Common Position (EC) No 65/2003 of 4 November 2003 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a directive of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use
Date: 2003-11-04
Institutions: Council of the European Union
Subjects: approximation of laws, medicinal product, pharmaceutical legislation, public health

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COMMON POSITION (EC) No 65/2003

adopted by the Council on 4 November 2003

with a view to the adoption of a Directive 2003/. . ./EC of the European Parliament and of the
Council of . . . amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on
the Community code relating to medicinal products for human use

(2003/C 305 E/03)

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 (1),

Having regard to the Opinion of the European Economic and
Social Committee (2),

Acting in accordance with the procedure laid down in Article
251 of the Treaty (3),

Whereas:

(1) Directive 2001/83/EC (4)

requires that applications for
authorisation to place a medicinal product on the
market have to be accompanied by a dossier containing
particulars and documents relating in particular to the
results of physico-chemical, biological or microbiological
tests as well as pharmacological and toxicological tests and
clinical trials carried out on the product and thus proving
its quality, safety and efficacy.

(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 within the
meaning 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

(3) A significant number of medicinal products, despite their
long tradition, do not fulfil the requirements of a well-

(1) OJ C 126 E, 28.5.2002, p. 263.
(2) OJ C 61, 14.3.2003, p. 9.
(3) Opinion of the European Parliament of 21 November 2002 (not yet
published in the Official
Journal), Council Common Position of
26 June 2003 and Position of the European Parliament of . . .
(not yet published in the Official Journal).

(4) OJ L 311, 28.11.2001, p. 67. Directive as last amended by
Commission Directive 2003/63/EC (OJ L 159, 27.6.2003, p. 46).

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 differing
procedures and provisions. The differences that currently
exist between the provisions laid down in the Member
States may hinder trade in traditional medicinal products
within the Community and lead to discrimination and
distortion of competition between manufacturers of these
products. They may also have an impact on the protection
of public health since the necessary guarantees of quality,
safety and efficacy are not always provided at present.

for

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

registration

for

or

(5) The long tradition of

the medicinal product makes it
possible to reduce the need for clinical trials, insofar as
the efficacy of the medicinal product is plausible on the
basis of long-standing use and experience. Pre-clinical tests
do not 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 a long tradition does not exclude the possibility that
there may be concerns with regard to the product's safety,
and therefore 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 physico-chemical, biological
and microbiological tests. Products should comply with
quality standards in relevant European Pharmacopoeia
monographs or
a
Member State.

in the pharmacopoeia of

those

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

therefore seems appropriate to limit

and coherent
It

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(7) The simplified 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
the medicinal product has been
into account only if
used within the Community for a certain time. Where
there is limited evidence of use within the Community,
it
is necessary to assess carefully the validity and
relevance of use outside the Community.

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 2001/83/EC is hereby amended as follows:

1. In Article 1 the following points shall be added:

(8) With the objective of further facilitating the registration of
certain traditional herbal medicinal products and of further
enhancing harmonisation, there should be the possibility
of establishing a Community list of herbal substances that
fulfil certain criteria, such as having been in medicinal use
for a sufficiently long time, and hence are considered not
to be harmful under normal conditions of use.

(EEC) No
The Committee

(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
the
Agency).
tasks
concerning the simplified registration and authorisation
of medicinal products as provided for in this Directive.
to establishing
Its
Community herbal monographs relevant
for the regis-
tration as well as the authorisation of herbal medicinal
products. It should be composed of experts in the field
of herbal medicinal products.

(hereinafter:
carry

2309/93 (1)
should

should relate

in particular

tasks

out

(10) It is important to ensure full consistency between the new
committee and the Committee for Human Medicinal
Products already existing within the Agency.

(11) In order to promote harmonisation, Member States should
recognise registrations of
traditional herbal medicinal
products granted by another Member State based on
of
Community
thereof
substances,
contained in a list to be established. For other products,
Member States should take due account of such regis-
trations.

herbal monographs
preparations

combinations

consisting

or

or

‘29. Traditional herbal medicinal product:

A herbal medicinal product that fulfils the conditions
laid down in Article 16a(1).

30. Herbal medicinal product:

Any medicinal product, exclusively 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.

31. Herbal substances:

fragmented or cut plants, plant
All mainly whole,
parts, algae,
lichen in an unprocessed —
fungi,
usually 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:

such

treatments

Preparations obtained by subjecting herbal substances
to
distillation,
as
fractionation, purification, concentration
expression,
comminuted or
or
powdered
extracts,
substances,
essential oils, expressed juices and processed exudates.’

fermentation. These
herbal

extraction,

tinctures,

include

of

the Chapter

(12) The Commission should present
on

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

a
traditional

2. The following Chapter shall be inserted in Title III:

‘CHAPTER 2a: Specific provisions applicable to tradi-

tional herbal medicinal products

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

accordingly,

Article 16a

(1) OJ L 214, 24.8.1993, p. 1. Regulation as last amended by Regu-

lation (EC) No 1647/2003 (OJ L 245, 29.9.2003, p. 19).

A simplified registration procedure (hereinafter “tradi-
1.
tional-use registration”)
is hereby established for herbal
medicinal products which fulfil all of the following criteria:

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(a) they have indications exclusively appropriate to tradi-
tional herbal medicinal products which, by virtue of
their
intended and
designed for use without the supervision of a medical
practitioner for diagnostic purposes or for prescription
or monitoring of treatment;

composition and purpose, are

(b) they are exclusively for administration in accordance

with a specified strength and posology;

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

(d) the period of traditional use as laid down in Article

16c(1)(c) has elapsed;

(e) the data on the traditional use of the medicinal product
are 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
are plausible on the basis of
long-standing use and
experience.

Notwithstanding Article 1(30),

the presence in the
2.
herbal medicinal product of vitamins or minerals for the
safety of which there is well-documented evidence shall
not prevent the product from being eligible for registration
in accordance with paragraph 1, provided that the action of
the vitamins or minerals is ancillary to that of the herbal
active ingredients regarding the specified claimed indi-
cation(s).

However,

3.
in cases where the competent authorities
judge that a traditional herbal medicinal product fulfils the
criteria for authorisation in accordance with Article 6 or
registration pursuant to Article 14, the provisions of this
Chapter shall not apply.

Article 16b

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

the second indent of Article 8(3)(i),

(iii) the summary of product characteristics, without the

data specified in Article 11(4),

(iv) in case of combinations, as referred to in Article
1(30) or Article 16a(2), the information referred
to in Article 16a(1)(e) relating to the combination
as such; if the individual active ingredients are not
sufficiently known, the data shall also relate to the
individual active ingredients;

(b) any authorisation or

in another Member State, or
to place

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

registration, whether

(c) bibliographical or expert evidence to the effect that the
in question, or a corresponding
medicinal product
product has been in medicinal use throughout a
period of at least thirty years preceding the date of
the application, including at least 15 years within the
Community. At the request of the Member State where
the application for traditional-use registration has been
submitted, the Committee for Herbal Medicinal Products
shall draw up an opinion on the adequacy of
the
evidence of the long-standing use of the product, or
of the corresponding product. The Member State shall
submit relevant documentation supporting the referral;

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

The applicant and registration holder shall be estab-

1.
lished in the Community.

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

In order

to obtain traditional-use registration,

2.
the
applicant shall submit an application to the competent
authority of the Member State concerned.

Article 16c

1.

The application shall be accompanied by:

(a) the particulars and documents:

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

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

route of administration as

the excipients used,

same or

similar

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.

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4. Where the product has been used in the Community
for less than 15 years, but is otherwise eligible for simplified
registration, the Member State where the application for
traditional-use registration has been submitted shall refer
for Herbal Medicinal
the product
Products. The Member State shall submit relevant documen-
tation supporting the referral.

to the Committee

The Committee shall consider whether the other criteria for
a simplified registration as referred to in Article 16a are
fully complied with.
it
possible, it shall establish a Community herbal monograph
as referred to in Article 16h(3) which shall be taken into
account by the Member State when taking its final decision.

the Committee

considers

If

Article 16d

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

(a) a Community herbal monograph has been established in

accordance with Article 16h(3), or

(b) the herbal medicinal product

substances,
combinations
contained in the list referred to in Article 16f.

preparations

or

consists of herbal
thereof

2.
For other herbal medicinal products as referred to in
Article 16a, each Member State shall, when evaluating an
application for traditional-use registration, take due account
of
registrations granted by another Member State in
accordance with this Chapter.

Article 16e

the
Traditional-use registration shall be refused if
1.
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,

The competent authorities of the Member States shall
2.
notify the applicant, the Commission and any competent
authority that requests it, of any decision they take to
refuse traditional-use registration and the reasons for the
refusal.

Article 16f

A list of herbal substances, preparations and combi-
1.
nations thereof shall be established in accordance with the
procedure referred to in Article 121(2). The list shall
contain with regard to each herbal substance the indication,
the specified strength and the posology, the route of admin-
istration 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, preparation or a combination thereof
contained in the list referred to in paragraph 1, the data
specified in Article 16c(1)(b)(c) and (d) do not need to be
provided. Article 16e(1)(c) and (d) shall not apply.

3.
If a herbal substance, preparation or a combination
thereof ceases to be included in the list referred to in
paragraph 1, registrations pursuant
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.

Article 16g

Articles 3(1) and (2), 4(4), 6(1), 12, 17(1), 19, 20, 23,
1.
24, 25, 40 to 52, 70 to 85, 101 to 108, 111(1) and (3),
112, 116 to 118, 122, 123, 125, 126 second subparagraph,
127 of
this Directive as well as Commission Directive
91/356/EEC (*) shall apply, by analogy, to traditional-use
registration granted under this Chapter.

2.
In addition to the requirements of Articles 54 to 65
any labelling and user package leaflet shall contain a
statement to the effect that:

(b) the indications do not comply with the conditions laid

down in Article 16a,

(a) the product is a traditional herbal medicinal product for
use in specified indication(s) exclusively based upon
long-standing use; and

(c) the product could be harmful under normal conditions

of use,

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

(b) the user should consult a doctor or a qualified health
care practitioner if the symptoms persist during the use
of
if adverse effects not
mentioned in the package leaflet occur.

the medicinal product or

(e) the pharmaceutical quality is not satisfactorily demon-

strated.

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

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In addition to the requirements of Articles 86 to 99
3.
any advertisement for a medicinal product registered under
this Chapter shall contain the following statement: “Tradi-
tional herbal medicinal product for use in specified indi-
cation(s) exclusively based upon long-standing use”.

Article 16h

A Committee for Herbal Medicinal Products is hereby
1.
established. That Committee shall be part of the Agency and
shall have the following competence:

(a) As regards simplified registrations, to:

— perform the tasks arising from Article 16c(1) and

(4),

— perform the tasks arising from Article 16d,

— prepare a draft list of herbal substances, preparations
and combinations thereof, as referred to in Article
16f(1), and

— establish Community monographs for

herbal medicinal products,
paragraph 3 of this Article.

as

traditional
referred to in

(b) As regards authorisations of herbal medicinal products,
to establish Community herbal monographs for herbal
medicinal products, as referred to in paragraph 3 of this
Article.

(c) As regards referrals to the Agency under Chapter 4 of
in relation to herbal medicinal products as
Title III,
referred to in Article 16a, to perform the tasks set out
in Article 32.

procedure to be determined by the Executive Director of the
Agency in accordance with Article 57(2) of Regulation
(EEC) No 2309/93.

2.
Each Member State shall appoint, for a three-year term
which may be renewed, one member and one alternate to
the Committee for Herbal Medicinal Products.

The alternates shall represent and vote for the members in
their absence. Members and alternates shall be chosen for
role and experience in the evaluation of herbal
their
medicinal products and shall
the competent
national authorities.

represent

The said Committee may co-opt a maximum of
five
additional members chosen on the basis of their specific
scientific competence. These members shall be appointed
for a term of three years, which may be renewed, and
shall not have alternates.

shall

With a view to the co-opting of such members, the said
complementary
the
Committee
additional member(s).
scientific
the
Co-opted members
experts
nominated by Member States or the Agency.

identify
of
shall be

chosen among

competence

specific

The members of the said Committee may be accompanied
by experts in specific scientific or technical fields.

The Committee for Herbal Medicinal Products shall
3.
establish Community herbal monographs
for herbal
medicinal products with regard to the application of
Article 10(1)(a)(ii) as well as traditional herbal medicinal
products. The said Committee shall fulfil further responsi-
bilities conferred upon it by provisions of this Chapter and
other Community law.

When Community herbal monographs within the meaning
of this paragraph have been established they shall be taken
into account by the Member States when examining an
application. Where
herbal
monograph has yet been established, other appropriate
monographs, publications or data may be referred to.

Community

such

no

(d) Where other medicinal products containing herbal
substances are referred to the Agency under Chapter 4
of Title III, to give an opinion on the herbal substance
where appropriate.

When new Community herbal monographs are established,
the registration holder shall consider whether it is necessary
to modify the registration dossier accordingly. The regis-
tration holder shall notify any such modification to the
competent authority of the Member State concerned.

Finally, the Committee for Herbal Medicinal Products shall
perform any other task conferred upon it by Community
law.

The herbal monographs shall be published.

The appropriate co-ordination with the Committee for
a
Human Medicinal

ensured by

shall be

Products

The

general

provisions

4.
No 2309/93 relating to the Committee
Medicinal
Committee for Herbal Medicinal Products.

apply by

Products

shall

of

Regulation

(EEC)
for Human
to the

analogy

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Article 16i

Before . . . (*) 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.
___________
(*) OJ L 193, 17.7.1991, p. 30.’

For the traditional herbal medicinal products as referred
2.
to in Article 1, which are already on the market on the entry
into force of this Directive, the competent authorities shall
apply the provisions of this Directive within seven years after
its entry into force.

Article 3

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

Article 2

Article 4

1.
The Member States shall take the necessary measures to
comply with this Directive by . . . (**). They shall forthwith
inform the Commission thereof.

When Member States adopt these measures, they shall contain
a reference to this Directive or shall be accompanied by such a
reference on the occasion of their official publication. The
methods of making such reference shall be laid down by the
Member States.

This Directive is addressed to the Member States.

Done at . . .

For the European Parliament

The President

For the Council

The President

(*) Three years after the date of entry into force of this Directive.
(**) 18 months after the date of entry into force of this Directive.

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 17 January 2002, the Commission submitted a proposal for a Directive relating to traditional

herbal medicinal products (1).

The proposal is based on Article 95 of the Treaty.

2. The European Parliament adopted its Opinion at first reading on 21 November 2002 (2). Following

this Opinion, the Commission presented an amended proposal on 9 April 2003 (3).

3. The Economic and Social Committee adopted its Opinion on 18 September 2002 (4).

4. On 4 November 2003, the Council adopted its Common Position in accordance with Article 251 of

the Treaty.

II. AIM

The aim of the proposal
is, within the framework of Directive 2001/83/EC relating to medicinal
products for human use, to set out specific rules and procedures on traditional herbal medicinal
products in order to facilitate the achievement of the internal market for these products while guar-
anteeing a high level of health protection.

III. ANALYSIS OF THE COMMON POSITION

The Council has been examining the proposal since 2002. The Council's Common Position is
consistent with the aims of the Commission's proposal.

However, the Council has agreed on a number of changes to the Commission's proposal, including
editorial and linguistic changes. Apart
from changes related to amendments by the European
Parliament, the more substantial changes are:

— clarifying the definition of a herbal medicinal product (point 30 of Article 1);

— providing the Member States with the possibility to request the Committee for Herbal Medicinal
Products for an opinion on the adequacy of the evidence of longstanding use in relation to Article
16c (1) (c);

— clarifying that medicinal use of corresponding products other than corresponding medicinal
products shall be taken into account for the purposes of fulfilling the criteria of longstanding
use in Article 16c (1) c if the corresponding product falls under the definition of Article 16c (2);

— clarifying the scope of the competent authorities' obligation to inform the applicant and the

Commission of decisions on refusals of applications (Article 16e (2)).

(1) OJ C 126 E, 28.5.2002, p. 263.
(2) Not yet published in the Official Journal.
(3) Not yet published in the Official Journal.
(4) OJ C 61, 14.3.2003, p. 9.

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A. European Parliament amendments accepted in full or in principle

1. Amendment 26 has been incorporated in full while amendments 2, 3, 5, 8, 12, 14, 15, 16, 17, 18,

19, 20, 21, 22, 23 and 24 have been accepted partly or in principle

2. In relation to the Committee for Herbal Medicinal Products' tasks and composition, the Council
agrees with the aim of amendments 2, 20, 21 and 22 to set out a broad competence for the
Committee in respect of herbal medicinal products, with due regard to the necessary coordination
with the Committee for Human Medicinal Products, and to ensure the necessary expertise for
evaluating herbal medicinal products.

The Council has considered it useful to set out more precisely which tasks the Committee for Herbal
Medicinal Products is to be entrusted with in relation to authorisations and registrations.

Specifically as regards amendment 21, the Council believes that the aim of this amendment is
the Committee for Herbal
achieved by applying the same provisions on the composition of
Medicinal Products as for the Committee for Human Medicinal Products in that they will provide
for the possibility of appointing five additional members and for the members to be accompanied
by experts.

In relation to amendment 22 that proposes to allow for other references than monographs, the
Council prefers as the Commission to restrict this possibility for cases where no monograph has yet
been established. Where a monograph has been established, it should be taken into account when
In addition, the information
applying for registration as it constitutes a harmonised reference.
referred to by the European Parliament can be used when establishing a monograph.

3. The Council can accept the principle of amendments 3 and 14 on having mutual recognition for
registered traditional herbal medicines. However, given that products and traditions vary between
Member States, the Council believes that it is advisable to make the mutual recognition dependent
on the existence of a common reference that will facilitate mutual recognition. Therefore the
Council has agreed to provide for mutual recognition when a Community herbal monograph has
been established as well as when the product contains substances etc. figuring on the list established
in accordance with Article 16f. For other products, there will be an obligation to take due account
of registrations granted by other Member States in accordance with the new procedure.

4. The Council has incorporated the essence of amendment 5 and part of amendment 12 allowing for
registration of herbal medicinal products that contain non herbal
ingredients, however only as
concerns vitamins and minerals and only if
their action is ancillary regarding the specified
claimed indication(s). The Council has chosen not to include other ‘non herbal
ingredients’ as
in opening up the registration procedure to
this term is too vague, and there is the risk that,
other unspecified combination products, the concept of a herbal medicinal product may be diluted.
For similar reasons and for the sake of clarity, the Council believes that rather than opening up for
such combination products via the definitions, it is more appropriate to do this via the criteria for
registrations, cf. Article 16a (2).

5. The Council has incorporated amendment 8 and the part of amendment 15 that refer to ‘specified
daily doses’, but believes that a reference to the strength should be maintained and that it would be
appropriate to use the general term ‘posology’ which means dosage schedule, be it a daily schedule
or other (Articles 16a (b) and 16f (1)).

6. The Council accepts the idea contained in amendment 12 that it could be justified to open up for
registration of products that have been in use for less than 15 years in the Community but believes
that for public health reasons the basic criteria should be kept but with the possibility to derogate
from this criterion in cases where the Member State and the Committee for Herbal Medicinal
Products consider that the product otherwise fulfils all criteria, in particular in relation to safety,
efficacy and quality.

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7. The essence of amendments 16, 17 and 19 concerning labelling and package leaflets have been
incorporated as these provide for more neutral and concise labelling (Article 16g (2) (a) and (3)) and
in case of amendment 17 for a useful additional statement (i.e. on reporting of adverse reactions, cf.
Article 16g (2) (b)).

8. In relation to amendments 18, 23 and 24,

the
amendments but as stated by the Commission in its amended proposal, the obligations proposed
already follow from existing provisions in Directive 2001/83/EC read in conjunction with the
present proposal and no rewording is thus necessary (1).

the Council has accepted the principle of

B. Amendments not accepted in total or partly

The Council has not been able to accept in total or partly amendments 1, 4, 6, 7, 9, 10, 11, 12, 13,
15, 25 and 27 for the same reasons as stated by the Commission in its amended proposal.

(1) Cf. Article 16g (1) referring to the application of provisions on good manufacturing practice and pharmacovigilance

and Article 16g (2) referring to the application of in particular Article 59 (see paragraph 1, point c)).