Amended proposal for a Directive of the European Parliament and of the Council amending the Directive 2001/83/EC as regards traditional herbal medicinal products (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)
Date: 2003-04-09
Institutions: European Commission
Subjects: health policy, medical plant, medicinal product, pharmaceutical legislation, public health, single market

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 9.4.2003
COM(2003) 161 final

2002/0008 (COD)

Amended proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending the Directive 2001/83/EC as regards traditional herbal medicinal products

(presented by the Commission pursuant to Article 250 (2) of the EC Treaty)

2002/0008 (COD)

Amended proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending the Directive 2001/83/EC as regards traditional herbal medicinal products

(Text with EEA relevance)

1. 

BACKGROUND

Transmission of the proposal to the Council and to the European Parliament
- COM(2002) 1 final – 2002/0008 (COD) -
by virtue of article 175, paragraph 1 of the Treaty:

17 January 2002

Opinion of the European Economic and Social Committee:

18 September 2002

Opinion of the European Parliament – first reading:

21 November 2002

2. 

OBJECTIVE OF THE COMMISSON PROPOSAL

The  proposal  aims  to  guarantee  a  high  level  of  health  protection  for  European  patients  by
giving  them  access  to  medicines  of  their  choice,  provided  all  the  necessary  safeguards  are
met. It will also ensure a single market for herbal medicines by introducing harmonised rules
and procedures and  encourage  cross-border  trade  in these products, which  at the moment is
very limited. The proposal provides for a simplified registration system for traditional herbal
products. The quality requirements, which will have to be met, are the same as those for all
medicinal  products.  But  to  avoid  unnecessary  testing  and  burdens  on  firms,  the  legislation
foresees  that  new  pre-clinical  and  clinical  trials  will  not  be  necessary  when  sufficient
knowledge already exists about a particular product.

3. 

OPINION OF THE COMMISSION ON THE AMENDMENTS ADOPTED BY
THE PARLIAMENT

The  European  Parliament  adopted  27  amendments  in  total,  out  of  which  the  modified
proposal incorporates one plus parts of a second amendment without any change and thirteen
plus  parts  of  three  further  amendments  in  principle,  while  ten  plus  parts  of  two  further
amendments are rejected.

3.1. 

Amendments accepted by the Commission: 3 (2nd sentence) and 26.

The  Commission  can  accept  the  following  amendments  with  the  wording  proposed  by  the
European Parliament.

–  The  2nd  sentence  of  amendment  3,  which  deletes  in  the  recital  on  the  recognition  of
decisions taken by other Member States the possibility to refuse this recognition in case of
major objections of public health.

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“Recital 11, 2nd sentence:

In  cases  where  the  authorisation  or  registration  refers  to  a  herbal  medicinal  product  for
which a monograph has been established under this Directive, it should be recognised.”

–  The  amendment  26,  which  stipulates  that  the  Commission  shall  present  its  report  on  the
functioning of the new procedure within three  years after  the entry into  force  of  the  new
directive:

“Article 16i, subparagraph 1:

Not later than three years after the date of entry into force of this Directive, the Commission
shall present a report to the European Parliament and the Council concerning the application
of the provisions of this chapter.”

3.2. 

Amendments accepted in principle by the Commission: 2, 3 (1st sentence), 5, 8,
12 (2nd and 3rd part), 14, 15 (reference to specified daily doses), 16, 17, 18, 19, 20,
21, 22, 23 and 24

–  The Commission can accept in principle amendment 2 and the first part of amendment 20
aiming  at  extending  the  responsibilities  of  the  new  Committee  for  Herbal  Medicinal
Products. It is acceptable to extend the new committee’s responsibilities to issues regarding
national  authorisations  and  registrations  of  herbal  medicinal  products,  including  in
particular  the  referral/arbitration  procedure  for  such  products.  However,  a  rewording  is
needed  since  the  new  committee  should  not  take  over  responsibilities  for  the  centralised
procedure,  which  is  of  little  relevance  for  the  herbal  medicines  and  for  which  full
coherence  needs  to  be  guaranteed  by  the  existing  committee.  For  medicinal  products,
which  contain  herbal  ingredients  without  fulfilling  the  definition  of  a  herbal  medicinal
product,  the  new  Committee  for  Herbal  Medicinal  Product  should  be  entitled  to  give  an
opinion  on  the  herbal  ingredients  to  be  considered  when  deciding  on  the  product  in  its
entirety.

“Recital 9:

Having  regard  to  the  particularities  of  herbal  medicinal  products,  a  Committee  for  Herbal
Medicinal Products should be established within the European Agency for the Evaluation of
Medicinal Products set up by Council Regulation [(EEC) No 2309/93 of 22 July 1993 laying
down Community procedures for the authorisation and supervision of medicinal products for
human  and  veterinary  use  and  establishing  a  European  Agency  for  the  Evaluation  of
Medicinal Products] 10 (hereinafter: the Agency). The Committee should take over the tasks
of the Committee for Human Medicinal Products (CPMP) with regard to authorisations or
registrations of herbal medicinal products by the Member States; its tasks should relate in
particular to establishing Community herbal monographs relevant for the registration as well
as  the  authorisation  of  herbal  medicinal  products.  It  should  be  composed  of  experts  in  the
field of herbal medicinal products.

Article 16h, paragraph 1, subparagraphs 1 to 3:

A Committee for Herbal Medicinal Products is hereby established. That Committee shall be
part of the Agency.

The Committee for Herbal Medicinal Products shall take over the tasks of the Committee
for Human  Medicinal Products with  regard to authorisations  or  registrations  by  Member

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States of herbal medicinal products.

Where  other  medicinal  products  containing  herbal  substances  are  referred  to  the  Agency
under  Chapter  4  of  Title  III,  the  Committee  for  Herbal  Medicinal  Products  shall,  where
appropriate, give an opinion on the herbal substance.”

–  The Commission can accept in principle the 1st sentence of amendment 3 and amendment
14,  that  provide  for  an  obligation  of  Member  States  to  recognise  decisions  by  other
Member  States  instead  of  a  mere  obligation  to  take  due  account  of  such  decisions.  A
rewording is necessary however since the obligation to recognise authorisations is already
foreseen in the existing legislation and the obligation to recognise registrations should be
limited  to  those  granted  on  the  basis  of  the  new  directive.  In  addition,  to  ensure  the
functioning of such recognition, the necessary procedural provisions need to apply. These
provisions  however  can  apply  only  “by  analogy”  inasmuch  as  the  mutual  recognition  of
simplified registrations is based on different dossiers than that of regular authorisations.

“Recital 11, 1st sentence:

When deciding upon an application for registration of a traditional herbal medicinal product,
the Member State concerned should be obliged to recognise registrations previously granted
by another Member State for that product on the basis of the provisions of this chapter.

Article 16d:

Without  prejudice  to  Article  16h(1),  Chapter  4  of  Title  III  shall  apply  by  analogy  to
registrations granted in accordance with Article 16a.”

–  The Commission can accept in principle amendment 5 and the 2nd part of amendment 12
that shall extend the simplified registration procedure to those medicinal products, which
contain apart from herbal substance(s) in addition other non-herbal ingredients. However, a
rewording  of  Article  1,  paragraph  1  is  needed  to  render  more  precisely  that  such
combination  product  may  contain  in  particular  vitamins  or  minerals,  but  also  other  non-
biological substances for which there is well document evidence for its safety. In addition,
in  all  combination  products  the  action  of  the  non-herbal  substances  must  be  ancillary  to
that of the herbal ingredients. Substances of a biological origin pose specific risks so that
the regular procedure with the full scientific data has to be maintained to safeguard public
health. In addition, the inclusion requires a change of Art. 1, paragraph 1 point 30 which
contains the definition of a herbal medicinal product and not of Art. 1, paragraph 1, point
29. Article 16c, paragraph 4 to the contrary does not need to be changed; the extension of
the simplified procedure to certain combination products flows already from the amended
Article  1,  paragraph  1  point  30,  read  together  with  the  concept  of  a  “corresponding
medicinal product” as referred to in Article 16c, paragraph 2.

“Article 1, paragraph 1, point 29:

Traditional herbal medicinal product:

a herbal medicinal product that fulfils the conditions laid down in Article 16a;

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Article 1, paragraph 1, point 30:

Herbal medicinal product

any  medicinal  product,  containing  as  active  ingredients,  one  or  more  herbal  substances  or
one or more herbal preparations, or one or more such herbal substances in combination with
one  or  more  such  herbal  preparations;  in  addition,  the  product  may  contain  vitamins  or
minerals  or  other  non-biological  substances  for  which  there  is  well  documented  evidence
for its safety; the action of the non-herbal substances must be ancillary to that of the herbal
active ingredients.”

–  The  Commission  can  accept  in  principle  amendment  8  and  part  of  amendment  15
(reference  to  specified  daily  doses)  that  introduces  the  dosage  schedule.  However,  the
current term “specified strength” relates to the dose and hence needs to  be maintained  in
parallel to the dosage schedule. In addition, “specified daily doses” should be replaced by
the general term “posology”, which means the dosage schedule, be it a daily schedule or
other.

“Article 16a, point b:

they are exclusively for administration in accordance with a specified strength and posology;

Article 16f, paragraph 1:

The Committee referred to in Article 16h shall set up a list of herbal substances. The list shall
contain  with  regard  to  each  herbal  substance  the  therapeutic  indication,  the  specified
strength and the posology, the route of administration and any other information necessary
for the safe use of the herbal substance.”

–  The  Commission  can  accept  in  principle  the  3rd  part  of  amendment  12  (reference  to  the
minimum time of use) that reduces the minimum time of use within the Community from
15 to 10 years. However, with regard to the directive’s key objectives to safeguard public
health while promoting the free movement of herbal medicines, it is preferable to maintain
as a rule the  requirement of 30  years in  total and at least  15  years  in the Community.  In
order  to  assess  whether  for  a  particular  product  an  exception  from  this  rule  can  be
accepted, the product should be referred to the new committee for herbal medicines at the
EMEA. The committee could be empowered to analyse whether the available information
on at least 30 years of use is sufficient, even if the minimum time of use is less than 15 or
even 10  years. For reasons of clarity, the rule of 30/15  years should be moved  to  Article
16c, paragraph 1, point (c). This requires the following rewording and alignment:

“Article 16c, paragraph 1, point (c):

bibliographical or expert evidence to the effect that the  medicinal product in  question, or a
corresponding medicinal product has been  in  medicinal use  throughout a period  of  at  least
thirty years, including at least 15 years within the Community;

Article 16c, paragraph 4:

If the product has been available within the Community for less than 15 years, the Member
State where the application for traditional use registration has been lodged shall refer the
product  to  the  Committee  for  Herbal  Medicinal  Products.  The  Committee  shall  analyse
whether  the  other  criteria  for  a  simplified  registration  as  referred  to  in  Article  16a  are

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fulfilled. On this basis, the Committee shall establish a Community herbal  monograph as
referred  to  in  Article  16h(3)  on  whose  basis  the  Member  State  shall  grant  or  refuse  the
registration.”

–  The Commission can accept in principle the amendment 16 regarding particularities of the
labelling  and  user  package  leaflets  of  traditional  herbal  medicines.  A  rewording  is
necessary though to ensure that it is clear from the labelling and the leaflet that safety and
efficacy are based on information on the traditional use without the regular scientific data.
In addition, a clarification is needed that the product could be registered for more than one
specified indication.

“Article 16g, paragraph 2, point a:

is  a  herbal  medicinal  product 

the  product 
in  a  specified
indication/specified  indications  and  that  the  safety  and  efficacy  of  the  product  rely
exclusively on information obtained from its long-term use and experience; and”.

traditional  use 

for 

–  The Commission can accept in principle the amendment 17, which extends the warning to
consult  a  doctor  or  a  qualified  practitioner  to  situations  where  adverse  reactions  occur.
However, it should be reworded inasmuch the wording needs to take into account that the
patient often will not be able to decide whether an adverse reaction is “serious” or not. To
the  contrary,  the  patient  will  be  able  to  decide  whether  or  not  the  adverse  reaction  is
mentioned in the package leaflet:

“Article 16g, paragraph 2, point b:

the user should consult a doctor or a qualified practitioner if the symptoms persist during the
use of the medicinal product or should adverse effects not mentioned in the package leaflet
occur.”

–  The  Commission  can  accept  in  principle  the  amendment  18  according  to  which  the
labelling  and  user  package  leaflets  of  traditional  herbal  medicines  shall  point  to  possible
dangerous  interactions  with  food  and/or  medicinal  products.  However,  such  obligation
follows already from Article 16g, paragraph 2 read together with Article 59, paragraph 1,
point c. The additional reference in Article 16g is redundant therefore.

–  The  Commission  can  accept  in  principle  the  amendment  19  regarding  advertising  for
traditional herbal medicines. A rewording is necessary though to align this provision with
Article 16g, paragraph 2, point a as changed in response to amendment 16.

“Article 16g, paragraph 3:

In addition to the provisions laid down in Articles 86 to 99 any advertisement for a medicinal
product registered under this chapter shall contain the following  statement: ‘the  safety and
efficacy of the product rely exclusively on information obtained from its long-term use and
experience’”.

–  The Commission can in principle accept the 2nd part of amendment 20, which provides for
an obligation of the Executive Director of the European Medicines Evaluation Agency to
ensure the  co-ordination  between the  new  Committee for Herbal Medicinal Products  and
the existing Committee for Human Medicinal Products. However, a rewording is necessary
to  refer  to  the  legal  tools  available  to  the  Executive  Directives.  In  fact,  the  provision  of
Article  16h,  paragraph  3,  second  sentence  can  be  used  for  this  purpose,  which  provide

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already  for  some  co-ordination  by  the  Executive  Director,  even  in  a  more  restricted
context.  Article  16h,  paragraph  3  hence  needs  to  be  aligned  to  avoid  unnecessary
repetition:

“Article 16h, paragraph 1, subparagraph 4:

The appropriate co-ordination with the Committee for Human Medicinal Products shall be
ensured  by  a  procedure  to  set  up  by  the  Executive  Director  of  the  Agency  according  to
Article 55(2) of Regulation 2309/93.”

Article 16h, paragraph 3, subparagraph 1:

The Committee shall establish Community herbal monographs for herbal medicinal products
with  regard  to  the  application  of  Article [10a]  [10(1)(a)(ii)]  as  well  as  traditional  herbal
medicinal  products.  The  Committee  shall  fulfil  further  responsibilities  conferred  upon  it  by
provisions of this chapter and other Community law.”

–  The  Commission  can  accept  in  principle  the  amendment  21  aiming  to  ensure  that  the
experts of the various backgrounds are represented in the Committee for Herbal Medicinal
Products. However, a rewording is  necessary to  align the  composition of this  Committee
and  the  procedure  to  nominate  its  members  with  that  proposed  for  the  other  scientific
committees at the EMEA.

“Article 16h, paragraph 2:

With  a  view  to  the  appointment  of  the  members  of  the  Committee  for  Herbal  Medicinal
Products,  each  Member  State  shall  propose  at  least  five  persons  selected  on  the  basis  of
their role and their experience in the evaluation of herbal medicinal products.

On  the  basis  of  those  proposals  the  Executive  Director  shall  appoint  one  member  per
Member  State,  taking  into  account  the  need  for  the  committee  to  be  multidisciplinary  in
nature.  Those  members  shall  maintain  relevant  contacts  with  the  competent  national
authorities.

The  members  appointed  on  a  proposal  from  the  Member  States  may  propose  to  the
Executive  Director  (with  a  view  to  securing  their  appointment)  up  to  five  additional
members for the committee, chosen on the basis of their specific scientific competence.

The  members  of  the  committee  shall  be  appointed  for  a  three-year  period  which  shall  be
renewable.

Wherever possible, the committee shall seek to establish contacts, on an advisory basis, with
associations of people affected, patients and people working in the sector.”

–  The  Commission  can  accept  in  principle  the  amendment  22  that  shall  allow  the  use  of
monographs, publications or data in the simplified procedure, even if not established by the
Committee  for  Herbal  Medicinal  Products.  A  rewording  is  necessary  to  clarify  that  such
information shall be used only where the Committee for Herbal Medicinal Products has not
yet established specific monographs.

“Article 16h, paragraph 3, subparagraph 2:

When  Community  herbal  monographs  in  the  sense  of  this  paragraph  have  been  established
they  shall  be  used  as  the  basis  for  any  application.  Where  no  such  Community  herbal
monograph has  yet  been established, other  appropriate monographs,  publications  or  data

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may be referred to.”

–  The  Commission  can  accept  in  principle  the  amendment  23  according  to  which  the
provisions on pharmacovigilance of Directive 2001/83/EC shall apply to traditional herbal
medicines.  However,  such  obligation follows already from Article 16g,  paragraph  2  read
together with Article 101. The additional reference in Article 16h is redundant therefore.

–  The  Commission  can  accept  in  principle  the  amendment  24  according  to  which  the
provisions  on  good  manufacturing  practice  of  Directive  2001/83/EC  shall  apply  to
traditional herbal  medicines.  However, such obligation  follows already from  Article  16g,
paragraph  2  read  together  with  Articles  40  ff.  The  additional  reference  in  Article  16h  is
redundant therefore.

3.3. 

Amendments not accepted by the Commission: 1, 4, 6, 7, 9, 10, 11, 12 (1st part),
13, 15 (apart from reference to specified daily doses), 25 and 27.

–  The  Commission  cannot  accept  amendment  1  that  would  allow  Member  States  having  a
tradition of use of herbal medicinal products from outside the Community to register such
products regardless of  the time  of use  within  the  Community  where  valid  evidence  from
outside the Community exists. Generally, the minimum time of use within the Community
is therefore indispensable to exempt the products from the  regular  requirement to submit
scientific data on safety and  efficacy. An  exception  is acceptable  only  on the basis of  an
assessment by new Committee for Herbal Medicinal Products has assessed on a European
level as explained in the response to the 3rd part of amendment 12.

–  The  Commission  cannot  accept  amendment  4  obliging  the  Commission  to  present  a
legislative  proposal  on  traditional  herbal  medicines  for  veterinary  use  by  2006.  This
commitment  would  undermine  the  Commission’s  right  of  initiative.  In  addition,  the
experience  with  the  simplified  procedure  has  to  be  evaluated  before  it  can  be  evaluated
whether such an extension is appropriate.

–  The  Commission  cannot  accept  amendment  6  on  the  definition  of  a  herbal  medicinal
product.  The  definition  contained  in  the  Commission’s  proposal  is  identical  with  the
scientific  definition  of  herbal  medicinal  products  agreed  within  the  Council  of  Europe
(European  Pharmacopoeia).  There  is  no  reason  to  deviate  from  this  agreed  scientific
definition, which in addition is already used in some national legal systems. Regarding the
reference  to  « pharmacologically  active  levels »,  the  distinction  between  a  medicinal
product  and  other  categories  of  products  (like  food  supplements)  is  laid  down  in  Art. 1
point  1  (in  the  version  proposed  by  Commission  proposal  COM(2001)  404  final  –  the
« Review  2001 »).  The  reference  to  pharmacological  activity  is  part  of  that  general
definition  of a  medicinal  product  and  should  not  be  repeated  in  the  separate  proposal  on
traditional herbal medicinal products.

–  The  Commission  cannot  accept  amendment  7  regarding  the  therapeutic  indications,  for
which a product could be registered under the new simplified procedure by referring to its
classification  as  “non-prescription”  medicine.  The  classification  of  a  medicine  is  the
outcome  of  the  assessment  procedure  and  cannot  serve  as  a  criterion  for  validating  the
application. In addition, the current wording goes beyond the proposed amendment since
the indication must be « adapted to a traditional herbal medicinal product » and « by virtue
of  its  composition  and  purpose »  it  shall  be  « intended  and  designed  for  use  without
intervention of a medical practitioner » for certain purposes.

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–  The Commission cannot  accept amendment 9,  amendment  11,  the  1st  part  of  amendment
12  introducing  a  reference  to  the  pharmacological  activity  of  the  herbal  ingredients
contained  in  the  traditional  herbal  medicinal  product.  The  reasoning  is  the  same  like  for
amendment 6. The proposed reference to herbal substances, herbal  preparations or active
ingredients  is  covered  by  the  concept  of  a  corresponding  medicinal  product  contained
already in the proposal and therefore redundant. For the same reason, amendment 13 is not
acceptable  that  refers  to  such  herbal  products  containing  herbal  ingredients  below
pharmacological level.

–  The Commission cannot accept  amendment  10  regarding  the  data  to  be  submitted  by  the
applicant. Article 16c, paragraph 1, point d is dealing only with the product’s safety so that
a reference to the therapeutic utility is not appropriate.

–  The Commission cannot accept amendment 15 (apart from the reference to specified daily
doses) according to which the Committee for Herbal Medicinal Products should draw up a
classification  of  herbal  medicinal  products.  Such  a  provision  is  redundant  since  the
Committee  will  have  to  determine  whether  a  particular  product  fulfils  the  criteria  for  an
authorisation based on well-established medicinal use or for a simplified registration based
on traditional use anyway when establishing the lists and monographs foreseen by the new
Directive. Further categories of herbal medicinal products are not foreseen by the current
law.

–  The Commission cannot accept amendment 25 that excludes certain categories of products
from the scope of the new Directive. As far as these products do not fulfil the definition of
a medicinal product as contained in Article 1, paragraph 1 of Directive 2001/83/EC, they
are  automatically  excluded  from  the  new  Directive  anyway.  Amendment  25  is  therefore
redundant.

–  The  Commission  cannot  accept  amendment  27  allowing  Member  States  to  introduce  or
retain specific national  laws  for traditional  medicines other than those  of  a  herbal  origin.
National  break-out  clauses  that  allow  Member  States  to  disregard  the  harmonisation  as
embodied  in  the  directive  are  not  acceptable  against  the  intention  to  contribute  to
completing  the  single  market.  Such  clauses  are  also  conflicting  with  the  objective
underlying several amendments to reinforce mutual recognition of simplified registrations.

4. 

MODIFIED PROPOSAL

In keeping with Article 250, paragraph 2, of the EC treaty, the Commission has modified its
proposal along the lines indicated.

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