Modified proposal for a Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision and pharmacovigilance of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)
Date: 2002-12-10
Institutions: European Commission
Subjects: European Medicines Agency, drug surveillance, health policy, pharmaceutical legislation, single market

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 10.12.2002
COM(2002) 735 final

2001/0252 (COD)

Modified proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

laying down Community procedures for the authorisation and supervision and
pharmacovigilance of medicinal products for human and veterinary use and establishing
a European Agency for the Evaluation of Medicinal Products

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

2001/0252 (COD)

Modified proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

laying down Community procedures for the authorisation and supervision and
pharmacovigilance of medicinal products for human and veterinary use and establishing
a European Agency for the Evaluation of Medicinal Products

1. 

BACKGROUND

(Text with EEA relevance)

Transmission of the proposal to the Council and to the European Parliament
- COM(2001) 404 final – 2001/0252 (COD) -
by virtue of article 175, paragraph 1 of the Treaty:

26 November 2001

Opinion of the European Economic and Social Committee:

18 September 2002

Opinion of the European Parliament – first reading:

23 October 2002

2. 

OBJECTIVE OF THE COMMISSON PROPOSAL

Regulation  2309/93  provides  for  the  possibility  of  an  evaluation  of  the  Community
procedures for the authorisation and the supervision of medicinal products which entered into
force  in  1995.  In  view  of  the  experience  gained  during  1995  and  2000  and  the  analysis
performed by the Commission in its report ‘on the operation of the Community procedures for
the marketing authorisation of medicinal products  (COM(2001)  606  final  of  23.10.2001)’  it
appeared necessary to amend Regulation 2309/93 and Directives 2001/83/EC and 2001/82/EC
laying down the Community codes in relation to medicinal products for human and veterinary
use.

In general, four major objectives appear to be particularly relevant.

(1) 

(2) 

(3) 

(4) 

to assure a high level of public health protection, notably by making safe, innovative
products available to patients as quickly as possible, and by an increased supervision
inspection  procedures  and  of
the  market 
of 
pharmacovigilance;

the  strengthening  of 

through 

to  complete  the  single  market  for  pharmaceutical  products  taking  into  account  the
stakes  of  globalisation  and  to  establish  a  regulatory  and  legislative  framework  that
favours the competitiveness of European industry;

to respond to the challenges of the future enlargement of the European Union;

to rationalise and simplify the system as well as to improve its overall coherence and
visibility and the transparency of its procedures.

Finally  with  respect  to  veterinary  medicines,  the  proposals  aim  specifically  to  take  into
account the problem of the availability of medicinal products for veterinary use.

2

3. 

3.1. 

OPINION OF THE COMMISSION ON THE AMENDMENTS ADOPTED BY
THE PARLIAMENT

Amendments accepted by the Commission: 12, 14, 16, 28, 30, 32, 33, 36, 37, 40,
41, 61, 69, 72, 75, 77, 78, 84, 90, 95, 98, 99, 101 (in part), 102, 103, 104, 106, 107
(in part), 108 (in part), 110 (in part), 111, 112, 114, 115, 116, 117, 120, 123, 124,
125, 126, 127, 128 (in part), 130 and 135.

The  Commission  can  accept  the  following  amendments  with  the  wording  proposed  by  the
European Parliament. Certain provisions, other than those targeted by the amendments, have
been brought into line with the new wording,  where  necessary. This  concerns, in particular,
Article  13,  paragraph  3;  Article  32,  paragraph  1,  subparagraph  1;  Article  32,  paragraph  2,
subparagraph  2a;  Article  34,  paragraph  2;  Article  35,  paragraph  3  and  Article  44,
paragraph 3a.

–  Amendment 12 aimed at introducing a new recital concerning the financial aspects of the

agency in view of enlargement:

“Recital 17 a

Paragraph  25  of  the  Interinstitutional  agreement  of  6  May  1999  between  the  European
Parliament, the Council and the Commission on budgetary discipline and improvement of
budgetary procedure (1) provides that the Financial Perspective will be adjusted on order to
cover the new needs resulting from enlargement

(1) OJ C172 18.6.1999, p.1

–  Amendment  14  aimed  at  including  a  negative  benefit/risk  analysis  as  a  reason  for

withdrawing a medicinal product from the market:

“Recital 24:

It is also necessary to take measures for the supervision of medicinal products authorised by
the Community, and in particular for the intensive supervision of undesirable effects of these
medicinal products within the framework of Community pharmacovigilance  activities, so as
to  ensure  the  rapid  withdrawal  from  the  market  of  any  medicinal  product  presenting  a
negative benefit/ risk balance under normal conditions of use.

–  Amendment 16 aimed at modifying the name of the Agency in certain linguistic versions :

“Article 1, first paragraph:

The purpose of this Regulation is to lay  down Community procedures  for the authorisation,
supervision and pharmacovigilance of medicinal products for human and veterinary use, and
to establish a European Medicinal Products Agency (hereinafter referred to as ‘the Agency’).

–  Amendments 28 and 69 aimed at strengthening the inspection of the manufacturing sites of

the applicant for medicinal products for human and veterinary use:

“Article 8, paragraph 2, subparagraph 1:

2. Where it considers it necessary in order to complete its examination of an application, the
Committee for Human Medicinal Products may require the applicant to submit to a specific

3

inspection  of  the  manufacturing  site  of  the  medicinal  product  concerned.  Such  inspections
may be carried out unannounced.

“Article 30, paragraph 2, subparagraph 1:

1. Where it considers it necessary in order to complete its examination of the application, the
Committee  for  Veterinary  Medicinal  Products  may  require  the  applicant  to  submit  to  a
specific inspection of the manufacturing site of the veterinary medicinal product concerned.
Such inspections may be made unannounced.”

–  Amendments 30, 32, 33 and 72 aimed at shortening the time limit for the decision-making

process:

“Article 9, paragraph 3:

3. Within 15 days of its adoption, the Agency shall send the final opinion of the Committee for
Human  Medicinal  Products  to  the  Commission,  to  the  Member  States  and  to  the  applicant.
The  opinion  shall  be  accompanied  by  a  report  describing  the  assessment  of  the  medicinal
product by the Committee and stating the reasons for its conclusions.

Article 10, paragraph 1, subparagraph 1:

1.  Within  15  days  of  receipt  of  the  opinion  referred  to  in  Article  5,  paragraph  2,  the
Commission shall prepare a draft of the decision to be taken in respect of the application.

Article 10, paragraph 2, subparagraph 2 a:

The Commission decision shall adopt its final decision within 15 days after the end of the
procedures referred to in Articles 77, paragraph 3 and 77, paragraph 4.

Article 31, paragraph 3:

3. Within 15 days of its adoption, the Agency shall send the final opinion of the Committee for
Human  Medicinal  Products  to  the  Commission,  to  the  Member  States  and  to  the  applicant,
together with a report describing the assessment of the medicinal product by the Committee
and stating the reasons for its conclusions.

Article 32, paragraph 1, subparagraph 1:

1.  Within  15  days  of  receipt  of  the  opinion  referred  to  in  Article  27,  paragraph  2,  the
Commission shall prepare a draft of the decision to be taken in respect of the application.

Article 32, paragraph 2, subparagraph 2 a:

The Commission decision shall adopt its final decision within 15 days after the end of the
procedures referred to in Articles 77, paragraph 3 and 77, paragraph 4.”

Amendments 36 and 75 aimed at publishing information concerning the refusals or negative
opinions for applications for marketing authorisation:

“Article 11, paragraph 2 a:

2a.  Information  about  all  refusals  and  the  reasons  for  them  shall  be  made  publicly
accessible.

4

Article 33, paragraph 2 a:

2a.  Information  about  all  refusals  and  the  reasons  for  them  shall  be  made  publicly
accessible.”

–  Amendment  37  aimed  at  completing  the  details  of  the  notifications  of  marketing

authorisations published in the Official Journal:

“Article 12, paragraph 2:

2. Notifications of marketing authorisations shall be published in the Official Journal of the
European  Communities,  quoting  in  particular  the  date  of  authorisation,  the  registration
number  in  the  Community  Register,  the  INN  (international  non-proprietary  name)  of  the
active substance of the medicinal product, the pharmaceutical form and the ACT code.

“Article 34, paragraph 2:

2. Notifications of marketing authorisations shall be published in the Official Journal of the
European  Communities,  quoting  in  particular  the  date  of  authorisation,  the  registration
number  in  the  Community  Register,  the  INN  (international  non-proprietary  name)  of  the
active substance of the medicinal product, the pharmaceutical form and the ACT code.

Amendments 40 and 77 aimed at altering the period of validity of the marketing authorisation
in the case where this has not  been followed  by the placing  on the  market  of  the  medicinal
product.  The  same  provision  is  introduced  in  the  case  of  previously  authorised  medicinal
products which have not been on the market for a certain period:

“Article 13, paragraph 2:

2. Any authorisation which is not followed by the actual placing of the medicinal product for
human  use  authorised  on  the  Community  market  within  three  years  of  authorisation  shall
cease to be valid.

Article 13, paragraphe 3:

3. When a previously marketed medicinal product for human use has not been marketed for
three consecutive years, the authorisation granted for this medicinal product shall cease to be
valid.

Article 35, paragraph 2:

2. Any authorisation which is not followed by the actual placing of the medicinal product for
human  use  authorised  on  the  Community  market  within  three  years  of  authorisation  shall
cease to be valid.

Article 35, paragraph 3

3. When a previously marketed medicinal product for human use has not been marketed for
three consecutive years, the authorisation granted for this medicinal product shall cease to be
valid.

–  Amendments 41 and 78 aimed at introducing a derogation from the rule that a marketing

authorisation is valid for three years:

5

“Article 13, paragraph 3 a:

2  a.  In  exceptional  circumstances  and  on  public  health  grounds  the  competent  authority
may grant a derogation from paragraphs 2 and 3. Such a derogation must be duly justified.

“Article 35, paragraph 3 a:

2  a.  In  exceptional  circumstances  and  on  public  health  or  animal  health  grounds  the
competent authority may grant a derogation from paragraphs 2 and 3. Such a derogation
must be duly justified.

–  Amendment  61  aimed  at  preventing  the  marketing  authorisation  holder  from  providing

pharmacovigilance information without the consent of the Agency:

“Article 22, paragraph 3 a:

3a.  The  holder  of  a  marketing  authorisation  shall  not  be  authorised  to  communicate
information concerning pharmacovigilance issues to the general public without the consent
of the Agency.

Article 44, paragraph 3 a:

3a.  The  holder  of  a  marketing  authorisation  shall  not  be  authorised  to  communicate
information concerning pharmacovigilance issues to the general public without the consent
of the Agency.”

–  Amendments  84,  102,  103,  104,  106  and  114  aimed  at  modifying  the  method  of
nominating  and  of  working  of  the  Committees  of  the  Agency  and  101,  107  and  108,  in
part, except for the reference to the Committee for Herbal Medicinal Products (the method
of  nominating  and  the  work  of  the  committee,  along  the  lines  of  what  is  set  out  for  the
Committee  on  Orphan  Medicinal  Products  in  the  specific  Regulation,  is  set  out  in  the
proposal  for  the  Directive  concerning  medicinal  products,  currently  undergoing  its  first
reading in the European Parliament and the Council):

–  “Article 50, paragraph 2:

2. The Committees referred to in points (a) to (d) of paragraph 1 may each establish standing
and temporary working parties. The Committees referred to paragraph 1(a) and (b) shall set
up panels in order to secure, in connection with the evaluation of medicinal products, the
benefit  of  expertise  focused  in  particular  on  a  specific  type  of  medicinal  product  or
treatment. The Committees referred to paragraph 1(a) to (d) shall lay down in their rules of
procedures the precise arrangements for consulting the panels and delegating certain tasks
to  them.  They  shall  also  determine  the  arrangements  for  nominating  members  of  the
working parties and the panels on the basis of the lists of experts referred to in the second
subparagraph of Article 55(2).

Article 54, paragraph 1, subparagraphs 1 and 2:

With  a  view  to  the  appointment  of  the  members  of  the  Committee  for  Human  Medicinal
Products, the Committee on Herbal Medicinal Products and the Committee for Veterinary
Medicinal  Products,  each  Member  State  shall  propose,  for  each  committee,  five  persons
selected  on  the  basis  of  their  role  and  their  experience  in  the  evaluation  of  human  or
veterinary medicinal products.

6

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

The  members  appointed  on  a  proposal  from  the  Member  States  shall  propose  to  the
Executive Director (with a view to securing their appointment) five additional members for
each  committee,  chosen  on 
their  specific  scientific  competence.
The members of each committee shall be appointed for a three-year period which shall be
renewable.

the  basis  of 

Wherever  possible,  the  committees  shall  seek  to  establish  contacts,  on  an  advisory  basis,
with patients associations, professionals working in the sector, etc.

Article 54, paragraph 1, subparagraph 4:

The  Executive  Director  of  the  Agency  or  his/her  representative  and  representatives  of  the
Commission  shall  be  entitled  to  attend  all  the  meetings  of  the  Committees  and  all  the
meetings convened by the Agency or its committees.

Article 54, paragraph 5:

5. Each Committee shall establish its own rules of procedure. These rules shall in particular
lay down:

(a) the procedures for appointing and replacing the Chairman,

(b) the procedures for consulting and delegating certain tasks to working parties,

(c)  consultation,  in  connection  with  the  evaluation  procedures  for  medicinal  products,  of
the  panels  referred  to  in  the  second  subparagraph  of  Article  50,  paragraph  2,
subparagraph 2.

(d)  the  establishment  of  a  procedure  for  the  urgent  adoption  of  opinions,  particularly  in
relation  to  the  provisions  on  market  surveillance  and  pharmacovigilance  laid  down  in  this
Regulation.

They shall enter into force after receiving a favourable opinion from the Commission and the
Management Board.

Article 55, paragraph 1,subparagraph 1 a and 1 b:

When  the  panels  referred  to  in  the  second  subparagraph  of  Article  50  paragraph  2,
subparagraph  2  are  consulted,  the  Committee  shall  forward  to  them  the  evaluation
report(s) drawn up by the rapporteur or the co-rapporteur. The opinion issued by the panel
shall be forwarded to the chairman of the relevant Committee in such a way as to ensure
that the deadlines laid down in Article 6, paragraph 3 and Article 28, paragraph 3 are met.

The  substance  of  the  opinion  shall  be  included  in  the  final  evaluation  report  published
pursuant to Article 12, paragraph 3 and Article 34, paragraph 3.

7

Article 55, paragraph 1, subparagraph 2:

If  there  is  an  appeal  against  one  of  its  opinions,  the  Committee  concerned  shall  appoint  a
different rapporteur and, where necessary, a different co-rapporteur from those appointed for
the initial opinion. This appeal procedure may deal only with the points relating to the initial
opinion  provisionally  identified  by  the  applicant  and  may  only  be  based  on  scientific  data
available at the time the Committee adopted the initial opinion. Consultation of a panel may
be requested in connection with such an appeal

Article 55, paragraph 2, subparagraph 1:

Member  States  shall  transmit  to  the  Agency  the  names  of  national  experts  with  proven
experience  in  the  assessment  of  medicinal  products  who  would  be  available  to  serve  on
working  parties  or  expert  groups  of  the  Committee  for  Human  Medicinal  Products  or  the
Committee  for  Veterinary  Medicinal  Products,  and  also  on  panels,  together  with  an
indication of their qualifications and specific areas of expertise.

Article 57, paragraph 2, subparagraph 1:

2.  The  Executive  Director  shall  be  the  legal  representative  of  the  Agency.  He/she  shall  be
responsible for appointing the members of the scientific committees, pursuant to Article 54,
paragraph 1 or other provisions of Community law:”

–  Amendment 90 aimed at modifying the functions of the Agency, concerning inspections of

compliance with good practices:

“Article 51, paragraph 1, point g):

(g)  coordinating  the  verification  of  compliance  with  the  principles  of  good  manufacturing
practice, good laboratory practice, good clinical practice and the verification of compliance
with pharmacovigilance obligations;”

–  Amendment 95, aimed at specifying the contents of the database on medicinal products:

“Article 51, paragraph 2:

2.  The  database  provided  for  in  point  (j)  of  paragraph  1  shall  include  the  summaries  of
product characteristics, the patient or user package leaflet and the information shown on the
labelling.  The  database  shall  be  developed  in  stages,  priority  being  given  to  medicinal
products authorised under this Regulation and those authorised under Chapters IV (Title III)
of  Directive  2001/83/EC  and  Directive  2001/82/EC  respectively.  The  database  shall
subsequently  be  extended  to  include  any  medicinal  product  marketed  in  the  European
Union.”

–  Amendments  98  and  99  aimed  at  publishing  documents  prepared  in  the  event  of  a

disagreement between the Agency and a scientific committee:

“Article 53, paragraphs 3 and 4:

3.
Where  there  is  a  fundamental  disagreement  over  scientific  points  and  the  body
concerned  is  a  Community  agency  or  a  scientific  committee,  the  Agency  and  the  body
concerned shall work together either to solve the disagreement or to submit a joint document

8

to  the  Commission  clarifying  the  scientific  points  of  disagreement.  This  document  shall  be
published immediately after its adoption

4.
Except where otherwise provided for in this Regulation, in Directive 2001/83/EC or in
Directive 2001/82/EC, where there is a fundamental disagreement over scientific points and
the body concerned is a body in a Member State, the agency and the national body concerned
shall work together either to solve the disagreement or to prepare a joint document clarifying
the scientific points of disagreement. This document shall be published immediately after its
adoption”

–  Amendments 110 (second and third part), 111 and 112 aimed at specifying the contents of
the code of conduct of the Agency as well as publishing and making accessible on request
the declarations of interest of the Members of the boards and committees of the Agency:

“Article 56, paragraph 2, subparagraph 1, 1a and 2:

Members  of  the  Management  Board,  members  of  the  Advisory  Board,  members  of  the
Committees,  rapporteurs  and  experts  shall  not  have  financial  or  other  interests  in  the
pharmaceutical industry which could affect their impartiality. They shall undertake to act in
the  public  interest  and  in  an  independent  manner,  and  they  shall  make  an  annual
declaration  of  their  financial  interests.  All  indirect  interests  which  could  relate  to  the
pharmaceutical industry shall be entered in a register held by the Agency which is accessible
to the public, on request, at the Agency's offices.

The  Agency´s  code  of  conduct  shall  provide  for  the  implementation  of  this  article  with
particular reference to the acceptance of gifts.

Members  of  the  Management  Board,  members  of  the  Advisory  Board,  members  of  the
Committees,  rapporteurs  and  experts  who  participate  in  meetings  or  working  groups  of  the
Agency shall declare, at each meeting, any specific interests which could be considered to be
prejudicial to their independence with respect to the points on the agenda. These declarations
shall be available to the public.”

–  Amendment  115  aimed  at  covering  the  activities  of  the  Committee  on  Herbal  Medicinal

Products in the context of the responsibilities of the executive director:

“Article 57, paragraph 3, subparagraph 1:

Each year, the  Executive  Director  shall  submit  the  following to  the  Management  Board  for
approval,  while  making  a  distinction  between  the  Agency's  activities  concerning  medicinal
products  for  human  use,  herbal  medicinal  products  and  those  concerning  veterinary
medicinal products:”

–  Amendments 116 and 117 aimed at modifying the composition of the Management Board:

“Article 58, paragraphs 1 and 2

1.
The  Management  Board  shall  consist  of  15  members  appointed  by  the  Council  in
consultation  with  the  European  Parliament  on  the  basis  of  a  list  drawn  up  by  the
Commission  which  includes  considerably  more  names  of  candidates  than  there  are
members to be appointed, together with one representative of the Commission. Two of the
members  shall  come  from  industrial  associations,  one  from  patients’  organisations,  one
from  doctors’  organisations,  and  one  shall  represent  social  security  schemes.  The  list

9

drawn up by the Commission shall be forwarded to the European Parliament, together with
the relevant documentation. As soon as possible, and  within three months of notification,
the  European  Parliament  may  submit  its  views  for  consideration  to  the  Council,  which
shall  then  appoint  the  Management  Board.  Appointment  of  the  members  of  the
Management Board shall be carried out in such a way as to guarantee the highest level of
competence, a broad range of relevant expert knowledge and, with respect to these criteria,
the widest possible geographical spread in the Union.

Each representative may arrange to be replaced by an alternate.

2. The term of office of the representatives shall be three years. It shall be renewable once.”

–  Amendments 120, 123, 124, 125 and 126 aimed at reviewing the provisions relative to the

finances of the Agency:

“Article 60, paragraph 1:

1. The revenues of the Agency shall consist of contributions from the Community and the fees
paid  by  undertakings  for  obtaining  and  managing  a  marketing  authorisation  and  for  other
services provided by the Agency. The budgetary authority will  re-examine when necessary
the level of the contributions on the basis of an evaluation of needs and the level of fees.

“Article 60, paragraph 3:

3. By 15 February of each year at the latest, the Director shall draw up a preliminary draft
estimate covering the operational expenditure and the draft programme of work anticipated
for  the  following  financial  year,  and  shall  forward  this  preliminary  draft,  including  an
establishment plan, to the Management Board.

“Article 60, paragraph 6:

6. The Management Board shall adopt the Agency's final work programme and final budget
before  the  beginning  of  the  financial  year,  adjusting  it  where  necessary  to  the  Community
subsidy and the Agency's other resourc es. Any modification of the establishment plan and
of  the  budget  shall  be  notified  to  the  budgetary  authority  under  the  form  of  a  rectifying
budget.

“Article 60, paragraph 9:

9. By 31 March of each year at the latest, the Director shall forward to the Commission, the
Management Board and the Court of Auditors the accounts for all the Agency's revenue and
expenditure in respect of the preceding financial  year. The  Court of Auditors shall examine
them in accordance with Article 248 of the Treaty and shall publish an annual report on the
Agency’s activities.

“Article 60, paragraph 10:

10.  On  a  recommendation  from  the  Council,  the  European  Parliament  shall  give  a
discharge to the Director in respect of the implementation of the Agency's budget.”

–  Amendment 127 aimed at making the Community rules relative to the fight against fraud

applicable to the activities of the Agency:

10

“Article 60 a:

1. In order to combat fraud, corruption and other unlawful activities the provisions of
Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May
1999  concerning 
investigations  conducted  by  the  European  Anti-Fraud  Office
(OLAF)(*) shall apply without restriction.

2. The Agency shall accede to the Interinstitutional Agreement of 25 May 1999 concerning
internal investigations by the European Anti-Fraud Office (OLAF) and shall issue, without
delay, the appropriate provisions applicable to all the employees of the Agency.”

(*) OJ L 136,31.5.1999, p.1”

–  Amendment 128 (in part) aimed at replacing the term “amount” by “level” of fees:

“Article 61:

The structure and the level of the fees referred to in Article 60(1) shall be established by the
Council  acting  under  the  conditions  provided  for  by  the  Treaty  on  a  proposal  from  the
Commission, following the latter’s consultation of organisations representing the interests of
the pharmaceutical industry at Community level.”

–  Amendment  130  aimed  at  extending  the  possibility  of  helping  small  and  medium-sized
pharmaceutical firms at the time of submission of marketing authorisation applications or
for applications relating to diseases with a regional distribution:

“Article 69:

The  Management  Board  shall,  in  the  case  of  veterinary  medicinal  products  which  have
limited  markets,  or  in  the  case  of  human  and  veterinary  medicinal  products  intended  for
diseases with a regional distribution, adopt the necessary administrative measures to provide
help to small and medium-sized pharmaceutical companies at the time of submission of their
applications  These  administrative  measures  shall  include,  in  particular,  taking  over  the
responsibility for translations by the Agency.”

–  Amendment  135  aimed  at  making  public,  at  the  request,  of  the  Agency  the  names  of

marketing authorisation holders subject to financial penalties by the Commission:

“Article 74, paragraph 3:

3.
At  the  Agency's  request,  the  Commission  may  impose  financial  penalties  on  the
holders  of  marketing  authorisations  granted  under  this  Regulation  if  they  fail  to  observe
certain obligations laid down in connection with the authorisations. The maximum  amounts
as well as the conditions and methods for collection of these penalties shall be laid down by
the Commission in accordance with the procedure provided for in Article 77, paragraph 2.

The  Commission  shall  publish  the  names  of  the  holders  of  the  marketing  authorisations
involved and the amounts of and reasons for the financial penalties imposed.”

11

3.2. 

Amendments accepted in part or in principle by the Commission : 1, 4, 13, 15,
18, 20, 22, 23, 24, 25 (second part), 31, 34, 38, 43, 44, 47, 49 (first sentence), 50,
51, 52, 53, 54, 59, 60, 62, 63, 64, 66, 68, 73, 76, 79, 80, 81, 82, 86, 87, 88, 89, 91
(last sentence), 93 (except the last sentence), 96, 100, 105 (second part), 109, 113,
118,  121,  129,  131  (without  the  references  to  Regulation  (EC)  N°  1049/2001),
134, 140, 141, 153, 155, 163, 165 and 166.

Certain provisions other than those targeted by the amendments accepted in principle by the
Commission  have  been  brought  into  line  with  the  amendments  introduced  by  the  European
Parliament. These concern, in particular, Article 28, paragraph 1, subparagraph 1; Article 34,
paragraph  3,  subparagraph  2;  Article  35,  paragraph  4;  Article  40,  paragraph  4a;  Article  42,
subparagraph  3;  Article  43a;  Article  44,  paragraph  3,  subparagraph  2;  Article  46,
subparagraph 1 and 3a; and Article 48a.

–  The Commission can accept amendments 1 and 13 aimed at providing particular support to
small  and  medium-sized  enterprises  by  reason  of  the  extension  of  the  scope  of  the
centralised  procedure  to  all  medicinal  products  containing  a new  active  substance.  These
measures  are  aimed  at  reducing  the  costs  associated  with  the  request  for  authorisation
submitted to the  Agency and to facilitate  the  requests  for scientific  advice. Rewording is
necessary  to  indicate  the  possibility  of  a  specific  but  not  dispensatory  system  for  these
companies  and  to  indicate  specifically,  but  not  exclusively,  the  possibility  for  small  and
medium-sized enterprises to request scientific advice :

“Recital 8:

With a view  to harmonising the internal market for new medicinal products, this procedure
should  also  be  made  compulsory  for  any  medicinal  product  which  is  intended  to  be
administered to humans or animals and contains an entirely new active substance, that is, one
that has not yet been authorised in the Community. Provision should be made in this context
for a derogation for small and medium-sized enterprises so that the cost of marketing the
medicinal products developed by these enterprises can be kept within reasonable bounds.

Recital 20:

The  field  of  activity  of  the  scientific  committees  should  be  enlarged  and  their  operating
methods  and  composition  modernised.  Scientific  advice  for  future  applicants  seeking
marketing authorisation should be provided more generally and in greater depth. Similarly,
structures allowing for the development of advice for companies  – in particular, small and
medium sized enterprise – should be put in place. The committees should be able to delegate
some of their evaluation duties to standing working parties, open to recognised experts from
the  scientific  world  appointed  for  this  purpose,  whilst  retaining  total  responsibility  for  the
scientific  opinions  issued.  The  appeal  procedures  should  be  amended  to  provide  a  better
guarantee for applicants’ rights.”

–  Similarly, the Commission accepts the  principle of amendment  129  aimed  at  introducing
an arrangement to provide for a reduction in the fees payable by small and medium-sized
enterprises. A rewording is necessary, however, to avoid in  the  body  of  the Regulation a
reference  to  an  example  or  precedent  so  as  to  determine  the  procedure  by  which  the
Commission will adopt the measures to implement such an arrangement. Therefore, a new
subparagraph is introduced in article 61 and worded as follows:

12

“Article 61, subparagraph 1 a:

Applications related to medicinal products submitted by small and medium size companies,
established in the Community, shall benefit from a fee reduction and/or a delayed payment
of  the  fee,  as  for  orphan  drugs,  according  to  provisions  which  will  be  adopted  by  the
Commission”.

–  The  Commission  can  accept  in  principle  amendments  4  (first  part)  and  100  aimed  at
making  a  reference  to  the  principle  of  comparative  efficacy;  it  is  however  useful  when
referring to such a principle to acknowledge its development by the Member States and the
importance  of  analysing  the  methods  used  by  the  Member  States.  It  is  important  also  to
emphasise  that  this  evaluation  should  not  be  considered  as  a  necessary  criterion  for  the
application or for the authorisation of medicinal products. In effect only the criteria of the
quality,  safety  and  efficacy  of  the  particular  medicinal  product  should  be  used  in  the
evaluation of medicinal products. Recital 11 should not be modified; a new recital 28 a is
introduced and worded as follows:

“The Member States have developed an evaluation of the comparative efficacy of medicinal
products  aimed  at  positioning  a  new medicinal  product with  respect  to  those  that  already
exist in the same therapeutic class. Similarly, the Council, in its conclusions on medicinal
products  and  public  healt,  adopted  on  29  June  2000,  emphasised  the  importance  of
identifying  medicinal  products  that  presented  an  added  therapeutic  value.  However  this
evaluation should not be conducted in the context of the marketing authorisation for which
it is agreed that the fundamental criteria should be retained. It is useful in this respect to
allow for the possibility to gather information on the methods used by the Member States to
determine the therapeutic benefit obtained by each new medicinal product.”

A new article is also introduced to provide for the possibility for the Agency, at the request of
the Commission, to collect information from the competent authorities of the Member States
in  charge  of  performing  evaluations  of  efficacy  compared  to  that  of  already  authorised
medicinal products. A new article 53 a is introduced and worded as follows:

“At  the  request  of  the  Commission,  the  Agency  will  collect  information  on  the  methods
used  by  the  competent  authorities  in  the  Member  States  to  determine  the  therapeutic
progress contributed by each new medicinal product.”

–  The  Commission  can  accept  the  principle  contained  in  the  second  part  of  amendment  4
concerning  the  application  of  the  ethical  requirements  of  Directive  2001/20/EC  on  the
implementation  of  good  clinical  practice  in  the  conduct  of  clinical  trials  on  medicinal
products  authorised  by  the  Community  as  well  as  the  application  of  these  same
requirements  to  clinical  trials  conducted  outside  the  Community  on  medicinal  products
destined  to  be  authorised  by  the  Community.  A  new  recital  12  a  is  therefore  introduced
and is worded as follows:

“There is also a need to provide for the ethical requirements of Directive 2001/20/EC of the
European Parliament and the Council on the approximation  of the  laws, regulations and
administrative  provisions  of  the  Member  States  relating  to  the  implementation  of  good
clinical practice in the conduct of clinical trials on medicinal products for human use (*) to
apply  to  medicinal  products  authorised  by  the  Community.  In  particular,  with  respect  to
clinical  trials  conducted  outside  the  Community  on  medicinal  products  destined  to  be
authorised  within  the  Community,  at  the  time  of  the  evaluation  of  the  application  for
authorisation, it will be verified that these trials were conducted respecting the principles of

13

good  clinical  practice  and  the  ethical  requirements  equivalent  to  the  provisions  of  this
Directive.

(*) OJ L 121 of 1.5.2001, p. 34”

–  In  the  same  context  of  Directive  2001/20/EC  on  clinical  trials,  the  Commission  also
accepts the principle of amendment 96, aimed at providing that the database on medicinal
products  established by article  51,  paragraph  1,  point  j)  contains  information  relating  to
clinical trials. However, the addition of such a provision does not appear to be necessary;
the  Directive  on  clinical  trials  already  provides  for  a  specific  database  for  clinical  trials
conducted with a view to the authorisation of medicinal products for human use.

–  The  Commission  accepts  the  principle  contained  in  amendments  15  and  47  concerning
Directive 89/105/EEC relating to national procedures for the pricing and reimbursement of
medicinal  products  and  the  conduct  of  a  specific  study  on  its  implementation.  In  this
context the Commission intends to present a report on the implementation of this Directive
by the Member  States.  To  preserve  the  Commission’s  right  of  initiative,  a  recital  and  an
explicit provision for this intention does not seem necessary in a text that is aimed only at
the procedure of authorisation and supervision of medicinal products.

–  The Commission accepts the principle contained in amendments 18 and 22 concerning the
naming  of  generic  medicinal  products  of  reference  products  authorised  through  the
centralised  procedure.  The  international  non-proprietary  name  and  its  translation  into  the
different languages of the Member States, even if these differ, are considered as equivalent
in all the Member States. Article 3, paragraph 3, point c) is worded as follows:

“c)  the  generic  medicinal  product  is  authorised  under  the  same  name  in  all  the  Member
States  where  the  application  has  been  made.  For  the  purposes  of  this  provision,  all  the
linguistic  versions  of  the  international  non-proprietary  name  are  considered  to  be  the
same.”

–  The  Commission  accepts  the  principle  of  amendment  20  concerning  the  use  of  the
evaluation  of  the  benefit  risk  analysis  in  the  context  of  the  authorisation  of  a  medicinal
product. The principle is already set out in the general provisions of Directive 2001/83/EC
on  the  Community  code  for  medicinal  products  for  human  use  to  which  the  Regulation,
which is  the  object  of  the  present  proposal,  refers.  A  specific  provision,  therefore,  is  not
necessary.

–  The  Commission  accepts  the  principle  of  amendments  23  and  68  aimed  at  making  an
explicit reference to the competence of the Committees on Medicinal Products for Human
and Veterinary Use to give opinions in the case of arbitration between the Member States
in the context of the mutual recognition procedure. Directives 2001/83/EC and 2001/82/EC
on  the  Community  codes  for  medicinal  products  for  human  and  veterinary  use  define
explicitly the competences of these committees in the context of these procedures. Specific
provisions in the Regulation, which is the object of the present proposal, are therefore not
necessary.

–  Regarding the first part of amendment 24 and the second part of amendment 25 aimed at
certain  requirements  set  out  in  Directive  2001/20/EC  on  clinical  trials,  the  Commission
accepts  the  principle  and  refers  to  the  new  recital  12  a,  introduced  as  a  result  of
amendment 4, second part. An explicit reference to the implementation of this Directive is
therefore not necessary.  It is not necessary either in  relation  to  specific  trials  in  children;

14

this  Directive  already  contains  specific  provisions  that  apply  to  studies  conducted  in
children with respect to the second part of amendment 24, the Commission accepts this but
proposes a new wording which delineates more precisely the scope of the derogation from
the  principle  of  one  single  name  for  medicinal  products  authorised  by  the  Community.
Article 6, paragraph 1, subparagraph 1 for medicinal products for human use and article
28, paragraph 1, subparagraph 1 for medicinal products for veterinary use are worded as
follows:

“Article 6, paragraph 1, subparagraph 1:

Each application for authorisation for a medicinal  product for human use  shall specifically
include  all  the  information  and  documents  referred  to  in  Articles  8(3),  10a  and  11  of
Directive  2001/83/EC,  and  Annex  I  thereto.  The  information  and  documents  are  to  take
account of  the Community nature  of the authorisation requested,  and  except in  exceptional
cases  relating  to  the  application  of  the  law  on  trade  marks,  use  a  single  name  for  the
medicinal product.

“Article 28, paragraph 1, subparagraph 1:

Each  application  for  authorisation  for  a  medicinal  product  for  veterinary  use  shall
specifically include all the information and documents referred to in Articles 12, paragraph 3,
13a  and  14  of  Directive  2001/82/EC,  and  Annex  I  thereto.  The  information  and  documents
are  to  take  account  of  the  Community  nature  of  the  authorisation  requested,  and  except  in
exceptional cases relating to the application of the law on trade marks, use a single name
for the medicinal product.

–  The Commission accepts the principle of amendments 31 and 73 aimed at permitting in the
opinions of  the committees of the Agency, the  inclusion of  the conditions  relating  to  the
use  of  certain  medicinal  products  so  as  to  guarantee  their  safe  and  effective  use.  A  new
point b) a is added to article 9, paragraph 4 with respect to medicinal products for human
use and a new point c) a to article 31, paragraph 4 with respect to medicinal products for
veterinary use. They are worded as follows:

“Article 9, paragraph 4

b a) details of any conditions or restrictions which should be imposed so as to guarantee the
safe and  effective  use  of  the  medicinal  product, in  particular mechanisms  for  controlling
and monitoring its use and administration.

Article 31, paragraph 4

c a) details of any conditions or restrictions which should be imposed so as to guarantee the
safe and  effective  use  of  the  medicinal  product, in  particular mechanisms  for  controlling
and monitoring its use and administration.”

–  The Commission accepts the principle of amendment 34 aimed at including an accelerated
procedure  for medicinal products used in  certain  treatments  with  a  view  to  making  them
available  to  patients  more  quickly.  This  procedure  is  already  foreseen  in  article  13,
paragraph 6 of the draft Regulation; the additional reference in article 10 is, therefore, not
necessary.

–  The Commission accepts the principle of amendments 38 and 76. They aim at introducing
the  notion  of  a  register  of  assessment  reports  for  medicinal  products.  The  Commission,

15

however, considers that this register is not necessary since the assessment reports shall be
made available to the general public. With respect to the requirement aimed  at  providing
the  separate  reasons  for  each  authorised  indication,  this  is  already  the  practice  in  the
opinions  of  the  committees  of  the  Agency.  An  explicit  provision  is,  therefore,  not
necessary. Article 12, paragraph 3 and article 34, paragraph 3 are reworded as follows:

“Article 12, paragraph 3:

The  Agency  shall  immediately  publish  the  assessment  report  on  the  medicinal  product  for
human use drawn up by the Committee for Human Medicinal Products, and the reasons for
its opinion, after deletion of any information of a commercially confidential nature.

Article 34, paragraph 3

The  Agency  shall  immediately  publish  the  assessment  report  on  the  medicinal  products  for
veterinary  use  drawn  up  by  the  Committee  for  Veterinary  Medicinal  Products,  and  the
reasons  for  its  opinion,  after  deletion  of  any  information  of  a  commercially  confidential
nature”.

–  The Commission accepts the principle of amendments 43, 51, 53, 79, 81, the first part of
amendment  87,  the  last  part  of  amendment  109  and  part  of  amendment  131  aimed  at
introducing specific provisions for the publication amongst other things of the opinions of
the  committee  of  the  Agency  concerning  conditional  authorisations,  assessment  reports,
summaries  of  product  characteristics,  labels  and  package  leaflets  as  well  as  information
related  to  suspected  adverse  effects  of  medicinal  products  authorised  by  the  Community
and urgent decisions aimed at suspending the use of a medicinal product, by reference to
the implementation of Regulation 1049/2001 relating to public access to documents of the
European  Parliament,  Council  and  the  Commission.  However,  the  application  of  the
provisions set out in this Regulation to the documents of the Agency is already the object
of  a  separate  proposal  to  modify  Regulation  2309/93.  This  proposal,  currently  under
discussion  in  the  European  Parliament  aims  to  make  the  provisions  of  Regulation
1049/2001 obligatory “for documents held by the Agency”.

–  The Commission accepts the principle of amendment 44 aimed at clarifying the provisions
the  authorisation  of  certain  medicinal  products  under  exceptional
concerning 
circumstances. Article 13, paragraph 5 for medicinal products for human  use and  article
35, paragraph 4 for medicinal products for veterinary use have been reworded as follows:

“Article 13, paragraph 5:

In  exceptional  circumstances  and  following  consultation  with  the  applicant,  authorisation
may  be  granted  subject  to  a  requirement  to  introduce  specific  procedures,  in  particular
concerning the safety of the medicinal product, for notifying the relevant authorities of any
incident related to its use and for any action 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
to  Directive  2001/83/EC.  The  maintenance  of  the  authorisation  is  bound  to  the  annual
reassessment of these requirements.

Article 35, paragraph 4:

In  exceptional  circumstances,  and  following  consultation  with  the  applicant,  authorisation
may  be  granted  subject  to  a  requirement  to  introduce  specific  procedures,  in  particular
concerning product safety, for notifying the relevant authorities of any incident related to

16

its  use  and  for  any  action  taken.  Such  authorisation  may  be  granted  only  for  objective,
verifiable reasons. The maintenance of the authorisation is bound to the annual reassessment
of these requirements.”

–  The Commission accepts in part the principle of amendment 49 aimed at introducing  the
responsibility of  the applicant for the  accuracy of the  documents  and  the  data  submitted.
However, the second part of the amendment which is aimed at setting out the procedure to
be  followed  by  the  Agency  in  the  case  of  incorrect  data  should  not  appear  in  the
Regulation. It could be set out in the framework of the internal rules of the Agency. Article
15 a is worded as follows:

“The  applicant  or  the  holder  of  a  marketing  authorisation  shall  be  responsible  for  the
accuracy of the documents and the data submitted.”

The Commission accepts  the  principle  of  amendment  50  aimed  at  assuring  the  provision  of
information  to  health-care  professionals  by  means  ofnetworks  provided  by  professional
associations, amongst other things. A new paragraph 4 a, Article 18, for medicinal products
for human use and a new paragraph 4 a, Article 40, for medicinal products for veterinary use
are worded as follows:

“Article 18, paragraph 4 a:

In  this  case,  the  Member  State  shall  assure  that  health-care  professionals  are  rapidly
informed  of  its  action  and  the  reasons  for  the  action.  The  network  provided  by  the
professional associations shall be fully used to this effect. The Member States shall inform
the Commission and the Agency of the procedures put in place for this purpose

Article 40, paragraph 4 a:

In  this  case,  the  Member  State  shall  assure  that  health-care  professionals  are  rapidly
informed  of  its  action  and  the  reasons  for  the  action.  The  network  provided  by  the
professional associations shall be fully used to this effect. The Member States shall inform
the Commission and the Agency of the procedures put in place for this purpose. ”

–  The Commission accepts the principle of amendments 52, 80 and 121 aimed at providing
public  funding  commensurate  with  the  pharmacovigilance  activities  carried  out  by  the
Agency. This provision, however, should figure in the chapter in the proposed Regulation
which  concerns  the  finances  of  the  Agency.  A  new  paragraph,  therefore,  should  be
included in Article 60 of the proposed Regulation; it is reworded as follows:

“Article 60, paragraph 1 a:

In  order  to  ensure  full  independence,  the  activities  relating  to  pharmacovigilance,  to  the
operation  of  communications  networks  and  to  market  surveillance  should  receive
guaranteed and adequate funding.”

–  The Commission accepts the principle of amendment 54 concerning the role of patients in
the  communication  of  adverse  effects.  However,  a  rewording  is  necessary  to  limit  the
number  receiving  these  communications;  in  effect  it  does  not  seem  appropriate  that
patients  should  transmit  this  information  directly  to  marketing  authorisation  holders,
without the intervention of a health-care professional or a competent authority who could
manage or filter such information. Articles 20, subparagraph 3 and 42, subparagraph 3 is
therefore reworded as follows:

17

Article 20, subparagraph 3

“The  holder  of  the  marketing  authorisation  and  the  competent  authorities  of  the  Member
States  shall  ensure  that  all  relevant  information  about  suspected  adverse  reactions  to  the
medicinal  products  for  human  use  authorised  under  this  Regulation  are  brought  to  the
attention of the Agency in accordance with the provisions of this Regulation. Patients shall be
encouraged  to  communicate  any  adverse  reaction  to  their  health-care  professionals  or  to
the competent authorities for pharmacovigilance.

Article 42, subparagraph 3

“The  holder  of  the  marketing  authorisation  and  the  competent  authorities  of  the  Member
States  shall  ensure  that  all  relevant  information  about  suspected  adverse  reactions  to  the
medicinal  products  for  veterinary  use  authorised  under  this  Regulation  are  brought  to  the
attention of the Agency in accordance with the provisions of this Regulation. Animal owners
and  breeders  shall  be  encouraged  to  communicate  any  adverse  reaction  to  health-care
professionals or to the competent authorities for pharmacovigilance.”

–  The  Commission  accepts  the  principle  of  amendments  59  and  60  aimed  at  clarifying  the
time-lines for the submission of the first updated period in safety report and the contents of
these reports. Rewording is necessary, however, to indicate the Community context of the
medicinal  products  to  which  the  Regulation  applies.  Therefore,  article  22,  paragraph  3,
subparagraph  two  for  medicinal  products  for  human  use  and  article  44,  paragraph  3,
subparagraph two for medicinal products for veterinary use are worded as follows:

“Article 22, paragraph 3, subparagraphs 2 and 3:

Unless other requirements have been laid down as a condition of granting of the marketing
authorisation by the Community, these records shall be submitted in the form of an updated
periodical report on safety, to the Agency and Member States immediately upon request or at
least every six months during the first two years following the initial placing on the market
in the Community, and once a year for the following two years. Thereafter, the reports shall
be submitted at three-yearly intervals, or immediately on request.

These reports shall be accompanied by a scientific evaluation, notably a benefit-risk analysis
of the medicinal product.

Article 44, paragraph 3, subparagraphs 2 and 3:

Unless other requirements have been laid down as a condition of the marketing authorisation
by  the  Community,  these  records  shall  be  submitted  in  the  form  of  an  updated  periodical
report on safety, to the Agency and Member States immediately upon request or at least every
six  months  during  the  first  two  years  following  the  initial  placing  on  the  market  in  the
Community,  and  once  a  year  for  the  following  two  years.  Thereafter  the  reports  shall  be
submitted at three-yearly intervals, or immediately on request.

These reports shall be accompanied by a scientific evaluation, notably a benefit-risk analysis
of the medicinal product.”

The Commission accepts the principle of amendment 62 aimed at specifying the contents of
the  guidance  developed  for  the  collection,  verification  and  presentation  of  adverse  reaction
reports. A rewording is necessary, however, so as not to place constraints on the contents of

18

such guidance. Article 24, subparagraph 1 for medicinal products for human use and article
46, subparagraph 1 for medicinal products for veterinary use are worded as follows:

“Article 24, subparagraph 1:

The Commission, in consultation with the Agency, the Member States and interested parties,
shall  draw  up  guidance  on  the  collection,  verification  and  presentation  of  adverse  reaction
reports.  This  guidance  shall  contain,  in  particular  for  the  benefit  of  health-care
professionals, rules concerning the transmission of information on adverse reactions.

Article 46, subparagraph 1:

The Commission, in consultation with the Agency, the Member States and interested parties,
shall  draw  up  guidance  on  the  collection,  verification  and  presentation  of  adverse  reaction
reports.  This  guidance  shall  contain,  in  particular  for  the  benefit  of  health-care
professionals, rules governing the transmission of information on adverse reactions.”

–  The  Commission  accepts  the  principle  of  amendments  63  and  88  concerning  the
dissemination  of  pharmacovigilance  information  by  means  of  the  access  of  all  interested
parties  to  the  database  containing  this  information.  Article  51,  paragraph  1,  point  d)  is
worded as follows:

“d)  ensuring  the  dissemination  of  information  on  adverse  reactions  to  medicinal  products
authorised in the Community by means of a database permanently accessible to all Member
States; health-care professionals, companies and the public shall have appropriate levels of
access to these databases; with personal data protection being guaranteed;”

The  Commission  accepts  the  principle  of  amendment  64  aimed  at  providing  a  specific
provision for data collected during the two years following the initial placing on the market. A
new subparagraph is introduced  into article  24,  subparagraph  3  for  medicinal  products  for
human use and into article 46, subparagraph 3 for medicinal products for veterinary use, with
a rewording which makes such a collection of data possible but not obligatory.

“Article 24, subparagraph 3 a:

For a period of two years following the initial placing on the market in the Community, the
Agency may request that specific pharmacovigilance data be collected from targeted groups
of patients. These data shall be evaluated by the Agency.

Article 46, subparagraph 3 a:

For a period of two years following the initial placing on the market in the Community, the
Agency  may  request  that  specific  pharmacovigilance  data  be  collected  under  targeted
conditions. These data will be evaluated by the Agency.”

–  The  Commission  accepts  the  principle  of  amendment  66  aimed  at  providing  for
strengthened  coordination  between  the  national  pharmacovigilance  systems  and  the
Agency.  However,  the  detailed  organisation  of  national  pharmacovigilance  systems  is  a
matter for the competence of each Member State; a rewording of the provision is therefore
necessary.  Article  25  a,  for  medicinal  products  for  human  use  and  article  47  a  for
medicinal products for veterinary use are worded as follows:

19

“Article 25 a:

The  Agency  and  the  national  public  pharmacovigilance  systems  shall  be  organised  and
operate  as  a  coherent  and  interactive  pharmacovigilance  system  through  which  the
monitoring  of  the  occurrence  of  adverse  reactions  takes  place  continuously.  The  Agency
shall  coordinate  the  national  pharmacovigilance  systems,  which  shall  operate  in
accordance with the criteria of transparency and objectivity.

Article 47 a:

The  Agency  and  the  national  public  pharmacovigilance  systems  shall  be  organised  and
operate  as  a  coherent  and  interactive  pharmacovigilance  system  through  which  the
monitoring  of  the  occurrence  of  adverse  reactions  takes  place  continuously.  The  Agency
shall  coordinate  the  national  pharmacovigilance  systems,  which  shall  operate  in
accordance with the criteria of transparency and objectivity.”

–  The  Commission  accepts  the  principle  of  amendment  82  aimed  at  providing  a  particular
provision in the context of medicinal products for veterinary use, regarding the obligations
of the qualified person responsible for pharmacovigilance. In particular this person should
also  inform  the  competent  authorities,  amongst  other  things,  of  the  presence  of  residues.
Article 43, point d) is therefore reworded as follows:

“d) providing the competent authorities with any other information relevant to the evaluation
of  the  risks  and  benefits  of  a  veterinary  medicinal  product,  particularly  information
concerning post marketing studies, as well as information regarding residues of medicinal
products.”

–  The  Commission  accepts  the  principle  of  amendment  86  aimed  at  providing  that  the
Agency  shall  contain  minority  views,  if  these  have  been  expressed.  This  provision  is
already set out in article 54, paragraph 4 of the proposed Regulation which specifies that
“the  opinion  shall  consist  of  the  position  of  the  majority  of  the  Members  and  their
divergent positions, with their grounds”. A new position is, therefore, not necessary.

–  The  Commission  accepts  the  principle  of  the  second  part  of  amendment  87  aimed  at
providing  for  the  labels  and  package  leaflets  or  inserts  to  be  written  in  a  manner  that  is
comprehensive to the public, and checked as  being  scientifically  accurate, in cooperation
with industry, patient association and health-care professionals. However, these provisions
clearly  appear  in  title  V  of  Directive  2001/83/EC  on  the  Community  code  relating  to
medicinal  products  for  human  use  as  well  as  in  title  V  of  Directive  2001/82/EC  on  the
Community code relating to medicinal products for veterinary use. These titles also apply
to medicinal products authorised by the centralised procedure that is set out in the proposed
Regulation.

–  With  respect  to  the  functions  of  the  Agency  set  out  in  article  51,  paragraph  1  of  the
proposed  Regulation,  the  Commission  accepts  the  principle  of  amendments  89  and
partially those of amendments 91 and 93. Amendment 89 aims to establish the function of
assisting  the  Member  States  in  the  communication  of  pharmacovigilance  information.  A
rewording  is  necessary  so  as  not  to  refer  to  the  Commission;  in  effect,  in  the  area  of
pharmacovigilance,  for  medicinal  products  authorised  through  the  centralised  procedure,
the Agency is directly competent for the handling of such information. A new point d) a) is
introduced and worded as follows:

20

“Article 51, paragraph 1

d) a) assisting  the  Member  States  in  the  rapid communication of  information  concerning
pharmacovigilance to health-care professionals.”

The  last  part  of  amendment  91  aims  to  establish  that  the  information  held  in  the  database
accessible  to  the  general  public  shall  be  worded  in  an  appropriate  and  comprehensible
manner. Point j) is therefore reworded as follows:

“Article 51, paragraph 1

j) creating a database on medicinal products to be accessible to the general public and giving
technical  assistance  for  its  maintenance;  the  information  provided  to  the  public  shall  be
worded in an appropriate and comprehensive manner;”

The Commission accepts amendment 93, except the last part, with the goal of strengthening
the competences of the Agency in relation to the fight against bioterrorism. The last part is not
acceptable;  in  effect,  it  is  not  up  to  the  Agency  to  determine  shortcomings  in  research  and
strategies to combat biological warfare. A new point n) a) should be introduced, therefore, and
worded as follows:

“Article 51, paragraph 1

n) a)  compilation  of  scientific  information  concerning  pathogenic  agents  which might  be
used in biological warfare, and assessment of the stocks of vaccines and medicinal products
currently available to treat them;”

–  The Commission partially accepts the principle of amendment 105 aimed at providing for
contacts between the rapporteurs and patient organisations in relation to the preparation of
the  evaluation.  Article  55,  paragraph  1,  first  subparagraph  is  therefore  reworded  to
provide  for  the  possibility  of  such  a  consultation  should  the  rapporteur  deem  it
necessary:“where, in accordance with the provisions of this Regulation, the Committee for
Human  Medicinal  Products  or  the  Committee  for  Veterinary  Medicinal  Products  is
required  to  evaluate  a  medicinal  product,  it  shall  appoint  one  of  its  members  to  act  as
rapporteur for the coordination of the evaluation. The committee concerned may appoint a
second  member  to  act  as  co-rapporteur.  The  rapporteur  may  establish  contact  with  the
representatives  of  patient  organisations  relevant  to  the  indication  of  the  medicinal
product concerned.”

–  The Commission accepts the principle of amendment 109 (first part) aimed at providing an
obligation  for  all  members  of  the  committees  and  boards  of  the  Agency,  as  well  as  the
rapporteurs and experts, to declare their conflicts of interest at each meeting. However, this
provision  is  already  set  out  in  article  56,  paragraph  2,  second  subparagraph  of  the
proposed Regulation. A specific provision is therefore not necessary.

–  The  Commission  accepts  the  principle  of  amendment  113  aimed  at  setting  out  the
procedure for nominating the Executive Director of the Agency. A rewording is necessary
to  provide  for  the  proposal  of  the  Commission  at  the  time  of  a  removal  of  an  Executive
Director  from  his  post  by  the  Management  Board.  Article  57,  paragraph  1  is  therefore
reworded as follows:

“The Executive Director  shall  be appointed by the  Management  Board  for  a  period  of  five
years, on the basis of a list of candidates proposed by the Commission following a call for

21

expressions of interest published in the Official Journal of the European Communities and
elsewhere. Before appointment, the candidate nominated by the Management Board shall
be  invited  forthwith  to  make  a  statement  to  the  European  Parliament  and  to  answer  any
questions put by  its Members. The  mandate may be renewed  once. At  the proposal  of  the
Commission, the Executive Director may be removed from the post by a majority vote of the
Members of the Management Board.”

–  The  Commission  accepts  the  principle  of  amendment  118  aimed  at  providing  for  the
attendance of the chairmen of the scientific committees at the meetings of the Management
Board. A rewording is necessary, however, to include such attendance as an option, which
reflects current practice, and to remove the reference to the absence of the right to vote; in
effect, the chairmen would not be members of the Management Board and therefore would
not have the right to vote. Article 58, paragraph 3 is therefore reworded as follows:

“The Management Board shall elect its chairman for a term of three years and shall adopt its
rules  of  procedure.  Decisions  of  the  Management  Board  shall  be  adopted  by  a  majority  of
two-thirds of its members. The chairman of the scientific committees may be invited to the
meetings of the Management Board.”

–  The  Commission  accepts  in  part  the  principle  of  amendment  131  aimed  at  introducing  a
provision  for  the  publication  of  the  rules  and  internal  procedures  of  the  Agency,  its
committees  and  its  working  groups.  A  new  subparagraph  is  therefore  introduced  into
article 70 and reworded as follows:

“Article 70, second subparagraph :

The  internal  rules  and  procedures  of  the  Agency,  its  committees  and  its  working  groups
shall be made available to the public at the Agency and on the internet.”

This amendment also provides for the introduction of provisions concerning the way in which
the  assessment  reports  are  written  as  well  as  the  contents  of  the  reports.  A  rewording  is
necessary, however, aimed firstly at introducing these provisions in  the chapters concerning
the  authorisation  and  evaluation  of  medicinal  products  for  human  and  veterinary  use  and
secondly to limit, in view of the  public  access, the requirement for the  assessment report to
contain  a  summary  which  includes,  in  particular  the  conditions  of  use  of  the  medicinal
product.  A  new  subparagraph  is  introduced  therefore  into  article  12,  paragraph  3,  and  34,
paragraph 3 reworded as follows:

“Article 12, paragraph 3, subparagraph 2

The European Public Assessment Reports  (EPARs)  shall  include a summary  written  in  a
manner that is accessible to the public. This summary shall contain in particular a section
relating to the conditions of use of the medicinal product.

Article 34, paragraph 3, subparagraph 2

The European Public Assessment Reports  (EPARs)  shall  include a summary  written  in  a
manner that is accessible to the public. This summary shall contain in particular a section
relating to the conditions of use of the medicinal product.

–  The  Commission  accepts  the  principle  of  amendment  134  aimed  at  including  in  the
framework of provisions relative to compassionate use a requirement for continued access
of  a  patient  to  a  medicinal  product  after  its  authorisation,  during  the  period  between

22

authorisation and placing on the market. However, a rewording is necessary to clarify the
wording of the provision. A new paragraph 7 bis is introduced to article 73 and worded as
follows:

“Article 73, paragraph 7 a:

Where a compassionate use  programme  is  set  up,  the manufacturer shall  ensure  that  the
patients  who  benefit  from  the  medicinal  product  made  available  in  this  context  shall
continue to have access to the medicinal product once authorised, during the time between
the authorisation and the placing on the market.”

–  The Commission accepts the principle of amendment 140 which aims to clarify the notion
of  the  responsibility  for  placing  a  medicinal  product  on  the  market.  It  recognises  the
possibility  of  effecting  the  placing  on  the  market  by  the  marketing  authorisation  holder
himself  or  by  his  representative.  A  rewording  is  necessary  to  clarify  that  the  notion  of
responsibility lies only with the holder of the authorisation.

Article 2, subparagraph 2 is therefore worded as follows :

“Article 2, subparagraph 2

The  holder  of  a  marketing  authorisation  for  the  medicinal  products  covered  by  this
Regulation should be established in the Community. He is responsible for the placing on the
market  of the medicinal  product  whether  this  is  done  in  practice  by  himself  or  by  one  or
other persons designated to this effect”.

–  The  Commission  accepts  the  principle  of  amendment  141  which  aims  to  provide  a
requirement  on  the  part  of  the  holder  of  the  marketing  authorisation  to  inform  the
competent  authorities  of  any  suspension  of  the  marketing  of  the  medicinal  product.  The
provision  should  be  reworded,  however,  to  use  the  term  “suspension”  and  not  “ban  or
withdrawal” and to include a time limit within which the information should be provided.
A new article 21 a and a new article 43 a are introduced and worded as follows :

“Article 21a

The  holder  of  a  marketing  authorisation  shall  also  inform  the  agency  of  any  possible
suspension,  temporary  or  permanent,  of  the  marketing  of  the  product.  This  notification
shall take place, unless there are exceptional circumstances, at least two months before the
interruption in the marketing

Article 43 a

The  holder  of  a  marketing  authorisation  shall  also  inform  the  agency  of  any  possible
suspension,  temporary  or  permanent,  of  the  marketing  of  the  product.  This  notification
shall take place, unless there are exceptional circumstances, at least two months before the
interruption in the marketing”

–  The Commission accepts amendments 153 and 155 which aim to include a requirement on
the part of the Agency with respect to the competent authorities of the  Member States at
the  time  of  the  withdrawal  of  applications  for  marketing  authorisation  for  medicinal
products  for  human  and  veterinary  use  before  the  opinion  of  the  competent  scientific
committee  has  been  given.  Rewording  is  necessary  to  provide  a  requirement  for  the
applicant  to  communicate  the  reasons  for  such  a  withdrawal  and  a  greater  obligation  to

23

inform on the part of the Agency. A new Article 10a and a new Article 32a are therefore
introduced and worded as follows :

“Article 10a :

If an applicant withdraws an application for marketing authorisation submitted to the Agency
before  an  opinion  has  been  given  on  the  application,  the  applicant  shall  communicate  his
reasons and the Agency shall publish this information.

Article 32a :

If an applicant withdraws an application for marketing authorisation previously submitted to
the  Agency  before  an  opinion  has  been  given  on  the  application,  the  applicant  shall
communicate his reasons and the Agency shall publish this information.

–  The Commission accepts the principle of amendments 163, 165 and 166 aimed at changing
the  period  of  validity  of  the  marketing  authorisation.  In  effect  the  European  Parliament
proposes to amend  the  Commission’s proposal  which  aims to remove  the  requirement  to
renew  the  authorisation  after  5  years.  The  European  Parliament  proposes  to  introduce  a
requirement  to  renew  the  authorisation  five  years  after  the  first  marketing  authorisation.
After  this  first  renewal,  the  authorisation  will  be  considered  as  valid  for  an  unlimited
period. Recital 29 and Article 13 paragraph 1 for medicinal products  for  human use and
Article 35 paragraph 1 for medicinal products for veterinary use are therefore amended as
proposed by the European Parliament. A rewording is necessary, however, to specify better
the  context  of  the  first  evaluation  as  well  as  to  avoid  adding  time  limits  for  such  a
procedure.

“Recital 29 :

In  line  with  the  current  provisions  of  Directives  2001/83/EC  and  2001/82/EC  the  term  of
validity  of  a  Community  marketing  authorisation  for  new  medicinal  products  should  be
limited initially to five years. After this first renewal, the marketing authorisation shall be
considered as valid for an unlimited period.

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 medicinal product in the Community during that
period,  should  be  considered  invalid,  in  order,  in  particular,  to  avoid  the  administrative
burden linked to maintaining such authorisations.

Article 13, paragraph 1 :

Without prejudice to paragraphs 2 and 3, the marketing authorisation shall be valid for five
years.

This authorisation may be renewed after five years on the basis of a reassessment of benefit
compared to risk. On the occasion of the five year renewal of the marketing authorisation,
the  authorisation  holder  shall  submit  a  consolidated  dossier  on  the  quality,  safety  and
efficacy of the medicinal product with all the variations introduced during the five years of
validity.

The application for renewal shall be submitted to the Agency at least six months prior to the
date of expiry of the authorisation.

After this renewal, the marketing authorisation shall be valid for an unlimited duration.

24

Article 35, paragraph 1 :

Without prejudice to paragraphs 2 and 3, the marketing authorisation shall be valid for five
years.

This authorisation may be renewed after five  years on the basis of a reassessment of benefit
compared to risk. On the occasion of the five year renewal of the marketing authorisation, the
authorisation holder shall submit a consolidated dossier on the quality, safety and efficacy of
the medicinal product with all the variations introduced during the five years of validity.

The application for renewal shall be submitted to the Agency at least six months prior to the
date of expiry of the authorisation.

After this renewal, the marketing authorisation shall be valid for an unlimited duration”.

3.3. 

Amendments  not  accepted by  the  Commission:  2,  3,  5,  6,  7,  8,  10,  21,  25  (first
part), 26, 27, 29, 39, 42, 45, 46, 48, 49 (except the first sentence), 56, 57, 58, 65,
67, 70, 71, 83, 85, 91 (except the last sentence), 92, 93, (last sentence), 94, 97, 101
(the reference to the Committee on Herbal Medicinal Products), 105 (first part),
107  (first  part),  108  (the  reference  to  the  Committee  on  Herbal  Medicinal
Products), 110 (the first part), 119, 122, 128 (last part), 132, 133, 145, 147, 148,
152, 157 (first part), 162, 173, 174 and 175.

–  The Commission does not accept amendment 2 aimed at explicitly citing herbal medicinal
products  as  medicinal  products  that  may  be  of  particular  benefit  to  to  patients  and
consequently could benefit, on an optional basis, from  access to an authorisation through
the  centralised  procedure.  Although  not  excluding  this  possibility,  the  Commission  does
not  consider  it  necessary  to  mention  this  explicitly  in  a  recital;  in  effect,  in  effect,  the
characteristics  of  these  medicinal  products  through  their  “traditional”  nature  will  mean
that the possibility foreseen in article 3, paragraph 2 of the proposed regulation will not
apply to this type of medicinal products in particular.

–  The Commission does not accept amendment 3 aimed at foreseeing  an  obligation for the
Commission to prepare a proposal for a specific regulation establishing a policy for orphan
medicinal  products  for  veterinary  use.  This  recital  does  not  reflect  any  provision  for  the
proposed regulation. In addition, it would oblige the Commission to propose a regulation
within  a  precise  time  limit  which  would  go  against  the  Commission’s  right  of  initiative.
The  position  of  the  Commission  regarding  the  basic  question  is  contained  in  the
Commission Communication of 5 December 2000 (COM(2002)806 final) concerning the
availability of veterinary medicinal products.

–  The Commission does not accept amendments 5, 6, 10 and 83 aimed at introducing into the
recitals, on the one hand a reference to the provisions of Directive 2001/20/EC on clinical
trials  and  on  the  other  hand  obligations  concerning  paediatric  indications  as  well  as  a
provision  obliging  the  scientific  committee  to  consult  experts  in  paediatrics.  Concerning
the reference to the provisions of Directive 2001/20/EC on clinical trials, this has already
been  taken  up  within  the  context  of  amendments  4  and  96,  which  the  Commission  has
accepted in principle. The issues concerning medicinal products for paediatric use will be
taken up in the future legislative proposal that will be aimed specifically at the questions
relating to these medicinal products.

–  The  Commission  does  not  accept  amendments  7,  8  and  26  aimed  at  introducing  two
recitals concerning medicines destined for export and incentives for research on medicinal

25

products  against  tropical  diseases.  Another  provision  is  also  aimed  at  introducing  an
obligation  to  verify  at  the  time  of  the  request  for  marketing  authorisation  whether  the
medicinal product may also be suitable for the treatment of tropical diseases. The proposed
regulation is aimed uniquely, with the exception of article 52 concerning cooperation with
the  World  Health  Organisation,  at  medicinal  products  to  be  placed  on  the  market  in  the
Community.  In  addition  it  would  not  be  justifiable  to  require  research  on  use  in  the
treatment of possible tropical diseases for all medicinal products without distinction. The
consequence of such an obligation would be an increase in the requirements for marketing
authorisation and delay the availability of medicinal products to patients.

–  The Commission does not accept amendment 21 aimed at introducing an exception to one
of  the  three  conditions  allowing  the  optional  application  of  national  authorisation
procedures  to  generics  of  medical  products  that  have  been  authorised  through  the
centralised procedure. The condition in question is the one concerning the conformity in all
respects of  the  summary of  product  characteristics of the  generic  medicinal  product  with
that  of  the  reference  medicinal  product.  The  exception  would  aim  to  exclude  from  this
condition  certain  parts  of  the  summary  of  product  characteristics,  which  would  still  be
covered  by  patent  law  at  the  time  the  generic  medicinal  product  was  marketed.  The
Commission  considers,  however,  that  the  competent  authorities  in  charge  of  the
authorisation  of  generic  medicinal  products  do  not  have  the  competence  to  take  into
consideration  during their  evaluation criteria other  than  the  criteria  of  quality,  safety  and
efficacy.

–  The Commission does not accept the first part of amendment 25 aimed at introducing an
obligation/option to include with the request for authorisation a comparison with existing
medicinal  products  authorised  for  the  same  indications.  The  comparative  efficacy  of  a
medicinal  product  cannot  be  considered  as  a  criterion  for  authorisation.  Only  those
elements  necessary  to  demonstrate  the  quality,  efficacy  and  safety  of  each  individual
product can be required at the time of the request for marketing authorisation.

–  The  Commission  does  not  accept  amendment  27  aimed  at  introducing  an  obligation  for
State  laboratories  or  laboratories  designated  by  the  Member  State  fore  the  testing  of
medicinal products not to have a direct interest in the final authorisation of the medicinal
product. This obligation is neither justified nor necessary; in effect State laboratories have
no interest , direct or indirect, in the authorisation of medicinal products. In this context for
each Member State they exercise an activity of surveillance or control in the name of the
competent authority of each Member State.

–  The Commission does not accept amendments 29 and 70 aimed at making obligatory the
possibility  of  a  rapporteur  or  expert  appointed  by  the  committees  of  the  Agency  to
accompany  the  inspectors  from  the  Member  States.  This  must  remain  a  possibility;  it
would be disproportionate to make this systematic for each inspection carried out.

–  The Commission does not accept amendment 39 aimed at adding to the body of data that
the  marketing  authorisation  holder  must  provide  to  the  Agency,  data  relating  to  adverse
reactions to  the  product  concerned.  The  transmission  of  these  data  is  already  foreseen  in
the specific framework of the rules relating to pharmacovigilance.

–  The Commission does not accept amendment 42, 56 and 58 aimed at obliging the package
leaflet  of  all  new  medicinal  products  authorised  by  the  Agency  to  include  the  phrase
‘newly  authorised  medicinal  product’  as  well  as  an  invitation  to  patients  to  report  any
adverse  effects  and  an  obligation  to  the  marketing  authorisation  holder  to  handle  any

26

information reported directly by the patient. However, and as formulated in amendment 54
which  the  Commission  has  accepted  in  principle,  patients  cannot  be  invited  to
communicate  adverse  effects  directly  to  the  marketing  authorisation  holders  without  an
intervention or a filter of the health professionals or the competent authorities.

–  The  Commission  does  not  accept  amendment  45  aimed  at  setting  out  a  procedure  to  be
followed by the scientific committee of the Agency following the submission of a request
for the application of the accelerated procedure. The Commission considers that the details
of such a procedure should be decided in the context of the adoption of the internal rules of
procedure of the relevant committee.

–  The Commission does not accept amendment 46 aimed at removing the period of 10 years
data protection proposed in the context of medicinal products authorised according to the
centralised procedure and at proposing that this period should automatically be the period
applicable  in  the  context  of  medicinal  products  authorised  according  to  national
procedures.  The  Commission  considers  that  the  period  of  data  protection  for  medicinal
products  authorised  through  the  centralised  procedure  is  particular  to  that  procedure;  in
effect, by virtue  of  its scope it  applies to  more  innovative medicines or medicines which
have  been  manufactured  using  a  procedure  of  biotechnology.  For  this  reason,  the  period
currently foreseen by Regulation 2309/93 should not be modified nor depend on the final
outcome of the period of data protection which will be decided for medicines authorised in
the Member States.

–  The  Commission  does  not  accept  amendment  48  aimed  at  intoducing  a  reference  to
Community  law  in  the  context  of  the  provisions  relating  to  the  adaptation  to  technical
progress  of  methods  of  manufacture  and  control.  The  Commission  considers  that  this
reference is not legally necessary.

–  The  Commission  does  not  accept  amendment  49,  apart  from  the  first  sentence  which
concerns the responsibility for the data submitted, aimed at providing for a procedure to be
applied by the Agency when the data submitted by the applicant or the authorisation holder
are incorrect. The Commission considers that the question of the procedure to be followed
in such a case is already set out in article 11, paragraph 2 of the proposed regulation.

–  The  Commission  does  not  accept  amendment  57  aimed  at  removing  the  possibility,  in
exceptional  cases,  to  communicate  adverse  effects  by  a  means  other  than  electronic
reporting. It is necessary to maintain this reference for the cases where transmission by the
electronic route prove to be technically impossible.

–  The Commission does not accept amendment 65 aimed at providing an obligation for the
agency to publish an annual report on reported adverse effects as well as to indicate areas
of  further  research  requirements.  As  the  reports  on  the  adverse  effects  of  individual
products are not compiled on an annual basis, it does not seem appropriate to provide for
such  an  obligation.  In  addition,  the  Agency  does  not  have  the  competence  to  define
research policy at the Community level.

–  The Commission does not accept amendment 67 aimed at providing for an obligation for
authorisation holders to contribute to the costs incurred by the pharmacovigilance activities
developed  by  the  Agency.  On  the  other  hand,  the  Commission  has  accepted  in  principle
amendments 52, 80 and 121 which aim to guarantee that the pharmacovigilance activities
will benefit from an adequate and guaranteed financing.

27

–  The Commission does not accept amendment 71, nor amendment 107, first part, aimed at
providing  for  the  possibility  that  the  grounds  for  appeal  against  the  opinions  of  the
committees of the Agency could be based on new data that were not available at the time
of the first opinion. The Commission considers that the appeal should only be possible on
the basis of data  which has already been evaluated. n effect, if  new data were  to  appear,
these should be the subject of a completely new evaluation.

–  The  Commission  does  not  accept  amendment  85,  nor  the  reference  to  the  committee  for
herbal medicinal products contained in amendments 101, 105, and 108 aimed  at defining
the competences, the rules of nomination of the members as well as the way of working of
this  committee.  These  provisions  figure  in  the  proposed  directive  on  medicinal  products,
which  is  currently  the  subject  of  a  first  reading  before  the  Council  and  Parliament.  In
effect, the competences of this committee, its composition and its way of working, in line
with  the  provisions  for  the  committee  on  orphan  medicinal  products  in  the  specific
regulation, should be established in the framework of the new directive.

–  The Commission does not accept the first, second and third parts of amendment 91 aimed,
in  the  context  of  the  data  base  on  authorised  medicinal  products,  at  assuring  the
independence  with  respect  to  pharmaceutical  companies,  at  permitting  a  comparison
between different medicines and at including a specific section on medicines authorised for
paediatric  use.  As  far  as  the  first  part  is  concerned,  it  cannot  be  excluded  that
pharmaceutical  firms  do  not  contribute  financially  to  the  development  of  this  data  base;
with  regard  to  the  second  part  the  data  base  will  contain  necessary  and  particular
information  for  each  medicinal  product  on  the  basis  of  which  a  comparison  could  be
possible;  finally,  as  far  as  the  third  part  is  concerned,  the  future  legislative  proposal
specifically medicines for children will contain the necessary elements for the development
of a data base.

–  The  Commission  does  not  accept  the  last  part  of  amendment  93  aimed  at  giving  to  the
Agency,  within  the  framework  of  activities  against  bioterrorism,  the  competence  to
evaluate  the  deficiencies  in  research  in  this  area  and  the  strategies  to  combat  biological
warfare.  This  concerns  a  competence  which  should  belong  to  policy-making  bodies  and
not to a scientific agency.

–  The Commission does not accept amendment 94 aimed at providing for the participation of
the Agency in the implementation of specific measures relative to the capacity-building in
developing  countries,  particularly  through  initial  and  further  training  courses  for
employees of the authorisation and inspection authorities in such countries. The provisions
of  the  proposed  regulation  are  only  aimed  at  the  authorisation,  supervision  and
pharmacovigilance  of  authorised  medicines;  such  a  provision  would  not  fall  within  the
scope of the proposal.

–  The Commission does not accept amendment 97 aimed at extending the cooperation with
the  World  Health  Organisation  to  a  cooperation  also  with  the  International  Office  of
Epizooties.  The  establishment  of  such  a  procedure  in  the  sector  of  veterinary  medicinal
products has not been the subject of a specific request on the part of the Office concerned.
Such a procedure requires a collaboration and engagement on the part of the international
organisation which so far has not been discussed.

–  The  Commission  does  not  accept  the  first  part  of  amendment  110  aimed  at  providing
requirements  for  the  personnel  of  the  Agency  relating  to  financial  interests  or  other
interests concerning the pharmaceutical industry. This provision is not necessary as these

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personnel  are  already  subject  to  the  rules  of  the  statute  applicable  to  officials  or  other
agents working for the European institutions.

–  The  Commission  does  not  accept  amendment  119  aimed  at  providing  for,  within  the
composition  of  the  Advisory  Board,  representatives  of  interested  parties  or  other
organisations other than the competent authorities of the Member States. As the objective
of such an Advisory  Board  is to bring  together  the  competent  authorities  of  the  Member
States and in particular considering amendment 116 which the Commission has accepted
on the composition of the Management Board, it is not considered appropriate to provide
for  representatives  of  other  interested  parties  within  the  Advisory  Board  in  addition.
Moreover, the functions of this board are not decision making  and are supposed to allow
the positions of the competent authorities of the Member States to be heard.

–  The Commission does not accept amendment 122 aimed at providing for the commitment
on the part of the budgetary authority to assure the adequate financial resources for all new
competences or tasks  that  are  transferred  to  the  Agency.  A  similar  provision  has  already
been accepted by the Commission in the context of amendment 120.

–  The Commission does not  accept  the last  part of  amendment  128  aimed  at  providing  for
the possibility for the Management Board to adjust the level of the fees each  year in line
with the rate of inflation. The  fees regulation,  Council Regulation (EC) No 297/95  of 10
February 1995, sets out that a modification of the level of the fees should be adopted by the
Commission  through  a  comitology  procedure.  An  amendment  of  the  regulation  is
necessary for each modification of the fees.

–  In  the  context  of  the  provision  concerning  compassionate  use  the  Commission  does  not
accept  amendments  132  and  133  aimed  firstly  at  providing  that  the  entirety  of  title  II,
chapter  3  on  pharmacovigilance  applies  to  medicines  made  available  in  the  name  of
compassionate  use,  and  secondly  at  requiring  the  manufacturer  to  finance  the  medicinal
products.  The  reference  to  the  entirety  of  the  chapter  on  pharmacovigilance  can  not  be
applied  to  medicines  for  compassionate  use  as  they  are  not  yet  authorised.  The  essential
provisions  of  this  chapter  which  should  be  applied  are  already  taken  up  in  the  original
proposal of the Commission. With respect to financing, the public authorities’ decision to
finance compassionate treatments cannot be excluded.

–  The Commission does not accept amendment 145 aimed at removing the requirement that
only a single authorisation may be granted to a particular applicant for a specific medicinal
product.  The  reason  for  and  the  objective  of  the  centralised  procedure  are  to  have  one
medicinal  product,  one  authorisation,  one  name  valid  throughout  the  Community.  The
Commission proposal, however, provides for certain exceptional cases where, for reasons
of  public  health  linked  to  the  availability  of  a  medicinal  product  the  same  medicinal
product could be the object of several authorisations. These cases will remain limited and
should be considered as exceptional.

–  The  Commission  does  not  accept  amendments  147  and  148  aimed  at  introducing  the
question  of  the  difference  between  the  sexes  as  an  obligatory  criteria  to  take  into
consideration  during  the  evaluation  of  a  medicinal  product.  In  any  event,  this  question
comes under the procedure of scientific evaluation and a differentiated approach according
to the application. The reference in the body of the legislation is not necessary.

–  The  Commission  does  not  accept  amendment  152  aimed  at  introducing  a  recital  that
considers that the central tasks of the Agency should be financed through the community

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budget.  The  fees  should  serve  to  pay  for  the  services  carried  out  for  industry;  the
community contribution should serve to finance the tasks of a public nature required of the
Agency by the legislators, whether they are central or not.

–  The Commission does not accept the first part of amendment 157 aimed at including in the
database  on  authorised  medicinal  products  the  data  concerning  pharmacovigilance.
Specific databases for pharmacovigilance and for clinical trials are already provided for in
Community legislation.

–  The Commission does not accept amendment 162 aimed at defining patient representative
groups as well as specifying their composition and way of working. This question will be
taken up during the adoption of the public health programme which, amongst other things,
will establish the legal basis for the financing and Community support for these groups.

–  The Commission does not accept amendment 173 aimed at specifying that the legislation
applicable  to  medicinal  products  involves  matters  relating  to  public  health.  This
consideration already figures in a number of recitals in the Commission proposal and is the
basis of a number of provisions of this proposal.

–  The  Commission  does  not  accept  amendment  174  aimed  at  introducing  an  obligation  to
publish  evaluation  reports  including  the  elements  which  could  be  considered  to  be
commercially  confidential.  It  seems  appropriate  for  legal  reasons  to  preserve  without
derogation the exemption of certain commercially confidential elements of the evaluation
report from any publishing requirements.

–  The Commission does not accept amendment 175 aimed at providing that the duration of
the  evaluation  could  not  be  less  than  90  days.  The  detail  of  the  different  stages  of  the
scientific  evaluation  procedure  should  be  left  to  the  internal  rules  of  procedure  of  the
different scientific committees. It is not appropriate to include them in the regulation.

4. 

MODIFIED PROPOSAL

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

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