or she has concluded with a seller or supplier, to pay ordinary interest, since the payment of default interest and any penalties provided for in that agreement and, where appropriate, the payment of compensation, cover the harm actually suffered by that seller or supplier.


In the third place, as regards Riamar Shipping, which, according to the applicant, is dissolved, it should be noted that, according to Resolution No 77 of the Director of Internal Trade and <mask> of Tartus of 20 November 2018, produced by the applicant, the reference to ‘Abdulkader Sabra & Co (RIAMAR SHIPPING)’, the object of which relates to maritime transport, was removed from the commercial register on account, inter alia, of its dissolution by agreement between its members of 27 June 2018. Furthermore, it is apparent from that resolution that Riamar Shipping is the trade name of Abdulkader Sabra & Co. Accordingly, it must be concluded that Abdulkader Sabra & Co, the company name corresponding to the trade name of Riamar Shipping, has in fact been dissolved.


(Reference for a preliminary ruling — <mask> — Directive 93/13/CEE — Unfair terms in consumer contracts — Article 3(1) and (3) — Annex to Directive 93/13/EEC — Point 1(m) and (q) — Loan agreement secured by a mortgage — Notarial instrument — Affixation of the enforcement clause by a notary — Reversal of the burden of proof — Article 5(1) — Plain and intelligible drafting)


61 In this instance, as was confirmed by the German Government at the hearing in the present case, the German legislature did not adopt, following the entry into force of the GDPR, particular provisions specifically designed to implement Article 80(2) of that regulation in its national law. The national legislation at issue in the main proceedings, adopted in order to transpose Directive 2009/22, already allows <mask> associations to bring legal proceedings against the person allegedly responsible for an infringement of the laws protecting personal data. That government observes, moreover, that, in its judgment of 29 July 2019, Fashion ID (C‑40/17, EU:C:2019:629), concerning the interpretation of the provisions of Directive 95/46, the Court held that those provisions do not preclude that national legislation.


The referring court notes, first of all, that the objective limitation period of three years begins to run and expires even though the injured consumer was not aware of the unfair or unlawful nature of the contractual term giving rise to the unjust enrichment. In its view, such a national rule is likely to infringe the right to effective judicial protection guaranteed by Article 47 of the Charter and to be incompatible with the case-law of the Court relating to <mask>, laid down, in particular, by Directive 93/13 and Directive 2008/48.


The requirement set out in Article 19(5), namely that the information referred to in Article 19(1)(b) to (d) and (f) and in Article 19(2) to (4) be provided in the language laid down by the law of the Member State in which the product is made available to the end user, ensures a high level of <mask>. The protection of human health cannot be comprehensively ensured unless consumers are fully informed about and understand, inter alia, the information about the function of the cosmetic product concerned and the particular precautions to be observed in use. The information which producers or distributors of the cosmetic products covered by Regulation No 1223/2009 are obliged to put on the product’s container and packaging, save where it can be effectively conveyed by the use of pictogrammes or signs other than words, will be of no practical use unless it is provided in a language which can be understood by the persons for whom it is intended (see, by analogy, judgment of 13 September 2001, Schwarzkopf, C‑169/99, EU:C:2001:439, paragraph 40 and the case-law cited).


21. The referring court has doubts, however, as to whether the appellate court was correct to consider that the Federation’s action was admissible. It questions whether a <mask> association, such as the Federation, still has, since the entry into force of Regulation 2016/679, standing to bring proceedings, by lodging an action before the civil courts, against infringements of that regulation, independently of an actual infringement of the rights of individual data subjects and without being mandated by them, by invoking an infringement of the law within the meaning of Paragraph 3a of the UWG, infringement of a law on consumer protection within the meaning of point 11 of the first sentence of Paragraph 2(2) of the UKlaG or even the use of a general term or condition that is invalid in application of Paragraph 1 of the UKlaG.


3 Recitals 1, 4, 7 and 8 of Regulation No 261/2004 read as follows: ‘(1) Action by the Community in the field of air transport should aim, among other things, at ensuring a high level of protection for passengers. Moreover, full account should be taken of the requirements of <mask> in general. … (4) The Community should therefore raise the standards of protection set by that Regulation both to strengthen the rights of passengers and to ensure that air carriers operate under harmonised conditions in a liberalised market. … (7) In order to ensure the effective application of this Regulation, the obligations that it creates should rest with the operating air carrier who performs or intends to perform a flight, whether with owned aircraft, under dry or wet lease, or on any other basis. (8) This Regulation should not restrict the rights of the operating air carrier to seek compensation from any person, including third parties, in accordance with the law applicable.’


(Request for a preliminary ruling — <mask> — Directive 1999/44/EC — Sale of consumer goods — Rights of the consumer — Lack of conformity of the goods delivered — Subsequent bringing into conformity of the goods — Obligations of the seller — Determination of the place where the goods have to be made available for repair or replacement (place of subsequent performance) — Meaning of ‘significant inconvenience to the consumer’ — Meaning of ‘to repair free of charge’ — Right to have the contract rescinded)


As indicated by certain provisions and recitals to Directive 2009/72, the NRAs play a collaborative role with other competent authorities in ensuring the effectiveness and enforcement of the <mask> measures set out in that directive,   which may include complaint handling. Under Article 3(13) of Directive 2009/72, ‘Member States shall ensure that an independent mechanism such as an energy ombudsman or a consumer body is in place in order to ensure efficient treatment of complaints and out-of-court dispute settlements’. It may be inferred from the wording ‘such as’ in that provision that the choice of the competent authority for handling consumer complaints and dispute settlement falls within the discretion of the Member States. The Finnish Government’s observations concerning the legislative history of Directive 2009/72, whereby the European Parliament’s proposed amendments regarding the handling of consumer complaints by NRAs were moved from what is now Article 37 to Article 3 of Directive 2009/72,   further support this point.


This reference for a preliminary ruling is a further opportunity for the Court to examine the balance to be struck between, on the one hand, the need for pharmaceutical companies to promote the goods they produce and, on the other, the need for health-care professionals, in this case basically doctors and pharmacists, to have objective information about the products they are to prescribe or supply. Such a balance must be struck, furthermore, bearing in mind the compelling requirement to safeguard and protect <mask>.


17. VL was employed as a psychologist at the Szpital Kliniczny im. dr. J. Babińskiego, Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie (Dr J. Babiński Clinical Hospital, Independent <mask> Care Institution in Kraków; ‘the Hospital’), most recently from 3 October 2011 to 30 September 2016. On 8 December 2011, VL obtained a certificate attesting to a moderate, permanent disability, which she submitted to her employer on 21 December 2011.


5 Recital 54 of Regulation No 1306/2013 states: ‘That cross-compliance system incorporates in the CAP basic standards concerning the environment, climate change, good agricultural and environmental condition of land, <mask>, animal health, plant health and animal welfare. Cross-compliance aims to contribute to the development of sustainable agriculture through better awareness on the part of beneficiaries of the need to respect those basic standards. It aims also to contribute to make the CAP more compatible with the expectation of society through improving consistency of that policy with the environment, public health, animal health, plant health and animal welfare policies. The cross-compliance system forms an integral part of the CAP and should therefore be maintained. Its scope, however, which consists so far in separate lists of statutory management requirements and standards of good agricultural and environmental condition of land should be streamlined so that consistency of the cross-compliance system is ensured and made more visible. For this purpose, the requirements and standards should be organised in a single list and grouped by areas and issues. …’


Regulation in the area of medicinal products aims at reconciling a variety of goals. The first of these is quite obviously the safeguarding of <mask>, but it is also vital to create incentives to enable pharmaceutical companies to carry out much needed research into new medicinal products. Other public interests also quite obviously come into play. Public health systems should, of course, be provided with medicinal products that are not over-priced and repetitive trials on humans and animals should also be avoided whenever they are not necessary.   Regulation of clinical trials ensures that ethical standards are observed and that the person and bodily integrity of the subjects of clinical trials are appropriately protected.


verification that the third-country national concerned, his or her means of transport and the objects he or she is transporting are not likely to jeopardise the public policy, internal security, <mask> or international relations of any of the Member States. Such verification shall include direct consultation of the data and alerts on persons and, where necessary, objects included in the SIS and in national data files and the action to be performed, if any, as a result of an alert;


It should be emphasised that A satisfies the two conditions set out in Article 7(1)(b) of Directive 2004/38. It is apparent from the decision to refer   and it is common ground between the parties that, at the time when he requested affiliation to the Latvian social security in order to receive such benefits, A had sufficient resources and comprehensive sickness insurance. As regards the latter condition, it was stated at the hearing before the Court that he had taken out that insurance with a private insurance company. Nor is it disputed that he continued to satisfy both of those conditions at all times, after requesting to be affiliated to the social security of the host Member State. Such a Union citizen should therefore, in principle, enjoy equal treatment with nationals, under Article 24(1) of Directive 2004/38, provided that he does not come within one of the three cases referred to in paragraph 2 of that provision, and should therefore be able to be affiliated to the social security of the host Member State on the same conditions as nationals.   That would mean that he could not only have access to health care benefits coming within the <mask> system, but also that those benefits should be provided by the State on the same conditions as those applicable to nationals.


In the light of the foregoing, I propose to answer the first question as follows: Article 26 of Regulation No 1169/2011 should be interpreted as having harmonised the conditions under which the indication of the country of origin or place of provenance of milk used as a final product or as an ingredient may be made mandatory by Member States. That provision does not, however, preclude Member States from making that indication mandatory on the basis of Article 39 of that regulation where this is justified by considerations such as the protection of <mask>, the rights of consumers, the avoidance of fraud or the prevention of unfair competition and where the conditions laid down in that provision are fulfilled.


It would appear that the objective of the protection of <mask> was not specifically part of the equation in the balance struck by the EU legislature at EU level when setting the rules for the operation of the common market concerning wine products.   That objective was part of a different national regulatory regime, guided by different considerations, which only incidentally overlapped with the EU one. The national rule at stake was a measure applicable only at the retail stage. Thus, although retail is naturally also a stage (the last stage) of the marketing chain, the overlap and thus ensuing conflict between EU rules and the national rules was indeed marginal.


According to the settled case-law of the Court, since the health and life of humans rank foremost among the assets and interests protected by TFEU, it is for Member States to determine the level of protection which they wish to afford to <mask> and the way in which that level has to be achieved. Since that level may vary from one Member State to another, Member States should be allowed some measure of discretion (see judgment of 8 June 2017, Medisanus, C‑296/15, EU:C:2017:431, paragraph 82 and the case-law cited). Consequently, the fact that a Member State imposes less strict rules than another Member State does not mean that the latter’s rules are disproportionate (judgment of 18 September 2019, VIPA, C‑222/18, EU:C:2019:751, paragraph 71 and the case-law cited).


2. This Directive shall not affect the right of a Member State to maintain or introduce further requirements, applicable to all products placed on its market, in relation to the standardisation of the packaging of tobacco products, where it is justified on grounds of <mask>, taking into account the high level of protection of human health achieved through this Directive. Such measures shall be proportionate and may not constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States. Those measures shall be notified to the Commission together with the grounds for maintaining or introducing them.


The first of those conditions is clearly fulfilled in the present case. The referring court starts from the premiss that, as the tribunal de commerce de Paris (Commercial Court, Paris) found, Articles R. 4235‑22 and R. 4235‑64 of the <mask> Code apply to all pharmacies selling medicinal products to the French public, whether they are established in France or in another Member State.


In exercising their discretion relating to the protection of <mask>, the Member States must comply with the principle of proportionality. The means which they choose must therefore be confined to what is actually necessary to ensure the safeguarding of public health; they must be proportional to the objective thus pursued, which could not have been attained by measures which are less restrictive of intra-Community trade (judgment of 28 January 2010, Commission v France, C‑333/08, EU:C:2010:44, paragraph 90).


The Plant Protection Regulation was adopted on the basis of Article 37(2), Article 95 and Article 152(4)(b) EC. These are the legal bases for the common agricultural and fisheries policies (now Article 41 TFEU), the internal market (now Article 114 TFEU) and measures in the veterinary and phytosanitary fields which derogate from the common agricultural policy and have as their direct objective the protection of <mask> (now Article 168(4)(b) TFEU).


The referring court observes that, as clear from recital 11 and Article 1 of Regulation No 1069/2009, its chief objectives are to control risks to public and animal health and to protect the safety of the food and feed chain. Any danger is therefore not limited to <mask>. Article 14(d) of Regulation No 1069/2009, it suggests, also emphasises that decomposition and spoilage cause risks to public and animal health.


In that context, it should be recalled that the overriding need for safety in the field of <mask> (see, to that effect, judgment of 19 April 2012, Artegodan v Commission, C‑221/10 P, EU:C:2012:216, paragraph 99 and the case-law cited) logically presupposes that authorities can, when there are doubts concerning the reliability of information provided in support of an MA application, incline towards refusing an MA.


The criteria attached to the grant of prior authorisation should be justified in the light of the overriding reasons of general interest capable of justifying obstacles to the free movement of healthcare, such as planning requirements relating to the aim of ensuring sufficient and permanent access to a balanced range of high-quality treatment in the Member State concerned or to the wish to control costs and avoid, as far as possible, any waste of financial, technical and human resources. The Court … has identified several potential considerations: the risk of seriously undermining the financial balance of a social security system, the objective of maintaining on grounds of <mask> a balanced medical and hospital service open to all and the objective of maintaining treatment capacity or medical competence on national territory, essential for the public health, and even the survival of the population. …’


It has already been shown   that the renewal of successive fixed-term employment contracts in order to fill vacant posts in the <mask> sector pending the completion of selection processes is not justified, in principle, by an objective reason within the meaning of Clause 5(1) of the Framework Agreement if the national rules in question do not, at the same time, lay down in binding form the time frame for holding and completing those selection processes. These considerations in relation to the absence of appropriate national measures to prevent the misuse of successive fixed-term employment contracts apply a fortiori with regard to the requirement under EU law to penalise possible abuse effectively.


In that regard, first, the Court has held that the continuity requirement of services in the areas of <mask>, public safety and public order does not prevent the activities of those services, when performed in normal circumstances, from being organised, including as regards the working hours of their employees, with the consequence that the exception provided for in the first subparagraph of Article 2(2) of Directive 89/391 is applicable to such services only in circumstances whose gravity and scale are exceptional, such as natural or technological disasters, attacks or serious accidents, which require the adoption of measures indispensable for the protection of the life, health and safety of the community at large, measures the proper implementation of which would be jeopardised if all the rules laid down in Directive 2003/88 had to be observed. In such cases, it is appropriate to give absolute priority to the objective of protecting the population, to the detriment of compliance with the provisions of Directive 2003/88, which may be temporarily disregarded within those services (see, to that effect, judgments of 20 November 2018, Sindicatul Familia Constanţa and Others, C‑147/17, EU:C:2018:926, paragraph 67, and of 30 April 2020, Készenléti Rendőrség, C‑211/19, EU:C:2020:344, paragraph 42 and the case-law cited).


In that regard, it must, again, be noted that the purpose of the classification of substances and mixtures such as CTPHT, according to Article 1(1) of Regulation No 1272/2008, is to ensure a high level of protection of human health and the environment. Moreover, although the precautionary principle is not expressly mentioned in Regulation No 1272/2008, that principle, on which the provisions of, inter alia, Regulation No 1907/2006 are based, cannot be disregarded when classifying chemical substances and mixtures, which is a closely connected field to that covered by Regulation No 1907/2006. The precautionary principle, which is a general principle of EU law, authorises the competent authorities, where there is uncertainty, to take appropriate measures in order to prevent certain potential risks for <mask>, safety and the environment without having to wait until the reality and seriousness of those risks become fully apparent (see, to that effect, judgment of 10 April 2014, Acino v Commission, C‑269/13 P, EU:C:2014:255, paragraph 57 and the case-law cited).


‘1. This Royal Decree shall govern the conditions for the exercise of the rights of entry and exit, free movement, stay, residence and work in Spain for nationals of other Member States of the European Union and other States parties to the Agreement on the European Economic Area, as well as the limits imposed on those rights for reasons of public policy, public safety or <mask>.


It has been made in the context of two disputes, the first between Italy Emergenza Cooperativa Sociale (‘Italy Emergenza’) and ULSS 5 Polesana Rovigo (local <mask> unit 5 of the Polesine of Rovigo, Italy, ‘ULSS 5 Polesana’), and the second between Associazione Volontaria di Pubblica Assistenza ‘Croce Verde’ (‘Croce Verde’) and ULSS 5 Polesana and Regione del Veneto (Region of Veneto, Italy), concerning the award by ULSS 5 Polesana, by means of direct contracting, of a contract for ambulance transport services.


2. Member States may, to the extent justified by national security, public safety, <mask>, security of transport, protection of the environment, protection of biological resources and of national treasures possessing artistic, historic or archaeological value, safety of installations and of workers, planned management of hydrocarbon resources (for example the rate at which hydrocarbons are depleted or the optimisation of their recovery) or the need to secure tax revenues, impose conditions and requirements on the exercise of the activities set out in Article 2(1).


That interpretation also enables a fair balance to be struck between, on the one hand, the objective of the SPC regime, as it is made apparent from recitals 3 to 5 and 9 of Regulation No 469/2009, of compensating for the inadequacy of protection conferred by a patent for the purpose of covering the investment put into research concerning new active ingredients or combinations of active ingredients and, therefore, of encouraging such research and, on the other hand, the EU legislature’s intention, as set out in recital 10 of that Regulation, to achieve that objective in a manner that takes into account all the interests at stake, including those of <mask>, in a sector as complex and sensitive as the pharmaceutical sector (see, to that effect, judgment of 21 March 2019, Abraxis Bioscience, C‑443/17, EU:C:2019:238, paragraph 36).


A appealed against that decision to the cour d’appel de Paris (Court of Appeal, Paris, France), arguing that Articles R. 4235-22 and R. 4235-64 of the <mask> Code do not apply to it. Those provisions, it argued, constitute barriers to the principle of the application of the rules of the country of origin, laid down in Article 3 of Directive 2000/31 and Article 85c of Directive 2001/83, and to the free movement of goods guaranteed under Article 34 TFEU, which are not justified by the protection of public health.


11. The purpose of the Medicinal Products Directive (7) is set out in its recitals: ‘(2) The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard <mask>. (3) However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community.’


41 In that context, the Court has already ruled that the database of a system for the identification and registration of animals is designed to ensure efficient tracing in real time of those animals, which is essential for <mask> reasons, and that such a database is able to confirm the fact that the conditions governing eligibility for aid are met, such as those relating to the density of livestock (see, to that effect, judgment of 21 July 2011, Nagy, C‑21/10, EU:C:2011:505, paragraph 42).


I consider, in that respect, that it is appropriate to adopt a more nuanced interpretation than that proposed both by the Latvian and Spanish Governments and by the Commission, as the judgment in Jobcenter Krefeld, concerning the condition requiring sufficient resources, suggests. Such an approach is all the more desirable, to my mind, in the case of the condition requiring comprehensive sickness insurance. I shall demonstrate that the systematic refusal to allow economically inactive nationals of other Member States to receive <mask> care benefits, on the same conditions as nationals, before they have acquired a permanent right of residence, after residing for five years in the territory of the host Member State, is not supported by the wording of Articles 7, 14 and 24 of Directive 2004/38 and that it is contrary to the objective of freedom of movement for Union citizens and to the very concept of ‘citizenship of the Union’.


From a factual point of view, the CAT refers here, first, as regards the GUK and Alpharma Agreements, to the limited benefits already considered above afforded by those agreements to consumers in terms of costs and quality.   Second, as regards the IVAX Agreement, the CAT refers to the fact that it involved a reduction in the reimbursement level for paroxetine by reason of the structure of the national system for reimbursement to pharmacies by the <mask> authorities, which resulted in a substantial saving to those authorities.


Border control is in the interest not only of the Member State at whose external borders it is carried out but of all Member States which have abolished internal border control. Border control should help to combat illegal immigration and trafficking in human beings and to prevent any threat to the Member States’ internal security, public policy, <mask> and international relations;


In that respect, it must be noted that, in the same way as the substantive conditions for the suspension or withdrawal of an MA, the conditions for granting an MA must be interpreted in accordance with the general principle that can be identified from case-law that the protection of <mask> must unquestionably take precedence over economic considerations (see judgment of 19 April 2012, Artegodan v Commission, C‑221/10 P, EU:C:2012:216, paragraph 99 and the case-law cited). Furthermore, the precautionary principle, which is a general principle of EU law, empowers, inter alia, the Commission to do no more than establish whether there is solid and persuasive evidence which may raise reasonable doubts regarding the safety of the medicinal product concerned or of the existence of a favourable risk-benefit balance (see, by analogy, regarding decisions to suspend, withdraw or vary an MA, judgment of 3 December 2015, PP Nature-Balance Lizenz v Commission, C‑82/15 P, not published, EU:C:2015:796, paragraph 23 and the case-law cited).


In that respect, it is important to recall that the decision whether or not to authorise the placing on the market of a medicinal product must be based on a thorough examination of the quality, safety and efficacy of the product, and that such an examination must generally be based on an objective evaluation of its likely effects in the light of the scientific data submitted by the MA applicants. It is established that <mask> requirements must be recognised as fundamentally important (see in particular paragraphs 45 and 46 above).


By decision of 15 January 2018, the Minister refused to issue the visa. The refusal decision was based on the fact that one or more Member States, in this instance the Federal Republic of Germany, consider K.A. to be a threat to public policy, internal security or <mask>, as defined in Article 2(19) of the Schengen Borders Code, or to the international relations of one of the Member States.


The peculiar nature of such a proposition becomes even more obvious if one were to consider the standard way in which any other area of administrative law is enforced, be it, for example, environmental law, <mask>, public safety, or the rules relating to safety at work. In those areas, there is likely to be a dedicated, specialised public authority at the national level tasked with supervising and enforcing the relevant substantive standards. However, would anybody suggest that just because a given public authority did not investigate or prosecute (or actually did, but for whatever reason discontinued or limited the administrative proceedings), that the same behaviour could not give rise to private law claims for compensation by the potentially injured person?


The Court has often dealt with the use of fixed-term employment relationships in the Member States’ public services. In particular, the specific circumstances of the <mask> service of the Comunidad de Madrid, to which this case relates, were the subject of Case C‑16/15. Because the referring courts still have serious doubts whether the requirements of EU law stemming from Clause 5 of the Framework Agreement are complied with in the public health service of the Comunidad de Madrid, they consider it necessary to make further references to the Court.


43 As is set out in recital 24 of Regulation No 1107/2009, the provisions governing the grant of authorisations must ensure a high standard of protection of human and animal health and the environment. It is that objective which, according to recital 35 of the same regulation, is pursued by the proper use of plant protection products, in accordance with their authorisation. It should be recalled, in that context, that, according to Annex II to Regulation No 1306/2013, SMR 10, concerning compliance with the first paragraph and the first sentence of the second paragraph of Article 55 of Regulation No 1107/2009, seeks specifically to protect <mask>, animal health and plant health. SMR 10 is thus part of the basic CAP standards on public health, animal health and plant health integrated in the cross-compliance system, compliance with which is a condition for the full payment to beneficiaries of some supports under the CAP, in accordance with recitals 53 and 54 of Regulation No 1306/2013.


In the light of that explanation, legislation such as that at issue in the main proceedings would appear to pursue the objective of protecting <mask> which can, in accordance with Article 52(1) TFEU, in principle justify restrictions on the freedom of establishment.   More specifically, in paragraph 28 of the judgment of 19 May 2009, Apothekerkammer des Saarlandes and Others (C‑171/07 and C‑172/07, EU:C:2009:316), the Court stated that restrictions on the freedom of establishment may be justified by the objective of ensuring that the provision of medicinal products to the public is reliable and of good quality.


(References for a preliminary ruling – Area of freedom, security and justice – Community Code on Visas – Regulation (EC) No 810/2009 – Article 32(1) to (3) – Decision to refuse a visa – Annex VI – Standard form – Statement of reasons – Threat to public policy, internal security or <mask>, or to the international relations of any of the Member States – Article 22 – Procedure of prior consultation of central authorities of other Member States – Objection to the issuing of a visa – Appeal against a decision to refuse a visa – Scope of judicial review – Article 47 of the Charter of Fundamental Rights of the European Union – Right to an effective remedy)


Based on the case-law of the Court, the Commission Communication on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted, of 30 December 2003 (COM(2003) 839 final), states, in point 3 thereof, ‘in particular, when the information necessary for the purposes of protecting <mask> is already available to the competent authorities of the Member State of destination as a result of the first marketing of a product in this Member State, a parallel imported medicinal product is subject to a licence granted on the basis of a proportionally simplified procedure provided [that] the imported product has been granted a marketing authorisation in the Member State of exportation [and that] the imported product is sufficiently similar to a product that has already received marketing authorisation in the Member State of destination even if there are differences relating to the excipients’.


Contrary to arguments put forward by the United Kingdom, it seems to me that this is a situation which must be remedied by enforcement action. Here, it is a matter of removing meat that presents a danger to <mask> by deciding not to apply a health mark. As indicated by the claimants, there is no distinction between Articles 4 and 5 of Regulation No 854/2004 as regards decisions taken by competent authorities which are subject to Article 54 of Regulation No 882/2004, particularly as this would run counter to the broad concept of non-compliance in Article 2 of Regulation No 882/2004 and the measures envisaged by Article 54(2) thereof. Article 4(3) of Regulation No 854/2004 also states that official controls for the purposes of Article 4(1) of that regulation include those specified in Article 5 thereof.


With respect to companies of veterinary surgeons, the Republic of Austria submits that it is not possible to maintain that there is no connection between the profession of veterinary surgeon and the protection of <mask>, in so far as that profession plays the part of guarantor as regards the production of safe foodstuffs. The Republic of Austria submits that veterinary surgeons are obliged, not only under the TÄG but also under other legislation, to declare diseases of animals and certain human diseases or the suspicion of infection by one of those diseases.


The importance of the objective of protecting <mask> is confirmed by Article 168(1) TFEU and Article 35 of the Charter under which, inter alia, a high level of protection for human health is to be ensured in the definition and implementation of all policies and activities of the European Union. See to that effect, judgment of 5 December 2013, Venturini and Others (C‑159/12 to C‑161/12, EU:C:2013:791, paragraphs 40 and 41 and the case-law cited). It is settled case-law that the aim of maintaining the quality of medical services, such as pharmaceutical services, may be covered by one of the exceptions provided for in Article 52(1) TFEU, in so far as it contributes to the attainment of a high level of health protection. Judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 53 and the case-law cited).


So far as the issue of any teleological interpretation is concerned, recitals 22 to 27 of Directive 2004/38 are particularly enlightening. First, after recalling that the Treaty allows restrictions to be placed on the right of free movement and residence on grounds of public policy, public security or <mask>, recital 22 provides that ‘in order to ensure a tighter definition of the circumstances and procedural safeguards subject to which Union citizens and their family members may be denied leave to enter or may be expelled, this Directive should replace Council Directive 64/221/EEC of 25 February 1964 on the coordination of special measures concerning the movement and residence of foreign nationals, which are justified on grounds of public policy, public security or public health’,   which actually dealt only with expulsion. Second, all of the other recitals relating to Chapter VI of Directive 2004/38 refer only to expulsion (recitals 23, 24 and 27) or refusal of entry to another Member State (recitals 25 and 26).


That division of tasks between the Commission and the competent authorities of third countries, such as is established by Regulation No 854/2004, required that provision be made for a safeguard measure for the protection of <mask> in the European Union. Therefore, according to Article 12(4)(c) of that regulation, whenever the Commission considers it necessary to modify a list of establishments drawn up by the authorities of a third country, in the light of relevant information such as European Union inspection reports or RASFF notifications put in place to that end pursuant to Article 50 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1), it is to inform all Member States and include the point on the agenda of the next meeting of the relevant section of the Standing Committee for decision, where appropriate, in accordance with the procedure referred to in Article 19(2) of Regulation No 854/2004. That procedure leads to the adoption of an implementing act, such as the contested implementing regulation, modifying the list of third-country establishments whose products of animal origin may be imported into the European Union.


Within the process leading to the adoption by an institution of appropriate measures to prevent certain potential risks to <mask>, safety and the environment by reason of the precautionary principle, three successive stages can be identified: first, identification of the potentially adverse effects arising from a phenomenon; second, assessment of the risks to public health, safety and the environment which are related to that phenomenon; and, third, when the potential risks identified exceed the threshold of what is acceptable for society, risk management by the adoption of appropriate protective measures (judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 60).


By contrast, the rules on advertising online sales services relating to medicinal products could, in so far as they have the effect of restricting the online sale of medicinal products to patients, constitute conditions for the retail sale, within the territory of a Member State, of medicinal products for sale at a distance to the public by means of information society services. Under Article 85c(2) of Directive 2001/83, Member States may lay down such conditions provided that they are justified on grounds of <mask> protection.


Inasmuch, therefore, as the Court appears to have suggested in paragraph 54 of L.u.p. that the discretion conferred by Article 132(1)(b) of the VAT Directive on the Member States would enable them to impose a requirement that the medical centre in question treat a specified percentage of patients covered by health insurance schemes as a condition of recognition, that suggestion is, with respect, incorrect and is unsupported by both the actual legislative text and, for that matter, the earlier case-law. The due recognition requirement of Article 132(1)(b) of the VAT Directive simply enables Member States to ensure that the medical establishments meet appropriate standards of health care delivery: it should not be interpreted as permitting Member States, so to speak, to conscript private health care providers into a <mask> system by subjecting the former to a disadvantageous treatment for VAT purposes. As I have just indicated, in so far as the Court appears to suggest otherwise in paragraph 54 of L.u.p., I consider – again, with respect – that this was in error and should not now be followed or applied.


By decision of 11 July 2017, the tribunal de commerce de Paris (Commercial Court, Paris) ruled that the creation of A’s French website was governed by Netherlands law. However, according to that court, Articles R. 4235‑22 and R. 4235‑64 of the <mask> Code are applicable to companies established in other Member States which sell medicinal products via the internet to French patients. By distributing more than three million advertising leaflets outside of its pharmacy, A had solicited French clients by methods unworthy of the profession of pharmacist and in breach of those provisions. The tribunal de commerce de Paris (Commercial Court, Paris) concluded that the failure to comply with those provisions, which conferred on A an economic advantage over other market operators, amounted to unfair competition.


As regards the objective of protection of <mask>, it follows from the Court’s case-law that requirements relating to shares in companies of veterinary surgeons being held exclusively by members of that profession are suitable for reducing the risks that such companies may adopt economic strategies liable to undermine the objective of protection of health and the independence of veterinary surgeons (see, to that effect, judgment of 1 March 2018, CMVRO, C‑297/16, EU:C:2018:141, paragraphs 82 and 83).


May not, on the other hand, disregard the other mandatory EU provisions: in so far as is relevant for the present purposes, those adopted in the field of <mask> and, more specifically, the hygiene of foodstuffs. Recital 6 of Directive 2004/18 reads: ‘Nothing in this Directive should prevent the imposition or enforcement of measures necessary to protect … health [and] human … life …, provided that these measures are in conformity with the Treaty.’


73. In accordance with the second recital of Directive 96/62, recital 2 of Directive 2008/58 and Article 1(1) of both directives, those directives aim to avoid, prevent or reduce harmful effects on human health. (45) The rules on ambient air quality laid down in those directives thus put into concrete terms the EU’s obligations concerning environmental protection and the protection of <mask>, which stem, inter alia, from Article 3(3) TEU and Article 191(1) and (2) TFEU. According to those provisions, Union policy on the environment is to aim at a high level of protection, taking into account the diversity of situations in the various regions, and is to be based, inter alia, on the precautionary principle and on the principle that preventive action should be taken. (46) That obligation of protection also follows from Articles 2, 3 and 37 of the Charter of Fundamental Rights of the European Union. (47)


(Reference for a preliminary ruling – Medicinal products for human use not subject to compulsory medical prescription – Online sales – Advertising for a pharmacy’s website – Limitations – Obligation to require a patient to complete a health questionnaire prior to validation of his or her first order on a pharmacy’s website – Free movement of goods – Article 34 TFEU – Selling arrangements – Obstacles – Article 36 TFEU – Justification – Protection of the dignity of the profession of pharmacist – Prevention of the abusive consumption of medicinal products – Protection of <mask> – Directive 2000/31/EC – Electronic commerce – Article 2(a) – Information society service – Article 2(h) – Coordinated field – Article 3 – Country-of-origin principle – Derogations – Justification – Protection of public health – Information and notification obligation – Directive 2001/83/EC – Community code relating to medicinal products for human use – Article 85c(2) – Option for Member States to impose conditions, justified on grounds of public health protection, for the retail supply within their territory of medicinal products sold online)


(Reference for a preliminary ruling – <mask> – Health rules applicable to animal by-products not intended for human consumption – Regulation (EC) No 1069/2009 – Article 7(1) – Classification reflecting the level of risk to public and animal health – Article 10(a) and (f) – Category 3 material – Decomposition, spoilage and presence of foreign bodies in the material – Obligation to downgrade to Category 2 material – Article 9(h) – Article 4(1) and (2) – Obligation to monitor operators from the collection to the use or disposal of animal by-products)


Freedom of establishment may, in the absence of EU harmonisation measures, be limited by national regulations justified by the reasons stated in Article 52(1) TFEU or by pressing reasons in the general interest. Thus, in accordance with Article 52(1) TFEU, where a restriction results from a measure which discriminates on grounds of nationality, it may be justified on grounds of public policy, public security or <mask>. Where there is no such discrimination, the restriction may also be justified by overriding reasons in the public interest. In that context, it is for the Member States to decide on the level at which they intend to ensure the protection of the objectives set out in Article 52(1) TFEU and of the general interest and also on the way in which that level must be attained. However, they can do so only within the limits set by the Treaty and, in particular, they must observe the principle of proportionality, which requires that the measures adopted be appropriate for ensuring attainment of the objective which they pursue and do not go beyond what is necessary for that purpose.


Article 3(4)(a) of Directive 2000/31 provides that any measure restricting the free movement of an information society service must be necessary to safeguard public policy, the protection of <mask>, public security or the protection of consumers, must be taken against a service which effectively prejudices those objectives or presents a serious and grave risk of prejudice to them and must be proportionate to those objectives. Those requirements of necessity and proportionality largely overlap with the requirements which must be fulfilled by any obstacle to the fundamental freedoms guaranteed in Articles 34 and 56 TFEU. Accordingly, as the Commission has argued, it is in the light of the case-law relating to those provisions that it is necessary to assess whether the measures at issue are compatible with Article 3(4) of Directive 2000/31.


That being so, the consequences that follow from such a link of integration must still be assessed, in the light of the fact that the <mask> sector has particular characteristics that are recognised by the FEU Treaty and reflected in the Court’s case-law. The Court has consistently held that the protection of public health is one of the overriding reasons in the general interest which can, under Article 52 TFEU, justify restrictions of freedom of establishment   and freedom to provide services.   The same applies with respect to the freedom of movement and of residence of a Union citizen under Article 27 of Directive 2004/38. That derogation covers, more specifically, two objectives, namely the objective of maintaining a balanced high-quality medical or hospital service open to all and the objective of preventing the risk of serious harm to the financial balance of the social security system.


19 In addition, although Article 3(1) of Regulation No 2073/2005 obliges food business operators to ensure that foodstuffs comply with the relevant microbiological criteria set out in Annex I to that regulation, that obligation cannot prevent competent authorities from searching for pathogenic microorganisms other than those listed in that annex, in accordance with the objective of a high level of protection of <mask> set out in recital 1 of that regulation. As the European Commission has emphasised in its written observations, in order to take account of the food safety criteria set out in Chapter 1 of that annex, food business operators must include, in the procedures they apply, systematic checks of contamination by certain microorganisms, although such an obligation does not mean that the pathogenic microorganisms covered by those criteria are the only ones unsafe for human health.


The pharmacovigilance system shall be used to collect information on the risks of medicinal products as regards patients’ or <mask>. That information shall in particular refer to adverse reactions in human beings, arising from use of the medicinal product within the terms of the marketing authorisation as well as from use outside the terms of the marketing authorisation, and to adverse reactions associated with occupational exposure.


Furthermore, beyond the various criteria for the interpretation of Article 69(1) of Directive 2001/83 set out in the preceding paragraphs of the present judgment, the conclusion in paragraph 41 thereof is corroborated by the interest of safeguarding <mask>, which is, as stated in recital 2 of that directive, the essential aim of any rules governing the production, distribution and use of medicinal products.


As regards capitalising on the professional experience gained in order to ensure that pharmacies are run more effectively, it is apparent from the file before the Court that the unconditional right of pre-emption granted to the pharmacists employed by a municipal pharmacy, where that pharmacy is sold by tender, gives rise to an non-rebuttable presumption that those employees are best placed to manage that pharmacy as owners. Such a right of pre-emption is not based on any real assessment of the experience actually gained, the quality of service provided or the duties actually performed within the municipal pharmacy. Consequently, it cannot be regarded as being appropriate for attaining the objective of protecting <mask>.


It is clear that the reasons relied on to justify the expulsion of Ms Chenchooliah are not based on grounds of public policy, public security or <mask> covered by Chapter VI of Directive 2004/38.   As the Minister stated in his written observations and confirmed at the hearing, her expulsion is based on the fact that, since his return to Portugal, her Union citizen spouse has ceased exercising his right of free movement in Ireland. The Minister also stated that a deportation order, such as the proposed order to deport Ms Chenchooliah, is a measure to control immigration adopted to serve economic ends.


Directive 2004/38 lays down restrictions and procedural safeguards applicable to the expulsion of Union citizens and their family members. More specifically, that directive draws a distinction between two different sets of rules which are based on the grounds justifying the expulsion. Thus, an expulsion decision may be justified either on grounds of public policy, public security or <mask> (Chapter VI), or on other grounds (Article 15), inter alia the fact that a beneficiary of Directive 2004/38 ceases to fulfil the conditions of residence laid down in that directive.


It is apparent from the case file submitted to the Court that the Decree of 28 November 2016 of the Minister for Social Affairs and Health on the technical rules applicable to websites for the electronic commerce in medicinal products provided for in Article L. 5125‑39 of the <mask> Code (JORF of 1 December 2016, text no 26; ‘the Decree on technical rules’) contains an annex, Section 1 of which, entitled ‘Functional aspects of websites for the electronic commerce in medicinal products’, provides that ‘paid referencing on search engines or price comparison websites shall be prohibited’.


On 22 November 2017, R.N.N.S. lodged an appeal against the latter decision before the referring court, maintaining that he cannot be considered to be a threat to public policy, internal security or <mask> or to the international relations of one of the Member States. The applicant relies, in particular, on the absence of effective judicial protection, since he is not able to challenge the substance of the Minister for Foreign Affairs’ refusal decision. According to the Minister, Hungary’s ground for refusal cannot be reviewed as to its substance in the Netherlands and for that reason R.N.N.S. should bring proceedings before the Hungarian courts to that end.


As is apparent from the order for reference, Article R. 4235‑64 of the <mask> Code has also been interpreted by the tribunal de commerce de Paris (Commercial Court, Paris) as prohibiting promotions linked to the amount of the order where they are displayed on a pharmacy’s website. Moreover, the Decree on technical rules prohibits pharmacies from using paid referencing on search engines and price comparison websites. In so far as the purpose of that technique is to attract to a pharmacy’s website potential consumers who conduct internet searches, paid referencing is also in the nature of advertising.


(Reference for a preliminary ruling – Citizenship of the Union – Article 21 TFEU – Right of citizens of the Union and their family members to move and reside freely within the territory of the Member States – Directive 2004/38/EC – Article 15 – Decision restricting free movement on grounds other than public policy, public security or <mask> – Illegal residence of a Union citizen in the host Member State – Expulsion decision – Physical departure of the Union citizen from the host Member State – Temporal effects of the expulsion decision – Articles 5, 6 and 7 – Possibility of the Union citizen enjoying a new right of entry or of residence on his or her return to the host Member State)


9 Under Article 16 of Directive 2008/98, entitled ‘Principles of self-sufficiency and proximity’: ‘1. Member States shall take appropriate measures, in cooperation with other Member States where this is necessary or advisable, to establish an integrated and adequate network of waste disposal installations and of installations for the recovery of mixed municipal waste collected from private households, including where such collection also covers such waste from other producers, taking into account best available techniques. By way of derogation from Regulation (EC) No 1013/2006, Member States may, in order to protect their network, limit incoming shipments of waste destined to incinerators that are classified as recovery, where it has been established that such shipments would result in national waste having to be disposed of or waste having to be treated in a way that is not consistent with their waste management plans. Member States shall notify the Commission of any such decision. Member States may also limit outgoing shipments of waste on environmental grounds as set out in Regulation (EC) No 1013/2006. 2. The network shall be designed to enable the Community as a whole to become self-sufficient in waste disposal as well as in the recovery of waste referred to in paragraph 1, and to enable Member States to move towards that aim individually, taking into account geographical circumstances or the need for specialised installations for certain types of waste. 3. The network shall enable waste to be disposed of or waste referred to in paragraph 1 to be recovered in one of the nearest appropriate installations, by means of the most appropriate methods and technologies, in order to ensure a high level of protection for the environment and <mask>. 4. The principles of proximity and self-sufficiency shall not mean that each Member State has to possess the full range of final recovery facilities within that Member State.’ Decision 2000/532/EC


In that regard, and in so far as the Court does not have sufficient information regarding the possible existence of more precise conditions governing the application of the prohibition on promotional offers and, in particular, regarding whether that prohibition relates only to the promotion of medicinal products or also to the promotion of para-pharmaceutical products, it is for the referring court to ascertain how the prohibition at issue is applied in practice and whether such application goes, in some circumstances, beyond what is necessary to protect <mask>.


Article 31(1) of Directive 2004/38, for its part, provides that Union citizens have access to judicial and, where appropriate, administrative redress procedures in the host Member State to appeal against or seek review of any decision restricting their right to move and reside freely in the Member States taken against them on the grounds of public policy, public security or <mask>.


In those circumstances, it does not appear that a pharmacy established in another Member State is deprived of every possibility of advertising its online sales services targeted at French consumers.   In any event, I note that the case in the main proceedings concerns only the compatibility with EU law of a prohibition on a pharmacist conducting an advertising campaign for its online sales services consisting in the dispatch of unsolicited advertising leaflets to the public offering, in some circumstances, discounts on the price of the medicinal products ordered. The resolution of this case does not require a decision on whether the provisions of the <mask> Code are disproportionate, in so far as they also prohibit other forms of advertising.


On the other hand, according to the settled case-law of the Court, the right to property, which is guaranteed by Article 17 of the Charter, is not an absolute right, but must be considered in relation to its function in society (see, to that effect, judgment of 10 July 2003, Booker Aquaculture and Hydro Seafood, C‑20/00 and C‑64/00, EU:C:2003:397, paragraph 68). In the context of the case in the main proceedings, the right to property must be reconciled with Article 38 of the Charter, which, like Article 168(4)(b) TFEU, seeks to ensure a high level of consumer protection in EU policies, including the protection of <mask>.


Although the procedure laid down by that directive may, in accordance with the fourth subparagraph of Article 5(1) of that directive, relate to a Member State’s measures seeking to restrict the marketing or use of a chemical substance or product on grounds of <mask> or protection of the environment, the fact remains that the two procedures referred to in the first question are different.


The <mask> objective appears to it to be already taken into consideration in Regulation No 1308/2013 in so far as that regulation limits its scope to varieties providing safeguards to be determined in respect of the content of intoxicating substances and adopts, first, a restriction regarding seeds and, second, a level of 0.2% in respect of the THC content of hemp.


The referring court also indicates that neither R.N.N.S. nor K.A. were aware of any decision concerning them in relation to public policy, internal security, <mask> or the international relations of any of the Member States that might have been adopted by the competent authorities of the Member States that objected to the issuing of their visas. In addition, that court emphasises that, even if such decisions had been adopted, it is not possible, on the basis of the information in the main proceedings, to verify whether R.N.N.S. and K.A. had effective remedies against those decisions in those Member States.


Such an objective, inasmuch as it is akin to the objective of protecting <mask>, expressly referred to in Article 52(1) TFEU, may justify a restriction of freedom of establishment. It has also been held that restrictions of freedom of establishment may be justified by the objective of ensuring that the public has a supply of medicinal products which is reliable and of good quality, which constitutes an overriding reason in the general interest (see, to that effect, judgment of 5 December 2013, Venturini and Others, C‑159/12 to C‑161/12, EU:C:2013:791, paragraphs 40 and 41).


The applicant claims that the need clause introduces indirect discrimination between Swiss medical practitioners, who are mostly trained in Switzerland and are therefore not concerned by that clause, and medical practitioners who are nationals of a Member State, who are mostly trained in the European Union and are directly concerned by the prohibition on practising under the Swiss compulsory sickness insurance scheme. In addition, the need clause introduces discrimination between medical practitioners who have practised at a recognised Swiss post-graduate training facility for at least three years and other medical practitioners. The introduction of that clause constitutes an infringement of Articles 2, 7 and 13 of the AFMP and of Article 55 of Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (OJ 2005 L 255, p. 22), as well as a failure to observe the case-law of the Court, which the Swiss Confederation committed to take into account pursuant to Article 16(2) of the AFMP. In addition, the Swiss authorities are failing to comply with the principle of reciprocity. The applicant asserts that the grounds of the judgment of the TAF of 19 March 2018 justifying the discrimination at issue in the light of <mask> objectives are vitiated by an error of law in the light of the case-law of the Court and are not valid in scientific terms. In any event, the need clause infringes the principle of proportionality. The applicant adds that the discrimination at issue is exacerbated in his regard by the fact that his experience at SOS médecins of Geneva cannot be taken into account by way of an exemption from the need clause, and by application, within the public authorities of the canton of Geneva, of a directive requiring that preference be given to employing local jobseekers over cross-border workers. Given the uncertainty as to his ability to continue practising within SOS médecins of Geneva, he has been placed in a situation of legal uncertainty.


In accordance with the principle of proportionality, the measures provided for in this Directive are strictly limited to the minimum needed to achieve the objective of the proper functioning of the internal market; where action at Community level is necessary, and in order to guarantee an area which is truly without internal frontiers as far as electronic commerce is concerned, the Directive must ensure a high level of protection of objectives of general interest, in particular the protection of minors and human dignity, consumer protection and the protection of <mask>; …


122. In those circumstances, and should the Court conclude, contrary to my suggestion above, that the prohibition at issue constitutes a restriction to trade caught by Article 34 TFEU, I consider that that prohibition is justified by the objective of protecting <mask> and the environment, is appropriate to attain that objective, and does not go beyond what is necessary to achieve it. V. Conclusion


As is clear from the case-law recalled in paragraph 23 of this judgment, it is for the Member Stated concerned, in this connection, to adopt a comprehensive legislative framework, which may include, in accordance with Article 16(1)(b) and (c) of the Habitats Directive, measures intended to prevent serious damage, in particular to crops or livestock, or measures adopted in the interests of <mask> and public safety, or for other imperative reasons of overriding public interest, including those of a social or economic nature.


In particular, it is apparent from those factors — and above all from the decision of the competent judge authorising on-the-spot investigations in respect of a series of natural persons, adopted on 4 March 2018 — that the investigations by the Brazilian Federal Police and the judicial authorities relate to extensive cases of fraud in the form of falsifications linked to the certification of products of animal origin with the participation of high-ranking staff and the knowledge of members of the applicants’ board of directors. That decision refers to conduct within the group to which the applicants belong aimed at frustrating the <mask> control system by means of falsified certificates. In that context, the fact, assuming it were established, that, at the time when that document was drawn up, a single establishment appearing until that point on the lists at issue was directly concerned, namely the establishment bearing approval number 1001, does not affect the Commission’s assessment on the scale of the threat posed by such conduct and, consequently, on the reliability of the guarantees provided by the Brazilian authorities specifically against that type of threat. Moreover, as the Commission submits, the fully integrated nature of that group means that their products must move from one establishment to another in order to undergo the necessary processing operations. In addition, the possible involvement of members of the board of directors and of the applicants’ senior staff does not permit a conclusion to be drawn with certainty, while the investigation is still ongoing, that the conduct complained of is confined to a single establishment.


A has put forward a series of less restrictive measures which, in its view, would make it possible to achieve the desired aim of protecting <mask> with the same effectiveness. In particular, it argues, the Decree on best practice in the dispensing of medicinal products already ensures that patients can benefit from individual advice by requiring virtual pharmacies to provide them with the possibility of an interactive exchange with a pharmacist. A states that it also monitors the quantities ordered via its website on the basis of various factors, including the patient’s order history. Those controls are claimed to be sufficient to prevent the risk of overconsumption of medicinal products. The Commission also considers that giving a patient access to the package leaflet, reminding him of the main contra-indications and giving him the option of questioning a pharmacist before placing an order, as well as the possibility of pharmacists contacting a patient on the basis of the information available to them and in particular the order history, constitute less restrictive alternative measures.


In those circumstances, I propose that the Court’s answer to the first question should be that <mask> care benefits, such as those at issue in the main proceedings, which are granted to recipients without any individual and discretionary assessment of personal needs, on the basis of a legally defined situation, do not come within the concept of ‘social and medical assistance’ within the meaning of Article 3(5)(a) of Regulation No 883/2004, but come within the concept of ‘sickness benefits’ within the meaning of Article 3(1)(a) of that regulation.


I note that the Court adopted that approach in the judgment of 25 July 2002, MRAX,   on the right of residence of a third-country national, the spouse of a national of a Member State. It recognised that, in view of the importance attached by the EU legislature to the protection of family life,   a Member State cannot, without infringing the principle of proportionality, send back at the border a third-country national who is married to a national of a Member State and attempts to enter its territory without being in possession of a valid identity card or passport or, if necessary, a visa, where that national is able to prove his or her identity and the conjugal ties and there is no evidence to establish that he or she represents a risk to the requirements of public policy, public security or <mask> within the meaning of Article 10 of Directive 68/360/EEC   and Article 8 of Directive 73/148.


the supply of services and of goods closely linked to social security, welfare or <mask>, carried out by bodies governed by public law, mutual investment funds, public bodies or those of public interest, care homes, old peoples’ homes, gerontological or geriatric institutions, hospital or charitable organisations and other similar private sector institutions, where those bodies are recognised by the competent public authorities as being devoted to social wellbeing;


In addition, the decision whether or not to grant an MA, which must be founded on a high standard of <mask> protection, must be taken solely on the basis of the criteria of safety and efficacy arising from the relevant provisions of EU law. While it cannot be excluded that an MA applicant may rely on pre- and post-marketing data concerning third countries, no argument can be inferred, in absolute terms, from the fact that an MA has been granted in those countries (see, by analogy, as regards the grant of the status of orphan medicinal product, judgment of 9 September 2010, Now Pharm v Commission, T‑74/08, EU:T:2010:376, paragraph 57).


Article 23(1)(e) of that regulation, which reproduces and amends the provision formerly set out in Article 13(1)(e) of that directive, states that Union or Member State law may restrict by way of a legislative measure the scope of the obligations and rights provided for in, inter alia, Articles 13 to 15 thereof when such a restriction respects the essence of the fundamental rights and freedoms and is a necessary and proportionate measure in a democratic society to safeguard certain important objectives of general public interest, in particular an important economic or financial interest of the Union or of a Member State, including monetary, budgetary and taxation matters, <mask> and social security.


Although it is admittedly a close call, in the light of all the legal and factual elements in the case file, I would, on balance, be inclined to give a positive answer to that question. The contested regulation indeed has an impact on the way in which the respondents are able lawfully to exercise their specific powers in the area of environmental protection and the protection of <mask> when tackling pollution and ensuring the appropriate standards of air quality, as they are legally obliged to do.


In this sense falling under Article 34 TFEU in principle, while it certainly can still be justified under both, protection of the environment and/or of <mask>, if proportionate – see judgment of 4 June 2009, Mickelsson and Roos (C‑142/05, EU:C:2009:336, paragraphs 31 to 40), and of 10 February 2009, Commission v Italy (C‑110/05, EU:C:2009:66, paragraphs 59 to 69). See also judgment of 21 December 2011, Commission v Austria (C‑28/09, EU:C:2011:854, paragraphs 125 and 140).


The third question raised by the referring court seeks to assess the proportionality of a system of day fines, such as that provided for by the Finnish Criminal Code, in the light of Article 27(2) of Directive 2004/38. That article concerns the justifications for restrictions on freedom of movement on grounds of public policy, public security or <mask>. According to the Court, failure to comply with legal formalities pertaining to persons’ access, movement and residence does not by itself constitute a threat to public policy or security.


The referring court considers that it is necessary to assess the applicant’s specific situation. It emphasises, in particular, that A moved to Latvia to join his family, that he was employed in Italy, that he has sought work in Latvia and that he has, in that Member State, two infant children with dual Latvian and Italian nationality. In its view, those factors argue in favour of the existence of close personal links between the applicant and the Republic of Latvia that do not allow him to be automatically excluded from affiliation to its <mask> system.


19 Under Paragraph 3 of Law No 100/2001, in the version in force at the time of the facts in the main proceedings, for the purposes of that law: ‘… (c) the territory concerned is the territory whose environment and population could be subject to a significant effect in the event of the implementation of the project or plan; (d) the self-governing territorial unit concerned is the self-governing territorial unit whose administrative district encompasses at least a part of the territory concerned; … (i) the part of public concerned … 2. A legal entity under private law whose line of business is, pursuant to its legal deed of establishment, environmental protection or protection of <mask> and whose main line of business is not enterprise or another gainful activity, which was established at least three years prior to the date of the publication of information concerning the follow-up proceedings referred to in Paragraph 9b(1) or prior to the date of the adoption of a decision pursuant to Paragraph 7(6), or which is supported by the signatures of at least 200 persons.’


The seemingly persistent and widespread use of fixed-term working to meet staffing needs within the <mask> service in the Comunidad de Madrid (Autonomous Community of Madrid) is sharply criticised by the referring courts at points in both requests for a preliminary ruling. They have now addressed a total of 16 questions to the Court to clarify their powers to penalise possible abuse arising from the use of successive fixed-term employment relationships in accordance with Clause 5 of the Framework Agreement on fixed-term work of 18 March 1999 (‘the Framework Agreement’).


That is why Directive 2001/83 lays down precise rules governing the advertising of medicinal products. The resulting limitation on the freedom of pharmaceutical companies to conduct business is fully justified by what is an essential objective in EU law, namely, as already indicated, that of protecting <mask>. The provisions of Directive 2001/83 must therefore be read in the light of that objective.


Although, in paragraph 39 of that judgment, the Court concluded that the advertising scheme at issue in that case was inconsistent and therefore unsuitable for ensuring the attainment of its objective relating to the protection of <mask>, on the ground that it included a prohibition on advertising for medical and surgical treatments on national television channels, while offering the possibility of broadcasting such advertising on local television channels, such a conclusion is clearly explained by the fact that, as far as advertising for such treatments is concerned, that objective of protecting public health was equally relevant whether such advertising was broadcast on national or local television channels.


By virtue of Article 20(2) of Regulation No 883/2004, the Member State of affiliation must bear the costs of that healthcare in the Member State of treatment, whereas in the case of Articles 7 and 8 of Directive 2011/24, the obligations of the Member State of affiliation are simply to discharge the costs which its <mask> system would have had to bear anyway had the treatment been carried out in that Member State.


‘Member States may, to the extent justified by national security, public safety, <mask>, security of transport, protection of the environment, protection of biological resources and of national treasures possessing artistic, historic or archaeological value, safety of installations and of workers, planned management of hydrocarbon resources (for example the rate at which hydrocarbons are depleted or the optimisation of their recovery) or the need to secure tax revenues, impose conditions and requirements on the exercise of the activities set out in Article 2(1).’


The French Government argues that the purpose of Article R. 4235‑22 of the <mask> Code is, as its wording indicates, to protect the dignity of the profession of pharmacist. That purpose, it submits, contributes to the pursuit of the wider objective of protecting public health. Article R. 4235‑64 of that code seeks to prevent the excessive or inappropriate use of medicinal products and, therefore, also works to protect public health.


In my view, the alleged absence of a proven causal link between prohibiting paid referencing and preventing the risk that a significant number of pharmacies may disappear in isolated areas cannot, in itself, preclude the appropriateness of that prohibition for attaining the objective relied upon. According to the case-law, where there is uncertainty as to the existence or extent of risks to human health – including, more specifically, risks to the supply of safe and high quality medicinal products to the population – the Member State in question is entitled to take protective measures without having to wait until the reality of those risks becomes fully apparent. In such a situation, that Member State may take the measures that reduce, as far as possible, the risks to <mask>.


It is apparent from the case file submitted to the Court that the Decree of 28 November 2016 of the Minister for Social Affairs and Health on best practice in the dispensing of medicinal products in dispensing pharmacies, mutual pharmacies and emergency mining pharmacies referred to in Article L. 5121‑5 of the <mask> Code (JORF of 1 December 2016, text no 25; ‘the Decree on best practice in the dispensing of medicinal products’) contains an annex, Section 7 of which, entitled ‘Supplementary rules applicable to the electronic commerce of medicinal products’, provides in its point 7.1, entitled ‘Pharmaceutical advice’: