1 This request for a preliminary ruling concerns the interpretation of Articles 70 to 73 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), as amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 (OJ 2012 L 299, p. 1) (‘Directive 2001/83’), and of Article 36 TFEU.
2 The request has been made in proceedings between Pharma Expressz Szolgáltató és Kereskedelmi Kft. (‘Pharma Expressz’) and Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (National Institute of Pharmacy and Nutrition, Hungary; ‘the Institute’) concerning the sale in Hungary of a medicinal product which does not have a marketing authorisation in that Member State but does have such an authorisation in another Member State of the European Economic Area (EEA) where it is dispensed without medical prescription.
3 Recital 12 of Directive 2001/83 states: ‘With the exception of those medicinal products which are subject to the centralized Community authorization procedure established by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products [(OJ 1993 L 214, p. 1)], a marketing authorization for a medicinal product granted by a competent authority in one Member State ought to be recognized by the competent authorities of the other Member States unless there are serious grounds for supposing that the authorization of the medicinal product concerned may present a risk to public health. …’
4 Under recital 30 of that directive: ‘In this connection persons moving around within the Community have the right to carry a reasonable quantity of medicinal products lawfully obtained for their personal use. It must also be possible for a person established in one Member State to receive from another Member State a reasonable quantity of medicinal products intended for his personal use.’
5 Article 5(1) of that directive is worded as follows: ‘A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his direct personal responsibility.’
6 Article 6(1), first subparagraph, of that directive provides: ‘No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004 [of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1)], read in conjunction with Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use [and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ 2006 L 378, p. 1)], and Regulation (EC) No 1394/2007 [of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ 2007 L 324, p. 121)].’
7 Article 70 of Directive 2001/83 provides: ‘1. When a marketing authorization is granted, the competent authorities shall specify the classification of the medicinal product into: - a medicinal product subject to medical prescription, - a medicinal product not subject to medical prescription. To this end, the criteria laid down in Article 71(1) shall apply. 2. The competent authorities may fix sub-categories for medicinal products which are available on medical prescription only. In that case, they shall refer to the following classification: (a) medicinal products on medical prescription for renewable or non-renewable delivery; (b) medicinal products subject to special medical prescription; (c) medicinal products on “restricted” medical prescription, reserved for use in certain specialised areas.’
8 Under Article 71 of that directive: ‘1. Medicinal products shall be subject to medical prescription where they: - are likely to present a danger either directly or indirectly, even when used correctly, if utilized without medical supervision, or - are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health, or - contain substances or preparations thereof, the activity and/or adverse reactions of which require further investigation, or - are normally prescribed by a doctor to be administered parenterally. 2. Where Member States provide for the sub-category of medicinal products subject to special medical prescription, they shall take account of the following factors: - the medicinal product contains, in a non-exempt quantity, a substance classified as a narcotic or a psychotropic substance within the meaning of the international conventions in force, such as the United Nations Conventions of 1961 and 1971, or - the medicinal product is likely, if incorrectly used, to present a substantial risk of medicinal abuse, to lead to addiction or be misused for illegal purposes, or - the medicinal product contains a substance which, by reason of its novelty or properties, could be considered as belonging to the group envisaged in the second indent as a precautionary measure. 3. Where Member States provide for the sub-category of medicinal products subject to restricted prescription, they shall take account of the following factors: - the medicinal product, because of its pharmaceutical characteristics or novelty or in the interests of public health, is reserved for treatments which can only be followed in a hospital environment, - the medicinal product is used in the treatment of conditions which must be diagnosed in a hospital environment or in institutions with adequate diagnostic facilities, although administration and follow-up may be carried out elsewhere, or - the medicinal product is intended for outpatients but its use may produce very serious adverse reactions requiring a prescription drawn up as required by a specialist and special supervision throughout the treatment. 4. A competent authority may waive application of paragraphs 1, 2 and 3 having regard to: (a) the maximum single dose, the maximum daily dose, the strength, the pharmaceutical form, certain types of packaging; and/or (b) other circumstances of use which it has specified. 5. If a competent authority does not designate medicinal products into sub-categories referred to in Article 70(2), it shall nevertheless take into account the criteria referred to in paragraphs 2 and 3 of this Article in determining whether any medicinal product shall be classified as a prescription-only medicine.’
9 Article 72 of that directive is worded as follows: ‘Medicinal products not subject to prescription shall be those which do not meet the criteria listed in Article 71.’
10 Article 73 of that directive provides: ‘The competent authorities shall draw up a list of the medicinal products subject, on their territory, to medical prescription, specifying, if necessary, the category of classification. They shall update this list annually.’
11 Article 85c of Directive 2001/83 provides: ‘1. Without prejudice to national legislation prohibiting the offer for sale at a distance of prescription medicinal products to the public by means of information society services, Member States shall ensure that medicinal products are offered for sale at a distance to the public by means of information society services as defined in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services [(OJ 1998 L 204, p. 37), as amended by Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998 (OJ 1998 L 217, p. 18)] under the following conditions: (a) the natural or legal person offering the medicinal products is authorised or entitled to supply medicinal products to the public, also at a distance, in accordance with national legislation of the Member State in which that person is established; (b) the person referred to in point (a) has notified the Member State in which that person is established of at least the following information: (i) name or corporate name and permanent address of the place of activity from where those medicinal products are supplied; (ii) the starting date of the activity of offering medicinal products for sale at a distance to the public by means of information society services; (iii) the address of the website used for that purpose and all relevant information necessary to identify that website; (iv) if applicable, the classification in accordance with Title VI of the medicinal products offered for sale at a distance to the public by means of information society services. Where appropriate, that information shall be updated; (c) the medicinal products comply with the national legislation of the Member State of destination in accordance with Article 6(1); …’
12 Paragraph 25(2) of the emberi alkalmazásra kerülő gyógyszerekről és egyéb, a gyógyszerpiacot szabályozó törvények módosításáról szóló 2005. évi XCV. törvény (Law XCV of 2005 on medicinal products for human use and amending other laws governing the market in medicinal products; ‘Law on medicinal products’) provides: ‘Medicinal products that do not have a marketing authorisation in a State which is a party to the [Agreement on the European Economic Area (EEA)] but do have a marketing authorisation in another country may be used for medical purposes in special cases where their use is justified in the pursuit of an interest relating to patient care to which particular regard must be had and where the State pharmaceutical administrative body has authorised their use in accordance with the specific conditions laid down in a special provision. Medicinal products that have a marketing authorisation in a State which is a party to the EEA Agreement may be used for medical purposes if they have been notified to the State pharmaceutical administrative body in accordance with a special provision. The assessment of an interest relating to patient care to which particular regard must be had shall be carried out, where necessary, in the light of the professional association’s opinion concerning the safety and effectiveness of the therapeutic procedure.’
13 Paragraph 3(5) of the emberi felhasználásra kerülő gyógyszerek rendeléséről és kiadásáról szóló 44/2004. EszCsM rendelet (Ministry of Health, and Social and Family Affairs Regulation 44/2004 on prescribing and dispensing medicinal products for human use) of 28 April 2004 (‘Ministerial Regulation 44/2004’), in force until 13 February 2018, provided: ‘In accordance with Paragraph 25(2) of the Law on medicinal products, medical practitioners may prescribe medicinal products which are not authorised to be placed on the market in Hungary but which are authorised to be placed on the market in another Member State of the [EEA], or in a State which has the same legal status as that held by Member States of the EEA pursuant to an international treaty concluded with the European Community or the EEA …, only if, before prescribing those medicinal products, they lodge a notification with the Institute and they obtain a declaration from that Institute …’
14 Under Paragraph 12/A of that regulation: ‘In the context of the direct supply of medicinal products to the public, pharmacists may supply medicinal products prescribed in accordance with Paragraph 3(5) and Paragraph 4(1) only after lodging a copy of the declaration issued by the Institute.’
15 Paragraph 5 of the emberi felhasználásra kerülő gyógyszerek egyedi rendelésének és felhasználásának engedélyezéséről szóló 448/2017. Korm. Rendelet (Government Regulation 448/2017 on authorisation of the prescription and individual use of medicinal products for human use) of 27 December 2017, in force since 1 January 2018, is worded as follows: ‘1. In accordance with Paragraph 25(2) of the Law on medicinal products, medical practitioners may prescribe medicinal products which are not authorised to be placed on the market in Hungary but which are authorised to be placed on the market in another Member State of the EEA, or in a State which has the same legal status as that held by Member States of the EEA pursuant to an international treaty concluded with the European Community or the EEA …, only if, before prescribing those medicinal products, they lodge a notification with the Institute and they obtain a declaration from that Institute concerning the following matters: (a) whether the medicinal product which the medical practitioner wishes to prescribe has a marketing authorisation in a Member State of the EEA or in a State party to an EEA treaty identified by the medical practitioner, in relation to the pharmaceutical indications given by that practitioner, (b) whether the competent authority has withdrawn the marketing authorisation for the medicinal product which the medical practitioner wishes to prescribe or suspended its distribution, and (c) whether, in the medical practitioner’s opinion and based on information provided by the medical practitioner, there is an interest relating to patient care to which particular regard must be had, as defined in Paragraph 1(23) of the Law on medicinal products. 2. Medical practitioners shall request that the declaration referred to in subparagraph 1 be issued on the data sheet included in Annexes 3 to 5 to Ministerial Regulation 44/2004. The Institute shall notify the medical practitioner who is prescribing the medicinal product of its opinion on the matters set out in subparagraph 1 within eight working days of receipt of the data sheet. 3. Where the Institute issues a declaration according to which the conditions set out in subparagraph 1 are satisfied, the medical practitioner shall give the patient - in the case of a prescription-only medicine - a copy of the declaration from that Institute together with the prescription. 4. Where the Institute issues a declaration according to which, in its opinion, there is no interest relating to patient care to which particular regard must be had, as defined in Paragraph 1(23) of the Law on medicinal products, the medical practitioner shall give the patient - if the practitioner considers that it is necessary to prescribe the medicinal product and it is a prescription-only medicine - a copy of the declaration from that Institute together with the prescription and shall provide the patient with information concerning the contents of the declaration and its possible consequences.’
16 The Institute, in its capacity as the authority with competence for overseeing the distribution of medicinal products, found that the Pharma Expressz had, on a number of occasions, imported from another EEA Member State a medicinal product which does not have a marketing authorisation in Hungary, but which was registered in that other EEA Member State as a medicinal product that could be dispensed as a medical prescription.
17 The Institute considered that such a medicinal product can be used for medical purposes if it has been notified to the Institute by the medical practitioner who is prescribing the medicinal product and who should obtain a declaration from it regarding its use.
18 By decision of 7 March 2019, the Institute ordered Pharma Expressz to refrain from marketing medicinal products ordered from another Member State where they were not subject to medical prescription, without requiring such a medical prescription and a declaration from the Institute to order and dispense those products. It found that such conduct breached Paragraph 12/A of Ministerial Regulation 44/2004.
19 Pharma Expressz brought an action against that decision before the Fővárosi Törvényszék (Budapest High Court, Hungary) seeking a declaration that it had not committed any offence in the context of the individual acquisition of medicinal products.
20 Pharma Expressz submits that the interpretation of Hungarian law adopted by the Institute constitutes a quantitative restriction on imports contrary to Article 34 TFEU which cannot be justified in the interests of the objective of protecting the health and life of humans laid down in Article 36 TFEU, and that the declaration from the Institute, necessary for the import of medicinal products, does not serve to protect the health of humans.
21 It argues that the requirement for a declaration is disproportionate because, in particular, the EEA Member State has authorised the medicinal product concerned and has classified it in the category of medicines which can be acquired without a prescription in accordance with criteria which are compatible with the harmonised provisions and principles of the European Union. In some Member States, patients can order directly, in pharmacies, medicines not subject to medical prescription, which are on the market in another Member State, because the classification of medicinal products carried out by the other Member State is accepted.
22 The Institute contends that the Hungarian legislation at issue in the main proceedings constitutes a quantitative restriction on imports which can be justified by the aim of protecting the health and life of humans who rank foremost among the assets protected by the TFEU. It states that the Member States are competent to determine the level of protection which they wish to afford to public health in relation to the supply of medicinal products.
23 The Institute ensures that the population has access to safe medicines by gathering information from equivalent authorities of the Member States concerning the use of foreign medicinal products for medical purposes, concerning whether a marketing authorisation exists and concerning whether it can be used in relation to the pharmaceutical indications given by the medical practitioner.
24 It states that, as long as a medicinal product does not have a marketing authorisation in Hungary, it is not possible to determine whether it can be supplied with or without a medical prescription, which explains why it did not examine which category the imported medicinal products in the present case were classified under in the Member State of origin.
25 The referring court considers it necessary to determine whether the fact that Directive 2001/83 lays down uniform principles for the classification of medicinal products imposes on a Member State an obligation to accept unconditionally the classification carried out by another Member State and to treat that medicine in the same way as medicinal products which have a national marketing authorisation in the first of those States.
26 In the light of the Court’s case-law, the referring court considers that the Hungarian legislation at issue in the main proceedings constitutes a measure restricting the free movement of goods, thus requiring an interpretation of Article 36 TFEU in order to determine whether that measure can be justified by the protection of the health and life of humans.
27 It notes that the restriction introduces two additional requirements to those laid down in respect of medicinal products which have a national marketing authorisation and which can be supplied without a medical prescription, namely a declaration from the Institute and the existence of a medical prescription.
28 The referring court asks whether it is justified that the use of a medicinal product which has been classified in another Member State as a medicinal product not subject to medical prescription is allowed only as part of treatment provided by a doctor.
29 The referring court notes that the declaration from the Institute contains, on the one hand, information that is important from the perspective of public health and the patient, obtained from the equivalent authority of the other Member States, which may not be directly consulted by the patient, the medical practitioner and the pharmacy, and, on the other, the authority’s opinion concerning whether there is an interest relating to patient care, but which is a professional medical question.
30 It considers that the declaration from the Institute contains relevant information from the point of view of the safety of medicinal products which must be brought to the attention of the patient before the medicine is ordered.
31 Lastly, the referring court notes that, for health protection purposes, it is important to know the length of time which it takes to obtain the declaration, but that it does not have any information in that regard. The legislation lays down a time limit of eight days to receive that declaration, whereas Pharma Expressz refers to an instance in which the declaration took three months.
32 In those circumstances the Fővárosi Törvényszék (Budapest High Court) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling: ‘(1) Does an obligation flow from Articles 70 to 73 of Directive 2001/83 to regard a medicinal product which can be dispensed without medical prescription in one Member State as a medicinal product which can also be dispensed without medical prescription in another Member State, including where, in that other Member State, the medicinal product in question does not have a marketing authorisation and has not been classified? (2) Is a quantitative restriction which makes the possibility of ordering and dispensing to a patient a medicinal product which does not have a marketing authorisation in one Member State but does have such an authorisation in another Member State … conditional on the existence of a medical prescription and a declaration from the pharmaceutical authority, including where the medicinal product is registered in the other Member State as a medicinal product not subject to medical prescription, justified in the interests of protection of the health and life of humans, as referred to in Article 36 TFEU?’
33 By its first question, the referring court asks, in essence, whether Articles 70 to 73 of Directive 2001/83 must be interpreted as meaning that a medicinal product which can be supplied without medical prescription in one Member State must also be considered to be a medicinal product which can be supplied without medical prescription in another Member State where, in that other Member State, the medicinal product in question does not have a marketing authorisation and has not been classified.
34 As is apparent from the order for reference, the referring court starts from the premiss that Articles 70 to 73 of Directive 2001/83 lay down uniform principles for the classification of medicinal products, from which it follows that the supply of certain medicinal products is subject to medical prescription and that the supply of other medicinal products is not subject to such a requirement. The referring court therefore asks whether a Member State is obliged to accept the classification of a medicinal product determined by another Member State.
35 It should be noted that Directive 2001/83 contains a general rule set out in Article 6(1) according to which no medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State or by the European Commission, in application of the centralised procedure established by Regulation No 726/2004. It follows that, in order to be marketed in such a Member State, medicinal products must first have obtained prior marketing authorisation, in accordance with the procedures laid down in that directive (judgment of 20 September 2007, Antroposana and Others, C‑84/06, EU:C:2007:535, paragraph 35), or in accordance with the centralised procedure established by Regulation No 726/2004.
36 In addition, Directive 2001/83 also contains provisions which make it possible, under exhaustively listed conditions, to derogate from the rule set out in Article 6(1), for example as provided in Article 5(1) of that directive which gives a Member State the possibility to exclude the marketing of certain medicinal products from the provisions of that directive.
37 Consequently, it is necessary to reword the first question and to consider that the referring court asks, in essence, whether Articles 70 to 73 of Directive 2001/83, read in the light of Article 5(1) and Article 6(1) of that directive, must be interpreted as meaning that they preclude a medicinal product which can be supplied without medical prescription in one Member State from also being considered a medicinal product which can be supplied without medical prescription in another Member State where, in that other Member State, the medicinal product in question does not have a marketing authorisation and has not been classified.
38 In the first place, Articles 70 to 73 of Directive 2001/83 appear in Title VI of that directive, which is entitled ‘Classification of Medicinal Products’, a process which takes place in the wider context of the marketing authorisation procedure, as highlighted, moreover, by the first provision in that title - Article 70(1), first subparagraph, of that directive - which states that ‘when a marketing authorisation is granted, the competent authorities shall specify the classification of the medicinal product into … a medicinal product subject to medical prescription [or] a medicinal product not subject to medical prescription’.
39 It follows from that provision that the competent authority in a Member State may carry out such a classification only after a marketing authorisation has been granted for the marketing of that product in that Member State.
40 As Advocate General Szpunar noted in point 46 of his Opinion, Article 6(1) of Directive 2001/83 implies that the Member States must, in principle, prohibit entirely the marketing of medicinal products which are not covered by a marketing authorisation granted by a Member State, under that directive, or by the Commission, in accordance with the centralised procedure established by Regulation No 726/2004 (see, to that effect, judgments of 11 December 2003, Deutscher Apothekerverband, C‑322/01, EU:C:2003:664, paragraph 52, and of 8 November 2007, Ludwigs-Apotheke, C‑143/06, EU:C:2007:656, paragraph 19).
41 Consequently, if a medicinal product does not have a marketing authorisation granted by the competent authority of the Member State in which it is offered for sale or a marketing authorisation granted in accordance with the centralised procedure, it cannot be marketed in that Member State and the process for the classification of medicinal products provided for in Articles 70 to 73 of Directive 2001/83 is irrelevant in that regard.
42 With regard to the procedure for the mutual recognition of a marketing authorisation, referred to, in essence, in recital 12 of Directive 2001/83 and which appears in Chapter 4 of Title III of that directive, it must be noted that it is carried out under strict conditions and that it is conditional on an application from the marketing authorisation holder for a given medicinal product in a Member State with a view to recognising the marketing authorisation in other Member States, a situation which does not fit in with the circumstances of the case in the main proceedings.
43 In the second place, the principle set out in Article 6(1) of Directive 2001/83 may be subject to exceptions, as stated in paragraph 36 above.
44 In that regard, the national provisions at issue in the main proceedings, as submitted by the Institute and Hungary in the proceedings before the Court, appear to transpose Article 5(1) of Directive 2001/83 into Hungarian law.
45 By excluding the application of the other provisions of Directive 2001/83, Article 5(1) of that directive has the effect of allowing, in order to meet special needs, the dispensation of medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his or her direct personal responsibility.
46 Accordingly, in line with Article 5(1) of Directive 2001/83, it is possible to supply a medicinal product in a Member State without that medicinal product having been issued a marketing authorisation there.
47 Consequently, Articles 70 to 73 of Directive 2001/83, read in the light of Article 5(1) and Article 6(1) of that directive, must be interpreted as meaning that, without prejudice to the implementation of the derogation provided for in Article 5(1), they preclude a medicinal product which can be supplied without medical prescription in one Member State from also being considered a medicinal product which can be supplied without medical prescription in another Member State where, in that other Member State, the medicinal product in question does not have a marketing authorisation and has not been classified.
48 In the third place, the arguments put forward by the applicant in the main proceedings do not call that finding into question.
49 First, with regard to the possibility for a natural person to purchase a medicinal product in a Member State other than his or her Member State of residence, it is true that, as noted by Advocate General Szpunar in point 57 of his Opinion, recital 30 of Directive 2001/83 states that: ‘persons moving around within the [European Union] have the right to carry a reasonable quantity of medicinal products lawfully obtained for their personal use’. However, the very specific situation established by that directive does not correspond to the situation where a pharmacist established in a Member State dispenses a medicinal product which does not have a marketing authorisation in that Member State but does have such authorisation in another Member State. Recital 30 refers to the situation of a resident of a Member State who goes to another Member State and acquires a medicinal product there and brings it back to his or her Member State of residence.
50 Second, medicinal products purchased by a person in a Member State other than that in which he or she resides, by means of a courier service, are, in principle, subject to the obligation laid down in Article 6(1) of Directive 2001/83. Nevertheless, in the light of recital 30 of that directive, the Court has accepted that a Member State may provide for the possibility of such a purchase, even if the medicinal products in question do not have a marketing authorisation in the consumer’s Member State of residence, as this implements the derogation provided for in Article 5(1) of Directive 2001/83 and provided it complies with the conditions set out therein, that is to say it corresponds to the placing on the market of a limited quantity of medicinal products in the context of an individual order justified by special needs (see, to that effect, judgment of 8 November 2007, Ludwigs-Apotheke, C‑143/06, EU:C:2007:656, paragraphs 21 and 22).
51 However, that situation does not appear to correspond to the one at issue in the main proceedings.
52 Third, the applicant in the main proceedings also puts forward the possibility, for a person resident in a Member State, to purchase medicinal products over the Internet.
53 In that regard, it should be noted that, where the offer for sale at a distance of medicinal products to the public is not prohibited by the legislation of the Member State of destination of the medicinal products in question, those products must, under Article 85c(1)(c) of Directive 2001/83, comply with the national legislation of that Member State in accordance with Article 6(1) of that directive. The supply of medicinal products over the Internet is therefore possible only if they have a marketing authorisation in the Member State of destination.
54 It follows that the provisions relating to the offer for sale at a distance of medicinal products to the public are not capable of having any effect on the conclusion reached by the Court in paragraph 47 above.
55 Lastly, the applicant in the main proceedings considers that Directive 2001/83 does not harmonise completely the sale of medicinal products to end consumers, so that Article 6(1) of that directive is irrelevant.
56 It is true that the Court has held that national legislation relating to certain conditions for the supply of medicinal products does not fall within a harmonised area of EU law (judgment of 18 September 2019, VIPA, C‑222/18, EU:C:2019:751, paragraph 56).
57 However, in doing so, the Court ruled only with regard to the material conditions for the supply of medicinal products, such as, in particular, in the case which gave rise to that judgment, the conditions for recognising documents issued by health professionals and submitted to pharmacies for the supply of medicinal products for use by their patients or clients.
58 It cannot therefore be inferred from the judgment of 18 September 2019, VIPA (C‑222/18, EU:C:2019:751), that the supply, in a Member State, of medicinal products which do not have a marketing authorisation in that Member State could be exempt from the rules laid down in Directive 2001/83 in that regard, in particular the rule set out in Article 6(1) of that directive. So far as concerns the registration and marketing authorisation of medicinal products for human use, that directive established a comprehensive regulatory framework.
59 Consequently, it follows from all of the foregoing considerations that the answer to the first question is that Articles 70 to 73 of Directive 2001/83, read in the light of Article 5(1) and Article 6(1) of that directive, must be interpreted as meaning that, without prejudice to the implementation of the derogation provided for in Article 5(1), they preclude a medicinal product which can be supplied without medical prescription in one Member State from also being considered a medicinal product which can be supplied without medical prescription in another Member State where, in that other Member State, the medicinal product in question does not have a marketing authorisation and has not been classified.
60 By its second question, the referring court asks, in essence, whether Article 36 TFEU must be interpreted as meaning that a quantitative restriction on imports which requires, for the supply of a medicinal product that does not have a marketing authorisation, a medical prescription and a declaration from the competent health authority, is justified in the interests of protecting the health and life of humans, even if that medicinal product is registered in another Member State as one which may be supplied without medical prescription.
61 In order to answer that question, it is necessary to take account of the fact that, as is apparent from paragraph 44 above, the national provisions at issue in the main proceedings, laying down those requirements, appear to transpose Article 5(1) of Directive 2001/83 into Hungarian law.
62 Consequently, it is necessary to reword the second question and to consider that the referring court asks, in essence, whether a national measure transposing Article 5(1) of Directive 2001/83 and which requires, for the supply of a medicinal product that does not have a marketing authorisation, a medical prescription and a declaration from the competent health authority, intended to ensure compliance with the conditions established in that provision, constitutes a quantitative restriction on imports or a measure having equivalent effect, within the meaning of Article 34 TFEU, which may be justified under Article 36 TFEU on grounds related to the protection of the health and life of humans, even if that medicinal product is registered in another Member State as one which may be supplied without medical prescription.
63 At the outset, it should be borne in mind that a national rule whereby a Member State discharges its obligations under Directive 2001/83 cannot be characterised as a quantitative restriction on imports or a measure having equivalent effect within the meaning of Article 34 TFEU (judgment of 11 December 2003, Deutscher Apothekerverband, C‑322/01, EU:C:2003:664, paragraph 53).
64 As Advocate General Szpunar noted in point 93 of his Opinion, implementation of the derogation provided for in Article 5(1) of Directive 2001/83 is conditional on fulfilment of a set of cumulative conditions. In addition, that provision must be interpreted strictly, in so far as the possibility of importing medicinal products which do not have a marketing authorisation, provided for under national legislation implementing the power laid down in that provision, must remain exceptional in order to preserve the practical effect of the marketing authorisation procedure and can be exercised only if that is necessary, taking account of the specific needs of patients (see, to that effect, judgment of 29 March 2012, Commission v Poland, C‑185/10, EU:C:2012:181, paragraphs 30 to 33).
65 It follows that, in order to ensure implementation of the derogation provided for in Article 5(1) of Directive 2001/83, legislation must satisfy the conditions required in that regard, that is to say, inter alia, that medicinal products supplied on the basis of that derogation are necessary to meet special medical needs (see, to that effect, judgment of 29 March 2012, Commission v Poland, C‑185/10, EU:C:2012:181, paragraphs 42 and 43).
66 Only national legislation which is consistent with the derogation, in accordance with the conditions set out in Article 5(1) of Directive 2001/83, and thus correctly transposes that provision, does not constitute a quantitative restriction on imports or a measure having equivalent effect (see, to that effect, judgment of 5 April 2001, Bellamy and English Shop Wholesale, C‑123/00, EU:C:2001:214, paragraph 21).
67 In the present case, the first condition established by Hungarian legislation in order to allow the supply of medicinal products which do not have a marketing authorisation in Hungary concerns the existence of a medical prescription for the product issued by a doctor, who is the only person entitled to approach the Institute for an assessment of an interest relating to patient care to which particular regard must be had, in accordance with Paragraph 25(2) of the Law on medicinal products.
68 In that regard, it should be noted that Article 5(1) of Directive 2001/83 provides for the possibility to derogate from the provisions of that directive in respect of medicinal products ‘formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his direct personal responsibility’.
69 Accordingly, the requirement, provided for by national law, for a medical prescription fulfils the conditions set out in Article 5(1) of Directive 2001/83, provided that the doctor is a health-care professional, within the meaning of that provision, which, as the Court has held, concerns situations in which the doctor plays a crucial role (see, to that effect, judgment of 11 April 2013, Novartis Pharma, C‑535/11, EU:C:2013:226, paragraph 46).
70 The second condition established by Hungarian legislation allows a doctor, by means of the declaration from the Institute, to obtain information on the existence and validity, in another Member State, of a marketing authorisation for the medicinal product the supply of which is envisaged in Hungary, even in the absence of a marketing authorisation in that State. That declaration also contains an opinion of the Institute on whether there is an interest relating to patient care to which particular regard must be had.
71 In that regard, the essential condition for implementing the derogation provided for in Article 5(1) of Directive 20013/83 is that the medicinal product the supply of which is not in line with the general rule set out in Article 6(1) of that directive, according to which the medicinal product must have a marketing authorisation in the Member State of supply, is indeed authorised in another Member State. It should be noted, as pointed out by Advocate General Szpunar in point 107 of his Opinion, that a declaration such as that referred to in the previous paragraph fulfils that condition.
72 Furthermore, the derogation provided for in Article 5(1) of Directive 2001/83 can be used only in the context of ‘special needs’, within the meaning of that provision, which must be taken into account when considering an objective of protecting public health. It therefore appears consistent with that objective that the competent authority may decide, on a case-by-case base, whether there is, in a given situation, a need capable of justifying derogation from the general rule established in Article 6(1) of Directive 2001/83.
73 Consequently, the use of a declaration from the competent authority may provide the doctor with additional advice on the administration of a medicinal product with which he or she is not necessarily familiar. In addition, a national provision providing for the transmission of that declaration to the patient appears to ensure, moreover, transparency of the procedure with regard to the patient.
74 Therefore, a requirement laid down by national law, pursuant to which a declaration from the competent authority is necessary to ensure fulfilment of the conditions set out in Article 5(1) of Directive 2001/83, correctly transposes that provision.
75 Consequently, the answer to the second question is that a national measure transposing Article 5(1) of Directive 2001/83 which requires, for the supply of a medicinal product that does not have a marketing authorisation, a medical prescription and a declaration from the competent health authority intended to ensure compliance with the conditions established in that provision, does not constitute either a quantitative restriction or a measure having equivalent effect, within the meaning of Article 34 TFEU.
76 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.