Common Position (EC) No 61/2003 of 29 September 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 Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance)
Date: 2003-09-29
Institutions: Council of the European Union
Subjects: approximation of laws, legal code, medicinal product, pharmaceutical legislation, public health, single market

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COMMON POSITION (EC) No 61/2003

adopted by the Council on 29 September 2003

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

(2003/C 297 E/02)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

to promote the operation of the internal market while
realising a high level of human health protection.

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

Having regard to the proposal by the Commission (1),

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

After consulting the Committee of the Regions,

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

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 (4), codified
and consolidated in a single text the texts of Community
legislation on medicinal products for human use, in the
interests of clarity and rationalisation.

(2) The Community legislation so far adopted has made a
major contribution to the achievement of the objective
of the free and safe movement of medicinal products for
human use and the elimination of obstacles to trade in
such products. However,
in the light of the experience
acquired,
it has become clear that new measures are
necessary to eliminate the remaining obstacles to free
movement.

(3)

It is therefore necessary to align the national laws, regu-
lations
and administrative provisions which contain
differences with regard to the basic principles in order

(1) OJ C 75 E, 26.3.2002, p. 216.
(2) OJ C 61, 14.3.2003, p. 1.
(3) Opinion of the European Parliament of 23 October 2002 (not yet
published in the Official Journal), Council Common Position of 29
September 2003 and Decision 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).

(4) The main purpose of any regulation on the manufacture
and distribution of medicinal products for human use
should be to safeguard public health. However,
this
objective should be achieved by means which do not
hinder the development of the pharmaceutical
industry
or trade in medicinal products in the Community.

(5) Article 71 of 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
the Evaluation of Medicinal Products (5)
Agency for
provided that, within six years of its entry into force,
the Commission was required to publish a general report
on the experience acquired as a result of the operation of
the marketing authorisation procedures laid down in that
Regulation and in other Community legal provisions.

(6)

In the light of the Commission's report on the experience
acquired, it has proved necessary to improve the operation
of the marketing authorisation procedures for medicinal
products in the Community.

sectors,

In order

sector and other

to take account both of

(7) Particularly as a result of scientific and technical progress,
the definitions and scope of Directive 2001/83/EC should
be clarified in order to achieve high standards for the
quality, safety and efficacy of medicinal products for
human use.
the
emergence of new therapies and of the growing number
of so-called ‘borderline’ products between the medicinal
product
the definition of
‘medicinal product’ should be modified so as to avoid
to the applicable legislation when a
any doubt as
fully falling within the definition of a
product, whilst
medicinal product, may also fall within the definition of
other regulated products. Also,
in view of the charac-
teristics of pharmaceutical
legislation, provision should
be made for such legislation to apply. With the same
objective of clarifying situations, where a given product
comes under the definition of a medicinal product but
could also fall within the definition of other regulated
in case of doubt and in order
products, it is necessary,
explicitly which
to ensure
provisions have to be complied with. Where a product

certainty,

to state

legal

(5) OJ L 214, 21.8.1993, p. 1. Regulation repealed by Regulation (EC)
No . . ./2003. Of the European Parliament and of the Council (see
page . . . of this Official Journal).

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the definition of other product
comes clearly under
categories,
in particular food, food supplements, medical
devices, biocides or cosmetics, this Directive should not
apply. It is also appropriate to improve the consistency
of the terminology of pharmaceutical legislation.

authorised within the Community, it should be verified,
at the time of the evaluation of the application for auth-
orisation, that these trials were conducted in accordance
with the principles of good clinical practice and the ethical
requirements equivalent to the provisions of that Directive.

(8) Wherever it

is proposed to change the scope of

the
centralised procedure, it should no longer be possible to
opt for the mutual-recognition procedure or the decen-
tralised procedure
in respect of medicinal products
which contain new active substances and for which the
therapeutic indication is the treatment of acquired immune
deficiency syndrome, cancer, neurodegenerative disorder
or diabetes.

(9) On the other hand,

authorisation under

in the case of generic medicinal
products of which the reference medicinal product has
the
been granted a marketing
centralised procedure, applicants seeking marketing auth-
orisation should be able to choose either of
the two
procedures, on certain conditions. Similarly, the mutual-
recognition or decentralised procedure should be available
as an option for medicinal products which represent a
therapeutic innovation or which are of benefit to society
or to patients.

(10) In order to increase availability of medicinal products, in
particular on smaller markets, it should, in cases where an
applicant does not apply for an authorisation for a
medicinal product in the context of the mutual-recog-
nition procedure in a given Member State, be possible
for that Member State, for justified public health reasons,
to authorise the placing on the market of the medicinal
product.

(11) Evaluation of the operation of marketing authorisation
procedures has revealed the need to revise, in particular,
the mutual-recognition procedure in order to improve the
opportunities for cooperation between Member States.
This cooperation process should be formalised by setting
this procedure and by
up a coordination group for
defining its operation so as
to settle disagreements
within the framework of a revised decentralised procedure.

(12) With regard to referrals, the experience acquired reveals
the need for an appropriate procedure, particularly in the
case of referrals relating to an entire therapeutic class or to
all medicinal products
active
substance.

containing

same

the

in medicinal products,

(14) Since generic medicines account for a major part of the
market
to the
Community market should be facilitated in the light of
the period for
the experience acquired. Furthermore,
protection of data relating to pre-clinical
tests and
clinical trials should be harmonised.

access

their

(15) The criteria of quality, safety and efficacy should enable
the risk-benefit balance of all medicinal products to be
assessed both when they are placed on the market and
at any other time the competent authority deems this
is necessary to
connection,
appropriate.
harmonise and adapt the criteria for refusal, suspension
and revocation of marketing authorisations.

In this

it

(16) A marketing authorisation should be renewed once five
years after the granting of the marketing authorisation.
Thereafter, the marketing authorisation should normally
be of unlimited validity. Furthermore, any authorisation
not used for three consecutive years, that is to say one
which has not led to the placing on the market of a
concerned
medicinal product
during that period,
in
order,
in particular, to avoid the administrative burden
of maintaining such authorisations. However, exemptions
from this rule should be granted when these are justified
on public health grounds.

should be considered invalid,

in the Member States

(17) The quality of medicinal products for human use manu-
factured or available
in the Community should be
guaranteed by requiring that the active substances used
in their composition comply with the principles of good
manufacturing practice in relation to those medicinal
the
products.
Community provisions on inspections and to compile a
Community register of the results of those inspections.

It has proved necessary to reinforce

(18) Pharmacovigilance

and, more

generally, market
surveillance and sanctions in the event of
failure to
comply with the provisions should be stepped up. In the
field of pharmacovigilance, account should be taken of the
facilities offered by new information technologies
to
improve exchanges between Member States.

(13) There is a need to provide for the ethical requirements of
Directive 2001/20/EC of the European Parliament and the
Council of 4 April 2001 on the approximation of the
laws,
the
regulations and administrative provisions of
Member States relating to the implementation of good
clinical practice in the conduct of clinical
trials on
medicinal products for human use (1)
to apply to all
medicinal products authorised within the Community. In
particular, with respect to clinical trials conducted outside
the Community on medicinal products destined to be

(19) As part of the proper use of medicinal products, the rules
on packaging should be adapted to take account of the
experience acquired.

(20) The measures necessary for the implementation of this
Directive should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down the
procedures
implementing powers
the exercise of
conferred on the Commission (2).

for

(1) OJ L 121, 1.5.2001, p. 34.

(2) OJ L 184, 17.7.1999, p. 23.

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(21) Directive 2001/83/EC should be amended accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

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

The name, which may be either an invented name
not liable to confusion with the common name,
or a common or scientific name accompanied by
a trade mark or the name of the marketing auth-
orisation holder.’;

(g) the heading of point 26 shall be replaced by the

following:

1. Article 1 shall be amended as follows:

(only concerns the Portuguese version);

(a) point 1 shall be deleted;

(h) point 27 shall be replaced by the following:

(b) point 2 shall be replaced by the following:

‘27. Agency:

‘2. Medicinal product:

The European Medicines Agency established by
Regulation (EC) No . . ./2003 (*);

(a) Any substance or combination of substances
presented as having properties for treating or
preventing disease in human beings; or

___________
(*) OJ L . . .’

(b) Any substance or combination of substances
which may be used in or administered to
human beings with a view to making a
medical diagnosis or to restoring, correcting
or modifying physiological functions.’;

(i) point 28 shall be replaced by the following points:

‘28. Risks relating to use of the medicinal product:

(c) point 5 shall be replaced by the following:

‘5. Homeopathic medicinal product:

the European Pharmacopoeia or,

Any medicinal product prepared from substances
called homeopathic stocks in accordance with a
homeopathic manufacturing procedure described
in the
by
absence thereof, by the pharmacopoeias currently
used officially in the Member States. A homeo-
pathic medicinal product may contain a number
of principles.’;

(d) the Title of point 8 shall be replaced by ‘Kit’;

Any risk relating to the quality, safety or efficacy
of the medicinal product as regards the health of
patients;

29. Risks relating to the environment:

Any risk of unwanted effects on the environment;

30. Risk-benefit balance:

An evaluation of the positive therapeutic effects
of the medicinal product in relation to the risks
as defined in point 28.’;

(e)

the following point shall be inserted:

2. Article 2 shall be replaced by the following:

‘18a. Representative of the marketing authorisation holder:

‘Article 2

The person, commonly known as local represen-
tative, designated by the marketing authorisation
holder to represent him in the Member State
concerned’.

This Directive shall apply to medicinal products for
1.
human use intended to be placed on the market
in
Member States and either prepared industrially or manu-
factured by a method involving an industrial process.

(f) point 20 shall be replaced by the following:

‘20. Name of the medicinal product:

2.
In cases of doubt, where a product falls within the
definition of “medicinal product”, this Directive shall apply,
even in cases where the product also falls within the scope
of other Community legislation.

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Notwithstanding paragraph 1 and Article 3(4), Title
3.
IV of
this Directive shall apply to medicinal products
intended only for export and to intermediate products.’;

3. Article 3 shall be amended as follows:

(a) point 2 shall be replaced by the following:

‘2. Any medicinal product which is prepared in a
pharmacy in accordance with the prescriptions of
a pharmacopoeia and is intended to be supplied
directly to the patients served by the pharmacy
in question (commonly known as the officinal
formula)’;

(b) point 3 shall be replaced by the following:

‘3. Medicinal products

intended for

research and
development trials, but without prejudice to the
provisions of Directive 2001/20/EC of the Euro-
pean Parliament and of the Council of 4 April
the laws, regu-
2001 on the approximation of
lations
the
Member States relating to the implementation of
good clinical practice in the conduct of clinical
trials on medicinal products for human use (*).

and administrative provisions of

___________
(*) OJ L 121, 1.5.2001, p. 34.’;

(c) point 6 shall be replaced by the following:

‘6. Whole blood, plasma or blood cells of human
origin, except for plasma which is prepared by a
method involving an industrial process.’;

4. Article 5 shall be replaced by the following:

‘Article 5

1.
A Member State may, in accordance with legislation
in force and to fulfil special needs, exclude from the
provisions of this Directive medicinal products supplied
in response to a bona fide unsolicited order, formulated
in accordance with the specifications of an authorised
health-care professional and for use by an individual
patient under his direct personal responsibility.

temporarily

the
2. Member States may
distribution of an unauthorised medicinal product
in
response to the suspected or confirmed spread of path-
ogenic
agents or nuclear
toxins,
radiation any of which could cause harm.

authorise

chemical

agents,

lay down provisions

3. Without prejudice to paragraph 1, Member States
that
shall
marketing
and
health professionals are not subject to civil or adminis-

to ensure
authorisation holders, manufacturers

in order

trative liability for any consequences resulting from the
use of a medicinal product otherwise than for the auth-
orised indications or from the use of an unauthorised
medicinal product, when such use is recommended or
required by a competent authority in response to the
suspected or confirmed spread of pathogenic agents,
toxins, chemical agents or nuclear
radiation any of
which could cause harm. Such provisions shall apply
whether or not national or Community authorisation has
been granted.

4.
Liability for defective products, as provided for by
Council Directive 85/374/EEC of 25 July 1985 on the
approximation of the laws, regulations and administrative
provisions of the Member States, concerning liability for
defective products (*), shall not be affected by paragraph 3.

___________
(*) OJ L 210, 7.8.1985, p. 29. Directive as last amended
by Directive 1999/34/EC of the European Parliament
and of the Council (OJ L 141, 4.6.1999, p. 20)’;

5. Article 6 shall be amended as follows:

(a)

in paragraph 1, the following subparagraph shall be
added:

‘When a medicinal product has been granted an initial
marketing authorisation in accordance with the first
subparagraph, any additional strengths, pharmaceutical
forms, administration routes, presentations, as well as
any variations and extensions shall also be granted an
authorisation
first
accordance
subparagraph or be included in the initial marketing
authorisation. All these marketing authorisations shall
be
same global
marketing authorisation, in particular for the purpose
of the application of Article 10(1).’;

considered as belonging to the

with

the

in

(b) the following paragraph shall be inserted:

The marketing authorisation holder shall be
‘1a.
responsible for marketing the medicinal product. The
designation of a representative shall not relieve the
marketing authorisation holder of his legal responsi-
bility.’;

(c)

in paragraph 2, ‘radionuclide kits’ shall be replaced by
‘kits’;

6.

in Article 7,

‘radionuclide kits’ shall be replaced by ‘kits’;

7. Article 8(3) shall be amended as follows:

(a) points (b) and (c) shall be replaced by the following:

‘(b) Name of the medicinal product.

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(c) Qualitative and quantitative particulars of all the
constituents of the medicinal product,
including
the reference to its international non-proprietary
name (INN) recommended by the WHO, where an
the medicinal product exists, or a
INN for
reference to the relevant chemical name;’;

(d) the following subparagraph shall be added:

‘The documents and information concerning the results
of the pharmaceutical and pre-clinical tests and the
the first
clinical
(i) of
subparagraph shall be
accompanied by detailed
summaries in accordance with Article 12.’;

trials referred to in point

(b) points (g),

(h),

(i) and (j) shall be replaced by the

following points:

8. Article 10 shall be replaced by the following:

‘(g) Reasons

for

and

any precautionary

safety
measures to be taken for the storage of
the
medicinal product, its administration to patients
and for the disposal of waste products, together
with an indication of potential risks presented by
the medicinal product for the environment.

(h) Description of the control methods employed by

the manufacturer.

(i)

Results of:

— pharmaceutical

(physico-chemical, biological

or microbiological) tests,

— pre-clinical

(toxicological

and pharmaco-

logical) tests,

— clinical trials.

(ia) A detailed description of the pharmacovigilance
and, where appropriate, of the risk-management
system which the applicant will introduce.

(j)

A summary, in accordance with Article 11, of the
product characteristics, a mock-up of the outer
packaging, containing the details provided for in
Article 54, and of the immediate packaging of
the medicinal product, containing the details
provided for
together with a
in Article 55,
package leaflet in accordance with Article 59.’;

(c) the following points shall be added:

‘(m) A copy of any designation of

the medicinal
product as an orphan medicinal product under
Regulation (EC) No 141/2000 of the European
Parliament and of the Council of 16 December
1999 on orphan medicinal products (*), accom-
panied by a copy of the relevant Agency opinion.

the applicant has the services of a
(n) Proof that
qualified
phar-
person
macovigilance and has the necessary means for
the
reaction
suspected of occurring either in the Community
or in a third country.

notification

responsible

adverse

any

for

of

___________
(*) OJ L 18, 22.1.2000, p. 1.’;

‘Article 10

1.
By way of derogation from Article 8(3)(i), and
without prejudice to the law relating to the protection of
industrial and commercial property, the applicant shall not
be required to provide the results of pre-clinical tests and
of clinical trials if he can demonstrate that the medicinal
product
is a generic of a reference medicinal product
which is or has been authorised under Article 6 for not
less
in the
Community.

in a Member State or

than eight years

A generic medicinal product authorised pursuant to this
provision shall not be placed on the market until ten years
have elapsed from the initial authorisation of the reference
product.

In this case,

is submitted.
in the

application form the name of

The first subparagraph shall also apply if the reference
medicinal product was notauthorised in the Member
State in which the application for the generic medicinal
the applicant shall
product
indicate
the
Member State in which the reference medicinal product
is or has been authorised. At
the
competent authority of the Member State in which the
application is submitted, the competent authority of the
other Member State shall transmit within a period of one
reference medicinal
month, a confirmation that
product is or has been authorised together with the full
composition of
the reference product and if necessary
other relevant documentation.

request of

the

the

2.

For the purposes of this Article:

(a) “reference medicinal product” shall mean a medicinal
product authorised under Article 6, in accordance with
the provisions of Article 8;

the

ethers,

form as

studies. The different

(b) “generic medicinal product” shall mean a medicinal
product which has the same qualitative and quanti-
tative composition in active substances and the same
reference medicinal
pharmaceutical
product, and whose bioequivalence with the reference
medicinal product has been demonstrated by appro-
salts,
priate bioavailability
esters,
isomers,
isomers, mixtures
complexes or derivatives of an active substance shall
be considered to be the same active substance, unless
they differ significantly in properties with regard to
safety and/or efficacy. The various immediate-release
oral pharmaceutical forms shall be considered to be
one and the same pharmaceutical form. Bioavailability
studies need not be required of the applicant if he can
demonstrate that the generic medicinal product meets
the relevant criteria as defined in the appropriate
detailed guidelines.

of

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In cases where the medicinal product does not fall
3.
within the definition of a generic medicinal product as
provided in paragraph 2(b) or where the bioequivalence
cannot be demonstrated through bioavailability studies or
in case of changes in the active substance(s), therapeutic
indications, strength, pharmaceutical
form or route of
administration, vis-à-vis the reference medicinal product,
the results of the appropriate pre-clinical tests or clinical
trials shall be provided.

4. Where a biological medicinal product which is
similar to a reference biological product does not meet
certain conditions in the definition of generic medicinal
products, owing to, in particular, differences in manufac-
turing processes of the biological medicinal product and
the reference biological medicinal product, the results of
appropriate pre-clinical tests or clinical trials relating to
these conditions must be provided. The results of other
tests and trials from the reference medicinal product's
dossier shall not be provided.

5.
Conducting the necessary studies and trials with a
view to the application of paragraphs 1, 2, 3 and 4 to a
generic medicinal product and the consequential practical
requirements shall not be regarded as contrary to patent
rights or to supplementary protection certificates for those
medicinal products.’;

contained in the file on the medicinal product, with a
view to examining subsequent applications relating to
other medicinal products possessing the same qualitative
and quantitative composition in terms of active substances
and the same pharmaceutical form.’;

10. Article 11 shall be replaced by the following:

‘Article 11

The summary of the product characteristics shall contain,
in the order indicated below, the following information:

1.

2.

3.

4.

name of
strength and the pharmaceutical form.

the medicinal product

followed by the

active

qualitative and quantitative composition in terms of
the
substances
the
excipient, knowledge of which is
for
proper administration of the medicinal product. The
usual common name or chemical description shall be
used.

and constituents of
essential

pharmaceutical form.

clinical particulars:

9. the following Articles shall be inserted:

4.1. therapeutic indications,

‘Article 10a

trials

the applicant

if he can demonstrate that

By way of derogation from Article 8(3)(i), and without
prejudice to the law relating to the protection of industrial
shall not be
and commercial property,
required to provide the results of pre-clinical
tests or
clinical
the active
substances of the medicinal product have been in well-
established medicinal use within the Community for at
least ten years, with recognised efficacy and an acceptable
level of safety in terms of the conditions set out in Annex
I. In that event, the test and trial results shall be replaced
by appropriate scientific literature.

Article 10b

composition of

In the case of medicinal products containing active
substances used in the
authorised
medicinal products but not hitherto used in combination
for therapeutic purposes, the results of new pre-clinical
tests or new clinical trials relating to that combination
shall be provided in accordance with Article 8(3)(i), but
it shall not be necessary to provide scientific references
relating to each individual active substance.

Article 10c

Following the granting of a marketing authorisation, the
authorisation holder may allow use to be made of the
pharmaceutical, pre-clinical and clinical documentation

4.2. posology and method of administration for adults

and, where necessary for children,

4.3. contra-indications,

immunological medicinal products,

4.4. special warnings and precautions for use and, in the
case of
any
special precautions to be taken by persons handling
such products and administering them to patients,
together with any precautions to be taken by the
patient,

4.5.

interaction with other medicinal products and other
forms of interactions,

4.6. use during pregnancy and lactation,

4.7. effects on ability to drive and to use machines,

4.8. undesirable effects,

4.9. overdose (symptoms, emergency procedures, antidotes).

5.

pharmacological properties:

5.1. pharmacodynamic properties,

5.2. pharmacokinetic properties,

5.3. preclinical safety data.

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6.

pharmaceutical particulars:

6.1.

list of excipients,

6.2. major incompatibilities,

6.3. shelf life, when necessary after reconstitution of the
medicinal product or when the immediate packaging
is opened for the first time,

6.4. special precautions for storage,

6.5. nature and contents of container,

The detailed summaries shall form part of the file
3.
which the applicant submits to the competent authorities.’;

12. Article 13 shall be replaced by the following:

‘Article 13

shall

States

ensure

1. Member
that homeopathic
medicinal products manufactured and placed on the
market within the Community are registered or authorised
in accordance with Articles 14, 15 and 16, except where
such medicinal products are covered by a registration or
authorisation granted in accordance with national
legis-
lation on or before 31 December 1993.

6.6. special precautions for disposal of a used medicinal
product or waste materials derived from such
medicinal product, if appropriate.

2. Member States shall establish a special simplified
registration procedure for
the homeopathic medicinal
products referred to in Article 14.’;

7. marketing authorisation holder.

13. Article 14 shall be amended as follows:

8. marketing authorisation number(s).

(a)

in paragraph 1, the following second subparagraph
shall be inserted:

9.

date of the first authorisation or renewal of the auth-
orisation.

10. date of revision of the text.

11.

radiopharmaceuticals,

for
radiation dosimetry.

full details of

internal

12.

for radiopharmaceuticals, additional detailed instruc-
tions for extemporaneous preparation and quality
control of such preparation and, where appropriate,
maximum storage time during which any inter-
mediate preparation such as an eluate or the ready-
to-use pharmaceutical will conform with its specifi-
cations.’;

11. Article 12 shall be replaced by the following:

‘Article 12

1.
The applicant shall ensure that, before the detailed
summaries referred to in the last subparagraph of Article
8(3) are submitted to the competent authorities, they have
been drawn up and signed by experts with the necessary
technical or professional qualifications, which shall be set
out in a brief curriculum vitae.

Persons having the technical and professional qualifi-
justify any use
in

2.
cations referred to in paragraph 1 shall
made of
accordance with the conditions set out in Annex I.

literature under Article 10a

scientific

‘If new scientific evidence so warrants, the Commission
may amend the third indent of the first subparagraph
by the procedure referred to in Article 121(2).’;

(b) paragraph 3 shall be deleted;

14. Article 15 shall be amended as follows:

(a) the second indent shall be replaced by the following:

‘— dossier describing how the homeopathic stock or
stocks
and
justifying its/their homeopathic use, on the basis
of an adequate bibliography,’;

controlled,

obtained

is/are

and

(b) the sixth indent shall be replaced by the following:

‘— one or more mock-ups of the outer packaging and
the medicinal

immediate packaging

of

the
products to be registered,’;

15. Article 16 shall be amended as follows:

(a)

in paragraph 1,
replaced by ‘Articles 8, 10, 10a, 10b, 10c and 11’.

‘Articles 8, 10 and 11’ shall be

(b) in paragraph 2,

‘toxicological and pharmacological

tests’ shall be replaced by ‘pre-clinical tests’;

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16. Articles 17 and 18 shall be replaced by the following:

‘Article 17

1. Member States shall take all appropriate measures to
ensure that the procedure for granting a marketing auth-
orisation for medicinal products is completed within 210
days after the submission of a valid application.

The

competent

the pharmaceutical and pre-clinical

shall draw up an
authorities
4.
assessment report and comments on the file as regards
the results of
tests
and the clinical trials of the medicinal product concerned.
The assessment report shall be updated whenever new
information becomes available which is of
importance
for the evaluation of the quality, safety or efficacy of the
medicinal product concerned.

Applications for marketing authorisations in two or more
Member States in respect of the same medicinal product
shall be submitted in accordance with Articles 27 to 39.

The competent authorities shall make publicly accessible
without delay the assessment report,
together with the
reasons for their opinion, after deletion of any information
of a commercially confidential nature.’;

2. Where a Member State notes that another marketing
authorisation application for the same medicinal product is
being examined in another Member State, the Member
State concerned shall decline to assess the application
and shall advise the applicant that Articles 27 to 39 apply.

Article 18

Where a Member State is informed in accordance with
Article 8(3)(1) that another Member State has authorised
a medicinal product which is the subject of a marketing
authorisation application in the Member State concerned,
it shall reject the application unless it was submitted in
compliance with Articles 27 to 39.’;

17. Article 19 shall be amended as follows:

(a)

‘Articles 8 and 10(1)’
in the introductory sentence,
shall be replaced by ‘Articles 8, 10, 10a, 10b and 10c’;

(b) in point 1, ‘Articles 8 and 10(1)’ shall be replaced by

‘Articles 8, 10, 10a, 10b and 10c’;

(c)

in point 2,
‘a State laboratory or a laboratory
designated for that purpose’ shall be replaced by ‘an
Official Medicines Control Laboratory or a laboratory
that a Member State has designated for that purpose’;

(d) in point 3, ‘Articles 8(3) and 10(1)’ shall be replaced by

‘Articles 8(3), 10, 10a, 10b and 10c’;

18.

in point (b) of Article 20,
cases’ shall be replaced by ‘in justifiable cases’;

‘in exceptional and justifiable

19.

in Article 21, paragraphs 3 and 4 shall be replaced by the
following:

20. Article 22 shall be replaced by the following:

‘Article 22

In exceptional circumstances and following consultation
with the applicant,
the authorisation may be granted
subject to a requirement for the applicant to introduce
specific procedures, in particular concerning the safety of
the medicinal product, notification to the competent auth-
orities of any incident relating to its use, and action to be
taken. This authorisation may be granted only for
objective, verifiable reasons and must be based on one
of the grounds set out in Annex I. Continuation of the
authorisation shall be linked to the annual reassessment of
these conditions.’;

21.

in Article 23, the following paragraphs shall be added:

‘The authorisation holder shall
forthwith supply to the
competent authority any new information which might
entail
the particulars or documents
referred to in Articles 8(3), 10, 10a, 10b and 11, or
32(5), or Annex I.

the amendment of

forthwith inform the competent
In particular, he shall
authority of any prohibition or restriction imposed by
the competent authorities of any country in which the
for human use is marketed and of
medicinal product
influence the
any other new information which might
evaluation of
the medicinal
the benefits and risks of
product for human use concerned.

The

authorities

competent

shall make publicly
‘3.
available without delay
authorisation
together with the summary of the product characteristics
for each medicinal product which they have authorised.

the marketing

In order that the risk-benefit balance may be continuously
assessed, the competent authority may at any time ask the
the marketing authorisation to forward data
holder of
demonstrating that
remains
favourable.’;

risk-benefit balance

the

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22. the following Article shall be inserted:

consecutive years,
shall cease to be valid.

the authorisation for

that product

‘Article 23a

the
After a marketing authorisation has been granted,
holder of the authorisation shall
inform the competent
authority of the authorising Member State of the date of
actual marketing of the medicinal product for human use
the various
in that Member State,
presentations authorised.

taking into account

The holder shall also notify the competent authority if the
product ceases to be placed on the market of the Member
State, either temporarily or permanently. Such notification
shall, otherwise than in exceptional circumstances, be
made no less than 2 months before the interruption in
the placing on the market of the product.

Upon request by the competent authority, particularly in
the context of pharmacovigilance, the marketing author-
isation holder shall provide the competent authority with
all data relating to the volume of sales of the medicinal
product, and any data in his possession relating to the
volume of prescriptions.’;

23. Article 24 shall be replaced by the following:

‘Article 24

1. Without prejudice
marketing authorisation shall be valid for five years.

to paragraphs 4 and 5,

a

The marketing authorisation may be renewed after
2.
five years on the basis of a re-evaluation of the risk-benefit
balance by the competent authority of
the authorising
Member State.

To this end,
the marketing authorisation holder shall
provide the competent authority with a consolidated
version of
safety and
the file in respect of quality,
efficacy,
introduced since the
marketing authorisation was granted, at least six months
before the marketing authorisation ceases to be valid in
accordance with paragraph 1.

including all variations

Once renewed, the marketing authorisation shall be
3.
valid for an unlimited period, unless
the competent
authority decides, on justified grounds relating to phar-
macovigilance, to proceed with one additional five-year
renewal in accordance with paragraph 2.

4.
Any authorisation which within three years of its
granting is not followed by the actual placing on the
market of
in the authorising
the authorised product
Member State shall cease to be valid.

5. When an authorised product previously placed on
the market in the authorising Member State is no longer
three
actually present on the market

for a period of

6.
The competent authority may, in exceptional circum-
stances and on public health grounds grant exemptions
from paragraphs 4 and 5. Such exemptions must be
duly justified.’;

24. Article 26 shall be replaced by the following:

‘Article 26

The marketing authorisation shall be refused if, after
the particulars and documents listed in

1.
verification of
Articles 8, 10, 10a, 10b and 10c, it is clear that:

(a) the risk-benefit balance is not considered to be

favourable; or

(b) its therapeutic efficacy is insufficiently substantiated by

the applicant; or

(c)

its qualitative and quantitative composition is not as
declared.

Authorisation shall

any
2.
refused if
particulars or documents submitted in support of
the
application do not comply with Articles 8, 10, 10a, 10b
and 10c.

likewise be

The applicant or the holder of a marketing author-
the

3.
isation shall be responsible for
documents and the data submitted.’;

the accuracy of

25. the heading of Chapter 4 of Title III shall be replaced by

the following:

‘CHAPTER 4

Mutual
procedure’;

recognition procedure

and decentralised

26. Articles 27 to 32 shall be replaced by the following:

‘Article 27

1.
A coordination group shall be set up for the exam-
ination of any question relating to marketing authorisation
of a medicinal product in two or more Member States in
accordance with the procedures laid down in this Chapter.
The Agency shall provide the secretariat of
this coor-
dination group.

2.
The coordination group shall be composed of one
representative per Member State appointed for a renewable
period of three years. Members of the coordination group
may arrange to be accompanied by experts.

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The coordination group shall draw up its own Rules
3.
of Procedure, which shall
into force after a
favourable opinion has been given by the Commission.
These Rules of Procedure shall be made public.

enter

Article 28

1. With a view to the granting of a marketing author-
isation for a medicinal product in more than one Member
State, an applicant shall submit an application based on an
identical dossier in these Member States. The dossier shall
contain the information and documents referred to in
Articles 8, 10, 10a, 10b, 10c and 11. The documents
States
a
shall
submitted
concerned by the application.

list of Member

include

The applicant shall request one Member State to act as
“reference Member State” and to prepare an assessment
report on the medicinal product
in accordance with
paragraphs 2 or 3.

reference Member

2. Where the medicinal product has already received a
marketing authorisation at the time of application,
the
concerned Member States shall recognise the marketing
authorisation granted by the reference Member State. To
this end, the marketing authorisation holder shall request
an
the
State
assessment
if
necessary, to update any existing assessment report. The
reference Member State shall prepare or update the
assessment report within 90 days of receipt of a valid
together with the
application. The assessment
approved summary of product characteristics,
labelling
and package leaflet
to the concerned
shall be sent
Member States and to the applicant.

report on the medicinal product or,

to prepare

report

either

shall

In cases where the medicinal product has not
3.
the
time of
received a marketing authorisation at
application,
the reference
request
the applicant
Member State to prepare a draft assessment report, a
draft summary of product characteristics and a draft of
the labelling and package leaflet. The reference Member
State shall prepare these draft documents within 120
days after receipt of a valid application and shall send
them to the concerned Member States and to the
applicant.

4. Within 90 days of receipt of the documents referred
to in paragraphs 2 and 3, the Member States concerned
shall approve the assessment report,
the summary of
product characteristics and the labelling and package
leaflet and shall
inform the reference Member State
accordingly. The reference Member State shall record the
agreement of all parties, close the procedure and inform
the applicant accordingly.

Each Member State in which an application has been
5.
submitted in accordance with paragraph 1 shall adopt a
decision in conformity with the approved assessment
report, the summary of product characteristics and the
labelling and package leaflet as approved, within 30 days
after acknowledgement of the agreement.

Article 29

1.
If, within the period laid down in Article 28(4), a
Member State cannot approve the assessment report, the
summary of product characteristics, the labelling and the
package leaflet on the grounds of potential serious risk to
public health,
it shall give a detailed exposition of the
reasons for its position to the reference Member State, to
the other Member States concerned and to the applicant.
The points of disagreement shall be forthwith referred to
the coordination group.

Guidelines to be adopted by the Commission shall

2.
define a potential serious risk to public health.

3. Within the coordination group, all Member States
referred to in paragraph 1 shall use their best endeavours
to reach agreement on the action to be taken. They shall
allow the applicant the opportunity to make his point of
view known orally or in writing. If, within 60 days of the
communication of the points of disagreement, the Member
States reach an agreement, the reference Member State
record the agreement, close the procedure and
shall
inform the applicant accordingly. Article 28(5) shall apply.

If

the Member States fail

4.
to reach an agreement
within the 60-day period laid down in paragraph 3, the
Agency shall be immediately informed, with a view to the
application of the procedure under Articles 32, 33 and 34.
The Agency shall be provided with a detailed statement of
the matters on which the Member States have been unable
to reach agreement and the reasons for their disagreement.
A copy shall be forwarded to the applicant.

As soon as the applicant is informed that the matter
5.
forthwith
has been referred to the Agency, he shall
forward to the Agency a copy of the information and
documents
subparagraph of
Article 28(1).

referred to in the first

6.
In the circumstances referred to in paragraph 4,
Member States that have approved the assessment report,
the draft summary of product characteristics and the
labelling and package leaflet of
the reference Member
State may, at the request of the applicant, authorise the
medicinal product without waiting for the outcome of the
procedure laid down in Article 32.
the
authorisation granted shall be without prejudice to the
outcome of that procedure.

In that event,

Article 30

1.
If two or more applications submitted in accordance
with Articles 8, 10, 10a, 10b, 10c and 11 have been made
for marketing authorisation for a particular medicinal
product, and if Member States have adopted divergent
decisions concerning the authorisation of the medicinal
product or its suspension or revocation, a Member State,
the Commission or the applicant or the marketing auth-
orisation holder may refer the matter to the Committee for
Medicinal Products for Human Use, hereinafter referred to
as “the Committee”, for the application of the procedure
laid down in Articles 32, 33 and 34.

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In order to promote harmonisation of authorisations
2.
for medicinal products authorised in the Community,
Member States shall, each year,
forward to the coor-
dination group a list of medicinal products for which a
harmonised summary of product characteristics should be
drawn up.

The coordination group shall lay down a list taking into
account the proposals from all Member States and shall
forward this list to the Commission.

The Commission or a Member State, in agreement with
the Agency and taking into account the views of interested
parties, may refer these products to the Committee in
accordance with paragraph 1.

Article 31

the Commission or

The Member States or

1.
the
applicant or the marketing authorisation holder shall, in
specific cases where the interests of the Community are
involved, refer the matter to the Committee for application
of the procedure laid down in Articles 32, 33 and 34
before any decision is
for a
marketing authorisation or on the suspension or revo-
cation of an authorisation, or on any other variation to
the terms of a marketing authorisation which appears
necessary, in particular to take account of the information
collected in accordance with Title IX.

reached on a request

The Member State concerned or the Commission shall
clearly identify the question which is referred to the
Committee
inform the
applicant or the marketing authorisation holder.

consideration and shall

for

In an emergency, and on a proposal from its Chairman,
the Committee may agree to a shorter deadline.

2.
In order to consider the matter, the Committee shall
appoint one of its members to act as rapporteur. The
Committee may also appoint individual experts to advise
it on specific questions. When appointing experts,
the
Committee
tasks and specify the
time-limit for the completion of these tasks.

shall define

their

Before issuing its opinion,

the Committee shall
3.
provide the applicant or
the marketing authorisation
holder with an opportunity to present written or oral
explanations within a time limit which it shall specify.

The opinion of the Committee shall be accompanied by a
draft summary of product characteristics for the product
and a draft text of the labelling and package leaflet.

If necessary,
the Committee may call upon any other
person to provide information relating to the matter
before it.

The Committee may suspend the time-limits referred to in
paragraph 1 in order
the
marketing authorisation holder to prepare explanations.

to allow the applicant or

4.
The Agency shall forthwith inform the applicant or
the marketing authorisation holder where the opinion of
the Committee is that:

(a) the application does not satisfy the criteria for author-

isation; or

The Member States and the applicant or the marketing
authorisation holder shall supply the Committee with all
available information relating to the matter in question.

(b) the summary of the product characteristics proposed
by the applicant or the marketing authorisation holder
in accordance with Article 11 should be amended; or

2. Where the referral
to the Committee concerns a
range of medicinal products or a therapeutic class, the
Agency may limit the procedure to certain specific parts
of the authorisation.

(c) the authorisation should be granted subject to certain
conditions, in view of conditions considered essential
for the safe and effective use of the medicinal product
including pharmacovigilance; or

In that event, Article 35 shall apply to those medicinal
products only if they were covered by the authorisation
procedures referred to in this Chapter.

(d) a marketing authorisation should be suspended, varied

or revoked.

Article 32

1. When reference is made to the procedure laid down
in this Article, the Committee shall consider the matter
concerned and shall issue a reasoned opinion within 60
days of the date on which the matter was referred to it.

in cases

submitted to the Committee

However,
in
accordance with Articles 30 and 31, this period may be
extended by the Committee for a further period of up to
90 days, taking into account the views of the applicants or
the marketing authorisation holders concerned.

Within 15 days after receipt of the opinion, the applicant
or the marketing authorisation holder may notify the
Agency in writing of his intention to request a re-exam-
ination of the opinion. In that case, he shall forward to the
Agency the detailed grounds for the request within 60
days after receipt of the opinion.

Within 60 days following receipt of the grounds for the
request, the Committee shall re-examine its opinion in
accordance with the fourth subparagraph of Article 62(1)
of Regulation (EC) No . . ./2003. The reasons for the
conclusion reached shall be annexed to the assessment
report referred to in paragraph 5 of this Article.

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5. Within 15 days after its adoption, the Agency shall
forward the final opinion of the Committee to the Member
States, to the Commission and to the applicant or the
marketing authorisation holder,
together with a report
describing the assessment of the medicinal product and
stating the reasons for its conclusions.

In the event of an opinion in favour of granting or main-
taining an authorisation to place the medicinal product
concerned on the market, the following documents shall
be annexed to the opinion:

(a) a draft summary of

the product characteristics, as

referred to in Article 11;

(b) any conditions affecting the authorisation within the

meaning of paragraph 4(c);

(c) details of any recommended conditions or restrictions
with regard to the safe and effective use of
the
medicinal product;

(d) the proposed text of the labelling and leaflet.’;

27. Article 33 shall be amended as follows:

(a)

in the first paragraph, ‘30 days’ shall be replaced by ‘15
days’;

involved. This time-limit shall not, otherwise than in
exceptional circumstances, be shorter than 5 days;

(c) Member States shall have the option of submitting a
written request that the draft Decision be discussed in
a plenary meeting of the Standing Committee.

Where,
in the opinion of the Commission, the written
observations of a Member State raise important new
questions of a scientific or technical nature which have
not been addressed in the opinion delivered by the
Agency, the Chairman shall suspend the procedure and
refer
the application back to the Agency for further
consideration.

The provisions necessary for the implementation of this
paragraph shall be adopted by the Commission in
accordance with the procedure referred to in Article
121(2).

States

The decision as referred to in paragraph 1 shall be
3.
and reported for
addressed to all Member
information to the marketing authorisation holder or
applicant. The
the
concerned Member
reference Member State shall either grant or revoke the
marketing authorisation, or vary its terms as necessary to
comply with the decision within 30 days following its
notification, and they shall refer to it. They shall inform
the Commission and the Agency accordingly.’;

States

and

(b) in the second paragraph, ‘Article 32(5)(a) and (b)’ shall
be replaced by ‘Article 32(5), second subparagraph’;

29. the third subparagraph of Article 35(1) shall be deleted;

(c)

in the fourth paragraph, the words ‘or the marketing
authorisation holder’ shall be added after the word
‘applicant’;

28. Article 34 shall be replaced by the following:

‘Article 34

The Commission shall

1.
take a final decision in
accordance with, and within 15 days after the end of,
the procedure referred to in Article 121(3).

2.
The rules of procedure of the Standing Committee
established by Article 121(1) shall be adjusted to take
this
account of
Chapter.

incumbent upon it under

the tasks

Those adjustments shall entail the following provisions:

(a) except in cases referred to in the third paragraph of
Article 33, the opinion of the Standing Committee
shall be given in writing;

(b) Member States shall have 22 days to forward their
written observations on the draft decision to the
if a decision has to be taken
Commission. However,
time-limit may be set by the
urgently, a shorter
to the degree of urgency
Chairman according

30.

in Article 38, paragraph 2 shall be replaced by the
following:

At

least every ten years

‘2.
the Commission shall
publish a report on the experience acquired on the basis
of
the procedures described in this Chapter and shall
propose any amendments which may be necessary to
improve those procedures. The Commission shall submit
this
to the European Parliament and to the
Council.’;

report

31. Article 39 shall be replaced by the following:

‘Article 39

Article 29(4), (5) and (6) and Articles 30 to 34 shall not
apply to the homeopathic medicinal products referred to
in Article 14.

Articles 28 to 34 shall not apply to the homeopathic
medicinal products referred to in Article 16(2).’;

32. the following paragraph shall be added to Article 40:

‘4.
The Member States shall forward to the Agency a
copy of the authorisation referred to in paragraph 1. The
Agency shall enter that information on the Community
database referred to in Article 111(6).’;

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33.

in Article 46, point (f) shall be replaced by the following:

39.

in Article 51(1), point
following:

(b)

shall be replaced by the

‘(f)

to comply with the principles and guidelines of good
manufacturing practice for medicinal products and to
use as starting materials only active substances, which
have been manufactured in accordance with the
detailed guidelines on good manufacturing practice
for starting materials.

shall

also be

applicable

This point
to certain
excipients, the list of which as well as the specific
conditions of application shall be established by a
Directive adopted by the Commission in accordance
with the procedure referred to in Article 121(2).’;

‘(b)

in the case of medicinal products coming from third
irrespective of whether the product has
countries,
been manufactured in the Community,
that each
production batch has undergone in a Member State
a full qualitative analysis, a quantitative analysis of at
least all the active substances and all the other tests or
checks necessary to ensure the quality of medicinal
products in accordance with the requirements of the
marketing authorisation.’;

40. Article 54 shall be amended as follows:

34. the following Article shall be inserted:

(a) point (a) shall be replaced by the following:

‘Article 46a

1.
For the purposes of this Directive, manufacture of
active substances used as starting materials shall include
both total and partial manufacture or import of an active
substance used as a starting material as defined in Part I,
point 3.2.1.1 (b) Annex I, and the various processes of
dividing up, packaging or presentation prior to its incor-
poration into a medicinal product, including repackaging
or re-labelling, such as are carried out by a distributor of
starting materials.

2.
Any amendments necessary to adapt paragraph 1 to
new scientific and technical developments shall be laid
down in accordance with the procedure referred to in
Article 121(2).’;

35.

in Article 47, the following paragraphs shall be added:

‘The principles of good manufacturing practice for active
substances used as starting materials referred to in point (f)
of Article 46 shall be adopted in the form of detailed
guidelines.

The Commission shall also publish guidelines on the form
and content of the authorisation referred to in Article
40(1), on the reports referred to in Article 111(3) and
on the form and content of the certificate of good manu-
facturing practice referred to in Article 111(5).’;

‘(a)

the name of the medicinal product followed by its
strength and pharmaceutical form, and, if appro-
priate, whether it is intended for babies, children
or adults; the common name shall be included
where the product contains only one active
substance and if its name is an invented name;’;

(b) in point (d),
guidance’;

‘guidelines’ shall be replaced by ‘detailed

(c) point (f) shall be replaced by the following:

‘(f) a special warning that the medicinal product must
be stored out of the reach and sight of children;’;

(d) point (k) shall be replaced by the following:

‘(k)

the name and address of the marketing author-
isation holder and, where applicable,
the name
of the representative appointed by the holder to
represent him;’;

(e) point (n) shall be replaced by the following:

‘(n)

the

in
products, instructions for use’;

case

of

non-prescription medicinal

41. Article 55 shall be amended as follows:

36.

in Article 49(1), ‘minimum’ shall be deleted;

(a)

in paragraph 1,
replaced by ‘in Article 54’;

‘in Articles 54 and 62’ shall be

37.

in Article 49(2), fourth subparagraph, first indent ‘Applied
physics’ shall be replaced by ‘Experimental physics’;

(b) the first indent of paragraph 2 shall be replaced by the

following:

38.

in Article 50(1), ‘in the State concerned’ shall be replaced
by ‘within the Community’;

‘— the name of the medicinal product as laid down in

point (a) of Article 54,’;

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(c) the first indent of paragraph 3 shall be replaced by the

following:

‘— the name of the medicinal product as laid down in
point (a) of Article 54 and, if necessary, the route
of administration,’;

(iii) the frequency of administration, specifying if
necessary the appropriate time at which the
medicinal product may or must be administered;

and, as appropriate, depending on the nature of the
product:

42.

in Article 57, the following paragraph shall be added:

(iv) the duration of treatment, where it should be

limited;

‘For medicinal products authorised under Regulation (EC)
No . . ./2003, Member States shall, when applying this
Article, observe the detailed guidance referred to in
Article 65 of this Directive.’;

43. Article 59 shall be replaced by the following:

‘Article 59

1.
The package leaflet shall be drawn up in accordance
with the summary of the product characteristics; it shall
include, in the following order:

(a)

for the identification of the medicinal product:

(i) the name of the medicinal product followed by its
strength and pharmaceutical form, and, if appro-
priate, whether it is intended for babies, children or
adults. The common name shall be included where
the product contains only one active substance and
if its name is an invented name;

(ii) the pharmaco-therapeutic group or type of activity
in terms easily comprehensible for the patient;

(b) the therapeutic indications;

(v) the action to be taken in case of an overdose
(such as symptoms, emergency procedures);

(vi) what to do when one or more doses have not

been taken;

(vii) indication, if necessary, of the risk of withdrawal

effects;

(viii) a specific recommendation to consult the doctor
or the pharmacist, as appropriate, for any clari-
fication on the use of the product;

(e) a description of the adverse reactions which may occur
under normal use of the medicinal product and,
if
necessary, the action to be taken in such a case; the
patient should be expressly asked to communicate any
adverse reaction which is not mentioned in the
package leaflet to his doctor or pharmacist;

(f) a reference to the expiry date indicated on the label,

with:

(i) a warning against using the product after that

date;

(c) a list of information which is necessary before the

medicinal product is taken:

(ii) where appropriate, special storage precautions;

(i) contra-indications;

(ii) appropriate precautions for use;

(iii) forms of interaction with other medicinal products
interaction (e.g. alcohol,
and other
tobacco, foodstuffs) which may affect the action
of the medicinal product;

forms of

(iv) special warnings;

(d) the necessary and usual

instructions for proper use,

and in particular:

(i) the dosage,

(iii) if necessary, a warning concerning certain visible

signs of deterioration;

(iv) the

full

qualitative

composition (in

active
substances and excipients) and the quantitative
composition in active substances, using common
the medicinal
names,
product;

for each presentation of

(v) for each presentation of the product, the phar-
maceutical form and content in weight, volume
or units of dosage;

(vi) the name and address of the marketing author-
isation holder and, where applicable, the name of
his appointed representatives
in the Member
States;

(ii) the method and, if necessary, route of adminis-

tration;

(vii) the name and address of the manufacturer;

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(g) where

the medicinal product

in
accordance with Articles 28 to 39 under different
names in the Member States concerned, a list of the
names authorised in each Member State;

authorised

is

(h) the date on which the package leaflet was last revised.

2.

The list set out in point (c) of paragraph 1 shall:

(b) paragraphs 2 and 3 shall be replaced by the following:

‘2.
The package leaflet must be written and designed
to be clear and understandable, enabling the users to
act appropriately, when necessary with the help of
health professionals. The package leaflet must be
clearly legible in the official language or languages of
the Member State in which the medicinal product is
placed on the market.

(a) take into account the particular condition of certain
categories of users (children, pregnant or breastfeeding
women, the elderly, persons with specific pathological
conditions);

from being printed in several

The first subparagraph shall not prevent the package
leaflet
languages,
provided that the same information is given in all
the languages used.

(b) mention, if appropriate, possible effects on the ability

to drive vehicles or to operate machinery;

(c)

list those excipients knowledge of which is important
for the safe and effective use of the medicinal product
and which are included in the detailed guidance
published pursuant to Article 65.

The package leaflet shall reflect the results of consul-
is

3.
tations with target patient groups to ensure that
legible, clear and easy to use.’;

it

44. Article 61(1) shall be replaced by the following:

One or more mock-ups of the outer packaging and
‘1.
the immediate packaging of a medicinal product, together
with the draft package leaflet, shall be submitted to the
authorities competent for authorising marketing when the
marketing authorisation is
results of
in cooperation with target
assessments
patient groups shall also be provided to the competent
authority.’;

requested. The

carried out

3. When the product is not intended to be delivered
directly to the patient, the competent authorities may
grant an exemption to the obligation that certain
particulars should appear on the labelling and in the
package leaflet and that the leaflet must be in the
official language or languages of the Member State in
which the product is placed on the market.’;

48. Article 65 shall be replaced by the following:

‘Article 65

In consultation with the Member States and the parties
concerned, the Commission shall draw up and publish
detailed guidance concerning in particular:

(a) the wording of certain special warnings for certain

categories of medicinal products;

(b) the

particular

information

needs

relating

to

non-prescription medicinal products;

(c) the legibility of particulars on the labelling and

45.

in Article 61(4),
‘and’;

‘or as appropriate’ shall be replaced by

package leaflet;

46.

in Article 62,
‘for the patient’;

‘for health education’ shall be replaced by

47. Article 63 shall be amended as follows:

(d) the methods for the identification and authentication

of medicinal products;

(e) the list of excipients which must

feature on the
labelling of medicinal products and the way in which
these excipients must be indicated;

(a) the

following

subparagraph shall be

added to

paragraph 1:

(f) harmonised provisions

for

the implementation of

Article 57.’;

‘In the case of certain orphan medicinal products, the
listed in Article 54 may, on reasoned
particulars
request, appear in only one of the official
languages
of the Community.’;

49. Article 66(3), fourth indent shall be replaced by:

‘— the name and address of the manufacturer,’;

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50. Article 69(1) shall be amended as follows:

(b) the following paragraphs shall be added:

(a) the first indent shall be replaced by the following:

‘— the scientific name of the stock or stocks followed
by the degree of dilution, making use of
the
symbols of the pharmacopoeia used in accordance
with Article 1(5);
if the homeopathic medicinal
product is composed of two or more stocks, the
scientific names of the stocks on the labelling may
be supplemented by an invented name’;

(b) the last indent shall be replaced by the following:

‘— a warning advising the user to consult a doctor if

the symptoms persist’;

‘2.
In the case of wholesale distribution and storage,
medicinal products shall be covered by a marketing
authorisation granted pursuant to Regulation (EC) No
. . ./2003 or by the competent authorities of a Member
State in accordance with this Directive.

Any distributor, not being the marketing author-
3.
isation holder, who imports a product from another
Member State shall notify the marketing authorisation
holder and the competent authority in the Member
State to which the product will be imported of his
intention to import it. In the case of products which
have not been granted an authorisation pursuant to
Regulation (EC) No . . ./2003, the notification to the
competent authority shall be without prejudice to
additional procedures provided for in the legislation
of that Member State.’;

51. Article 70(2) shall be amended as follows:

(a) point (a) shall be replaced by the following:

55. the second indent of point
replaced by the following:

(e) of Article 80 shall be

‘(a) medicinal products on medical prescription for

‘— name of the medicinal product,’;

renewable or non-renewable delivery;’;

(b) point (c) shall be replaced by the following:

56. Article 81 shall be replaced by the following:

‘Article 81

‘(c) medicinal

products

“restricted” medical
on
prescription, reserved for use in certain specialised
areas.’;

52. Article 74 shall be replaced by the following:

‘Article 74

the
When new facts are brought
competent authorities shall examine and, as appropriate,
amend the classification of a medicinal product by
applying the criteria listed in Article 71.’;

to their attention,

53. the following Article shall be inserted:

‘Article 74a

Where a change of classification of a medicinal product
has been authorised on the basis of significant pre-clinical
tests and clinical trials, the competent authority shall not
refer to the results of those tests or trials when examining
an application by another applicant
for or holder of
marketing authorisation for a change of classification of
the same substance for one year after the initial change
was authorised.’;

54. Article 76 shall be amended as follows:

With regard to the supply of medicinal products to phar-
macists and persons authorised or entitled to supply
medicinal products to the public, Member States shall
not impose upon the holder of a distribution authorisation
which has been granted by another Member State any
obligation,
in particular public service obligations, more
stringent than those they impose on persons whom they
have
in equivalent
activities.

themselves authorised to engage

The holder of a marketing authorisation for a medicinal
product and the distributors of the said medicinal product
actually placed on the market in a Member State shall,
within the limits of their responsibilities, ensure appro-
priate and continued supplies of that medicinal product
so that
the needs of patients in the Member State in
question are covered.

The arrangements for implementing this Article should,
moreover, be justified on grounds of public health
in relation to the
protection and be proportionate
in compliance with the
objective of such protection,
Treaty rules, particularly those
free
concerning the
movement of goods and competition.’;

57.

in Article 82, the second indent of the first paragraph shall
be replaced by the following:

‘— the name and pharmaceutical form of the medicinal

(a) the existing text shall become paragraph 1;

product,’;

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58. Article 84 shall be replaced by the following:

and approved by the competent authorities of the Member
States.

‘Article 84

The Commission shall publish guidelines on good
distribution practice. To this end,
the
Committee for Medicinal Products for Human Use and
the Pharmaceutical Committee established by Council
Decision 75/320/EEC (*).

it shall consult

The prohibition referred to in paragraph 1 shall
to Article 14 of Directive

5.
apply without prejudice
89/552/EEC.

6. Member States shall prohibit the direct distribution
of medicinal products to the public by the industry for
promotional purposes.’;

___________
(*) OJ L 147, 9.6.1975, p. 23.’;

62. Article 89 shall be amended as follows:

59. Article 85 shall be replaced by the following:

replaced by the following:

(a) the first indent of point (b) of paragraph 1 shall be

‘Article 85

(does not affect the English version);

This Title shall apply to homeopathic medicinal products.’;

(b) paragraph 2 shall be replaced by the following:

60. The fourth indent of Article 86(2) shall be replaced by the

following:

‘— information relating to human health or diseases,
provided that there is no reference, even indirect, to
medicinal products’;

61. Article 88 shall be replaced by the following:

‘Article 88

‘2. Member States may decide that the advertising of
a medicinal product
to the general public may,
notwithstanding paragraph 1, include only the name
international
product
of
non-proprietary name, where
the
exists, or
trademark if it is intended solely as a reminder.’;

the medicinal

or
this

its

63.

in Article 90, point (l) shall be deleted;

64.

in Article 91, paragraph 2 shall be replaced by the
following:

1. Member States shall prohibit the advertising to the
general public of medicinal products which:

(a) are

available on medical prescription only,

in

accordance with Title VI;

‘2. Member States may decide that the advertising of a
medicinal product
to persons qualified to prescribe or
supply such products may, notwithstanding paragraph 1,
include only the name of the medicinal product, or its
international non-proprietary name, where this exists, or
the trademark, if it is intended solely as a reminder.’;

(b) contain substances defined as psychotropic or narcotic
the United
convention,

by international
such as
Nations Conventions of 1961 and 1971.

2. Medicinal products may be advertised to the general
public which, by virtue of their composition and purpose,
are intended and designed for use without the intervention
of a medical practitioner for diagnostic purposes or for the
prescription or monitoring of treatment, with the advice of
the pharmacist, if necessary.

3.
Member States shall be entitled to ban, on their
territory, advertising to the general public of medicinal
products the cost of which may be reimbursed.

4.
The prohibition contained in paragraph 1 shall not
apply to vaccination campaigns carried out by the industry

65. Article 94(2) shall be replaced by the following:

‘2.
Hospitality at sales promotion events shall always be
strictly limited to their main purpose and must not be
extended to persons other than health-care professionals.’;

66. Article 95 shall be replaced by the following:

‘Article 95

The provisions of Article 94(1) shall not prevent hospi-
tality being offered, directly or indirectly, at events for
purely professional and scientific purposes; such hospi-
tality shall always be strictly limited to the main scientific
objective of the event; it must not be extended to persons
other than health-care professionals.’;

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67. point

(d) of Article 96(1)

shall be replaced by the

following:

72.

the introductory phrase of
in Article 103,
paragraph shall be replaced by the following:

the second

‘(d) each sample shall be no larger than the smallest pres-

entation on the market;’;

‘That qualified person shall reside in the Community and
shall be responsible for the following:’;

68.

in Article 98, the following paragraph shall be added:

73. Articles 104 to 107 shall be replaced by the following:

States

The Member

the
‘3.
co-promotion of a medicinal product by the holder of
the marketing authorisation and one or more companies
nominated by him.’;

prohibit

shall

not

69. Article 100 shall be replaced by the following:

‘Article 100

the homeopathic medicinal products
Advertising of
referred to in Article 14(1)
to the
provisions of this Title with the exception of Article 87(1).

shall be subject

However, only the information specified in Article 69(1)
may be used in the advertising of
such medicinal
products.’;

70.

in Article 101, the second paragraph shall be replaced by
the following:

‘The Member States may impose specific requirements on
doctors and other health-care professionals in respect of
the reporting of suspected serious or unexpected adverse
reactions.’;

71. Article 102 shall be replaced by the following:

‘Article 102

decisions

regulatory

concerning

to ensure the adoption of appropriate and
In order
harmonised
the
medicinal products authorised within the Community,
having regard to information obtained about adverse
reactions to medicinal products under normal conditions
a phar-
of use,
macovigilance system. This
system shall be used to
collect information useful in the surveillance of medicinal
products, with particular reference to adverse reactions in
human beings, and to evaluate such information scien-
tifically.

the Member States

shall operate

shall ensure that

Member States
suitable information
collected within this system is communicated to the
other Member States and the Agency. The information
shall be recorded in the database referred to in point (k)
of the second subparagraph of Article 57(1) of Regulation
(EC) No . . ./2003 and shall be permanently accessible to
all Member States and without delay to the public.

This system shall also take into account any available
information on misuse and abuse of medicinal products
which may have an impact on the evaluation of their
benefits and risks.’;

‘Article 104

1.
The marketing authorisation holder shall be required
to maintain detailed records of all suspected adverse
reactions occurring either in the Community or in a
third country.

Save in exceptional circumstances, these reactions shall be
communicated electronically in the form of a report in
accordance with the guidelines
referred to in Article
106(1).

The marketing authorisation holder shall be required
2.
to record all suspected serious adverse reactions which are
brought to his attention by a health-care professional and
to report them promptly to the competent authority of the
Member State on whose territory the incident occurred,
and no later than 15 days following the receipt of the
information.

3.
The marketing authorisation holder shall be required
to record and report all other suspected serious adverse
reactions which meet
in
the
accordance with the guidelines
referred to in Article
106(1), of which he can reasonably be expected to have
knowledge, promptly to the competent authority of the
Member State in whose territory the incident occurred,
and no later than 15 days following the receipt of the
information.

notification

criteria

The marketing authorisation holder shall ensure that
4.
all suspected serious unexpected adverse reactions and any
suspected transmission via a medicinal product of any
infectious agent occurring in the territory of a third
country are reported promptly in accordance with the
the
so that
referred to in Article 106(1),
guidelines
Agency and the competent authorities of
the Member
States in which the medicinal product is authorised are
informed of them, and no later than 15 days following
the receipt of the information.

5.
By way of derogation from paragraphs 2, 3 and 4, in
the case of medicinal products which are covered by
Directive 87/22/EEC or which have qualified for
the
this
procedures laid down in Articles 28 and 29 of
Directive or which have been the subject of the procedures
under Articles 32, 33 and 34 of
the
marketing authorisation holder shall also ensure that all
suspected serious adverse reactions occurring in the
Community are reported in such a way as to be accessible
to any competent
to the reference Member State or
authority
State. The
reference Member State shall assume the responsibility of
analysing and monitoring such adverse reactions.

reference Member

this Directive,

acting

as

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Unless other requirements have been laid down as a
6.
condition of the granting of authorisation, or subsequently
as indicated in the guidelines referred to in Article 106(1),
reports of all adverse reactions shall be submitted to the
competent authorities in the form of a periodic safety
update report, either immediately upon request or period-
ically as follows: six-monthly for the first two years after
authorisation, annually for the subsequent two years, and
thereafter at three-yearly intervals.

The periodic safety update reports shall include a scientific
evaluation of
the medicinal
the risk-benefit balance of
product.

7.
The Commission may lay down provisions to amend
paragraph 6 in view of experience gained through its
operation. The Commission shall adopt the provisions in
accordance with the procedure referred to in Article
121(2).

Following the granting of a marketing authorisation,
8.
the
the marketing authorisation holder may request
amendment of the periods referred to in paragraph 6 in
accordance with the procedure laid down by Commission
Regulation (EC) No 1084/2003 (*).

9.
The holder of a marketing authorisation may not
communicate information relating to pharmacovigilance
concerns to the general public in relation to its authorised
medicinal product without giving prior or simultaneous
notification to the competent authority.

marketing authorisation holder, and in any case within
15 days after their notification at the latest.

Article 106

the

within

Community,

In order to facilitate the exchange of information on
1.
the
pharmacovigilance
Commission, after consulting the Agency,
the Member
States and interested parties, shall draw up guidelines on
the collection, verification and presentation of adverse-
reaction reports, including technical requirements for elec-
tronic exchange of pharmacovigilance information in
accordance with internationally agreed formats, and shall
publish a reference to an internationally agreed medical
terminology.

Acting in accordance with the guidelines, marketing auth-
orisation holders shall use internationally agreed medical
terminology for the reporting of adverse reactions.

These guidelines shall be published in Volume 9 of The
in the European
Rules governing Medicinal Products
Community and shall
international
harmonisation work carried out
in the field of phar-
macovigilance.

account of

take

2.
For the interpretation of the definitions referred to in
points (11) to (16) of Article 1 and of the principles
outlined in this Title, the marketing authorisation holder
and the competent authorities shall follow the guidelines
referred to in paragraph 1.

In any case,
the marketing authorisation holder shall
ensure that such information is presented objectively and
is not misleading.

Article 107

Member States shall take the necessary measures to ensure
that a marketing authorisation holder who fails
to
to effective,
discharge
proportionate and dissuasive penalties.

these obligations

subject

is

Article 105

The Agency, in collaboration with the Member States
1.
and the Commission,
set up a data-processing
network to facilitate the exchange of pharmacovigilance
information regarding medicinal products marketed in
the Community in order to allow all competent authorities
to share the information at the same time.

shall

2. Making use of the network referred to in paragraph
1, Member States shall ensure that reports of suspected
serious adverse reactions that have taken place on their
territory are promptly made available to the Agency and
the other Member States, and in any case within 15 days
after their notification at the latest.

1. Where, as a result of
the evaluation of phar-
macovigilance data, a Member State considers that a
marketing authorisation should be suspended, revoked or
varied in accordance with the guidelines referred to in
Article 106(1), it shall forthwith inform the Agency, the
other Member States and the marketing authorisation
holder.

2. Where urgent action to protect public health is
necessary, the Member State concerned may suspend the
marketing authorisation of a medicinal product, provided
that the Agency, the Commission and the other Member
States are informed no later than the following working
day.

the

first

subparagraph of

When the Agency is
informed in accordance with
paragraph 1 in relation to suspensions and revocation,
or
the
Committee shall prepare an opinion within a time-frame
to be determined depending on the urgency of the matter.
In relation to variations, the Committee may upon request
from a Member State prepare an opinion.

this paragraph,

The Member States shall ensure that

3.
reports of
suspected serious adverse reactions that have taken place
on their territory are promptly made available to the

Acting on the basis of this opinion, the Commission may
request all Member States in which the product is being
marketed to take temporary measures immediately.

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The final measures shall be adopted in accordance with the
procedure referred to in Article 121(3).

___________
(*) OJ L 159, 27.6.2003, p. 1.’;

74. Article 111 shall be amended as follows:

(a) paragraph 1 shall be replaced by the following:

The competent authority of the Member State
‘1.
concerned shall
repeated
inspections, and if necessary unannounced inspections,
that
governing medicinal
legal
products are complied with.

ensure, by means of

requirements

the

The competent authority may also carry out unan-
nounced inspections at the premises of manufacturers
of active substances used as starting materials, or at the
premises of marketing authorisation holders whenever
it considers that
there are grounds for suspecting
non-compliance with the principles and guidelines of
good manufacturing practice referred to in Article 47.
These inspections may also be carried out at
the
request of a Member State, the Commission or the
Agency.

In order to verify whether the data submitted in order
to obtain a conformity certificate comply with the
monographs of the European Pharmacopoeia, the stan-
dardisation body of the nomenclatures and the quality
norms within the meaning of the Convention relating
to the elaboration of the European Pharmacopoeia (*)
(European Directorate for the quality of Medicinal
Products) may ask the Commission or the Agency to
request such an inspection when the starting material
concerned is the subject of a European Pharmacopoeia
monograph.

competent

authority of

the Member State
The
concerned may carry out
starting
material manufacturers at the specific request of the
manufacturer himself.

inspections of

Such inspections shall be carried out by officials repre-
senting
authority who shall be
empowered to:

competent

the

(a)

inspect
the manufacturing or commercial estab-
lishments of manufacturers of medicinal products
or of active substances used as starting materials,
and any laboratories employed by the holder of the
manufacturing authorisation to carry out checks
pursuant to Article 20;

(b) take samples;

(c) examine any documents relating to the object of
the inspection, subject to the provisions in force in

the Member States on 21 May 1975 placing
restrictions on these powers with regard to the
description of the manufacturing method;

(d) inspect the premises, records and documents of
marketing authorisation holders or any firms
employed by the marketing authorisation holder
to perform the activities described in Title IX,
and in particular Articles 103 and 104.

___________
(*) OJ L 158, 25.6.1994, p. 19.’;

(b) paragraph 3 shall be replaced by the following:

After

every

referred

‘3.
to in
inspection as
paragraph 1, the officials representing the competent
authority shall report on whether the manufacturer
complies with the principles and guidelines of good
manufacturing practice laid down in Article 47 or,
where appropriate, with the requirements laid down
in Articles 101 to 108. The content of such reports
shall be
communicated to the manufacturer or
marketing authorisation holder who has undergone
the inspection.’;

(c) the following paragraphs shall be added:

‘4. Without prejudice to any arrangements which
may have been concluded between the Community
and third countries, a Member State, the Commission
or the Agency may require a manufacturer established
to an inspection as
in a third country to submit
referred to in paragraph 1.

5. Within 90 days of an inspection as referred to in
paragraph 1, a certificate of good manufacturing
if
practice shall be issued to a manufacturer
the
outcome of
the manu-
the inspection shows that
facturer complies with the principles and guidelines
of good manufacturing practice as provided for by
Community legislation.

If inspections are performed as part of the certification
procedure for the monographs of the European Phar-
macopoeia, a certificate shall be drawn up.

6. Member States shall enter the certificates of good
in a
manufacturing practice which they
Community database managed by the Agency on
behalf of the Community.

issue

If the outcome of the inspection as referred to in
7.
paragraph 1 is that the manufacturer does not comply
with the principles and guidelines of good manufac-
turing practice as provided for by Community legis-
lation,
entered in the
Community database as referred to in paragraph 6.’;

information shall be

the

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75.

in Article 114(1) and (2), the terms ‘by a State laboratory
or a laboratory designated for that purpose’ shall be
replaced by the terms ‘by an Official Medicines Control
Laboratory or a laboratory that a Member State has
designated for that purpose’;

76. Article 116 shall be replaced by the following:

‘Article 116

The competent authorities shall suspend, revoke, withdraw
or vary a marketing authorisation if the view is taken that
the product is harmful under normal conditions of use, or
that it lacks therapeutic efficacy, or that the risk-benefit
balance is not positive under the normal conditions of use,
or that its qualitative and quantitative composition is not
as declared. Therapeutic efficacy is lacking when it
is
therapeutic results cannot be obtained
concluded that
from the medicinal product.

also be

suspended,

An authorisation shall
revoked,
withdrawn or varied where the particulars supporting
the application as provided for in Article 8 or Articles
10, 10a, 10b, 10c and 11 are incorrect or have not
been amended in accordance with Article 23, or where
the controls referred to in Article 112 have not been
carried out.’;

77. Article 117(1) shall be replaced by the following:

‘1. Without prejudice to the measures provided for in
Article 116, Member States shall take all appropriate steps
to ensure that
the supply of the medicinal product is
prohibited and the medicinal product withdrawn from
the market, if the view is taken that:

(a) the medicinal product
conditions of use; or

is harmful under normal

(b) it lacks therapeutic efficacy; or

(c) the risk-benefit balance is not favourable under the

authorised conditions of use; or

(d) its qualitative and quantitative composition is not as

declared; or

(e) the controls on the medicinal product and/or on the
ingredients and the controls at an intermediate stage of
the manufacturing process have not been carried out
or if some other requirement or obligation relating to
the grant of the manufacturing authorisation has not
been fulfilled.’;

78. Article 119 shall be replaced by the following:

‘Article 119

The provisions of this Title shall apply to homeopathic
medicinal products.’;

79. Articles 121 and 122 shall be replaced by the following:

‘Article 121

1.
The Commission shall be assisted by the Standing
Committee on Medicinal Products for Human Use, here-
in the task of
inafter called “the Standing Committee”,
adapting to technical progress
the directives on the
removal of technical barriers to trade in the medicinal
products sector.

2. Where reference is made to this paragraph, Articles 5
and 7 of Decision 1999/468/EC shall apply, having regard
to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision
1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Articles 4
and 7 of Decision 1999/468/EC shall apply, having regard
to the provisions of Article 8 thereof.

The period laid down in Article 4(3) of Decision
1999/468/EC shall be set at one month.

The Standing Committee shall adopt its own rules of

4.
procedure which shall be made public.

Article 122

the

that

competent

1. Member States shall take all appropriate measures to
ensure
concerned
communicate to each other such information as is appro-
priate to guarantee that the requirements placed on the
authorisations referred to in Articles 40 and 77, on the
certificates
referred to in Article 111(5) or on the
marketing authorisations are fulfilled.

authorities

Upon

reasoned

2.
shall
forthwith communicate the reports referred to in Article
111(3) to the competent authorities of another Member
State.

request, Member

States

The conclusions reached in accordance with Article

3.
111(1) shall be valid throughout the Community.

However, in exceptional cases, if a Member State is unable,
relating to public health,
for
the
reasons
conclusions
an inspection under
following
reached
Article 111(1), that Member State shall forthwith inform
the Commission and the Agency. The Agency shall inform
the Member States concerned.

to accept

When the Commission is informed of these divergences of
opinion,
it may, after consulting the Member States
concerned, ask the inspector who performed the original
inspection to perform a new inspection; the inspector may
be accompanied by two other inspectors from Member
States which are not parties to the disagreement.’;

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80.

in Article 125, the third subparagraph shall be replaced by
the following:

‘Decisions to grant or revoke a marketing authorisation
shall be made publicly available.’;

81. the following Article shall be inserted:

‘Article 126a

1.
In the absence of a marketing authorisation or of a
pending application for a medicinal product authorised in
another Member State in accordance with this Directive, a
Member State may for justified public health reasons
authorise
said
the placing on the market of
medicinal product.

the

2. When a Member State avails itself of this possibility,
it shall adopt the necessary measures in order to ensure
that the requirements of this Directive are complied with,
in particular those referred to in Titles V, VI, VIII, IX and
XI.

Before granting such an authorisation a Member

3.
State shall:

(a) notify the marketing authorisation holder,

in the
in which the medicinal product
Member State
concerned is authorised, of the proposal to grant an
authorisation under
the
product concerned; and

this Article in respect of

(b) request the competent authority in that State to furnish
a copy of the assessment report referred to in Article
21(4) and of the marketing authorisation in force in
respect of the said medicinal product.

4.
The Commission shall set up a register of medicinal
products authorised under paragraph 1. Member States
shall notify the Commission if any medicinal product is
authorised, or ceases to be authorised, under paragraph 1,
including the name or corporate name and permanent
address of
the authorisation holder. The Commission
shall amend the register of medicinal products accordingly
and make this register available on their website.

No later than . . . (*), the Commission shall present a
5.
report
to the European Parliament and the Council
concerning the application of this provision with a view
to proposing any necessary amendments.’;

82. the following Article shall be inserted:

‘Article 127a

is

to be authorised in
When a medicinal product
accordance with Regulation (EC)
. . ./2003 and the
Scientific Committee in its opinion refers to recommended
conditions or restrictions with regard to the safe and
effective use of the medicinal product as provided for in
Article 9(4) (c) of that Regulation, a decision addressed to
the Member States shall be adopted in accordance with the
procedure provided for in Articles 33 and 34 of
this
Directive, for the implementation of those conditions or
restrictions.’.

Article 2

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this
Directive no later
immediately
inform the Commission thereof.

than . . . (**). They shall

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.

Article 3

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

Article 4

This Directive is addressed to the Member States.

Done at . . .

For the European Parliament

The President

For the Council

The President

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

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 26 November 2001, the Commission submitted a proposal for a Directive relating to medicinal

products for human use (1).

The proposal is based on Article 95 of the Treaty.

The proposal, together with a proposal for a Regulation on Community procedures for the auth-
orisation and supervision of medicinal products and establishing a European Agency for the
for a
Evaluation of Medicinal Products (hereinafter called the ‘Regulation’) and a proposal
Directive relating to medicinal products for veterinary use,
the
Community legislation on medicinal products.

the review of

is part of

2. The European Parliament adopted its Opinion at first reading on 23 October 2002 (2). Following

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

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

4. On 29 September 2003, the Council adopted its Common Position in accordance with Article 251

of the Treaty.

II. AIM

The principal objectives of the three proposals making up the review of Community legislation are:

— to ensure that Community legislation can respond to new challenges, particularly the development

of new therapies, and thus to safeguard a high level of health protection in Europe;

— to ensure the proper operation of the internal market both before and after the future enlargement

of the European Union;

— to enhance the competitiveness of the European pharmaceutical industry to enable it better to meet

the challenges of globalisation; and

— to improve the transparency of procedures and decisions.

III. ANALYSIS OF THE COMMON POSITION

1. The Council has been examining the proposal since the end of 2001. 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. Apart
from changes introduced relating to amendments by the European Parliament and other changes on
substance, the Council has agreed on a number of changes, including editorial ones, to clarify the
provisions of the text, to update terminology or to align the text with the proposal for a Regulation
and the proposal for a Directive on medicinal products for veterinary use. The more substantial
changes are described below.

2. Deletion of the possibility to extend the data protection period to 11 years when a new therapeutic

use is found for a new product (Article 10(1)).

(1) OJ C 75 E, 26.3.2002, p. 216.
(2) Doc. 13241/03 (not yet published in the Official Journal).
(3) Doc. 8813/03 (not yet published in the Official Journal).
(4) OJ C 161, 14.3.2003, p. 1.

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3. Deletion of the proposal to harmonise of the legal status of a medicinal product (Article 11).

4. The Council has changed the provision on the choice of Committee procedure in relation to
decisions to be taken by the Commission following an opinion from the scientific committee
(Article 34(1)). The Council does not consider it consistent with Decision 1999/468/EC to have
two different procedures for decisions having the same object and believes that the management
procedure is the appropriate procedure to apply for these decisions.

5. The Council has provided for the possibility of adoption of amendments to the arrangements
concerning the periodic safety update reports through a Committee procedure in the light of
experience gained (Article 104(7)).

6. To improve availability of medicines — particularly in smaller markets — a new article 126a has
been introduced that will allow a Member State for public health reasons and under certain circum-
stances to grant an authorisation for a medicinal product authorised in another Member State.

7. Article 32(5) of the Directive allows for the scientific committee to give recommendations for
conditions and restrictions in respect of nationally authorised products. The new Article 127a
provides for adoption through comitology of decisions requiring Member States to implement
such conditions and restrictions in relation to the safe and effective use of centrally authorised
products, including vis-à-vis third parties (cf. Articles 9(4) and 34(4) of the Regulation).

8. Other changes include:

— Adjusting some time limits in relation to the evaluation procedure (Articles 28(4) and 34(2)).

— Strengthening the supervision powers of the competent authorities by providing them with the
explicit right to request the submission of data from the marketing authorisation holder at any
time (Article 23).

— A new Article 23a has been inserted that requires the marketing authorisation holder to inform
the competent authorities of the date of marketing of the medicinal product and any withdrawal
from the market of the product.

— Extending the requirements on good manufacturing practice to certain excipients (Article 46,

point f).

— Reinstating the existing provision of Article 90, point c).

— Extending the duty of the marketing authorisation holder to report adverse reactions occurring

in the territory of a third country (Article 104(4)).

— Extending the scope of the provision in Article 111 on inspections.

IV. ACCEPTED AMENDMENTS OF THE EUROPEAN PARLIAMENT

The Council has accepted amendments 2, 13, 25, 33, 42, 43, 47, 50, 57, 58, 61, 67, 68, 70, 82, 83, 88, 93,
97, 101, 110, 125, 130, 157, 158, 173 and 198, amendment 25 and 33 being subject to minor drafting
changes. Amendments 57 and 157 have been merged into one paragraph (Article 24(6)).

As a consequence of the acceptance of amendment 42 in relation to the summary of product charac-
teristics (Article 11), the Council has rearranged the order of information required. As concerns
amendment 82, it should be noted that the Council has switched the order of point d) and e) in
Article 59(1).

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V. AMENDMENTS OF THE EUROPEAN PARLIAMENT ACCEPTED PARTLY OR IN PRINCIPLE

1. The Council has partly or in principle accepted amendments 3, 5, 12, 14, 15, 24, 27, 30, 31, 32,
34, 36, 38, 51, 52, 53, 54, 55, 60, 63, 66, 69, 71, 84, 85, 86, 92, 94, 95, 99, 106, 107, 108,
116, 122, 123, 124, 134, 156, 159, 167, 168, 181, 185, 186, 191 and 202.

2. The concept of amendment 24 on temporary authorisations of medicinal products in relation to
bio-terrorism has been welcomed by the Council subject to some further clarification of the text, in
particular specifying that there should be no exemption from liability for defective products.
Further, on the subject of criminal liability, the Council believes that this issue falls within the
competence of each Member State.

3. The Council has accepted those parts of amendments 34 and 202 that relate to the right of a generic
company to submit an application after 8 years after the marketing authorisation for the reference
product has been granted, and that allows for marketing to take place immediately after 10 years.
To add that also the authorisation can only be granted after expiry of the 10 year period seems to
be in contradiction with allowing marketing upon expiry of the same period. See also section VI.

4. Amendment 36 on authorisation of generics in a Member State where the original product was not
authorised has been accepted in principle. The Council has reworded the amendment to specify the
information that is essential for the evaluation of the alleged generic product, i.e. the fact that the
reference product has been authorised and the composition of the reference product (to assess
whether the alleged generic product is a generic of the reference product), leaving it up to the
Member State of application to request further documentation, for example the assessment report.

5. Amendment 38 on the requirement of tests to be provided in case of change in the active
substance(s) in a generic medicinal product has been accepted in principle. The Council believes
that the redrafting of Article 10(3) further clarifies the provision to this end.

6. In relation to amendment 54 on making available marketing authorisations granted by Member
States on the Agency's website, the Council believes that no rewording is necessary as this request
in essence is covered by Article 57(2) of the Regulation relating to the content of the Agency
database.

7. Amendment 84 on consultations with patients in relation to the leaflet package has in substance
been accepted but has been redrafted to make clear that the package leaflet should actually reflect
the result of such consultations, cf. Article 59(3).

8. The Council agrees with the aim of amendment 92 to give an incentive to the marketing author-
isation holder to apply for a change in classification of the product from prescription only to non
prescription status but believes that one year of protection of the data is sufficient, taking account
of other benefits of changing classification such as increased marketing possibilities. In relation to
the first part of the amendment on applications for change of classification, Article 74 dealing with
‘new facts’ already covers the content of this provision.

9. Amendment 107 has been accepted in principle as it in substance reinstates the existing provision

in Article 90, point c) (see section III).

10. Amendments 122 and 159 on the marketing authorisation holder's obligation to inform without delay
the competent authorities of the withdrawal of a product from the market have been accepted. No
rewording is necessary as this obligation is already provided for in the new Article 23a.

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11. Amendment 134 relating to the so called Bolar clause on patent protection has been accepted in
principle except the part referring to products for exports. In relation to submission of applications
and granting of an authorisation, the Council believes that these activities, being of an adminis-
trative nature, will not
infringe patent protection. The Council and the Commission have
underlined this in a joint statement (1). Thus, it is neither necessary nor appropriate to include
those activities in a provision on exemptions from patent protection. As concerns the submission
of samples, this will be covered by the addition agreed by the Council:
‘and the consequential
practical requirements’.

12. Part of amendment 181 referring to hospitality at sales promotions, cf. Article 94(2) has been
accepted. Specifying in Article 94(3)
that medical sales representatives may not offer any
prohibited inducement seems unnecessary as the wording of the previous paragraphs indirectly
covers this.

13. As concerns the provisions on renewal of marketing authorisations, amendments 185 and 186 have
in principle been accepted by the Council in that it agrees to have one renewal after a five year
period. Thereafter the validity of the marketing authorisation should be unlimited. However, the
it is administratively simpler to
Council believes that for the purposes of the 5 year renewal
commence the 5 year period from the date of the marketing authorisation. In addition,
it is
necessary that the provision be the same as the corresponding provision of the Regulation. The
Council has thus basically agreed to the drafting of Article 24 as proposed by the Commission in
its amended proposal with some clarification of the wording and one important addition, i.e. to
provide for a possibility for the competent authorities to decide on one extra five year renewal
based on justified pharmacovigilance grounds. The Council believes that this addition provides the
competent authorities with an extra tool to ensure the effective surveillance of authorised products.

14. In relation to a number of amendments, the Council has accepted these in principle but prefers the
redrafting suggested by the Commission in its amended proposal as more precise and appropriate
for the same reasons stated by the Commission. In some cases slight additions have been made
(indicated below). The following amendments are concerned:

— Amendment 3 on the reference to a high level of health, cf. Recital 3.

— Amendments 5 and 32 on ethical criteria in the context of clinical trials, cf. new Recital 13.

— Amendment 12 on the simplification of the definition of homeopathic products, cf. Article 1,

point 5.

— Amendment 14 on the definition of a local representative, cf. Article 1, point 18a. The part

concerning responsibility has been transferred to Article 6(1a).

— Amendment 15 on definitions of risks and the risk-benefit balance, cf. Article 1, points 28, 29
and 30, with the clarification that ‘risks as defined above’ be changed to ‘risks as defined in
point 28’.

— Amendments 27, 30 and 31 on particulars and documents to be submitted, cf. Article 8(3)(g and ia).

— Amendment 51, 52 and 53 (partly) on making marketing authorisations, the assessment report

and the scientific reasoning available to the public, cf. Article 21(3 and 4).

— Amendment 55 on conditional marketing authorisations, cf. Article 22.

— Amendment 60 on the applicants responsibility for data submitted, cf. Article 26(3).

(1) ‘The Council and the Commission consider that the submission and subsequent evaluation of an application for a
marketing authorisation as well as the granting of an authorisation are considered as administrative acts and as such
do not infringe patent protection.’

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— Amendment 63 on the term ‘serious potential risk to public health’ as ground for a refusal to
recognise a marketing authorisation granted by another Member State, cf. Article 29(2).

— Amendment 66 on the arbitration procedures in relation to the mutual recognition procedure,

cf. Articles 29(4), 30(1), 31(1) and 116.

— Amendment 69 on the deadline for the transmission of the opinion of the Scientific Committee,

cf. Article 32(5).

— Part of amendment 71 on a report on the functioning of the Directive, cf. Article 38(2).

— Amendment 85 on assessments to be carried out on mock-ups of the outer packing, cf. Article

61(1).

— Amendment 86 concerning languages of the leaflet, cf. Article 63(2).

— Amendment 94 on notification of the marketing authorisation holder in connection with
imports, cf. Article 76(3), with the precision added that such a notification is

parallel
without prejudice to additional national procedures for authorising imports.

— Amendment 95 on the obligation concerning uninterrupted supply, cf. Article 81, with the

precision that the supply should be continued supply.

— Amendment 99 on the definition of advertising (reinstating the text of the existing provision of

Article 86(1))

— Amendments 106 and 191 on the reference to the non proprietary name, cf. Article 89(2).

— Amendment 108 on the mentioning of a trademark in advertising, cf. Article 91(2).

— Part of amendment 116 on the publication of pharmacovigilance information, cf. Article 102,

with a slight editorial change.

— Amendment 156 on the definition of a generic medicinal product, cf. Article 10(2)(b), with the
deletion of ‘solid’ as the Council is of the opinion that a limitation to solid oral forms would
make the definition too restrictive.

— Amendments 167 and 168 on the so called biosimilars in relation to generics, cf. Article 10(4),
with the inclusion of a reference to differences in manufacturing processes between the
biological medicinal product and the reference medicinal product.

VI. AMENDMENTS OF THE EUROPEAN PARLIAMENT REJECTED PARTLY OR IN TOTAL

1. The Council has rejected in total or partly amendments 1, 4, 6, 8, 9, 10, 11, 16, 18, 19, 20, 21,
22, 23, 26, 28, 29, 35, 40, 44, 45, 48, 49, 53, 56, 59, 62, 64, 65, 71, 72, 73, 74, 75, 76, 77, 78,
79, 80, 81, 87, 89, 91, 96, 98, 100, 102, 103, 104, 105, 111, 113, 114, 115, 117, 118, 119,
120, 121, 126, 127, 129, 131, 132, 134, 135, 136, 141, 151, 153, 154, 155, 172, 176, 179,
181, 182, 189, 190 and 196.

2. As stated above, the Council has accepted amendments 101 and 198 on the deletion of the
provision proposed by the Commission on information to patients. The Council believes that
the proposal does not make an appropriate distinction between information and advertising and
finds the approach based exclusively on industry provided information questionable.

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Although the Council, like the Parliament, sees the need to provide patients with better access to
reliable information and commends the efforts of the Parliament to come up with an alternative, it
has not been able to support the concrete text of amendments 8, 9, 98, 102, 103, 104, 113 and
182. The Council finds the amendments too far-reaching in that they entrust the Commission with
the task of preparing a comprehensive information strategy to be followed up by proposals that
would be binding upon Member States thereby potentially imposing heavy administrative burdens
on the national authorities. The Council considers that the issue of information to patients merits
further consideration and considers it premature to resolve the issue in the context of the present
revision of the Directive.

3. The Council has not accepted the addition in the definition of a medicinal product of the words
‘by exerting a pharmacological action’ as proposed amendment 11, as this addition would make the
definition too restrictive.

4. The Council shares the aim of amendments 18, 19, 20, 154, 21, 22 and 23 of resolving the issue of
the delineation of medicinal products and other products but can not agree to the concrete text of
these amendments, as this would in the view of the Council not solve the problem of the so called
borderline products, i.e. products that fulfil the definition of medicinal products for human use and
the definition of products regulated under one or more other legislative acts. As stated by the
Commission in its amended proposal, Article 2(2), which reflects the case law of the European
Court of Justice, is necessary to take account of the borderline cases and to ensure legal certainty.
Further, the Council agrees with the Commission in that the addition to recital 7 will clarify the
interpretation of Article 2(2) by setting out that when a product clearly comes under the definition
of a range of other sectorial
legislation, the product should not be regulated as a medicinal
product. Specifically, on amendment 19 on empowering the Agency to decide borderline cases,
the Council refers to the Commission's explanation that the Directive is to be applied by national
authorities and that the issue can be addressed in the context of the mutual recognition procedure.

5. As the Council has agreed on deleting Article 10(1), second subparagraph on the possibility of
extension of the data protection to 11 years, it has not been able to accommodate amendment 35
on inserting the word ‘maximum’ (11 years). The Council accepted the Commission's proposal to
retain 10 years' data exclusivity for products for which use of the centralised procedure is
mandatory, and a further year if a new therapeutic use is found for the products. However, and
bearing in mind the widely differing data protection periods available in the Member States, and
increase in data protection that the acceptance of the ‘8+2’ provision
hence the significant
represents to a number of Member States, there is no justification for adding a further year's
data exclusivity for nationally authorised products.

6. In relation to amendment 44 on homeopathic medicinal products, the Council is of the opinion that
reinstating the requirement for Member States to take due account of registrations by other
Member States is superfluous as it would not change the legal situation, i.e. there is no legal
requirement to recognise registrations of other Member States. Consequently amendment 62 on
extending the mutual recognition procedure to registered homeopathic medicinal products has
been rejected.

7. Amendment 46 and the consequential amendments 48 and 89 thereof have been rejected as the
Council does not consider ‘potentisation’ to be the correct terminology to apply in this context as
potentisation is a different operation from dilution.

8. The Council has not accepted amendment 49 aimed at setting an 80 day time limit for preparation of
the rapport of the rapporteur as the Council prefers, in line with the corresponding provision of the
Regulation (Article 6(3)), to retain the all inclusive time limit of 210 days for the processing of an
application thereby providing the necessary flexibility in the operation of the procedure (Article
17(1)).

9. Amendment 80 on the inducement of patients to report adverse reactions to the competent auth-
orities has not been accepted. The Council considers that, in general, the proper addressee for
patients' reporting of adverse reaction should be a health care professional, also to avoid double
reporting to the competent authorities.

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10. Amendment 91 on using the phrase ‘without specific therapeutical indication’ in relation to the
labelling of homeopathic medicinal products has not been accepted, as those products are deemed
not to have therapeutic indications in general but adapted for each patient.

11. In relation to amendment 114 aimed at setting out a requirement for doctors and health care
professionals to report adverse reactions to the competent authorities, the Council prefers to leave
it up to the national authorities to require this, also taking into account that the marketing
authorisation holder is obliged to report adverse reactions to the authorities,
including those
reported by a health care professional.

12. As concerns amendment 119 on obliging the marketing authorisation holder to report adverse
reactions reported to him or her by a patient, the Council does not believe that it, in general,
would be appropriate to encourage patients to report directly to the marketing authorisation
holder without
the
the intervention of a health care professional, also taking into account
potential for double reporting. Consequently, the Council has not accepted the amendment.

13. Although the Council understands the aim of the first part of amendment 120 as concerns the
periodic safety update reports,
it cannot accept this part of the amendment as it considers it
administratively simpler to relate the period to the date of the authorisation. In addition, it is
necessary that the provision be the same as the corresponding provision of the Regulation. It
should be noted that the Council has agreed on a provision (Article 104(7)) whereby amendments
to the arrangements concerning the periodic safety update reports can be adopted through a
Committee procedure in the light of experience gained. In relation to the second part of the
amendment the Council agrees with the statement of the Commission in its amended proposal
that there is no legal basis for giving the Agency's pharmacovigilance working group such
competence. As concerns the publication of the periodic safety update reports, this is already
provided for in Article 102.

14. The Council can agree to the aim of amendment 121 on communication of adverse reactions from
the marketing authorisation holder to ensure that such communication is correct and complete but
believes that the requirement of prior consent of the competent authority is disproportionate and
can therefore not agree to the concrete wording proposed by the Parliament. Given that the
marketing authorisation holder is responsible for such information and thus has an interest in
the accuracy and objectivity of this information, the Council believes that a requirement to notify
the competent authority and thereby giving the competent authority the possibility to counter any
misleading information, while underlining the responsibility of the marketing authorisation holder,
is sufficient to achieve the aim of the amendment (Article 104(9)).

15. In relation to part of amendment 134 and amendment 196 on exemptions from patent protection for
products intended for exports, the Council considers such exemptions to fall outside the scope of
what should be regulated in a Directive on medicinal products intended to be placed on the
market in Member States. As concerns amendment 196 specifically, the Council refers to the
Commission's amended proposal stating that it is in conflict with the WTO TRIPS agreement
(Agreement of Trade Related Intellectual Property Rights).

16. The Council has decided to delete the reference to classification of the legal status of a medicinal
product in Article 11, as such a reference according to Article 28 would entail an obligation to
recognise the classification granted by the reference Member State. Consequently, the Council has
not accepted amendment 151, albeit that the amendment appears to soften the requirement to
recognise the classification of the legal status. Article 71 of the Directive is recalled in this context,
which sets out criteria for when a medicinal product should be subject to a medical prescription.
The Council considers it to be unnecessary to add a specific obligation to mutually recognise the
legal status of a medicinal product.

17. Part of amendment 181 on gifts etc. offered to health care professionals aimed at deleting the
allowance of inexpensive gifts etc. that are relevant to the practice of medicine or pharmacy and
deleting the derogation for measures and practices in Member States have not been accepted as
such restrictions are impracticable, disproportionate and unjustified.

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18. In relation to a number of amendments, the Council has rejected these for the same reasons as stated

by the Commission in its amended proposal. These are the following:

— Amendment 1 on a recital distinguishing medicinal products from other goods.

— Amendment 4 on a recital making a reference to Articles 152 and 153 of the Treaty.

— Amendments 6, 29, 135 and 136 on requirements to differentiate between adults and children

and between sexes in relation to various issues.

— Amendment 10 and 26 on environmental issues.

— Amendment 16 and 73 on the same denomination for generic medicinal products in all Member

States.

— Amendment 28 on a reference in the documents and particulars accompanying the application

to all tests regardless of who carried them out.

— Amendment 40 on a three year data protection period for new indications for a well established

substance.

— Amendment 45 on the provision on routes of administration for registered homeopathic

medicinal products.

— Part of amendment 53 on a reference to each indication in the assessment reports.

— Amendment 56 on an obligation for the marketing authorisation holder to take account of

scientific and technical progress after authorisation.

— Amendments 59 and 131 on studies on the Community legislation concerning prices and on

comparison of new medicinal products authorised by the Community.

— Amendment 64 and 65 on the obligation to refer disagreement on certain issues in relation to

mutual recognition to the scientific committees.

— Part of amendment 71 on a requirement that the report on mutual recognition address the need

to standardise of the procedures on pre-clinical tests and clinical trials.

— Amendments 72, 74, 75, 76 and 77 on certain information to be put on the packaging.

— Amendment 78 on information in Braille to be put on the packaging or package leaflet.

— Amendment 79 on an obligation on Member States to maintain a database accessible through

the internet.

— Amendment 81 on the obligation to indicate if the medicinal product has been authorised

within five years.

— Amendment 87 on the guidelines to be adopted concerning the labelling and package leaflet.

— Amendments 96 and 132 relating to obligations to be imposed on pharmacies.

— Amendments 100 and 105 on certain requirements to advertising of a medicinal product.

— Amendment 111 on extending the provision to cover co-marketing.

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— Amendment 115 on the internal organisation of the Commission.

— Part of amendment 116 and amendments 123 and 124 on access to pharmacovigilance

information.

— Amendment 117 on the financing of national authorities' pharmacovigilance activities.

— Amendment 118 on a requirement to report all adverse electronically.

— Amendment 126 on an obligation to perform comparative risk-benefit analysis.

— Amendment 127 on a requirement of informing the prosecuting authorities in case of falsified

documents.

— Amendment 129 on requirements to the national authorities relating to independence, trans-

parency and organisation and content of databases.

— Amendment 141 on a recital referring to certain objectives of the legislation.

— Amendments 153 and 154 proposing a new category of products (herbal products).

— Amendment 155 on the deletion of the requirement of Article 6(1) to include the various
strengths, pharmaceutical forms, routes of administration and forms of presentation in the
same marketing authorisation. The Council has, however, clarified the wording of
this
paragraph.

— Amendment 172 on a recital making a reference to pharmacovigilance data collected in third

countries and by the WHO.

— Amendment 176 on including the results of long term tests in the application for a marketing

authorisation.

— Amendment 179 on the possibility for Member States to derogate from provisions on evaluation

of homeopathic medicinal products.

— Amendments 189 and 190 on additional information to be included in the summary of product

characteristics.