Judgment — ECLI:EU:C:1998:151
Date: 1998-04-02
Language of the case: English
Court formation: Fifth Chamber
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Agriculture and Fisheries;Approximation of laws;Veterinary legislation
Concepts: Medicinal products for veterinary use
Procedure: Reference for a preliminary ruling
Origin: United Kingdom

summary of the factual back­
ground to the main proceedings 29 it is 
explained that SS is not an active ingredient, 
but that it goes into the manufacture of the 
active ingredient, DHS, of which it is the 
sole ingredient, and that it is manufactured 
from the disputed product. 30 
46. At the hearing, the Commission's expert 
stated that the disputed product should be 
regarded as a 'starting material' within the 
meaning of Directive 92/18, which provides 
that: 
'Where source materials such as micro­
organisms, tissues of either plant or animal 
origin, cells or fluids (including blood) of 
human or animal origin or biotechnical cell 
constructs are used in the manufacture of 
veterinary medicinal products, the origin and 
history of starting materiah shall be described 
and documented. 
The description of the starting material shall 
include the manufacturing strategy, 
purification/inactivation procedures with 
their validation and all in-process control 
procedures designed to ensure the quality, 
safety and batch to batch consistency of the 
finished product.' 31 
According to that expert, that 'source mate­
rial' is to be assimilated to a 'starting mate­
rial' within the meaning of Directives 81/851 
and 81/852. The United Kingdom shares that 
opinion. 32 
47. Norbrook disputes the results of the sci­
entific analysis undertaken by the Commis­
sion and United Kingdom experts and does 
not agree that SS should be regarded as a 
starting material. It refers to the results of an 
expert study carried out at its request, and 
argues that Directive 92/18 did not come 
into force until after the company's dispute 
with the MAFF. 
28 — First protocol of the Annex to Directive 81/852, Part A, 
point 1, first paragraph, first, second and third indents. 
29 — Page 3 of the order for reference. 
30 — Not disputed by any of the parties, including Norbrook; 
see paragraph 1.4 of its observations. 
31 — Second part of the first protocol of the Annex to Directive 
92/18, Part C, first and second subparagraphs of paragraph 
2, emphasis added. 
32 — Paragraph 13 of the United Kingdom's observations. 
I -1545 
OPINION OF MR LÉGER — CASE C-127/95 
48. I do not think that the latter argument is 
capable of preventing the competent auth­
ority from requiring production of new tests 
in support of an application for marketing 
authorisation, for two main reasons. 
49. First, the Community legislature has 
itself indicated that, because of the specificity 
of the subject-matter of these directives, the 
tests provided for in Directive 81/852 may 
be replaced by others, which may be more 
relevant in the light of scientific progress. 33 
Thus, the first paragraph of Article 14 of 
Directive 81/851 provides: 
'The person responsible for marketing shall 
modify the control test method provided for 
in point 9 of Article 5 34 in accordance with 
technological and scientific progress, if such 
modification is needed to enable the veteri­
nary medicinal product to be controlled with 
a greater degree of security.' 
50. To hold otherwise would risk neutralis­
ing the effectiveness of such legislation. Since 
the main aim of this Community legislation 
is to safeguard public health, where new sci­
entific data show that more efficient tests are 
advisable in order to ensure the safety, effec­
tiveness and quality of the medicinal prod­
uct, those tests must be carried out. 
51. Secondly, the Court has already con­
firmed that interpretation in the Scotia Phar­
maceuticals judgment, cited above, by stating 
that: 'The competent authority may ... use its 
power of assessment to ascertain whether or 
not the applicant seeking an authorisation, 
and consequently the expert who prepared 
the documentation supporting the applica­
tion, took account of current technical devel­
opments and scientific progress and whether 
or not he or she was satisfied that the scien­
tific publications, on the basis of which the 
application for authorisation was submitted 
under the abridged procedure, were still up 
to date.' 35 
52. However, it is not appropriate to assess 
the argument based on the expert study car­
ried out at the request of Norbrook. Under 
the first paragraph of Article 14 of Directive 
81/851, only the national court, taking 
account of the particular characteristics of SS 
and current technological and scientific 
progress, has jurisdiction to assess whether 
the tests prescribed for starting materials 
under Directives 81/851 and 81/852 must be 
carried out on SS. 
33 — First paragraph of Part A of the first protocol of the Annex 
to Directive 81/852. 
34 — This provision, which deals with the control methods used 
by the manufacturer, will be considered in detail in the con­
text of the answers to be given to Question 1. 35 — Paragraph 21. 
I - 1546 
NORBROOK LABORATORIES v MAFF 
53. In the remainder of my argument, in 
order to avoid the trap of reasoning on a 
purely hypothetical basis, 36 and taking into 
account the information contained in the 
documents before the Court, I can usefully 
proceed only on the basis put forward by the 
Commission and the United Kingdom, 
whereby SS is to be assimilated to a 'starting 
material' within the meaning of the 'stan­
dards and protocols' directive. 37 
54. The expression 'starting material' should 
be understood as meaning '... all the constitu­
ents of the ... medicinal product and, if neces­
sary, of its container, as referred to in point 
A, paragraph 1.' 38 
55. That latter provision provides that the 
constituents of medicinal products are: 
— the active ingredient(s), 
— the constituents) of the excipient(s) what­
ever their nature or the quantity used, 
including colouring agents, preservatives, 
stabilisers, thickeners, emulsifiers, anti-
agglutinating agents, flavouring and aro­
matic substances, propellants, etc., 
— the constituents of the pharmaceutical 
form intended to be ingested or other­
wise administered to animals. 
(1) Information concerning the manufactur­
ing processes of a starting material 
56. Article 5, second paragraph, point 4 of 
Directive 81/851 provides that the infor­
mation and documents submitted in support 
of an application for marketing authorisation 
must include a 'brief description of the 
method of preparation'. 39 
57. The 'standards and protocols' directive 
provides that the brief description of the 
method of preparation must include at least: 
'— mention of the various stages of manu­
facture, so that an assessment can be 
made of whether the processes-
36 — Prohibited by the judgment in Case C-83/91 Meilicke v 
ADV/ORGA [1992] ECR I-4871. 
37 — N o other facts or arguments have been adduced to allow 
me to argue cogently on any other basis, because, although 
Norbrook denies that SS is to be assimilated to a starting 
material, it does not adduce any facts or arguments to 
enable me seriously to consider any possibility other than 
that put forward by the Commission and the United King­
dom. Thus, in Norbrook's submission, the disputed prod­
uct is neither an active ingredient, nor an excipient, nor a 
starting material, nor a constituent, but only a 'substance' 
(points 2.4 and 2.8 of its observations). 
38 — First paragraph of Part C of the first protocol of the Annex 
to the 'standards and protocols' directive, emphasis added. 39 — Emphasis added. 
I - 1547 
OPINION OF MR LÉGER — CASE C-127/95 
employed in producing the pharmaceu­
tical form might have produced an 
adverse change in the constituents; 
— the actual manufacturing formula, with 
the quantitative particulars of all the 
substances used, the quantities of 
excipients, however, being given in 
approximate terms in so far as the phar­
maceutical form makes this necessary; 
mention shall be made of any 
substances which may disappear in the 
course of manufacture; 
— a statement of the stages of manufacture 
at which sampling is carried out for 
in-process control tests, where other 
data in the documents supporting the 
application show such tests to be 
necessary for quality control of the 
proprietary medicinal product.' 40 
58. I therefore have to conclude that, in 
answer to the questions of the referring 
court, the requirement that an applicant for 
marketing authorisation must provide par­
ticulars of the manufacturing method of the 
disputed product, in so far as it constitutes a 
starting material, is in accordance with the 
provisions of Directives 81/851 and 81/852. 
(2) Particulars of the control methods used by 
the manufacturer of a starting material 
59. In Question 1(b), the national court 
amplifies one of the aspects of Question 1(a), 
by asking whether a national practice con­
sisting, among other things, in requiring a 
person responsible for marketing a veteri­
nary medicinal product to submit for 
approval the results of tests on each batch of 
the disputed product purchased by him is 
permissible. 
60. Article 5, second paragraph, point 9 of 
Directive 81/851 provides that an application 
for marketing authorisation must contain a 
'description of the control testing methods 
employed by the manufacturer (qualitative 
and quantitative analysis of the constituents 
and the finished product, specific tests, e. g. 
sterility tests, tests for the presence of pyro­
gens, for the presence of heavy metals, stabil­
ity tests, biological and toxicity tests, tests on 
intermediate products).' 41 
40 — First protocol of the Annex to the 'standards and protocols' 
directive, Part B, second paragraph, first, third and fourth 
indents, emphasis added. 41 — My emphasis. 
I -1548 
NORBROOK LABORATORIES v MAFF 
61. The 'standards and protocols' directive 
provides that 'the particulars and documents 
accompanying the application for marketing 
authorisation pursuant to points 9 and 10 of 
the second paragraph of Article 5 of Direc­
tive 81/851/EEC must include the results of 
the tests relating to quality control of all the 
constituents used. These shall be submitted in 
accordance with the following provisions 
...'. 42 There follows an exhaustive list of pro­
visions to be complied with in order to meet 
the statutory requirements, which makes a 
distinction according to whether the starting 
materials are listed 43 or not listed 44 in phar­
macopoeias. 45 
62. It is clear from the analysis of part C of 
the first protocol of the Annex to Directive 
81/852 that the concern of the Community 
legislature is, above all, to check that the 
starting material, whether listed in a pharma­
copoeia or not, was prepared according to a 
method which cannot leave impurities. 46 
63. By way of example, if the starting mate­
rial used is not listed in any pharmacopoeia, 
it must be the subject of a monography con­
cerning 'purity tests ... described in relation to 
the sum total of predictable impurities, espe­
cially those which may have a harmful effect, 
and, if necessary, those which, having regard 
to the combination of substances to which 
the application refers, may adversely affect 
the stability of the medicinal product or dis­
tort analytical results.' 47 However, if the 
starting material used is listed in the pharma­
copoeias, it is to be verified that it '... has 
been prepared by a method liable to leave 
impurities not mentioned in the pharmaco­
poeia monograph. These impurities and their 
maximum tolerance levels must be declared 
and a suitable test method advanced'. 48 
64. Moreover, I think that it is important t o 
point out, having regard to the kind of dis­
pute now before the Court — and although 
this concerns only a factual matter — that 
the Commission expert emphasised that the 
risk of any impurities existing in the product 
in question spreading in the DHS was not 
negligible, in particular because of the use of 
boron in the SS manufacturing process. That 
is why this expert concluded that it is very 
important to be able to know the manufac­
turing methods used by SS producers in 
order to set up the appropriate tests. Again, 
still according to the Commission expert, 
42 — Second paragraph of Part C of the first protocol of the 
Annex to Directive 81/852, concerning the control of start­
ing materials, emphasis added. 
43 — Point 1 of Part C of the first protocol of the Annex to 
Directive 81/852. 
44 — Ibid., point 2. 
45 — Definition given in the Nouveau Larousse Médical: 'Com­
pendium containing: the nomenclature of drugs, simple and 
composite medicinal products, medicinal articles; a list of 
common names for medicines; tables of maximum and nor­
mal dosages of medicinal products for [the animal]; infor­
mation which may be useful to a pharmacist for pharma­
ceutical practice'. 
46 — See, in particular, point 1 of part C of the first part of the 
Protocol of the Annex to Directive 81/852, paragraphs 4, 5 
and 7, and point 2 of part C, at (b), (d) and (e). 
47 — First paragraph of point 2(d) of part C of the first Protocol 
of the Annex to Directive 81/852. 
48 — Fourth paragraph of point 1 of the part C of the first Pro­
tocol o f the Annex to Directive 81/852. 
I - 1549 
OPINION OF MR LÉGER — CASE C-127/95 
controls based on analytical tests of the 
active ingredient (DHS), of the final product 
(Pen & Strep) or the starting material itself 
(SS) would be insufficient to exclude all risk 
of impurities in the final product. That 
analysis was confirmed by the United King­
dom, 49 but contested by Norbrook. 
65. Moreover, if the product in question is 
listed in a pharmacopoeia, the clarification 
requested by the national court in point (b) 
of its first question can also be answered 
since, in the Annex to Directive 81/852, it is 
stated that 'the routine tests to be carried out 
on each batch of starting materials shall be 
declared in an application for authorisation 
to market. These tests must make it possible 
to provide evidence that each batch of start­
ing material satisfies the quality require­
ments of the relevant pharmacopoeial mono­
graph'. 50 However, as the Commission 
rightly points out, 51 in no case do Directives 
81/851 and 81/852 provide for preliminary 
approval by the competent authorities of 
batches used in the manufacture of the 
medicinal product concerned. 
66. Thus, I propose that the Court should 
reply to these points as follows: a request for 
particulars of the control methods used by 
the manufacturer of starting materials is in 
conformity with the requirements of Direc­
tives 81/851 and 81/852. Moreover, if the 
product in question is listed in the existing 
pharmacopoeias 52 — which is for the 
national court to determine — the requiring 
particulars of the results of tests on each 
batch of starting material is also in confor­
mity with the provisions of Directives 
81/851 and 81/852. However, those direc­
tives preclude a competent authority from 
making the grant of a marketing authorisa­
tion for a veterinary medicinal product sub­
ject to approval of the batches of starting 
material entering into the manufacture of the 
medicinal product. 
(3) Particulars of the manufacturer of a 
starting material 
67. These particulars, 53 more precisely the 
names and addresses of the manufacturer or 
manufacturers and details of the site or sites 
of manufacture of a starting material, are not 
required by Directives 81/851 and 81/852. 
Point 1 of the second paragraph of Article 5 
of Directive 81/851 provides only that the 
person responsible for marketing must state 
the 'name or corporate name and permanent 
address or registered place of business of the 
person responsible for marketing and of the 
manufacturer, if different'. By 'manufacturer' 
must be understood the manufacturer of the 
medicinal product, the finished product, and 
not the manufacturer of each constituent. 
49 — First paragraph of the French translation of its observa­
tions. 
50 — Ibid., seventh paragraph, my emphasis. 
51 — Under the heading 'Answer to question lb ' on page 9 of 
the Commission's observations. 
52 — The participating parties are unanimous that this is the case. 
53 — Point (a) of the first preliminary question. 
I - 1550 
NORBROOK LABORATORIES v MAFF 
68. To the list of information to be provided 
by the person responsible for the marketing 
of a veterinary product Directive 92/18 
added this requirement: 'The name and 
address of the applicant shall be given, 
together with the name and address of the 
manufacturers and the sites involved in the 
different stages of the manufacture (including 
the manufacturer of the finished product and 
the manufacturer(s) of the active ingredi-
ent(s), and where relevant the name and 
address of the importer'. 54 This provision is 
not, however, applicable in this case. 
69. At the hearing, the United Kingdom 
accepted that these particulars were not men­
tioned in Directive 81/851 as being particu­
lars which must be appended to applications 
for the grant of a marketing authorisation for 
a veterinary medical product and that it had 
requested them in order to be able to get in 
touch directly with the manufacturers of the 
product in question in order to obtain the 
information about the manufacturing process 
and control methods for the preparation of 
SS which was lacking in Norbrook's applica­
tion documents. It states that point 3 of the 
first paragraph of Article 9 of Directive 
81/851 allows it to demand this further 
information. 55 
70. That article provides that the competent 
authority '[may], where appropriate, require 
the applicant to provide further information 
as regards the items listed in Article 5'. 56 
71. I think that not only the requirements 
imposed by the United Kingdom are con­
trary to Directives 81/851 and 81/852 but 
also that point 3 of the first paragraph of 
Article 9 of Directive 81/851 is not appli­
cable in this case. 
72. Directives 81/851 and 81/852 require the 
competent authorities of each Member State 
to make the grant of marketing authorisa­
tions subject to observance of all the condi­
tions expressly laid down by them and do 
not authorise a Member State to prescribe 
others. 
73. This is clear from the wording of a num­
ber of provisions of those directives. 
74. Thus, Article 11 of Directive 81/851 pro­
vides that: 'The authorisation provided for in 
Article 4 shall he withheld if examination of 
the documents and particulars listed in 
Article 5 establishes that: ... . 57 Authorisa­
tion shall also be withheld if the application 
documents submitted to the competent 
authorities do not comply with Articles 5, 6 
and 7'. 58 
75. Similarly, point 1 of the first paragraph 
of Article 9 of Directive 81/851 provides 
that: 'In order to examine the application 
submitted pursuant to Article [5], the com­
petent authorities of the Member States: 1. 
shall check that the documentation submitted 
in support of the application complies with 
54 — Second paragraph of section A of Part 1 of Title I of the 
Annex to Directive 92/18. 
55 — Point 14 of the United Kingdom Government's observa­
tions. 
56 — My emphasis. 
57 — Ibid., first paragraph, my emphasis. 
58 — Ibid., second paragraph, my emphasis. 
I -1551 
OPINION OF MR LÉGER — CASE C-127/95 
Article 5 and, on the basis of the reports 
drawn up by the experts pursuant to Article 
7, ascertain whether the conditions for the 
issue of the marketing authorisation have 
been fulfilled.' 
76. O r take the first paragraph of Article 1 
of the 'standards and protocols' Directive, 
which, as we have seen, states: 'Member 
States shall take all appropriate measures to 
ensure that the particulars and documents 
which shall accompany applications for 
authorisation to place a veterinary medicinal 
product on the market pursuant to points 3, 
4, 6, 8, 9 and 10 of the second paragraph of 
Article 5 of Directive 81/851/EEC, are sub­
mitted by the persons concerned in accord­
ance with t he Annex to this Directive'. 59 
77. It seems to me that, by using the present 
indicative, the present subjunctive, the 
adverbs 'also' and 'in accordance with', verbs 
expressing an obligation or a prohibition 
such as 'shall' and 'refuse', the Community 
legislature clearly expressed its intention to 
make the grant of marketing authorisation 
subject to observance of all the precise and 
unconditional conditions of those directives-
and if the particulars required by Article 5 
are not given, as is the case here, a marketing 
authorisation must be refused. 
78. Moreover, the interpretation according 
to which all the requirements of Article 5 of 
Directive 81/851, submitted in accordance 
with the Annex to Directive 81/852, must be 
observed has the purpose of ensuring the 
attainment of the aim of protecting public 
health. 60 I have previously explained the 
risks which could be involved in non-
observance of points 3, 4 and 9 of the second 
paragraph of Article 5 of Directive 81/851 61 
as regards public health. 
79. Finally, the Court held in its judgment in 
the Scotia Pharmaceuticals case, 62 cited 
above, which is transposable to this case, 63 
that all the requirements of the directives 
concerning the grant of marketing authorisa­
tions for medicinal products for human use 
must be observed. 
80. Moreover, the first and second indents of 
the first paragraph of Article 41 of Directive 
81/851 state: 
'No decision to: 
—- withhold, withdraw or suspend market­
ing authorisation, 
59 — My emphasis. 
60 — Third recital of the preamble to the 'standards and proto­
cols' directive, my emphasis: 'Whereas standards and pro­
tocols for the performance of tests and trials on veterinary 
medical products are an effective means of control of these 
products and, hence, of protecting public health ... .' 
61 — Paragraphs 62 to 65 of my Opinion. 
62 — Paragraph 21. 
63 — Paragraph 42 of my Opinion. 
I -1552 
NORBROOK LABORATORIES v MAFF 
— prohibit the supply of a veterinary 
medicinal product or have it withdrawn 
from the market, 
may be taken on grounds other than those set 
out in this Directive'. 64 
81. The wording of that article is clear. It 
requires the Member States not to add other 
requirements to those laid down by the 
directives as regards the grant, withdrawal, 
refusal and suspension of marketing author­
isation. 
82. The purpose of observance of the 
requirements of Article 41 of Directive 
81/851 is to ensure attainment of the aim of 
providing freedom of movement for medici­
nal products: 'Whereas standards and proto­
cols for the performance of tests and trials 
on veterinary medicinal products ... can 
facilitate the movement of these products by 
laying down uniform rules applicable to tests 
and trials and the compilation of dossiers'. 65 
83. In my view, allowing the Member States 
to demand other information than that pro­
vided for by Article 5 of Directive 81/851 
would amount to authorising the competent 
authorities to substitute the sufficiently pre­
cise and unconditional requirements of the 
directive with other requirements unilater­
ally decided upon, with the consequence that 
there would be a risk of jeopardising the aim 
of harmonising national procedures for deliv­
ery of marketing authorisations for veteri­
nary medicinal products, which is a clearly 
stated aim, 66 and thereby jeopardising the 
free movement of medicinal products. 
84. The Court has also held that only the 
matters exhaustively listed by the harmonis­
ing directives on marketing authorisation for 
medicinal products for human use may be 
required by the competent authority. 67 
85. The conclusion must therefore be that 
Directive 81/851 precludes a national prac­
tice consisting in demanding information 
about the manufacturer of the starting mate­
rial. 
86. It follows from the foregoing that point 
3 of the first paragraph of Article 9 of Direc­
tive 81/851 may not be interpreted as 
64 — My emphasis. 
65 — Third recital of the preamble to the 'standards and proto­
cols' directive, my emphasis. 
66 — Second, third, fourth and ninth recitals of the preamble to 
Directive 81/851; first, second, third and fourth recitals of 
the preamble to the 'standards and protocols' directive. 
67 — Case 301/82 Clin-Midy and Others [1984] ECR 251, para­
graph 11, and Case C-83/92 Pierreland Others [1993] ECR 
I-6419, paragraphs 21 to 23. 
I -1553 
OPINION OF MR LÉGER — CASE C-127/95 
authorising a Member State to demand par­
ticulars other than those strictly listed by the 
aforementioned directives, but only as per­
mitting Member States to demand from an 
applicant for marketing authorisation further 
information about a particular previously 
given, in accordance with the provisions of 
Article 5, where information is judged 
incomplete with regard to the requirements 
of public health. This would be the case, for 
example, if, having regard to scientific 
progress, Member States considered that 
additional information would be of use for 
checking the harmlessness and therapeutic 
effectiveness of a product. 68 Similarly, in my 
view, it affords them the right, as I will 
examine below, 69 to suspend a marketing 
authorisation pending receipt only of par­
ticulars expressly listed in Article 5. 
The requirements imposed by Directives 
81/851 and 81/852 regarding refusal and sus­
pension of marketing authorisations 
87. Secondly, points (c) and (d) of the first 
preliminary question ask the Court in 
substance to determine whether, in circum-
stances such as those described in the order 
for reference, Directives 81/851 and 81/852 
are to be interpreted as authorising a compe­
tent authority to refuse or suspend market­
ing authorisation for a veterinary medical 
product if the person responsible for market­
ing has not complied with the aforemen­
tioned requirements. 70 
(1) Refusal to issue marketing authorisation 
88. The national court asks in point (c) of 
this first question, precisely, whether the 
provisions of the directives in question allow 
a competent authority like the VMD to 
refuse to issue a marketing authorisation for 
a veterinary medicinal product like Pen & 
Strep if the person responsible for marketing 
(Norbrook) has not provided particulars 
about the manufacturer, about the results, 
with a view to their approval, of control tests 
carried out on each batch of starting ma­
terial, about the manufacturing process and 
about the control methods used by the 
manufacturer of the starting material (SS). 
89. I refer to my arguments relating to 
examination of the requirements imposed by 
the aforementioned directives regarding 
grant of marketing authorisation in so far as 
I perceive no difference between the two 
questions. 
68 — Artide 14 of Directive 81/851. 
69 — See paragraphs 96 to 101 of my Opinion. 70 — Sec paragraphs 56 to 86 above. 
I - 1554 
NORBROOK LABORATORIES v MAFF 
90. When examining those questions, I 
emphasised that a competent authority is 
obliged to make grant of marketing author­
isation subject to observance of all the condi­
tions listed by Article 5 of Directive 81/851. 
A fortiori that authority must refuse to grant 
marketing authorisation for a veterinary 
medicinal product if one of the items of 
information required by Article 5 of Direc­
tive 81/851 is missing. 
91. On the other hand, I have stated that it 
cannot make the grant of marketing author­
isation subject to the making available of par­
ticulars which are not listed by that provi­
sion. Similarly and a fortiori, it cannot refuse 
to grant marketing authorisation on the 
ground that documents and information not 
expressly stipulated by the directives are 
lacking. 
92. The Court is further asked to determine 
whether the provisions of the aforemen­
tioned directives permit the VMD to make 
grant of this marketing authorisation subject 
to proof of purchase of quantities of active 
ingredients from a specified third party. 
93. N o provision in the directives in ques­
tion authorises the competent authority to 
require an applicant for marketing authorisa­
tion to obtain supplies from a manufacturer 
which it approves. 
94. For the reasons explained above, the 
conclusion must therefore be that a compe­
tent authority cannot refuse to grant market­
ing authorisation for a veterinary medicinal 
product either on the ground that particulars 
of the manufacturer of the product in ques­
tion are missing or on the ground that active 
ingredients have not been obtained from an 
approved manufacturer, or on the ground 
that batches of the starting material used in 
the manufacture of the medicinal product 
have not been previously approved. On the 
other hand, it must refuse to grant a market­
ing authorisation for the medicinal product if 
the particulars of the manufacturing process 
and of the control methods used by the 
manufacturer of the starting material are not 
contained in the application documents. 
(2) Suspension of marketing authorisation 
95. In point (d) of its first question the 
national court asks the Court to interpret the 
provisions of Article 8 of Directive 81/851 
and to determine whether the competent 
authority may suspend the time-limit for 
grant of a marketing authorisation until the 
applicant has supplied the information relat­
ing to the manufacturing process, control 
methods and the manufacturer. 
96. I consider that it follows expressly from 
a reading of the combined provisions of 
Article 8 and point 3 of the first paragraph of 
Article 9 of Directive 81/851 and from the 
ratio legis of the relevant legislation that the 
period for the grant of marketing authorisa-
I -1555 
O P I N I O N O F MR LÉGER — CASE C-127/95 
tion may indeed be suspended until the 
applicant has supplied the information 
required by Article 5 of Directive 81/851. 
O n the other hand, it may not be suspended 
in the case of information not expressly 
required by Directives 81/851 and 81/852, 
such as nameś and addresses of the manufac­
turer or manufacturers of the starting ma­
terial and the site or sites of manufacture. 
97. As far as the wording of the relevant 
provisions are concerned: 
The first paragraph of Article 8 of Directive 
81/851 provides: 
'Member States shall take all appropriate 
measures to ensure that the procedure for 
granting marketing authorisation is com­
pleted within 120 days after the date of sub­
mission of the application.' 
The first paragraph of point 3 of Article 9 
provides, as already stated: 
'[The competent authorities] may, where 
appropriate, require the applicant to provide 
further information as regards the items 
listed in Article 5. Where the competent 
authorities take this course of action, the 
time-limits specified in Article 8 shall be 
suspended until the further data required 
have been provided. Similarly, these time-
limits shall be suspended for any period 
which the applicant may be given to provide 
oral or written explanations'. 7 1 
98. Instead of immediately refusing to grant 
a marketing authorisation to an applicant 
who has not provided full information, 72 the 
competent authorities may take the course of 
suspending the authorisation for as long as 
the missing documents have not been 
appended. 73 
99. The verb 'compléter' means in fact 'to 
add what is missing' and not 'to add some­
thing else' or 'supply something else'. 74 
Thus, in accordance with what I have argued 
previously, the competent authorities may 
not demand any information other than that 
expressly prescribed by the directive and 
may suspend the marketing authorisation 
only for the reasons it expressly men­
tioned. 7 5 
100. The ratio legis of the legislation on mar­
keting authorisation for veterinary medicinal 
products is in accordance with that interpre-
71 — My emphasis. 
72 — Sec, in particular, paragraph 77 of my Opinion. 
73 — Paragraph 86 above. 
74 — In comparison with the French, Italian, Dutch, German and 
Spanish versions of the provision, the English version is less 
precise since it provides: 'may, where appropriate, require 
the applicant to provide further information as regards the 
items listed in Article 5' (my emphasis). 
75 — See, to this effect, the judgment in Pierrel, cited above, para­
graphs 28 and 33. 
I-1556 
NORBROOK LABORATORIES v MAFF 
tation. As we have seen, the aims which it 
pursues are to protect public health and 
ensure freedom of movement for veterinary 
medicinal products. 76 The means chosen to 
attain these aims consisted in harmonising 
national procedures for issue, suspension and 
refusal of marketing authorisations. 77 To 
suspend the grant of a marketing authorisa­
tion pending receipt of information which 
must be compulsorily appended to the appli­
cation is therefore in strict accordance with 
the aims pursued by the Community legisla­
ture. 
101. It follows from the foregoing that the 
competent authorities have the right to sus­
pend the period for grant of the marketing 
authorisation laid down in Article 8 of 
Directive 81/851 for as long as the applicant 
has not supplied the information on the 
manufacturing process and on the control 
testing methods for the starting material. 
102. On the other hand, and I here refer to 
my arguments concerning the examination of 
the requirements laid down by Directives 
81/851 and 81/852 concerning the grant of a 
marketing authorisation in so far as I per­
ceive no difference between the two ques­
tions, 78 a competent authority may not sus­
pend grant of a marketing authorisation if an 
item of information not expressly stipulated 
by Directives 81/851 and 81/852, such as the 
identity of the manufacturer and the sites of 
manufacture, is missing. 
The second question 
103. By this question, the national court 
asks the Court to state whether the replies 
given to the first question would be appre­
ciably different if a substance such as SS was 
produced by a 'continuous' process, that is 
to say by a process in which the constituents 
are not separated. 
104. It must be deduced from a reading of 
the account of the method of manufacturing 
the medicinal product that neither SS nor 
DHS are made according to a process which 
consists in mixing the constituents: 'The 
Applicant produces DHS from SS by 
"reduction" or "hydrogénation", whereby 
the molecular structure of the [product in 
question] is altered. This latter process 
involves the use of a catalyst called sodium 
borohydride, which contains the element 
boron. Once the DHS has been produced it 
is mixed with the other active ingredient 
[PP], and the non-active ingredients (known 
as "excipients") to make the final product 
Pen & Strep'. 79 Production by continuous 
process does not therefore occur until after 
the manufacture of DHS. 
105. According to the Court's established 
case-law, 80 where it clearly appears that the 
interpretation of Community law is not 
76 — Paragraphs 18, 78 and 82 of my Opinion. 
77 — Third, fourth and eighth recitals of the preamble to Direc­
tive 81/852. 
78 — Paragraphs 67 to 86 of my Opinion. 
79 — Paragraph 3 of the order for reference. 
80 — See, in particular, a judgment delivered on 5 October 1995 
in Case C-96/94 Centro Servizi Spediporto [1995] ECR 
I-2883. 
I -1557 
OPINION OF MR LÉGER — CASE C-127/95 
relevant for the outcome of the proceedings, 
the second question is redundant. 
The third question 
106. If the demands made by the competent 
authority are in conformity with the provi­
sions of Directives 81/851 and 81/852, the 
national court asks, by this question, 
whether those directives contain provisions 
which would allow the person responsible 
for marketing to be exempt from providing 
the items of information and, if so, on what 
conditions. 
107. In Scotia Pharmaceuticals, cited above, 
the Court has already had to reply to such a 
question concerning marketing authorisation 
for a medicinal product for human use. In 
that case the Court held that the tests and 
particulars listed by the directives in force 
had to be appended to the application for 
marketing authorisation and that only scien­
tific progress could entail a change in the 
information to be supplied for the purposes 
of the grant of marketing authorisation. 81 
The sixth question 
108. By this question the national court asks 
for an interpretation of the provisions of 
Article 40 of Directive 81/851 and whether 
reasons must be given for the various 
requests for information made in this case by 
the VMD as regards the decisions to suspend 
and refuse marketing authorisation men­
tioned in the preliminary questions previ­
ously examined. If the answer is in the affir­
mative, the Court is asked to state the 
conditions which must be observed by the 
competent authority if they are to be 
regarded as in conformity with the pro­
visions of that article. 
109. The first paragraph of Article 40 of 
Directive 81/851 provides: 'All decisions 
taken pursuant to Articles 11, 82 36, 83 37 84 
and 38, 85 all negative decisions taken 
pursuant to Article 10, point 2, and 
Article 19(3) of this Directive and all 
decisions to withdraw authorisation to 
manufacture or to import from third 
countries or to suspend or withdraw 
manufacturing authorisation shall state in 
details the reasons on which they are based. 
Such decisions shall be notified to the party 
concerned who shall at the same time be 
informed of the remedies available to him 
under current legislation and the time 
allowed for seeking such remedies.' 
81 — Paragraphs 41 and 49 of my Opinion. 
82 — Provision listing the cases in which marketing authorisation 
which must be refused. 
83 — Provision listing the cases in which marketing authorisation 
must be suspended or withdrawn. 
84 — Provision listing the cases in which marketing authorisation 
must be withdrawn. 
85 — Provision listing the cases in which marketing authorisation 
must be suspended or withdrawn. 
I - 1558 
NORBROOK LABORATORIES v MAFF 
110. The wording of the first paragraph of 
Article 40 of Directive 81/851, read in com­
bination with the articles to which it refers, 
is very clear. It lists the cases in which the 
competent authority must give reasons for 
its decisions. The competent authorities are 
only obliged to state reasons for decisions to 
refuse, withdraw or suspend a marketing 
authorisation for a veterinary medicinal 
product from a Member State or a third 
country. The provision does not therefore 
apply to demands for supplementary infor­
mation made by the VMD during examina­
tion of applications for marketing authorisa­
tions. 
111. It is stated that the reasons given must 
be detailed, that they must be notified to the 
party concerned who at the same time must 
be informed of the remedies available to him 
under current legislation and of the time 
allowed for seeking such remedies. 
112. As regards the obligation to state in 
detail the reasons for the decisions in ques­
tion, I consider that reasons which show 
clearly and unequivocally why a competent 
authority has refused, withdrawn or sus­
pended a marketing authorisation meets the 
requirements of Article 40. This will be the 
case, for example, with reasons indicating the 
particulars and items of information missing. 
Replies to questions concerning determina­
tion of the validity of Directives 81/851 and 
81/852 
113. In the event of an affirmative answer to 
the first question, the Court is asked, in the 
fourth and fifth questions, to determine the 
validity of the provisions of Directives 
81/851 and 81/852 with reference to the 
principles of proportionality and free move­
ment of goods. 
The fourth question: breach of the principle 
of proportionality 
114. By this question, the Irish court would 
appear to be asking the Court to determine 
whether the requirements and requests for 
information made by the VMD and exam­
ined in the first question are contrary to the 
principle of proportionality. 
115. In my view, a distinction must be made 
between such requests, according to whether 
or not they are prescribed by Directives 
81/851 and 81/852. 
116. If they are not provided for by those 
directives (as is the case with requirements 
I -1559 
OPINION OF MR LÉGER — CASE C-127/95 
concerning prior approval of each batch of 
SS or DHS or of the sites of manufacture of 
SS), there are no grounds for them to be 
made, and any application of the principle of 
proportionality will be redundant. 
117. O n the other hand, in the case of 
demands required to be made by those direc­
tives, it will indeed be necessary to determine 
whether those stipulations comply with that 
principle. As far as I know, this is the first 
time that the Court has been asked to do 
this. 
118. The precise question put to the Court is 
whether point 4 of the second paragraph of 
Article 5 of Directive 81/851 and the stipula­
tions contained in the first to fourth indents 
of the first and second paragraphs of Part B 
of the first Protocol of the Annex to Direc­
tive 81/852, relating to the description of the 
method of preparation of starting materials, 
and point 9 of the second paragraph of 
Article 5 of Directive 81/851 and the stipula­
tions in Part C of the first Protocol of the 
Annex to Directive 81/852, relating to the 
description of the methods of control for the 
starting materials used by the manufacturer, 
are in accordance with the principle of pro­
portionality. 
119. This general principle of Community 
law requires that acts of Community institu­
tions must not exceed the limits of what is 
appropriate and necessary for attaining the 
objectives legitimately pursued by the legis­
lation in question. When there is a choice 
between several appropriate measures, 
recourse must be had to the least onerous, 
and the disadvantages caused must not be 
disproportionate to the aims pursued. 86 
120. The very high level of requirement 
imposed by those provisions for the market­
ing of a veterinary medical product is in con­
formity with the aim of providing absolute 
protection for public health pursued by that 
legislation. 
121. Moreover, owing to the very purpose 
of Directives 81/851 and 81/852, the Com­
munity legislature must assess complex situ­
ations since it is a question of legislating on 
the basis of technical and scientific factors 
which can change rapidly. I therefore con­
sider that its assessment is to be censured 
only if it appears to be manifestly incorrect 
in view of the information it had at the time 
of the adoption of the legislation or if the 
institution adopting the measure in question 
committed a misuse of power or manifestly 
exceeded the limits of its discretion. 87 
86 — See, in particular, the judgment in Case 265/87 Schräder 
[1989] ECR 2237, paragraph 21, and, more recently, the 
judgment in Case C-84/94 United Kingdom v Council, not 
yet published in the ECR, paragraph 57. 
87 — See, in particular, the judgment in United Kingdom v Coun­
cil, cited above, paragraph 58, or the judgment in Joined 
Cases C-296/93 and C-307/93 France and Ireland v Com­
mission [1996] ECR I-795, paragraphs 30 and 31. 
I - 1560 
NORBROOK LABORATORIES v MAFF 
122. Norbrook claims 88 that the principle of 
proportionality has been contravened in that, 
in particular '... the nature of this require­
ment, in particular the frequent impossibility 
of compliance and the consequences of such 
non-compliance, is wholly out of proportion 
to such infinitesimal risk to public health ... 
which might result from ignorance ... of [SS] 
manufacturing processes'. 89 
123. The Court has held that the provisions 
of directives harmonising marketing author­
isations for medicinal products for human use 
'... cannot be interpreted as requiring the per­
formance of tests which are in practice 
impossible to carry out.' 90 The argument 
that the requirements are 'difficult to satisfy' 
is not relevant in view of the interests in 
question, those of public health. 
124. In so far as no conclusive evidence has 
been adduced concerning any manifest error 
of assessment or misuse of power on the part 
of the Community legislature, it must be 
found that there is no factor to support the 
conclusion that the principle of proportion­
ality has been contravened. 
The fifth question: breach of Articles 30 to 36 
of the Treaty 
125. The national court also asks whether 
the VMD's demands for information under 
Directives 81/851 and 81/852 are in breach 
of Articles 30 to 36 of the Treaty. 
126. The Court has already answered this 
question in its judgment in the Bruyère case 
by stating that 'although Directive 81/851 
describes itself as "one stage in the achieve­
ment of the aim of freedom of movement of 
veterinary medicinal products" (11th recital 
in the preamble), it cannot be inferred from 
this that, for medicinal products coming 
within its scope, the directive leaves room 
for the application of Articles 30 and 36 of 
the Treaty. As the development of Commu­
nity law shows, that wording means only 
that the system of multiple national author­
isations for the marketing of products, first 
introduced by Directive 81/851, was destined 
to be replaced by a system under which 
account was to be taken of authorisations 
granted by other Member States (Directive 
90/676) and subsequently by a system for 
the mutual recognition in principle of such 
authorisations (Directive 93/40)'. 91 
88 — Pages 43 to 47 of its observations. 
89 — Ibid., paragraph 11.4. 
90 — Case C-40/93 Scotia Pharmaceuticals, cited above, para­
graph 21. 91 — Paragraph 18. 
I -1561 
OPINION OF MR LÉGER — CASE C-127/95 
127. In the present case, the medicinal prod­
uct Pen & Strep does fall within the scope of 
Directives 81/851 and 81/852. Accordingly, 
its marketing is subject to issue of a market­
ing authorisation by the VMD, which must 
observe all the legal provisions in force. 
128. It must therefore be concluded that 
there is no factor enabling it to be concluded 
that a breach of Articles 30 to 36 of the 
Treaty has occurred. 
Answers to the questions concerning the 
conditions under which a Member State 
incurs liability for breach of Community 
law 
The seventh question 
129. Finally, by this question, the Court is 
asked to make clear the conditions under 
which a Member State incurs liability for 
breach of Community law. 
130. The Court's case-law is now well-
established and in the judgment of 8 October 
1996 in the Dillenkofer case 92 the Court 
clearly and precisely reiterated the condi­
tions under which a Member State incurs 
liability for breach of Community law. 
131. The Court has held 93 that individuals 
who have suffered damage have a right to 
reparation where three conditions are met: 
the rule of Community law infringed must 
have been intended to confer rights on them; 
the breach must be sufficiently serious; and 
there must be a direct causal link between 
that breach and the damage sustained by the 
individuals. 94 
132. As regards the condition concerning a 
sufficiently serious breach of a rule of Com­
munity law, the Court has also held that it is 
fulfilled 'if ... a Member State, in the exercise 
of its rule-making powers, manifestly and 
gravely disregards the limits on those pow­
ers' and that 'if, at the time when it commit­
ted the infringement, the Member State in 
question was not called upon to make any 
legislative choices and had only considerably 
reduced, or even no discretion, the mere 
92 — Joined Cases C-178/94, C-179/94, C-188/94, C-189/94 and 
C-190/94, not yet published in the ECR. 
93 — Joined Cases C-6/90 and C-9/90 Francovich and Others 
[1991] ECR I-5357; Joined Cases C-46/93 and C-48/93 
Brasserie du Pêcheur and Factortame and Others [1996] 
ECR I-1029; Case C-392/93 British Telecommunications 
[1996] ECR I-1631; and Case C-5/94 Hedley Lomas [1996] 
ECR I-2553. 
94 — Dillenkofer, cited above, paragraphs 21 and 23. 
I - 1 5 6 2 
NORBROOK LABORATORIES v MAFF 
infringement of Community law may be suf­
ficient to establish the existence of a suf­
ficiently serious breach ... .' 95 
133. As we have seen above, the provisions 
of Directives 81/851 and 81/852 are precise 
and sufficiently clear for it to be said that the 
discretion left to the Member States when 
they transpose those directives is extremely 
reduced, 96 or even non-existent. 
134. Therefore, where, in breach of the third 
paragraph of Article 189 of the Treaty, a 
Member State incorrectly transposes or mis­
applies sufficiently clear and precise provi­
sions of the aforementioned directives, that 
Member State manifestly and gravely disre­
gards the limits on the exercise of its powers. 
135. Consequently, such a breach affords 
individuals a right to obtain reparation if the 
result prescribed by the directive entails con­
ferment on them of rights whose content 
may be identified on the basis of the provi­
sions of the directive and if there is a causal 
link between the breach of the Member 
State's obligation and the damage suffered by 
the aggrieved persons, without there being 
any need to take into account other condi­
tions. 
Conclus ion 
136. In conclusion, for the reasons explained above, I p ropose that the quest ions 
submit ted by the C o u r t of Appeal in N o r t h e r n Ireland should be answered as fol­
lows: 
(1) Counc i l Direct ive 8 1 / 8 5 1 / E E C of 28 September 1981 o n the approximat ion of 
the laws of the M e m b e r States relating t o veter inary medicinal p r o d u c t s and 
Counc i l Direct ive 8 1 / 8 5 2 / E E C of 28 September 1981 o n the approximat ion of 
the laws of the M e m b e r States relating to analytical, pharmaco-toxicological 
and clinical s tandards and pro toco l s in respect of the testing of veter inary 
medicinal p roduc t s (and in part icular Articles 5, 8, 9, 11 , 29 to 31 , 35, 40 and 
95 — Ibid., paragraph 25, my emphasis. 
96 — Point 41 of my Opinion. 
I -1563 
OPINION OF MR LÉGER — CASE C-127/95 
41 of Directive 81/851/EEC and the first part of the Annex to Directive 
81/852/EEC in the form in which they existed prior to any amendment) must 
be interpreted as: 
(a) requiring the competent authority of a Member State, taking account of 
current technical developments and scientific progress, to make the grant 
of marketing authorisation for a veterinary medicinal product conditional 
upon the provision by the person responsible for the marketing of that 
medicinal product of information concerning the manufacturing and con­
trol methods used by the manufacturer of a starting material, and to refuse 
such authorisation if that information is not provided; 
(b) permitting that authority to suspend, pending receipt of the abovemen-
tioned information, the time-limit for granting such authorisation pre­
scribed in Article 8 of Directive 81/851. 
(c) precluding that competent authority from: 
(i) suspending, pending receipt of the name(s) and address(es) of the 
manufacturer(s) and details of the manufacturing site(s) of the starting 
material, the time-limit prescribed in Article 8 of Directive 81/851 for 
granting such authorisation; 
(ii) making the grant of such authorisation conditional upon the submis­
sion for approval of the results of tests carried out upon each batch of 
the starting material, upon the use, for the manufacture of a veterinary 
medicinal product, only of supplies of the starting material and the 
active ingredient which were purchased from a specified third party, 
and upon the provision of information as to the name(s) and 
address(es) of the manufacturer(s) and the manufacturing site(s) of the 
starting material; 
(iii) refusing to grant such authorisation if the information referred to in 
(ii) above is not provided; 
I -1564 
NORBROOK LABORATORIES v MAFF 
(d) requiring the competent authority to state reasons for any decision refus­
ing, suspending or withdrawing marketing authorisation for a veterinary 
medicinal product. This requirement is satisfied if the decision shows 
clearly and unequivocally the reasons for which that authority refused, 
suspended or withdrew such authorisation. 
(2) Examination of the provisions of the abovementioned directives, in the light of 
the grounds of the order for reference, has not revealed any factor of such a 
kind as to affect their validity. 
(3) A Member State is liable for damage suffered by individuals as a result of a 
breach of Community law for which it can be held responsible if the rule of 
Community law infringed was intended to confer rights on individuals, the 
breach is sufficiently serious, and there is a direct causal link between the 
breach and the damage suffered by the individuals. 
I -1565