Proposal for a Directive of the European Parliament and of the Council amending the Directive 2001/83/EC as regards traditional herbal medicinal products
Date: 2002-01-17
Institutions: European Commission
Subjects: approximation of laws, legal code, medicinal product, pharmaceutical legislation, public health, single market

28.5.2002

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Official Journal of the European Communities

C 126 E/263

Proposal for a Directive of the European Parliament and of the Council amending the Directive
2001/83/EC as regards traditional herbal medicinal products

(2002/C 126 E/03)

(Text with EEA relevance)

COM(2002) 1 final — 2002/0008(COD)

(Submitted by the Commission on 17 January 2002)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION

Having regard to the Treaty establishing the European
Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the Economic and Social
Committee,

Acting in accordance with the procedure laid down in Article
251 of the Treaty (1),

Whereas:

(1) Directive 2001/83/EC of the European Parliament and of
the Council of 6 November 2001 on the Community
code relating to medicinal products for human use (2)
requires that applications for the authorisation to place
a medicinal product on the market have to be accom-
panied
and
documents relating in particular to the results of physico-
chemical, biological or microbiological as well as phar-
macological and toxicological
trials
carried out on the product and thus proving its quality,
safety and efficacy.

tests and clinical

containing

particulars

dossier

by

a

(2) Where

the

applicant

to published scientific

can demonstrate by detailed
references
the
literature
constituent or the constituents of the medicinal product
have a well established medicinal use with recognised
efficacy and an acceptable level of safety in the sense of
Directive 2001/83/EC, he should not be required to
provide the results of pre-clinical tests or the results of
clinical trials.

that

products within the Community and lead to discrimi-
nation and distortion of competition between manu-
facturers of these products. They may also have impact
on the protection of public health since the necessary
guarantees of quality, safety and efficacy are not always
given at present.

(4) Having regard to the particular characteristics of these
medicinal products, especially their long tradition,
it is
desirable to provide a special,
simplified registration
procedure for certain traditional medicinal products.
this simplified procedure should be eligible
However,
only where no marketing authorisation under Directive
sufficient
2001/83/EC,
scientific
established
literature demonstrating a well
medicinal use with recognised efficacy and an acceptable
level of safety, can be obtained. It should likewise not
apply to homeopathic medicinal product eligible for a
marketing authorisation or
for a registration under
Directive 2001/83/EC.

in particular due to lack of

trials,

tests do not

insofar as the efficacy of

(5) The long tradition of the medicinal product enables to
renounce clinical
the
medicinal product is plausible on the basis of long-term
use and experience. Pre-clinical
seem
necessary, where the medicinal product on the basis of
the information on its traditional use proves not to be
harmful in specified conditions of use. However, even the
there may be
long tradition does not exclude that
concerns with regard to the product's safety, so that the
competent authorities should be entitled to ask for all data
necessary for assessing the safety. The quality aspect of
the medicinal product is independent of its traditional use
so that no derogation should be made with regard to the
necessary
and micro-
biological tests.

physico-chemical,

biological

(3) A significant number of medicinal products, despite their
long tradition, do not fulfil the requirements of a well
established medicinal use with recognised efficacy and
an acceptable level of safety and are not eligible for a
marketing authorisation. To maintain these products on
the market,
the Member States have enacted different
procedures and provisions. These differences currently
laid down in the
existing between the provisions
Member States may hinder trade in traditional medicinal

(1) OJ C 95, 30.3.1998, p. 1.
(2) OJ L 311, 28.11.2001, p. 67.

(6) The vast majority of medicinal products with a sufficiently
tradition are based on herbal
long and coherent
substances.
It therefore seems appropriate to limit the
scope of the simplified registration in a first step to tradi-
tional herbal medicinal products.

(7) The facilitated registration should be acceptable only
where the herbal medicinal product may rely on a
sufficiently long medicinal use
in the Community.
Medicinal use outside the Community should be taken
into account only,
the medicinal product has been
used within the Community for a certain time.

if

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(8) With the objective to further facilitate the registration of
certain traditional herbal medicinal products and to
further enhance harmonisation, there should be the possi-
bility to establish a Community list with herbal substances
that fulfil certain criteria, such as being in medicinal use
for a sufficiently long time, and hence do not seem
harmful in the normal conditions of use.

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 2001/83/EC is amended as follows:

for

(9) Having regard to the particularities of herbal medicinal
products, a specific committee 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
the authorisation and supervision of
medicinal products for human and veterinary use and
establishing a European Agency for the Evaluation of
Medicinal Products) (1)
the Agency). The
committee should be composed of experts in the field
of herbal medicinal products. Its tasks should relate in
particular to establishing Community herbal monographs
relevant for the registration as well as the authorisation of
herbal medicinal products.

(hereinafter:

(10) It is important to ensure full consistency between the new
committee and the committee for human medicinal
products already existing at the Agency, in particular in
case of a procedure regarding an application, which
concerns a herbal medicinal product and relies on
Directive 2001/83/EC, appropriate coordination between
the two committees should be ensured, relying on the
provisions of Article 55(2) of Regulation 2309/93.

(11) When deciding upon an application for registration of a
traditional herbal medicinal product, the Member State
concerned should be obliged to take due account of auth-
orisations or registrations previously granted by another
Member State for that product. In case where the author-
isation or registration refers to a herbal medicinal product
for which a monograph has been established under this
Directive, it should be recognised, unless there are major
objections of public health.

the

(12) The Commission should present
on
of

report on the
application
herbal
medicinal products to the European Parliament and to
the Council
including an assessment on the possible
extension of traditional use registration to other categories
of medicinal products.

a
traditional

chapter

1. In Article 1 the following points 29 to 32 are added:

‘29. Traditional herbal medicinal product:

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

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 prep-
arations;

31. Herbal substances:

all mainly whole, fragmented or cut plants, plant parts,
algae, fungi, lichen in an unprocessed, usually in dried
form but sometimes fresh. Certain exudates that have
not been subjected to a specific treatment are also
considered to be herbal substances. Herbal substances
are precisely defined by the plant part used and the
botanical name according to the binomial
system
(genus, species, variety and author);

32. Herbal preparations:

preparations obtained by subjecting herbal substances
to treatments such as extraction, distillation, expression,
fractionation, purification, concentration and fermen-
tation. These include comminuted or powdered herbal
substances, tinctures, extracts, essential oils, expressed
juices and processed exudates.’

2. The following new chapter 2a is inserted in title III.

‘Chapter 2a: Specific provisions applicable to traditional
herbal medicinal products

Article 16a

A simplified registration procedure (hereinafter “traditional
use registration”)
is hereby installed for herbal medicinal
products which fulfil the following criteria:

(13) It is therefore appropriate to amend Directive 2001/83/EC

accordingly,

(1) OJ L 214, 24.8.1993, p. 1, Regulation as last amended by
Commission Regulation (EC) No 649/1998 (OJ L 88, 24.3.1998,
p. 7).

its composition and purpose,

(a) they are indicated exclusively for indications adapted to
a traditional herbal medicinal product, which, by virtue
of
intended and
designed for use without the intervention of a medical
practitioner for diagnostic purposes or for prescription
or monitoring of treatment;

is

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(b) they are exclusively for administration in accordance

with a specified strength;

Community or a third country, and the reasons for
such a decision;

(c) they are an oral, external and/or inhalation preparation;

(d) the period of traditional use as stipulated in Article

16c(1)(c) has elapsed;

(e) the data on the traditional use of the medicinal product
is sufficient, in particular the product proves not to be
harmful in the specified conditions of use and the phar-
macological effects or efficacy of the medicinal product
long-term use and
are plausible on the basis of
experience.

However,
in cases where the competent authorities judge
the
that a traditional herbal medicinal product
criteria for an authorisation in accordance with Article 6
or a registration pursuant to Article 14, the provisions of
this chapter do not apply.

fulfils

Article 16b

(c) bibliographical or expert evidence to the effect that the
in question, or a corresponding
medicinal product
medicinal product has been in medicinal use in the
Community throughout a period of at
thirty
years preceding the date of application;

least

(d) a bibliographic review of safety data together with an
expert report, and where required by the competent
authority, upon justified request, data necessary for
assessing the safety of the medicinal product.

Annex I shall apply by analogy to the particulars and
documents specified in point (a).

2.
A corresponding medicinal product, as referred to in
paragraph 1(c), is characterised by having the same active
ingredients, irrespective of the excipients used, the same or
similar intended purpose, equivalent strength and the same
or similar route of administration as the medicinal product
applied for.

The applicant and registration holder shall be estab-

1.
lished in the Community.

2.
the
In order to obtain traditional use registration,
applicant shall submit an application to the competent
authority of the Member State concerned.

The requirement to show medicinal use throughout
3.
the period of thirty years, referred to in paragraph 1(c), is
satisfied even where the marketing of the product has not
been based on a specific authorisation. It is likewise satisfied
if the number or quantity of ingredients of the medicinal
product has been reduced during that period.

Article 16c

1.

The application shall be accompanied by:

(a) the particulars and documents:

If

the product has been available within the
4.
Community for at
the applicant may
least 15 years,
supply evidence of medicinal use throughout a period of
time, which completes the period of 30 years in a specified
territory or territories outside the Community.

Article 16d

(i) referred to in Article 8(3)(a) to (h), (j) and (k),

(ii) the results of pharmaceutical tests referred to in the

first indent of Article 8(3)(i),

When evaluating an application for traditional use regis-
tration, each Member State shall take due account of regis-
trations or authorisations granted by another Member State.

(iii) the summary of product characteristics without the

data specified in Article 11(4),

Article 16e

(iv) in case of a combination, as referred to in Article
1(30), the information data referred to in Article
16a(e) relating to the combination as such; if the
individual active ingredients are not sufficiently
known, the data need also relate to the individual
active ingredients;

(b) any authorisation or

registration obtained by the
in a third
applicant
country,
the medicinal product on the
market, and details of any decision to refuse to grant
in the
an authorisation or

in another Member State, or
to place

registration, whether

1.
the
Traditional use registration shall be refused if
application does not comply with Articles 16a, 16b or
16c or if at least one of the following conditions is fulfilled:

(a) the qualitative and/or quantitative composition is not as

declared,

(b) the therapeutic indications do not comply with the

conditions laid down in Article 16a,

(c) the product could be harmful in the normal conditions

of use,

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(d) data on traditional use is insufficient, especially if phar-
macological effects or efficacy are not plausible on the
basis of long-term use and experience,

A Member State may provide that the labelling and the user
package leaflet shall also state the nature of the tradition in
question.

(e) the pharmaceutical quality is not satisfactorily demon-

strated.

2.
The competent authorities of the Member States shall
provide the applicant, the Commission and any competent
authority requesting this, with any decision it makes to
refuse traditional use registration on safety grounds and
the reasons for this.

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:
“traditional herbal medicinal product for use in [specified
indication] for which efficacy has not been proven”.

Article 16h

Article 16f

1.
A Committee for Herbal Medicinal Products is hereby
established. That Committee shall be part of the Agency.

The Committee referred to in Article 16h shall set up
1.
a list of herbal substances. The list shall contain with regard
to each herbal substance the therapeutic indication,
the
specified strength,
the route of administration and any
other information necessary for the safe use of the herbal
substance.

2.
If an application for traditional use registration relates
to a herbal substance contained in the list, referred to in
paragraph 1, the data specified in Article 16c(1)(b)(c) and (d)
does not need to be provided. Article 16e(1)(c) and (d) shall
not apply.

If a herbal substance ceases to be included in the list,
3.
referred to in paragraph 1,
to
paragraph 2 for herbal medicinal products containing this
substance shall be revoked unless
the particulars and
documents, referred to in Article 16c(1) are submitted
within three months.

registrations pursuant

Article 16g

1.
Articles 3(1) and (2), 4(4), 12, 17(1), 19, 20, 23, 24,
25, 40 to 52, 70 to 85, 101 to 108, 111(1) and (3), 112,
116 to 118, 122, 123, 125, 126 second indent, 127 of this
Directive as well as Commission Directive 91/356/EEC (1)
to traditional use registration
shall apply, by analogy,
granted under this chapter.

2.
In addition to the provisions laid down in Articles 54
to 65 any labelling and user package leaflet shall contain a
statement to the effect that:

(a) the product is a herbal medicinal product for traditional
use in a specified indication and that the efficacy of the
product has not been clinically proven but
relies
exclusively on long-term use and experience; and

(b) the user should consult a doctor or a qualified practi-
tioner if the symptoms persist during the use of the
medicinal product.

(1) OJ L 193, 17.7.1991, p. 30.

The Committee for Herbal Medicinal Products shall
2.
consist of one member nominated by each Member State
for a term of 3 years, which shall be renewable. They shall,
as appropriate, be chosen by reason of
their role and
experience in the evaluation of herbal medicinal products
and shall represent their competent authorities.

3.
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 tradi-
tional herbal medicinal products. The appropriate co-ordi-
nation with the committee for human medicinal products
shall be ensured by the Executive Directive of the Agency
according to Article 55(2) of Regulation 2309/93. The
responsibilities conferred
Committee shall
further
upon it by provisions of
and other
this
Community law.

chapter

fulfil

When Community herbal monographs in the sense of this
paragraph have been established they shall be used as the
basis for any application.

When new Community herbal monographs are established,
the registration holder shall within one year after the date of
establishment of such monograph, introduce a modification
to the registration dossier in order to comply with that
monograph. The registration holder shall notify that modi-
fication to the competent authority of the Member State
concerned.

4.

The Committee shall adopt its own rules of procedure.

Article 16i

Until . . . [date], the Commission shall present a report to
the European Parliament and the Council concerning the
application of the provisions of this chapter.

The report shall
include an assessment on the possible
extension of traditional use registration to other categories
of medicinal products.’

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Article 2

The Member States shall take the measures necessary to
1.
comply with this Directive by 31 December 2004. They shall
forthwith inform the Commission thereof. When Member States
adopt the said measures, they shall contain a reference to this
Directive or be accompanied by such a reference when officially
published.

the
competent authorities
present Directive within five years after its entry into force.

shall apply the provisions of

Article 3

This Directive shall enter into force on the day of its publi-
cation in the Official Journal of the European Communities.

2.
For the traditional herbal medicinal products as referred
to in Article 1 of this Directive, which are already on the
the
market on the

entry into force of

this Directive,

Article 4

This Directive is addressed to the Member States.