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
Date: 1991-08-02
Institutions: European Commission
Subjects: alternative medicine, approximation of laws, homeopathic product, labelling, marketing standard, medicinal product

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 

products  and  laying  down  additional  provisions  on 

SYN  251 

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 

Amended  proposa 

-  6  -

Fourth  recital 

Whereas  homeopathic  medicine  is 

Whereas  homeopathic medicine  is 

officially  recognized  in  certain 

officially  recognized  in  certain 

Member  States  but  is only  tolerated 

Member  States  but  is only  tolerated 

in other  Member  States; whereas, 

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 

Eighth  recital 

Whereas,  having  regard  to  the 

Whereas,  having  regard  to  the 

particular  characteristics of  these 

particular  characteristics of  these 

medicinal  products,  such  as  their 

medicinal  products,  such  as  their ' 

very  low content  of  active  principles 

very  low content  of  active  principles 

and  the  difficulty  of  applying  to  them 

and  the  difficulty  of  applying  to  them 

the  conventional  statistical  methods 

the conventional  statistical  methods 

relating  to clinical  trials,  it  is 

relating  to clinical  trials,  it  is 

appropriate  to provide  a  simplified 

appropriate  to provide  a  simplified 

registration  system  for  those 

registration  system  for  those 

traditional  homeopathic medicinal 

traditional  homeopathic  medicinal 

products which  are  placed  on  the  market 

products  which  are  placed  on  the  market 

without  specific  therapeutic 

without  specific  therapeutic 

indications  in a preparation  which 

indications  in a preparation  and  dosage 

does  not  present  a  risk  for  the  patient; 

which  does  not  present  a  risk  for  the 

patient; 

9th  recital  unchanged 

-  7 -

Original  proposal 

Amended  proposal 

Art 

icle 1 

For  the purposes of  this Directive 

For  the purposes of  this Directive 

"homeopathic  medicinal  product"  shall 

"homeopathic  medicinal  product" shall 

mean  any medicinal  product  prepared  in 

mean  any pharmaceutical  preparation 

accordance with  a homeopathic manufac 

prepared  in accordance  with a 

turing procedure  described  by  the 

homeopathic manufacturing  procedure 

European  Pharmacopoeia, or  in the 

described  by  the  European 

absence  thereof, by  the official 

Pharmacopoeia, or  in the  absence 

pharmacopoeia of  a Member  State. 

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 

Homeopathic  preparations are  produced 

produced  from  products,  substances 

from  products, substances or  composi 

or  compositions called  homeopathic 

tions called  homeopathic  stocks by 

stocks by successive  dilutions. 

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 

Amended  proposa 

-  8  -

Article  8,  introductory  phrase  and  first  three  indents 

An  application  for  a  simplified 

An  application  for  a  simplified 

registration  submitted  by  the  person 

registration  submitted  by  the  person 

responsible  for marketing may  cover 

responsible  for marketing may  cover 

a series of  preparations  derived  from 

a series of  preparations  derived  from 

the same  homeopathic  stock.  The 

the same  homeopathic  stock or  stocks. 

following  documents shall  be  included 

The  following  documents shall  be 

with  the application  in order  to 

included with  the application  in order 

demonstrate,  in particular,  the 

to demonstrate,  in particular,  the 

pharmaceutical  quality  and  the  batch 

pharmaceutical  quality  and  the  batch 

consistency  of  the products  concerned  : 

consistency  of  the products  concerned 

scientific  name of  the  homeopathic 

-  scientific  name of  the  homeopathic 

stock,  together  with  a mention of 

stock or  stocks, together  with a 

the various  routes of  administra 

mention of  the various  routes of 

tion, pharmaceutical  forms and 

administration,  pharmaceutical  forms 

dilut ions  to be  registered; 

and  strengths  to be  registered; 

dossier  describing  how  the 

-  dossier  describing  how  the 

homeopathic  stock  is obtained  and 

homeopathic  stock  or  stocks  is/are 

controlled, and  Justifying  its 

obtained  and  controlled,  and 

homeopathic  nature, on  the  basis 

Justifying  its homeopathic  nature, 

of  an adequate  homeopathic  biblio 

on  the basis of  an  adequate  homeopa 

graphy; 

thic or  anthroposophical  bib Iio-

graphy; 

manufacturing  and  control  file 

- manufacturing  and  control  file 

for  each  pharmaceutical  form  and 

for  each  pharmaceutical  form  and 

a description of  the method  of 

a description  of  the method  of 

dilut ion; 

dilution  and  potent iat ion; 

Rest  of  the article  unchanged 

Original  proposal 

Amended  proposal 

-  9  -

Article  9  (1) 

1. Homeopathic medicinal  products 

1. Homeopathic  and  antroposophical 

other  than  those  referred  to  in 

medicinal  products  other  than  those 

Article 7 shall  be authorized  and 

referred  to  in Article  7 shall  be 

label led  in accordance  with  the 

authorized  and  labelled  pursuant  to 

provisions  of Articles  5  to 21 of 

the provisions  of  Articles  5  to 21 of 

Directive 65/65/EEC  and Articles 1 

Directive 65/65/EEC  and Articles 1 

to 7 of  Directive  75/319/EEC, 

to 7 of  Directive  75/319/EEC, 

including  the provisions  concerning 

including  the  provisions  concerning 

proof  of  therapeutic  effect. 

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 

SYN  252 

veterinary medicinal  products 

(presented  by  the Commission  in accordance  with  Article  149, 

paragraph  3 of  the EEC  Treaty) 

Original  proposal 

Amended  proposal 

First  recital 

Whereas  differences  currently 

Whereas  differences  currenlty 

existing  between  the provisions  laid 

existing  between  the provisions  laid 

down  by  law, regulation or  administra 

down  by  law, regulation or  administra 

tive action  by  the Member  States may 

tive  action  in the Member  States may 

hinder  trade  in homeopathic medicinal 

hinder  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; 

3rd  recital  unchanged 

Fourth  recital 

Whereas  homeopathic  medicine  is 

Whereas  homeopathic medicine  is 

officially  recognized  in certain 

officially  recognized  in certain 

Member  States  but  is only  tolerated 

Member  States  but  is only  tolerated 

in other  Member  States; whereas, 

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 

Amended  proposal 

-  11  -

Eighth 

recital 

Whereas, having  regard  to  the 

Whereas,  having  regard  to  the 

particular  characteristics of  these 

particular  characteristics of  these 

medicinal  products,  such  as  their 

medicinal  products,  such  as  their 

very  low content  of  active  principles 

very  low content  of  active  principles 

and  the  difficulty  of  applying  to  them 

and  the difficulty of  applying  to  them 

the conventional  statistical  methods 

the conventional  statistical  methods 

relating  to clinical  trials,  it  is 

relating  to clinical  trials,  it  is 

appropriate  to provide  a  simplified 

appropriate  to provide  a  simplified 

registration  system  for  those 

registration  system  for  those 

traditional  homeopathic  veterinary 

traditional  homeopathic  veterinary 

medicinal  products which  are  placed 

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; 

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 

For  the purposes  of  this  Directive 

"homeopathic  veterinary  medicinal 

"homeopathic  veterinary  medicinal 

product"  shall  mean  any  veterinary 

product"  shall  mean  any  pharmaceuticai 

medicinal  product  prepared  in 

accordance  with  a  homeopathic 

preparation  prepared  in accordance  with 

a  homeopathic  manufacturing  procedure 

manufacturing  procedure  described  by 

described  by  the  European 

the  European  Pharmacopoeia, or  in 

Pharmacopoeia, or  in the  absence 

the absence  thereof,  by  the official 

thereof,  by  the official  pharmacopoeia 

pharmacoposia of  a Member  State. 

of  a Member  State. 

Homeopathic  preparations are  produced 

Homeopathic  preparations are  produced 

from  products, substances  or 

from  products,  substances  or 

compositions  called  homeopathic  stocks 

compositions  called  homeopathic  stocks 

by  successive  dilutions. 

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 

An  application  for  a  simplified 

registration  submitted  by  the  person 

registration  submitted  by  the  person 

responsible  for marketing  may  cover 

responsible  for  marketing may  cover 

a series of  preparations  derived  from 

a series of  preparations  derived  from 

the same  homeopathic  stock.  The 

the same  homeopathic  stock or  stocks. 

following documents  shall  be  included 

The  following  documents  shall  be 

with  the application  in order  to 

included  with  the  application  in order 

demonstrate,  in particular,  the 

to demonstrate,  in particular,  the 

pharmaceutical  quality  and  the  batch 

pharmaceutical  quality  and  the  batch 

to batch  consistency  of  the  products 

to batch  consistency  of  the  products 

concerned  : 

concerned  : 

scientific name of  the  homeopathic 

scientific  name of  the  homeopathic 

stock,  together  with  a mention of 

stock  or  stocks,  together  with a 

the various  routes of  administration, 

mention of  the  various  routes of 

pharmaceutical  forms and  dilut Ions 

administration,  pharmaceutical  forms 

to be  registered; 

and  strengths  to be  registered; 

dossier  described  how  the stock  is 

dossier  describing  how  the 

obtained  and  controlled,  and 

homeopathic  stock/stocks  is/are 

Justifying  its homeopathic  nature, 

obtained  and  controlled, and 

on  the basis of  an  adequate 

homeopathic  bibliography; 

Justifying  its/their  homeopathic 

nature, on  the basis of  an 

adequate  homeopathic  bibliography; 

-  13 -

manufacturing and  control  file 

- manufacturing and  control  file 

for each  pharmaceutical  form  and 

for each  pharmaceutical  form  and 

a description of  the method  of 

a description  of  the method  of 

dilution; 

d iI ut i on and  potent I at ion; 

manufacturing authorization  for 

- manufacturing authorization  for 

the preparations  concerned; 

the preparations  concerned; 

copies of  any  registrations or 

copies of  any  registrations or 

authorizations obtained  for  the 

authorizations obtained  for  the 

same preparations  in other  Member 

same preparations  in other  Member 

States; 

States; 

one or more specimens or  mock-ups 

one or more  specimens or  mock-ups 

of  the sales presentation of  the 

of  the sales presentation  of  the 

preparations  to be  registered. 

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 

Amended  proposal 

-  14 -

Art icle 9 

Homeopathic  veterinary  medicinal 

Homeopathic  veterinary  medicinal 

products  other  than  those  referred 

products  other  than  those  referred 

to  in Article  7 shall  be  authorized 

to  in Article 7 shall  be  authorized 

and  labelled  in accordance  with  the 

and  labelled  in accordance  with  the 

provisions  of  Articles  5  to  15 of 

provisions  of  Articles 5  to  15 of 

Directive 81/851/EEC,  including  the 

Directive 81/851/EEC,  including  the 

provisions concerning  proof  of 

provisions concerning  proof  of 

therapeutic  effect,  and  shall  be 

therapeutic effect,  and  shall  be 

labelled  in accordance  with  the 

label led  pursuant  to  the  provisions 

provisions  of  Articles  43  to 50 of 

of  Articles  43  to 50 of  Directive 

Directive  81/851/EEC. 

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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