C-104/75

JUDGMENT OF 20. 5. 1976 — CASE 104/75

authorities of the Member State Article 36 of the Treaty, unless it is into which the first product has clearly proved that any other rules or been imported altready possess the practices would obviously be beyond documents relating to the method the means which can be reasonably of preparation and also to the expected of an administration quantitative and qualitative com­ operating in a normal manner. position, since these documents It is only if the information or were produced to them previously documents to be produced by the by the manufacturer or his duly manufacturer or his duly appointed appointed importer in support of importer show that there are several an application for authorization to variants of the medicinal preparation place them on the market; and that the differences between these national rules or practices which make variants have a therapeutic effect that it possible for a manufacturer of the there would be any justification for pharmaceutical product in question trating the variants as different and his duly appointed representative, medicinal preparations, for the simply by refusing to produce the purpose of authorizing them to be documents relating to the medicinal placed on the market and as regards preparation in general or to a specific producing the relevant documents, it batch of that preparation, to enjoy a being understood that the answer to monopoly of the importing and the first question remains valid as marketing of the product, must be regards each of the authorization regarded as being unnecessarily procedures which have become restrictive and cannot therefore come necessary. within the exception specified in

Advocate-General: H. Mayras Registrar: A. Van Houtte

gives the following

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JUDGMENT

Facts

The order making the reference, the (a) the name and address of the procedure and the written observations manufacturer or importer; submitted under Article 20 of the (b) the pharmaceutical packaging of Protocol on the Statute of the Court of the preparation; Justice of the EEC may be summarized (c) full particulars concerning the as follows: quantitative and qualitative com­ position of the preparation, or, if this proves to be impossible, I — Facts and procedure full particulars of the basic 1. The 'Besluit farmaceutische Pre­ constituents and of the processing paraten' (the Decree on Pharmaceutical (bewerkingen) which the latter Preparations) adopted by the Netherlands have undergone giving in each Secretary of State for Social Security and case particulars of the active Public Health on 22 January 1970 ingredients (werkzame bestandde­ len). (Staatscourant No 22) and hereinafter called 'the BFP' — in the version in 2. For a period of six weeks after the force when the proceedings in the main date when he receives the application action were instituted — contains inter the Chief Public Health Inspector alia the following provisions: may, with reference to the preparation in question, by a registered letter Article 1 addressed to the applicant, require him to produce all the reports, For the purposes of this Decree, publications and other scientific data relating to the results of every analysis (e) 'importer' shall mean any person who and observation, of which he has a imports pharmaceutical preparations knowledge, as well as, in duplicate, and supplies them on a large scale. one of the files referred to, as the case may be, in Article 5 (1) or in Article 6 Article 3 (1) (1); Article 5 (2) and (4), or as the case The manufacturer and importer shall not, may be, Article 6 (2), shall apply to without the consent of the Chief Public the file in so far as signing and Health Inspector, supply a pharma­ endorsing the particulars 'seen and ceutical packaging of a pharmaceutical approved (de ondertekening van de preparation, whatever its quantitative gegevens voor 'gezien en akkoord') is concerned. composition may be. 3.— 6 …

this packaging is offered in several (e) a description of the contents of quantitative compositions, for each every commercial package, and to composition. Each file, compiled in the extent to which the packages accordance with the model prepared concerned are of a standard type, by the Chief Public Health Inspector the label on the packages, as well must contain the following particulars as a specimen of the packages and (gegevens): a description of their composition (a) (similar wording to that of Article (hoedanigheid). 4 (1) (c)) 2. The particulars referred to in the first (b) the manufacturing formula (berei­ paragraph must be signed by the dingsvoorschrift) of the prep­ pharmacist referred to in Article 9 (1) aration including: or, as the case may be, by the person (1) a brief description of the referred to in the second paragraph of processes undergone by the that Article (signature) certifying that constituents before completion the particulars were 'seen and of the finished product and of approved' (… moeten door de the packing operations; apotheker … 'voor gezien en akkoord' (2) particulars of the amounts of zijn getekend). the constituents referred to in 3. The tiles referred to in the first

subparagraph (1) above which paragraph must at all times be have to be used for the available to the Chief Public Health preparation of a given quantity Inspector and the Inspectors so that of the end product; they may examine them. (3) particulars of the checks 4.—6. …

carried out during manufacture Article 6 in order to be able to

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referred to in Article 5 (1) (b) documents referred to in Article 6 (2) and (c); of the BFP. (b) — (d) … — It did not have in its possession the 2.-3. … records referred to in Article 14 of the BFP, since the foreign 2. A — In 1973 the Centrafarm manufacturer had not placed such company purchased from a wholesale records at its disposal. business house in the UK various quantities of Valium tablets of doses of 5 Contrary to the objections raised by Mr and 10 mg and imported them into the De Peijper the Netherlands provisions in Netherlands as Valium coming from the question, which apply to domestic as

JUDGMENT OF 20. 5. 1976 — CASE 104/75

Although of arbitrary discrimination or a disguised the Court held in those cases that the restriction on trade between Member behaviour of proprietors of patents or States'. Nor do they run counter to trade-marks in a particular way infringes Commission Directive No 70/50/EEC of Community law, it must be borne in 22 December 1969 on the abolition of mind that in this case much more measures which have an effect equivalent important interests are at issue. to quantitative restrictions on imports and are not covered by other provisions B — By order of 29 September 1975 the adopted in pursuance of the EEC Treaty Kantongerecht decided to refer to the

proprietary medicinal product So far as subparagraph (1) is concerned to the manufacturer or — as the provisions in question are necessary the case may be — the person in order to guarantee the identity and the responsible for putting the quantitative and qualitative composition proprietary medicinal product of the product which is a very important in question on the market in factor in determining its therapeutic each of those Member States; efficacy and ensuring that it is not (b) knowledge of the tact that such dangerous. authorizations have been

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aldaar voor het in de handel proprietary medicinal product? brengen van de farmaceutische In the grounds of the order making the specialiteit verantwoordelijk is); reference the Kantongerecht, after In such circumstances do the finding that the offences with which Mr exceptions to the rule relating to De Peijper was charged had been proved, free circulation of goods within the makes inter alia, the following Community, namely Article 36 of observations. the Treaty, in so far as the protection of the health of humans The provisions of the BFP in force at is concerned, justify the authorities that time did not expressly provide that of the importing Member State in the importation of pharmaceutical making the marketing there of the preparations may only be effected by an proprietary medicinal product importer having his place of business in the Netherlands who must have in his

JUDGMENT OF 20. 5. 1976 — CASE 104/75

The observations of the Officier van from the manufacturer or importer Justitie for the District of Rotterdam duly approved by the latter.

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An analysis of every proprietary medicine — Articles 5 and 6 provide that the purchased in this way covering the manufacturer or importer must keep identity, purity and the amount of active a file for — in short — every ingredients is carried out in the pharmaceutical preparation which he company's laboratories under the wishes to market in the Netherlands. supervision of its pharmacists. — The provisions of Article 7 provide that the Chief Inspector shall keep Since the judgments of the Court in one copy of the file; he is therefore at Cases 15/74 and 16/74 the industry and all times able to take note of the the wholesalers' organizations have particulars relating to the proprietary brought pressure to bear on the medicinal products in respect of Netherlands authorities to apply Nether­ which he has granted his consent. lands law with a view to prevent parallel — The questions referred do not strictly imports. Hoffman-La Roche, in speaking relate to Article 14 (1) of particular, whose trading policy is infringing of which Mr De Peijper is moreover being investigated by the also accused. The obligation in Commission, is seeking to retain question in this case arises out of the territorial frontiers within the Com­ duty to compile a file (Article 5). The munity. national court obviously took the The relevant Netherlands law view that, if this latter obligation is inconsistent with Community law, it Pursuant to the ‘Wet op de follows that the obligation provided Geneesmiddelenvoorziening’ (the Law for by Article 14 is as well. relating to the supply of medicinal preparations, Staatsblad 1958, p. 408) and The practices adopted by manufacturers its implementing provisions, the ofproprietary medicinal products manufacture of and trade in phar­ maceutical products is subject to It is in the interest of the manufacturer

JUDGMENT OF 20. 5. 1976 — CASE 104/75

The Hoffmann-La Roche company kept manufacturer of pharmaceutical products such a master file for Valium. If the may market a specific medicinal quantitative and qualitative composition preparation of his own manufacture and of Valium recorded in this file is even under the same designation in every compared with the data for valium sold case, the qualitative and quantitative on the Netherlands market which are composition of which varies, however, found in the particulars supplied by according to the country where it is Hoffmann-La Roche to the Chief marketed. Inspector it is evident that the two products are absolutely identical. Article 20 et seq. of the Treaty

Mr De Peijper refers to correspondence The view defended in this case has also between Centrafarm and the Chief been accepted by the Court, in particular Inspector during the years 1972 to 1973 by its judgment of 11 February 1974 which establishes that there was a dispute (Dassonville, Case 8/74, [1974] ECR 837). concerning the question whether — as This judgment moreover allows the Centrafarm considered was the case conclusion to be drawn that Article 30 having regard to the provisions of the also applies to a national measure which BFP which were in force at that time — results in certain importers, in particular a parallel importer of a medicinal those who undertake parallel imports, preparation already on sale in the having to fulfil requirements which they Netherlands did not have to produce his cannot satisfy or which they can satisfy own file for this medicinal preparation. less easily than other importers. The Chief Inspector's submission in support of the oppsosite view was The case-law of the Court also shows that essentially that it was not sufficient to the exceptions specified by Article 36 argue that the public authorities already must not be given a wide interpretation. have a file for the medicinal preparation This means that national measures, imported by the parallel importer; in fact introduced for the purpose of protecting the possibility cannot be rules out that a one of the interests referred to by this

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If The particulars which have to be these data have been supplied by the supplied to enable the Netherlands manufacturer or the duly appointed authorities to check a file and in the end importer it is unecessary to ask other to grant their authorization under Article importers for this information as well. 3 of the BFP can only be given either by the manufacturer or the importer duly In any case it is quite impossible to appointed by him or by third parties accept the view that the burden of proof with the cooperation of the manufacturer lies on the parallel importer.

JUDGMENT OF 20. 5. 1976 — CASE 104/75

For example these authorities are entitled to In the absence of a complete make the granting of a distribution harmonization of the national rules on licence subject to conditions and to the distribution and marketing of withdraw it if it is in the interest of medical products the aims pursued by public health to do so. national laws in this field cannot in fact be attained at the present time by a Finally in the light of the Dassonville method which exempts the importer judgment there is no doubt whatever that from producing to the authorities placing obstacles in the way of parallel documents relating to the method of imports by insisting on formalities which preparing and to the composition of the the parallel importer either cannot or can product. In fact the protection which the only fulfil with greater difficulty amounts law extends to medical products should to arbitrary discrimination or a disguised not only cover their preparation and restriction on trade between Member composition but also a number of other States. points (the origin of the constituents, the synthetic processes adopted, packaging, The British Government makes the

From another point of The applicability of Article 30 of the view, for reasons which the British Treaty Government states in detail, the safety, efficacy and quality of the presentation of The disputed measures are not measures most medical products cannot in practice having an effect equivalent to a be established by any method of analysis quantitative restriction, because they are in a laboratory. The only possible way of applied without any distinction to checking these products is, on the one domestic and imported products and do hand, to know the manufacturing process not in fact make the sale of the latter used for the packaging of the medicinal more difficult than that of the former. preparation and to be convinced that it is Unlike the situation underlying the satisfactory and, on the other hand, to Dassonville judgment there is no reason check whether the product intended for

the two directives of the Council expression 'the person responsible for concerning the approximation of marketing'. For the purpose of national provisions relating to proprietary interpreting this expression reference medicinal products (No 65/65/EEC, OJ must be made to the first recital of of 9. 2. 1965, p. 369; No 75/319/EEC, Directive No 65/65/EEC which reads L 147 of 9. 6. 1975, p. 13) which the 'the essential purpose of any British Government analyses in detail; it rules concerning production and makes the following observations: distribution of proprietary medicinal — Under Article 3 of the first directive products must be to protect public 'No proprietary medicinal product health'. Consequently in the case of may be marketed in a Member State an imported product the importer or without an authorization issued by the person who has arranged for it to the competent authority of such be imported should be regarded as Member State'. 'the responsible person'. If several — Article 4 of this directive provides operators import and distribute a that for the purpose of granting this product independently of each other authorization 'the person responsible each of these importers is 'the person for marketing shall make application responsible'. This is the only to the competent authority of the interpretation which allows the Member States' giving the 'qualitative checks provided for by the directive and quantitative composition of all to be carried out effectively. constituents of the proprietary — The national authorities would be product' and 'a brief description of unable to perform, wherever it was the method of preparation'. necessary, the obligations referred to — Under Article 5 of this directive the above which are in Articles 5 and 11 beforementioned authorization shall of Directive No 65/65/EEC, if it had be refused if the required particulars to consider whether an importer in are not produced or if 'the qualitative the circumstances envisaged in the and quantitative composition of the first question referred by the national proprietary medicinal product is not court may market a product without as declared'. In the latter case or, if having an authorization from the the particulars supplied are incorrect, public authority and without having Article 11 provides that the produced to them the necessary authorization shall either be sus­ documents. In such a case, in the pended or revoked. absence of an authorization, the — No provision of the said directives importer would moreoever avoid the entitles a Member State to derogate sanctions provided for in Article 11 from the obligations laid down by of the directive. Directive No 65/65/EEC on the There is no evidence that the

It is to be expected that the view by the manufacturer either with a view to defended by the British Government preventing parallel imports or for the could mean that a trader would be purpose of complying with the unable to import a product into his own requirements of different national laws is state and market it there. But if this not a decisive factor under Article 36 but, siutation arises the appropriate remedy is to put it at its highest, could be of to be found in Articles 85 and 86 of the considerable relevance as regards other Treaty. provisions of the Treaty, for example

The Danish of health and life of humans without Government invokes also Directive No constituting a means of arbitrary 75/318/EEC of the Council relating to discrimination or a disguised restriction the approximation of the laws of Member on trade between Member States. It is States relating to analytical, pharmaco fitting to add that all the Member States toxicological and clinical standards and have adopted or are in the process of protocols in respect of the testing of adopting similar rules pursuant to the proprietary medicinal products (OJ L beforementioned directives of the 147 of 9. 6. 1975, p. 1).

the consumer. These authorities should The second question have the power to decide how these checks shall be carried out. In support of Even apparently trivial differences in the this, the Danish Government refers again method of preparing the product or in its to the obligations to carry out checks quantitative or qualitative composition imposed upon Member States by the can have an effect on its therapeutic three abovementioned directives and in properties or entail unacceptable side particular by Article 4 of Directive No effects. The possibility that such 65/65 and Articles 5 of Directive No differences were introduced intentionally 75/319.

It is not sufficient that the authorities dispute and, on the other hand, that the have in their possession corresponding relevant subject-matter in this case has data relating to the 'same' preparation been covered by the provisions of the which has already been lawfully placed Council's directives. on the market. If they were confined to these data, they could only embark upon Foolproof supervision is all the more random sampling checks or upon similar necessary where the methods of checks to make sure that the preparation manufacturing and making up a which has to be examined corresponds to proprietary medicinal product are the composition specified, but would different from those used for a similar find it impossible to check whether it preparation which has already been

to withdraw specific batches, because The Netherlands Government, too, does they have been found to produce serious not deny that the measures in question side effects or because there has been have an effect equivalent to a quantitative some mistake in their production. In restriction but takes the view that they order to ensure that the identity of the are covered by the exceptions specified product can be checked at any time the in Article 36. It defines the scope of the person wishin to place proprietary disputed provisions in the sense that they products on the market must be able to prohibit the marketing of a proprietary produce, in the case of each separate medicinal product if, inter alia: batch of the products, data relating to the — its qualitative and quantitative manufacture of that batch of the composition does not correspond to products (time, conditions, producer, that of the product for which

arising from defective pharmaceutical products is a matter of legitimate Even an apparently trivial change in the concern and is the main purpose of the method of preparation or in the exceptions specified in Article 36. composition of the product may either Although in these judgments the Court have an unfavourable influence on its has defined the limits of these therapeutic efficacy or have unacceptable exceptions, there are grounds for the harmful side effects. If it were not for the view that, on the one hand, the disputed legislation the authorities would subject-matter of the said cases was not have any guarantee concerning the entirely different from that of the present composition of the imported product,

importing country to ascertain whether a There is neither discrimination nor a proprietary medicinal product may be disguises restriction on trade between authorized in that country if it has been Member States. On the one hand the modified in the way indicated above. disputed rules do not distinguish Further, it follows from Article 11 of between national and foreign products. Directive No 65/65 — which provides On the other hand they do not have any that an authorization to market a restrictive effect on imports; the most proprietary medicinal product shall be that can be claimed is that, were it not suspended or revoked if its qualitative or for these rules, the pattern of trade might quantitative composition does not perhaps be different; but the rules do not correspond to that for which the restrict the total amount of imports. authorization was granted — that any The Netherlands Government invokes, modification, however trivial, is in support of the same views as the prohibited in so far as it has not been British and Danish Governments, accepted by the national authorities. Directives No 65/65/EEC and No 75/319/EEC of the Council. It states that The Commission makes the following observations: none of the provisions of these directives contain an exception to the requirement of an authorization when more than one The Netherlands legislation person are responsible for putting the same product on the market. This is In accordance with a generally accepted bound to be the position having regard practice 'pharmaceutical preparations' must be understood to mean medicinal to the obligations imposed upon such persons and upon the competent preparations sold under a name derived authorities under these directives (cf. for from the substance used fonder hun example Articles 8, 11 and 20 of stofnaam'). 'Pharmaceutical preparations' Directive No 65/65; Articles 27 and 36 are capable of being distinguished from of Directive No 75/319). If Mr De 'medicinal preparations in packages' Peijper's argument was accepted, the said (Verpakte geneesmiddelen'), since this authorities would find that it was expression refers to medicinal prep­ arations sold under a trade-mark. impossible to fulfil the obligations to carry out checks imposed upon them by these provisions. The present proceedings relate to pharmaceutical preparations in spite of These considerations also make it the fact that the national court 'suddenly possible for the second question referred introduced into its questions the

expression "proprietary medicinal Read together these provisions have two product"'. objectives: — they require that the records relating In the Netherlands the supervision of the to the medicinal preparation which sale of medicinal preparations takes place has in fact been imported (cf. Articles in two stages, the first being the 14, 11) conform with the data on the authorization to market the medicinal file relating to the authorized med­ preparations on the Netherlands market icinal preparation (cf. Articles 5, 6); (cf. Article 3 of the BFP) and the second — in the case of imports they designate the manufacture of and trade in the the person whose duty it is to prove authorized medicinal preparations. this conformity. It appears from Articles 3 to 7 inclusive of the BFP that the authorization covers In this way the Netherlands authorities not only a specific substance having are absolutely sure that there is specific characteristics but also the conformity which makes it easier to carry out the later checks. method of preparation and the system of checks used during the preparation. 'In other words an authorized medicinal It appears from certain statements of the Netherlands Government that in its view preparation is a product which has been manufactured in accordance with a the difficulties arising out of the laws and method described with a high degree of practices of the Netherlands in the case accuracy and has undergone specific of parallel imports must be accepted not checks'. only for the purpose of protecting public health but also having regard to the Even if a medicinal preparation has been technical aspects of the supervision authorized the authorites are concerned which has to be undertaken. to ensure that it is manufactured in a way which corresponds completely to the The first question data produced for its authorization. The medicinal preparation which is placed on This question assumes that there is a the market must therefore correspond in parallel import of a medicinal every way to the product which was preparation which has been authorized in authorized. As far as imported products the importing as well as the exporting are concerned the Netherlands legislature country on the basis in both cases of an endeavours to obtain this guarantee by identical method of preparation and adopting two different methods: on the qualitative and quantitative composition. one hand it makes the manufacturer In other words this question deals with responsible for ensuring the above- the case where the medicinal prep­ mentioned conformity (Article 12 of the arations manufactured in the exporting BFP); on the other hand the importer country are in all respects the same must himself be able to prove this whether they are intended for the conformity (cf. Article 14). domestic market or for export.

narrowly' to the obligation to provide a effect within the meaning of Article 30. file imposed upon the importer by The restriction in question in this case Article 6 of the BFP. It is true that the has an adverse quantitative effect on the performance of this obligation does not supply of imported products. Further, it provide the authorities with any prevents offers being made at lower additional information. However the aim prices and this precludes the normal of the legislature is not to provide the expansion of trade channels.

This records. Therefore the Netherlands conclusion follows from the wording of Article 36 and from the fact that it legislature makes the parallel import dependent upon the cooperation of the constitutes an exception. manufacturer, which means that in It is clear from the case-law of the Court practice such an import cannot be that formalities with which only direct effected, as the manufacturer is under no importers are in fact able to comply may legal obligation to cooperate in this way constitute a means of arbitrary and it is very much in his interest not to discrimination or a disguised restriction

appropriate to recall the judgment of the Governments are in no way connected Court of 30 April 1974 (Sacchi, Case with the questions referred. On the one 155/73, [1974] ECR 409) which held that hand they only apply to medicinal it is incompatible with Article 30 to preparations in packages ('proprietary favour particular trade channels in medicinal products' according to the relation to others. wording of the directives) whereas the questions refer to pharmaceutical prep The restriction in question is not arations. On the other hand they aim at justified by concern for the protection of the harmonization of laws and can only public health. In fact, as the Commission therefore cover national provisions which explains in detail, this objective can be are compatible with Community law. attained by less restrictive methods.

National rules relating to the sale of necessary means to decide whether the differences recorded between the two imported medicinal preparations which provide as a condition precedent to such variants of the medicinal preparation in sale that importers must have in their question may have a therapeutic effect. If possession the manufacturer's data which they do not, there is no need to retain establish the conformity of the imported the obstacles to the sale of this product with the authorized medicinal prep­ in the importing country. In the event of aration only comes within the limits of doubt or dispute, an independent expert Article 36 if the national authorities can give his opinion on this question. If concerned also make use, where they do, the protection of public health necessary, of other data enabling the is a valid ground for opposing the sale of these two variants on one and the same requisite compatibility to be established market. or demand the necessary data directly from the manufacturer. To sum up the Commission submits that The second question the second question should be answered as follows:

It is appropriate to call attention first of all to the fact that the difference in the When the sale of the same medicinal

Legal Adviser, Mr B. Van der Esch, exchange of views on this matter, developed the arguments put forward in whether the Commission has finished its

the written procedure. examination of the decree and, if so, whether it has stated its views on the The new matters raised on this occasion conformity of the decree with may be summarized as follows: Community law.

The Court invited the Netherlands Mr De Peijper, in answer to a question Government to state whether the by the Court during the hearing asking Netherlands authorities already had in what opportunities the manufacturer has their possession the file relating to the of following what happens to each batch medicinal preparations in question, of which he produces, although it has been failing to compile which Mr De Peijper packaged by the importer, produced to has been accused and which the the Court by way of example a bottle Netherlands representative of the originating from the manufacturer and Hoffmann-La Roche firm handed over to containing tablets. The label on this them. bottle shows that the medicinal

preparation was produced in the United The Officier van Justitie for the District Kingdom. The batch number ('batch- of Rotterdam in his answer to this nummer') is on the right hand side of the question in the name of the Netherlands label. After packaging Centrafarm puts Government states that the British on the left hand side of the label on its manufacturer of the Hoffmann-La Roche own bottle its own file number group never placed the said file at the ('chargenummer). The company adopts a disposal of the Netherlands authorities. daily system of accounting which enables On the other hand the latter have the file it to determine in the case of each batch relating to the products manufactured by the relationship between the English and Hoffmann-La Roche in Switzerland. the Netherlands numbers.

3 Under that legislation 'file' means a document which the importer must keep for 'every pharmaceutical packaging of a pharmaceutical preparation which he imports' and which must contain detailed particulars concerning the said packaging and especially of the quantitative and qualitative composition as well as the method of preparation; these particulars have to be signed and endorsed 'seen and approved' by 'the person who is responsible for the manufacture abroad'.

4 It is the practice for the importer to produce the 'file' to the competent authorities for 'certification' which at the same time authorizes him to market the packaging in the Netherlands so that only an importer who has the 'file' in his possession can obtain this authorization.

5 Under the Netherlands legislation 'records' mean documents which an importer must have in his possession when he supplies a pharmaceutical preparation which he has imported and which establish that the latter has in fact been manufactured and checked in accordance with the particulars on the above mentioned 'file' and relating to the manufacturing formula as well as the rules for checking the preparation and the substances of which this preparation is composed.

JUDGMENT OF 20. 5. 1976 —CASE 104/75

6 It appears that the 'file' relates to the product in general whereas the 'records' refer to each specific batch of the product which the importer wishes to place on the market.

7 The accused in the main proceedings does not deny the matters of which he is accused but argues that he could not comply with the rules in question because he was unable to obtain the documents which are at issue in those

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— the fact that such authorizations have been granted in each of the Member States is made known by general notice given by official publication or in some other way; and

— this product is in every respect similar to a product in respect of which the public health authorities of the Member State into which the first product has been imported already possess the documents relating to the method of preparation and also to the quantitative and qualitative composition, since these documents were produced to them previously by the manufacturer or his duly appointed importer in support of an application for authorization to place them on the market.

11 The Court is asked to rule whether national authorities faced with such a

situation adopt a measure equivalent to a quantitative restriction and prohibited by the Treaty when they make the authorization to place a product on the market, for which a parallel importer has applied, conditional upon the production of documents identical with those which the manufacturer or his duly appointed importer has already lodged with them.

12 1. National measures of the kind in question have an effect equivalent to a quantitative restriction and are prohibited under Article 30 of the Treaty if they are likely to constitute an obstacle, directly or indirectly, actually or potentially, to imports between Member States.

18 In particular Article 36 cannot be relied on to justify rules or practices which, even though they are beneficial, contain restrictions which are explained primarily by a concern to lighten the administration's burden or reduce public expenditure, unless, in the absence of the said rules or practices, this burden or expenditure clearly would exceed the limits of what can reasonably be required.

19 The situation described by the national court must be examined in the light of these considerations.

20 B. — For this purpose a distinction must be drawn between on the one hand the documents relating to a medicinal preparation in general, in this case the 'file' prescribed by the Netherlands legislation, and, on the other hand, those relating to a specific batch of this medicinal preparation imported by a particular trader, in this case the 'records' which have to be kept under the said legislation.

21 (a) With regard to the documents relating to the medicinal preparation in general, if the public health authorities of the importing Member State already have in their possession, as a result of importation on a previous occasion, all the pharmaceutical particulars relating to the medicinal preparation in question and considered to be absolutely necessary for the purpose of checking that the medicinal preparation is effective and not harmful, it is clearly unnecessary, in order to protect the health and life of humans, for the said authorities to require a second trader who has imported a medicinal preparation which is in every respect the same, to produce the above-mentioned particulars to them again.

26 National authorities possess legislative and administrative methods capable of compelling the manufacturer or his duly appointed representative to supply particulars making it possible to ascertain that the medicinal preparation which is in fact the subject of parallel importation is identical with the medicinal preparation in respekt of which they are already informed.

27 Moreover, simple co-operation between the authorities of the Member States would enable them to obtain on a reciprocal basis the documents necessary for checking certain largely standardized and widely distributed products.

28 Taking into account all these possible ways of obtaining information the national public health authorities must consider whether the effective protection of health and life of humans' justifies a presumption of the non-conformity of an imported batch with the description of the medicinal preparation, or wether on the contrary it would not be sufficient to lay down a presumption of conformity with the result that, in appropriate cases, it would be for the administration to rebut this presumption.

JUDGMENT OF 20. 5. 1976 — CASE 104/75

29 Finally, even if it were absolutely necessary to require the parallel importer to prove this conformity, there would in any case be no justification under Article 36 for compelling him to do so with the help of documents to which he does not have access, when the administration, or as the case may be, the court, finds that the evidence can be produced by other

30 The British, Danish and Netherlands Governments are of the opinion that measures such as those which are the subject-matter of the main proceedings are necessary in order to comply with the requirements of Council Directives Nos 65/65/EEC, 75/318/EEC and 75/319/EEC (OJ, English Special Edition 1965, p. 20; OJ L 147 of 9. 6. 1975, p. 1 and p. 13) concerning the approximation of national provisions relating to proprietary medicinal products.

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34 The answer must be in the affirmative.

35 The competent administration of the importing Member State is clearly entitled to require the manufacturer or his duly appointed importer, when the person concerned applies for an authorization to market the medicinal preparation and lodges the relevant documentation (a) to state whether the manufacturer or, as the case may be, the group of manufacturers to which he belongs, manufactures under the same name for different Member States several variants of the medicinal preparation and (b) if his answer is in the affirmative, to produce similar documentation for the other variants too, specifying what are differences between all these variants.

36 It is only if the documents produced in this way show that there are differences which have a therapeutic effect that there would be any justification for treating the variants as different medicinal preparations, for the purposes of authorizing them to be placed on the market and as regards producing the relevant documents, it being understood that the answer to the first question remains valid as regards each of the authorization procedures which have become necessary.

Costs

37 The costs incurred by the British, Danish and Netherlands Governments and the Commission of the European Communities, which have submitted their observations to the Court, are not recoverable.

2. Given a factual situation such as that described in the first

question national rules or practices which make possible for a manufacturer of the pharmaceutical product in question and his duly appointed representatives, simply by refusing to produce the documents relating to the medicinal preparation in general or to a specific batch of that preparation, to enjoy a monopoly of the importing and marketing of the product, must be regarded as being unnecessarily restrictive and cannot therefore come within the exceptions specified in Article 36 of the Treaty, unless it is clearly proved that any other rules or practices would obviously be beyond the means which can reasonably be expected of an administration operating in a normal manner.

3. It is only if the information or documents to be produced by the manufacturer or his duly appointed importer show that there are several variants of the medicinal preparation and that the differences between these variants have a therapeutic effect that there would be any justification for treating the variants as different medicinal preparations, for the purpose of authorizing them to be placed on the market and as regards producing the relevant documents, it being understood that the answer to the first question remains valid as regards each of the authorization produres which have become necessary.

Lecourt Kutscher O'Keeffe

Donner Mertens de Wilmars Sørensen Mackenzie Stuart

Delivered in open court in Luxembourg on 20 May 1976.