CELEX: 62001CJ0322
Language: en
Date: 2003-12-11
Title: Judgment of the Court of 11 December 2003.#Deutscher Apothekerverband eV v 0800 DocMorris NV and Jacques Waterval.#Reference for a preliminary ruling: Landgericht Frankfurt am Main - Germany.#Articles 28 EC and 30 EC - Directives 92/28/EEC and 2000/31/EC - National legislation restricting internet sales of medicinal products for human use by pharmacies established in another Member State - Doctor's prescription required for supply - Prohibition on advertising the sale of medicinal products by mail order.#Case C-322/01.

Case C-322/01 Deutscher Apothekerverband eVv0800 DocMorris NV and Jacques Waterval(Reference for a preliminary ruling from the Landgericht Frankfurt am Main (Germany))
         
            «(Articles 28 EC and 30 EC – Directives 92/28/EEC and 2000/31/EC – National legislation restricting internet sales of medicinal products for human use by pharmacies established in another Member
               State – Doctor's prescription required for supply – Prohibition on advertising the sale of medicinal products by mail order)»
            
            
               
                  Opinion of Advocate General Stix-Hackl delivered on 11 March 2003 
                     
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                  Judgment of the Court, 11 December 2003  
                     
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            Summary of the Judgment
         
         
                  1..
                  Free movement of goods – Quantitative restrictions – Measures having equivalent effect – Definition – Prohibition on the sale by mail order of medicinal products the sale of which is restricted to pharmacies – Whether included – Justification limited to medicinal products subject to prescription – Reimportation of medicinal products into the Member State concerned – Not relevant(
                   Arts 28 EC and 30 EC ) 
         
                  2..
                  Approximation of laws – Proprietary medicinal products – Advertising – Prohibition on advertising the sale by mail order of medicinal products the sale of which is restricted to pharmacies – Permissible only in respect of medicinal products subject to prescription(
                   Directive 2001/83/EC of the European Parliament and of the Council, Art. 88 ) 
         
         1.
          Commercial rules which govern the arrangements for the sale of products constitute measures of equivalent effect for the purposes
         of Article 28 EC if they do not apply to all relevant traders operating in national territory and if they do not affect in
         the same manner, in law and in fact, the marketing of both domestic products and those from other Member States. A national prohibition on the sale by mail order of medicinal products the sale of which is restricted to pharmacies in the
         Member State concerned is in that regard a measure having an effect equivalent to a quantitative restriction where the prohibition
         has a greater impact on pharmacies established outside the national territory and could impede access to the market for products
         from other Member States more than it impedes access for domestic products.   Article 30 EC may, however, be relied on to justify such a national prohibition on the sale by mail order of medicinal products
         in so far as the prohibition covers medicinal products subject to prescription. Given that there may be risks attaching to
         the use of these medicinal products, the need to be able to check effectively and responsibly the authenticity of doctors'
         prescriptions and to ensure that the medicine is handed over either to the customer himself, or to a person to whom its collection
         has been entrusted by the customer, is such as to justify a prohibition on mail-order sales. However, Article 30 EC cannot
         be relied on to justify an absolute prohibition on the sale by mail order of medicinal products which are not subject to prescription
         in the Member State concerned. Those findings do not need to be assessed differently where medicinal products are imported into a Member State in which they
         are authorised, having been previously obtained by a pharmacy in another Member State from a wholesaler in the importing Member
         State. see paras 68, 74, 76, 112, 119, 124, 134, operative part 1
         
         2.
          Article 88(1) of Directive 2001/83 on the Community code relating to medicinal products for human use, which prohibits advertising
         for prescription medicines, precludes a national prohibition on advertising the sale by mail order of medicinal products which
         may be supplied only in pharmacies in the Member State concerned in so far as the prohibition covers medicinal products which
         are not subject to prescription. Article 88(2) of the Community Code, which allows medicinal products not subject to prescription to be advertised to the general
         public, cannot be interpreted as precluding advertising for the sale by mail order of medicines on the basis of the alleged
         need for a pharmacist to be physically present, since the prohibition on the sale by mail order cannot itself be justified,
         in relation to non-prescription medicines, by that alleged need. see paras 143-144, 148, operative part 2
      

      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
            
            JUDGMENT OF THE COURT11 December 2003  (1)
         
         
            
         
               ((Articles 28 EC and 30 EC – Directives 92/28/EEC and 2000/31/EC – National legislation restricting internet sales of medicinal products for human use by pharmacies established in another Member
                  State – Doctor's prescription required for supply – Prohibition on advertising the sale of medicinal products by mail order))
               
               
            In Case C-322/01, 
            REFERENCE to the Court under Article 234 EC by the Landgericht Frankfurt am Main (Germany) for a preliminary ruling in the
            proceedings pending before that court between
            
            
            
             Deutscher Apothekerverband eV 
            
            
            and
            
             0800 DocMorris NV,  Jacques Waterval, 
            
            
            on the interpretation of Articles 28 EC and 30 EC and of Article 1(3) and (4) and Articles 2 and 3 of Council Directive 92/28/EEC
            of 31 March 1992 on the advertising of medicinal products for human use (OJ 1992 L 113, p. 13), in conjunction with Directive
            2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services,
            in particular electronic commerce, in the internal market (
            the Directive on electronic commerce) (OJ 2000 L 178, p. 1),
            
            THE COURT,,
            
            composed of: V. Skouris, President, P. Jann, C.W.A. Timmermans, C. Gulmann, J.N. Cunha Rodrigues and A. Rosas (Presidents of Chambers), D.A.O. Edward (Rapporteur), A. La Pergola, J.-P. Puissochet, R. Schintgen, F. Macken, N. Colneric and S. von Bahr, Judges, 
            
            Advocate General: C. Stix-Hackl, Registrar: H.A. Rühl (Principal Administrator), 
            
            
            after considering the written observations submitted on behalf of:
               
               
               ─
               Deutscher Apothekerverband eV, by C. Dechamps, Rechtsanwalt, assisted by J. Schwarze, 
               
               
               ─
               0800 DocMorris NV and J. Waterval, by Professor C. Koenig, 
               
               
               ─
               the German Government, by W.-D. Plessing and B. Muttelsee-Schön, acting as Agents, 
               
               
               ─
               the Greek Government, by F. Georgakopoulos, D. Kalogiros and E.-M. Mamouna, acting as Agents, 
               
               
               ─
               the French Government, by G. de Bergues and R. Loosli-Surrans, acting as Agents, 
               
               
               ─
               the Irish Government, by D.J. O'Hagan, acting as Agent, and N. Hyland, Barrister, 
               
               
               ─
               the Austrian Government, by C. Pesendorfer, acting as Agent, 
               
               
               ─
               the Commission of the European Communities, by J.-C. Schieferer, acting as Agent, assisted by M. Núñez Müller, Rechtsanwalt,
               
               
               
            
            
            having regard to the Report for the Hearing,
            
            after hearing the oral observations of Deutscher Apothekerverband eV, represented by C. Dechamps, assisted by J. Schwarze,
               0800 DocMorris NV and J. Waterval, represented by C. Koenig, the German Government, represented by W.-D. Plessing, the Greek
               Government, represented by D. Kalogiros and M. Apessos, acting as Agent, the French Government, represented by R. Loosli-Surrans,
               and the Commission, represented by J.-C. Schieferer, at the hearing on 10 December 2002,
            
            
            after hearing the Opinion of the Advocate General at the sitting on 11 March 2003,
         gives the following
         
         
         Judgment
         1
            
         By order of 10 August 2001, received at the Court Registry on 21 August 2001, the Landgericht Frankfurt am Main (Regional
         Court, Frankfurt am Main) referred to the Court for a preliminary ruling pursuant to Article 234 EC three questions concerning
         the interpretation of Articles 28 EC and 30 EC and of Article 1(3) and (4) and Articles 2 and 3 of Council Directive 92/28/EEC
         of 31 March 1992 on the advertising of medicinal products for human use (OJ 1992 L 113, p. 13), in conjunction with Directive
         2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services,
         in particular electronic commerce, in the internal market (
         the Directive on electronic commerce) (OJ 2000 L 178, p. 1). 
         
         
         2
            
         Those questions arose in proceedings between (i) Deutscher Apothekerverband eV (
         the Apothekerverband) and (ii) 0800 DocMorris NV (
         DocMorris) and Mr Waterval concerning internet sales of medicinal products for human use in a Member State other than that in which
         DocMorris and Mr Waterval are established. 
         
            
               Legal background
            Community legislation
         Directives regulating the sale of medicinal products
         
         
         3
            
         Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative
         action relating to medicinal products (OJ, English Special Edition 1965-1966, p. 20), as amended by Council Directive 93/39/EEC
         of 14 June 1993 (OJ 1993 L 214, p. 22), (
         Directive 65/65), makes the placing on the market of medicinal products subject to prior authorisation.  Article 3 of the directive provided:
         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 Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation 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].The provisions of this Directive shall not affect the powers of the Member States' authorities either as regards the setting
         of prices for medicinal products or their inclusion in the scope of national health insurance schemes, on the basis of health,
         economic and social conditions.
         
         
         4
            
         With effect from 18 December 2001, Directive 65/65 was repealed and replaced by 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;  
         the Community Code).  Article 6(1) of the Community Code, which is in Title III (
         Placing on the Market), Chapter 1, concerning  
         marketing authorisation, 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 (EEC) No 2309/93.
         Directives concerning the classification for the supply of medicinal products
         
         
         5
            
         Article 2(1) of Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of medicinal products
         for human use (OJ 1992 L 113, p. 5) provided that when the competent authorities of a Member State granted a marketing authorisation
         for a medicinal product, they were to specify its classification as either a medicinal product subject to medical prescription
         or a medicinal product not subject to medical prescription and, to that end, they were to apply the criteria laid down in
         Article 3(1) of the directive.  Under Article 3(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 utilised 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 side effects of which require further investigation, or 
         
         
         
         ─
            are normally prescribed by a doctor to be administered parenterally.
         
         
         
         6
            
         Article 4 of Directive 92/26 provided that medicinal products not subject to medical prescription were those which did not
         meet the criteria listed in Article 3 thereof. The directive was repealed and replaced by the provisions of Title VI of the
         Community Code,  
         Classification of Medicinal Products.  Article 70 of the Code reproduces, in similar terms, Article 2 of Directive 92/26, whilst Articles 71(1) and 72 of the
         Community Code reproduce, likewise in similar terms, Articles 3(1) and 4 of the directive. 
         Directives concerning the advertising of medicinal products
         
         
         7
            
         Article 1(3) and (4) of Directive 92/28 provided: 3. For the purposes of this Directive,  
         advertising of medicinal products shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription,
         supply, sale or consumption of medicinal products; it shall include in particular:
         
         
         ─
            the advertising of medicinal products to the general public, 
         
         
         
         ─
            advertising of medicinal products to persons qualified to prescribe or supply them, 
         
         
         
         ─
            visits by medical sales representatives to persons qualified to prescribe medicinal products, 
         
         
         
         ─
            the supply of samples, 
         
         
         
         ─
            the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus,
            whether in money or in kind, except when their intrinsic value is minimal, 
         
         
         
         ─
            sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products, 
         
         
         
         ─
            sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular
            payment of their travelling and accommodation expenses in connection therewith. 
         
         
         4.
          The following are not covered by this Directive: 
         
         
         
         ─
            the labelling of medicinal products and the accompanying package leaflets, which are subject to the provisions of Directive
            92/27/EEC; 
         
         
         
         ─
            correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a
            particular medicinal product; 
         
         
         
         ─
             factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings
            as part of general drug precautions, trade catalogues and price lists, provided they include no product claims; 
         
         
         
         ─
            statements relating to human health or diseases, provided there is no reference, even indirect, to medicinal products.
         
         
         
         8
            
         Article 2(1) of Directive 92/28 provided: Member States shall prohibit any advertising of a medicinal product in respect of which a marketing authorisation has not
         been granted in accordance with Community law.
         
         
         9
            
         Article 3 of Directive 92/28, in Chapter II thereof, headed  
         Advertising to the general public, provided: 1. Member States shall prohibit the advertising to the general public of medicinal products which:
         
         
         ─
            are available on medical prescription only, in accordance with Directive 92/26/EEC, 
         
         
         
         ─
            contain psychotropic or narcotic substances, within the meaning of the international conventions, 
         
         
         
         ─
            may not be advertised to the general public in accordance with paragraph 2. 
         2. Medicinal products may be advertised to the general public which, by virtue of their composition and purpose, are intended
         and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or
         monitoring of treatment, with the advice of the pharmacist, if necessary....3. Member States shall also be able to ban on their territory advertising to the general public of medicinal products the
         cost of which may be reimbursed.
         
         
         10
            
         Article 5 of Directive 92/28 gives details of the material which may not be contained in any advertising of a medicinal product
         to the general public. 
         
         
         11
            
         Directive 92/28 was also repealed and replaced by the Community Code with effect from 18 December 2001.  Article 86, which
         forms part of Title VIII of the Code (
         Advertising), reproduces Article 1(3) and (4) of the directive in almost identical terms. 
         
         
         12
            
         Article 87 of the Community Code, which replaces Article 2 of Directive 92/28, provides: 1. Member States shall prohibit any advertising of a medicinal product in respect of which a marketing authorisation has not
         been granted in accordance with Community law.2. All parts of the advertising of a medicinal product must comply with the particulars listed in the summary of product characteristics.3. The advertising of a medicinal product:
         
         
         ─
            shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties,
            
         
         
         
         ─
            shall not be misleading.
         
         
         
         13
            
         Article 88 of the Community Code restates Article 3 of Directive 92/28 in similar terms, referring, instead of to Directive
         92/26, to Title VI of the Code concerning the classification of medicinal products.  Under Article 88(1) and (2): 1. Member States shall prohibit the advertising to the general public of medicinal products which:
         
         
         ─
            are available on medical prescription only, in accordance with Title VI, 
         
         
         
         ─
            contain psychotropic or narcotic substances, [within the meaning of the international conventions] ..., 
         
         
         
         ─
            may not be advertised to the general public in accordance with the second subparagraph of paragraph 2. 
         2. Medicinal products may be advertised to the general public which, by virtue of their composition and purpose, are intended
         and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or
         monitoring of treatment, with the advice of the pharmacist, if necessary....
         
         
         14
            
         Article 90 of the Community Code restates Article 5 of Directive 92/28. 
         Directives concerning distance sales and electronic commerce
         
         
         15
            
         Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of
         distance contracts (OJ 1997 L 144, p. 19) regulates distance sales.  According to Article 1 thereof, its object is to approximate
         the laws, regulations and administrative provisions of the Member States concerning distance contracts between consumers and
         suppliers. 
         
         
         16
            
         Article 14 of Directive 97/7 provides: Member States may introduce or maintain, in the area covered by this Directive, more stringent provisions compatible with
         the [EC] Treaty, to ensure a higher level of consumer protection.  Such provisions shall, where appropriate, include a ban,
         in the general interest, on the marketing of certain goods or services, particularly medicinal products, within their territory
         by means of distance contracts, with due regard for the Treaty.
         
         
         17
            
         The directive on electronic commerce seeks to ensure the free movement of information society services between the Member
         States.  The 11th recital in the preamble to the directive states: This Directive is without prejudice to the level of protection for, in particular, public health and consumer interests, as
         established by Community acts; amongst others, ... Directive 97/7 ... form[s] a vital element for protecting consumers in
         contractual matters; ... that same Community  
          acquis , which is fully applicable to information society services, also embraces in particular ... Directive 92/28 ...
         
         
         18
            
         The 21st recital in the preamble to the directive on electronic commerce states: The scope of the coordinated field is without prejudice to future Community harmonisation relating to information society
         services and to future legislation adopted at national level in accordance with Community law; the coordinated field covers
         only requirements relating to on-line activities such as on-line information, on-line advertising, on-line shopping, on-line
         contracting and does not concern Member States' legal requirements relating to goods such as safety standards, labelling obligations,
         or liability for goods, or Member States' requirements relating to the delivery or the transport of goods, including the distribution
         of medicinal products; the coordinated field does not cover the exercise of rights of preemption by public authorities concerning
         certain goods such as works of art.
         
         
         19
            
         Article 1 of the directive on electronic commerce, entitled  
         Objective and Scope, provides at paragraphs (1) to (3): 1. This Directive seeks to contribute to the proper functioning of the internal market by ensuring the free movement of information
         society services between the Member States.2. This Directive approximates, to the extent necessary for the achievement of the objective set out in paragraph 1, certain
         national provisions on information society services relating to the internal market, the establishment of service providers,
         commercial communications, electronic contracts, the liability of intermediaries, codes of conduct, out-of-court dispute settlements,
         court actions and cooperation between Member States.3. This Directive complements Community law applicable to information society services without prejudice to the level of protection
         for, in particular, public health and consumer interests, as established by Community acts and national legislation implementing
         them in so far as this does not restrict the freedom to provide information society services.
         
         
         20
            
         Article 3(2) of the directive provides: Member States may not, for reasons falling within the coordinated field, restrict the freedom to provide information society
         services from another Member State.
         
         
         21
            
         Article 3(4) of the directive provides: Member States may take measures to derogate from paragraph 2 in respect of a given information society service if the following
         conditions are fulfilled:
         
         (a)
         the measures shall be: 
         
         (i)
         necessary for one of the following reasons: 
         
         
         
               ─
                  ... 
               
         
         
         
         
               ─
                  the protection of public health, 
               
         
         
         
         
               ─
                   ... 
               
         
         
         
         (ii)
         taken against a given information society service which prejudices the objectives referred to in point (i) or which presents
         a serious and grave risk of prejudice to those objectives; 
         
         
         (iii)
         proportionate to those objectives.
         
         
         
         
         22
            
         Article 22(1) of the directive on electronic commerce provides that Member States are to bring into force the laws, regulations
         and administrative provisions necessary to comply with the directive before 17 January 2002. 
         National legislation
         The sale of medicinal products
         
         
         23
            
         The sale of medicinal products in Germany is regulated by the Arzneimittelgesetz (Law on Medicinal Products), in the version
         of 7 September 1998 (BGBl. 1998 I, p. 2649;  
         the AMG). 
         
         
         24
            
         Paragraph 43(1) of the AMG prohibits the sale by mail order of medicinal products which may be sold only in pharmacies.  Pursuant
         to that provision: Medicinal products ... which are not freely available for sale other than in pharmacies in accordance with the provisions
         of Paragraph 44 or regulations adopted under Paragraph 45(1) may, except in the cases provided for in Paragraph 47, be marketed
         professionally or commercially to the end consumer only in pharmacies and not by mail order. ..., medicinal products the sale
         of which is restricted to pharmacies in accordance with the first sentence of this subparagraph may not be sold other than
         in pharmacies.
         
         
         25
            
         The AMG lays down a number of exceptions to that prohibition, which do not apply, however, in the case before the national
         court.  Thus, under Paragraph 44 of the AMG, certain medicines which are not intended to serve as medicinal products for human
         use may be sold otherwise than in pharmacies.  Paragraph 45(1) of the AMG enables the competent Federal ministry to authorise
         the release for sale other than in pharmacies of certain preparations.  Paragraph 47 of the AMG provides for exceptions so
         that doctors and hospitals may be supplied directly without recourse to pharmacies. 
         
         
         26
            
         Further, Paragraph 73(1) of the AMG imposes a prohibition in respect of medicinal products which are not in conformity with
         it in the following terms: Medicinal products which are subject to authorisation or registration may be brought into the territory in which this Law
         applies ... only if they are authorised or registered for being placed on the market in that territory, or if they have been
         exempted from the obligation to be so authorised or registered, and subject to the following conditions:
         
         1.
          where the product has been imported from a Member State of the European Communities or from another State party to the Agreement
         on the European Economic Area, the recipient must be a pharmaceutical business, a wholesaler or a veterinarian or must run
         a pharmacy, or 
         
         
         2.
          ...
         
         
         
         27
            
         Paragraph 73(2), point 6a, of the AMG provides for an exception to that prohibition for medicinal products which  
         may be marketed in their country of origin and which have been purchased, without a professional or commercial intermediary,
         in a quantity not exceeding the amount needed for normal personal use in a Member State of the European Community or in another
         State party to the Agreement on the European Economic Area.  According to the German Government, the expression  
         without a professional or commercial intermediary was included in order to prevent individual importation for personal requirements being developed professionally, including
         by means of mail-order selling, thus circumventing the prohibition. 
         
         
         28
            
         As regards the sale of medicinal products in pharmacies, the latter must comply with the provisions of the Apothekenbetriebsordnung
         (Pharmacists' professional code;  
         the ABO).  Paragraph 2(2) of the ABO provides: The manager of the pharmacy must direct the pharmacy in person.  He is responsible for ensuring that the pharmacy is operated
         in compliance with the law in force.
         
         
         29
            
         The ABO also requires pharmacists to examine the medicinal products with which they are supplied before selling them (Paragraph
         12 of the ABO), to stock the full range of preparations needed by their customers, or to be in a position to procure those
         preparations within a few hours (Paragraph 15), to hand the medicines to the customer himself or arrange for dispensing staff
         with specialised knowledge to do so (Paragraph 17(1)), to advise and consult with the customer and to ascertain, where necessary,
         whether the prescription contains errors (Paragraph 17(2)), in cases of doubt to contact the doctor who issued the prescription
         (Paragraph 17(5)) and to postpone supplying the medicines where there is a reasonable suspicion of intentional misuse (Paragraph
         17(8)). 
         
         
         30
            
         It should be added that the Arzneimittelpreisverordnung (Regulation on the prices of medicines;  
         the APO) regulates the prices at which prescription drugs are sold to end consumers.  Although pharmaceutical manufacturers may set
         their prices freely, the prices at which medicinal products are sold for end use are set by the APO, with the result that
         a given medicinal product is sold at the same price in all German pharmacies. 
         National law regulating the advertising of medicinal products
         
         
         31
            
         Under Paragraph 3a of the Heilmittelwerbegesetz (Law on the advertising of medicinal products;  
         the HWG), in the version published on 19 October 1994 (BGBl. 1994 I, p. 3068): Any advertising of medicinal products which require authorisation and which are not authorised or deemed to be authorised
         under the law on pharmaceutical products is illegal.
         
         
         32
            
         Paragraph 8 of the HWG states: 1. Any advertising the aim of which is to sell by mail order medicinal products which may be supplied only by pharmacies is
         illegal.  This prohibition does not apply to advertising relating to the supply of medicinal products in the cases provided
         for in Paragraph 47 of the [AMG].2. Any advertising the aim of which is to sell (i) medicinal products by way of teleshopping or (ii) particular medicinal
         products by way of individual importation as described in Paragraph 73(2), point 6a, or Paragraph 73(3) of the AMG is also
         illegal.
         
         
         33
            
         Paragraph 10 of the HWG provides: 1. As regards prescription-only medicines, advertising may be sent only to doctors, dentists, veterinarians, pharmacists or
         persons authorised to trade in medicinal products.2. Medicinal products intended to treat, in humans, insomnia or psychological problems, or which are psychotropic, may not
         be advertised otherwise than in professional circles.
         The main proceedings and the questions referred for a preliminary ruling
         
         34
            
         The Apothekerverband, the claimant in the main proceedings, is an association whose aim is to protect and promote the economic
         and social interests of pharmacists.  Its members are the Landesapothekerverbände and the Landesapothekervereine (federations
         and associations of pharmacists at Länder level), which, since they represent more than 19 000 managers of pharmacies, bring
         together the majority of the 21 600 dispensing pharmacies in Germany. 
         
         
         35
            
         DocMorris, the first defendant in the main proceedings, is a limited company established in Landgraaf (Netherlands).  As well
         as selling medicinal products by mail order, it carries on a  
         standard pharmaceutical business via a traditional dispensary in the Netherlands, to which the public has access.  Both that activity
         and its internet site are covered by a licence issued by the Netherlands authorities and are subject to control by the latter.
          Mr Waterval, the second defendant in the main action, a Netherlands national, is an authorised pharmacist in the Netherlands.
          He was, until 30 May 2001, a director of DocMorris and is still one of its legal representatives. 
         
         
         36
            
         Since 8 June 2000 DocMorris and Mr Waterval have been offering for sale, at the internet address 0800 DocMorris, prescription
         and non-prescription medicines for human use, in languages including German, for end consumers in Germany.  The defendants
         in the main action sell only authorised medicines, some of which have been authorised in Germany and others in the Netherlands.
         
         
         
         37
            
         According to the order for reference, the internet site is divided under the headings  
         Pharmacy,  
         Health Forum,  
         About us,  
         Contact and  
         Help.  The individual medicines are divided into product groups, under headings such as  
         Painkillers,  
         Blood-pressure reducers,  
         Cancer therapy,  
         Immunostimulants,  
         Cholesterol reduction,  
         Urologics/Potency,  
         Detoxification and others.  Each heading first contains an introduction of a few sentences.  The medicines are then listed alphabetically
         under their product name, the contents of the package being described and the price stated in euro.  Finally, further information
         about the product itself may be obtained by clicking on the product name. 
         
         
         38
            
         The order for reference also explains that, where a particular medicinal product is available only on prescription, notice
         of that is given next to the product description.  A given medicine is classified as available only on prescription where
         it is regarded as such in the Netherlands or in the Member State in which the consumer resides.  In that regard, the rules
         in relation to prescription applied are always those which are the most strict, and may be the rules of the country of origin
         or those of the country to which the relevant product is being sent.  This type of medicine is supplied only on production
         of the original prescription. 
         
         
         39
            
         The consumer also has the opportunity, if he clicks on the appropriate icon, to look for a particular product from the range
         offered by the defendants in the main proceedings and to consult a group of experts on health issues.  Generally, the consumer
         can contact the defendants not only via the internet but also on a free telephone number or by letter. 
         
         
         40
            
         Delivery can take place in a number of ways.  The customer may collect the order in person from the pharmacy at Landgraaf,
         a town near the border between the Netherlands and Germany.  Alternatively he may, at no additional cost, use a courier service
         recommended by the defendants in the main action to collect the order and bring it to the address given by the recipient.
          In addition, the customer can use at his own expense another courier service, which is also recommended by the defendants
         and which collects the order and delivers it to the recipient's address.  It is also open to the customer to use another courier
         service at his own expense. 
         
         
         41
            
         The Apothekerverband is challenging before the Landgericht Frankfurt am Main the offer of medicines for sale in the way described
         in paragraphs 36 to 40 of this judgment and their delivery by international mail order.  It submits that the provisions of
         the AMG and the HWG do not permit the defendants in the main proceeding to carry on a business of that kind, and that the
         prohibition imposed by those two laws cannot be challenged on the basis of Articles 28 EC and 30 EC. 
         
         
         42
            
         The defendants in the main proceedings contend that their business is permitted even under national law and that, in any event,
         a prohibition on the sale of medicinal products by mail order is incompatible with Community law. 
         
         
         43
            
         In that regard, the Landgericht Frankfurt am Main first expresses doubt as to whether prohibitions such as those laid down
         by Paragraphs 43(1) and 73(1) of the AMG violate the principle of the free movement of goods.  Next, assuming that there is
         an infringement of Article 28 EC, it seeks to ascertain whether the German legislation at issue in the main action is necessary
         for the effective protection of the health and life of humans for the purposes of Article 30 EC or whether, in view of the
         increasing harmonisation of procedures for authorising medicinal products, human health and life may be protected as effectively
         by measures which are less restrictive of intra-Community trade, in accordance with the principles laid down by the Court
         in Case C-320/93  
          Ortscheit  [1994] ECR I-5243.  Finally, it asks whether advertising bans such as those imposed by the HWG are compatible with the principles
         of the free movement of goods and the free movement of information society services within the meaning of Article 1(1) and
         (2) of the directive on electronic commerce. 
         
         
         44
            
         In those circumstances, the Landgericht Frankfurt am Main decided to stay proceedings and refer the following questions to
         the Court for a preliminary ruling: 
         
         1.
          Are the principles of the free movement of goods under Article 28 EC et seq. infringed by national legislation whereby medicinal
         products for human use the sale of which is restricted to pharmacies may not be imported commercially by way of mail order
         through authorised pharmacies in other Member States on the basis of individual orders placed by consumers over the internet?
         
         
         (a)
         Does such a national prohibition constitute a measure having an effect equivalent to a quantitative restriction on imports
         within the meaning of Article 28 EC? 
         
         
         (b)
         If it does, is Article 30 EC to be interpreted as meaning that a national prohibition designed to protect the health and life
         of humans is justified if, before prescription medicines are sent out, a doctor's original prescription must have been produced
         to the pharmacy sending out the medicines? In such a situation, what requirements should be placed on that pharmacy as regards
         control of orders, packaging and receipt? 
         
         
         (c)
         Are Questions 1(a) and 1(b) to be assessed differently in the light of Articles 28 EC and 30 EC if the imported medicines
         in question are medicines authorised in the importing State, which a pharmacy in an EU Member State previously obtained from
         wholesalers in the importing State? 
         
         
         
         2.
          Is it compatible with Articles 28 EC and 30 EC for a national prohibition on advertising medicines by mail order or medicines
         for human use available only on prescription or through pharmacies authorised in the State of origin but not the importing
         State to be interpreted so broadly that the internet presentation of a pharmacy of an EU Member State, which in addition to
         the mere presentation of its business describes individual medicines with their product name, prescription status, package
         size and price and at the same time offers the possibility of ordering those medicines by means of an on-line order form,
         is classified as prohibited advertising, with the result that cross-border orders of medicines by internet, including cross-border
         delivery of those orders, is at least made substantially more difficult? 
         
         (a)
         Having regard to Article 1(3) of Directive 2000/31 ..., do Articles 28 EC and 30 EC require the internet presentation of a
         pharmacy of an EU Member State, as described above, or parts of that presentation, to be excluded from the definition of advertising
         to the general public for the purposes of Articles 1(3) and 3(1) of Directive 92/28 ... in order to make it possible in practice
         as well to offer certain information society services? 
         
         
         (b)
         Can any restriction of the definition of advertising required by Articles 28 EC and 30 EC be justified by the consideration
         that on-line order forms containing only the minimum information necessary for placing an order, and/or other parts of the
         internet site of a pharmacy of an EU Member State, are comparable with trade catalogues and/or price lists within the meaning
         of Article 1(4) of Directive 92/28/EEC? 
         
         
         
         3.
          If some aspects of the internet presentation of a pharmacy of an EU Member State infringe provisions concerning the advertising
         of medicines, is it to be inferred from Articles 28 EC and 30 EC that cross-border trade in medicines which takes place with
         the aid of such a presentation must be regarded as lawful despite the prohibited advertising, in order more effectively to
         implement the principle of the free cross-border movement of goods?
         
         The first question
         
         45
            
         By its first question, the national court is asking essentially whether the principle of the free movement of goods under
         Articles 28 EC to 30 EC is infringed by national legislation, such as that at issue in the main proceedings, whereby medicinal
         products for human use the sale of which is restricted to pharmacies in the Member State concerned may not be imported commercially
         by way of mail order through pharmacies approved in other Member States in response to individual orders placed by consumers
         over the internet. 
         
         
         46
            
         In the light of the arguments put forward, particularly by the defendants in the main proceedings, it is appropriate to examine
         this question, first, in relation to medicinal products which have not been authorised in Germany.  The question will then
         be examined in relation to products which are authorised there.  The latter category can be further subdivided into non-prescription
         and prescription-only medicines. 
         Medicinal products which are not authorised in Germany
         
         
         47
            
         Of the national provisions at issue in the main proceedings, Paragraph 73(1) of the AMG prohibits, as a general rule, the
         importation of medicinal products subject to authorisation or registration within the national territory on the sole ground
         that they have not been authorised or registered for being placed on the market there. Consequently, the importation of such
         products into German territory is precluded for the sole reason that they have not been authorised, irrespective of the method
         of sale. 
         
         
         48
            
         If a provision such as Paragraph 73(1) of the AMG is compatible with Community law, it will not be necessary to consider whether,
         in respect of this category of medicines, Articles 28 EC to 30 EC preclude national legislation which prohibits the sale by
         mail order of medicinal products the sale of which is restricted to pharmacies. 
         Observations submitted to the Court
         
         
         49
            
         Both the German Government and the Commission submit that Paragraph 73 of the AMG, which prohibits imports of medicinal products
         which have not obtained the requisite authorisation, corresponds to the prohibition on placing on the market medicinal products
         which have not been authorised in the Member State concerned, which is laid down in Article 3 of Directive 65/65, as replaced
         by Article 6(1) of the Community Code.  Thus, the national legislation is intended to ensure that there is no circumvention
         of the existing obligation to obtain authorisation. 
         
         
         50
            
         The Greek Government supports that view, arguing that if medicinal products which have not obtained the authorisation required
         by the importing Member States can be ordered over the internet, the system of marketing authorisations for pharmaceutical
         products will be fatally undermined.  Manufacturers of medicinal products will be able to obtain authorisation in the Member
         State with the least stringent legislation in this domain and release the products into circulation in Member States in which
         they are not authorised.  Such a situation is tantamount to a complete absence of controls on the importation of medicinal
         products, whether authorised or not, which would make any control of parallel imports impossible. 
         
         
         51
            
         The defendants in the main proceedings submit, for the reasons put forward in relation to authorised medicines (see paragraphs
         61 and 62 of this judgment), that Paragraph 73(1) of the AMG must be regarded as a measure having an effect equivalent to
         a quantitative restriction on the free movement of goods within the meaning of Article 28 EC. 
         The Court's reply
         
         
         52
            
         As the German and Greek Governments and the Commission rightly observe, the general prohibition imposed by Paragraph 73(1)
         of the AMG corresponds to the prohibition, at Community level, on placing on the market medicinal products which have not
         been authorised in the Member State concerned, which was laid down in Article 3 of Directive 65/65, now replaced by Article
         6(1) of the Community Code.  According to those provisions, medicinal products, even if they are authorised in one Member
         State, must also, if they are to be placed on the market of another Member State, have been authorised either by the competent
         authority of that State or under the Community rules referred to in those provisions. 
         
         
         53
            
         Consequently, a national rule such as Paragraph 73(1) of the AMG, whereby a Member State discharges its obligations under
         Directive 65/65 and the Community Code, cannot be characterised as a measure having equivalent effect to a quantitative restriction
         on imports within the meaning of Article 28 EC (see, to that effect, in the context of Council Directive 86/469/EEC of 16
         September 1986 concerning the examination of animals and fresh meat for the presence of residues (OJ 1986 L 275, p. 36), Case
         C-246/98  
          Berendse-Koenen  [2000] ECR I-1777, paragraph 25).  Accordingly, Articles 28 EC to 30 EC cannot be relied on in order to circumvent the system
         of national authorisation provided for by Directive 65/65 and the Community Code, which is implemented in national law by
         Paragraph 73(1) of the AMG. 
         
         
         54
            
         It follows from that finding that, as regards medicinal products which are subject to, but which have not obtained, authorisation
         there is no need to consider whether the national provisions at issue in the main proceedings are precluded by Articles 28
         EC to 30 EC. 
         Medicinal products which are authorised in Germany
         
         
         55
            
         The first question is more germane as regards medicinal products which have obtained marketing authorisations for the German
         market.  More specifically, this question seeks to ascertain whether the prohibition on the sale by mail order of medicinal
         products which may be sold only in pharmacies in the Member State concerned, such as the prohibition laid down in Paragraph
         43(1) of the AMG, is compatible with the principle of the free movement of goods.  That question is divided into three parts,
         which must be dealt with separately. Is the national prohibition on mail-order sales a measure having equivalent effect within the meaning of Article 28 EC? (Question
         1(a))
         Observations submitted to the Court
         
         
         56
            
         The Apothekerverband and the Commission, supported on this point by the German, Greek, French and Austrian Governments, submit
         that the free movement of goods is not impeded.  They maintain that the prohibition laid down in Paragraph 43(1) of the AMG,
         which does not concern the production or composition of particular products but solely the ways in which they are marketed,
         applies in the same way, both in law and in fact, to the marketing of domestic products and those from other Member States
         alike.  Such a prohibition therefore falls outside the scope of Article 28 EC for the reasons given by the Court in Joined
         Cases C-267/91 and C-268/91  
          Keck and Mithouard  [1993] ECR I-6097, paragraphs 15 to 17, and Case C-292/92  
          Hünermund and Others  [1993] ECR I-6787, paragraph 21. 
         
         
         57
            
         The French Government supports that view, pointing to the judgment in Case C-391/92  
          Commission  v  
          Greece  [1995] ECR I-1621, in which the Court, in paragraphs 11 to 13, acknowledged the compatibility with the Treaty of a monopoly
         for pharmacies on the sale of baby milk and also pointed out that that monopoly was not designed to regulate trade in goods
         between Member States. 
         
         
         58
            
         As regards the Court's subsequent clarification in Case C-368/95  
          Familiapress  [1997] ECR I-3689 and Case C-254/98  
          TK-Heimdienst  [2000] ECR I-151, the Apothekerverband, supported by the Commission and by the German, French and Austrian Governments, submits
         that the effect of the prohibition at issue before the national court is neither to give rise to any unequal treatment between
         domestic pharmacies and those established in other Member States as regards their scope for using mail-order selling, nor
         to make release into circulation more difficult for foreign products than for domestic ones, in particular by making such
         release subject to additional costs or to duties to which domestic products are not subject. 
         
         
         59
            
         Although the Apothekerverband and the Commission challenge the argument that access to the German market is barred, maintaining
         that under the current provisions of the AMG pharmaceutical products may be, and are frequently, imported and reimported,
         the German Government acknowledges that the fact that the sale of medicinal products by mail order is precluded makes it more
         difficult for foreign pharmacies to gain access to the German market.  They are in fact obliged to open their own pharmacy
         in Germany.  However, in view of the requirements of the ABO that the pharmacist be present in person, even pharmacies established
         in Germany do not have unfettered access to the whole German market either.  It follows that any difficulty in exploiting
         the German market as a whole affects domestic and foreign pharmacists in the same way and thus does not amount to a discriminatory
          
         measure having equivalent effect for the purposes of Article 28 EC. 
         
         
         60
            
         In the alternative, both the Apothekerverband and the German and Austrian Governments submit that the scope of Article 28
         EC should be limited so as to permit the Member States to retain sufficient latitude to regulate general aspects of the sale
         of medicinal products which are in the public interest.  For that reason, the general prohibition on the sale by mail order
         of medicinal products the sale of which is restricted to pharmacies cannot be considered to be a measure having an effect
         equivalent to a quantitative restriction on imports for the purposes of Article 28 EC. 
         
         
         61
            
         The defendants in the main proceedings reject that interpretation of the national legislation as too superficial.  In their
         submission, the prohibition on marketing pharmaceutical products by mail order does not affect the sale of domestic medicinal
         products and that of medicinal products imported from other Member States in the same manner.  The prohibition, in conjunction
         with the rules of professional conduct laid down in the ABO, makes it virtually impossible for pharmacies established in other
         Member States to gain access to the German market of end consumers of medicinal products.  More specifically, under the ABO,
         DocMorris cannot gain access to that market unless the pharmacist responsible for the company gives up his pharmaceutical
         business in the Netherlands and opens a  
         traditional pharmacy in Germany.  Furthermore, foreign pharmacists are not entitled to apply for authorisation to sell medicines by mail
         order in Germany unless they have already operated their pharmacy there for at least three years. 
         
         
         62
            
         The defendants in the main proceedings also rely on Case C-323/93  
          Centre d'insémination de la Crespelle  [1994] ECR I-5077, paragraph 29, Joined Cases C-34/95 to C-36/95  
          De Agostini and TV-shop  [1997] ECR I-3843, paragraphs 43 to 47, Case C-189/95  
          Franzén  [1997] ECR I-5909, paragraphs 67 to 73, and  
          TK-Heimdienst , cited above, paragraphs 27 to 37, to show that where, as in the case before the national court, access to end consumers
         in the Member State into which products are imported is prevented or rendered more difficult than for domestic products by
         national rules, these rules amount to a restriction on the free movement of goods, even where they merely regulate a selling
         arrangement which does not relate to the characteristics of the product concerned. 
         The Court's reply
         
         
         63
            
         It must be stated at the outset that the prohibition laid down in Paragraph 43(1) of the AMG falls within the scope of Directive
         97/7.  Article 14 of the directive allows Member States to  
         introduce or maintain, in the area covered by this Directive, more stringent provisions compatible with the Treaty, to ensure
         a higher level of consumer protection.  Article 14 also states that  
         such provisions shall, where appropriate, include a ban, in the general interest, on the marketing of certain goods or services,
         particularly medicinal products, within their territory by means of distance contracts, with due regard for the Treaty. 
         
         
         64
            
         A national measure in a sphere which has been the subject of exhaustive harmonisation at Community level must be assessed
         in the light of the provisions of the harmonising measure and not those of the Treaty (see Case C-37/92  
          Vanacker and Lesage  [1993] ECR I-4947, paragraph 9, and Case C-324/99  
          DaimlerChrysler  [2001] ECR I-9897, paragraph 32).  However, the power conferred on Member States by Article 14(1) of Directive 97/7 must
         be exercised with due regard for the Treaty, as is expressly stated in that provision. 
         
         
         65
            
         Such a provision does not, therefore, obviate the need to ascertain whether the national prohibition at issue in the main
         proceedings is compatible with Articles 28 EC to 30 EC. 
         
         
         66
            
         In that regard, there is settled case-law to the effect that all measures which are capable of hindering directly or indirectly,
         actually or potentially, intra-Community trade are to be regarded as measures having equivalent effect to quantitative restrictions
         and, on that basis, as prohibited by Article 28 EC (see Case 8/74  
          Dassonville  [1974] ECR 837, paragraph 5, and Case C-420/01  
          Commission  v  
          Italy  [2003] ECR I-6445, paragraph 25). 
         
         
         67
            
         Even if a measure is not intended to regulate trade in goods between Member States, the determining factor is its effect,
         actual or potential, on intra-Community trade.  By virtue of that factor, in the absence of harmonisation of legislation,
         obstacles to the free movement of goods which are the consequence of applying, to goods coming from other Member States where
         they are lawfully manufactured and marketed, rules that lay down requirements to be met by such goods constitute measures
         of equivalent effect prohibited by Article 28 EC, even if those rules apply to all products alike, unless their application
         can be justified by a public-interest objective taking precedence over the requirements of the free movement of goods (Case
         120/78  
          Rewe-Zentral  (
          Cassis de Dijon ) [1979] ECR 649, paragraphs 6, 14 and 15;  
          Keck and Mithouard , paragraph 15, and  
          Familiapress , paragraph 8). 
         
         
         68
            
         Furthermore, as the Court held in  
          Keck and Mithouard , even if commercial rules do not relate to the actual characteristics of the products but govern the arrangements for their
         sale, they may constitute measures of equivalent effect for the purposes of Article 28 EC if they fail to meet two conditions.
          Those conditions are that such rules must apply to all relevant traders operating in national territory and must affect in
         the same manner, in law and in fact, the marketing of both domestic products and those from other Member States (see  
          Keck and Mithouard , paragraph 15;  
          Hünermund , paragraph 21, and Case C-412/93  
          Lerclerc-Siplec  [1995] ECR I-179, paragraph 21). 
         
         
         69
            
         As regards the first condition in the preceding paragraph, the prohibition in Paragraph 43(1) of the AMG applies to all the
         traders concerned, whether German or not, with the result that the first condition is fully met. 
         
         
         70
            
         As to the second condition in paragraph 68 of this judgment, it must be borne in mind that the  
         marketing of a product on a domestic market may entail a number of stages between the time when the product is manufactured and the
         time when it is ultimately sold to the end consumer. 
         
         
         71
            
         In order to ascertain whether a particular measure affects in the same manner the  
         marketing of both domestic products and those from other Member States, the scope of the restrictive measure concerned must be ascertained.
          Thus, the Court has found that a prohibition on pharmacists from advertising quasi-pharmaceutical products outside the pharmacy,
         which they were authorised to offer for sale, did not affect the ability of traders other than pharmacists to advertise those
         products (see  
          Hünermund , paragraph 19).  Similarly, the prohibition on broadcasting the advertising at issue in  
          Leclerc-Siplec  was not extensive, since it covered only one particular form of promotion (television advertising) of one particular method
         of marketing products (distribution) (see  
          Leclerc-Siplec , paragraph 22). 
         
         
         72
            
         By contrast, the Court has accepted the relevance of the argument that a prohibition on television advertising deprived a
         trader of the only effective form of promotion which would have enabled it to penetrate a national market (see  
          De Agostini and TV-Shop , paragraph 43).  Furthermore, the Court has found that in the case of products such as alcoholic beverages, the consumption
         of which is linked to traditional social practices and to local habits and customs, prohibiting all advertising directed at
         consumers in the form of advertisements in the press, on the radio and on television, the direct mailing of unsolicited material
         or the placing of posters on the public highway is liable to impede access to the market for products from other Member States
         more than it impedes access for domestic products, with which consumers are instantly more familiar (see Case C-405/98  
          Gourmet International Products  [2001] ECR I-1795, paragraphs 21 and 24). 
         
         
         73
            
         As regards a prohibition such as that laid down in Paragraph 43(1) of the AMG, it is not disputed that the provision contains
         both a requirement that certain medicines be sold only in pharmacies and a prohibition on mail-order sales of medicines. 
         It is true that such a prohibition on mail-order sales may be regarded as merely the consequence of the requirement for sales
         to be made exclusively in pharmacies.  However, the emergence of the internet as a method of cross-border sales means that
         the scope and, by the same token, the effect of the prohibition must be looked at on a broader scale than that suggested by
         the Apothekerverband, by the German, French and Austrian Governments and by the Commission (see paragraphs 56 to 59 of this
         judgment). 
         
         
         74
            
         A prohibition such as that at issue in the main proceedings is more of an obstacle to pharmacies outside Germany than to those
         within it.  Although there is little doubt that as a result of the prohibition, pharmacies in Germany cannot use the extra
         or alternative method of gaining access to the German market consisting of end consumers of medicinal products, they are still
         able to sell the products in their dispensaries.  However, for pharmacies not established in Germany, the internet provides
         a more significant way to gain direct access to the German market.  A prohibition which has a greater impact on pharmacies
         established outside German territory could impede access to the market for products from other Member States more than it
         impedes access for domestic products. 
         
         
         75
            
         Accordingly, the prohibition does not affect the sale of domestic medicines in the same way as it affects the sale of those
         coming from other Member States. 
         
         
         76
            
         The answer to Question 1(a) is therefore that a national prohibition on the sale by mail order of medicinal products the sale
         of which is restricted to pharmacies in the Member State concerned, such as the prohibition laid down in Paragraph 43(1) of
         the AMG, is a measure having an effect equivalent to a quantitative restriction for the purposes of Article 28 EC. Whether there is any justification for the prohibition on mail-order sales (Question 1(b))
         
         
         77
            
         By its first question, under subparagraph (b), the national court is asking essentially whether the prohibition on the sale
         by mail order of medicines the sale of which is restricted to pharmacies can be justified under Article 30 EC where, before
         prescription medicines are supplied, a doctor's original prescription must have been produced to the pharmacy dispatching
         the medicines.  On that point, the national court wonders what requirements should be placed on that pharmacy as regards control
         of orders, packaging and receipt. 
         Observations submitted to the Court
         
         
         78
            
         As regards the principles applicable in the case before the national court, the Apothekerverband and the defendants in the
         main proceedings, together with the French and German Governments, submit that Article 30 EC remains applicable as long as
         full harmonisation of national rules has not been achieved (see Case 215/87  
          Schumacher  [1989] ECR 617, paragraph 15; Case C-369/88  
          Delattre  [1991] ECR I-1487, paragraph 48; Case C-347/89  
          Eurim-Pharm  [1991] ECR I-1747, paragraph 26; Case C-62/90  
          Commission  v  
          Germany  [1992] ECR I-2575, paragraph 10; and  
          Ortscheit , paragraph 14). 
         
         
         79
            
         Both the parties in the main proceedings and the French and German Governments also agree on the fact that the health and
         life of humans rank foremost among the assets and interests protected by Article 30 EC and that it is for the Member States,
         within the confines imposed by the Treaty, to decide the degree of protection they wish to ensure and, in particular, the
         stringency of the checks to be carried out.  Pursuant to the case-law in this area, any national legislation having a restrictive
         effect must be necessary and proportionate. 
         
         
         80
            
         In that regard, the Apothekerverband and the German and Austrian Governments submit that the health of the population cannot
         be protected in any manner which is less restrictive of intra-Community trade than the manner applied in Germany, which provides
         for an outright prohibition on the sale by mail order of medicinal products the sale of which is restricted to pharmacies
         (see  
          Commission  v  
          Germany , paragraph 11, and Case C-55/99  
          Commission  v  
          France  [2000] ECR I-11499, paragraph 42). 
         
         
         81
            
         The Apothekerverband states that the purpose of the prohibition on the sale by mail order of such medicinal products is to
         ensure that the customer receives individual information and advice from the pharmacist when the product is purchased and
         to ensure the safety of medicines and pharmacovigilance. 
         
         
         82
            
         In that regard, the Apothekerverband, supported on this point by the Greek and Austrian Governments, maintains that, so far
         as questions linked to a particular medicine are concerned, even if the mail-order buyer is able to obtain advice on the internet
         or by telephone, that is no substitute for advice given in a pharmacy in a direct face-to-face conversation with the customer.
          The customer's physical and psychological state, his bearing, his life-style and his current medication are factors which
         must be taken into account during such a consultation. 
         
         
         83
            
         The Austrian Government points out that many medicinal products ordered over the internet reach the addressee in damaged or
         inadequate packaging, often without a label or without any information in the addressee's own language. 
         
         
         84
            
         Furthermore, the Apothekerverband maintains that, unlike traditional pharmacies, wholly virtual pharmacies can be set up by
         anybody, without any major investment and with minimal capital.  Given that the activities of virtual pharmacies are currently
         not subject to adequate supervision, the necessary protection of the health and life of human requires preventive control.
         
         
         
         85
            
         Mail-order sales of medicinal products also jeopardise the continued existence of traditional pharmacies.  Whilst pharmacies
         marketing their products by internet can  
         cherry-pick, concentrating on certain economically attractive market segments, traditional pharmacies, bound by the ABO, are subject
         to a set of costly obligations, including maintaining a full range of products, stocking a minimum quantity of medicines and
         providing a duty service.  That entails distortion of the conditions of competition. 
         
         
         86
            
         More specifically, the Apothekerverband submits that, as regards prescription medicines, all German pharmacies are obliged
         by law to charge the prices set by the ABO, reached by applying increases to the manufacturers' prices, which the latter are
         free to set.  By contrast, undertakings selling medicinal products by mail order from abroad are not subject to the requirements
         of the ABO and take advantage of that to offer a limited range of products, essentially composed of expensive medicines, which
         they offer at prices that are competitive in comparison with those in traditional pharmacies. 
         
         
         87
            
         Consequently, in the Apothekerverband's submission, the prohibition on selling medicines by mail order forms an integral part
         of the social security system, the aim of which is to ensure that a reliable and balanced supply of medicines is available
         to the general public at any time.  The prohibition cannot be modified or abolished in isolation unless the system as a whole
         is reviewed.  In that regard, the Apothekerverband mentions the considerations developed by the Court in Case C-368/98  
          Vanbraekel and Others  [2001] ECR I-5363, paragraphs 47 to 49, and Case C-157/99  
          Smits and Peerbooms  [2001] ECR I-5473, paragraphs 72 to 74, relating to safeguarding the social security system and a balanced hospital and medical
         service. 
         
         
         88
            
         The Greek Government supports that view, pointing out the importance placed on the method of distributing medicines in pharmacies
         and the role of the pharmacist both by the Court's case-law and by certain Community law provisions (see  
          Commission  v  
          Germany , paragraph 20, and Council Directive 85/432/EEC of 16 September 1985 concerning the coordination of provisions laid down
         by law, regulation or administrative action in respect of certain activities in the field of pharmacy (OJ 1985 L 253, p. 34)
         and Council Directive 85/433/EEC of 16 September 1985 concerning the mutual recognition of diplomas, certificates and other
         evidence of formal qualifications in pharmacy, including measures to facilitate the effective exercise of the right of establishment
         relating to certain activities in the field of pharmacy (OJ 1985 L 253, p. 37)). 
         
         
         89
            
         The Irish Government favours an outright prohibition on the sale of prescription medicines over the internet.  It recognises
         that checking the authenticity of prescriptions is facilitated by the local knowledge and experience of pharmacists who are
         in close and daily contact with patients and doctors in their region.  Allowing prescription medicines to be supplied following
         receipt of a prescription and without any other control would greatly increase the risk of prescription fraud or misuse. 
         Furthermore, doctors usually only prescribe medicines which are available to their patients and therefore prescribe medicines
         which are authorised in the Member State in which they practise.  However, a doctor may prescribe a medicine not authorised
         in the Member State in which he practises if he is aware that the medicine may be obtained from an internet pharmacy.  In
         that way, prescription medicines unauthorised in a Member State may be marketed in that Member State without the authorities
         being informed that that is the case. 
         
         
         90
            
         The defendants in the main proceedings put forward a number of arguments against the dangers allegedly posed by the sale of
         medicinal products by mail order. First, the guarantee that the customer will receive expert advice from the pharmacist when
         the medicine is supplied does not provide justification for an all-out prohibition on mail-order sales, on the basis of Article
         30 EC.  The pharmacist can also advise and monitor when he is not in the presence of the customer but sends the customer the
         medicines after having given him thorough advice and carefully checked the order. 
         
         
         91
            
         The defendants in the main proceedings add that in the case of an internet order the customer has the opportunity to contact
         the pharmacist by telephone or in writing (for example, by e-mail).  The quality of the advice given in that way may even
         be superior to that of normal pharmaceutical advice given directly to the customer in the pharmacy. 
         
         
         92
            
         The argument that the  
         virtual pharmacist is not in a position to take the initiative in giving advice is not justified.  The necessary information about taking the
         medicine, or using it appropriately, is provided in writing by the pharmacist when the medicine is dispatched.  That initiative
         may be backed up, should the need arise, by a telephone call from the pharmacy to the customer. 
         
         
         93
            
         As to the alleged need for the physical presence of the customer when a medicine is purchased, the defendants in the main
         proceedings also observe that a great many consumers do not come to the pharmacy in person to collect their medicines. 
         
         
         94
            
         Second, as regards the alleged lack of control of  
         virtual pharmacies, the defendants in the main proceedings submit that such pharmacies are subject to State supervision and to requirements
         that orders be checked internally.  First, DocMorris is subject to supervision by the competent authorities in the Member
         State of origin, namely the State inspector of Netherlands pharmacies.  That supervision covers all procedures and operations
         carried out in the course of operating the pharmacy and selling medicines by mail order.  Second, under Netherlands law, all
         pharmacies must record their internal security rules and operational procedures in a quality manual.  DocMorris complies with
         the rules of the European Association of Mail Service Pharmacies of which it is a member, which contain more detailed provisions
         on the question of checking orders, packaging and receipt. 
         
         
         95
            
         The internal security measures imposed by DocMorris ensure that the processing of orders and the provision of advice are solely
         within the purview of authorised pharmacists and qualified pharmaceutical technicians and comply with certain quality requirements.
          The fact that the purchase of a medicinal product takes place in a pharmacy in another Member State is not relevant given
         that the conditions for access to the profession of pharmacist and those relating to the exercise of the profession are harmonised
         at Community level (see, in relation to Directive 85/432,  
          Schumacher , paragraph 20, and  
          Commission  v  
          Germany , paragraph 19). 
         
         
         96
            
         Third, concerning the risks linked to prescription medicines, the pharmacist, in accordance with the requirements of the European
         Association of Mail Service Pharmacies, must ensure that medicines are sent only where the pharmacy concerned has received
         the original prescription, issued by a doctor or a dentist, and only where the person who will receive the product is actually
         the prescription holder. 
         
         
         97
            
         Since the conditions in which a medicinal product must be subject to a doctor's prescription have been harmonised (see Directive
         92/26, as replaced by Title VI of the Community Code), there is a uniform level of protection throughout the Community.  Where,
         exceptionally, the classification of the medicine in the Member State of origin differs from that in the importing Member
         State, DocMorris always proceeds on the basis of the most stringent national legislation, so that national rules concerning
         the need for a prescription are never evaded. 
         
         
         98
            
         Fourth, given the advanced stage of harmonisation of provisions concerning the authorisation of medicinal products within
         the Community and the system of mutual recognition laid down thereby (see Regulation No 2309/93, and Directive 93/39 and Commission
         Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/319/EEC on the approximation
         of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ 2000 L 139, p. 28)),
         it is appropriate to start from the principle that a medicinal product which is authorised in one Member State cannot give
         rise to health risks which are so serious that they warrant an absolute ban on any cross-border mail-order trade in medicines.
         
         
         
         99
            
         Fifth, nor does the use of the internet give rise to any additional health risks, which can be avoided only by an absolute
         prohibition on mail-order business in medicinal products.  However, the technical potential of the internet, in particular
         the ability to prepare customised interactive pages, can be used in order to ensure optimum health protection. 
         
         
         100
            
         Finally, the prohibition at issue in the main proceedings is not justified on the ground that it ensures, from an economic
         point of view, that the population at large is supplied with medicinal products commensurate with its needs.  In that regard,
         the defendants in the main proceedings maintain that, since any  
         virtual pharmacy must be approved in the same way as a pharmacy to which the public has access in the Member State in which it is established,
         the ability to sell medicinal products by mail order must not be perceived as an alternative in competition with pharmacies
         open to the public but as an offer complementing sales by the latter.  Since they are bound by national requirements applicable
         in the Member State of origin,  
         virtual pharmacists are precluded from confining themselves to selling a range of expensive products. 
         
         
         101
            
         The defendants in the main proceedings conclude that neither the German Government nor the Apothekerverband has shown that
         cross-border mail-order trade in medicinal products constitutes a danger to health, which can be avoided only by an absolute
         prohibition on that type of business.  In reality, health may be  protected just as effectively by appropriate rules, in particular
         by requirements relating to the control of orders, packaging and receipt, as imposed by the Member State from which the medicinal
         products come. 
         The Court's reply
         
         
         102
            
         As is maintained by the parties to the main action, the Member States which have submitted observations to the Court and the
         Commission, Article 30 EC continues to apply in relation to the manufacture and marketing of specialised pharmaceutical products
         as long as harmonisation of national rules has not been fully achieved in those areas (see  
          Schumacher , paragraph 15;  
          Delattre , paragraph 48;  
          Eurim-Pharm , paragraph 26;  
          Commission  v  
          Germany , paragraph 10; and  
          Ortscheit , paragraph 14). In that regard, it should be noted that the sale of medicinal products to end consumers has not been subject
         to full Community harmonisation. 
         
         
         103
            
         It is settled case-law that the health and life of humans rank foremost among the assets or interests protected by Article
         30 EC and it is for the Member States, within the limits imposed by the Treaty, to decide what degree of protection they wish
         to assure (see  
          Schumacher , paragraph 17;  
          Eurim-Pharm , paragraph 26; and  
          Ortscheit , paragraph 16). 
         
         
         104
            
         However, national rules or practices likely to have a restrictive effect, or having such an effect, on the importation of
         pharmaceutical products are compatible with the Treaty only to the extent that they are necessary for the effective protection
         of health and life of humans.  A national rule or practice cannot benefit from the derogation provided for in Article 30 EC
         if the health and life of humans may be protected just as effectively by measures which are less restrictive of intra-Community
         trade (
          Schumacher , paragraphs 17 and 18;  
          Delattre , paragraph 53;  
          Eurim-Pharm , paragraph 27;  
          Commission  v  
          Germany , paragraphs 10 and 11; and  
          Ortscheit , paragraph 17). 
         
         
         105
            
         In the case before the national court, no doubt is cast on the fact that the  
         virtual pharmacy is subject to supervision by the Netherlands authorities, with the result that the arguments put forward by the Apothekerverband
         to assert generally that the supervision to which such a pharmacy is subject is inadequate, in comparison with that to which
         a traditional pharmacy is subject, cannot be accepted. 
         
         
         106
            
         The only arguments which are capable of providing adequate reasons for  prohibiting the mail-order trade in medicinal products
         are those relating to the need to provide individual advice to the customer and to ensure his protection when he is supplied
         with medicines and to the need to check that prescriptions are genuine and to guarantee that medicinal products are widely
         available and sufficient to meet requirements. 
         
         
         107
            
         Looked at generally, most of those reasons are based on the possible dangers posed by medicinal products and, accordingly,
         on the care which must be taken with all aspects of the marketing of those products, objectives which are also those of the
         Community legislation in the pharmaceuticals field.  Thus, and in any event, consideration of the reasons put forward to justify
         the prohibition on the sale by mail order of medicinal products must take into account the various provisions of Community
         law which may affect that issue. 
         
         
         108
            
         First, the Community Code provides, in Title VI,  
         Classification of Medicinal Products, that when the competent authorities of the Member States grant a marketing authorisation for a medicinal product they must
         specify its classification, namely whether or not it is subject to prescription.  Although it is for those authorities to
         determine the classification of medicinal products, they must none the less take as their basis the criteria set out in Article
         71(1) of the Code, namely those concerning the potential dangers connected with use of the relevant product (see paragraphs
         5 and 6 of this judgment). 
         
         
         109
            
         Second, the distinction between medicinal products which are subject to prescription and those which are not, which is based
         on those criteria and which thus concerns the potential danger of the product concerned, is applied in the Community rules
         concerning advertising for medicinal products.  As pointed out in paragraphs 7 to 13 of this judgment, advertising of prescription
         medicines is prohibited (Article 88(1) of the Community Code), whilst, in general, advertising of medicinal products intended
         and designed for use without the intervention of a medical practitioner is permitted, provided that certain conditions are
         complied with (see Article 88(2) of the Community Code). 
         
         
         110
            
         In addition to the distinction mentioned in the preceding paragraph, Article 14 of Directive 97/7, which regulates distance
         selling for the purpose of consumer protection, allows the Member States to adopt, with due regard for the provisions of the
         Treaty, measures which prohibit, on grounds of general interest, the marketing of certain goods or services,  
         particularly medicinal products, within their territory by means of distance contracts.  That provision indicates that the Community legislature did not
         intend to prevent Member States from prohibiting the sale by mail order of medicinal products merely because the provisions
         relating to authorisations to market such products within the Community have been harmonised and merely because of the existence
         of a system of mutual recognition and of provisions intended to coordinate the rules relating to certain activities in the
         field of pharmacy and the mutual recognition of diplomas in pharmacy. 
         
         
         111
            
         In the light of the foregoing, the reasons advanced by the Apothekerverband by way of justification must be examined in relation
         to non-prescription medicines, on the one hand, and prescription medicines, on the other hand. 
         Non-prescription medicines
         
         
         112
            
         None of the reasons which the Apothekerverband advances by way of justification can provide a valid basis for the absolute
         prohibition on the sale by mail order of non-prescription medicines. 
         
         
         113
            
         First, as regards the need to provide the customer with advice and information when a medicinal product is purchased, it is
         not impossible that adequate advice and information may be provided.  Furthermore, as the defendants in the main proceedings
         point out, internet buying may have certain advantages, such as the ability to place the order from home or the office, without
         the need to go out, and to have time to think about the questions to ask the pharmacists, and these advantages must be taken
         into account. 
         
         
         114
            
         As to the argument that  
         virtual pharmacists are less able to react than pharmacists in dispensaries, the disadvantages which have been mentioned in this regard concern,
         first, the fact that the medicine concerned may be incorrectly used and, second, the possibility that it may be abused.  As
         regards incorrect use of the medicine, the risk thereof can be reduced through an increase in the number of on-line interactive
         features, which the customer must use before being able to proceed to a purchase.  As regards possible abuse, it is not apparent
         that for persons who wish to acquire non-prescription medicines unlawfully, purchase in a traditional pharmacy is more difficult
         than an internet purchase. 
         
         
         115
            
         Second, as regards non-prescription medicines, considerations relating to their delivery do not justify an absolute prohibition
         on their sale by mail order. 
         
         
         116
            
         Third, as regards the reasons based on the need to guarantee that medicinal products are widely available and sufficient to
         meet requirements, the Court notes that, in the submission of the defendants in the main proceedings (see paragraph 100 of
         this judgment), the Netherlands  
         virtual pharmacy is subject to public-service obligations such as those mentioned by the Apothekerverband, with the result that it is not,
         in that respect, in a better position than German pharmacies. Furthermore, the APO, which sets the ultimate selling price
         of medicinal products, applies solely to prescription-only medicines and thus is not a reason for prohibiting mail-order sales
         of non-prescription medicines, the prices of which may be set freely by German pharmacies. 
         Prescription medicines
         
         
         117
            
         The supply to the general public of prescription medicines needs to be more strictly controlled.  Such control could be justified
         in view of, first, the greater risks which those medicines may present (see Article 71(1) of the Community Code) and, second,
         the system of fixed prices which applies to them and which forms part of the German health system. 
         
         
         118
            
         As regards the first consideration, the fact that there might be differences in the way those medicines are classified by
         the Member States, so that a particular medicinal product may be subject to prescription in one Member State but not in another,
         does not mean that the first Member State forfeits the right to take more stringent action with regard to that type of medicinal
         product. 
         
         
         119
            
         Given that there may be risks attaching to the use of these medicinal products, the need to be able to check effectively and
         responsibly the authenticity of doctors' prescriptions and to ensure that the medicine is handed over either to the customer
         himself, or to a person to whom its collection has been entrusted by the customer, is such as to justify a prohibition on
         mail-order sales.  As the Irish Government has observed, allowing prescription medicines to be supplied on receipt of a prescription
         and without any other control could increase the risk of prescriptions being abused or inappropriately used.  Furthermore,
         the real possibility of the labelling of a medicinal product bought in a Member State other than the one in which the buyer
         resides being in a language other than the buyer's may have more harmful consequences in the case of prescription medicines.
         
         
         
         120
            
         The Apothekerverband has also put forward arguments concerning the integrity of the German health system, arguing that, since
         German pharmacies are obliged by the APO to sell prescription medicines at fixed prices, allowing the cross-border sale of
         those medicines at uncontrolled prices would jeopardise the existence of those pharmacies and thus the integrity of the German
         health system. 
         
         
         121
            
         That argument requires an examination of the rationale for the system set up by the APO, which sets the selling price of prescription
         medicines. 
         
         
         122
            
         Although aims of a purely economic nature cannot justify restricting the fundamental freedom to provide services, it is not
         impossible that the risk of seriously undermining the financial balance of the social security system may constitute an overriding
         general-interest reason capable of justifying a restriction of that kind (see  
          Kohll , paragraph 41;  
          Vanbraekel , paragraph 47;  
          Smits and Peerbooms , paragraph 72; and Case C-358/99  
          Müller-Fauré and Van Riet  [2003] ECR I-4509, paragraphs 72 and 73).  Moreover, a national market for prescription medicines could be characterised
         by non-commercial factors, with the result that national legislation fixing the prices at which certain medicinal products
         are sold should, in so far as it forms an integral part of the national health system, be maintained. 
         
         
         123
            
         However, neither the Apothekerverband nor the Member States which have submitted observations to the Court have put forward
         any arguments as to the necessity of the APO.  Therefore, in the absence of any such arguments, the Court cannot find that,
         as regards prescription medicines, the prohibition on mail-order sales in Germany may be justified on grounds of the financial
         balance of the social security system or the integrity of the national health system. 
         
         
         124
            
         In the light of the foregoing, the answer to Question 1(b) must be that Article 30 EC may be relied on to justify a national
         prohibition on the sale by mail order of medicinal products the sale of which is restricted to pharmacies in the Member State
         concerned in so far as the prohibition covers medicinal products subject to prescription.  However, Article 30 EC cannot be
         relied on to justify an absolute prohibition on the sale by mail order of medicinal products which are not subject to prescription
         in the Member State concerned. Reimportation of medicinal products (Question 1(c))
         
         
         125
            
         By Question 1(c), the national court is asking whether Questions 1(a) and 1(b) concerning, first, whether Paragraph 43(1)
         of the AMG amounts to a measure having an effect equivalent to a quantitative restriction and, second, whether there is any
         possible justification for it, should be assessed differently, in the light of Articles 28 EC and 30 EC, where medicinal products
         are imported into a Member State in which they are authorised, having been previously obtained by a pharmacy in another Member
         State from a wholesaler in the importing Member State. 
         Observations submitted to the Court
         
         
         126
            
         The defendants in the main proceedings observe that Article 28 EC prohibits all obstacles to imports regardless of where the
         goods were manufactured.  The Court has expressly accepted that the protection of the free movement of goods covers reimportation
         of goods (see Case C-240/95  
          Schmit  [1996] ECR I-3179, paragraph 10; Case C-201/94  
          Smith & Nephew and Primecrown  [1996] ECR I-5819, paragraphs 18 to 22; Joined Cases C-267/95 and C-268/95  
          Merck and Beecham  [1996] ECR I-6285, and Case C-379/97  
          Upjohn  [1999] ECR I-6927, paragraphs 13 and 14).  They submit that, contrary to the view expressed by the Court in Case 33/74  
          Van Binsbergen  [1974] ECR 1299 and Case 229/83  
          Leclerc and Others  [1985] ECR 1, the reimportation of authorised medicinal products from a pharmacy established in another Member State does
         not constitute unlawful circumvention of mandatory national provisions.  The defendants in the main action state that the
         cross-border commercial transaction at issue before the national court was carried out in two distinct marketing stages and,
         in addition, at different levels of the market (first, the medicinal products were exported by German wholesalers to pharmacies
         established in another Member State and second, they were reimported by way of retail sale to private customers).  The defendants
         conclude that the transaction merits protection under Article 28 EC, given that it is conducive precisely to the attainment
         of the objectives of that article.  Nor is there any abuse of the free movement of goods, for the simple reason that sale
         by mail order pursues precisely the objective at the heart of the free movement of goods (see, as regards freedom of establishment,
         Case C-212/97  
          Centros  [1999] ECR I-1459). 
         The Court's reply
         Whether Paragraph 43(1) of the AMG is a measure having an effect equivalent to a quantitative restriction
         
         
         127
            
         The place of manufacture of a product is of no significance as regards the question whether Paragraph 43(1) of the AMG is
         a measure having an effect equivalent to a quantitative restriction for the purposes of Article 28 EC.  Accordingly, a product
         manufactured in the territory of a Member State which is then exported and reimported into the first Member State constitutes
         an imported product in the same way as a product manufactured in another Member State which is then directly introduced into
         the national territory (see, to that effect,  
          Leclerc , paragraph 26, and  
          Schmit , paragraph 10). 
         
         
         128
            
         That analysis holds good even if the law governing the sale of the products at issue in the main proceedings, namely medicinal
         products, is not harmonised at Community level, with the result that a product which comes from the importing State may, in
         principle, by virtue of its movement across borders, enjoy the protection of Community law. 
         
         
         129
            
         However, the Court has accepted, in relation to the free movement of goods, that that finding does not apply where, on the
         basis of objective factors, it is established that the products concerned were exported for the sole purpose of reimportation
         in order to circumvent legislation such as that in the main proceedings (see  
          Leclerc , paragraph 27). 
         
         
         130
            
         In the case before the referring court, since the trader which exported the medicinal products was not involved in their reimportation,
         the reimportation of the products by the defendants in the main action cannot be found to be an abuse of the free movement
         of goods. 
         
         
         131
            
         Consequently, since a provision such as Paragraph 43(1) of the AMG could restrict the marketing of medicinal products from
         other Member States, the finding that such a provision constitutes a measure having an effect equivalent to a quantitative
         restriction cannot be confined to medicinal products originating in Member States other than the importing Member State but
         also relates to medicinal products which were purchased from wholesalers established in the importing Member State. 
         Whether there is justification
         
         
         132
            
         In answering the question whether the prohibition on the sale by mail order of medicinal products is justified, it is appropriate
         again to draw a distinction between prescription and non-prescription medicines.  In relation to the first category, the considerations
         underpinning the finding, in paragraphs 112 to 116 of this judgment, that the prohibition is not warranted apply in the same
         way to reimported products. There is thus no need to modify the answer to Question 1(b) in the light of Article 28 EC. 
         
         
         133
            
         Given that considerations relating to the reimportation of prescription medicines ─ in particular the fact that any such reimported
         medicines will not be subject to the APO since they have been purchased over the internet ─ have already been taken into account
         in the context of the answer to Question 1(b), there is no need to modify that answer either. 
         
         
         134
            
         The answer to Question 1(c) must therefore be that Questions 1(a) and 1(b) do not need to be assessed differently where medicinal
         products are imported into a Member State in which they are authorised, having been previously obtained by a pharmacy in another
         Member State from a wholesaler in the importing Member State. 
         The second question
         
         135
            
         By the first part of its second question, the national court is asking essentially whether, in the context of a national prohibition
         on advertising the sale by mail order of medicinal products, Articles 28 EC and 30 EC preclude a broad interpretation of 
         
         advertising, whereby a number of features of the internet portal of a pharmacy established in a Member State are classed as  
         prohibited advertising, making cross-border ordering of medicines over the internet appreciably more difficult. 
         
         
         136
            
         The question presupposes the co-existence of a lawful internet sale of medicinal products with a lawful prohibition on the
         advertising of those products, which might adversely affect the sale.  Accordingly, it should be made clear that two distinct
         questions are being raised: first, whether national prohibitions on advertising the sale by mail order of medicinal products
         are compatible with Articles 28 EC and 30 EC, and second whether, in so far as those prohibitions (or some of them) are found
         compatible, a broad interpretation of  
         advertising, which would make internet selling more difficult, would also be compatible with Articles 28 EC and 30 EC. 
         
         
         137
            
         It is only when a prohibition on advertising which is compatible with Community law coincides with an internet sale which
         is also compatible with Community law that it will be necessary to consider how broadly the concept of  
         advertising should be interpreted, as well as Questions 2(a) and 2(b). 
         Whether the prohibitions on advertising are compatible with Community law
         
         
         138
            
         As explained in paragraphs 31 to 33 of this judgment, the German legislation provides for three kinds of prohibition on the
         advertising of medicinal products.  It is necessary to ascertain whether each of those prohibitions complies with Community
         law.  First, as regards Paragraph 3 of the HWG, which in essence lays down a prohibition on advertising medicinal products
         which require authorisation but have not been authorised, it is sufficient to note that such a prohibition is in conformity
         with the prohibition referred to in Article 2(1) of Directive 92/28, replaced by Article 87(1) of the Community Code.  Thus
         there is no reason to examine the compatibility of such a prohibition with the Treaty. 
         
         
         139
            
         Second, Paragraph 10(1) of the HWG provides, in general, for a prohibition on advertising prescription medicines.  As was
         stated in connection with Paragraph 3 of the HWG, a prohibition of the kind in Paragraph 10(1) of that law is compatible,
         as the Commission has observed, with Article 3(1) of Directive 92/28, replaced by Article 88(1) of the Community Code, which
         lays down a corresponding prohibition at Community level.  Accordingly, since a domestic prohibition of that kind constitutes
         a national measure implementing a Community harmonising measure, its compatibility with the Treaty cannot be called in question
         either. 
         
         
         140
            
         Third, Paragraph 8(1) of the HWG lays down a prohibition on advertising the sale by mail order of medicinal products which
         may be supplied exclusively in pharmacies.  Paragraph 8(2) also prohibits advertising in connection with the sale of medicinal
         products by way of individual import as described in Paragraph 73(2), point 6a, and Paragraph 73(3) of the AMG.  According
         to the observations of the German Government, that prohibition, read with Paragraph 73(1) of the AMG, seeks to prevent individual
         imports of unauthorised medicinal products becoming so extensive, as a result of advertising, as to undermine the system of
         authorisation, whereas under the AMG individual imports are possible only in exceptional cases. In any event, as the Advocate
         General has noted in point 171 of her Opinion, according to the documents provided to the Court by the national court, the
         latter considers that only the prohibition laid down in Paragraph 8(1) of the HWG applies in relation to the sale by mail
         order of medicinal products.  Thus, the provisions of Paragraph 8(2) of the HWG do not form part of the legal and factual
         framework of the dispute in the main proceedings. 
         
         
         141
            
         The prohibition in Paragraph 8(1) of the HWG has no precise corollary at Community-law level.  Article 88(1) of the Community
         Code prohibits advertising of prescription medicines, whilst Article 88(2) permits, as a general rule, advertising for medicines
         intended and designed for use without the intervention of a medical practitioner, but with the advice of the pharmacist, if
         necessary. 
         
         
         142
            
         The Austrian Government relies on that provision to observe that even if that type of advertising is permissible in principle,
         and given that Article 88 of the Code does not state to what extent the pharmacist's advice is deemed necessary, it must be
         assumed that the Member States have some latitude in this sphere.  The Austrian Government concludes that a prohibition on
         internet advertising is also justified for medicinal products which may be sold only in pharmacies and for which a prescription
         is not required. 
         
         
         143
            
         In that regard, it is appropriate to bear in mind the answer to Question 1(b), in paragraphs 112 to 116 of this judgment,
         concerning justification for the prohibition on the sale by mail order of non-prescription medicines.  In its reply, the Court
         held that the prohibition cannot be justified, in relation to those medicines, by the alleged need for a pharmacist to be
         physically present when medicines of that type are purchased. 
         
         
         144
            
         It follows that Article 88(2) of the Community Code, which allows medicinal products not subject to prescription to be advertised
         to the general public, cannot be interpreted as precluding advertising for the sale by mail order of medicines on the basis
         of the alleged need for a pharmacist to be physically present. Accordingly, Article 88(1) of the Community Code, which prohibits
         advertising for prescription medicines, precludes a prohibition such as that laid down in Paragraph 8(1) of the HWG in so
         far as that prohibition covers non-prescription medicines. 
         Scope of the concept of  
         advertising to the general public under Article 1(3), first indent, and Article 3(1) of Directive 92/28
         
         
         145
            
         It is apparent from the foregoing that only prohibitions on advertising such as those in Paragraphs 3a and 10 of the HWG,
         namely those concerning unauthorised medicinal products and prescription medicines respectively, are compatible with Community
         law.  Accordingly, the Court must consider whether the scope of either of those prohibitions is such as may prevent internet
         sales of medicinal products, in order to ascertain whether it is necessary to give an interpretation of the term  
         advertising to the general public and, in particular, to state how broadly that term should be interpreted. 
         
         
         146
            
         As regards a prohibition of the kind referred to in Paragraph 3a of the HWG, it suffices to observe that the very placing
         on the market of medicinal products within the territory of a Member State in which they are subject to authorisation but
         have not been authorised is prohibited at Community level.  Accordingly, it cannot be maintained that a prohibition of that
         kind prevents the lawful sale of medicines over the internet. 
         
         
         147
            
         Community law does not preclude a prohibition on mail-order selling of prescription medicines, which means that a prohibition
         on advertising the sale by mail order sale of that class of medicinal products cannot be found to prevent a lawful method
         of selling medicinal products. 
         
         
         148
            
         In light of the foregoing, the answer to the first part of the second question must be that Article 88(1) of the Community
         Code precludes a national prohibition on advertising the sale by mail order of medicinal products which may be supplied only
         in pharmacies in the Member State concerned, such as the prohibition laid down in Paragraph 8(1) of the HWG, in so far as
         the prohibition covers medicinal products which are not subject to prescription. 
         
         
         149
            
         Consequently, and in light of the answer to Question 1(b), the Court finds that in the main case there is no prohibition on
         advertising compatible with Community law which is such as may prevent the lawful sale of medicinal products over the internet.
          Accordingly, there is no need to answer Question 2(a) and (b). 
         The third question
         
         150
            
         Given the answer to the second question, there is no need to reply to the third question. 
         
         Costs
         151
            
         The costs incurred by the German, Greek, French, Irish and Austrian Governments and by the Commission, which have submitted
         observations to the Court, are not recoverable.  Since these proceedings are, for the parties to the main proceedings, a step
         in the action pending before the national court, the decision on costs is a matter for that court. 
         
         On those grounds, 
         
         
         
            
            THE COURT,
         
         
         in answer to the questions referred to it by the Landgericht Frankfurt am Main by order of 10 August 2001, hereby rules: 
         
            
            1
               
            
            
            (a)
            A national prohibition on the sale by mail order of medicinal products the sale of which is restricted to pharmacies in the
            Member State concerned, such as the prohibition laid down in Paragraph 43(1) of the Arzneimittelgesetz (Law on medicinal products)
            in the version of 7 September 1998, is a measure having an effect equivalent to a quantitative restriction for the purposes
            of Article 28 EC. 
            
            
            (b)
            Article 30 EC may be relied on to justify a national prohibition on the sale by mail order of medicinal products which may
            be sold only in pharmacies in the Member State concerned in so far as the prohibition covers medicinal products subject to
            prescription. However, Article 30 EC cannot be relied on to justify an absolute prohibition on the sale by mail order of medicinal
            products which are not subject to prescription in the Member State concerned.
            
            
            (c)
             Questions 1(a) and 1(b) do not need to be assessed differently where medicinal products are imported into a Member State in
               which they are authorised, having been previously obtained by a pharmacy in another Member State from a wholesaler in the
               importing Member State.  
            
            
            
            
            2.
              Article 88(1) 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 precludes a national prohibition on advertising the sale by mail order of medicinal
               products which may be supplied only in pharmacies in the Member State concerned, such as the prohibition laid down in Paragraph
               8(1) of the Heilmittelwerbegesetz (Law on the advertising of medicinal products), in so far as the prohibition covers medicinal
               products which are not subject to prescription.  
            
            
                  Skouris
               
               
                  Jann 
               
               
                  Timmermans 
               
            
                  Gulmann
               
               
                  Cunha Rodrigues 
               
               
                  Rosas 
               
            
                  Edward
               
               
                  La Pergola 
               
               
                  Puissochet 
               
            
                  Schintgen
               
               
                  Macken 
               
               
                  Colneric 
               
            
                  von Bahr 
               
               
                  
               
               
                  
               
            
            
            
            
            
            
            
            
         
         
         Delivered in open court in Luxembourg on 11 December 2003. 
         
         
         
         
                  R. Grass 
               
               
                  V. Skouris  
               
            
         
         
         
                  Registrar
               
               
                  President
               
            
      
      
          1 –
            
             Language of the case: German.