No C 332/32 Official Journal of the European Communities 31. 12. 90 
Opinion on the proposal for a Council Directive widening the scope of Directive 
81/851/EEC on the approximation of the laws of the Member States on veterinary medicinal 
products and laying down additional provisions on homeopathic veterinary medicinal 
products^) 
(90/C 332/08) 
On 5 April 1990 the Council decided, in accordance with Article 100A of the Treaty 
establishing the European Economic Community, to consult the Economic and Social Com­
mittee on the abovementioned proposal. 
The Section for Industry, Commerce, Crafts and Services, which was responsible for preparing 
the Committee's work on the subject, adopted its Opinion on 5 September 1990. The 
Rapporteur was Mr Rolao Goncalves. 
At its 279th plenary session (meeting of 19 September 1990), the Economic and Social 
Committee adopted unanimously the following Opinion. 
1. Introduction 
1.1. While eschewing value j udgements, either absol­
ute or relative, on the principles governing allopathic 
or homeopathic medicine, it is nevertheless the case 
that homeopathic medicine has been used to treat 
human beings in several Member States for at least two 
centuries. Nowadays the percentage of the population 
accepting this form of medicine varies from 18% ins 
ome countries to 75 % in others. Its use has gradually 
been spreading to domestic animals, be they pets or 
farm animals. 
1.2. Over the last few years, there has been excessive 
substitution of 'natural' products by 'synthetic' prod­
ucts, sometimes because there has been no alternative, 
sometimes on economic grounds not always compatible 
with ensuring the quality of life. Possibly in reaction 
to this, there has recently been increased demand for 
traditional and old-fashioned practices and products 
adapted to the modern day, such as homeopathy and 
homeopathic medicines. 
1.3. It is not easy for the man in the street to dis­
tinguish between what is 'genuine' and what is 'fake', 
between qualified homeopathic practitioners and 
opportunists. He has the right to expect that the state, 
as guardian of public welfare, should take the responsi­
bility for sorting things out. This is all the more impro-
tant since foodstuff requirements are becoming increas­
ingly stringent and are moving towards complete rejec­
tion of any significant levels of medicinal residues in 
meat or other products of animal origin. 
1.4. Consequently, as in other sectors, there is a need 
to take steps to guarantee users—in this case the breeder 
or owner of the sick animal—the requisite safety in 
terms of both the actual treatment, and impeccable 
quality of the medicines used. Likewise, the consumer 
should have access to this form of medicine throughout 
the Community area, in line with the principles of free 
circulation of goods. 
(J) OJ No C 108,1. 5. 1990, pp. 10-13. 1.5. Various Member States have already legally 
recognized the importance of this issue, although they 
have dealt with it in quite different ways. 
2. Principles of the proposal 
2.1. While maintaining the neutrality of Community 
rules, and without interfering in an individual Member 
State's decision to accept or reject homeopathy, the 
proposal seeks to align legislation within the Com­
munity governing the free circulation of homeopathic 
remedies for veterinary use; this is to be done at the 
highest level of health, safety, environmental and con­
sumer protection. 
2.2. On the basis of Article 100A of the Treaty 
establishing the European Economic Community, the 
proposal seeks to extend the scope of current legislation 
on medicinal products (Directive 81/851/EEC) to cover 
homeopathic products also. 
2.3. At the same time, it introduces a simplified 
registration procedure for homeopathic medicines 
which are considered safer because of their high degree 
of dilution, the way they are administered (i.e. not 
injected) and the lack of specific (therapeutic) indi­
cations. For other products, however, the existing 
arrangements for allopathic or traditional medicines 
will continue to apply. In any case, the simplified regis­
tration process will be aligned throughout the Com­
munity. 
2.4. For magistral preparations prescribed by home­
opathic practitioners, the same principles apply as for 
allopathic medicine equivalents; this covers a high pro­
portion of the homeopathic pharmacopoeia. 
31. 12. 90 Official Journal of the European Communities No C 332/33 
2.5. No provisions have been made for revising the 
registers already in existence on the date the Directive 
comes into force; these registers will still apply only to 
those Member States employing them. 
3. General comments 
3.1. The Committee welcomes the proposal, subject 
to the following comments: 
3.2. The Committee fully understands the difficulties 
involved in aligning legislation on homeopathic prac­
tices in general and the different schools of homeopathy 
in particular. It does, however, feel that the goals of 
the proposed Directive would be much better served if 
steps were taken to secure a convergence of views 
leading to a joint, non-restrictive agreement on home­
opathic practices. 
3.3. The Committee likewise considers that the com­
pilation of a European homeopathic pharmacopoeia 
should be encouraged, under the auspices of the Council 
of Europe, so as to bring these remedies under general 
rules on medicines and thus guarantee maximum pro­
tection for users. 
3.4. The Committee thinks that the rules on the 
distribution of homeopathic medicines in the broadest 
sense should be fully clarified, in line with the rules for 
allopathic medicines. 
3.5. The Committee also considers that rules on 
labelling and accompanying literature should be the 
same for all medicines of whatever type, the only accept­
able exception being for medicines approved under the 
simplified registration procedure; in this case thera­
peutic indications may not be given for these medicines. 
3.6. Moreover, the Committee feels that it must 
point out that inconsistencies might appear in the 
assessment, (for the purposes of the general approval 
procedure) of therapeutic effects of homeopathic medi­
cines, because the assessment is geared to allopathic 
medicine and is carried out by allopathic doctors. The 
possibility of testing homeopathic medicines according 
to the principles underlying the practices of the home­
opathic school should be considered; these medicines 
are, after all, intended for the practice of homeopathy. 
3.7. The Committee believes that failure to solve 
problems relating to (a) homeopathic practices, (b) 
official recognition of homeopaths' legal right to pre­
scribe homeopathic medicines and (c) the distribution 
of these medecines, could jeopardize the intended objec­
tive of this proposal, namely the free circulation of 
homeopathic medicines. 
3.8. The Committee notes that, since there is no 
provision for back-dating, the proposed Directive will not cover current registers for products on sale in 
Member States which have approved them. It does, 
however, agree with the Commission's approach, i.e. 
that, from the date the Directive enters into force, 
free circulation of homeopathic products outside these 
Member States throughout the Community will be 
authorized only if these products are on registers which 
have been compiled on the basis of principles adopted 
in line with the present proposal. 
4. Specific comments 
4.1. Recital 
The Committee believes that insertion of the following 
three recitals, which expand on the eighth recital, will 
provide greater clarity: 
'Whereas, having regard to the specific character­
istics of these medicinal products, such as their very 
low content of active principles, it is difficult to 
apply to them the conventional methods used for 
clinical trials on allopathic medicines;' 
'Whereas it is appropriate to introduce simplified 
registration arrangements for those traditional 
homeopathic medicinal products placed on the mar­
ket without specific therapeutic indications;' 
'Whereas veterinarians frequently administer par­
enteral injections to animals they are treating.' 
4.2. Article 1 
First paragraph 
While endorsing the thrust of the definition, the Com­
mittee queries its validity in those Member States whose 
pharmacopoeia does not cover this sector; it reiterates 
the need for measures to encourage the compilation of 
the European homeopathic pharmacopoeia, as 
mentioned in point 3.2. 
In order to avoid misinterpretation, in the French ver­
sion, the phrase 'd'un Etat membre' should be replaced 
by 'd'un des £tats membres'. 
Second paragraph 
In the interests of using a more precise technical term, 
the expression 'by successive dilutions' should be 
replaced by 'by successive decimal, centesimal and mil­
lesimal dilutions', so as to guarantee to the customer 
that the concentration marked on the labelling is cor­
rect. 
No C 332/34 Official Journal of the European Communities 31. 12. 90 
4.3. Article 7 
(1)—First indent 
In typical veterinary practice, veterinarians frequently 
treat animals by injection (generally administered by 
themselves). The Committee considers that this line 
should read as follows: 'they are administered orally, 
externally or parenterally.' The Committee rec­
ommends that this matter be studied in greater depth by 
the Commission jointly with relevant technical experts. 
(1)—Third indent 
The Committee is surprised at the lack of scientific 
accuracy in determining the minimum dilution limit 
(1:1 000 000), in view of the considerable variety of the 
active principles used and therefore the wide variations 
in toxicity limit values. While understanding the aim 
of the proposal here, the Committee recommends that 
this indent be replaced by the following text, or one 
equivalent in meaning: 
'—There is a sufficient degree to guarantee the 
safety of the preparations, i.e. if the preparation 
contains less than one part per million of any active 
principle, which, when used in medicines, requires 
Done at Brussels, 19 September 1990. a medical prescription. If the concentration is high­
er, the simplified registration procedure can still be 
used, as long as the above requirements are met, 
but the competent licensing authority can require 
appropriate written toxicological evidence of the 
medicine's safety.' 
Article 7(2) 
Except where there are therapeutic indications (home­
opathic medicines can only be authorized according to 
the simplified registration procedure if they have no 
therapeutic indications), the Committee feels that label­
ling rules for homeopathic products and allopathic 
products should be identical (cf. point 3.4). For this 
reason, it considers it essential to replace the restriction 
'and no other information' at the end of the fourth line 
by 'at the very least'. Consumer information should 
not be limited without good reason; on the contrary, 
manufacturers should be urged to provide as much 
information as possible. 
4.4. Article 8 
The expression 'batch-to-batch consistency' (fifth line) 
is rather ambiguous; it should be replaced by 'sustained 
consistency of batch-to-batch characteristics'. 
The Chairman 
of the Economic and Social Committee 
Alberto MASPRONE