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
Date: 1990-03-22
Institutions: European Commission
Subjects: alternative medicine, approximation of laws, homeopathic product, labelling, marketing standard, medicinal product

COMMISSION  OF  THE  EUROPEAN  COMMUNITIES 

C0MC90)  72  f i n al  -  SYN  251/252 

B r u s s e l s,  22  March  1990 

^ S f f iE 

Proposal  f or  a 

COUNCIL  DIRECTIVE 

SYN  251 

widening  t he  scope  of  D i r e c t i v es  65/65/EEC  and  75/319/EEC  on  the 

approximation  of 

the 

laws  of 

the  Member  States  on  m e d i c i n al 

products  and  l a y i ng  down  a d d i t i o n al  p r o v i s i o ns  on 

homeopathic  m e d i c i n al  products 

Proposal  f or  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 V IM  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  M l: 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. 

Article 7 

27 -

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