Re-examined proposal for a COUNCIL DIRECTIVE modifying Directives 65/65/EEC, 75/318/EEC and 75/319/EEC relating to medicinal products
Date: 1992-06-01
Institutions: European Commission
Subjects: approximation of laws, marketing standard, medicinal product, pharmaceutical legislation, pharmacology, public health

COMMISSION OF THE EUROPEAN  COMMUNITIES 

C0MC93) 220 final  - SYN 310,311 

Brussels,  1  June  1993 

JEW 

Re-examined  proposal  for a 

SYN 310 

COUNCIL  DIRECTIVE 

modifying  Directives 65/65/EEC, 75/318/EEC and 75/319/EEC 

relating  to medicinal  products 

Re-examined proposal  for a 

SYN 311 

COUNCIL DIRECTIVE 

modifying  Directives 81/851/EEC and 81/852/EEC 

on the approximation of  the  laws of  the Member  States 

relating to veterinary medicinal  products 

(presented  by  the Commission  pursuant  to Article  149(2)(d) 

of  the EEC Treaty) 

-  2 

On  21  April  1993  the  European  Parliament  examined  three  Common  Positions 
reached  by the Council  on  17 December  1992 relating  to the  following  proposals  of 
the Commission: 

proposal  for  a Council  Directive  modifying  Directives  65/65/EEC,  75/318/EEC 
and 75/319/EEC relating to medicinal products (SYN 310); 

proposal  for  a  Council  Directive  modifying  Directives  81/851/EEC  and 
81/852/EEC  on  the  approximation  of  laws  of  the  Member  States  relating  to 
veterinary medicinal products (SYN 311); 

proposal  for  a  Council  Directive  repealing  Directive  87/22/EEC  on  the 
approximation of national measures relating to the placing on the market of high 
technology  medicinal  products,  particularly  those  derived  from  biotechnology 
(SYN 312). 

The parliament has, during the second reading of the co-operation procedure, adopted 
13 amendments  to  the  first  proposal,  4  amendments  to  the  second  proposal  and  no 
amendments to the third proposal. 

In accordance  with Article  149(2)(d) of the Treaty, the Commission  has  re-examined 
the first  two proposals, having  it in mind  to take up some of the amendments  of the 
parliament, as described  hereafter. 

The  Commission  wishes,  meanwhile,  to  remind  the  Parliament  and  the  Council  that 
the decentralised procedure for the authorisation of medicinal products for human and 
veterinary use instituted by these Directives will not be able to function  in the absence 
of the European Medicines Evaluation Agency. 

Consequently,  the Commission  hopes that  the Parliament  will  be prepared  rapidly  to 
give  its  opinion  on  the  change  envisaged  by  the  Council  in  the  legal  base  of  the 
proposal  for  a  Regulation  laying  down  Community  procedures  for  the  authorisation 
and  the  supervision  of  medicines  for  human  and  veterinary  use, and  establishing  an 
European Agency for the evaluation of medicinal  products (SYN 309).  As far as this 
is concerned,  the  Commission  recalls  it preference  for  article  100A as the  legal  base 
for the Regulation. 

-  3  -

REVISED PROPOSAL FOR A COUNCIL DIRECTIVE (SYN 310) 

MODIFYING  DIRECTIVES 
RELATING TO MEDICINAL PRODUCTS 

65/65/EEC, 

75/318/EEC  AND 

75/319/EEC 

In accordance with Article  149(2)(d) of the Treaty, the Commission  has re-examined 
the  above  proposal,  having  it  in  mind  to  take  up  5  of  the  13  amendments  of  the 
Parliament, as detailed in annex  1.  The amendments rejected  by the Commission can 
be found  in annex 2. 

i  Amendments accepted  by the Commission 

The  CoML^esio:-  if.  i\.ady  to  accept  the  amendments  whi.h  • !  tr-d  already 
"-.di^g,  but  which  the  Council  has  ;'••_  ».  .i"ed  h:  ils 
'-;c?"tfd  \\i  the  I:-" 
C?.'•• >m:r-  r 

'^i*;"»n 

1 

-' 

i 

• 

.

-

.

.

,

.

'

'• 

ia»ion oi 

relating 

fô/65/FEC 
Two  amendments 
artiele  10  (Î)  and  75/319/EEC  article  29g)  have  the  merit  ;.-i  introducing  a 
greater  coherence  with  the  corresponding  text  of  articles  46  and  47  of  the 
Regulation. 

to  pharmacovigi!anc\." 

(Direcih:.. 

2.  Amendments  rejected  by the  Commission 

The  Commission  is  not  prepared  to  accept  the  other  eight  amendments  for  the 
following  reasons: 

Concerning  the  amendment  of  article  7 (2)  of  Directive  65/65/EEC,  the  text  of 
the common  position  is preferable  because  it defines  in  a more detailed  manner 
the  mechanism  of  co-ordination  between  the  Member  States  when  they  receive 
simultaneously  the same file,  and moreover clarifies  which documents  should  be 
exchanged, and what should be the time limits. 

-  4 

into  the  field  of 
introduce  concepts  and  terminology 
Four  amendments 
pharmacovigilance  incompatible  with  those  practised  by  the  Community  and 
recommended  by  the  World  Health  Organisation.  The  amendments  concerned 
are those to article  10(2) of Directive 65/65/EEC, as well as those to articles 29a, 
29b and 29d of Directive 75/319/EEC. 

The  amendment  of  article  13(1)  third  sub-paragraph  (a)  new  of  Directive 
75/319/EEC  aims  to  establish  a  right  to  indemnity  when  national  authorities 
initiate hastily the supplementary period of 90 days which is allowed for  in order 
to  examine  conflicts  in  decisions  between  Member  States.  The  Commission 
considers  that  it  falls  to  the  national  courts  to  sanction  possible  abuses  in  line 
with  national  law,  without  having  to  create  a  new  right  of  damages  under 
Community law. 

The amendment  of article  14 (4) of directive 75/319/EEC calls into doubt  again 
the  unity  of  the  market  and  of  the  Community  examination  criteria,  since  it 
permits  a  medicinal  product,  considered  through  a  Community  arbitration 
procedure not to be efficacious,  to remain authorised  in the country  of origin.  It 
should be remembered that a traditional medicinal product, of which the  efficacy 
recognised  only  by  a  single  Member  State,  is  not  affected  by  the  Community 
arbitration  procedure,  unless  the  firm  which  markets  it  itself  decides  to  have  it 
recognised by other countries, thus taking the risk of seeing it rejected. 

The  amendment  to  article  29f  first  paragraph  (a)  new  of  Directive  75/319/EEC 
risks  creating  a system  of  press  censorship.  The  Commission  does  not  think  it 
appropriate  that  national  or  community  authorities  should  institute  a  system  of 
prior authorisation  for any information,  which concerns medicinal products, even 
if it is alarmist. 

-  5 

ANNEX 1  AMENDMENTS ACCEPTED BY THE COMMISSION 

Common position of the Council 

Amendments 

Third recital 

relating 

Whereas  in  the  interests  of  public 
health it is necessary that decisions 
on  the  authorization  to  place 
medicinal products on the market be 
exclusively based on the criteria of 
quality, safety and efficacy; whereas 
these criteria have been extensively 
harmonized  by  Council  Directive 
65/65/EEC of 26 January  1965 on the 
approximation of provisions laid down 
by law, regulation or administrative 
action 
medicinal 
products,  by  Council  Directive 
75/319/EEC, and by Council Directive 
75/318/EEC  of  20 May  1975  on  the 
approximation  of  the  laws  of  the 
Member States relating to analytical, 
pharmacotoxicological  and  clinical 
standards and protocols in respect of 
the  testing  of  medicinal  products; 
whereas,  however,  Member  States 
should  exceptionally  be  able  to 
prohibit  the use on their territory 
of medicinal products which infringe 
objectively  defined  concepts  of 
public order or public morality; 

to 

Whereas  in  the  interests  of  public 
health  and  consumers  of  medicinal 
products  it  is  necessary  that 
decisions  on  the  authorization  to 
place  medicinal  products  on  the 
market  be  exclusively  based  on  the 
criteria  of  quality,  safety  and 
efficacy; whereas these criteria have 
been  extensively  harmonized  by 
Directive  65/65/EEC  of  26 January 
1965  on  the  approximation  of 
provisions  laid  down  by  law, 
regulation  or  administrative  action 
relating  to  medicinal  products, by 
Directive 75/319/EEC, and by Council 
Directive  75/318/EEC of  20 May  1975 
on the approximation of the laws of 
the  Member  States  relating  to 
analytical, 
pharmaco-toxicological 
and clinical standards and protocols 
in  respect  of  the  testing  of 
medicinal products; whereas, however, 
Member States should exceptionally be 
able  to  prohibit  the  use  on  their 
territory of medicinal products which 
infringe objectively defined concepts 
of public order or public morality; 

- 6 -

Common position of the Council 

Amendments 

ARTICLE 1(4) 
Article 4b, second paragraph a (new) (Directive 65/65/EEC) 

the  market 

Before a medicinal product is placed 
on 
the  competent 
authorities  shall  forward  to  the 
European Aaencv for the Evaluation of 
Medicinal  Products  a  copy  of  the 
decision together with the summary of 
the product characteristics referred 
Ço in this Article.  The Aaencv shall 
give the authorized medicinal product 
a  European  Register  number  which 
shall be marked on the packaging; the 
register number shall be preceded bv 
the initials of the Member States in 
which 
been 
product 
the 
authorized. 

has 

ARTICLE 1(6) 
Article 7(1) (Directive 65/65/EEC) 

1. Member  States  shall  take  all 
appropriate measures to ensure that 
the  procedure  for  granting  an 
authorization  to  place  a  medicinal 
product  on  the  market  is  completed 
within 2JL9_ days of the submission of 
a valid application. 

1.  Member  States  shall  take  all 
appropriate  measures  to ensure that 
the  procedure  for  granting  an 
authorization  to  place  a  medicinal 
product  on  the  market  is completed 
within  V40  days  of  the  date  the 
application is submitted. 

ARTICLE 1(9) 
Article 10(1) (Directive 65/65/EEC) 

1. Authorization  shall be valid for 
five years and shall be renewable for 
five-year periods, on application by 
the  holder  at  least  three  months 
before  the  expiry  date  and  after 
consideration  of a dossier updating 
the information previously submitted. 

1.  Authorization shall be valid for 
five years and shall be renewable for 
five-year periods, on application by 
the  holder  at  least  three  months 
before the expiry date and after the 
competent authority has considered a 
dossier 
up-to-date 
pharmacovigilance data and the other 
information 
the 
supervision of the medicinal product. 

containing 

relevant 

to 

- 7 -

Common position of the Council 

Amendments 

ARTICLE 3(3) 
Article 29g (Directive 75/319/EEC) 

a b o ut 

i n f o r m a t i on 

In order  to facilitate the exchange 
of 
the 
pharmacovigilance 
Community, 
in 
consultation with the Agency, Member 
States and interested parties, shall 
draw up guidance on the collection, 
verification  and  presentation  of 
adverse reaction reports. 

within 
Commission, 

the 

within 

ab ou t 

i n f o r m a t i on 

In order  to  facilitate the exchange 
of 
the 
pharmacovigilance 
Community, 
in 
consultation with the Agency, Member 
States and interested circles, shall 
draw up guidance on the collection, 
verification  and  presentation  of 
adverse reaction reports. 

the  Commission, 

Such guidance shall take into account 
the work carried  out bv  the WHO on 
the harmonization of terminology and 
classification  in  the  field  of 
It  shall  also 
pharmacovigilance, 
establish the arrangements for use of 
the  data-processing  network between 
the  competent  authorities  in  the 
event  of  an  alert  concerning  a 
manufacturing  fault  or  serious 
undesirable  reactions,  and  other 
pharmacovigilance  information  on 
medicinal  products  marketed  in  the 
Community. 

-  8  -

ANNEX 2 AMENDMENTS REJECTED BY THE COMMISSION 

Common position of the Council 

Amendments 

ARTICLE  1(6) 
Article 7(2)  (Directive 65/65/EEC) 

for 

2. Where a Member State notes that an 
application 
authorization 
submitted  after  1  January  1995  is 
already  under  active  examination  in 
another  Member  State  in  respect  of 
that  medicinal  product,  the  Member 
State concerned mav decide to suspend 
the  detailed  examination  of  the 
application  in  order  to  await  the 
assessment  report  prepared  by  the 
other Member State in accordance with 
Article 4b. 

2.  In  assessing  applications  for 
competent 
authorization. 
the 
shall  assist 
marketing  authorities 
entrust  one 
each  Qtfrer  anâ ffiây_ 
another  with  assessments  of  all  or 
part of the dossier. 

The  competent  authorities  of  the 
Member States shall notify the Agency 
and  the  other  Member  States  of  any 
applications 
marketing 
authorization thev receive. 

for 

A  Member  State  that  receives 
notification  shall.  if  the  same 
application  for  authorization  has 
been  submitted  in  another  Member 
State, contact the latter with a view 
to  coordinating  their  action  and 
issuing 
report 
jointly. 

assessment 

the 

If the Member States with an interest 
in  the  application  do  not  reach 
agreement, they mav. once all other 
possibilities  have  been  exhausted, 
have recourse  to the procedure laid 
down  in  Chapter  III  of  Directive 
75/319/EEC. 

The" Member  State  concerned  shall 
inform the other Member State and the 
applicant of its decision to suspend 
the 
derailed -  examination 
application in question.  As soon as 
it has completed  the examination of 
the'  application  and  reached  a 
decision,  the  other  Member  State 
shall  forward  a  copy  of  its 
assessment report to the Member State 
concerned. 

of 

Within 90 davs of the receipt of the 
assessment  report, the Member  State 
concerned shall either recognize the 
decision  of  the  other  Member  State 
and  the  summary  of  the  product 
characteristics  as  approved  bv  it. 
or.  if  it considers  that  there are 
grounds  for  supposing  that  the 
authorization  of  the  medicinal 
product concerned mav present a risk 
to public health, it shall apply the 
procedures set out in Articles 10 to 
14 of Directive 75/319/EEC. 

- 9 

Common position of the Council 

Amendments 

ARTICLE 1(9) 
Article 10(2), first subparagraph  (Directive 65/65/EEC) 

2. In exceptional circumstances, and 
following  consultation  with  the 
applicant,  an  authorization  may  be 
granted  subject  to certain  specific 
obligations, including: 

and 

exceptional 

2.  In 
duly 
substantiated  circumstances,  and 
following  consultation  with  the 
applicant,  an  authorization  may  be 
granted  subject  to certain specific 
obligations,  defined  and  reviewed 
annually bv the Agency, to: 

the  carrying  out  of  further 
studies following the granting of 
authorization; 

conduct further studies following 
the granting of authorization; 

-  the  notification  of  adverse 
the  medicinal 

to 

reactions 
product. 

-  report 

side-effects 

of 

medicinal product. 

the 

C o m m on position of the Council 

Amendments 

ARTICLE  3 d) 
Article 13(1), third subparagraph a (new) 
(Directive 75/319/EEC) 

Anv delays arising in the marketing 
of a medicinal product because this 
procedure has been initiated hastily 
or with the sole intention of causing 
a delay mav entitle the applicant to 
demand  compensation  in  accordance 
with  the  legislation  applicable  in 
the Member State in question. 

*«V 

Article 3(1) 
Article 14(4) (Directive 75/319/EEC) 

A decision adopted in accordance with 
this  Article  shall  be  addressed  to 
the  Member  States  concerned  by  the 
matter and to the person responsible 
for  marketing.  The  Member  States 
shall  either  grant  or  withdraw 
marketing authorization, or make any 
adjustment  to  the  terms  of  a 
marketing authorization which may be 
necessary to comply with the decision 
within 30 days of  its notification. 
They shall inform the Commission and 
the Committee thereof. 

A decision adopted in accordance with 
this  Article  shall  be  addressed  to 
the  Member  States  concerned  by  the 
matter and to the person responsible 
for  marketing.  The  Member  States 
shall  either  grant  or  withdraw 
marketing authorization, or make any 
adjustment  to  the  terms  of  a 
marketing authorization which may be 
necessary to comply with the decision 
within 30 days of its notification. 
In adopting its decision, the Member 
State in which the authorization was 
originally  granted  shall  take  into 
account experience with the medicinal 
product  in  question.  An  existing 
national authorization may be upheld, 
even in the event of a prior negative 
Decision  in  accordance  with  this 
Article, if the medicinal product is 
harmless and of high gualitv.  They 
shall  inform  the Commission and the 
Committee thereof. 

11  -

Common position of the Council 

Amendments 

ARTICLE 3(3) 
Article 29a (Directive 75/319/EEC) 

In order  to ensure  the adoption of 
appropriate  regulatory  decisions 
concerning  the  medicinal  products 
authorized  within  the  Community, 
having regard to information obtained 
about adverse reactions to medicinal 
products under normal  conditions of 
use,  the  Member  States  shall 
establish a pharmacovigilance system. 
This system shall be used to collect 
the 
information 
surveillance  of  medicinal  products, 
with particular reference to adverse 
reactions  in  human  beings,  and  to 
evaluate 
scientifically. 

information 

useful 

such 

in 

In order  to  ensure  the adoption of 
appropriate  regulatory  decisions 
continued 
the 
c o n c e r n i ng 
authorization  of  medicinal  products 
within  the Community,  having regard 
to  information  obtained  about  the 
side-effects  of  medicinal  products 
under  normal  conditions  of  use, 
Member  States  shall  establish  a 
pharmacovigilance 
for 
collecting  information  about  the 
side-effects of medicinal products in 
human beings and  for the scientific 
evaluation of such information, such 
that  the  information  about  side-
effects is systematically related to 
the information on the consumption of 
medicinal products. 

system 

ARTICLE 3(3; 
Article 29b, indents (Directive 75/319/EEC) 

"adverse 
means  a 
reaction" 
reaction  which  is  harmful  and 
unintended  and  which  occurs  at 
doses normally used in man for the 
prophylaxis, 
or 
treatment  of  disease  or  the 
modification  of  physiological 
function; 

diagnosis 

"serious  adverse  reaction" means 
an  adverse  reaction  which  is 
1 i f e - t h r e a t e n i n g, 
fatal, 
disabling,  incapacitating,  or 
which  results  in  or  prolongs 
hospitalization; 

"unexpected  adverse  reaction" 
means an adverse reaction which is 
not  mentioned  in  the  summary  of 
product characteristics; 

serious 

unexpected 

adverse 
reaction"  means 
adverse 
reaction which is both serious and 
unexpected. 

an 

"side-effects"  means  a  reaction 
which  is  harmful  and  unintended 
and which occurs at doses normally 
used  in man  for  the prophylaxis, 
diagnosis or treatment of disease 
or 
of 
physiological function; 

modification 

the 

"serious  side-effects"  means  an 
unfavourable  reaction  which  is 
f a t a l, 
1i f e - t h r e a t e n i n g, 
disabling,  incapacitating,  or 
which  results  in  hospitalization 
or prolonged hospitalization; 

"unexpected side-effects" means an 
unfavourable reaction which is not 
mentioned  in  the  summary  of 
product characteristics; 

"serious unexpected side-effects" 
means  an  unfavourable  reaction 
which  is  both  serious  and 
unexpected. 

Common position of the Council 

Amendments 

ARTICLE 3(3) 
Article 29d(1)(Directive 75/319/EEC) 

1. The person responsible for placing 
the medicinal product on the market 
shall  be  required  to record  and  to 
report all suspected serious adverse 
reactions  which  are  brought  to his 
attention 
care 
a 
professional 
competent 
authorities  immediately,  and  in any 
case within 15 days of their receipt 
at the latest-

health 

the 

by 

to 

1.  The  person  responsible  for 
placing the medicinal product on the 
market  shall  be  required  to  record 
and to report  all suspected serious 
unexpected  side-effects  which  are 
brought  to  his  attention  by  a 
qualified health care professional to 
the 
authorities 
immediately,  and  in any case within 
15 days of their receipt. 

competent 

ARTICLE 3(3) 
Article 29f, first paragraph a (new) (Directive 75/319/EEC) 

The Member States shall take steps to 
ensure  that  pharmacovigilance  data 
which is not officially confirmed and 
which  mav  give  rise  to unnecessary 
alarm  is  not  disseminated. 
The 
dissemination  of data which has not 
been  officially  confirmed,  if  it 
proves to be  inaccurate, mav be the 
subject of compensation in accordance 
with the legislation of each Member 

-  13  -

REVISED PROPOSAL FOR A COUNCIL DIRECTIVE SYN 311 

MODIFYING  DIRECTIVES 
81/852/EEC  ON  THE 
APPROXIMATION  OF  LAWS  OF  THE  MEMBER  STATES  RELATING  TO 
VETERINARY MEDICINAL PRODUCTS 

81/851/EEC  AND 

In accordance with Article  149(2)(d) of the Treaty, the Commission has re-examined 
the  above  proposal,  in  order  to  assimilate  three  of  the  four  amendments  from  the 
parliament, as detailed in annex  1.  The amendment rejected can be found  in annex 2. 

1.  Amendments accepted by the Commission 

The  Commission  is  prepared  to  accept  the  amendments  which  it  had  already 
accepted  during  the  first  reading,  but  which  the  Council  did  not  retain  in  its 
common position. 

The role given to the European  Agency  (Directive  81/851/EEC, article  5b, third 
paragraph new) in attributing European number to each medicinal product which 
is  authorised  in  the  Community  in  the  future  will  contribute  to  a  greater 
transparency  of the market.  The  present  wording  of this  amendment  envisages 
that  the  countries  which  have  authorised  the  medicine  should  be  mentioned, 
which will avoid any risk of confusion  with the numbers attributed to community 
authorisations. 

The  reduction  of  the  duration  of  the  national  examination  procedure  from  210 
days to  140 (Directive  X1/85 l/EEC, article 8( I )) takes account  of the  fact  that, as 
a  general  rule, the national  procedure  concerns  conventional  medicines, and  not 
high-technology  medicines  dealt  with  under  the  centralised  procedure,  the 
examination of which requires a longer time-limit, of the order of 210 days. 

The  amendment  relating  to  pharmacovigilance  (Directive  81/851/EEC  article 
42g) has the merit  of introducing a greater coherence with the corresponding text 
of articles 46 and 47 of the Regulation. 

2.  Amendments rejected by the Commission 

The  Commission  is  not  prepared  to  accept  the  amendment  of  article  15(1)  of 
Directive  81/851/EEC, because  it  introduces  into the  five  yearly  re-examination 
of  the  authorization  of  a  veterinary  medicinal  product  concepts  which  are  not 
clear  and  which  appear  to  move  away  from 
the  customary  criteria  of 
authorization  (quality, security and  efficacy). 

AjsiNRy  t  AMENDMENTS ACCEEEEDBYJTHE_COMMISSION 

-  14  -

Common position of the Council 

Amendments 

ARTICLE  1(5) 
Article 5b, third paragraph  (new) 
(Directive 81/851/EEC) 

the 

the 

market 

Before a medicinal  product  is placed 
on 
competent 
authorities  shall  forward  to  the 
European Agency for the Evaluation of 
Medicinal  Products  a  copy  of  the 
decision together with the summary of 
the product  characteristics  referred 
to in this Article.  The Agency shall 
veterinary 
authorized 
give 
medicinal product a European Register 
number  which  shall  be marked  on the 
packaging;  the  registration  number 
shall be preceded by the initials of 
the  Member  State  in  which  the 
product's use has been authorized. 

the 

ARTICLE  1(6) 
Article 8(1) 
(Directive 81/851/EEC) 

1.  Member  States  shall  take  all 
appropriate  measures  to  ensure  that 
the  procedure  for  granting  an 
authorization  to  place  a  veterinary 
medicinal  product  on  the  market  is 
completed  within  210  days  of  the 
submission of a valid application. 

1.  Member  States  shall  take  all 
appropriate  measures  to  ensure  that 
the  procedure  for  granting  an 
authorization  to  place  a  medicinal 
product  on  the  market  is  completed 
within  140  days  of  the  date  the 
application  is submitted. 

ARTICLE 1(12) 
Article 42g 
(Directive 81/851/EEC) 

a b o ut 

i n f o r m a t i on 

In  order  to  facilitate  the  exchange 
of 
the 
pharmacovigilance 
Community, 
in 
consultation with  the Agency,  Member 
States and  interested  parties, shall 
draw  up  guidance  on  the  collection, 
verification  and  presentation  of 
adverse reaction reports. 

within 
Commission, 

the 

the 

a b o ut 

verification 

i n f o r m a t i on 

within 
Commission, 

In  order  to  facilitate  the  exchange 
of 
the 
pharmacovigilance 
Community, 
in 
consultation with  the Agency,  Member 
States and  interested  circles, shall 
draw  up  detailed  guidance  on  the 
collection, 
and 
presentation  of  adverse  reaction 
reports.  Such  guidance  shall  take 
into account  the work carried out bv 
the  WHO  on  the  harmonization  of 
terminology and classification in the 
field  of  pharmacovigilance,  where 
this  can  be  used  in connection with 
veterinary  medicinal  products.  The 
guidance  shall  also  establish  the 
arrangements  for  the  use  of  the 
information 
network 
the 
competent„au_thori tips in the__event_pf 
JLQ-JLU\lJL^QI?gf-LU3Jnq  a  nianuf acturinq 
fault  or  serious  adverse  reactions, 
as  well  as  other  pharmacovigilance 
information  on  veterinary  medicinal 
products marketed  in the Community. 

among 

-  15  -

ANNfiX  2  AMENDMENTS  REJECT*vn  KV Jim  COMMISSION 

Common position of the Council 

Amendments 

ARTICLE 1(9) 
Article 15(1) 
(Directive 81/851/EEC) 

1. Authorization  shall be  valid  for 
five years and shall be renewable for 
five-year periods, on application by 
the  holder  at  least  three  months 
before  the  expiry  date  and  after 
consideration  of  a  dossier updating 
the information previously submitted. 

1. Authorization  shall be  valid  for 
five years and shall be renewable for 
five-year periods, on application by 
the  holder  at  least  three  months 
before the expiry date and after the 
competent  body  has  considered  a 
dossier 
containing  _ updated 
pharmacovigilance data and the other 
the 
information 
monitoring of the product. 

relevant 

to 

When  delivering  its ' opinion  the 
responsible  body  shall  take  account 
off any  new  information  available  on 
side-effects 
medicinal 
product,  its  efficacy  and  its olacs 
in its therapeutic class. 

of. ,. ^3 

M 

ISSN 0254-1475 

COM(93) 220  final 

DOCUMENTS 

EN 

05  03 06 

Catalogue number : CB-CO-93-247-EN-C 

ISBN 92-77-55872-.' 

Office for Officiai Publications of the European Communities 
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