COMMISSION OF THE EUROPEAN COMMUNITIES 
^SffiE C0MC90) 72 final - SYN 251/252 
Brussels, 22 March 1990 
Proposal for a 
COUNCIL DIRECTIVE SYN 251 
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 
Proposal for a 
COUNCIL DIRECTIVE SYN 252 
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) 
- 2 -
EXPLANATORY MEMORANDUM AND REPORT TO THE COUNCIL 
1• Qenerai remarks 
1. When the Council adopted Directive 87/22/EECi, and 
specifically Article 5 thereof, It instructed the Commission to 
present it with "proposals for Regulations to harmonize, along 
the lines of Directive 75/319/EEC, the conditions for 
authorizing the manufacture and placing on the market of the 
proprietary medicinal products excluded by Article 34 of 
Directive 73/319/EEC2 and of the veterinary medicinal 
products referred to In Article 2(2) of Directive 
81/851/EEC5". 
2. Three of the four kinds of medicines for human use which were 
provisionally excluded in 1975 have recently been incorporated 
into Community pharmaceutical legislation, namely: 
Immunological medicinal products by Directive 89/342/EEC*, 
radio-pharmaceuticals by Directive 89/343/EEC5 and medicinal 
products derived from human blood by Directive 89/381/EEC6. 
In the veterinary field, a proposal for a Directive on 
Immunological medicinal products was transmitted to the Council 
in January 19897. It has proved more difficult to harmonize 
legislation on homeopathic medicinal products because of the 
conflicting conceptions of medicine involved. 
(1) OJ N° L 15, 17.1.1987, p.38. 
(2) OJ Np L 147, 9.6.1975, p.13. 
(3) OJ N° L 317, 6.11.1981, p.1. 
(4) OJ N° L 142, 25.5.1989, p.14. 
(5) OJ Np L 142, 25.5.1989, p.16. 
(6) OJ N° L 181, 26.6.1989, p.44. 
(7) OJ N° C 61, 10.3.1989, p.20. 
- i -
3. While homeopathic medicine has traditionally been recognized in 
some Member States, it has merely been tolerated in others or even 
ignored by orthodox medicine altogether. Nonetheless, homeopathy 
has been practised in Europe for more than two centuries and has 
become Increasingly popular with the public in the last decade or 
so with the rise In "natural" therapies and alternative medicine. 
4. It Is not for the Commission to take sides for or against a 
particular style of medical practice. The aim should be rather, In 
the light of legislative experience In some of the Member States, 
to provide European consumers with safeguards about the quality and 
safety of the homeopathic medicines currently available In all 
Community countries. Proof of therapeutic efficacy cannot be 
obtained by generally accepted scientific methods or, at the least, 
is highly contentious. 
5. Whether recognized or simply tolerated, homeopathic remedies 
represent a small but not insignificant share of the 
pharmaceuticals market, of the order of half a billion 
(500 000 000) ECU. Trade between Member States Is impeded by the 
differences In regulation and practice at national level. The 
proposals the Commission is now presenting to the Council, on 
homeopathic medicinal products for human and for veterinary use, 
are intended to further the completion of the Internal market in 
the pharmaceuticals sector as provided for In the 1985 White Paper 
programme. 
- 4 -
!'' ALTERNATIVE REMEDIES IN EUROPE 
6. In 1987 the Commission asked the Belgian Consumers' Association to 
carry out a study on the market for alternative medicine among 
European consumers. This study, written by G. Sermus, covers seven 
Community countries (Belgium, Denmark, Germany, France, Italy, 
Netherlands, United Kingdom) as well as Finland and Switzerland. It 
shows that a considerable proportion of the population (from 18% to 
75% depending on country) makes use of alternative therapies. 
Homeopathy Is the principal method among them, well ahead of 
acupuncture and manipulations such as chiropractic, osteopathy and 
various types of massage. Then come herbal remedies, followed by 
what one might call "paranormal" methods, Including mystical and 
religious approaches. Finally the author lists what he classifies 
as fringe methods (In Europe) such as iridology, anthroposophy, 
"biomedlclne", aroma therapy, cell therapy and hypnotherapy. The 
author notes that it is generally aduits between the ages of 40 and 
60 with a high level of education who make most use of alternative 
medIcI ne. 
7. These diverse therapies have little In common except being almost 
uniformly rejected by science as lacking a rational basis. Whereas 
conventional or allopathic medicine has made considerable progress 
through advances In biology, pharmacology and surgical techniques, 
the various forms of alternative medicine generally adopt an 
empirical approach backed by what are often obscure explanations. 
But conventional medicine Itself does not meet all the expectations 
of patients with certain chronic or supposedly "incurable" 
diseases. Furthermore, patients are often put off by the impersonal 
and highly technological nature of modern medicine. The alternative 
medicines, on the other hand, tend to be holistic in the sense that 
they look at the person as a whole and encourage the patient to 
participate in the healing process. Although alternative medicine 
can be sincere in approach and rest on established traditions, It 
must be admitted that a degree of opportunism has developed to 
exploit recent fashions, even to the extent of combining methods 
that are Incompatible. 
- 5 -
8. Homeopathic remedies represent by far the most Important type of 
alternative medicines used in Europe. For our present purposes, 
plant-based medicinal products will be considered as belonging to 
the allopathic or conventional tradition; medicinal herbs are in 
fact the origin of many modern medicines, either by extraction or 
by synthesis, although the action of the plant as a whole may be 
poorly understood. While allopathy treats a condition by tackling 
the causes or, at second-best, the symptoms, homeopathy is based on 
the principle of similarity - like cures like - and extreme 
dilutions. The theory was developed by Samuel Hahnemann (1755-1843) 
and consists of trying to cure the patient by administering very 
small doses of a substance which, in a healthy individual, would 
produce similar symptoms to those observed In the patient. This 
theory has evolved into various opposing schools: complex Ists, 
pluralIsts ("materialists") and unieIsts ("dynamists"). 
Anthroposophy (following Rudolf Steiner) and "biomedlcine" 
(following Dr Schuss 1er), which are more widespread in Germany than 
In the rest of the Community, make frequent use of homeopathic 
remedies while being based on other Ideas. 
9. When the Community's pharmaceuticals directives were being 
transposed Into German law In the "Arznelmlttelgesetz 1976", a 
wide-ranging debate took place about the position of alternative 
remedies. The quality of homeopathic and anthroposophlc medicines 
Is standardized in a separate official pharmacopoeia 
(HomeopathIsches Arzneibuch - HAB); such medicinal products are 
evaluated by special committees of the Federal Health Office 
(Bundesgesundheltsamt - BGA). France also has a well-established 
homeopathic tradition, with special authorization procedures and 
the Inclusion of monographs on homeopathic preparations and 'mother 
tinctures' or stocks In the French Pharmacopoeia (editions VIM and 
X). Homeopathic medicinal products are also mentioned, albeit in 
much less detail, in the pharmaceutical legislation of Belgium, 
Denmark, the Netherlands, the United Kingdom and Ireland. These 
countries, as well as Italy and Portugal, are waiting to see what 
action the Community will take before reviewing their own 
legislatIon. 
- 6 -
III. CONSULTATIONS AT COMMUNITY LEVEL 
10. In the period since 1987, the Commission has put three 
successive preliminary drafts of a Directive on homeopathic 
medicinal products to the Pharmaceuticals Committee, which is 
composed of representatives of the Member States. The reaction 
to these drafts varied widely according to the different 
national positions, from official recognition to outright 
rejection. Since homeopathic medicines are available on all the 
national markets, there have been suggestions that they be 
classified as articles for household consumption rather than as 
medicines. However, this does not seem consistent either with 
the Community definition of medicinal products or with the 
instructions given by the Council. While some convergence of 
views seems possible In the case of traditional homeopathic 
medicines, the same cannot be said of anthroposophical 
products, nor of aspects felt to carry too much risk 
(preparations for injection, for example) or considered hardly 
compatible with the basic principles of homoeopathy 
(encouragement of self-medlcation). 
11. The preliminary draft Directive on homeopathic medicinal 
products for human use was distributed widely through several 
European organizations representing professionals in the field: 
the pharmaceuticals Industry (EFPIA), homeopathic and 
anthroposophic laboratories, the Association of EEC pharmacists 
and mutual pharmacies, and homoeopaths and anthroposophical 
practitioners. The overall reaction was positive, since the 
draft text introduced greater legal security while eliminating 
various sharp practices which damage the reputation of serious 
practitioners. At the request of the Commission, the Consumers' 
Consultative Committee Issued an opinion on 16 February 1989; 
this was favourable, and was accompanied by complete and 
detailed reference documentation. In addition to this, an 
international workshop on homeopathic medicines was held in 
Berlin on 2 and 3 February 1989 at the Invitation of the 
Federal Health Office; 11 health ministries of European 
countries were represented, as well as the Commission. Most of 
the participants met again In Strasbourg on 17 and 18 May at 
the invitation of the Secretary of the European Pharmacopoeia. 
- 7 -
12. Several preliminary drafts of a Directive on medicinal products for 
veterinary use have been submitted to the Committee for Veterinary 
Medicinal Products. Despite the great differences between 
countries, most members of the Committee underlined the need to 
improve standards of quality and safety for this category of 
medicines, which are being used more and more. The competant 
authorities would also like to eliminate a number of abuses in the 
field, in particular the sale of medicines described as homeopathic 
for collectively treating livestock as part of specific medications 
for which a therapeutic effect has not been shown. 
IV. THE QUALITY OF HOMEOPATHIC MEDICINES 
13. Homeopathic medicinal products are defined primarily by the way 
they are made up, as described in the European Pharmacopoeia if It 
Is extended to include homeopathy or, If not, in national 
pharmacopoeias (currently those of France and Germany). This 
"objective" method of definition, which Is the one adopted in the 
German legislation, has the advantage of not taking sides In the 
argument over the philosophy or rational basis of homeopathy or 
other traditions using the same products, such as is often the case 
for anthroposophy. Homeopathic medicines should be clearly 
Identifiable as such for the general public, by means of a special 
legend on the label, so that there can be no confusion between 
these, more controversial, homeopathic products and orthodox 
medicines. The general approach of Community pharmaceutical 
legislation Is followed in that the proposals cover only medicines 
which are widely distributed, I.e. prepared industrially and thus a 
major potential risk for the public, in particular by being sold In 
Intra-Communlty trade. This would not affect In any way the right 
to prescribe or prepare other alternative therapies in Individual 
cases according to magistral or officinal formulae, within the 
bounds of current national legislation. 
- 8 -
14. The wide distribution of industrially prepared homeopathic 
medicines means that the first priority must be to harmonize the 
manufacture and monitoring of them. Apart from having to comply 
with the European Pharmacopoeia or, If not covered by It, the 
existing official pharmacopoeias, homeopathic medicines will become 
subject to all the Community rules safeguarding the quality of 
medicinal products manufactured in and Imported/exported to or from 
the Community. A consequence Is that the authorization to 
manufacture, export or Import such products will be conditional on 
possession of suitable premises and equipment. All raw materials 
and each batch manufactured will have to be monitored by a 
qualified person, who will Issue a properly registered certificate 
of conformity. The rules of good manufacturing practice (GMP) will 
become mandatory, which is particularly Important In the case of 
highly diluted products. Establishments will also become subject to 
regular monitoring by pharmaceuticals Inspectors. The competent 
authorities In the Member States will be required to exchange 
inspection reports and other data relevant to safeguarding the 
quality and safety of homeopathic medicines. 
V. PLACEMENT OF HOMEOPATHIC MEDICINES ON THE MARKET 
15. Harmonizing the terms on which homeopathic medicines are to receive 
market authorization poses more complicated problems. Some Member 
States, while accepting that it is useful to ensure the quality of 
homeopathic products, do not want to give them official status and 
yet are prepared to admit products legally sold in other Member 
States, within certain constraints. On the other hand, where a 
Member State wishes to regulate the marketing of homeopathic 
medicines It will have a choice between two different regimes. 
- 9 -
16. The first of these, full harmonization, consists of a simplified 
registration procedure applicable to medicinal products which, 
without therapeutic claims being made, are put up in pharmaceutical 
forms and at dilutions that carry no risk. Such medicines, sold 
under their common name and bearing a fully harmonized labelling, 
will usually be prescribed by a practitioner qualified according to 
the specific features of the case under treatment. Medicines of 
this type will be considered to belong to the homeopathic tradition 
and their therapeutic effect Is to be assessed in terms of that 
tradition. Since some of the Information would be repetitive, it 
will be possible to combine dossiers to cover a series of like 
preparations. 
17. The other, and more rigorous, regime cannot be entirely harmonized 
at this Juncture. For homeopathic medicines other than those 
qualifying for the simplified registration procedure, proof of 
therapeutic effect balanced against potential risks will have to be 
provided. Member States will apply either the ordinary rules on 
market authorization, especially criteria of efficacy and safety, 
or special rules for homeopathic preparations. In this second case, 
these special rules will have to be notified to the Commission with 
a view to later harmonization. 
VI. CONCLUSIONS 
18. By 1993, with the entry Into effect of the Directives, homeopathic 
medicines sold in the Community will all have to meet the same high 
quality standards. First-time applications for registration or 
authorization will be examined under the terms of the Directives. 
Experience with implementation will lead to a greater convergence 
of practice as between Member States despite the present wide 
differences. 
- 10 -
In accordance with Articles 8a and 8c of the Treaty establishing 
the European Economic Community, the Commission calls on the Member 
States to take the necessary steps to comply with the proposals 
presented here by 1 January 1993. 
19. The Commission has given due consideration to the requirements of 
Article 8c of the Treaty and has concluded that no special 
provisions are needed In this case. 
The Commission has also looked at the matter of the high level of 
protection for health, safety, the environment and consumers 
required by the third paragraph of Article 100a. This review was 
conducted after consulting concerned parties and after analysing 
the Inherent risks in this area, given current technical capacity 
within European Industry. The proposals take full account of these 
factors, in the light of the underlying aims of the Treaty. 
- 11 -
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 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European Economic 
Community, and in particular Article 100a thereof, 
Having regard to the proposal from the Commission*1), 
In cooperation with the European Par I lament*2>, 
Having regard to the opinion of the Economic and Social Committee*3*, 
Whereas differences currently existing between the provisions laid down 
by law, regulation or administrative action in the Member States may 
hinder trade in homeopathic medicinal products within the Community; 
Whereas the essential aim of any rules governing the production, 
distribution and use of medicinal products must be to safeguard public 
health; 
Whereas the provisions of Council Directive 65/65/EEC*4^ and the 
Second Directive 75/319/EEC*5*, as last amended by Directive 
89/341/EEC*6*, are not always appropriate for homeopathic medicinal 
products; 
(1) 
(2) 
(3) 
(4) OJ No 22, 9.2.1965, p. 369/65. 
(5) OJ No L 147, 9.6.1975, p. 13. 
(6) OJ No L 142, 25.5.1989, p. 11. 
- 12 -
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 even if homeopathic remedies are not always officially 
recognized, they are nevertheless prescribed and used in ail Member 
States; 
Whereas It Is desirable in the first Instance to provide users of these 
remedies with a clear indication of their homeopathic character and 
with sufficient guarantees of their quality and safety; 
Whereas the rules relating to the manufacture, the control and 
inspection of homeopathic medicinal products must be harmonized to 
permit the circulation throughout the Community of preparations which 
are safe and of good quality; 
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, however, the usual rules governing the authorization to market 
medicinal products should be applied to a homeopathic medicinal product 
marketed with therapeutic indications or in a form which may present 
risks which must be balanced against the desired therapeutic effect; 
whereas those Member States which have a homeopathic tradition should 
13 -
be able to apply particular rules for the evaluation of tests and 
trials Intended to establish the safety and efficacy of these medicinal 
products provided that they notify them to the Commission, 
HAS ADOPTED THIS DIRECTIVE: 
- 14 -
Chapter I : Scope 
Article 1 
For the purposes of this Directive "homeopathic medicinal product" 
shall mean any medicinal product prepared In accordance with a 
homeopathic manufacturing procedure described by the European 
Phamacopoeia, 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. 
Article 2 
1. The provisions of this Directive shall apply to industrially 
prepared homeopathic medicinal products for human use to the 
exclusion of homeopathic medicinal products prepared In accordance 
with a magistral or an officinal formula as defined In Article 1 of 
Directive 65/65/EEC. 
2. The medicinal products referred to In paragraph 1 must be 
identified by the inclusion on their labels in clearly legible form 
of the words "homeopathic medicinal product". 
- 15 -
Chapter II: Manufacture, Control and Inspection 
Article 3 
The provisions of Chapter IV of Directive 75/319/EEC shall apply to the 
manufacture, control, Import and export of homeopathic medicinal 
products. 
Article 4 
The measures of supervision and the sanctions provided for In Chapter V 
of Directive 75/319/EEC shall apply to homeopathic medicinal products 
together with Articles 31 and 32 of the same Directive. 
However, the proof of therapeutic effect mentioned in Article 28(1)(b) 
of the same Directive shall not be required for homeopathic medicinal 
products registered in accordance with Article 7 of this Directive. 
Article 5 
The Member States shall communicate to each other all the information 
necessary to guarantee the quality and safety of homeopathic medicinal 
products manufactured and marketed within the Community, and in 
particular the Information mentioned in Articles 30 and 33 of Directive 
75/319/EEC. 
- 16 -
Chapter III: Placing on the market 
Articfa 6 
1. Member States shall ensure that homeopathic medicinal products 
manufactured and marketed within the Community are registered or 
authorized In accordance with the provisions of Articles 7, 8 and 
9. Each Member State shall take registrations and authorizations 
previously granted by another Member State Into due consideration. 
2. A Member State may refrain from establishing any system of 
registration or authorization for homeopathic medicinal products. 
A Member State applying this provision shall Inform the Commission 
thereof. The Member State concerned shall allow the use in its 
territory of homeopathic medicinal products registered or 
authorized by other Member States In accordance with Articles 7, 8 
and 9. 
- 17 -
Article 7 
1. Homeopathic medicinal products shall be subject to a simplified 
registration procedure If they satisfy all of the following 
conditions: 
they are administered orally or externally; 
they are marketed without any specific therapeutic 
indication, whether on the labelling of the product or in 
any accompanying product Information; 
there is a sufficient degree of dilution to guarantee the 
safety of the preparation; in particular, the preparation 
shall contain less than one part per million of any active 
principle which is subject to the requirement of a medical 
prescription. 
2. In addition to the clear mention of the words "homeopathic 
medicinal product", the labelling and packaging of the homeopathic 
medicinal products referred to In paragraph 1 shall consist of the 
following Information and no other information: 
the scientific name of the stock followed by the degree of 
dilution, using the symbols used in the official 
pharmacopoeia of the Community, 
name and address of the person responsible for marketing, 
and of the manufacturer, 
method of administration, 
expiry date, in plain language, 
special storage precautions, if any, 
manufacturer's batch number, 
registration number. 
3. The criteria and rules of procedure provided for in Articles 5 to 
12 of Directive 65/65/EEC shall apply to the simplified 
registration procedure for homeopathic medicinal products, with the 
exception of the proof of therapeutic effect. 
- 18 -
Article 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: 
scientific name of the homeopathic stock, together with a mention 
of the various routes of administration, pharmaceutical forms and 
dilutions to be registered; 
dossier describing how the stock is obtained and controlled, and 
justifying Its homeopathic nature, on the basis of an adequate 
homeopathic bibliography; 
manufacturing and control file for each pharmaceutical form and a 
description of the method of dilution; 
manufacturing authorization for the preparations concerned; 
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. 
- 19 -
Article 9 
1. Homeopathic medicinal products other than those referred to In 
Article 7 shall be authorized and labelled 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. 
2. A Member State may lay down specific rules for the pharmacological 
and toxIcolog lea I tests and clinical trials of homeopathic 
medicinal products other than those referred to In Article 7. In 
this case, before the date referred to in Article 10 (1) the Member 
State concerned shall notify the Commission of the specific rules 
in force. 
- 20 -
Chapter IV: Final Provisions 
Article 10 
1. Member States shall take the measures necessary to comply with 
this Directive by 31 December 1992. They shall inform the 
Commission thereof forthwith. 
The provisions adopted pursuant to the first subparagraph shall 
make express reference to this Directive. 
2. Applications for registration or for marketing authorization for 
products covered by this Directive lodged after the date set out in 
paragraph 1 shall comply with the provisions of this Directive. 
Article 11 
This Directive is addressed to the Member States 
Done at Brussels, For the Council 
The President 
- 21 -
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 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European Economic 
Community, and In particular Article 100a thereof, 
Having regard to the proposal from the Commission*1*, 
In cooperation with the European Parliament*2*, 
Having regard to the opinion of the Economic and Social Committee*3*, 
Whereas differences between the provisions laid down by law, regulation 
or administrative action in the Member States may hinder trade in 
homeopathic veterinary medicinal products within the Community; 
Whereas the essential aim of any rules governing the production, 
distribution and use of veterinary medicinal products must be to 
safeguard human and animal health; 
Whereas the provisions of Council Directive 81/851/EEC*4* are not 
always appropriate for homeopathic veterinary medicinal products; 
(1) 
(2) 
(3) 
(4) OJ No L 317, 6.11.1981, p. 1. 
- 22 -
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 even If homeopathic remedies are not always officially 
recognized, they are nevertheless prescribed and used In all Member 
States; 
Whereas It Is desirable in the first instance to provide users of these 
remedies with a clear Indication of their homeopathic character and 
with sufficient guarantees of their quality and safety; 
Whereas the rules relating to the manufacture, the control and 
Inspection of homeopathic veterinary medicinal products must be 
harmonized to permit the circulation throughout the Community of 
preparations which are safe and of good quality; 
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; 
- 23 
Whereas, however, the usual rules governing the authorization to market 
veterinary medicinal products should be applied to a homeopathic 
veterinary medicinal product marketed with therapeutic indications or 
in a form which may present risks which must be balanced against the 
desired therapeutic effect; whereas those Member States which have a 
homeopathic tradition should be able to apply particular rules for the 
evaluation of tests and trials Intended to establish the safety and 
efficacy of these veterinary medicinal products provided that they 
notify them to the Commission, 
HAS ADOPTED THIS DIRECTIVE: 
- 24 -
Chapter I : Scope 
Article 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 
pharmacopoeia of a Member State. 
Homeopathic preparations are produced from products, substances or 
compositions called homeopathic stocks by successive dilutions. 
Article 2 
1. The provisions of this Directive shall apply to homeopathic 
veterinary medicinal products to the exclusion of products prepared 
by a pharmacist or a veterinarian in accordance with a magistral or 
an officinal formula and Intended for administration to a single 
animal or a small number of animals. 
2. The medicinal products referred to in paragraph 1 must be 
identified by the inclusion on their labels in clearly legible form 
of the words "homeopathic medicinal product, for animal treatment 
only". 
3. This Directive shall not apply to immunological homeopathic 
veterinary medicinal products which shall be authorized by Member 
States in accordance with the provisions of Council Directive 
90/.../EEC [extending the scope of Directive 81/851/EEC on the 
approximation of the laws of the Member States relating to 
veterinary medicinal products and laying down additional provisions 
for immunological veterinary medicinal products]*5*. 
(5) OJ No L 
- 25 -
Chapter II: Manufacture, Control and Inspection 
Article 3 
The provisions of Chapter V of Directive 81/851/EEC shall apply to the 
manufacture, control, import and export of homeopathic veterinary 
medicinal products. 
Article 4 
The measures of supervision and the sanctions provided for in 
Chapter VI of Directive 81/851/EEC shall apply to homeopathic 
veterinary medicinal products. 
However, the proof of therapeutic effect mentioned in Article 37(1)(b) 
of the same Directive shall not be required for homeopathic veterinary 
medicinal products registered in accordance with Article 7 of this 
Directive. 
Article 5 
The Member States shall communicate to each other all the information 
necessary to guarantee the quality and safety of homeopathic veterinary 
medicinal products manufactured and marketed within the Community, and 
in particular the information mentioned in Articles 39 and 42 of 
Directive 81/851/EEC. 
- 26 -
Chapter Ml: Placing on the market 
Article 6 
1. Member States shall ensure that homeopathic veterinary medicinal 
products manufactured and marketed within the Community are 
registered or authorized In accordance with the provisions of 
Articles 7, 8 and 9. Each Member State shall take registrations 
and authorizations previously granted by another Member State Into 
due consideration. 
2. A Member State may refrain from establishing any system of 
registration or authorization for homeopathic veterinary medicinal 
products. A Member State applying this provision shall inform the 
Commission thereof. The Member State shall allow the use in its 
territory of homeopathic veterinary medicinal products registered 
or authorized by other Member States in accordance with Articles 7, 
8 and 9. 
27 -
Article 7 
1. Homeopathic veterinary medicinal products shall be subject to a 
simplified registration procedure If they satisfy all of the 
fo11owIng cond11 i ons: 
they are administered orally or externally; 
they are marketed without any specific therapeutic 
indication, whether on the labelling of the medicinal 
product or in any accompanying product information; 
there is a sufficient degree of dilution to guarantee the 
safety of the preparation, and in the case of homeopathic 
veterinary medicinal products Intended for administration 
to food producing animals, to guarantee the absence of 
harmful residues In foodstuffs produced from these animals; 
in particular, the preparation shall contain less than one 
part per million of any active principle which is subject 
to the requirement of a veterinary prescription. 
2. In addition to the clear mention of the words "homeopathic 
medicinal product, for animal treatment only", the labelling and 
packaging of the homeopathic veterinary medicinal products referred 
to in paragraph 1 shall consist of the following information and no 
other information: 
the scientific name of the stock followed by the degree of 
dilution, using the symbols used in the official 
pharmacopoeia of the Community, 
name and address of the person responsible for marketing, 
and of the manufacturer, 
method of administration, 
expiry date, In plain language, 
special storage precautions, if any, 
manufacturer's batch number, 
registration number, 
In the case of products intended for administration to food 
producing animals, a statement that there is a nil 
withdrawal period. 
28 -
3. The criteria and rules of procedure provided for in Articles 8 to 
15 of Directive 81/851/EEC shall apply to the simplified 
registration procedure for homeopathic veterinary medicinal 
products, with the exception of the proof of therapeutic effect. 
Article 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: 
scientific name of the homeopathic stock, together with a mention 
of the various routes of administration, pharmaceutical forms and 
dilutions to be registered; 
dossier describing how the stock is obtained and controlled, and 
justifying Its homeopathic nature, on the basis of an adequate 
homeopathic bibliography; 
manufacturing and control file for each pharmaceutical form and a 
description of the method of dilution; 
manufacturing authorization for the preparations concerned; 
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. 
- 29 -
Article 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. v.-
- 30 -
Chapter IV: Final Provisions 
Article 10 
1. Member States shall take the measures necessary to comply with this 
Directive by 31 December 1992. They shall inform the Commission 
thereof forthwith. 
The provisions adopted pursuant to the first subparagraph shall 
make express reference to this Directive. 
2. Applications for registration or for marketing authorization for 
products covered by this Directive lodged after the date set out In 
paragraph 1 shall comply with the provisions of this Directive. 
Article 11 
This Directive Is addressed to the Member States, 
Done at Brussels, For the Council 
The President 
- 31 -
IMPACT ON COMPETITIVENESS AND EMPLOYMENT 
1. What is the main reason for introducing the measure? 
White Paper on completing the internal market; improvement of 
protection of public health; instructions from the Council to Include 
in Community legislation all industrially produced medicinal products 
2. Features of the businesses concerned 
The market for homeopathic medicines is relatively restricted (2% of 
the market for pharmaceuticals). Industrial preparation of homeopathic 
medicines Is carried out by about 15 Community companies which are 
disadvantaged by present legislation and the lack of legal certainty 
for their activities in some Member States where homeopathy is not 
recognized. Small manufacturing or dilution runs produced by local 
homeopathic , dispensing pharmacies are not affected by the proposals. 
According to the information available to the Commission, the 
industrial-scale firms are located particularly in certain areas: 
France, Germany, United Kingdom; however, their products are already 
being sold throughout the Community. 
3. What direct obligations does this measure impose on businesses? 
The measures introduced all seem necessary to protect the consumer and 
should therefore already be standard practice for a bona fide producer; 
in particular: 
- 32 -
- good pharmaceutical manufacturing practice, 
- a qualified person to check and certify each production batch, 
- submission of documentation, especially a bibliography, to guarantee 
the quality and safety of the homeopathic medicines so produced. 
Firms must also agree to try to standardize the quality of raw 
materials and production processes, as has already been achieved in 
some countries (Germany, France) but which still remain to be 
harmonized In the context of the European Pharmacopoeia (Council of 
Europe convention). 
4- What obligations are local authorities likely to Impose on businesses? 
National-level inspection of premises and manufacturing conditions, 
where this Is not already instituted by the national authorities. 
5. Do any special measures apply In respect of SMEs? 
No, since products manufactured by local pharmacies on a small scale 
(magistral and officinal preparations) are not covered by the proposed 
measures. 
6. What Is the likely effect on: 
(a) business competitiveness? 
A greater degree of harmonization in the production of 
homeopathic medicines and the authorization of them could 
improve the competitiveness of both manufacturers geared to 
Intra-Communlty trade and producers with an interest In exporting 
outside the Community. 
(b) employment? 
No significant effect Is foreseen. 
- 33 -
Have both sides of Industry been consulted? 
Apart from the European federations representing manufacturers of 
homeopathic medicinal products, there has been consultation of 
associations representing homeopathic pharmacists and practitioners 
The result has been general agreement on the principles behind the 
measures proposed. 

ISSN 0254-1475 
COM(90) 72 final 
DOCUMENTS 
EN 03 05 
Catalogue number : CB-CO-90-096-EN-C 
ISBN 92-77-57911-0 
Office for Officia] Publications of the European Communities 
1-2985 Luxembourg