Amended proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)
Date: 2003-04-03
Institutions: European Commission
Subjects: drug surveillance, health control, market approval, pharmaceutical legislation, public health, veterinary drug, veterinary legislation

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 3.4.2003
COM(2003) 163 final

2001/0253 (COD)
2001/0254 (COD)

Amended proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Directive 2001/83/EC on the Community code relating to medicinal products
for human use

Amended proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Directive 2001/82/EC on the Community code relating to veterinary medicinal
products

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

2001/0253 (COD)

Amended proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Directive 2001/83/EC on the Community code relating to medicinal products
for human use

1. 

BACKGROUND

(Text with EEA relevance)

Proposal sent to the Council and Parliament
COM(2001) 404 final -2001/0253(COD)under Article 175(1)
of the EC Treaty:

26 November 2001

Opinion of the European Economic and Social Committee:

18 September 2002

Position of the European Parliament - first reading:

23 October 2002

2. 

OBJECTIVE OF THE COMMISSION PROPOSAL

Regulation 2309/93 makes provision for the evaluation  of  the  Community  procedures  for  the
authorisation  and  supervision  of  medicinal  products  which  entered  into  force  in  1995.  In  the
light of the experience acquired from 1995 to 2000, and the Commission’s analysis in its report
“on  the  operation  of  the  procedures  for  granting  marketing  authorisations  for  medicinal
products”  (COM  (2001)  606  final,  23.10.2001),  it  appeared  necessary  to  adapt  Regulation
2309/93  and  Directives  2001/83/EC  and  2001/82/EC  on  the  Community  code  relating  to
medicinal products for human use and for veterinary use.

Generally speaking, four main objectives are particularly relevant:

(1) 

(2) 

(3) 

(4) 

to guarantee a high level of public health protection, particularly by providing patients,
as swiftly as  possible,  with innovative  and  reliable  products  and  by  increasing  market
surveillance by reinforcing monitoring and pharmacovigilance procedures;

to complete the internal market in pharmaceutical products while taking account of the
implications  of  globalisation,  and  to  establish  a  regulatory  and  legislative  framework
that favours the competitiveness of the European pharmaceuticals sector;

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

to  rationalise  and  simplify  the  system,  thus  improving  its  overall  consistency  and
visibility, and the transparency of procedures.

Lastly, with regard to veterinary medicinal products, the proposals intend to specifically address
the problem of availability of such medicinal products.

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3. 

COMMISSION OPINION ON PARLIAMENT’S AMENDMENTS

3.1. 

Amendments accepted by the Commission: 2,  13, 24,  25, 33, 35, 42, 43,  44, 47,
48, 50, 57, 58, 61, 67, 68, 70, 82, 83, 84, 88, 89, 93, 97, 110, 120 (first part), 125,
130 and 158.

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

–  Amendment  2,  which  introduces  into  recital  2  the  reference  to  a  “safe”  movement  of

medicinal products:

“Recital 2:

Community legislation is a major milestone in the achievement of the objective of the free and
safe movement of medicinal products for human use and the elimination of obstacles to trade
in such products. However, in the light of the experience acquired, new measures have proved
necessary to eliminate the remaining obstacles to free movement.”

–  Amendment 13, that deletes in the definition of “radionuclide kit” the word “radionuclide”.
To maintain coherence with certain provisions of the Directive, it is necessary to align the
provisions of Article 6(2) and of Article 7:

“Title of Article 1, point 8:

8) Kit.

Article 6(2):

2.  The  authorisation  referred  to  in  paragraph  1  shall  also  be  required  for  radionuclide
generators,  kits,  radionuclide  precursor  radiopharmaceuticals  and  industrially  prepared
radiopharmaceuticals.

“Article 7:

A  marketing  authorisation  shall  not  be  required  for  a  radiopharmaceutical  prepared  at  the
time of use by a person or by an establishment authorised, according to national legislation,
to  use  such  medicinal  products  in  an  approved  health  care  establishment  exclusively  from
authorised  radionuclide  generators,  kits  or  radionuclide  precursors  in  accordance  with  the
manufacturer’s instructions.”

–  Amendment 24 reinforcing the means to respond to the threat of bioterrorist attacks:

"Article 5

1. Without prejudice to Regulation [(EEC) No 2309/93], a Member State may, in accordance
with  legislation  in  force  and  to  fulfil  special  needs,  exclude  from  the  provisions  of  this
Directive  medicinal  products  supplied  in  response  to  a  bona  fide  unsolicited  order,
formulated  in  accordance  with  the  specifications  of  an  authorised  health  care  professional
and for use by an individual patient under his direct personal responsibility.

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2. Member States may temporarily authorise the distribution of an unauthorised medicinal
product in response to the suspected or confirmed spread of a pathogen which could cause
harm.

Without  prejudice  to  paragraph  1,  Member  States  must  lay  down  provisions  removing
criminal,  civil  and  administrative 
liability  from  marketing  authorisation  holders,
manufacturers and health professionals for any consequences resulting from the use of a
medicinal  product  other  than  for  the  authorised  indications  or  from  the  use  of  an
unauthorised medicinal product, when such use is recommended by a competent authority
in response to the suspected or confirmed spread of pathogenic agents which could cause
harm. Such provisions shall apply whether or not national or Community authorisation has
been issued.”

–  Amendment  25  regarding  the  documents  to  be  submitted  by  the  applicant  on  the

constituents of the medicinal product:

“Article 8(3)(c):

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

–  Amendment  33,  according  to  which  an  applicant  has  to  submit  documents  to  proof  that

he/she will be able to meet certain pharmacovigilance obligations:

“Article 8(3)(n):

n)  Proof  that  the  applicant  has  the  services  of  a  qualified  person  responsible  for
pharmacovigilance  and  has  equipment  for  the  notification  of  any  adverse  reaction
suspected of occurring either in the Community or in a third country.”

–  Amendment  35  that  clarifies  that  the  data  protection  period  of  11  years  constitutes  the

maximum time:

“Article 10(1), second subparagraph:

The ten-year period referred to in the first subparagraph shall be extended to a maximum of
eleven  years  if,  during  the  first  eight  years  of  those  ten  years,  the  marketing  authorisation
holder  obtains  an  authorisation  for  one  or  more  new  therapeutic  indications  which,  during
the scientific evaluation prior to  their  authorisation,  are  held  to  bring  a  significant  clinical
benefit in comparison with existing therapies.”

–  Amendment  42,  according  to  which  the  summary  of  the  product  characteristics  shall

contain certain information in the prescribed order:

“Article 11, introductory sentence:

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

–  Amendment  43,  that  reintroduces  “major  incompatibilities”  into  the  summary  of  the

product characteristics in the section on pharmaceutical particulars:

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“Article 11(6), point 6.1a:

6.1a major incompatibilities.”

–  Amendment  44,  that  reintroduces  a  provision  according  to  which  homeopathic  products
authorised or registered before December 1993 do not need to be updated according to the
new legislation:

“Article 13(1):

1. Member States shall ensure that homeopathic medicinal products manufactured and placed
on the market within the Community are registered or authorised in accordance with Articles
14,  15  and  16,  except  where  such  medicinal  products  are  covered  by  a  registration  or
authorisation issued in accordance with national legislation up to 31 December 1993. Each
Member State shall take due account of the registrations and authorisations issued by other
Member States.”

–  Amendment  47  on  the  dossier  to  be  submitted  for  a  simplified  registration  of  a

homeopathic medicinal product:

“Article 15, second indent:

- dossier describing how the homeopathic stock or stocks is/are obtained and controlled, and
justifying its/their homeopathic use, on the basis of an adequate bibliography,”

–  Amendment  48  on  certain  particulars  to  be  submitted  in  an  application  for  simplified
registration of a homeopathic medicinal product. It is acceptable to delete the reference to
the method of dilution.

“Article 15, third indent:

-  manufacturing  and  control  file  for  each  pharmaceutical  form  and  a  description  of  the
method of potentisation,”

–  Amendment 50, introducing a correction in the reference to Article 8(3):

"Article 18

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

–  Amendments 57 and 58 on the invalidity of a marketing authorisation where the authorised

product is not effectively marketed:

“Article 24(2) and (3):

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

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The competent authority may, in exceptional circumstances and on public health grounds,
grant a derogation from the provisions of the previous subparagraph. The derogation shall
be duly justified.

3.  When an  authorised  product  previously  placed on  the  market  in  the  authorising  Member
State is no longer actually present on the market for a period of three consecutive years, the
authorisation for that product shall cease to be valid.

The competent authority may, in exceptional circumstances and on public health grounds,
grant a derogation from the provisions of the previous subparagraph. The derogation shall
be duly justified.”

–  Amendment 61 according to which the rules of procedure of the co-ordination group are to

be made public:

“Article 27(3):

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

–  Amendment  67,  which  is  intended  to  ensure  that  the  Committee  appoints  a  rapporteur

when the arbitration procedures are examined:

“Article 32(2):

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

–  Amendment  68  according  to  which  the  committee  shall  specify  the  time  limit  for

explanations by the applicant:

“Article 32(3), first subparagraph:

3.  Before  issuing  its  opinion,  the  Committee  shall  provide  the  applicant  or  the  marketing
authorisation  holder  with  an  opportunity  to  present  written  or  oral  explanations  within  a
time-limit which it shall specify.”

–  Amendment  70  which  reduces  the  time  limit  for  the  Commission  to  prepare  a  draft

decision from 30 to 15 days:

“Article 33, first subparagraph:

Within  15  days  of  the  receipt  of  the  opinion  the  Commission  shall  prepare  a  draft  of  the
decision to be taken in respect of the application, taking into account Community law.”

–  Amendment  82  including  into  the  package  leaflet  a  specific  invitation  to  consult  health-

care professionals in certain situations:

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“Article 59(1)(e), indent (viii):

viii)  a  specific  invitation  to  consult  the  doctor  or  the  pharmacist,  as  appropriate,  for  any
clarification on the use of the product;”

–  Amendment  83  which  adds  the  manufacturer’s  contact  details  to  the  information  which

must be included in the package leaflet:

“Article 59(1)(f), indent via):

via) the name and address of the manufacturer;”

–  Amendment 84 on an assessment of the legibility and clarity of package leaflets:

“Article 59(3):

3. The legibility, clarity and ease of use for patients of the package leaflet shall be assessed
in consultation with target patient groups.”

–  Amendment 88 on information on the manufacturer of a vial:

“Article 66(3), fourth indent:

- the name and address of the manufacturer,”

–  Amendment 89 on the labelling of homeopathic medicinal products:

"Article 68

Without  prejudice  to  the  provisions  of  Article  69,  homeopathic  medicinal  products  shall  be
labelled in accordance with the provisions of this title and shall be identified by a reference
on their labels, in clear and legible form, to their potentised nature.”

–  Amendment 93 changing the heading of Title VII:

“Title VII:

Wholesale distribution of medicinal products ”

–  Amendment  97  which  extends  the  application  of  Title  VII  to  all  homeopathic  medicinal
products by deleting the words “with the exception of those referred to in Article 14(1)”:

"Article 85

The provision of this Title shall apply to homeopathic medicinal products.”

–  Amendment 110 on clarifying the notion of advertising in the context of professional and

scientific meetings:

"Article 95

The  provisions  of  Article  94(1)  shall  not  prevent  hospitality  being  offered,  directly  or
indirectly,  at  events  for  purely  professional  and  scientific  purposes;  such  hospitality  shall

7

always  be  strictly  limited  to  the  main  scientific  objective  of  the  meeting;  it  must  not  be
extended to persons other than health professionals.”

–  The  first  part  of  amendment  120  clarifying  how  to  calculate  when  the  periodic  safety

update reports have to be presented:

“Article 104(6):

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

–  Amendment  125  on  the  possibility  of  unannounced  inspections  by  the  competent

authorities:

“Article 111(1), second subparagraph:

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

–  Amendment  130  according  to  which  the  Rules  of  Procedure  of  the  Standing  Committee

shall be made publicy:

“Article 121(5):

5.  The  Standing  Committee  shall  adopt  its  own  rules  of  procedure,  which  shall  be  made
public.”

–  Amendment 158 according to which in the name of a homeopathic medicinal product, the

scientific names can be supplemented, but not be replaced by an invented name:

“Article 69(1), first indent:

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

3.2. 

Amendments accepted  in  part  or  principle  by  the  Commission:  3,  5,  8,  11,  12,
14, 15, 18, 27, 30, 31, 32, 36, 46 (first part), 51, 52, 53 (first part), 55, 60, 63, 66,
69, 71 (second part), 80, 85, 86, 91, 92 (second part), 94, 95, 98, 99, 104, 106, 108,
114, 116 (first part), 121, 122, 140, 151, 156, 159, 167, 168, 185, 186 and 191.

The Commission can accept in principle the following amendments:

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–  Amendment  3  introducing  into  recital  3  a  reference  to  the  high  level  of  public  health

protection:

“Recital 3:

It is therefore necessary to align the national laws, regulations and administrative provisions
which  contain  differences  with  regard  to  the  basic  principles  in  order  to  promote  the
operation of the internal market, while realising a high level of human health protection.”

–  Amendments 5 and 32 on the necessity to fulfil the relevant ethical criteria for all clinical
trials  submitted  for  a  new  medicinal  product.  Bearing  in  mind  that  these  criteria  have
already  been  made  obligatory  by  Directive  2001/20/EC,  a  similar  provision  in  Directive
2001/83/EC  is  redundant.  However,  a  recital  can  be  introduced  to  refer  to  these  ethical
criteria:

“Recital 10a:

There  is  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  all  medicinal  products  authorised  within  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
good  clinical  practice  and  the  ethical  requirements  equivalent  to  the  provisions  of  this
Directive."

–  Amendments  8  and  140  introduce  a  recital  to  justify  the  proposed  provision  to  allow
patients  to  obtain  information  on  certain  prescription  medicinal  products  with  regard  to
three  illnesses.  Rewording  is  required  to  ensure  consistency  with  Recital  16,  already
proposed by the Commission, which relates to this same provision:

“Recital 16:

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

Recital 16a:

Patients  legitimately  need  and  expect  information  on  medicinal  products.  With  regard  to
medicinal  products  which  require  a  prescription,  in  order  to  meet  these  needs  and
expectations,  strict  conditions  must  be  applied  to  authorisation  to  access  information  on
certain medicinal products in the interest of the patients. This information must not be in
the form of advertising or direct promotion of medicinal products subject to prescription.”

–  Amendment  11  on  further  clarifications  of  the  definition  of  a  medicinal  product.  A
reformulation is needed to refer, in addition to pharmacological action, to immunological
and  metabolic  action.  This  addition  helps  to  better  specify  the  definition  of  medicinal
product  and  is  in  line  with  Article  1(2)(a)  of  Council  Directive  93/42/EEC  on  medical
devices:

9

“Article 1, point 2 b:

b)  Any  substance  or  combination  of  substances  which  may  be  used  in  human  beings  either
with  a  view  to  making  a  medical  diagnosis  or  to  restoring,  correcting  or  modifying
physiological  functions  by  exerting  a  pharmacological,  immunological  or  metabolic
action.”

–  Amendment 12 deleting certain parts in the definition of a homeopathic medicinal product.
A  rewording  is  needed  to  reintroduce  the  reference  to  homeopathic  stocks,  which  are  an
important step in producing a homeopathic medicinal product.

“Article 1, point 5

5) Homeopathic medicinal product:

Any  medicinal  product  prepared  from  substances  called  homeopathic  stocks  in  accordance
with a homeopathic manufacturing procedure described by the European Pharmacopoeia or,
in absence thereof, by the pharmacopoeias currently used officially in the Member States. A
homeopathic medicinal product may contain a number of principles.”

–  Amendment  14  introducing  a  definition  of  the  local  representative.  A  rewording  is
necessary  to  bring  the  notion  in  line  with  the  wording  already  used  in  the  text  of  the
directive:

“Article 1, point 18a)

18a) Representative of the marketing authorisation holder:

The  person,  commonly  known  as  local  representative,  designated  by  the  marketing
authorisation  holder  to  represent  him  in  the  Member  State  concerned.  Any  delegation  of
activities to this person by the market authorisation holder shall not relieve the latter of his
legal responsibility.”

–  Amendment  15  introducing  a  definition  of  the  risk/benefit  balance.  A  rewording  is

necessary to distinguish between the effects on the patient and on the environment:

“Article 1, points 28, 29 and 30:

(28) Risks related to use of the medicinal product

- any risk relating to the quality, safety and efficacy of the medicinal product as regards the
health of patients;

(29) Risks related to the environment

- any risk of unwanted effects on the environment;

(30) Risk/benefit balance:

An evaluation of the positive therapeutic effects of the medicinal product in relation to the
risks as defined above.”

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–  Amendment 18 on the situation that a given product could fulfil the definition of different
regulatory  regimes.  In  order  to  improve  the  legal  certainty,  the  provision  of  Article  2(2)
needs  to  be  maintained.  But  its  objective  can  be  clarified  by  amending  Recital  7.  A
rewording of this recital allows equally taking account of amendments 20, 21, 22 and 23
on the exclusion of food, food supplements, medical devices and cosmetics from the scope
of Directive 2001/83/EC. While it is unnecessary to add a provision in the operative part of
the Directive, the underlying idea can be stated in a recital:

“Recital 7:

Particularly  as  a  result  of  scientific  and  technical  progress,  the  definitions  and  scope  of
Directive 2001/83/EC should be clarified in order to achieve high standards for the quality,
safety and efficacy of medicinal products for human use. In order to take account, both of the
emergence of new therapies and of the growing number  of so-called “borderline” products
between the medicinal product sector and other sectors, the definition of “medicinal product”
should be modified so as to avoid any doubt as to the applicable legislation, when a product,
whilst  fully  falling  within  the  definition  of  a  medicinal  product,  may  also  fall  within  the
definition of other regulated products. With the same objective to clarify situations, where a
given product comes under the definition of a medicinal product, but could also fulfil the
definition  of  other  regulated  products,  it  is  necessary,  in  case  of  doubt  and  in  order  to
provide  legal  certainty,  to  state  explicitely  which  provisions  have  to  be  complied  with.
Where  a  product  comes  clearly  under  the  definition  of  other  product  categories,  in
particular  food,  food  supplements,  medical  devices  or  cosmetics,  this  Directive  does  not
apply. It is also worth taking advantage of this opportunity to improve the consistency of the
terminology of pharmaceutical legislation.”

–  Amendments  27  and  30  on  certain  particulars  and  documents  to  be  submitted  with  an
application for marketing authorisation to be part of the dossier in all cases. The words “if
applicable” are deleted so as to make the requirement applicable in all cases.

“Article 8(3)(g):

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

–  Amendment  31 

information  on
pharmacovigilance and on risk-management systems. A rewording is necessary since risk-
management systems are not necessary for all medicinal products:

submit  detailed 

the  applicant 

requiring 

to 

“Article 8(3), point ia:

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

–  Amendment 36 allowing an abridged application for a generic product in a Member State
even if the reference product has not been authorised in that particular Member State, but
only in another Member State. As this exception is intrinsically linked to the provision of
Article  10(1),  it  should  be  introduced  into  this  same  paragraph  rather  than  constituting  a
separate paragraph:

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“Article 10(1), second indent:

The first indent shall also apply, if the reference medicinal product has not been authorised
in the Member State where the application for the generic medicinal product is submitted.
In this case, the applicant has to indicate in the application the name of the Member State
where  the  reference  medicinal  product  is  or  has  been  authorised.  On  request  of  the
competent authority of the Member State where the application is submitted, the competent
authority of the other Member State shall transmit within a period of one month, a copy of
the dossier and of the marketing authorisation of the reference medicinal product.”

–  The  first  part  of  Amendment  46  on  the  sufficient  degree  of  dilution.  Where  it  can  be
accepted  to replace  the term  “dilution”  by  “potentisation”  a  rewording  is  needed  to  keep
the word “active principles” in line with the Directive’s terminology.

“Article 14(1), third indent:

there is a sufficient degree of potentisation, which involves a sequential series of dilutions or
succussions,  to  guarantee  the  safety  of  the  medicinal  product;  in  particular,  the  medicinal
product may not contain either more than one part per 10 000 of the mother tincture or more
than  1/100th of the  smallest  dose  used  in  allopathy  with  regard  to  active  substances  whose
presence  in  an  allopathic  medicinal  product  results  in  the  obligation  to  submit  a  doctor's
prescription.”

–  Amendment 51 on ways to make information on marketing authorisations available to the
general  public.  A  rewording  is  necessary  as  neither  the  marketing  authorisation  nor  the
summary  of  the  product  characteristics  contain  any  confidential  information  whose
publication could be objected by the authorisation holder:

“Article 21(3):

3.  The  competent  authorities  shall  make  publicly  available  without  delay  the  marketing
authorisation  together  with  the  summary  of  the  product  characteristics  for  each  medicinal
product which it has authorised.”

–  Amendment  52  and  the  first  part  of  amendment  53  on  making  publicly  available  the
assessment report  and the scientific  reasoning. The contents of these amendments  can be
integrated in Article 21(4), second subparagraph which has to be reformulated:

“Article 21(4), second subparagraph:

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

–  Amendment  55  specifying  the  specific  obligations  under  which  a  conditional  marketing
authorisation  may  be  granted.  The  provision  needs  to  be  reworded  as  the  specific
mechanism could concern other issues than those explicitly listed:

12

“Article 22, first subparagraph:

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, notification of the relevant authorities of any incident related to
its use and  any action to be  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.”

–  Amendment  60  stressing  the  applicant’s  responsibility  that  the  submitted  data  is  correct
and  has  not  been  falsified.  A  rewording  is  necessary  since  criminal  sanctions  cannot  be
foreseen in Directive 2001/83/EC dealing with pharmaceutical legislation.

“Article 26, third subparagraph:

The  applicant  or  marketing  authorisation  holder  is  responsible  for  the  veracity  of  the
documents and the data submitted by him.”

–  Amendment 63 which shall clarify the notion of “serious potential risk to public health”.
The provision has to be reformulated as it needs to be clarified that the guidelines are to be
adopted by the Commission.

“Article 29(1a):

1a.  Guidelines  to  be  adopted  by  the  Commission  shall  define  a  serious  potential  risk  to
public health.”

–  Amendment 66 which reinforces the arbitration procedures. The Commission accepts the
Parliament’s amendment turning the current option to refer a matter to the Agency into an
obligation,  in  the  cases  of  referral  where  a  Community  interest  is  involved.  However,  to
give  full  effect  to  such  an  obligatory  referral  it  is  necessary  to  clarify  that  such  referral
leads to a scientific opinion followed by a Commission decision as foreseen in Articles 33
and 34. For reasons of coherence, this similar clarification has to be introduced in the two
other provisions on referral procedures. The referral procedure under Article 31 envisages
inter  alia  changes  of  the  marketing  authorisation  in  order  to  take  account  of
pharmacovigilance information. If this procedure is to be reinforced, Article 116 needs to
be  aligned  so  as  to  allow  the  competent  authorities  to  take  all  necessary  decisions,
including,  alongside  the  suspension  and  revocation,  the  variation  of  a  marketing
authorisation.

“Article 29(3) :

3.  If  the  Member  States  fail  to  reach  an  agreement  within  the  60-day  period  laid  down  in
paragraph 2, the Agency shall be immediately informed, with a view to the application of the
procedure  under  Articles  32,  33  and  34.  The  Agency  shall  be  provided  with  a  detailed
statement of the matters on which the  Member States have been unable  to  reach  agreement
and the reasons for their disagreement. A copy shall be forwarded to the applicant.

13

Article 30(1) :

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

Article 31(1), first subparagraph:

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

“Article 116:

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

An authorisation shall also be suspended, revoked or varied where the particulars supporting
the application as provided for in Article 8 or Articles 10 to 11 are incorrect or have not been
amended in accordance with Article 23, or where the controls referred to in Article 112 have
not been carried out. ”

–  Amendment 69 which cuts down the deadline within which the Agency has to transmit the
final opinion to the Commission from 30 to 15 days. A rewording is necessary to keep the
reference to the marketing authorisation holder:

“Article 32(5), first subparagraph:

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

–  The second part of amendment 71 on the report to be drawn up on the functioning of the
Directive.  A  rewording  is  necessary  to  include  the  Council  alongside  the  European
Parliament:

14

“Article 38(2):

2. No later than [date], the Commission shall publish a report on the experience acquired on
the  basis  of  the  procedures  described  in  this  Chapter  and  shall  propose  any  amendments
which may be necessary to improve those procedures. This report shall be forwarded to the
European Parliament and to the Council.”

–  Amendment 80 which adds the competent authorities to the list of those to whom patients
may  report  adverse  reactions.  However,  this  needs  to  be  reworded  in  order  to  specify
which competent authorities are being referred to:

“Article 59(1)(d):

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

–  Amendment 85 on assessments to be carried out on mock-ups of the outer packaging with
target patient groups. However, a rewording of this provision is necessary in order to align
it with point  (j)  of Article  8(3),  as  proposed  by  the  Commission,  according  to  which  the
applicant only has to provide mock-ups, but no specimens.

“Article 61(1):

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

–  Amendment 86 sets out how and in what languages the leaflet should be drawn up, with a
view to ensuring legibility. A subparagraph regarding the possibility that several languages
might be used needs to be added.

“Article 63(2):

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

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

–  Amendment  91  which  replaces  the  statement  “without  approved  therapeutic  indications”
on  the  label,  and,  where  appropriate,  in  the  package  leaflet  for  homeopathic  medicinal
products registered under the simplified registration procedure, with the statement “without
specific therapeutic indications”. However, this needs to be reworded to make it clear that
a  registered  homeopathic  medicinal  product  cannot  have  any  therapeutic  indication
whatsoever, neither general, nor specific:

15

“Article 69(1), eleventh subparagraph:

- homeopathic medicinal product “without therapeutic indications”.

–  The second part of amendment 92 sets out a period of protection for data provided in the
context of an application for a change of classification of a medicinal product. However, it
needs  to  be  reworded  to  limit  the  duration  of  the  period  of  protection  and  to  clarify  it.
Therefore, a new Article 74a should be added:

“Article 74a

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

–  Amendment 94 lays down a requirement for distributors importing in parallel a medicinal
product  originating  from  another  Member  State  to  inform  the  holder  of  the  marketing
organisation of their intention. However, rewording is needed to clarify the provision and
to add a requirement to also inform the competent authorities in the Member State to which
the product will be imported. A new paragraph 2a must be added to Article 76:

“Article 76(2a):

2a. Any  distributor, not  being the marketing authorisation holder, who imports a  product
from  another  Member  State  shall  notify  the  marketing  authorisation  holder  and  the
competent authority in the Member State to which the product will be imported of his/her
intention to import it.”

–  Amendment 95 lays down a requirement for the marketing authorisation holder and, within
the  limits  of  their  responsibilities,  the  distributors  to  provide  suitable  supplies.  However,
rewording is needed to include this provision in Article 81, which already lays down public
service obligations. It is also necessary to exclude pharmacists from this obligation, and to
limit  it  to  the  needs  of  patients  in  the  Member  State  where  the  supplies  are  kept.  The
application of the principles of proportionality and protection of public health, and the fact
that such provisions must be implemented in compliance with the rules of the EC Treaty
should  also  be  taken  into  account.  A  new  subparagraph  has  therefore  been  inserted  into
Article 81 after the first subparagraph and the second subparagraph has been reworded:

“Article 81:

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

The holder of a marketing authorisation for a medicinal product and the distributors of the
said medicinal product in a Member State shall, within the limits of  their  responsibilities,
ensure appropriate  supplies  of  that medicinal product so  that the needs  of  patients  in  the
Member State in question are covered.

16

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

–  Amendment  98,  which  introduces  into  the  wording  of  Title  VIII  the  concept  of
“information”. However, rewording appears appropriate in order to refer to “information”
in general and not only to “Communication of information”:

“Title VIII

ADVERTISING AND INFORMATION”.

–  Amendment  99, which  is  intended  to  make  the  definition  of  advertising  more  precise  by
distinguishing it from information. However, rewording is needed to clarify this provision.
Information is already defined in Article 88(2), as proposed by the Commission:

“Article 86(1), introductory sentence:

1. For the purposes of this Title, “advertising of medicinal products” shall include any form
of  door-to-door  information,  canvassing  activity  or  inducement  designed  to  promote  the
prescription,  supply,  sale  or  consumption  of  medicinal  products;  it  shall  include  in
particular:”

–  Amendment  104,  which  stipulates  certain  topics  to  be  covered  by  the  report  to  be
submitted  by  the  Commission  on  the  experience  with  the  pilot-case  on  information  to
patients.  It  needs  to  be  reworded  though,  in  particular  to  clarify  that  the  list  is  not
exhaustive:

“Article 88(7a):

7a. The evaluation of the information pilot project shall include, among other things:

–  overall quality of the information presented,

–  accuracy of the information,

–  dissemination of the information,

–  accessibility of the information.”

–  Amendments  106  and  191  on  the  reference  to  the  international  non-proprietary  name.  A

rewording is necessary to combine the wording of both amendments :

“Article 89(2):

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

17

–  Amendment  108  allowing  a  reference  to  the  trademark  in  advertising  under  certain
conditions.  A  rewording  is  necessary  to  align  the  provisions  with  the  one  covering  the
advertising of a medicinal product to the general public (Article 89(2)) :

“Article 91(2):

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

–  Amendment  114,  which  makes  it  compulsory  for  Member  States  to  take  measures  to
require doctors and other health care professionals to report adverse reactions. Rewording
is  needed  to  make  such  a  provision  obligatory,  while  maintaining  the  wording  of  the
Commission’s proposal:

“Article 101, paragraph 2:

The  Member  States  shall  impose  specific  requirements  on  doctors  and  other  health  care
professionals,  in  respect  of  the  reporting  of  suspected  serious  or  unexpected  adverse
reactions.”

–  The  first  part  of  amendment  116  which  lays  down  a  requirement  to  publish  information
concerning pharmacovigilance. Rewording is needed to avoid referring to the Register and
to preserve wording that is more accessible to public:

“Article 102, paragraph 2:

2.  Member  States  shall  ensure  that  suitable  information  collected  within  this  system  is
communicated to the other Member States and the Agency. This information shall be recorded
in the database referred to in point  (j)  of  the  second  paragraph  of Article  51  of  Regulation
(EEC) 2309/93 and shall be permanently and immediately accessible to the public.”

–  Amendment  121  on  the  communication  of  pharmacovigilance  information  by  the

authorisation holder to the public:

“Article 104(8):

8. The marketing authorisation holder shall not be authorised to communicate information
on pharmacovigilance issues to the public without the consent of the competent authority.”

–  Amendments 122 and 159 impose an obligation on the holder of a marketing authorisation
to inform the competent authorities of any imminent cessation of sales or withdrawal of a
medicinal product from the market. Rewording is needed to bring this provision into line
with the measure set out in the proposal for a Regulation amending Regulation 2309/93:

“Article 104a:

The marketing authorisation holder shall notify the competent authorities of any imminent
temporary or definitive cessation of sales of a medicinal product. He/ she shall ensure that,
except in exceptional circumstances, the notification is carried out at least two months prior
to the cessation of sales of the product.”

18

–  Amendment  151  on  the  classification  of  a  medicinal  product  by  the  reference  Member
State in the case of a mutual recognition procedure. However, a rewording is necessary to
make  clear  that  the  classification  remains  part  of  the  summary  of  the  product
characteristics:

“Article 11, point 10

10)  Classification  in  accordance  with  Article  70(1).  The  classification  by  the  reference
Member State shall be taken seriously into account when the mutual recognition procedure
referred  to  in  Articles  27  to  39  for  obtaining  marketing  authorisation  for  a  medicinal
product is applied.”

–  Amendment 156, which is intended to make the definition of a generic medicinal product
more  precise.  However,  this  needs  to  be  reworded  to  take  into  account  the  scientific
definition  commonly  accepted  by  the  Member  States  within  the  informal  “notice  to  the
applicant” group:

“Article 10(2)(b):

b) generic medicinal product shall mean a medicinal product which has the same qualitative
and  quantitative  composition  in  active  principles  and  the  same  pharmaceutical  form,  and
whose  bioequivalence  with  the  reference  medicinal  product  has  been  demonstrated  by
appropriate  bioavailability  tests.  The  different  salts,  esters,  ethers,  isomers,  mixtures  of
isomers, complexes or derivatives of an active substance are considered as the same active
substance,  unless  they  differ  significantly  in  properties  with  regard  to  safety  and/or
efficacy.  The  various  solid  immediate-release  oral  pharmaceutical  forms  are  deemed  to  be
one  and  the  same  pharmaceutical  form.  Bioavailability  studies  may  not  be  required  of  the
applicant if he/she can demonstrate that the product meets the criteria of Annex I.”

–  Amendments  167  and  168  explicitly  set  out  that  the  provisions  for  generic  medicinal
products also cover similar biological medicinal products. Such medicinal products cannot
always  be  considered  to  be  generic  medicinal  products  under  the  definition  in  Article
10(2)(b), but are nonetheless not required to provide a full dossier. Relevant studies which
take the place  of bioavailability  studies must be  included  in  the  dossier.  The  amendment
needs  to  be  reworded  so  that  it  reflects  the  conditions  for  such  medicinal  products,  in
particular by adding a paragraph on them to Article 10:

“Article 10(3a):

3a. Where a biological medicinal product which is similar to a reference biological product
does not meet certain conditions in the definition of generic medicinal products, the results
of  appropriate  pre-clinical  tests  and  clinical  trials  related  to  these  conditions  must  be
provided.  The  results  of  other  tests  and  trials  from  the  reference  medicinal  product’s
dossier shall not be provided.”

–  Amendments  185  and  186  which  change  the  period  of  validity  of  the  marketing
authorisation.  The  European  Parliament  proposes  that  the  Commission’s  proposal  to
abolish  the  requirement  of  five-yearly  renewal  be  amended.  It  is  proposed  that  a
requirement to renew the first marketing authorisation after five years be introduced. After
this  renewal,  the  marketing  authorisation  would  be  considered  to  be  valid  indefinitely.
Recital 13 and Article 24(1) are therefore amended. Rewording is needed to more precisely

19

set out the context of the first evaluation and to avoid increasing the amount of time needed
to complete such a procedure:

“Recital 13:

Marketing authorisations for new medicinal products must initially be limited to five years’
validity. After the first renewal, the marketing authorisation shall be considered to be valid
indefinitely. Furthermore, any authorisation not used for three consecutive years, that is, it
has not led to the actual placing on the market of a medicinal product during that period,
should  be  considered  invalid  in  order,  in  particular,  to  avoid  the  administrative  burden
linked to maintaining such authorisations.

Article 24(1):

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

This  authorisation  may  be  renewed  after  five  years  on  the  basis  of  a  comparative
reassessment  of 
the  marketing
the  risk/benefit  balance.  When,  after  five  years, 
authorisation is renewed, the holder shall provide a consolidated version of the dossier on
the  quality,  safety  and  efficacy  of  the  medicinal  product  which  includes  all  the
modifications made during its five years of validity.

The  application  for  renewal  shall  be  submitted  to  the  competent  authority  at  least  six
months before the authorisation’s validity lapses.

After this renewal, the marketing authorisation shall be valid indefinitely.”

3.3.

Amendments not accepted by the Commission: 1, 4, 6, 8, 9, 10, 16, 19, 26, 28, 29,
34, 38, 39, 40, 41, 45, 46 (second part), 49, 53 (second part), 54, 56, 59, 62, 64, 65,
71 (first sentence),  72, 73,  74, 75,  76, 77, 78,  79, 81, 87, 92 (first  part),  96, 100,
101,  102,  103,  105,  107,  111,  113,  115,  116  (second  part),  117,  118,  119,  120
(second part), 123, 124, 126, 127, 129, 131, 132, 134, 135, 136, 141, 153, 154, 155,
157, 172, 173, 176, 179, 181, 182, 189, 190, 196, 198 and 202.

–  The  Commission  does  not  accept  amendment  1,  which  defines  medicinal  products  as
opposed to other consumer goods. Specifying this is not necessary to make the provisions
in the proposal clearer, nor does it reflect any of its provisions.

–  The Commission does not  accept  amendment  4,  which  introduces  a  specific  reference  to
the  objectives  set  out  in  Articles  152  and  153  of  the  EC  Treaty.  This  reference  is  not
justified from a legal point of view, as the Commission’s proposal is based on Article 95 of
the EC Treaty.

–  The  Commission  does  not  accept  amendment  6,  which  states  in  a  recital  that  the  quality
requirements  for  medicinal  products  are  different  according  to  whether  the  medicinal
product is intended for adults or for children. This cannot be accepted, as there can be no
difference  between  quality,  safety  and  efficacy  requirements  for  medicinal  products
depending on their target population.

–  The  Commission  does  not  accept  amendments  8  and  9,  which  set  out  the  provisions
concerning  providing  patients  with  information.  The  proposed  recitals  do  not  reflect  the
contents of the provision on information in Article 88(2).

20

–  The  Commission  does  not  accept  amendment  10,  which  introduces  a  recital  on  the
environmental  classification  of  medicinal  products.  This  recital  is  not  reflected  by  any
measure in the proposal.

–  The Commission does not accept amendments 16 and 73, which lay down a  requirement
for generic medicinal products authorised by the Member States to be identified with the
same  denomination.  This  provision  cannot  be  applied  since  these  measures  are  also
applicable to generic medicinal products authorised under national procedures.

–  The  Commission  does  not  accept  amendment  19,  which  grants  the  Agency  the  power  to
determine the scope of the proposed Directive. Firstly, this must be the prerogative of the
national authorities entrusted with applying it. Secondly, and within the framework of the
mutual recognition procedure, if several Member States are in disagreement, the Agency’s
corresponding  scientific  committee  will  issue  an  opinion  in  the  context  of  arbitration
proceedings.

–  The  Commission  does  not  accept  amendment  26,  which  adds  to  Article  8,  on  the
requirements for preparing the dossier for the application for authorisation, a requirement
for  an  assessment  of  the  risk/benefit  balance  in  respect  of  the  release  of  the  product  as
waste into the environment. This provision already exists and is included under paragraph
3, point g of the same Article.

–  The Commission does not accept amendment 28, which introduces a reference to all tests,
regardless of who carried them out. The provision in the proposal is intended to cover all
tests and trials which are necessary and useful for the application for authorisation, without
specifying who carries them out. There is no need for this reference.

–  The Commission does not accept amendment 29, which introduces requirements to, firstly,
specify the tests for adults and for children, and secondly, provide for tests comparing the
new  medicinal  product  to  be  authorised  with  existing  medicinal  products  in  the  same
therapeutic  class  This  requirement  cannot  be  a  part  of  the  assessment  with  a  view  to
granting marketing authorisation. Such assessments must be based solely on the criteria of
quality, safety and efficacy. The competent authorities in Member States compare efficacy
in order to determine the price and the amount refunded. Such assessments should only be
carried out in such a context.

–  The Commission does not  accept  amendments  34,  39,  134  and  202,  which  introduce  the
possibility  of  conducting  the  tests  and  trials  needed  for  authorisation,  submitting  the
application  for  authorisation,  and  authorising  generic  medicinal  products  during  the  ten-
year  period  of  data  protection.  It  is  also  proposed  that  the  application  of  “Bolar”  type
clauses be extended to cover generic medicinal products, the submission of the application
for  authorisation  and  of  samples,  the  granting  of  authorisation,  and  exports  during  the
period in which the reference medicinal product is covered by a patent or a supplementary
protection  certificate.  These  derogations  from  the  rights  deriving  from  the  protection  of
data  and  from  intellectual  property  rights  are  detrimental  to  the  balance  proposed  by  the
Commission in its original proposal. It is important to maintain this balance between a ten-
year period of data protection for innovative medicinal products and a “Bolar” type clause
for generic medicinal products in order to allow the tests and trials needed for authorisation
to  be  carried  out  during  the  period  in  which  they  are  protected  by  intellectual  property
rights.  As  for  the  last  part  of  amendment  34,  which  introduces  a  reference  to  medicinal
products which are biosimilar to biological medicinal products, the principle of referring to
this type of product is acceptable but should be specified directly in Article 10.

21

–  The  Commission  does  not  accept  amendment  38,  which  lays  down  a  requirement  to
provide  appropriate  tests  and  trials  if  one  or  more  of  the  active  principles  in  a  generic
medicinal product is changed. There is no need for this reference as the modified provision
already makes this a requirement.

–  The Commission does not accept amendment 40, which introduces an additional period of
three-years  data  protection  for  data  submitted  with  regard  to  authorising  new  indications
for a medicinal product, which has already been authorised. The provision would lead to a
disproportionate  extension  of  the  data  protection  period  and  would  provoke,  in  addition,
disharmonisation  between  generic  medicines  and  the  reference  products,  which  would
obtain  these  protected  new  indications.  The  amendment  needs  to  be  considered  together
with  the  second  part  of  amendment  92,  which  the  Commission  has  accepted  and  which
provides for a protection of data submitted with regard to changing the classification of an
already authorised medicinal product.

–  The Commission does not accept amendment 41, which reduces of period of time required
to establish a “well-established medicinal use” from ten  years to eight  years. There is  no
justification for  such a reduction. To the  contrary, given  that scientific  literature  replaces
pre-clinical tests and clinical trials, a ten-year period is indispensable.

–  The Commission does not accept amendment 45, which  extends  the  option  of  simplified
registration  to  homeopathic  products  administered  by  any  route  of  administration  that  is
described  in  the  Pharmacopoeia  or  is  used  officially  in  the  Member  States.  Such  an
extension  of  the  simplified  registration  procedure  is  not  justified.  It  must  be  limited  to
homeopathic medicinal products administered orally or externally. The risk related to other
routes of administration must be accompanied by proven efficacy.

–  The  Commission  does  not  accept  the  second  part  of  amendment  46,  which  grants  the
Commission  the  option  of  adapting  to  technical  progress  the  conditions  which  apply  to
homeopathic  medicinal  products  which  are  eligible  for  the  simplified  registration
procedure. These provisions are  already included in the Commission’s proposal. There is
therefore no need to repeat them in this provision.

–  The Commission does not accept amendment 49, which reduces of period of time required
to  draw  up  an  assessment  report  from  the  120  days  proposed  by  the  Commission  to  90
days.  It  must  be  ensured  that  the  amount  of  time  for  assessing  the  medicinal  product  is
sufficient, and for this reason, the 120-day period must be maintained.

–  The  Commission  does  not  accept  the  second  part  of  amendment  53,  which  lays  down  a
requirement  to  state  the  grounds  for  each  indication  of  the  medicinal  product  being
assessed  when  publishing  the  assessment  report.  There  is  no  need  to  stipulate  such  a
requirement as this practice is already followed by the competent authorities.

–  The  Commission  does  not  accept  amendment  54,  which  lays  down  a  requirement  to
publish the authorisation granted, the  summary  of product characteristics, the  assessment
report  and  the  comments  on  this  report  for  each  medicinal  product  authorised.  This
provision is already set out in the proposed Directive.

–  The Commission does not accept amendment 56, which introduces a requirement to take
account of scientific and technical progress, after authorisation, and Community law. There
is  no  need  for  such  a  reminder  as  Community  law  or  scientific  developments  are  to  be
taken into account for all medicinal products which are already authorised.

22

–  The  Commission  does  not  accept  amendments  59,  131  and  157,  which  lay  down  a
requirement  for  the  Commission  to  conduct  studies  comparing  new  medicinal  products
authorised  by  the  Commission  and  examining  the  application  of  Council  Directive
89/105/EEC  relating  to  the  transparency  of  measures  regulating  the  prices  of  medicinal
products  for  human  use  and  their  inclusion  in  the  scope  of  national  health  insurance
systems.  Such  studies,  though  desirable,  do  not  fall  within  the  scope  of  legislation  on
authorisation, surveillance and pharmacovigilance of medicinal products.

–  The Commission does  not  accept  amendment 62, which extends  the  scope  of  the  mutual
recognition  procedure  to  homeopathic  medicinal  products  registered  under  the  simplified
procedure.  There  is  no  need  to  specify  this  as  Article  39  of  the  proposal  for  a  Directive
already sets out in detail the provisions of the mutual recognition procedure which apply to
this kind of medicinal product.

–  The  Commission  does  not  accept  amendments  64  and  65,  which  make  it  obligatory  to
inform  the  Agency’s  scientific  committee  when  Member  States  have  arrived  at  different
decisions regarding the authorisation, suspension, withdrawal or requests to harmonise the
summary of characteristics of a medicinal product. These procedures must not appear to be
automatic.  Discretion  is  needed  to  verify  their  usefulness  on  a  case-by-case  basis.  Not
allowing  this  would  risk  creating  an  excessive  number  of  procedures  which  the  Agency
would not be able to process.

–  The Commission does not accept the first sentence of amendment 71, which introduces a
requirement for the Commission to take account of the need to standardise the procedures
which apply to pre-clinical tests and clinical trials in the  context of the  general  report on
the  application  of  the  mutual  recognition  procedure.  Legislation  which  specifically
addresses  the  harmonisation  of  national  procedures  for  conducting  these  tests  already
exists (Directive 2001/20/EC relating to the implementation of good clinical practice in the
conduct of clinical trials on medicinal products for human use).

–  The Commission does not accept amendment 72, which replaces the term “common name”
with  “international  non-proprietary  name”  in  the  context  of  information  which  must
obligatorily  be  included  on  the  packaging.  There  is  no  need  for  this  provision  since  the
definition of “common name” in Article 1 already refers to “international non-proprietary
name”.

–  The Commission does not accept amendment 74, which requires an obligatory blank space
to be left on the packaging of the medicinal product for stating the dosage. The space on
the external packaging of medicinal products is already quite limited. Requiring additional
space would result in a reduction of the space available for other obligatory information.

–  Commission  does  not  accept  amendments  75,  76  and  103,  which  require  the  competent
authorities  to  set  up  a  website  containing  information  on  the  medicinal  product  and  to
include  its  address  on  the  packaging  and  the  package  leaflet.  Pharmaceutical  legislation
makes no provision for any requirement to publish information on websites.

–  The  Commission  does  not  accept  amendment  77,  which  requires  a  warning  concerning
disposal  of  unused  medicinal  products  or  waste  materials  from  medicinal  products  to  be
placed on the packaging. This requirement is already set out in a provision of the proposed
Directive.

23

–  The  Commission  does  not  accept  amendment  78,  which  lays  down  a  requirement  to
include  certain  information  on  the  packaging  or  the  package  leaflet  in  braille,  or  certain
typefaces, or in other formats, on request. This requirement would be disproportionate with
regard  to  the  goal  to  be  achieved  and  could  be  detrimental  to  the  normal  format  for  the
indications. The prescribing agent and the pharmacist must be capable of providing blind
or visually impaired patients with the necessary information in an appropriate form.

–  The Commission does not accept amendment 79, which sets out certain  requirements  for
the  competent  authorities  in  the  Member  States  with  regard  to  creating  a  database  and
making the data it contains accessible to all patients. Such provisions are the responsibility
of the Member States, which decide on the best means for guaranteeing  access to certain
information  for  all  patients.  The  proposal  for  a  regulation  amending  Regulation  2309/93
already provides for the creation of a database on all medicinal products authorised by the
Community and by the Member States.

–  The Commission does not accept amendment 81, which sets out a requirement to state on
the packaging that the medicinal product was authorised recently and asking for all adverse
reactions to be reported. The date on which a medicinal product was authorised is already
to be stated on the packaging, and asking for adverse reactions to be reported should apply
to all medicinal products, not only to new ones. Moreover, specifically asking for reports
solely  on  such  medicinal  products  could  call  into  question  the  fact  that  they  have
undergone a full assessment and authorisation procedure.

–  The  Commission  does  not  accept  amendment  87,  which  modifies  the  wording  of  the
purpose  of  the  guidelines  on  the  legibility  of  the  information  on  the  label  and  in  the
package  leaflet.  There  is  no  need  for  such  a  change,  as  the  goal  of  the  Commission’s
proposal is already clearly to check the legibility of the packaging and the leaflets.

–  The  Commission  does  not  accept  the  first  part  of  amendment  92,  which  lays  down  a
requirement  for  the  competent  authorities  to  examine  the  classification  of  the  medicinal
product  during  the  authorisation  procedure.  Such  a  provision  is  already  set  out  in  the
Commission’s proposal.

–  The  Commission  does  not  accept  amendments  96  and  132,  which  impose  obligations  on
pharmacists. Pharmaceutical legislation does not set out in detail the provisions governing
pharmacists’ professional activity.

–  The  Commission  does  not  accept  amendment  100,  which  lays  down  an  obligation  for
advertising  to  be  consistent  with  all  the  information  which  accompanies  the  marketing
authorisation  or  is  related  to  it.  Advertising  is  to  be  checked  only  on  the  basis  of  a
summary  of  the  product’s  characteristics  which  reflects  the  scientific  assessment  as
approved by the competent authority.

–  The Commission does not accept amendments 101,  102,  173,  182  and  198,  which  either
delete  or  amend  the  Commission’s  proposal  regarding  the  provision  of  information  to
patients regarding prescription medicinal products for certain conditions, subject to certain
requirements  and  controls,  and  for  a  three-year  trial  period.  The  Commission  is  of  the
opinion that its proposal should be maintained in order to ensure that patients are provided
with certain information which is legitimate but limited solely to certain conditions during
the first stage of trials. For the same reasons, the Commission does not accept amendment
113  which  introduces  a  new  chapter  on  the  provision  of  information,  and  which  would

24

make it possible to provide comparative information on all authorised medicinal products,
diseases or therapies.

–  The Commission does not accept amendment 105, which reforms what information should
be  brought  to  the  attention  of  patients  in  the  context  of  advertising  for  certain  medicinal
products.  This  provision  is  not  appropriate  in  the  context  of  advertising  for  non-
prescription medicinal products.

–  The  Commission  does  not  accept  amendment  107,  which  replaces  the  term  “state  of
health” with “health” in the provisions with which advertising must comply. The original
terminology in the Commission’s proposal was more precise.

–  The Commission  does  not  accept  amendment  111,  which  extends  the  possibilities  of  co-
promotion to co-marketing activities by the holder of the marketing authorisation and one
or more companies nominated by him/her. Co-promotion can in no way cover the placing
on  the  market  of  the  medicinal  product.  This  is  to  be  done  solely  by  the  holder  of  the
marketing authorisation, who is in all cases solely responsible for this activity.

–  The  Commission  does  not  accept  amendment  115,  which  asks  a  specific  service  of  the
Commission to put forward legislative proposals on pharmacovigilance. The distribution of
work and services within the Commission is the responsibility of the Commission itself.

–  The Commission does not accept the second part of amendment 116, nor amendments 123
and  124,  which  provide  for  access  to  pharmacovigilance  information  on  authorised
medicinal products. This information on authorised medicinal products is already referred
to in point e) of the second paragraph of Article 51 of Regulation 2309/93, as provided for
in the second paragraph of Article 102 and amended by the first part of amendment 116.

–  The Commission does not accept amendment 117, which sets out an obligation to provide
guaranteed  public  financing  for  activities  related  to  pharmacovigilance.  Decisions  on
financing  national  pharmacovigilance  activities  lie  solely  within  the  competence  of
Member States.

–  The  Commission  does  not  accept  amendment  118,  which  deletes  the  reference  to
exceptional circumstances for cases where electronic communication of pharmacovigilance
data  is  not  possible.  This  provision  must  be  maintained  and,  as  proposed  by  the
Commission, limited solely to exceptional circumstances.

–  The Commission does not accept amendment 119, which also includes patients as a source
of  information  on  adverse  reactions  that  is  forwarded  directly  to  the  holder  of  the
marketing  authorisation.  Such  direct  communication  between  patients  and  marketing
authorisation holders would not result in reliable and potentially usable information. Such
information  must  be  filtered  by  health  professionals  or  by  officials  from  the  competent
authority.

–  The  Commission  does  not  accept  the  second  part  of  amendment  120,  which  defines  the
areas of competence for the Agency’s pharmacovigilance working group. This group is not
explicitly created by Regulation 2309/93 and, as a result, no legal obligations can be laid
down. As for the last part of the amendment, which sets out that all periodic safety update
reports  must  be  accessible  to  the  public  in  a  Register,  the  obligation  to  provide  public
access is already set out in Article 102(2).

25

–  The  Commission  does  not  accept  amendment  126,  which  lays  down  an  obligation  to
consider  the  scientific  assessment  of  the  risk/benefit  balance  to  be  the  first  stage  in  the
analysis of the medicinal product’s relative efficacy. The purpose of a risk/benefit balance
is,  and  must  continue  to  be,  to  scientifically  assess  the  benefits  and  the  risks  of  the
medicinal  product  in  question  on  an  individual  basis,  and  not  to  compare  that  medicinal
product with others.

–  The Commission does not accept amendment 127, which lays down a requirement for the
competent authorities to inform the prosecuting authorities if they find that data submitted
by an applicant has been falsified. Such provisions do not fall under pharmaceutical law,
but rather under Member States’ administrative or criminal law.

–  The  Commission  does  not  accept  amendment  129,  which  introduces  four  new  Articles
requiring  Member  States  to  apply  the  criteria  of  independence,  transparency  and  data
protection in national activities concerning authorisation and scientific assessment. In  the
Commission’s  opinion,  these  are  areas  of  national  competence,  and  pharmaceutical  law
regarding  marketing  authorisation,  surveillance  and
relates 
pharmacovigilance for medicinal products, not to the internal administrative rules of each
Member State.

the  procedures 

to 

–  The  Commission  does  not  accept  amendments  135  and  136,  which  lay  down  a  specific
requirement  to  take  appropriate  consideration  of  the  sexes,  particularly  in  clinical  trials.
The criteria of differences between the sexes is already taken into account in the scientific
guidelines prepared with regard to the international harmonisation of the guidelines that the
Community applies to its evaluation procedures.

–  The  Commission  does  not  accept  amendment  141,  which  introduces  a  recital  regarding
three objectives which must underlie all national policies concerning the control of social
expenditure. The main aims of the pharmaceutical legislation are already expressed in the
recitals of the Commission’s proposal.

–  The  Commission  does  not  accept  amendments  153  and  154,  which  propose  that  a  new
category of medicinal product, “herbal health product”, be introduced. There is no need to
add such a category of products to the legislation. The new proposal on traditional herbal-
based  medicinal  products  already  includes  the  definitions  for  this  type  of  medicinal
product.

–  The  Commission  does  not  accept  amendment  155,  which  removes  the  requirement  to
include the various strengths, pharmaceutical forms, routes of administration and forms of
presentation  of  the  same  medicinal  product  in  the  same  marketing  authorisation.  This
clarification is needed from a legal point of view.

–  The  Commission  does  not  accept  amendment  172,  which  adds  a  recital  referring  to  the
pharmacovigilance  data  collected  by  the  agencies  of  third  countries  and  by  the  World
Health Organisation. This recital is not reflected by any measure in the proposed Directive.

–  The  Commission  does  not  accept  amendment  176,  which  adds  a  new  requirement  with
regard  to  the  documents  to  be  included  in  applications  for  marketing  authorisations
regarding “long-term tests” for medicinal products for long-term treatment. This wording
is too vague. Medicinal products must, in all cases, undergo tests which are appropriate for
the use for which they are authorised.

26

–  The  Commission  does  not  accept  amendment  179,  which  introduces  an  option  for  the
Member  States  to  lay  down  specific  rules  on  the  evaluation  of  homeopathic  medicinal
products. Such a derogation cannot be accepted. The legislation already allows for this, but
limits it to the rules which apply to pre-clinical tests and clinical trials.

–  The  Commission  does  not  accept  amendment  181,  which  replaces  Article  94  with  a  text
that  makes  stricter  the  conditions  under  which  medicinal  products  may  be  promoted  to
persons qualified to prescribe or  supply  them. Nevertheless,  the  proposed  wording  is  too
restrictive and makes such promotion impracticable.

–  The Commission does not accept amendments 189 and 190, which lay down a requirement
to  refer  to  clinical  information  using  natural  frequencies  in  the  relevant  part  of  the
summary of  product characteristics  and to include the research designs. The summary  of
product  characteristics,  which  contains  the  results  of  the  scientific  assessment,  is  not  the
appropriate place for this information.

–  The Commission does not accept amendment 196, which introduces a specific exception to
patent rights, allowing for the production of medicinal products intended for export to third
countries,  at  the  request  of  the  authorities  of  the  third  country  in  question,  when  it  is
covered by a patent. First, as drafted, this amendment does not meet the strict conditions on
possible  exceptions  to  patent  rights  set  by  the  WTO  Agreement  on  Trade  Related
Intellectual  Property  Rights.  Secondly,  such  provision  does  not  have  a  place  in  the
legislation  governing  the  placing  on  the  market  of  medicinal  products  within  the
Community.

4.

AMENDED PROPOSAL

Pursuant  to  Article  250(2)  of  the  EC  Treaty,  the  Commission  amends  its  proposal  in  the
aforementioned terms.

27

2001/0254 (COD)

Amended proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Directive 2001/82/EC on the Community code relating to veterinary medicinal
products

(Text with EEA relevance)

1. 

BACKGROUND

Transmission of the proposal to the Council and to the European Parliament
- COM(2001) 404 final – 2001/0254 (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  as  quickly  as  possible,  and  by  an  increased  supervision  of  the
market through the strengthening of inspection procedures and of pharmacovigilance;

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.

28

3. 

3.1. 

OPINION OF THE COMMISSION ON THE AMENDMENTS ADOPTED BY
THE PARLIAMENT

Amendments accepted by the Commission: 1,  15, 19,  20, 21, 22, 24, 28,  29, 31,
33, 34, 35, 39, 46 and 49.

The  Commission  can  accept  the  following  amendments  with  the  wording  proposed  by  the
European  Parliament.  For  certain  provisions,  other  than  those  targeted  by  the  amendments,
incoherence with other provisions, or with the corresponding provisions in the proposal for a
Directive  relating  to  medicinal  products  for  human  use  and  in  the  Regulation  laying  down
Community  procedures  for  the  authorisation  and  supervision  and  pharmacovigilance  of
medicinal  products  for  human  and  veterinary  use  and  establishing  a  European  Medicinal
Products Agency, have been removed by amending the wording, where necessary.

–  Amendment 1 aimed at introducing a reference to the need to protect public health:

“Recital 3:

It is therefore necessary to align the national laws, regulations and administrative provisions
which  contain  differences  with  regard  to  the  basic  principles  in  order  to  promote  the
operation of the internal market, without adversely affecting public health.”

–  Amendment 15 aimed at requiring the applicant to submit documents as proof that he/she

will be able to meet certain pharmacovigilance obligations:

“Article 12, paragraph 3, point na:

Proof  that  the  applicant  has  the  services  of  a  qualified  person  responsible  for
pharmacovigilance  and  has  equipment  for  the  notification  of  any  adverse  reaction
suspected of occurring either in the Community or in a third country.”

–  Amendment 19 aimed at specifying the order of the items to be mentioned in the summary

of product characteristics:

“Article 14, introductory sentence:

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

–  Amendment  20  aimed  at  further  specifying  the  incompatibilities  concerned  by  the

provision:

“Article 14, paragraph 6, point 6.1:

major incompatibilities;”

–  Amendment 21 aimed at strengthening the need for Member States to take due account of
registrations  and  authorisations  of  homeopathic  veterinary  medicinal  products  issued  in
other Member States:

29

“Article 16, paragraph 1:

Member  States  shall  ensure  that  homeopathic  veterinary  medicinal  products  manufactured
and  marketed  within  the  Community  are  registered  or  authorised  in  accordance  with  the
provisions  of  Article 17(1)  and  (2),  and  Articles 18  and 19.  Each  Member  State  shall  take
due account of the registrations and authorisations issued by other Member States:”

–  Amendment 22 aimed at defining the strength relating to effect of homeopathic medicinal
products and to delete the reference to allopathic medicines, as this reference is incoherent
with  the  proposal  to  allow  the  simplified  registration  procedure  also  for  homeopathic
veterinary  medicinal  products  for  food-producing  species  and  the  proposals  regarding
prescription requirements:

“Article 17, paragraph 1, point (c):

there is a sufficient degree of potentisation, which involves a sequential series of dilutions or
succussions,  to  guarantee  the  safety  of  the  medicinal  product;  in  particular,  the  medicinal
product may not contain either more than one part per 10 000 of the mother tincture.”

–  Amendment  24  aimed  at  further  defining  the  strength  relating  to  effect  of  homeopathic

medicinal products, as far as the method of manufacturing is concerned:

“Article 18, indent 3:

-  manufacturing  and  control  file  for  each  pharmaceutical  form  and  a  description  of  the
method of potentisation,”

–  Amendment  28  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. A derogation  clause is
introduced:

“Article 28, paragraph 2:

Any authorisation which is not followed within three years of its issue by the actual marketing
of the authorised veterinary medicinal product in the authorising Member State shall cease to
be valid.

The  competent  authority  may,  in  exceptional  circumstances,  grant  a  derogation  from  the
provisions of the previous subparagraph. The derogation shall be duly justified.

Article 28, paragraph 3:

When  an  authorised  veterinary  medicinal  product  previously  placed  on  the  market  in  the
authorising Member State is no longer actually present on the market in that Member State
for  three  consecutive  years,  the  authorisation  for  that  veterinary  medicinal  product  shall
cease to be valid.

The  competent  authority  may,  in  exceptional  circumstances,  grant  a  derogation  from  the
provisions of previous subparagraph. The derogation shall be duly justified.”

30

–  Amendment 29 aimed at making public the rules of procedure for the co-ordination group

in charge of decentralised procedures for marketing authorisation:

“Article 31, paragraph 3:

The  co-ordination  group  shall  draw  up  its  own  rules  of  procedure,  which  shall  enter  into
force after a favourable opinion of the Commission. These rules of procedure shall be made
public.”

–  Amendment 31 aimed at providing a timetable for the work to be undertaken to harmonise
the summary of product characteristics for veterinary medicinal products authorised for not
less than ten year in the Community:

“Article 34, paragraph 2, subparagraph 4:

The Commission, acting in collaboration with the Agency, and taking into consideration the
views of interested parties, shall agree the final list and timetable.”

–  Amendment 33 aimed at making it obligatory for the committee to appoint a rapporteur for

the assessment of a referral:

“Article 36, paragraph 2:

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

–  Amendment  34  aimed  at  providing  a  time  limit  for  oral  or  written  explanations  by  the
applicant  or  marketing  authorisation  holder  in  the  case  of  referrals  made  in  accordance
with Articles 33 or 34:

“Article 36, paragraph 3, first subparagraph:

Before  issuing  its  opinion,  the  Committee  shall  provide  the  applicant  or  the  marketing
authorisation holder with an opportunity to present written or oral explanations within a time
limit which it will specify.”

–  Amendment  35  aimed  at  shortening  the  time  limit  for  the  decision  making  process.  In
order  to  align  the  wording  with  amendment  70  proposed  by  the  European  Parliament  to
amend Article 33 of Directive 2001/83/EC for medicinal products for human use, accepted
by  the  Commission,  which  is  aimed  at  reducing  the  corresponding  time  limit  for  the
Commission to prepare a draft decision from 30 to 15 days, that same amendment is also
introduced in Article 37, first subparagraph:

“Article 36, paragraph 5, first subparagraph:

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

Article 37, first subparagraph:

31

Within 15 days of receipt of the opinion, the Commission shall prepare a draft of the decision
to be taken in respect of the application, taking into account Community law.”

–  Amendment 39 aimed at specifying the order of the items to be mentioned in the package

leaflet:

“Article 61, paragraph 2, introductory wording:

The package leaflet  shall  be  approved  by  the  competent  authorities.  It  shall  contain,  in  the
order indicated, at least the following information, which shall conform to the particulars and
documents  provided  pursuant  to  Articles  12  to  13d  and  the  approved  summary  of  product
characteristics:”

–  Amendment  46  aimed  at  specifying  that  inspections  can  be  carried  out  without  prior
notification. Alignment with the corresponding amendment 125 proposed by the European
Parliament  to  amend  Article  111  of  Directive  2001/83/EC  for  medicinal  products  for
human use, accepted by the Commission:

“Article 80, paragraph 1, subparagraph 2:

The  competent  authority  may  also  carry  out  unannounced  inspections  at  the  premises  of
manufacturers  of  active  substances  used  as  starting  materials  for  veterinary  medicinal
products,  and  of  the  premises  of  the  marketing  authorisation  holder  whenever  it  considers
that  there  are  serious  grounds  for  suspecting  non-compliance  with  the  provisions  of
Article 51. Such inspections may also be carried out at the request of another Member State,
the Commission or the Agency.”

–  Amendment  49  aimed  at  the  publication  of  the  rule  of  procedure  of  the  Standing

Committee for veterinary medicinal products:

“Article 89, paragraph 5:

The  Standing  Committee  shall  adopt  its  own  rules  of  procedure,  which  shall  be  made
public.”

3.2. 

Amendments accepted in part or in principle by the Commission: 4, 5, 8, 9, 11,
14, 18, 26, 32, 36, 41, 42, 43, 48, 52, 53, 57, 58, 65, 68.

Certain  provisions  other  than  those  targeted  by  the  amendments  accepted  in  principle  have
been  reformulated 
the
take  account  of  faulty  cross-references,  alignment  with 
corresponding provisions for medicinal products for human use and linguistic corrections.

to 

–  The  Commission  can  accept  in  principle  amendments  4  and  41  aimed  at  providing  a
precision  of  the  definition  of  a  homeopathic  veterinary  medicinal  product  and  its
identification:

“Article 1, point 8:

Homeopathic veterinary medicinal product

Any veterinary  medicinal product  prepared  from substances  called homeopathic  stocks in
accordance  with  a  homeopathic  manufacturing  procedure  described  by  the  European

32

Pharmacopoeia or, in absence thereof, by the pharmacopoeias currently used officially in
the Member States.

A homeopathic veterinary medicinal product may contain a number of active principles.

Article 64, paragraph 2, indent 1:

-  the  scientific  name  of  the  stock  or  stocks  followed  by  the  degree  of  dilution,  using  the
symbols  of  the  pharmacopoeia  used  in  accordance  with  point  (8)  of  Article  1;  if  the
homeopathic veterinary medicinal product is composed of more than one stock, the scientific
names of the stocks may be supplemented on the labelling by an invented name,”

–  The Commission can  accept in principle  amendment 5 aimed  at  providing  a  precision  of
the definition of the risks with the use of veterinary medicinal products and the benefit/risk
ratio:

“Article 1, points 19, 19a and 19b:

(19) Risks related to the use of the product:

- any risk relating to the quality, safety and efficacy of the veterinary medicinal product as
regards animal or human health;

(19a) Risks related to the environment:

- any risk of unwanted effects on the environment;

(19b) Benefit/risk ratio:

An  evaluation  of  the  positive  therapeutic  effects  of  the  veterinary  medicinal  product  in
relation to the risks as defined above.”

–  The Commission can accept in principle amendments 8 and 9 aimed at strengthening the
exceptional nature  of the  use  of  veterinary medicinal  products  outside  the  authorised  use
for  non-food  producing  species  in  a  Member  State,  while  allowing  for  the  possibility  to
have access to such products authorised in other Member States. However, a rewording is
necessary,  as  veterinary  medicinal  products  are  authorised  for  an  animal  species.  In
exceptional circumstances, for a non food-producing species, if a product is authorised in
another country, free import/export of veterinary medicinal products by veterinarians could
be possible if the Member States have put in place appropriate measures for the import and
control of such products:

“Article 10, paragraph 1:

If there is no authorised medicinal product in a Member State for a condition affecting a non
food-producing species, the veterinarian may, by way of exception, particularly in order to
avoid  causing  unacceptable  suffering  to  the  animal  concerned,  under  his/her  personal
responsibility, treat the animal(s) with:

(a)

a veterinary medicinal product authorised in the Member State concerned under this
Directive or under Regulation (EC) No …/…. [laying down Community procedures
for the authorisation and supervision and pharmacovigilance of medicinal products
for  human  and  veterinary  use  and  establishing  a  European  Medicinal  Products

33

Agency]  for  use  with  another  animal  species,  or  for  another  condition in  the  same
species; or

(b)

if there is no product as referred to in point (a),

(i)  either  a  medicinal  product  authorised  for  human  use  in  the  Member  State
concerned  in  accordance  with  Directive  2001/83/EC  of  the  European  Parliament
and  of  the  Council*  or  under  Regulation  (EC)  No  …/….  [laying  down  Community
procedures  for  the  authorisation  and  supervision  and  pharmacovigilance  of
medicinal  products  for  human  and  veterinary  use  and  establishing  a  European
Medicinal Products Agency]; or

(ii)  a  veterinary  medicinal  product  authorised  in  another  Member  State  in
accordance  with  this  Directive  for  use  in  the  same  species  for  the  condition  in
question  or for another condition. Member  States shall take  specific  measures  to
control such use; or

(c)

if there is no product as referred to in point (b) and within the limits of the law of the
Member 
prepared
extemporaneously  by  a  person  authorised  to  do  so  under  national  legislation  in
accordance with the terms of a veterinary prescription.

veterinary  medicinal 

concerned, 

product 

State 

a 

* OJ L 311, 28.11.2001, p.67.

Article 10, paragraph 2:

By way  of derogation from Article 11, the  provisions of paragraph 1  shall  also apply  to  the
treatment by a veterinarian of an animal belonging to the equidae family provided that it has
been  declared,  under  Commission  Decision 93/623/EEC*  and  Commission  Decision
2000/68/EC**, as never having been intended for the production of foodstuffs.

Article 10, paragraph 3:

By way of  derogation from Article  11, and in  accordance with the procedure  referred  to  in
Article 89(2), the Commission shall establish a list of substances essential for the treatment of
equidae and for which the withdrawal period shall be not less than six months according to
the  control  mechanisms  laid  down  in  Decision  93/623/EEC*  and  Commission  Decision
2000/68/EC**.

*

OJ L 298, 3. 12. 1993, p. 45, **

OJ L 23, 28.1.2000, p. 72.”

–  The Commission can accept in part amendment  11 aimed  at  providing a  precision of the
exceptional  circumstances  under  which  the  use  of  veterinary  medicinal  products  outside
the  authorised  use  for  food  producing  species  in  a  Member  State  is  permitted,  while
allowing  for  the  possibility  to  have  access  to  such  products  authorised  in  other  Member
States. However, a rewording is necessary, as veterinary medicinal products are authorised
for an animal species. In addition, Member States are obliged to control any import/export
of veterinary medicinal products by veterinarians. Alignment with the corresponding  text
in  Article  10  should  also  be  reintroduced.  Furthermore,  the  qualification  by  means  of
suitability  of  veterinary  medicinal  products  is  subjective,  and  such  wording,  can  not  be
introduced in Community legislation:

34

“Article 11, paragraph 1:

By way of exception, if there is no authorised medicinal product in a Member State for a
condition  affecting  a  food-producing  species,  the  veterinarian  responsible  may  under
his/her  personal  responsibility,  in  particular  to  avoid  unacceptable  suffering,  treat  the
animals concerned on a particular holding with:

(a)

a veterinary medicinal product authorised in the Member State concerned under this
Directive or under Regulation (EC) No …/…. [laying down Community procedures
for the authorisation and supervision and pharmacovigilance of medicinal products
for  human  and  veterinary  use  and  establishing  a  European  Medicinal  Products
Agency]  for  use  with  another  animal  species,  or  for  another  condition in  the  same
species; or

(b)

if there is no product as referred to in point (a),

(i)  either,  a  medicinal  product  authorised  for  human  use  in  the  Member State
concerned  in  accordance  with  Directive  2001/83/EC  or  under  Regulation  (EC)  No
…/….  [laying  down  Community  procedures  for  the  authorisation  and  supervision
and  pharmacovigilance  of  medicinal  products  for  human  and  veterinary  use  and
establishing a European Medicinal Products Agency]; or

(ii)  a  veterinary  medicinal  product  authorised  in  another  Member State  in
accordance  with  this  Directive  for  use  in  the  same  species  for  the  condition  in
question  or  for  another  condition.  Member  States  shall  take  specific  measures  to
control such use; or

(c)

if the product or products as referred to in point (b) is/are not available and within
the  limits  of  the  law  of  the  Member  State  concerned,  of  a  veterinary  medicinal
product prepared extemporaneously by a person authorised to do so under national
legislation in accordance with the terms of a veterinary prescription.”

–  The  Commission  can  accept  in  principle  amendments  14  and  68  aimed  at  adding  a
requirement  to  supply  information  in  the  application  dossier  on  the  pharmacovigilance
system  intended  for  a  veterinary  medicinal  product  and  specific  tests  relating  to  the
potential  environmental  risks  posed  by  the  veterinary  medicinal  product.  However,
sophisticated pharmacovigilance management systems are not necessary for all veterinary
medicinal  products  and  the  requirement  should  therefore  be  required  only  where
appropriate. Furthermore, the tests required to assess the potential risks to the environment
are  already  included  under  the  item  safety  tests.  However,  the  provision  relating  to  the
potential  environmental  risks  that  the  veterinary  medicinal  product  may  pose  may  be
reformulated to take account of amendment 5:

“Article12, paragraph 3, point g:

Reasons  for  any  precautionary  and  safety  measures  to  be  taken  for  the  storage  of  the
veterinary  medicinal  product,  its  administration  to  animals  and  for  the  disposal  of  waste
products,  together  with  an  indication  of  any  potential  risks  presented  by  the  veterinary
medicinal product for the environment and the health of humans, animals or plants;

35

Article12, paragraph 3, point ja:

A  detailed  description  of  the  pharmacovigilance  system  and,  where  appropriate,  the  risk
management system, which the applicant will introduce;”

–  The Commission can accept in part amendment 18 aimed at providing an extension of the
period allowed for development of products for use in additional food-producing species,
from three to five years, with the view of making use of an extended period of exclusivity.
However, the extension of the exclusivity period to new significant therapeutic indications
and non-food producing species can not be accepted, as this would be counterproductive to
the aim of the provision, namely provide an incentive for products for an extended number
of minor food producing species, which are at the core of the problem with availability of
veterinary medicines:

“Article 13, paragraph 4:

In the case of veterinary medicinal products intended for one or more food producing species
and  containing  a  new  active  substance  that  has  not  been  authorised  in  the  Community  by
[date]  the  ten-year  period  provided  for  in  the  first  subparagraph  of  paragraph  1  shall  be
extended  by  one  year  for  each  extension  of  the  marketing  authorisation  to  another  food
producing species if it is authorised within the five years following the granting of the initial
marketing authorisation.

This  period  cannot,  however,  exceed  a  total  of  13  years,  for  a  marketing  authorisation  for
four or more species.

The extension of the ten-year period to 11, 12, or 13 years for a food-producing species shall
be  granted  only  if  the  marketing  authorisation  holder  had  also  been  at  the  origin  of  the
maximum residue limits established for the species covered by the authorisation.”

–  The Commission  can  accept in principle  amendment  26 aimed  at  providing  for  a  way  to
make information on marketing authorisations available to the general public. A rewording
is  however  necessary  as  neither  the  marketing  authorisation  nor  the  summary  of  product
characteristics contain any confidential information the publication of which the marketing
authorisation  holder  can  contest.  In  addition,  the  Commission  proposes  to  modify  the
provisions  in  line  with  the  corresponding  amendments  51  and  52  and  the  first  part  of
amendment 53 proposed by the European Parliament to amend Article 21, paragraph 3 and
second  subparagraph  of  paragraph  4  of  Directive  2001/83/EC  for  medicinal  products  for
human use, accepted in principle by the Commission:

”Article 25, paragraph 3:

The competent authority shall make publicly available without delay a copy of the marketing
authorisation  together  with  the  summary  of  product  characteristics  for  each  veterinary
medicinal product, which it has authorised.

Article 25, paragraph 4, second subparagraph:

The competent authority shall make publicly accessible without delay the assessment report
together  with  the  reasons  for  its  opinion  after  deleting  any  information  of  commercially
confidential nature.”

36

–  The  Commission  can  accept  in  principle  amendment  32  aimed  at  providing  for  an
obligatory referral of cases of risks to human or animal health or the environment where a
Community  interest  is  involved  to  allow  for  a  scientific  assessment  of  the  question  at
Community level. However, to give full effect to such an obligatory referral it is necessary
to clarify that such referral leads to a scientific opinion followed by a Commission decision
as foreseen in Articles 37 and 38. For reasons of coherence, this similar clarification has to
be  introduced  in  the  two  other  provisions  on  referral  procedures.  The  referral  procedure
under Article 35 envisages inter alia changes of the marketing authorisation in order to take
account of pharmacovigilance information. If this procedure is to be reinforced, Article 83
needs to be aligned so as to allow the competent authorities to take all necessary decisions,
including,  alongside  the  suspension  and  revocation,  the  variation  of  a  marketing
authorisation:

“Article 33, paragraph 3:

If within the period of 60 days the Member States fail to reach an agreement, the Agency shall
be immediately informed with a view to application of the procedure laid down in Article 36,
37 and 38. The Agency shall be provided with a detailed description of the matters on which
agreement could not be reached and the reasons for the disagreement. The applicant shall be
provided with a copy of this information.

Article 34, paragraph 1:

If two or more applications submitted in accordance with Articles 12 to 14 have been made
for marketing authorisation for a particular veterinary medicinal product and Member States
have  adopted  divergent  decisions  concerning  the  authorisation  of  that  veterinary  medicinal
product, or suspension or withdrawal of authorisation, a Member State, or the Commission,
or the marketing-authorisation holder may refer the matter to the Agency for application of
the procedure laid down in Article 36, 37 and 38.

Article 35, paragraph 1, subparagraph 1:

The  Member  States  or  the  Commission  or  the  applicant  or  holder  of  the  marketing
authorisation shall, in specific cases where the interests of the Community are involved, refer
the matter to the Committee for the application of the procedure laid down in Article 36, 37
and  38  before  reaching  a  decision  on  a  request  for  a  marketing  authorisation  or  on  the
suspension  or  withdrawal  of  an  authorisation,  or  on  any  other  variations  to  the  terms  of  a
marketing  authorisation  which  appear  necessary,  so  as  to  take  account  in  particular  of  the
information collected in accordance with Title VII.

Article 83, paragraph 1, introductory wording:

The  competent  authorities  of  the  Member  States  shall  suspend,  revoke  or  vary  marketing
authorisation when it is clear that:

Article 83, paragraph 2, introductory wording:

Authorisation shall be suspended, revoked or varied where it is established that: ”

–  The Commission can accept in principle amendment 36 aimed at providing for the transfer
of  the  future  report  on  the  functioning  of  the  proposed  decentralised  system  for
authorisation of  veterinary  medicinal  products  to  the  European  Parliament.  However,  the
Council will also receive this report and should thus be added to the provision:

37

“Article 42, paragraph 2:

The  Commission  shall  publish,  no  later  than  [date],  a  report  on  experience  gained  on  the
basis  of  the  procedures  provided  for  in  this  chapter  and  shall  propose  any  amendments
necessary  to  improve  the  procedures.  This  report  shall  be  forwarded  to  the  European
Parliament and the Council.”

–  The Commission can accept in principle amendments 42 and 43 aimed at providing for a
possibility  to  minimise  the  prescribed  amount  of  medicines  to  the  actual  need  in  certain
cases  and  provisions  for  the  dispensing  of  veterinary  medicinal  products  authorised  for
food  producing  species,  for  which  a  precision  is  needed.  However,  the  placement  of  the
provisions of amendment 42 on prescriptions is incongruent with the provisions of Article
66  dealing  with  sales  of  medicines  and  is  better  placed  in  Article  67,  as  an  additonal
subparagraph,  and  vice  versa  for  amendment  43,  which  should  be  placed  in  Article  66
relating to the dispensing of veterinary medicinal products. Furthermore, there is a need to
limit  the  dispensing  rights  by  other  professions  than  veterinarians  and  pharmacists  as
concerns treatments of bacterial infections:

“Article 66, paragraph 2a:

Member  States  may  permit  on  their  territory  the  dispensing  of  veterinary  medicinal
products for food producing animals, for which a veterinary prescription is required, by or
under  the  supervision  of  a  registered  person  providing  guarantees  with  respect  to
qualifications,  record-keeping  and  reporting  as  appropriate  in  accordance  with  national
legislation.  The  Member  States  shall  notify  this  arrangement  to  the  Commission.  This
provision  shall  not  apply  to  the  dispensing  of  veterinary  medicinal  products  for  the  oral  or
parenteral treatment of bacterial infections.

Article 67, paragraph 1, point (d):

officinal formulae, as defined in Article 3(2)(b), intended for food-producing animals

Article 67, paragraph 1, second and third subparagraphs:

Member States shall take all necessary measures to ensure that, where medicinal products
are supplied solely on prescription, the quantity prescribed and supplied shall be restricted
to the minimum amount required for the treatment or therapy concerned.

In addition, a prescription shall be required for new veterinary medicinal products containing
an active substance which has been authorised for use in a veterinary medicinal product for
less than seven years.”

–  The  Commission  can  accept  in  principle  amendment  48  as  far  as  the  second  part  is
concerned,  aimed  at  prohibiting  the  direct  advertising  to  the  general  public  of  veterinary
medicinal products containing psychotropic or narcotic substances. These substances have
a  very  specific  status  according  to  international  law.  However  the  first  part  of  the
amendment on the prohibition of advertising to the public of veterinary medicinal products
available only after a veterinary prescription  is not  accepted, as it  ignores  that there is at
present no general Community legislation on advertising of veterinary medicinal products
on which such measures could be based:

38

“Article 85, paragraph 2a:

Member States shall prohibit the advertising to the general public of veterinary medicinal
products which contain psychotropic or narcotic substances, such as those covered by the
United Nations Conventions of 1961 and 1971.”

–  The Commission can accept in principle amendments 52 and 53 aimed at allowing for the
use  of  homeopathic  veterinary  medicinal  products  in  exceptional  circumstances  where
there  is  no  authorised  veterinary  medicinal  product  for  the  treatment  of  a  particular
condition.  The  proposed  provision  for  non-food  producing  animals  is  in  line  with  the
possibility  to  use  medicinal  products  for  human  use  in  exceptional  circumstances,  and
should  therefore  be  aligned  with  that  provision.  However,  the  provision  aimed  at
introducing  the  possibility  for  extra-label  use  of  homeopathic  veterinary  medicinal
products for food-producing animals is acceptable only if appropriately controlled by the
competent  authorities.  The  recording  of  all  treatments  for  food  producing  animals  is
furthermore  necessary  under  other  Community  legislation  and  has  therefore  to  be
maintained. The provision should be amended in this sense:

“Article 16, paragraph 2a:

By way of derogation from Article 10, homeopathic veterinary medicinal products may be
administered to non-food producing animals under the responsibility of a veterinarian.

Article 16, paragraph 2b:

By  way  of  derogation  from  Article  11(1)  and  11(2),  Member  States  shall  permit
administration of homeopathic veterinary medicinal products intended for food producing
species for which  the  active  constituents  are  included  in Annex  II  of  Council  Regulation
(EEC)  No  2377/90  under  the  responsibility  of  a  veterinarian.  Member  States  shall  take
appropriate  measures  to  control  the  use  of  veterinary  homeopathic  medicinal  products
registered or authorised in another Member State in accordance with this Directive for use
in the same species.”

–  The  Commission  can  accept  in  principle  amendments  57  and  58  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  13  and  Article  28,  paragraph  1,  are  therefore  amended.  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 13:

Marketing authorisation for new veterinary 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.

39

Article 28, 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/risk ratio. When, after five years, the marketing authorisation is renewed, the holder
shall  submit  a  consolidated  dossier  on  the  quality,  safety  and  efficacy  of  the  veterinary
medicinal product with all the variations introduced during the  five  years  of validity. The
application for renewal shall be submitted 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.”

–  The Commission can accept in principle amendment 65 aimed at allowing for a derogation
from  the  need  for  established  maximum  residue  limits  for  pharmacologically  active
substances  in  veterinary  medicinal  products  for  the  Equidae  species,  provided  the  target
species  is  limited  to  those  animals  never  having  been  intended  to  be  used  for  the
production of food-stuffs. However, it is not acceptable to allow this exemption for active
substances to be included in veterinary medicinal products, for which alternative products
are  available.  Likewise  it  is  not  acceptable  to  allow  for  marketing  authorisations  of
products which contain substances included in Annex IV of Regulation (EEC) No 2377/90,
as  this  would  preclude  the  possibility  to  restrict  import  of  foodstuffs  containing  such
substances from third countries. Therefore, the provision has to be restricted and reworded
as follows and a clarifying paragraph added to Article 12 dealing with the application for
marketing authorisation:

“Article 6, paragraph 3:

By  way  of  derogation  from  paragraph  1,  a  veterinary  medicinal  product  containing
pharmacologically  active  substances  not  included  in  Annexes  I,  II  or  III  of  Regulation
(EEC)  No  2377/90  may  be  authorised  for  the  particular  animals  of  the  Equidae  species,
which  have  been  declared,  under  Commission  Decision 93/623/EEC*  and  Commission
Decision 2000/68/EC**, as never having been intended for the production of foodstuffs. The
active substances of such veterinary medicinal products shall not be included in Annex IV
of Council Regulation (EEC) No 2377/90 or intended for use in the treatment of conditions
for which a veterinary medicinal product is authorised in the Community.

Article 12, paragraph 1, third subparagraph:

In  the  case  of  veterinary  medicinal  products  referred  to  in  Article  6(3),  a  marketing
authorisation may be applied for without a valid application in accordance with Regulation
(EEC)  No  2377/90.  All  scientific  documentation  necessary  for  the  demonstration  of  the
quality, safety and efficacy according to paragraph 3 shall be submitted.”

–  The  Commission  proposes  to  modify  Article  1,  point  2(b),  to  clarify  the  definition  of  a
veterinary medicinal product by making reference to pharmacological, immunological and
metabolic  action.  This  modification  is  in  line  with  amendment  11  proposed  by  the
European Parliament to amend Article 1, point 2b, of Directive 2001/83/EC for medicinal
products for human use, which has been accepted in principle by the Commission:

40

”Article 1, point 2(b):

which  may  be  administered  to  or  used  in  animals  either  with  a  view  to  making  a  medical
diagnosis  or  to  restoring,  correcting  or  modifying  physiological  functions  by  exerting  a
pharmacological, immunological or metabolic action.”

–  The Commission proposes to introduce a definition of the local representative in Article 1,
point 17a. This modification is in line with the wording of amendment 14 proposed by the
European Parliament of Directive 2001/83/EC for medicinal products for human use which
has been accepted in principle by the Commission:

”Article 1, point 17a:

Representative of the marketing authorisation holder:

The  person,  commonly  known  as  local  representative,  designated  by  the  marketing
authorisation holder to represent him/her in the Member State concerned. Any delegation
of activities to this person by the marketing authorisation holder shall not relieve the latter
of his/her legal responsibility.”

–  The  Commission  proposes  to  modify  Article  12,  paragraph  3,  point  c,  in  line  with  the
corresponding amendment 25 proposed by the  European Parliament to amend Article 10,
paragraph 1  of Directive 2001/83/EC for medicinal products for human use, accepted  by
the Commission. This amendment regards information to be submitted by the applicant the
on constituents of the medicinal product:

“Article 12, paragraph 3, point c:

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

–  The Commission proposes to modify  Article  13, paragraph 1,  and to add  a subparagraph
between the first and second subparagraphs, in line with the corresponding amendment 36
proposed  by  the  European  Parliament  to  amend  Article  10,  paragraph  1  of  Directive
2001/83/EC  for  medicinal  products  for  human  use,  accepted  in  principle  by  the
Commission.  This  amendment  would  allow  for  an  abridged  application  for  a  generic
product  in  a  Member  State  even  if  the  reference  product  has  not  been  authorised  in  that
particular Member State, but only in another Member State:

“Article 13, paragraph 1, second subparagraph:

The  first  subparagraph  shall  also  apply,  if  the  reference  medicinal  product  has  not  been
authorised in the Member State where the application for the generic medicinal product is
submitted.  In  this  case,  the  applicant  has  to  indicate  in  the  application  the  name  of  the
Member State where the reference medicinal product is or has been authorised. On request
of  the  competent  authority  of  the  Member  State  where  the  application  is  submitted,  the
competent authority of the other Member State shall transmit within a period of one month,
a  copy  of  the  dossier  and  of  the  marketing  authorisation  of  the  reference  medicinal
product.”

41

–  The Commission proposes to modify Article 13, paragraph 2, point (b), aimed at providing
a  more  precise  definition  of  a  generic  medicinal  product,  in  line  with  the  scientific
definition  informally  accepted  by  the  Member  States.  The  proposal  is  in  coherence  with
amendment 156 proposed by the European Parliament to amend Article 10, paragraph 2 of
Directive  2001/83/EC  for  medicinal  products  for  human  use,  which  the  Commission
accepted in principle, subject to reformulation to take account of the existing definition:

“Article 13, paragraph 2, point (b):

generic  medicinal  product  shall  mean  a  medicinal  product  which  has  the  same  qualitative
and  quantitative  composition  in  terms  of  active  substances,  the  same  pharmaceutical  form,
and  whose  bioequivalence  with  the  reference  medicinal  product  has  been  demonstrated  by
means  of  appropriate  bioavailability  tests.  The  different  salts,  esters,  ethers,  isomers,
mixtures of isomers, complexes or derivatives of an active substance are considered as the
same  active  substance,  unless  they  differ  significantly  in  properties  with  regard  to  safety
and/or  efficacy.  Bioavailability  tests  may  not  be  required  of  the  applicant  if  he/she  can
demonstrate that the medicinal product meets the criteria set out in Annex I.”

–  The Commission proposes a new paragraph 3a in Article 13 to specify the documentation
requirements  for  biological  generic  veterinary  medicinal  products.  These  medicinal
products  can  not  always  be  classified  as  generic  medicinal  products  in  the  sense  of  the
definition  provided  for  in  Article  13,  paragraph  2,  point  (b),  but  should  not  require  the
submission  of  a  complete  dossier  in  all  cases.  The  documentation  shall  nevertheless
include  all  necessary  documents  and  particulars  with  respect  to  the  safety  tests  and  the
preclinical  and  clinical  trials  to  replace  the  bioavailability  studies.  The  proposal  is  in
coherence with amendments 167 and 168 proposed by the European Parliament to amend
Article  10  of  Directive  2001/83/EC  for  medicinal  products  for  human  use,  which  the
Commission  accepted  in  principle,  subject  to  reformulation  as  indicated  above,  by  the
introduction of a separate paragraph:

“Article 13, paragraph 3a:

In the case that a biological veterinary medicinal product similar to a reference biological
veterinary medicinal product does not  fulfil all  the  conditions  of  the definition of  generic
medicinal product, the results of appropriate pre-clinical and clinical trials linked to these
conditions  shall  be  submitted.  The  results  of  other  tests,  referred  to  in  the  dossier  of  the
reference medicinal product, are not required to be submitted.”

–  The  Commission  proposes  to  modify  Article  23,  paragraph  3,  to  provide  for  correct

reference to Article 12:

“Article 23, paragraph 3:

may similarly check, in particular through consultation of a national or Community reference
laboratory, that the analytical method used for detecting residues presented by the applicant
in accordance with point (j) of Article 12(3) is satisfactory;”

–  The Commission proposes to modify Article 30, subparagraph 4, to align the wording with
the corresponding amendment 60 proposed by the European Parliament to amend Article
26  of  Directive  2001/83/EC  for  medicinal  products  for  human  use,  accepted  by  the
Commission subject to rewording, to introduce the explicit responsibility of the  applicant

42

or  marketing  authorisation  holder  for  the  correctness  of  data  submitted  in  support  of  an
application for marketing authorisation:

“Article 30, subparagraph 4:

The  applicant  or  marketing  authorisation  holder  is  responsible  for  the  veracity  of  the
documents and the data submitted by him/her.

–  The Commission proposes to modify Article 33, paragraph 1, to add a paragraph 1a aimed
at the introduction of a provision to clarify the notion of a potential serious risk to human
or  animal  health  or  the  environment.  This  modification  is  in  line  with  the  corresponding
amendment  63  proposed  by  the  European  Parliament  to  amend  Article  29  of  Directive
2001/83/EC  for  medicinal  products  for  human  use,  which  the  Commission  accepted
subject to rewording to take account of the need for any guidance proposed to be adopted
by the Commission:

“Article 33, paragraph 1a:

Guidelines to be adopted by the Commission shall define a serious risk to human or animal
health or the environment.”

–  The  Commission  proposes  to  modify  Article  58,  paragraph  1,  point  (a)  and  Article  61,
paragraph  2,  points  (a)  and  (b)  to  be  in  line  with  the  corresponding  proposal  to  amend
Directive 2001/83/EC for medicinal products for human use. It is also proposed to modify
Article  61,  paragraph  1  by  adding  a  second  subparagraph,  for  reasons  of  coherence  with
the corresponding amendment 86 proposed by the European Parliament to amend Article
63  of  Directive  2001/83/EC  for  medicinal  products  for  human  use,  to  allow  for  the
inclusion  of  information  in  several  languages  on  the  same  package  leaflet,  provided  the
information in all the languages is identical:

“Article 58, paragraph 1, point (a):

the name  of  the  medicinal product followed by its strength and  pharmaceutical  form,  if  the
medicinal  product  is  available  in  several  strengths  and/or  pharmaceutical  forms;  the
common name shall be included where the product contains only one active substance and
if its name is an invented name;

Article 61, paragraph 1:

The inclusion of a package leaflet in the packaging of veterinary medicinal products shall be
obligatory  unless  all  the  information  required  by  this  Article  can  be  conveyed  on  the
immediate  packaging  and  the  outer  packaging.  Member  States  shall  take  all  appropriate
measures to ensure that the package leaflet relates solely to the veterinary medicinal product
with  which  it  is  included.  The  package  leaflet  shall  be  worded  in  terms  that  are
comprehensible to the general public and in the official language or languages of the Member
State in which the medicinal product is marketed.

The  provisions  of  the  first  subparagraph  do  not  preclude  the  possibility  that  the  package
leaflet is written in several languages, on condition that the information is identical in all
the languages.

43

Article 61, paragraph 2, point (a):

name  or  corporate  name  and  permanent  address  or  registered  place  of  business  of  the
marketing authorisation holder and of the manufacturer and, where appropriate, of the local
representative designated by the marketing authorisation holder in the Member State;

Article 61, paragraph 2, point (b)

name of the veterinary medicinal product followed by its strength and pharmaceutical form.
The common name shall be included where the product contains only one active substance
and if its name is an invented name. Where the medicinal product is authorised according
to  the  procedure  provided  for  in  Articles  31  to  43  under  different  names  in  the  Member
States concerned, a list of the names authorised in each Member State;"

–  The  Commission  proposes  to  modify  Articles  64,  paragraph  2,  to  be  coherent  with  the
requirement  in  Article  17,  paragraph  1,  point  (b),  that  no  specific  therapeutic  indication
may  appear  either  on  the  labelling  or  on  any  information  relating  to  the  homeopathic
veterinary medicinal product and to align the wording with the corresponding amendment
89 proposed by the European Parliament to amend Article 68 of Directive 2001/83/EC for
medicinal products for human use:

“Article 64, paragraph 2, introductory wording:

In  addition  to  the  clear  mention  of  the  words  ‘homeopathic  veterinary  medicinal  product
without approved therapeutic indications’ and to the reference to the potentised nature of
the  product,  the  labelling  and,  where  appropriate,  package  leaflet  for  the  homeopathic
veterinary medicinal products referred to in Article 17(1) shall bear the following information
and no other information:"

–  The  Commission  proposes  to  modify  Article  72,  paragraph  2,  to  make  it  obligatory  for
Member  States  to  impose  specific  requirements  to  report  adverse  reactions  to  veterinary
medicinal products. This modification is proposed to achieve coherence  with  amendment
114 on pharmacovigilance issues proposed by  the  European Parliament to amend  Article
101  of  Directive  2001/83/EC  for  medicinal  products  for  human  use,  which  have  been
accepted by the Commission subject to reformulation:

“Article 72, paragraph 2:

The Member States shall impose specific requirements on veterinary practitioners and other
health  care  professionals  in  respect  of  the  reporting  of  suspected  serious  or  unexpected
adverse reactions and human adverse reactions.”

–  The Commission proposes to modify Article 73, third paragraph, to clarify the provisions
on  public  access  to  information  on  veterinary  medicinal  products.  This  modification  is
proposed  to  achieve  coherence  with  amendment  116  on  pharmacovigilance  issues
proposed  by  the  European  Parliament  to  amend  Article  102  of  Directive  2001/83/EC  for
medicinal products for human use, which have been accepted by the Commission subject
to reformulation, to avoid reference to the data base but allowing the widest possible public
access to the information:

44

“Article 73, third paragraph:

Member  States  shall  ensure  that  appropriate  information  collected  within  this  system  is
forwarded to the other Member States and the Agency. This information shall be recorded in
the  database  referred  to  in  point  (j)  of  the  second  paragraph  of  Article  51  of  Regulation
(EEC) No 2309/93 and shall be permanently accessible to the public without delay.”

–  The  Commission  proposes  to modify  Article  75,  paragraph 5, to clarify how  to  calculate
when the periodic safety update reports have to be presented, and to add a new paragraph 7
on  the  communication  of  pharmacovigilance  information  by  the  marketing  authorisation
holder  to  the  public.  These  modifications  are  proposed  to  achieve  coherence  with
amendments  120  and  121  on  pharmacovigilance  issues  proposed  by  the  European
Parliament  to  amend  Article  104  of  Directive  2001/83/EC  for  medicinal  products  for
human use, which have been accepted by the Commission:

“Article 75, paragraph 5:

Unless  other  requirements  have  been  laid  down  as  a  condition  for  the  granting  of
authorisation,  or  subsequently  as  indicated  in  the  guidance  referred  to  in  Article  77(1),
records of all adverse reactions shall be submitted to the competent authorities in the form of
a periodic safety update report, either immediately  upon request or  periodically  as follows:
six monthly for the first two years after the veterinary medicinal product was first placed on
the  market,  annually  for  the  subsequent  two  years,  and  thereafter  at  three-yearly  intervals.
The  periodic  safety  update  reports  shall  include  a  scientific  evaluation  of  the  benefits  and
risks of the veterinary medicinal product.

Article 75, paragraph 7:

The  marketing  authorisation  holder  shall  not  be  authorised  to  communicate  information
on pharmacovigilance issues to the public without the consent of the competent authority.”

–  The Commission proposes to add a new Article 75a aimed at providing a requirement on
the part of the  marketing authorisation  holder to inform  the  competent authorities  of  any
cessation of the marketing of a veterinary medicinal product for reasons other than safety
concerns.  A  time  limit  for  the  provision  of  such  information  should  also  be  introduced.
These  modifications  are  proposed  to  achieve  coherence  with  amendments  122  and  159
proposed  by  the  European  Parliament  to  amend  the  Directive  2001/83/EC,  which  have
been  accepted  in  principle  by  the  Commission,  subject  to  reformulation  in  line  with  the
revised proposal to amend Regulation (EEC) No 2309/93:

“Article 75a:

The  marketing  authorisation  holder  shall  also  inform  the  competent  authorities  of  any
possible suspension, temporary or permanent, of the marketing of the veterinary medicinal
product.  This notification shall take  place,  unless  there  are  exceptional  circumstances,  at
least two months before the cessation of the marketing of the product.”

–  The Commission proposes to modify Article 84, paragraph 1, point (a), to reflect that the

provisions of this article apply to already authorised veterinary medicinal products:

45

“Article 84, paragraph 1, point (a):

it  is  clear  that  the  benefit/risk  assessment  of  the  veterinary  medicinal  product  is,  under  the
authorised  conditions  of  use,  unfavourable,  particular  regard  being  had  to  the  benefits  for
animal health and welfare and to the safety  and health  benefits  for the consumer,  when  the
authorisation concerns a veterinary medicinal product for zootechnical use."

3.3. 

Amendments not accepted by the Commission: 2, 3, 7, 10, 13, 16, 17, 23, 25, 27,
30, 37, 38, 40, 44, 45, 47, 56, 59, 60, 62, 63, 64, 66, 67 and 69.

–  The Commission cannot accept amendment 2 in recital 8 aimed at restricting authorisation
of veterinary medicinal products for food producing animals to therapeutic purposes, as the
prohibition of other uses is not within the scope of the legislation related to pharmaceutical
products.

–  The  Commission  cannot  accept  amendment  3  in  a  new  recital  aimed  at  a  request  by  the
European Parliament to the Commission to develop a standard environmental classification
system for veterinary medicinal products. According  to the  Commission,  this  proposal  is
not  necessary,  as  each  new  veterinary  medicinal  product  is  evaluated  with  respect  to
environmental risk assessment in the overall benefit/risk profile of that particular product.
There  is  furthermore  a  problem  with  the  availability  of  veterinary  medicinal  products
which has to be underscored.

–  The Commission cannot accept amendment 7 aimed at limiting the marketing authorisation
of  a  veterinary  medicinal  product  to  a  single  pharmaceutical  form.  This  change  is  not
acceptable  as  the  concept  of  an  authorisation  covers  the  original  authorisation  and  any
extensions to additional strengths, pharmaceutical forms and presentations. The addition of
a  pharmaceutical  form  is  authorised  in  accordance  with  Regulation  541/95  on  variations
(implemented in accordance with Article 39).

–  The Commission cannot accept amendment 10 aimed at  allowing veterinarians  unlimited
access to treatment of all animals of the Equidae species, even with substances prohibited
for use in food producing animals (annex IV). However, the provision is being modified to
take  account  of  the  necessity  to  include  Equidae  for  breeding  and  production  within  the
scope  of  the  provisions  relating  to  Equidae  excluded  from  production  of  foodstuffs  in
accordance with Commission Decision 2000/68/EC (see section 3.2. amendments 8 and 9).

–  The  Commission  cannot  accept  amendment  13  aimed  at  providing  a  zero  withdrawal
period for all homeopathic veterinary medicinal products with a concentration of the active
principle  of  equal  or  less  than  one  part  per  million.  This  level  of  active  principle  is  not
referred  to  elsewhere  in  the  Directive  and  even  substances  included  in  homeopathic
veterinary medicinal products may be hazardous to human health.

–  The Commission cannot accept amendment 16 aimed at limiting the data protection period
for  products  containing  new  substances,  not  previously  included  in  veterinary  medicinal
products  in  the  European  Union,  to  eight  years.  This  amendment  shifts  the  balance
between protecting innovation and reinforcing generic competition which is included in the
Commission proposal.

–  The  Commission  cannot  accept  amendment  17  aimed  at  extending  the  period  of  data
protection for veterinary medicinal products containing new active substances to 15 years
for products for smaller species and laying hens if the applicants places the product on the

46

market within two years of authorisation. A definition of a smaller species is not possible
at  Community  level,  as  this  will  vary  from  region  to  region  in  the  Community.
Furthermore 15 years is too long in comparison with the Commission proposal of 10 years
as a general period for data protection. The proposal of the Commission to extend the data
protection period directly to 13 years for products for bees and fish was made because it is
unlikely  that  such  products  can  be  used  in  other  species.  The  same  conditions  cannot  be
applied  to  laying  hens  and  other  species.  Furthermore,  the  proposal  by  the  European
Parliament to qualify the amendment by a clause on placing on the market will not provide
any additional safeguard with respect to the availability of veterinary medicinal products.

–  The  Commission  cannot  accept  amendment  23  aimed  at  allowing  active  substances  of
human  or  animal  origin  to  be  included  in  homeopathic  veterinary  medicinal  products
provided  that  they  comply  with  the  monograph  on  homeopathic  preparations  of  the
European pharmacopoeia. For such substances there are additional essential requirements
to  be  complied  with,  such  as  absence  of  adventitious  agents  and  a  risk  assessment  with
respect to TSE.

–  The  Commission  cannot  accept  amendment  25  aimed  at  deleting  requirements  for  safety
tests  for  homeopathic  veterinary  medicinal  products  for  food-producing  species  if  the
substance is included in Annex II of Regulation (EEC) No 2377/90. There is no scientific
justification  to  deviate  from  the  harmonised  standards  as  contained  in  the  Directive  for
testing of the safety and efficacy of homeopathic veterinary medicinal products for food-
producing species.

–  The Commission cannot accept amendment 27 aimed at adding a reference to Community
law to the requirement on marketing authorisation holders after an authorisation has been
issued. Marketing authorisation holders have in any case to abide by Community law.

–  The Commission cannot accept amendment 30 aimed at making a referral obligatory in the
cases  where  divergent  decisions  have  been  taken  in  respect  of  marketing  authorisations.
The reasons of taking divergent decisions can vary significantly and may not pose a risk to
human  or  animal  health  or  the  environment.  Hence,  it  is  necessary  in  these  situations  to
maintain the discretion foreseen in the current provisions.

–  The Commission cannot accept amendment 37 aimed at providing a reference to containers
and  a  space  on  the  label  of  the  medicinal  product  to  provide  for  the  possibility  to  write
additional information. The definition chosen for the container is the immediate packaging,
which is already in the text. The extra label space is not feasible for all products, as there
may be a problem of space. If there is a need of extra information, it should be solved by
other means to provide the information.

–  The Commission cannot accept amendment 38 aimed at amending the wording related to
specific  precautions  for  the  disposal  of  veterinary  medicinal  products  and  making  it  a
requirement to return all unused medicinal product to the pharmacy. The  first part  of the
proposed wording does not add anything to the provision as proposed by the Commission.
The proposal to return all unused products to the pharmacy is not workable in practice, as
veterinary  medicinal  products  are  also  delivered  by  other  distribution  channels.
Furthermore there is no harmonised distribution system for veterinary medicinal products
in the Community.

47

–  The Commission cannot accept amendment 40 aimed at introducing a reference to article
59 in article 64. Article 59 is not relevant for homeopathic veterinary medicinal products as
all information relating to these products are listed in Article 64.

–  The  Commission  cannot  accept  amendment  44  aimed  at  reducing  the  period  for
compulsory  prescription  only  status  for  veterinary  medicinal  products  containing  new
active  substances  to  four  years  under  certain  circumstances.  The  need  to  strengthen  the
provisions  of  pharmacovigilance  cannot  be  limited  to  the  first  four  years  after
authorisation.

–  The Commission cannot accept amendments 45 and 69 aimed  at providing  guarantees of
the  field  of

independent  funding  of  activities  of 
pharmacovigilance, as this is a question of national competence.

the  national  authorities 

in 

–  The  Commission  cannot  accept  amendment  47  aimed  at  providing  for  a  relative
effectiveness assessment of a veterinary medicinal product. The risk /benefit ratio for one
medicinal  product is related  to the authorisation  of that  specific  product  and  not  to  other
products.

–  The  Commission  cannot  accept  amendment  56  aimed  at  introducing  four  new  articles  to
impose  on  Member  States  certain  criteria  of 
transparency  and
confidentiality to be applied in the framework of the scientific evaluation and authorisation
of  veterinary  medicinal  products.  The  Commission  considers  that  pharmaceutical
legislation  provides  for  a  framework  for  procedures  for  marketing  authorisation,
surveillance  and  control  of  medicinal  products  and  not  for  internal  administrative
procedures in the national competent authorities.

independence, 

–  The Commission cannot  accept amendment 59  aimed at introducing  a  derogation  for  the
application of Regulation (EEC) No 2377/90 on maximum residue limits (MRLs), to allow
veterinarians, in exceptional circumstances, to treat food-producing animals with medicinal
products  containing  substances  not  included  in  Annex  I,  II,  or  III  of  that  Regulation,
provided  that  he/she  specifies  a  withdrawal  period.  The  Commission  considers  that  this
derogation would have serious implications for consumer safety and for the future  of the
veterinary  pharmaceutical  industry,  if  veterinarians  were  given  the  possiblity  to  use  any
medicinal product in any species. No residue control possibilities would exist for such use
and  the  incentive  for  the  pharmaceutical  industry  to  develop  new  products  would  be
diminished.  The  veterinarian  would  furthermore  not  have  sufficient  information  to
establish a withdrawal period, as these are based on the preexistence of MRLs for at least
one food-producing species.

–  The Commission cannot accept amendment 60 aimed at introducing a definition of food-
producing animals in the Directive. The Commission considers that such a definition does
not fall within the scope of the pharmaceutical legislation.

–  The Commission cannot accept amendment 62 aimed at introducing a reference in Article
11  to  the  absence  of  validated  scientific  data,  as  a  prerequisite  for  the  application  of
administrative  withdrawal  periods.  The  Commission  considers  that  such  reference  is
superflouous  to  the  contents  of  the  paragraph,  which  gives  a  minimum  administrative
withdrawal  period  that  shall  always  be  respected  when  the  provisions  of  this  Article  are
applied.

48

–  The Commission cannot accept amendments 63 and 66 aimed  at  introducing  a  change  in
the  provisions  concerning  the  possibilities  of  the  Member  States  to  control  the  use  of
veterinary  medicinal  products  intended  for  food-producing  animals  but  not  authorised  in
the  Member  State.  The  Commission  considers  that  it  is  of  paramount  importance  that  a
national control system is  put  in  place.  The importation of  veterinary  medicinal  products
from  other  Member  States  have  to  be  strictly  controlled  by  the  authorities,  as  the  entire
marketing authorisation system would otherwise be undermined.

–  The  Commission  cannot  accept  amendment  64  aimed  at  introducing  a  new  recital  on
freedom  of  choosing  an  alternative  therapy,  despite  differences  in  legal  status  of  such
therapies  in  Member  States.  The  Commission  considers  that  such  a  recital  does  not
correspond to any provision of the proposal and thus, cannot be included in the proposal.

–  The Commission cannot accept amendment 67 aimed at introducing a new definition of a
veterinary  prescription  to  allow  only  authorised  veterinarians  to  prescribe  medicinal
products for use in animals. The Commission considers that this definition is too detailed
and restricted. It may be envisaged that other authorised professionals may be allowed to
prescribe  particular  types  of  medicinal  products  under  national  law.  Furthermore,  the
meaning of representative samples and good veterinary practice in this context is unclear.

4. 

MODIFIED PROPOSAL

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

49