COMMISSION OF THE EUROPEAN COMVTUNITIES 
C0M(91) 313 final - SYN 251 and 252 
Brussels, 2 August 1991 
silt Amendment to the proposal for a 
COUNCIL DIRECTIVE 
widening the scope of Directives 65/65/EEC and 75/319/EEC on the 
approximation of the laws of the Member States on medicinal 
products and laying down additional provisions on 
homeopathic medicinal products SYK 251 
Amendment to 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 SYN 252 
veterinary medicinal products 
(presented by the Commission pursuant to Article 149(3) 
of the EEC-Treaty) 
- 2 -
EXPLANATORY MEMORANDUM 
At its plenary session on 13 June 1991, the European Parliament, on first reading 
of the co-operation procedure, gave its opinion upon two proposals for Directives 
relating to homeopathic medicines for human and veterinary use - COM(90)72 of 
22.03.90, SYN 251-252. 
The Commission has decided, in accordance with Article 149, paragraph 3 of the EEC 
Treaty, to amend its proposals in order to incorporate into the text 17 out of the 
28 amendements adopted by the Parliament. 
The primary aims of the amendments accepted by the Commission are : 
- to avoid the distortion of competition between manufacturers 
- to maintain the principle of a free choice of therapies 
- to assimilate anthroposophic medicines as homeopathic medicines when described 
in an off I cal pharmacopoeia 
- to introduce appropriate references to homeopathic and anthroposophic 
principles. 
- 3 -
By contrast, the Commission rejected other amendments for three principal reasons. 
Certain of the amendments go far beyond the limits of those proposals which deal 
with the free movement of medicines, for example; training for and engaging in 
professional practice, and the way in which the cost of medicines to the patient 
is met by public funding. 
Some amendments show excessive partiality towards particular medical traditions, 
bearing in mind that the Commission must remain neutral in the debate between 
"conventional" and "alternative" medicine. 
Other amendments would widen excessively the scope of the simplified registration 
procedure (Article 7), to the extent that a full marketing authorization 
(Article 9) would become an exception to the normal rule. 
It is worth recalling that since 1965 throughout the Community the normal basis 
for a marketing authorization has been three standard criteria (quality, safety 
and efficacy) leading the competent authorities to undertake an evaluation of the 
risks and benefits expected of the medicament in question. 
4 -
However, the simplified registration procedure, in the form proposed by the 
Commission, constitutes rather an administrâtive notification, adequate for 
homeopathic medicines which do not present any known risk by virtue of their 
method of administration (oral) and the low concentration of their active 
constituents, which is fixed at less than one part per million. Manufacturing 
quality can be verified from the dossier supplied. 
The other routes of administration described by the pharmacopoeias, especially 
injectibles, or stronger concentrations of active constituents, can, in certain 
cases, expose patients to potential risks and necessitate because of this a more 
comprehensive authorization procedure based upon an evaluation of the risks and 
benefits by the competent authorities in accordance with the provisions of 
Article 9. 
- 5 -
Amendment to the proposal for a 
COUNCIL DIRECTIVE 
widening the scope of Directives 65/65/EEC and 75/319/EEC on the 
approximation of the laws of the Member States on medicinal 
SYN 251 products and laying down additional provisions on 
homeopathic medicinal products 
(Presented by the Commission in accordance with article 149, 
paragraph 3 of EEC Treaty) 
Original proposal Amended proposal 
Titles and visas unchanged 
First recital 
Whereas differences currently existing Whereas differences currently existing 
between the provisions laid down by between the provisions laid down by 
law, regulation or administrative law, regulation or administrative 
action in the Member States may hinder action in the Member States may hinder 
trade in homeopathic medicinal trade in homeopathic medicinal 
products within the Community; products within the Community and thus 
lead to discrimination and distorsion 
of competition between manufacturers of 
these products; 
2nd recital unchanged 
Recital 2a (new) 
Whereas freedom of choice with regard 
to therapy needs to be safeguarded; 
whereas, despite considerable dif­
ferences in the status of alternative 
medicines in the various Member States, 
patients should be guaranteed free 
access to the therapy of their choice, 
provided all precautions are taken to 
ensure the quality and safety of 
products; 
3rd recital unchanged 
Original proposal - 6 -
Amended proposa 
Fourth recital 
Whereas homeopathic medicine is 
officially recognized in certain 
Member States but is only tolerated 
in other Member States; whereas, 
therefore, it is appropriate to 
recognize certain national homeopathic 
traditions without imposing them 
throughout the Community; Whereas homeopathic medicine is 
officially recognized in certain 
Member States but is only tolerated 
in other Member States; 
5th, 6th and 7th recitals unchanged 
Eighth recital 
Whereas, having regard to the 
particular characteristics of these 
medicinal products, such as their 
very low content of active principles 
and the difficulty of applying to them 
the conventional statistical methods 
relating to clinical trials, it is 
appropriate to provide a simplified 
registration system for those 
traditional homeopathic medicinal 
products which are placed on the market 
without specific therapeutic 
indications in a preparation which 
does not present a risk for the patient; Whereas, having regard to the 
particular characteristics of these 
medicinal products, such as their ' 
very low content of active principles 
and the difficulty of applying to them 
the conventional statistical methods 
relating to clinical trials, it is 
appropriate to provide a simplified 
registration system for those 
traditional homeopathic medicinal 
products which are placed on the market 
without specific therapeutic 
indications in a preparation and dosage 
which does not present a risk for the 
patient; 
9th recital unchanged 
Original proposal 
Art 
For the purposes of this Directive 
"homeopathic medicinal product" shall 
mean any medicinal product prepared in 
accordance with a homeopathic manufac­
turing procedure described by the 
European Pharmacopoeia, or in the 
absence thereof, by the official 
pharmacopoeia of a Member State. - 7 -
Amended proposal 
icle 1 
For the purposes of this Directive 
"homeopathic medicinal product" shall 
mean any pharmaceutical preparation 
prepared in accordance with a 
homeopathic manufacturing procedure 
described by the European 
Pharmacopoeia, or in the absence 
thereof, by the official pharmacopoeia 
of a Member State. 
For the purposes of this Directive 
anthroposophical medicinal products 
described by an official pharmacopoeia 
shall be treated as equivalent to 
homeopathic medicinal products. 
Homeopathic preparations are 
produced from products, substances 
or compositions called homeopathic 
stocks by successive dilutions. Homeopathic preparations are produced 
from products, substances or composi­
tions called homeopathic stocks by 
successive dilutions and potentiation. 
A homeopathic medicinal product may 
also contain a member of different 
components. 
A homeopathic preparation may contain, 
with the exception of catalysts, only 
homeopathic stocks in a minimum 
dilut ion of 1:10. 
Articles 2, 3, 4, 5 and 6 unchanged 
Article 7, paragraph 1 unchanged 
Article 7 (2) 
Seventh indent a (new) 
- a sentence advising the user to 
consult a competent therapist whilst 
using the medicinal product if the 
if the symptoms persist. 
Rest of the article unchanged 
Original proposal - 8 -
Amended proposa 
Article 8, introductory phrase and first three indents 
An application for a simplified 
registration submitted by the person 
responsible for marketing may cover 
a series of preparations derived from 
the same homeopathic stock. The 
following documents shall be included 
with the application in order to 
demonstrate, in particular, the 
pharmaceutical quality and the batch 
consistency of the products concerned : An application for a simplified 
registration submitted by the person 
responsible for marketing may cover 
a series of preparations derived from 
the same homeopathic stock or stocks. 
The following documents shall be 
included with the application in order 
to demonstrate, in particular, the 
pharmaceutical quality and the batch 
consistency of the products concerned 
scientific name of the homeopathic 
stock, together with a mention of 
the various routes of administra­
tion, pharmaceutical forms and 
dilut ions to be registered; - scientific name of the homeopathic 
stock or stocks, together with a 
mention of the various routes of 
administration, pharmaceutical forms 
and strengths to be registered; 
dossier describing how the 
homeopathic stock is obtained and 
controlled, and Justifying its 
homeopathic nature, on the basis 
of an adequate homeopathic biblio­
graphy; - dossier describing how the 
homeopathic stock or stocks is/are 
obtained and controlled, and 
Justifying its homeopathic nature, 
on the basis of an adequate homeopa­
thic or anthroposophical bib Iio-
graphy; 
manufacturing and control file 
for each pharmaceutical form and 
a description of the method of 
dilut ion; - manufacturing and control file 
for each pharmaceutical form and 
a description of the method of 
dilution and potent iat ion; 
Rest of the article unchanged 
Original proposal - 9 -
Amended proposal 
Article 9 (1) 
1. Homeopathic medicinal products 
other than those referred to in 
Article 7 shall be authorized and 
label led in accordance with the 
provisions of Articles 5 to 21 of 
Directive 65/65/EEC and Articles 1 
to 7 of Directive 75/319/EEC, 
including the provisions concerning 
proof of therapeutic effect. 1. Homeopathic and antroposophical 
medicinal products other than those 
referred to in Article 7 shall be 
authorized and labelled pursuant to 
the provisions of Articles 5 to 21 of 
Directive 65/65/EEC and Articles 1 
to 7 of Directive 75/319/EEC, 
including the provisions concerning 
proof of therapeutic effect, in 
accordance with the basic principles 
and special nature of homeopathic or 
anthroposophlcal medicine. 
Article 9(2) unchanged 
Article 10 (1) and (2) unchanged 
Article 10 (3) (new) 
3. Not later than 31 December 1995 the 
Commission shall present a report to 
the Council and to the European 
Parliament concerning the operation of 
this Directive. 
Article 11 unchanged 
- 10 -
Amendment to 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 
(presented by the Commission in accordance with Article 149, 
paragraph 3 of the EEC Treaty) SYN 252 
Original proposal 
Whereas differences currently 
existing between the provisions laid 
down by law, regulation or administra­
tive action by the Member States may 
hinder trade in homeopathic medicinal 
products within the Community; Amended proposal 
First recital 
Whereas differences currenlty 
existing between the provisions laid 
down by law, regulation or administra­
tive action in the Member States may 
hinder trade in homeopathic medicinal 
products within the Community and thus 
lead to discrimination and distorsion 
of competition between manufacturers of 
these products; 
2nd recital unchanged 
Recital 2a (new) 
Whereas freedom of choice with 
regard to therapy needs to be 
safeguarded; 
3rd recital unchanged 
Fourth recital 
Whereas homeopathic medicine is 
officially recognized in certain 
Member States but is only tolerated 
in other Member States; whereas, Whereas homeopathic medicine is 
officially recognized in certain 
Member States but is only tolerated 
in other Member States; 
therefore, it is appropriate to 
recognize certain national homeopathic 
traditions without imposing them 
throughout the Community; 
5th, 6th and 7th recitals unchanged 
Original proposal - 11 -
Amended proposal 
Eighth 
Whereas, having regard to the 
particular characteristics of these 
medicinal products, such as their 
very low content of active principles 
and the difficulty of applying to them 
the conventional statistical methods 
relating to clinical trials, it is 
appropriate to provide a simplified 
registration system for those 
traditional homeopathic veterinary 
medicinal products which are placed 
on the market without specific 
therapeutic indications in a 
preparation which does not present 
a risk for the animal or the consumer 
of animal products; recital 
Whereas, having regard to the 
particular characteristics of these 
medicinal products, such as their 
very low content of active principles 
and the difficulty of applying to them 
the conventional statistical methods 
relating to clinical trials, it is 
appropriate to provide a simplified 
registration system for those 
traditional homeopathic veterinary 
medicinal products which are placed 
on the market without specific 
therapeutic indications in a 
preparation and dosage which does not 
present a risk for the animal or the 
consumer of animal products; 
9th recital unchanged 
Art icle 1 
For the purposes of this Directive 
"homeopathic veterinary medicinal 
product" shall mean any veterinary 
medicinal product prepared in 
accordance with a homeopathic 
manufacturing procedure described by 
the European Pharmacopoeia, or in 
the absence thereof, by the official 
pharmacoposia of a Member State. For the purposes of this Directive 
"homeopathic veterinary medicinal 
product" shall mean any pharmaceuticai 
preparation prepared in accordance with 
a homeopathic manufacturing procedure 
described by the European 
Pharmacopoeia, or in the absence 
thereof, by the official pharmacopoeia 
of a Member State. 
Homeopathic preparations are produced 
from products, substances or 
compositions called homeopathic stocks 
by successive dilutions. Homeopathic preparations are produced 
from products, substances or 
compositions called homeopathic stocks 
by successive dilutions and 
potentiation. A homeopathic medicinal 
product may also contain a number of 
different components. 
- 12 -
Homeopathic preparations may contain, 
with the exception of catalysts, only 
homeopathic stocks, in a minimum of 
1:10. 
Articles 2, 3, 4, 5, 6 and 7 unchanged 
Original proposa Amended proposa 
Art icle 8 
An application for a simplified 
registration submitted by the person 
responsible for marketing may cover 
a series of preparations derived from 
the same homeopathic stock. The 
following documents shall be included 
with the application in order to 
demonstrate, in particular, the 
pharmaceutical quality and the batch 
to batch consistency of the products 
concerned : An application for a simplified 
registration submitted by the person 
responsible for marketing may cover 
a series of preparations derived from 
the same homeopathic stock or stocks. 
The following documents shall be 
included with the application in order 
to demonstrate, in particular, the 
pharmaceutical quality and the batch 
to batch consistency of the products 
concerned : 
scientific name of the homeopathic 
stock, together with a mention of 
the various routes of administration, 
pharmaceutical forms and dilut Ions 
to be registered; scientific name of the homeopathic 
stock or stocks, together with a 
mention of the various routes of 
administration, pharmaceutical forms 
and strengths to be registered; 
dossier described how the stock is 
obtained and controlled, and 
Justifying its homeopathic nature, 
on the basis of an adequate 
homeopathic bibliography; dossier describing how the 
homeopathic stock/stocks is/are 
obtained and controlled, and 
Justifying its/their homeopathic 
nature, on the basis of an 
adequate homeopathic bibliography; 
- 13 -
manufacturing and control file 
for each pharmaceutical form and 
a description of the method of 
dilution; - manufacturing and control file 
for each pharmaceutical form and 
a description of the method of 
d iI ut i on and potent I at ion; 
manufacturing authorization for 
the preparations concerned; - manufacturing authorization for 
the preparations concerned; 
copies of any registrations or 
authorizations obtained for the 
same preparations in other Member 
States; copies of any registrations or 
authorizations obtained for the 
same preparations in other Member 
States; 
one or more specimens or mock-ups 
of the sales presentation of the 
preparations to be registered. one or more specimens or mock-ups 
of the sales presentation of the 
preparations to be registered; 
documents quaranteeing the safety 
of the preparation and, in the case 
of veterinary medicinal products 
intended for administration to food-
producing animals, quaranteeing the 
absence of harmful residues. 
Original proposal - 14 -
Amended proposal 
Art icle 9 
Homeopathic veterinary medicinal 
products other than those referred 
to in Article 7 shall be authorized 
and labelled in accordance with the 
provisions of Articles 5 to 15 of 
Directive 81/851/EEC, including the 
provisions concerning proof of 
therapeutic effect, and shall be 
labelled in accordance with the 
provisions of Articles 43 to 50 of 
Directive 81/851/EEC. Homeopathic veterinary medicinal 
products other than those referred 
to in Article 7 shall be authorized 
and labelled in accordance with the 
provisions of Articles 5 to 15 of 
Directive 81/851/EEC, including the 
provisions concerning proof of 
therapeutic effect, and shall be 
label led pursuant to the provisions 
of Articles 43 to 50 of Directive 
81/851/EEC, in accordance with the 
basic principles and special nature 
of homeopathic or anthroposophlcal 
medicine. 
Article 10, paragraphs 1 and 2 unchanged 
Article 10 (3) (new) 
3. Not later than 31 December 1995 
the Commission shall present a 
report to the Council and to the 
European Parliament concerning 
the operation of this Directive. 
Article 11 unchanged 
ISSN 0254-1475 
COM(91)313final 
DOCUMENTS 
EN 03 °5 °6 
Catalogue number : CB-CO-91-353-EN-C 
ISBN 92-77-74898-2 
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