Communication from the Commission to the Council and the European Parliament concerning the report on the experience acquired as a result of the application of the provisions of Chapter 2a of Directive 2001/83/EC, as amended by Directive 2004/24/EC, on specific provisions applicable to traditional herbal medicinal products (Document on the basis of Article 16i of Directive 2001/83/EC)
Date: 2008-09-29
Institutions: European Commission
Subjects: approximation of laws, legal code, medical plant, medicinal product, pharmaceutical legislation, public health, single market

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 29.9.2008 
COM(2008) 584 final 

COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE 
EUROPEAN PARLIAMENT 

concerning the 

Report on the experience acquired as a result of the application of the provisions of 
Chapter 2a of Directive 2001/83/EC, as amended by Directive 2004/24/EC, on specific 
provisions applicable to traditional herbal medicinal products 

Document on the basis of Article 16i of Directive 2001/83/EC 

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1. 

INTRODUCTION 

1.1. 

Background to the report 

In  order  to  overcome  the  difficulties  encountered  by  Member  States  in  applying  the 
pharmaceutical  legislation  to  herbal  medicinal  products  in  a  uniform  manner,  specific 
provisions for traditional herbal medicinal products have been introduced in the Community 
code relating to medicinal products for human use (Directive 2001/83/EC).  

Under  Articles  16a  to  16i  of  Directive  2001/83/EC,  introduced  by  Directive  2004/24/EC,  a 
specific  registration  procedure  is  to  be  used  by  the  Member  States  for  herbal  medicinal 
products  that  meet  the  criteria  for  a  traditional  herbal  medicinal  product.  Herbal  medicinal 
products  are  defined  as  any  medicinal  product  exclusively  containing  as  active  ingredients 
one or more herbal substances, one or more herbal preparations, or one or more such herbal 
substances in combination with one or more such herbal preparations.  

Article 16i requires the Commission to submit a report to the European Parliament and to the 
Council concerning the application of the simplified registration procedure and including an 
assessment  of  the  possible  extension  of  traditional-use  registration  to  other  categories  of 
medicinal  products.  This  document  was  prepared  in  consultation  with  the  European 
Medicines  Agency  and  the  Committee  on  Herbal  Medicinal  Products  (HMPC)  and  was 
submitted for consultation to the Member States and interested parties. As a major source of 
the  HMPC  report  of  31  October  2006 
information, 
(Doc.Ref.EMEA/HMPC/187219/2006) presenting the views of the EMEA and the HMPC. 

the  Commission  welcomed 

1.2. 

Current situation 

The  simplified  registration  procedure  is  intended  for  herbal  medicinal  products  that  have  a 
long  tradition,  but  do  not  fulfil  the  requirements  for  a  marketing  authorisation,  in  particular 
the  requirement  for  applicants  to  demonstrate  by  detailed  references  to  published  scientific 
literature  that  the  constituent  or  constituents  of  the  medicinal  products  has  or  have  a  well-
established  medicinal  use  with  recognised  efficacy  and  an  acceptable  level  of  safety  (‘well 
established use’).  

The  simplified  procedure  allows  the  registration  of  herbal  medicinal  products  without 
requiring  particulars  and  documents  on  tests  and  trials  of  safety  and  efficacy,  provided  that 
there is sufficient evidence of the medicinal use of the product throughout a period of at least 
30 years, including at least 15 years in the Community.  

The  application  for  a  simplified  registration  procedure  should  thus  be  accompanied  by 
bibliographical  or  expert  evidence  to  the  effect  that  the  medicinal  product  in  question  or  a 
corresponding  product  has  been  in  medicinal  use  the  relevant  period.  With  regard  to  the 
manufacturing  of  these  products  and  their  quality,  applications  have  to  fulfil  the  same 
requirements as applications for a marketing authorisation. However, a long tradition of use 
may remove the need for clinical data, if the efficacy of the medicinal product is plausible on 
the  basis  of  its  long-standing  use  and  experience  as  testified  by  bibliographic  or  expert 
evidence.  

Applicants must substantiate the safety of the medicinal product by means of a bibliographic 
review of safety data together with an expert report, complemented by any necessary data that 
the Member State’s competent authority may request.  

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Claimed indications must be exclusively appropriate to traditional herbal medicinal products 
that, by virtue of their composition and purpose, are intended and designed for use without the 
supervision  of  a  medical  practitioner  for  diagnostic  purposes,  for  prescription  or  for  the 
monitoring of treatment. 

In view of the particularities of herbal medicinal products, a Committee for Herbal Medicinal 
Products (HMPC) has been established at the EMEA.  

With  a  view  to  further  facilitating  the  registration  of  certain  traditional  herbal  medicinal 
products in the EU, a list of herbal substances, preparations and combinations of these for use 
in  traditional  herbal  medicinal  products  will  be  established  by  the  Commission  following  a 
proposal by the HMPC. In order to promote harmonisation, Member States will recognise the 
registration of traditional herbal medicinal products based on Community monographs.  

For  the  application  of  both  the  traditional-use  and  the  well-established  use  provisions, 
Community herbal monographs will also be established by the HMPC to serve as a basis for 
simplified registration or bibliographical marketing authorisation applications.  

When  this  new  simplified  registration  procedure  was  introduced,  it  seemed  appropriate  to 
limit  its  scope  in  a  first  step  to  traditional  herbal  medicinal  products.  It  also  seemed 
appropriate to evaluate in due course the application of this new procedure, together with an 
assessment  of  the  possible  extension  of  the  scope  of  traditional-use  registration  to  other 
categories of medicinal products. 

2. 

EXPERIENCE ACQUIRED WITH THE SIMPLIFIED REGISTRATION PROCEDURE 

2.1. 

Transposition of Directive 2001/83/EC 

Directive  2004/24/EC  had  to  be  transposed  by  30  October  2005.  By  10  March  2008,  it  had 
been  fully  transposed  in  25  Member  States.  Two  Member  States  have  still  not  transposed 
Directive  2004/24/EC  and  infringement  procedures  have  been  initiated  by  the  European 
Commission.  

2.2. 

Applications in Member States 

On 30 June 2007, 110 applications had been introduced in 17 Member States. The number of 
applications is very unevenly distributed, with more than 20 applications having been made in 
some Member States. In most Member States, however, no or very few applications have so 
far been introduced. A total of 23 applications have been finalised.  

2.3. 

Referrals to the HMPC 

Directive  2004/24/EC  amending  Directive  2001/83/EC  introduced  several  provisions 
allowing referral to the HMPC for an opinion on certain matters relating to herbal medicinal 
products.  Up  to  March  2008,  one  referral  had  been  made  to  the  HMPC  under  Article 
16c(1)(c).  

2.4. 

Herbal Medicinal Products Committee (HMPC) 

The  HMPC  was  established  in  2004  and  has  held  regular  meetings.  It  has  also  established 
temporary working parties and developed a number of guidance documents.  

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22 monographs have been adopted and published and another 17 are in public consultation. 
According to the HMPC, the full application of the Directive would require the publication of 
approximately 200-300 monographs.  

Two draft entries for the list have been proposed by the HMPC to the Commission so far. 

In its contribution to the European Commission for the preparation of this report, the HMPC 
stated  that  drafting  proposals  for  entries  in  the  Community  list  or  Community  monographs 
required significant resources. Moreover, the monographs adopted by the HMPC need to be 
periodically updated. The HMPC has stated that it does not have sufficient resources to carry 
out these tasks. 

2.5. 

Genotoxicity data issue 

Under  Article  16c(1)(d)  of  Directive  2001/83/EC,  an  application  for  simplified  registration 
must be accompanied by a bibliographic review of safety data together with an expert report. 
In  addition,  the  competent  authority  may  ask  for  any  further  data  necessary  to  assess  the 
safety of the medicinal products.  

The  introduction  of  the  simplified  registration  procedure  was  based  on  the  assumption  that 
safety and efficacy could be adequately substantiated by long-standing use without requiring 
additional  testing  and  systematic  documentation  on  all  points  of  Annex  I  of  Directive 
2001/83/EC  regarding  safety.  If  an  application  relates  to  a  herbal  substance,  preparation  or 
combination  contained  in  the  list,  the  safety  data  do  not  need  to  be  provided  and  the 
competent authority cannot ask for additional data. 

In  its  guideline  on  non-clinical  documentation  for  herbal  medicinal  products  in  applications 
for a marketing authorisation (bibliographical and mixed applications) and in applications for 
simplified  registrations,  the  HMPC  is  of  the  view  that  the  genotoxic  potential  of  herbal 
preparations  should  always  be  assessed.  The  guideline  further  states  that  genotoxic  data  are 
available  for  many  active  substances,  but  their  quality  is  often  inadequate  for  a  safety 
assessment.  When  such  an  assessment  cannot  be  made,  further  genotoxicity  testing  is  thus 
required. 

Similarly,  in  its  report,  the  HMPC  identified  major  issues  concerning  the  availability  and 
quality of genotoxicity data for herbal substances when developing the first series of draft list 
entries.  The  HMPC  is  of  the  view  that  if  relevant  questions  regarding  genotoxicity  data 
remain  unanswered,  even  after  a  comprehensive  literature  search  has  been  performed,  a 
positive  opinion  on  a  Community  list  entry  cannot  be  given.  In  order  to  obtain  these  data, 
further genotoxicity testing would have to be conducted.  

In  order  to  ensure  the  successful  application  of  the  Directive,  the  issues  relating  to 
genotoxicity demand careful scientific and legal consideration. As stated in the HMPC report, 
the  systematic  request  for  genotoxicity  data  has  made  the  proposal  of  list  entries  difficult 
since  these  data  are  generally  not  available.  It  has  probably  also  contributed  to  the  small 
number of applications received so far. Consequently, a request for genotoxicity data to assess 
traditional herbal medicinal products should be made on a case-by-case basis when there is a 
specific  concern  for  safety,  as  required  by  the  relevant  provisions  in  the  legislation.  This 
ensures  the  protection  of  public  health  while  allowing  the  registration  of  traditional  herbal 
medicinal  products.  A  more  restrictive  approach  would  create  the  risk  that  the  products 
concerned  will  end  up  being  marketed  under  another  classification  (and  not  as  medicinal 

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products),  without  the  necessary  quality,  safety  and  efficacy  controls  applicable  under 
pharmaceutical legislation.  

3. 

EXTENDING  TRADITIONAL-USE  REGISTRATION  TO  OTHER  CATEGORIES  OF 
MEDICINAL PRODUCTS 

3.1. 

Current situation 

Directive  2004/24/EC  was  intended  to  address  the  specific  situation  of  traditional  herbal 
medicinal  products.  In  order  to  gain  experience,  the  scope  of  the  Directive  was  deliberately 
limited  to  these  products.  However,  other  products  may  face  a  similar  situation  and  have  a 
long  tradition  as  medicinal  products  but  do  not  fulfil  the  requirements  for  a  full  marketing 
authorisation or a well-established use authorisation. This applies to several traditional forms 
of medicine, which include, for example, the following: 

Anthroposophic  medicine  has  been  established  in  Europe  since  1920.  It  is  practised  in 
Germany, the Netherlands, the UK, Italy, Spain, Poland and France, among others. It follows 
a  global  therapeutic  approach  that  embraces  the  individual  as  a  whole  taking  into 
consideration  both  the  personality  and  the  body.  Anthroposophic  products  are  designed  to 
stimulate the patient’s powers of self-healing and use mineral, vegetable, metal and animal-
based raw materials. They can be used in every form of dosage and administration, including 
the external, internal and parenteral routes.1 

Traditional  medicines  from  other  parts  of  the  world  include  Ayurveda  (traditional  Indian 
medicine)  and  Chinese  traditional  medicine.  These  systems  of  medicine  have  existed  for 
centuries  in  other  parts  of  the  world  and  have  their  own  specific  remedies.  Some  of  these 
remedies  could  qualify  as  traditional  herbal  medicinal  products,  but  other  traditional 
medicinal products do not qualify for the simplified registration procedure. 

Ayurveda  literally  means  ‘science  of  life’  in  Sanskrit.  It  is  not  only  a  medical  system  but  a 
way of life that aims for the holistic management of health and diseases. Ayurvedic medicinal 
products  include  ingredients  of  plant,  animal  and  mineral  origin.  Most  contain  only  herbal 
ingredients. The substances included in the products are described in the monographs of the 
Ayurveda Pharmacopoeia. 2  

A  variety  of  dosage  forms  and  presentations  of  Ayurvedic  formulations  are  used,  ranging 
from food-like presentations to pharmaceutical forms. There is no significant use of parenteral 
formulations, with non-invasive techniques predominating. 

Within  the  Ayurvedic  tradition,  no  particular  distinction  is  made  as  regards  the  legal 
classification (prescription or non-prescription) of products. They are typically prescribed by 
practitioners  following  examination  and  diagnosis  of  the  patient  and  their  administration  is 
followed up throughout use, normally in healthcare settings. 

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Anthroposophic Medicines, their origin, production and application, Medical section of the School of 
Spiritual  Science,  4143  Dornach,  Switzerland.  Anthroposophic  Pharmaceutical  Codex,  APC,  The 
International Association of Anthroposophic Pharmacists, Dornach, Switzerland, 11.2007, available at 
http://www.iaap.org.uk/downloads/codex.pdf, 4.12.07. 
Mission Report, Fact-Finding Mission of the European Commission to India 15-18 January 2007. 

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Traditional Chinese medicine theory asserts that processes of the human body are interrelated 
and  in  constant  interaction  with  the  environment.  It  is  largely  based  on  the  philosophical 
concept  that  the  human  body  is  a  small  universe  with  a  set  of  complete  and  sophisticated 
interconnected systems. Traditional Chinese medicinal products, which can also take the form 
of  injections,  are  often  combined  products  of  herbal  origin  but  also  may  contain  animal, 
mineral and metal ingredients.3  

The  major  reasons  why  the  above  products  may  not  be  able  to  obtain  a  marketing 
authorisation or a simplified registration under the current Community legal framework are as 
follows: 

–  Composition of the product  

Directive  2001/83/EC  requires  traditional  herbal  medicinal  products  to  be  composed 
exclusively of herbal substances or preparations, with the exception of vitamins and minerals 
having an ancillary action. Some traditional products are mostly but not exclusively composed 
of  herbal  substances.  They  may  also  include  mineral  components,  animal  products,  metal 
products or herbal constituents.  

–  Route of administration  

Traditional  herbal  medicinal  products  must  be  administrated  orally,  externally  or  via 
inhalation. According to the public statement of the HMPC on the interpretation of the term 
‘external use’ for use in the field of traditional herbal medicinal products, the term ‘external’ 
means mainly application on the skin, but includes topical, oral, nasal, rectal, vaginal, ocular 
or auricular use. The route of administration for certain medicinal products in other traditions 
can also be by injection.  

–  Unsupervised use and indications  

According  to  Directive  2004/24/EC,  traditional  herbal  medicinal  products  must  be  intended 
and  designed  for  use  without  the  supervision  of  a  medical  practitioner.  This  would  cover 
minor disorders or symptoms that are benign. However, some traditional medicinal products 
do not fulfil these criteria and are not suitable for administration without the supervision of a 
qualified practitioner. Traditional medicinal products with therapeutic indications that involve 
diseases such as cancer, psychiatric diseases, infectious diseases such as hepatitis or influenza, 
cardiovascular  diseases  or  metabolic  diseases  such  as  diabetes  are  not  suitable  for 
administration without the supervision of a medical practitioner. In some traditions, moreover, 
the  therapy  is  integrated  within  a  global  approach  as  part  of  a  general  diagnosis  by  a  duly 
qualified  practitioner.  However,  this  does  not  necessarily  mean  that  certain  of  the  products 
used  could  not  be  considered,  under  Community  pharmaceutical  legislation,  as  non-
prescription products. 

–  Proof of traditional use in the Community  

The traditional use of traditional herbal medicinal products is demonstrated by bibliographic 
and  expert  evidence  that  the  medicinal  product  in  question  or  a  corresponding  product  has 

3 

International  traditional  Chinese  medicine  programme  for  cooperation  in  science  and  technology, 
Ministry of Science and Technology, People’s Republic of China and various contacts with the Chinese 
delegation and Chinese medicine practitioners. 

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been  in  medicinal  use  throughout  a  period  of  at  least  30  years,  including  at  least  15  years 
within  the  Community.  The  rationale  behind  this  requirement  is  the  difficulty  of  verifying 
whether  information  on  use  outside  the  Community  provides  a  reliable  basis  to  assess  the 
efficacy and, especially, safety of a product. However, it is difficult for traditional medicinal 
products from other parts of the world to meet the requirement of at least 15 years use within 
the Community. In such cases, the product must be referred to the HMPC for an opinion to 
assess whether all the other conditions for simplified registration as set out in Article 16a of 
Directive 2001/83/EC are met. This situation can prevent access to the European market for 
some traditional herbal medicinal products from third countries.  

3.2. 

Extending the scope of the simplified registration procedure 

The  rationale  behind  the  current  simplified  registration  procedure  is  to  enable  products  that 
have  been  in  long-standing  traditional  medicinal  use  to  be  registered  under  a  simplified 
procedure because their safety and efficacy can be deduced from their long-standing use 
under  the  specified  conditions  of  use.  The  vast  majority  of  medicinal  products  with  a 
sufficiently  long  and  coherent  tradition  are  based  on  herbal  substances.  It  therefore  seemed 
appropriate to limit the scope of the simplified registration in a first step to traditional herbal 
medicinal  products.  There  are  several  conditions  to  be  met  for  a  product  to  be  eligible  for 
registration. Taken together, these conditions guarantee that only traditional herbal medicinal 
products  have  access  to  the  simplified  registration  procedure,  where  it  is  appropriate  and 
justified  to  depart  from  the  strict  requirements  of  Chapter  I  of  Title  III  of  Directive 
2001/83/EC.  

The purpose of this report is to evaluate whether there are other medicinal products that could 
meet the conditions for simplified registration. In view of the different aspects noted above, 
the following conclusions can be drawn regarding the extension of scope: 

–  Composition of the product  

Registration of traditional use could be extended to encompass substances that are not herbal 
substances  or  herbal  preparations  but  which  also  have  a  long-standing  tradition  with  well-
documented  safety  and  plausible  evidence  of  efficacy  or  pharmacological  effects.  These 
substances  may  be  used  on  their  own  or  in  association  with  herbal  products.  They  may 
include  substances  of  animal,  mineral  or  metallic  origin  and  micro-organisms.  These 
substances should be assessed under the same conditions and procedures as herbal medicinal 
products and their long-standing use would be documented under the same conditions as for 
traditional  herbal  products.  As  already  provided  for  in  Directive  2004/24/EC,  in  order  to 
substantiate quality, the applicant would have to provide the same particulars and documents 
as  for  an  application  under  Chapter  I  of  Title  III  of  Directive  2001/83/EC,  including  the 
results of physico-chemical, biological or microbiological tests. In particular, for products of 
animal  origin,  the  relevant  provisions  of  Module  3  of  Directive  2003/63/EC  will  apply, 
including  specific  measures  for  the  prevention  of  the  transmission  of  animal  spongiform 
encephalopathy. For starting material  of animal origin, the history  and  origin of the starting 
material must be described and documented. 

As  already  provided  for  in  Directive  2004/24/EC,  where  the  safety  of  the  product  is 
concerned,  the  applicant  would  have  to  prove  a  well-documented  traditional  use  under  the 
existing rules with relevant proof of the product’s safety. In cases of doubt as to the safety of 
the  traditional  use,  additional  data  may  be  required  by  the  competent  authority  before  the 
simplified registration can be granted. 

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As already provided for in Directive 2004/24/EC, where efficacy is concerned, the applicant 
would  have  to  document  the  pharmacological  effects  or  the  plausibility  of  efficacy  on  the 
basis of long-term use and experience.  

–  Route of administration  

Traditional-use registration is limited to certain routes of administration because these are the 
safest  ways  of  administration.  In  addition,  since  the  simplified  registration  procedure  is 
intended  for  products  that,  by  virtue  of  their  purpose,  are  intended  to  be  used  without  the 
supervision of a medical practitioner, it is not appropriate to extend the procedure to include 
other routes that would generally require the supervision of a practitioner. Injection products 
should therefore continue to follow the normal marketing authorisation procedure.  

–  Unsupervised use and indications  

Since simplified registration does not require clinical trials of safety and efficacy, as a lighter 
procedure  compared  with  the  marketing  authorisation  procedure,  it  appears  appropriate  to 
limit  the  scope  of  simplified  registration  to  products  aimed  at  minor  diseases  that  can  be 
treated without the intervention of a practitioner.  

–  Proof of long-standing use in a third country 

In the simplified registration procedure, applicants need to prove that the medicinal product in 
question or a corresponding product has been in medicinal use throughout a period of at least 
30 years preceding the date of application, including at least 15 years within the Community. 
The requirement for at least 15 years traditional use in the Community was introduced as it 
was considered more difficult to gather information on the traditional use of a product from 
other  parts  of  the  world,  especially  data  on  safety,  since  pharmacovigilance  systems  vary 
widely  across  the  world.  However,  use  in  the  Community  may  be  accepted  for  this 
requirement if evidence can be supplied of the same use for which registration is sought even 
if this use was without registration or authorisation as a medicinal product.  

More experience with the requirement for at least 15 years use in the Community has to be 
gathered  with  a  view  to  assessing  its  necessity.  Pending  this  assessment  the  requirement 
should be maintained.  

–  Procedure 

The  current  procedure  for  assessment  of  traditional  medicinal  products  would  remain 
unchanged.  This  means  that  the  assessment  would  be  performed  by  the  national  competent 
authorities, which would have to evaluate whether all the conditions for simplified registration 
are  met,  including  documented  safe  use.  As  already  provided  for  in  Article  16c(1)(c)  of 
Directive  2001/83/EC,  referral  to  the  HMPC  for  an  opinion  on  the  adequacy  of  the  long-
standing  use  would  continue  to  be  an  option.  Extending  the  scope  of  the  simplified 
registration procedure should thus not lead to an unduly high increase in the workload of the 
HMPC after an initial phase. 

3.3. 

Results of the public consultation 

A  draft  of  this  report  was  published  for  consultation  on  the  website  of  DG  Enterprise  and 
Industry’s Pharmaceuticals Unit on 30 May 2007. Comments on the document were invited 
by  10  August  2007.  During  the  consultation,  DG  ENTR  received  53  contributions.  A 

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summary of the responses was published on the pharmaceuticals website4. All the responses 
were carefully analysed and taken into consideration whenever possible.  

Most of the comments supported extending the scope of Directive 2004/24/EC based on the 
criterion  of  composition  as  proposed  in  the  draft  report.  However,  certain  respondents 
reported obstacles to the registration of products through the simplified registration procedure, 
linked  to  the  other  criteria  for  registration  or  to  implementation  issues.  The  specificity  of 
certain medical traditions as a whole was also raised as an issue in the consultation.  

4. 

SUMMARY AND CONCLUSION 

Directive  2004/24/EC  was  intended  to  address  the  specific  situation  of  medicinal  products 
that,  despite  their  long  tradition  of  use,  do  not  fulfil  the  requirements  for  a  marketing 
authorisation  as  set  out  in  the  Community  pharmaceutical  legislation.  By  introducing  a 
simplified  registration  procedure  with  specific  requirements,  the  Directive  aimed  to  allow 
these  products  to  be  marketed  under  harmonised  conditions  and  to  ensure  the  protection  of 
public health by making such products subject to the necessary guarantees of quality, safety 
and efficacy. During the public consultation on the draft of this report, numerous supportive 
views were expressed on the setting of harmonised safety standards for traditional products. 

During  the  public  consultation,  some  stakeholders  referred  to  the  experience  with  the 
application of the requirements of the simplified registration procedure. In particular, the issue 
of genotoxicity data needs careful consideration from a scientific and legal point of view. The 
requirement  for  genotoxicity  data  should  be  considered  on  a  case  by  case  basis  in  the 
framework  of  the  simplified  registration,  because  wrong  interpretation  of  the  legal 
requirements  could  possibly  lead  to  the  marketing  of  some  products  under  another 
qualification  that  would  not  necessarily  offer  the  same  guarantees  of  quality,  safety  and 
efficacy. Such a result would be contrary to the public health and harmonisation objectives of 
Directive 2001/83/EC and Directive 2004/24/EC. In order to overcome this difficulty, a case-
by-case decision, where specific concerns about safety exist, appears to be a proportionate and 
balanced approach and in line with the objectives of the Directive. 

As regards the possible extension of the scope of the Directive, any such extension should be 
in  line  with  the  objectives  of  Directive  2004/24/EC,  i.e.  to  have  harmonised  rules  for  the 
placing on the market of certain medicinal products with a long tradition of use but which do 
not  generally  satisfy  the  requirements  for  marketing  authorisation,  while  ensuring  the 
protection  of  public  health  by  introducing  specific  requirements  for  proof  of  quality,  safety 
and efficacy.  

In  this  regard,  the  European  Commission  is  prepared  to  consider  extending  the  simplified 
registration  procedure  to  products  other  than  herbal  substances  with  a  long  tradition  of  safe 
use. This proposal received general support during the public consultation on the draft of this 
report. On the other hand, the key requirements of the simplified registration procedure, based 
on  public  health  considerations,  such  as  the  limitation  to  products  with  15  years  use  in  the 
Community,  to  certain  routes  of  administration  and  to  products  that  do  not  need  the 
supervision  of  a  medical  practitioner,  should  be  maintained.  For  certain  requirements,  more 
experience is needed before any change to the system can be proposed.  

4 

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The proposed extension would enable certain medicinal products from specific European or 
non-European  medicine  systems  (such  as  —  in  alphabetical  order  —  anthroposophic, 
Ayurvedic,  Chinese,  Kampo  Korean,  Mongolian,  Thai,  Tibetan  Unani,  or  Vietnamese 
medicine),  as  well  as  traditional  products  with  a  long-standing  tradition  in  the  European 
Union  (such  as  honey,  royal  jelly,  propolis,  fish  oils,  minerals,  micro-organisms  and  other 
substances) to be eligible for the simplified registration procedure with a view to placing them 
on the market as traditional medicinal products.  

Many of these products are present in the Community market, and their inclusion under the 
simplified  registration  procedure  will  introduce  harmonisation  in  a  sector  where  differences 
currently exist between Member States as regards classification and placing on the market and 
will  increase  the  protection  of  public  health  since  the  quality,  safety  and  efficacy  of  the 
products concerned will be assessed during the simplified registration procedure.  

On  the  other  hand,  it  should  be  emphasised  that  Community  legislation  on  medicinal 
products, in particular Directive 2001/83/EC laying down the procedures for placing products 
on  the  market,  follows  a  product-specific  approach  and  does  not  attempt  to  provide  a 
framework for the regulation of traditions of medical practice. 

During the public consultation, proponents of three traditional medical systems using products 
with  a  long-standing  tradition  expressed  support  for  the  global  regulation  of  their  traditions 
within the EU: anthroposophic, Ayurvedic and traditional Chinese medicine. It was suggested 
that  proof  of  the  plausibility  of  efficacy  should  not  be  by  medicinal  product,  but  by 
therapeutic approach.  

Medical traditions such as those mentioned above are based on a holistic approach, and the set 
of  requirements  for  the  simplified  registration  procedure  under  Directive  2004/24/EC  is  not 
appropriate for a global regulation of such medical practices. The regulation of such traditions 
would demand a different approach from that introduced by Directive 2004/24/EC. Therefore, 
the  Commission  does  not  envisage  extending  the  scope  of  the  simplified  registration 
procedure  to  cover  traditional  medical  systems  as  such.  Nevertheless,  independently  of  this 
report, the suitability of a separate legal framework for products of certain traditions should be 
assessed.  

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