Amendment to the proposal for a COUNCIL REGULATION ( EEC ) laying down Community provisions for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products
Date: 1991-10-31
Institutions: European Commission
Subjects: European organisation, marketing standard, medicinal product, pharmaceutical legislation, public health, veterinary medicinal product

COMMISSION  OF THE EUROPEAN  COMMUNITIES 

C0M(91) 382 final - SYN 309-310-311 

Brussels, 31 October 1991 

Future  system  for  the  free movement  of medicinal  products 

in the European  Community 

Amendment  to  the proposal  for a 
COUNCIL  REGULATION  (EEC) 
laying  down  Community  provisions  for  the  authorization  and 
supervision  of medicinal  products  for human  and  veterinary  use 
and  establishing  a European  Agency  for  the Evaluation  of 
Nedicinal  Products 

SYN  309 

Amendment  to  the proposal  for a 
COUNCIL  DIRECTIVE 
amending  Directives  65/65/EEC,  75/318/EEC  and  75/319/EEC 
in respect  of medicinal  products 

SYN  310 

Amendment  to  the proposal  for a 
COUNCIL  DIRECTIVE 

amending  Directives  81/851/EEC  and  81/852/EEC 
in respect  of veterinary  medicinal  products 

SYN  311 

(presented  by  the Commission  pursuant  to 
Article  149  (3) of  the EEC  Treaty) 

- 1 -

EXPLANATORY  MEMORANDUM 

Following  the  first  readings  by  the  Eurpoean  Parliament  during 

its part  session  of  June  1991, the  Commission  has  decided  in 

accordance  with  Article  149, paragraph  3 of  the  EEC  Treaty  to 

amend  the  following  proposals:  (1) 

1. Proposal  for  a Council  Regulation  (EEC)  laying  down 

Community  provisions  for  the  authorization  and  supervision 

of medicinal  products  for human  and  veterinary  use  and 

establishing  a European  Agency  for  the  Evaluation  of 

Medicinal  Products  (SYN 309); 

2. Proposal  for  a Council  Directive  amending  Directives 

65/65/EEC,  75/318/EEC  and  75/319/EEC  in respect  of 

medicinal  products  (SYN 310); 

3. Proposal  for  a Council  Directive  amending  Directives 

81/851/EEC  and  81/852/EEC  in respect  of  veterinary 

medicinal  products  (SYN 311); 

1. O.J. N° C 330,  31.12.1990; COM  (90) 283  final 

The  Commission  has  decided  to  accept: 

- 2 -

- a series  of  amendments  which  would  appear  to  improve  the 

operation  or  the  transparency  of  the  centralized  and 

decentralized  Community  authorization  procedures  or  improve 

the  safeguards  for  industry  contained  in  those  procedures; 

- amendments  which  encourage  greater  cooperation  between  the 

Community  and  the  World  Health  Organisation  in relation  to 

pharmacovigilance ; 

- three  amendments  which  provide  that  medicinal  products 

consisting  of  genetically  modified  organisms  may  only  be 

authorized  for  use  in  the  Community  if  they  satisfy  the 

substantive  requirements  of  Council  Directive  90/220/EEC  of 

23 April  1991  on  the  deliberate  release  into  the  environment 

of genetically  modified  organisms  (2) 

-  that  part  of  amendment  168 which  allows  the  European 

Parliament  to nominate  two representatives  to  the  Management 

Board  of  the  Agency. 

2. O.J. N° L  117, 8.5.1990.  p 15 

- 3 -

However,  the  Commission  has  decided  not  to  accept; 

-  those  amendments  which  would  substantially  change  the 

balance  between  the  centralized  and  decentralized 

procedures,  or which  would  attribute  major  additional  tasks 

to  the Agency  in  the early  years  of  its  operation; 

- those  amendments  which  seek  to amend  the  substantive  rules 

for  the  authorization  of medicinal  products  as  they  have 

developed  since  1965; 

-  those  amendments  which  would  lay down  unduly  strict  rules  of 

a procedural  nature  which  are not  found  in  the  legislation  of 

any  Member  State; 

- the other  amendments  of  an  institutional  nature  which  would 

reduce  the rights  of Member  States, or  of  the  Commission. 

In summary  therefore,  the Commission  has  accepted,  in whole  or 

in part,  67 of  the  155 amendments  voted  by  Parliament. 

- 4 -

Amendment  to  the  proposal  for a 
COUNCIL  REGULATION  (EEC) 
laying  down  Community  provisions  for  the authorization  and 
supervision  of medicinal  products  for human  and veterinary  use 
and  establishing  a European  Agency  for  the Evaluation  of 
Medicinal  Products 

SYN  309 

Original  Text 

Amendment to the proposal 

Visas  and  recitals  1 -3  unchanged 

Fourth  recital 

Fourth  recital 

it  is  necessary 

Whereas  in  the  interests  of  public 
that 
health 
decisions  on  the  authorization  of 
such  medicinal  products  should  be 
based  on  the  objective  scientific 
criteria  of  the quality,  the  safety 
and  the  efficacy  of  the  medicinal 
product  concerned  to  the  exclusion 
of economic or other considerations; 
whereas,  however,  Member  States 
should  exceptionally  be  able  to 
prohibit  the  use  on  their  territory 
of medicinal  products  for  human  use 
which  infringe  objectively  defined 
concepts  of  oublie  order  or  public 
morality;  whereas  moreover  a 
veterinary  medicinal  product  may 
not  be  authorized  by  the  Community 
if  its  use  would  contravene  the 
ruloB  and  objectives  laid  down  by 
tho  Community  within  the  framework 
of the common agricultural policy? 

Whereas  in  the  interests  of  public 
health  and  the  consumers  of 
medicinal  products  it  is  necessary 
that  decisions  on  the  authorization 
of such medicinal products should be 
based  on  the  objective  scientific 
criteria  of  the  quality,  the  safety 
and  the  efficacy  of  the  medicinal 
product  concerned  to  the  exclusion 
of economic or other considerations; 
whereas,  however,  Member  States 
should  exceptionally  be  able  to 
prohibit  the  use  on  their  territory 
of  medicinal  products  for  human  use 
which  infringe  objectively  defined 
concepts  of  public  order  or  public 
morality;  whereas  moreover  a 
veterinary  medicinal  product  may 
not  be  authorized  by  the  Community 
if  its  use  would  contravene  the 
ruios  end  objectives  laid  down  by 
tho  Community  within  the  framework 
of the common  agricultural policy* 

Recitals  5 - 11  unchanged 

Twelfth  recital 

Twelfth  recital 

Whereas  the  primary  task  of  the 
Agency  should  be  to  provide 
scientific  advice  of  the  highest 
possible  quality  to  the  Community 
institutions  and  the  Member  States 
for  the  exercise  of  the  powers 
conferred  upon  them  by  Community 
legislation 
in  the  field  of 
medicinal  products  in  relation  to 
the authorization and supervision of 
medicinal products; 

Whereas  the  primary  task  of  the 
Agency 
should  be  to  provide 
scientific  advice  of  the  highest 
possible  quality  to  the  Community 
institutions  and  the  Member  States 
for  the  exercise  of  the  powers 
conferred  on  them  by  Community 
legislation 
in  the  field  of 
medicinal  products  in  relation  to 
the authorization  and supervision of 
medicinal  products  for the  purposes 
of 
protecting 
consumers'  interests  and  ensuring 
maximum transparency of procedures; 

-  5  -

Original  Text 

Amendment  to  the  proposal 

Recitals  13  -

17  unchanged 

Eighteenth  r e c i t al 

Eighteenth  r e c i t al 

in  c l o se 
Whereas  the  Agency,  working 
the  Commission, 
cooperation  with 
should  a l so  be  entrusted  with 
the 
task  of  coordinating  the  discharge  of 
s u p e r v i s o ry 
t he 
r e s p o n s i b i l i t i es  of  Member  S t a t es  and 
in  particular  monitoring  the  respect 
of  good  manufacturing  p r a c t i c e s,  good 
l a b o r a t o ry 
good 
p r a c t i c es 
c l i n i c al  p r a c t i c e s; 

v a r i o us 

and 

Whereas the Agency, working  in close 
cooperation  with  the  Commission, 
should  also  be  entrusted  with  the 
** task  of  coordinating  the  discharge 

the 

various 

supervisory 
of 
responsibilities  of  Member  States 
and  in  particular  the  provision  of 
information  concerning  medicinal 
products  and  monitoring  the  respect 
of  good  manufacturing  practices, 
good  laboratory  practices  and  good 
clinical practices; 

Nineteenth  recital  unchanged 

Twentienth  recital  (new) 

Whereas  risks  to  the 
environment  may  be  associated 
with  medicinal  products 
containing  or  consisting  of 
genetically  modified 
organisms: whereas  therefore 
it  is necessary  to provide  for 
an  environmental  risk 
assessment  of  such  products, 
similar  to  that  provided  for 
by  Directive  90/220/EEC  on  the 
deliberate  release  into  the 
environment  of  genetically 
modified  organisms (9). 
together  with  the  assessment 
of  the quality,  safety  and 
efficacy  of  the  product 
concerned  within  a single 
Community  procedure; 

n 

0. J . N°  L  117.  8.5.1990.  p. 15 

Original  Text 

Amendment  to the proposal 

- 6 -

Articles  1 - 5 unchanged 

Article 6 

Article 6 

Article  6,  paragraph  1,  unchanged 

Article  6  (2) 

Article  6  (2) 

The  application  shall  also  be  accompanied  by  the  fee 
the 

the  examination  of 

the  Agency 

for 

2. 
payable 
to 
application. 

2.  In the  case  of  a medicinal 
product  containing  or  consisting 
of  genetically  modified  organisms 
within  the meaning  of  Article  2 
paragraphs  1 and  2 of  Directive 
90/220/EEC  on  the  deliberate 
release  into  the  environment  of 
genetically  modified  organisms, 
the  application  shall  also be 
accompanied  by: 

"  a copy  of  the  written  consent, 
from  the  competent  authority, 
to  the  deliberate  release  of 
the  genetically  modified 
organisms  for  research  and 
development  purposes  provided 
for  in Article  6(4) of 
Directive  90/220/EEC: 

-  the  complete  technical  dossier 

supplying  the  information 
requested  in Annexes  II and  III 
of  Directive  90/220/EEC  and  the 
environmental  risk  assessment 
resulting  from  this  information 

Articles  11  to  18 of  Directive 
90/220/EEC  shall  not  apply  to 
medicinal  products  for  human  use 
containing  or  consisting  of 
genetically  modified  organisms. 

Article  6  (3) 

Article  6(3) 

The  Agency  shall  ensure  that  the  opinion  of  the 
3. 
Committee  is given  within  210  days  of  the  receipt  of  a  valid 
application. 

3. The  application  shall  also  be 
accompanied  by  the  fee  payable  to 
the  Agency  for  the  examination  of 
the  application. 

2) 

-  7 -

O r i g i n al  Text 

Amendment  to the proposa I 

A r t i c le  6  ( 4) 

A r t i c le  6  ( 4) 

4. 
The Agency shall, in consultation with Member States, 
the  Commission  and interested  parties,  draw  up detailed 
guidance on the form in which applications for authorization 
are to be presented. 

4_«_ The  Agency  s h a ll  ensure  that 
the  Opinion  Of  the  Committee 
is 
given  within  210  day S  of  the 
r e c e i pt  of  a  v a l id  a p p l i c a t i o n. 

In the case of a medicinal 
product  containing or consisting 
of  genetically  modified 
organisms, the opinion of the 
Committee  shall  take  account of 
the  environmental  safety 
requirements  laid  down by 
Directive  90/220/EEC. 

Article 6 (5)  (new) 

5. The Agency  shall, in 
consultation  with  Member  States, 
the  Commission and interested 
parties,  draw up detailed 
guidance on the form in which 
applications for authorization 
are to be presented. 

Articles 7 -9 unchanged 

Original  Text 

-8 

Amendment 

to  t he  proposal 

Article  10 (1) 

A r t i c le  10  ( 1) 

t a k en 

r e s p e ct 

the  Decision 

in 
taking 

the  Commission 

1.  Within  30  days  of  the  receipt  of 
s h a ll 
the  opinion, 
to 
prepare  a  draft  of 
be 
t he 
of 
a p p l i c a t i o n, 
i n to  account  the 
o b j e c t i v es  of  Community  p o l i c i es  and 
r e l e v a nt 
c o n s i d e r i ng 
event  of  a 
information. 
the 
draft  Decision  which  envisages 
m a r k e t i ng 
g r a n t i ng 
of 
d o c u m e n ts 
a u t h o r i z a t i o n, 
referred 
(b)  and 
in  points 
(c)  of  A r t i c le  9(3)  s h a ll  be  annexed. 
The  Commission 
the 
draft  Decision  to  the  Member  States 
and  to  the  applicant. 

transmit 

a 
t he 

a ll 
In 

shall 

( a ), 

t ho 

the 

to 

The  Commission 
d e t a il 
t he 
d i f f e r e n c es 
Decision 
Committee» 

and 

shall 
r e a s o ns 
between 
the 

explain 

in 

f or 

t he 

any 
d r a ft 
the 

opinion 

of 

1. Within  30 days  of the receipt of 
the  opinion,  the  Commission  shall 
prepare  a  draft  of  the Decision  to 
be  taken  in  respect  of  the 
application,  takina  into account the 
oblectives  of Community  policies and 
considering  all  tho  relevant 
information. 
In  the  event  of  a 
draft  Decision  which  envisages  the 
g r a n t i ng 
m a r k e t i ng 
authorization,  the  documents 
referred  to  in  points  (a), (b) and 
(c) of Article 9(3) shall be annexed. 
The  Commission  shall  transmit  the 
draft  Decision  to the Member  States 
and to the applicant. 

of 

a 

If,  exceptionally,  the  Commission 
Intends to draw up a draft  Decision 
which  differs  from  the  opinion  of 
the  Cormrittee, the  Commission  shall 
explain  in  detail  the  reasons  for 
any differences. 

Article  10 (2) 

Article  10 (2) 

2.  The  Commission  shall 
Decision  to  be  taken  in 
the  application  unless, 
days,  it  has  received 
request  from  a  Member 
reconsider  the  matter. 
State concerned  shall also 
copy  of  itn  request  to 
Member  States  and  the 
within the same time limit 

adopt  the 
respect  of 
within  30 
a  reasoned 
State  to 
The  Member 
transmit a 
the  other 
applicant 

2.  The  Commission  shall  adopt  the 
Decision  to  be  taken  in  respect  of 
the  application  unless,  within  30 
days,  it  has  received  a  reasoned 
request  from  a  Member  State  to 
reconsider  the  matter.  The  Member 
State concerned  shall also transmit a 
copy  of  it n  request  to  the  other 
Member  States  and  the  applicant 
within the same time limit. 

The  Member 
requesting 
State 
reconsideration  shall  provide  a 
detailed  justification  baaed  on 
scientific  evidence  or  Community 
law. 

Article  10. paragraphs  3 and 4 unchanged 

Article  10 (5). new 

The  Agency  shall,  upon  request, 
inform  any interested  person of the 
contents of its final opinion. 

Original  Text 

Amendment  to  the  proposal 

-  9 

Article  12  (1) 

Article  12  (1) 

Article  11  unchanged 

1.  Without  prejudice 
to  Article 6  of  Directive 
65/65/EEC,  a  marketing  authorization  which  has  been 
granted in accordance with the procedure laid down in this 
Regulation shall apply throughout the Community. It shall 
confer the same rights and obligations in each of the Member 
States as a marketing authorization granted by that Member 
State 
in  accordance  with  Article 3  of  Directive 
65/65/EEC. 

1.  Without  prejudice 
to  Article 6  of  Directive 
65/65/EEC,  a  marketing  authorization  which  has  been 
granted in accordance with the procedure laid down in this 
Regulation shall apply throughout the Community. It shall 
confer the same rights and obligations in each of the Member 
States as a marketing authorization granted by that Member 
in  accordance  with  Article 3  of  Directive 
State 
65/65/EEC. 

The 

authorized 

medicinal 
products  shall  be  entered  in  the 
Community  Register  of  Medicinal 
Products  and  they  shall  be  given  a 
number  which  must  appear  on  the 
packaging. 

Article  12  (2)  unchanged 

Article  12  (3) 

Article  12  (3) 

A n 

a n n o u n c e m e nt 

t h at 
authorization  has  been  granted  shall 
be  published 
information 
purposes  in  the  Official  Journal  of 
the European Communities. 

for 

of  marketing 
3 .  Notification 
authorization  shall  be  published  in 
the Official Journal of the European 
Communities,  Quoting  the  number  in 
the Community  Register. 

Article  12  (4)  unchanged 

Article  13  (1) 

Article  13  (1) 

1. Authorization  shall  be  valid  for 
five  years  and  may  be  renewable  for 
five-year  periods, on  application  by 
the  holder  at  least  three  months 
before  the expiry  date. 

1. Authorization  shall  be  valid  for 
five  years  and  may  be  renewable  for 
five-year  periods, on  application  by 
the  holder  at  least  three  months 
before  the  expiry  date  and  after 
consideration  by  the  Agency  of  a 
d o s s i er 
up-to-date 
containing 
information  on  pharmacovigilance. 

Original  Text 

-10 

Amendment to the proposa 

Article  13 (2) 

Article  13 (2) 

In  exceptional 

circumstances  and 

2. 
consultation  with  the applicant,  an authorization  may  be 
granted  subject  to such  conditions  as appear  necessary to 
ensure  the protection  of  public  health,  including  specific 
obligations to conduct further studies following the granting 
of  authorization  and specific  obligations  in respect of the 
reporting of adverse reactions to the medicinal product. 

following 

2.  In  exceptional  circumstances  and 
following  consultation  with  the 
be 
applicant.»  an  authorization  may 
granted  subject/ 

to  certain  specific  obligations, to 
be defined  and reviewed  annually by 
the Agency, to: 

-  conduct  further  studies  following 
the granting of authorization; 

- report  adverse  reactions  to the 
medicinal product. 

Such  exceptional  decisions may only 
be  adopted  for  objective  and 
verifiable reasons and must be based 
on  one of  the  causes  mentioned  in 
Chapter  III  of  Part  III  of  the 
Annex to Directive 75/318/EEC. 

Some products may be authorized 
only  for  use  in  hospitals  or for 
prescription by specialists. 

Article  13 paragraph  3 unchanged 

Article  14 unchanged 

Article  15 paragraphs  1 -3  unchanged 

Article  15 (4) 

Article  15 (4) 

in  consultation 
a d o pt 

4.  The  Agency  s h a l l, 
w i th 
t he 
appropriate 
e x a m i n a t i on 
v a r i a t i o ns 
marketing  authorization. 

C o m m i s s i o n, 
arrangements 

for 
amendments 
terms 

the 

to 

of 

the 
and 
a 

of 

The 

s h a l l, 

A g e n cy 

in 
4. 
the  Commission, 
consultation  with 
adopt  appropriate  arrangements 
for 
the  examination  of  amendments  and 
to 
v a r i a t i o ns 
a 
the 
These 
authorization. 
marketing 
a 
a r r a n g e m e n ts 
s h a ll 
n o t i f i c a t i on 
o r 
administrative procedures concerning 
minor  changes  and  define  precisely 
the concept of 'a minor change*. 

s y s t em 

i n c l u de 

terms 

of 

Articles  16 and 17 unchanged 

Original  Text 

Amendment  to  the  proposa I 

Article  18  (1) 

A r t i c le  18 

( 1) 

11  -

1.  Where  the  supervisory  authorities  or  the competent 
authorities of any other Member State are of the opinion that 
the  manufacturer  or  importer  from  third  countries  is  no 
longer fulfilling  the obligations laid down in Chapter IV of 
Directive  75/319/EEC,  they  shall  forthwith  inform  the 
Committee  and  the  Commission,  stating  their  reasons  in 
detail  and indicating the course of  action proposed. 

The same shall apply where a Member State considers that 
one  of  the  measures  envisaged  in  Chapter V  of  Directive 
75/319/EEC should be applied in respect of the medicinal 
product concerned. 

1. Where  the  supervisory  authorities 
or  the  competent  authorities  of  any 
other  Member  State  are  of  the 
opinion  that  the  manufacturer  or 
importer  from  third  countries 
Ls  no 
longer  fulfilling  the  obligations 
laid  down  in Chapter  IV of  Directive 
7&/319/EEC,  they  ahall  forthwith 
inform  the  Committee  and  the 
Commission,  stating  their  reasons  in 
detail  and  indicating  the  course  of 
notion proposed. 

The  sane  shall  apply  where  a  Member 
State  or  the  Commission  considers 
that  one  of  the measures  envisaged 
Chapter  Va  of 
or 
in  Chapter  V 
Direcitve 
should  be 
75/319/EEC 
applied  in respect  of  the  medicinal 
product  concerned. 

Article  18 paragraphs  2 and  3 unchanged. 

Article  18  (4) 

Article  18(4) 

4. In exceptional case*, where action 
ia  urgently  necessary  to  protect 
public  health,  a  Member  State  may 
suspend the use on its territory of a 
nedicinal  product  which  has  been 
authorized  in  accordance  with  this 
Regulation. 
It  shall  inform  the 
Commission  no  later  than  the 
following  working  day  of  the  reasons 
for its action.  The Commission shall 
immediately  consider  the  reasons 
given  by  the  Member  State  in 
accordance with paragraph 2 and shall 
initiate  the  procedure  provided  for 
in paragraph 3. 

4. In exceotional  caeee^ where action 
is  urgently  necessary  to  protect 
public  health,  a  Member  State  may 
3ubpend th« use on its territory  of a 
-edicinal  product  which  has  been 
authorized  in  accordance  with  this 
Regu1a t i on, if  it  finds  the foi lowing: 

(1) The  severity  of  the  harm  that 
cou Id  be 
the 
medicinal  product  cannot  await 
the  definitive  decision  of  the 
Comrcigaion; 

caused 

by 

(2) There  is  a  likelihood  that  the 
medicinal  product  will  cause 
t he__ suspected  harm  during  the 
Commission's deliberations; 
(3) The  risk  to  patients  currently 
taking  the  medicinal  product 
occasioned  by  the  removal  of 
the  product  from  the  market • is 
out-weighed  by  the  degree  of 
harm posed by the product. 

Original  Text 

Amendment  to the proposal 

12 -

The  Member  State  in  Question  shall 
inform  the Commission  no  later  than 
the  following  working  day  of  the 
It  shall 
reasons  for  its  action. 
also  Inform  the  health  authorities 
of  the  other  Member  States. 
The 
Commission 
immediately 
consider  the  reasons  given  by  the 
Member  State  in  accordance  with 
paragraph  2  and  shall  initiate  the 
procedure  provided  for  in  paragraph 
3.  In  such  cases  the  Member  State 
in  question  shall  immediately  take 
the necessary measures to inform the 
public. 

shall 

A r t i c le  18  ( 6 ).  new 

The  Agency  s h a l l,  upon  r e q u e s t, 
the 
t he  Committee's  opinion 

inform  any  i n t e r e s t ed  person  of 
contenta  of 
referred  to  in  paragraph  2. 

Article 18 (5) unchanged 

A r t i c l es  19  -  21  unchanged 

A r t i c le  22  paragraphs  1  and  2  unchanged 

A r t i c le  22  ( 3 ).  new 

The person responsible  for marketing 
shall  accompany  the  records  of 
adverse  reactions  with  an  analysis 
of 
such 
reactions,  in  order  to  make  them 
easier to understand. 

regarding 

data 

the 

Article  23 

Article  23 

Each  Member  State  shall  report  any 
suspected  serious  adverse  reaction 
arising  within  its  territory  to  a 
medicinal  product  authorized  in 
accordance  with  this  Regulation  to 
the 
and 
responsible  for  marketing  within  15 
days  of  receipt  of  a  report  from  a 
qualified  health care professional. 

A g e n cy 

person 

the 

to 

Each Member State shall organize the 
pharmacovlqilance service within its 
territory 
the 
according 
provisions  of  Article  24.  It shall 
report  any  suspected 
serious  adverse  reaction  arising 
within  its  territory  to  a medicinal 
product  authorized  in  accordance 
with  this  Regulation  to  the  Agency 
and  the  person  responsible  for 
marketing  within  15 days  of  receipt 
of  a report  from  a qualified  health 
care professional. 

Original  Text 

13  -

Amendment  to the proposal 

Article  24 

Article  24 

The  Agency  shall,  in  consultation 
with  Member  States/  the  Commission 
and  interested  parties,  draw  up 
detailed  guidance  on the collection, 
verification  and  presentation  of 
adverse reaction reports. 

s h a l l, 

C o mm i s s io n 

T he 
in 
consultation with the Agency, Member 
States  and  interested  parties, 
approve detailed guidance, common to 
all the Member  States 
on  the 
collection, 
verification  and 
presentation  of  adverse  reaction 
reports.  These reports shall have a 
format  similar  to that  used  by the 
World Health Organization; 

for 

The  Agency 
t he  Member  S t a t es 
c o n s u l t a t i on  with 
t he  Commission,  s h a ll  s et  up  a 
and 
t he 
network 
d a t a - p r o c e s s i ng 
r a p id 
t r a n s m i s s i on  of  data  between 
t he  competent  Community  a u t h o r i t i es 
in  t he  event  of  an  a l e rt  r e l a t i ng 
to 
s e r i o us 
m a n u f a c t u r e, 
f a u l ty 
o t h er 
u n d e s i r a b le 
regarding 
p h a r m a c o v i g i l a n ce 
medicinal  products  marketed 
the 
Community. 

e f f e c ts 

d a ta 

and 

in 

A r t i c le 

25  unchanged 

A r t i c le  25aJ  new 

The  Agency  shall  collaborate  wich 
the  World  Health  Organization 
on 
international  pharmocovigilance and 
shall  take  the  necessary  steps  to 
submit  promptly  to the World  Health 
Organization 
appropriate  and 
adequate  information  regarding  the 
measures  taken  in  the  Community 
which  may have a  bearing  on public 
health protection in third countries 
and shall send a copy thereof to tne 
Commission and the Member States. 

original  Text 

- 14 -

Amendment to the proposal 

Article  26 unchanged 

Article  27 

Article  27 

Article  27,  paragraph  1,  unchanged 

Article  27  (2) 

Article  27  (2) 

2. 
The application shall also be accompanied by the fee 
payable  to  the  Agency  for  the  examination  of  the 
application. 

2.  In  the  case  of  a veterinary 
medicinal  product  containing  or 
consisting  of  genetically 
modified  organisms  within  the 
meaning  of  Article  2 paragraphs 1 
and  2 of  Directive  90/220/EEC  on 
the  deliberate  release  into  the 
environment  of  genetically 
modified  organisms,  the 
application  shall  also be 
accompanied  by: 

"  a copy  of  the written  consent, 
from  the  competent  authority, 
to  the deliberate  release  of 
the  genetically  modified 
organisms  for  research  and 
development  purposes  provided 
for  in Article  6(4) of 
Directive  90/220/EEC: 

-  the  complete  technical  dossier 

supplying  the  information 
requested  in Annexes  II and  III 
of Directive  90/220/EEC  and  the 
environmental  risk  assessment 
resulting  from  this  information 

Articles  11  to  18 of  Directive 
90/220/EEC  shall  not  apply  to 
veterinary  medicinal  products 
containing  or  consisting  of 
genetically  modified  organisms. 

Article  27  (3) 

Article  27  (3) 

3. 
The  Agency  shall  ensure  that  the  opinion  of  the 
Committee is given within 210 days of the receipt of a valid 
application. 

3^ The  application  shall  also  be 
accompanied  by  the  fee  payable  to 
the  Agency  for  the  examination  of 
the  application. 

3) 

- 15 -

Original  Text 

Amendment  to  the  proposal 

Article  27  (4) 

A r t i c le  27 

( 4) 

4. 
The Agency shall, in consultation with Member States, 
the  Commission  and  interested  parties,  draw  up  detailed 
guidance on the form in which applications for authorization 
are to  be  presented. 

4. The  Agency  shall  ensure  that 
the  opinion  of  the  Committee  is 
given  within  210 days  of  the 
receipt  of  a valid  application. 

In  the  case  of  a veterinary 
medicinal  product  containing  or 
consisting  of  genetically 
modified  organisms,  the  opinion 
of  the  Committee  shall  take 
account  of  the  environmental 
safety  requirements  laid  down by 
Directive  90/220/EEC. 

Article  27  (5)  (new) 

5_i_ The  Agency  shall,  in 
consultation  with  Member  States, 
the  Commission  and  interested 
parties,  draw  up  detailed 
guidance  on  the  form  in which 
applications  for  authorization 
are  to be  presented. 

Articles  28  - 30  unchanged 

O r i g i n al  Text 

Amendment  to  the  proposa 

1 6-

A r t i c le  31 

( 1) 

A r t i c le  31 

( 1) 

1.  Within  30  days  of  the  receipt  of  the  opinion,  ths 
Commission  shall prepare a draft of the Decision to be taker. 

in  respect  of  the  application  taking  into  account  the 
objectives  of  Community  policies  and  considering  all 
relevant  information.  In the event of a draft  Decision  which 
envisages  the  granting  of  a  marketing  authorization,  the 
documents referred to in points (a), (b), and (c) of Article  30 
(3)  shall  be  annexed.  The  Commission  shall  transmit  the 
draft  Decision  to  the  Member  States and  to  the  applicant. 

1.  Within  30  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  the 
objectives  of  Community  policies  and  considering  all 
relevant information.  In the event of a draft  Decision  which 
envisages  the  granting  of  a  marketing  authorization,  the 
documents referred to in points (a), (b), and (c) of Article  30 
(3)  shall  be  annexed.  The  Commission  shall  transmit  the 
draft  Decision  to  the  Member  States and  to  the  applicant. 

the  reasons 

The  Commission  shall  explain  in 
detail 
any 
differences  between  the  draft 
Decision  and  the  opinion  of  the 
Committee. 

for 

If,  exceptionally,  the  Commission 
intends  to draw  up  a draft  Decision 
which  differs  from  the  opinion  of 
the  Camiittee^ the  Commission  shall 
explain  in  detail  the  reasons  for 
any differences. 

Article  31  (2) 

Article  31  (2) 

2.  The  Commission  shall  adopt  the 
Decision  to  be  taken  in  respect  of 
the  application  unless,  within  30 
days,  it  has  received  a  reasoned 
request  from  a  Member  State  to 
reconsider  the  matter. 
The  Member 
State concerned  shall also transmit a 
copy  of  it:i  request  to  the  other 
Member  States  and  the  applicant 
within tho same time limit. 

2.  The  Commission  shall  adopt  the 
Decision  to  be  taken  in  respect  of 
the  application  unless,  within  30 
days,  it  has  received  a  reasoned 
request  from  a  Member  State  to 
reconsider  the  matter. 
The  Member 
State concerned  shall also transmit a 
copy  of  it.i  request  to  the  other 
Member  States  and  the  applicant 
within the same time limit. 

T he  Member 
r e c o n s i d e r a t i on 
d e t a i l ed 
s c i e n t i f ic 
law. 

S t a te 
s h a ll 

r e q u e s t i ng 
provide 
based 
or  Community 

j u e t i f i c a t i on 
e v i d e n ce 

Article  31,  paragraphs  3  and  4  unchanged 

Article  31  (5).  new 

The  Agency  shall,  upon  request. 
Inform  any  Interested  person  of  the 
contents of  its final opinion. 

Original  Text 

Amendment  to  the  proposal 

-  17  .. 

Article 33 (1) 

Article 33 (1) 

Article 32 unchanged 

the 

extending 

1.  Without  prejudice  to  Article 4  of  Council  Directive 
scope  of  Directive 
. . . / ..  ./EEC 
81/851 /EEC  on  the  approximation  of  the  laws  of  the 
Member  States  relating  to  veterinary  medicinal  products, 
and  laying down  additional  provisions  for  immunological 
veterinary  medicinal  products,  a  marketing  authorization 
which  has  been  granted  in  accordance  with  the  procedure 
laid  down  in  this  Regulation  shall  apply  throughout  the 
Community. It shall confer the same rights and obligations in 
each  of  the  Member  States  as  a  marketing  authorization 
granted by that Member State in accordance with Article 4 of 
Directive  81/851/EEC. 

the 

extending 

1.  Without  prejudice  to  Article 4  of  Council  Directive 
scope  of  Directive 
. . . / ..  ./EEC 
81/851 /EEC  on  the  approximation  of  the  laws  of  the 
Member  States  relating  to  veterinary  medicinal  products, 
and  laying down  additional  provisions  for  immunological 
veterinary  medicinal  products,  a  marketing  authorization 
which  has  been  granted  in  accordance  with  the  procedure 
laid  down  in  this  Regulation  shall  apply  throughout  the 
Community. It shall confer the same rights and obligations in 
each  of  the  Member  States  as  a  marketing  authorization 
granted by that Member State in accordance with Article 4 of 
Dircctive'81/851/EEC. 

The  authorized  medicinal 
products  shall  be  entered  in  the 
Community  Register  of  Veterinary 
Medicinal Products and thev shall be 
given  a number which muet appear on 
the packaging. 

Article 33 (2) unchanged 

Article 33 (3) 

A r t i c le  33 

( 3) 

Ajn_ 

t h at 
a  n n o u n c e m e nt 
3. 
authorisation  has  been granted  shall 
be published  for information purposes 
in  the  Official  Journal  of  the 
European Communities. 

of 

marketing 
3.  Notification 
authorization  shall  be published  in 
the Official Journal of the European 
Communities,  quoting  the  number  in 
the Community Register of Veterinary 
Medicinal Products. 

Article 33 (4) unchanged 

Article 34 (l) 

Article 34 (1) 

1.  Authorisation  shall  be valid  for 
five  years  and  may  be  renewable  for 
five-year  période,  on  application  by 
the  holder  at  leaet  three  months 
before the expiry date. 

1.  Authorization shall be valid for 
five years  and may  be renewable for 
five-year periods, on application by 
the  holder  at  least  three  months 
before  the  expiry  date  and  after 
consideration  bv  the  Aoencv  of  a 
dossier 
up-to-date 
containing 
information on pharmacovloilance. 

Original Text 

Amendment  to  the  proposa 

-  18  -

A r t i c le  34  (2) 

A r t i c le  34  (2) 

In  exceptional 

circumstances,  and 

2. 
following 
consultation  with  the  applicant,  an  authorization  may be 
granted  subject  to  such conditions  as appear  necessary  to 
ensure the protection of human or animal health, including 
specific obligations to condua further studies following the 
granting of authorization and specific obligations in respect 
of  the  reporting  of  adverse  reactions  to  the  veterinary 
medicinal  product. 

c o n s u l t a t i on  with 

In  exceptional  circumstances,  and 
2. 
f o l l o w i ng 
the 
aDD)leant,  an  authorization  may  be 
t o/ 
granted 
obligations 
s p e c i f ic 
defined  and  reviewed  annually  by  the 
Agency, 
Z  to 

c o n d u ct 

f u r t h er 

certain 

subject 

t he 

g r a n t i ng 

s t u d i es 
of 

f o l l o w i ng 
authorization; 
report 

-  to 

t he 
products. 

adverse 
v e t e r i n a ry 

.reactions 

to 
m e d i c i n al 

A r t i c le  34  paragraph  3  unchanged 

A r t i c le  35  unchanged 

A r t i c le  36  paragraphs  1 -3  unchanged 

A r t i c le  36  (4) 

A r t i c le  36  (4) 

4.  The  Agency  s h a l l, 
w i th 
t he 
appropriate 
e x a m i n a t i on 
v a r i a t i o ns 
marketing  authorization. 

C o m m i s s i o n, 
arrangements 

in  accordance 
a d o pt 
the 
and 
a 

for 
amendments 
terms 

the 

of 

of 

to 

of 

C o m m i s s i o n, 
arrangements 

4.  The  Agency  s h a l l, 
w i th 
t he 
appropriate 
examination 
variations 
marketing 
arrangements  s h a ll 
n o t i f i c a t i on 
of 
procedures 
to 
changes  of  minor  importance. 

in  accordance 
adopt 
the 
and 
a 
These 
include  a  system 
administrative 
of 

for 
amendments 
terms 

to 
the 
authorization. 

or 
take 

account 

of 

Articles 37 and 38 unchanged 

Original  Text 

Amendment  to  the  proposal 

-  19  -

A r t i c le  39  (1) 

A r t i c le  39  (1) 

1.  Where  the supervisory  authorities  or the competent 
authorities of any other Member State are of the opinion that 
the  manufacturer  or  importer  from  third  countries  is no 
longer  fulfilling  the obligations  laid down  in Chapter V of 
Directive  81/851/EEC  they  shall  forthwith  inform  the 
Committee  and the Commission,  stating  their  reasons in 
detail and indicating the course of action  proposed. 

1.  Where  the supervisory  authorities  or the competent 
authorities of any other Member State are of the opinion that 
the  manufacturer  or  importer  from  third  countries  is no 
longer  fulfilling  the obligations laid down in Chapter  V of 
Directive  81/851/EEC  they  shall  forthwith  inform  the 
Committee  and the Commission,  stating  their  reasons in 
detail and indicating the course of action  proposed. 

The same shall apply where a Member State considers that 
one of the measures  envisaged  in Chapter VI of  Directive 
81/851/EEC should be applied in respect of the veterinary 
medicinal  product  concerned. 

apply 

The  sane  shall 
where  a 
Member  State  or  the  Commission 
considers  that one of the measures 
envisaged  in Chapter VI or Chapter 
Via  of Directive  81/851/EEC  should 
of  the 
be  applied  in  respect 
veterinary 
product 
medicinal 
concerned. 

Article  39 paragraphs  2 -5  unchanged 

Article  39 (6).  new 

A.  The Agency  shall, upon request, 
Inform  any  interested  person of the 
contents  of the Committee's  opinion 
referred to in paragraph 2. 

A r t i c l es  40  -  42  unchanged 

A r t i c le  43  paragraphs  1  and  2  unchanged 

A r t i c le  43  ( 3 ).  new 

accompany 

The  person  r e s p o n s i b le  for  marketing 
s h a ll 
of 
r e a c t i o ns  with  an  a n a l y s is 
adverse 
such 
d a ta 
of 
reactions, 
them 
in  o r d er 
e a s i er  to  understand. 

r e g a r d i ng 

to  make 

records 

t he 

t he 

Original  Text 

Amendment  to the proposal 

-21} -

Article  44 

Article  44 

medicinal 

Each  Member  State  shall  report  any 
suspected  serious  adverse  reaction 
arising  within  its  territory  to  a 
v e t e r i n a ry 
p r o d u ct 
authorized  in  accordance  with  this 
Regulation  to  the  Agency  and  the 
person  responsible  for  marketing 
within  15  days  of  receipt  of  a 
report  from  a  qualified  health  care 
professional . 

suspected 

to 
t he 
It  shall 

any 
adverse 
i ts 

Each Member  State  shall  organize  the 
pharmacovigilance  service within  its 
t e r r i t o ry 
a c c o r d i ng 
provisions  of  A r t i c le  45. 
report 
arising 
serious 
to 
a 
w i t h in 
p r o d u ct 
v e t e r i n a ry  m e d i c i n al 
t h is 
authorized 
the 
Regulation 
for  marketing 
person 
responsible 
within  15  days  of 
of  a 
r e c e i pt 
report  from  a  qualified  health  care 
professional. 

in  accordance  with 
the  Agency  and 
to 

reaction 
t e r r i t o ry 

A r t i c le  45 

A r t i c le  45 

The  Agency  shall,  in  consultation  with  Member  States,  the 
Commission  and 
interested  parties,  draw  up  detailed 
guidance  on  the  collection,  verification  and  presentation  of 
adverse  reaction  reports  to  veterinary  medicinal  products. 

shal 1 

C o m mi s s i on 

in 
T he 
consultation  with  the Agency•  Member 
States  and  the  interested  parties, 
approve detailed  guidance, common  to 
the  Member  States / 

on  the  collection, 
verification  and  presentation  of 
adverse  reaction  reports. 
These 
reports  shall  have  a  format  similar 
to  that  used  by  the  World  Heal th 
Organ 1zat i on 

The Agency,  in consultation  with  the 
Member  States  and  the  Commission, 
shall  set  up  a  data-processing 
network  for  the  rapid  transmission 
of  data 
between  the  competent 
Community  authorities  in  the  event 
of  an  alert  relating  to  faulty 
manufacture, 
serious  undesirable 
effects  and  other  pharmacovigi!ance 
data  regarding  medicinal  products 
marketed  in the  Community. 

Article  46  unchanged 

Original  Text 

Amendment  to  the  proposa 

-21 

-

A r t i c le  47  unchanged 

A r t i c le  47a  (new) 

The  Agency  shall  collaborate 
with  the  World  Health  Organization 
on  International  pharmocovigilance 
and  shall  take  the  necessary  steps 
to  submit  promptly  to  the  World 
Health  Organization  appropriate  and 
adequate  Information  regarding  the 
measures  taken  1n  the  Community 
which  may  have  a bearing  on  public 
health protection  in third countries 
and shall  send a copy thereof to the 
Commission  and the Member States. 

Article  48 

Article  48 

In  order  to  promote  the  protection 
of  public  health  throughout  the 
Community  and  the  adoption  of 
uniform  regulatory  decisions  based 
on  scientific  criteria  concerning 
the  marketing  and  use  of  medicinal 
products,  the  objective  of  the 
Agency  shall  be  to  provide  the 
Member  States  and  the  Institutions 
of  the  Community  with  the  best 
possible  scientific  advice  on  any 
question  relating  to  the  evaluation 
of  the  quality,  the  safety  or  the 
efficacy  of  medicinal  products  for 
human  or  veterinary  use  which  1s 
referred  to  1t  1n  accordance  with 
the  provisions 
Community 
legislation  relating  to  medicinal 
products. 

of 

In  order  to  promote  the  protection 
of  public  health  and  con s umcrs "o f 
medicinal  products  throughout  the 
Community  v and  the  adoption  of 
uniform  regulatory  decisions  based 
on  scientific  criteria  concerning 
the  marketing  and  rational  use  of 
medicinal products, the objective Y>f 
the  Agency  shall  be  to  provide  the 
Member  States  and  the  Institutions 
of  the  Community  with  the  best 
possible  scientific  advice  on  any 
question  relating  to the evaluation 
of  the  quality,  the  safety  or  the 
efficacy  of  medicinal  products  for 
human  or  veterinary  use  which  1s 
referred  to  1t  in  accordance  with 
of  Community 
the  provisions 
legislation  relating  to  medicinal 
products. 

In  particular  the  Agency 
undertake the following taskst 

shall 

In  particular  the  Agency  shall 
undertake the following tasks: 

Original  Text 

Amendment  to the proposal 

-22 -

Article  48, points  (a) and  (b) unchanged 

Point  (c) 

Point  (c) 

the  continuing 
supervision, 
under  practical  conditions  of 
use,  of medicinal  products which 
have  been  authorized  within  the 
Community  and  the  provision  of 
advice  on  the measures  necessary 
to ensure  the  safe  and  effective 
use  of  these  products,  In 
p a r t i c u l ar  . following 
the 
evaluation  of  reports of adverse 
reactions  (pharmacovigi! ance); 

the  continuing  supervision, 
under  practical  conditions  of 
use,  of  medicinal  produces 
which  have  been  authorized 
within  the  Community  and  the 
provision  of  advice  on  the 
measures  necessary  to  ensure 
the  safe  and  effective  use of 
these  products,  in  particular 
by  collecting,  evaluating  and 
making available through the a 
database  the  information  on 
adverse  reactions  to  thé 
medicinal  products in question 
(pharmacovigi!ance); 

Article  48, points  (d), (e), (f) and  (g) unchanged 

Point  (h) 

Point  (h) 

where  necessary,  to  advise  and  to 
allow  for  direct  dialogue  between 
the  applicant  and  the  Agency  on  the 
conduct  of  the  various  tests  and 
trials  necessary  to  demonstrate  the 
quality,  safety  and  efficacy  of 
medicinal  products. 

to advise andT  at the' request of the 
applicant,  to  allow  for  direct 
dialogue  between  the  applicant  and 
the  Agency  on  the  conduct  of  the 
various  tests  and  trials  necessary 
to  demonstrate  the  quality,  safety 
and efficacy of medicinal  products. 

Article  48, point  (i) unchanged 

Point 

( j ).  new 

s t e r i ng 

al 1  the 
r e gi 
authorizations  for  medicinal 
in  the 
products  granted 
European Community; 

Point  (k). new 

the  provision  to  health 
professionals  of  scientific 
information  on  the  medicinal 
products  authorized  by  this 
Regulation. 

Original Text 

Amendment  to  the  proposal 

- 23 

-

A r t i c le  49  unchanged 

A r t i c le  50  paragraphs  1 -3  unchanged 

A r t i c le  50  (4) 

(new) 

The opinions adopted by 
the Committees shall be 
made available to anyone 
requesting them. 

Articles 51 and 52 unchanged 

Article 53 paragraphs  1 and 2 unchanged 

Article 53 paragraph 3, first four indents unchanged 

Fifth indent  (new) 

been 

have 

a  list  of  medicinal  products 
granted 
which 
authorization,  those  for  which 
authorization  has  been  refused 
or  withdrawn  and  those  whose 
have 
information 
undergone significant changes. 

records 

Article  53 paragraph 4 unchanged 

Article 53  (5). new 

The  executive  director  may  not  have 
any  direct  or  indirect  interests  in 
the  pharmaceutical  Industry  which 
would  affect his impartiality. 

Article 54 (1) 

Article 54 (1) 

The  management  board  shall  consist  of 
from  each  Member  State  and 

two 
1. 
representatives 
two 
representatives of the Commission. One representative shall 
have specific  responsibilities relating to medicinal  products 
for  human  use  and  one  relating  to  veterinary  medicinal 
products. 

Manag 
of 
each 
tatives 
repres 

Board 
représenta 
r  State, 
the  Commi 
ives  appo 

shall 
1.  The 
ement 
t ives 
consist 
two 
two 
from 
Membe 
ssion 
represen 
of 
inted 
and  two 
entat 
by  the  European  Parliament.  One 
icif ic 
shal 
represen 
to 
responsi 
use 
medicina 
inary 
and  one 
medicina 

1 have spe< 
relating 
for human 
to  veter 

tative 
bilitie 
1  prod 
relat 
1 produ 

s 
ucts 
ing 
cts. 

Original  Text 

Amendment to the proposal 

-24 -

Article  54 paragraphs  2 -5  unchanged 

Articles  55 -64  unchanged 

Article  65 paragraphs  1 - 4 unchanged 

Article  65  (5). (new) 

Article  52  (2) shall  apply 
similarly  to members  of 
the Scientific  Council. 

Article  67 

Article  67 

Article  66 unchanged 

All  decisions  to  grant,  refuse, 
amend,  suspend,  withdraw  or  revoke a 
marketing  authorization  which  are 
taken  in  accordance  with  this 
regulation  shall  state  in detail  the 
reasons  on  which  they  are  based. 
Such  decisions  shall  be  notified  to 
the  party  concerned,  who  shall  be 
able  to  exercise  the  remedies 
conferred  upon  him  under  the  EEC 
Treaty. 

All  decisions  to  grant,  refuse, 
amend, suspend, withdraw or revoke a 
marketing  authorization  which  are 
taken  in  accordance  with  this 
regulation shall state in detail the 
reasons  on  which  they  are  based. 
Such  decisions  shall  be  notified  to 
the  party  concerned,  who  shall  be 
able  to  exercise  the  remedies 
conferred  upon  him  under  the  EEC 
Treaty,  in  particular  pursuant  to 
its Article 173. 

Articles  68 and  69  unchanged 

Article  70 

Article  70 

Without prejudice to Article 68, and without prejudice to the 
Protocol on the Privileges and Immunities of the European 
Communities,  each  Member  State  shall  determine  the 
penalties to be applied for the infringement of the provisions 
of  this  Regulation.  The  penalties  shall  be  sufficient  to 
promote compliance with those measures. 

Without prejudice to Article 68, and without prejudice to the 
Protocol on the Privileges and Immunities of the European 
Communities,  each  Member  State  shall  determine  the 
penalties to be applied for the infringement of the provisions 
of  this  Regulation.  The  penalties  shall  be  sufficient  to 
promote compliance with those measures. 

Member States shall forthwith inform the Commission of the 
institution of any infringement  proceedings. 

The  Member  States  shall  also 
determine  penalties  to  ensure 
compliance with professional  secrecy 
on  the  part  of  the  members  of  the 
Agency  In  accordance  with  the 
provisions of Article 62. 

Member States shall forthwith inform the Commission of the 
institution of any infringement  proceedings. 

Articles  71  - 73  unchanged 

Annex  unchanged 

2. 

Amendment  to the  proposal  for a 
COUNCIL  DIRECTIVE 
amending  Directives  65/65/EEC,  75/318/EEC  and  75/319/EEC 
in respect  of medicinal  products 

SYN  310 

-25  -

O r i g i n al  Text 

Amendment  to  the  proposal 

V i s as  and  r e c i t a ls  1  and  2  unchanged 

Third  recital 

Third  recital 

a m e n d ed 

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 
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,  as 
last 
Directive 
89/381/EEC,  and  by  Directive 
Council 
and 
7 5 / 3 1 9 / E E C, 
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,  as  last  amended 
by  Directive  89/341/EEC;  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; 

by 

by 

a m e n d ed 

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,  as 
Directive 
last 
89/381/EEC,  and  by  Directive 
75/319/EEC, 
Council 
and 
Directive  75/318/EEC  of  20 May  1975 
on  the  approximation  of  the laws of 
tho  Member  States  relating  to 
analytical,  pharmaco-toxicological 
and clinical  standards and protocols 
in  respect  of  the  testing  of 
medicinal  products,  as  last  amended 
by  Directive  89/341/EEC;  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; 

by 

by 

New  recital  inserted  after 
third  recital 

and 

already  exist 

in 
Whereat; _ there 
Commuait y. law  adequate  rules  for  the 
of 
e v a l u a t i on 
nr.edi çijna 1  products 
down 
maximum  levels  of  guality,  safety 
and  efficacy  and  allowing  the  mutual 
recognition  of  measures  taken  by  the 
authorities  in  the  Member  States 
with  regard  to medicinal  products; 

m o n i t o r i ng 
laying 

Remaining  recitals  unchanged 

Original  Text 

Amendment  to  the  proposa I 

A r t i c le  1  ( 1 ),  ( D i r e c t i ve  65/65/EEC,  A r t i c le  3) 

-26  -

No  medicinal  product  may  be  placed 
the  market  of  a  Member  State 
on 
unless 
an  authorization  has  been 
Issued  bv  the  competent  authority  of 
t h at  Member 
or.—fey—fcfee. 
Sfrgf 
CommunItVt 

the  market  of 

No  medicinal  product  may  be  placed 
a  Member  S t a te 
on 
has  been 
unless 
o b t a i n ed 
w i th 
Community  r u l e s. 

an  a u t h o r i z a t i on 

a c c o r d a n ce 

in 

A r t i c le  1(2)  unchanged 

A r t i c le  1  (3)  ( D i r e c t i ve  65/65/EEC,  A r t i c le  4b) 

Third  paragraph,  new 

Before a medicinal product is placed 
on  the  market  the  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  give  the  authorized 
medicinal  product  a  European 
Register  number  which  shall  be 
marked on the packaging. 

Article  1 (4) unchanged 

Article  1 (5) ( Directive  65/65/EEC  Article 7(1)) 

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  210  days  of  the  date  of 
submitting the 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  of 
submitting tho application. 

paragraph  2 unchanged 

Article  1 (6) and (7) unchanged 

- 27  -

Original  Text 

Amendment  to the proposal 

Article  1 (8), (Directive  65/65/EEC, Article  10) 

1. Authorization  shall  be  valid  for 
five  years  and  may  be  renewable  for 
five-year  periods, on  application  by 
the  holder  at  least  three  months 
before  the expiry  date. 

2.  In exceptional  circumstances, and 
following 
consultation,  with  the 
applicant,  an  authorization  may  be 
granted  subject  to  such  conditions 
as  appear  necessary  to  ensure  the 
protection 
health, 
including  specific  obligations  to 
conduct  further  studies  following 
the  granting  of  authorization  and 
specific  obligations  in  respect  of 
the  reporting  of  adverse  reactions 
to  the medicinal  product. 

of  public 

1. Authorization  shall  be  valid  for 
five  years  and  may  be  renewable  for 
five-year  periods, on application  by 
the  holder  at  least  three  months 
before  the  expiry  date  and  after 
consideration 
of  a 
d o s s i er 
up-to-date 
containing 
information  on  pharmacovigilance. 

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

including: 

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

the  notification 
reactions 
product. 

of  adverse 
to  the  medicinal 

These  decisions  shall  be  taken  in 
accordance  with  the  provisions  of 
Chapter  III,  Part  III  of  the  Annex 
to Directive  75/318/EEC. 

Article  2 unchanged 

Article  3 (1)  (Directive  75/319/EEC,  Chapter  III) 

Articles  8 - 1 1,  proposal  unchanged 

Article  12, first  paragraph 

The  Member  States  or  the  Commission 
may,  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  13 
before  reaching  a  decision  on  a 
m a r k e t i ng 
f or 
r e q u e st 
on  the  suspension 
authorization  or 
an  authorization, 
or  revocation  of 
amendment  to  the 
or  on  any  other 
terms  of  a  marketing  authorization 
w h i ch 
1n 
particular  to  take  account  of  the 
information  collected  in  accordance 
with  Chapter Va of this Directive. 

necessary, 

a p p e a rs 

a 

of 

the 

The Member  States, the Commission  or 
the  applicant  himself  may,  in 
specific  cases  where  the  interests 
of  the  Community  are  involved, 
refer  the  matter  to  the  Committee 
for 
the 
application 
procedure  laid  down  in  Article  13 
before  reaching  a  decision  on  a 
r e q u e st 
authorization  or  on  the  suspension 
or  revocation  of  an  authorization, 
or  on  any  other  amendment  to  the 
terms  of  a  marketing  authorization 
which 
in 
particular  to  take  account  of  the 
Information  collected  in  accordance 
with Chapter Va  of this  Directive. 

m a r k e t i ng 

necessary, 

a p p e a rs 

f or 

a 

Original  Text 

Amendment  to the proposal 

" 28  -

Article  12 paragraphs  2 and  3 unchanged 

Article  13 unchanged 

Article  14 paragraphs  1 -5  unchanged 

Article  14 paragraph  6, new 

pursuant 

procedure 

6.  The 
A r t i c l es  8  to  14  shall  not  apply 
t he 
Article  9(21  of  Directive 
homeopathic  medicinal 
(COM(90)  0072  final  -  SYN  251i. 

to 
in 
by 
on 
products 

i n s t a n c es 

c o v e r ed 

. .. 

Article  15 unchanged 

Article  15a 

1. Where  a  Member  State  considers 
that  the  amendment  of the  terms  of a 
marketing  authorization  which  has 
been  granted  in  accordance  with  the 
provisions  of  this  chapter  or  its 
is 
s u s p e n s i on 
n e c e s s a r y, 
State 
concerned  shall  forthwith  refer  the 
matter  to  the  Committee  for  the 
application  of  the  procedures  laid 
down  in Articles  13 and  14. 

withdrawal 

or 
the 

Member 

1. Where  a  Member  State  considers 
that  the amendment  of the  terms of a 
marketing  authorization  which  has 
been  granted  in  accordance  with  the 
provisions  of  this  chapter  or  its 
is 
s u s p e n s i on 
n e c e s s a r y, 
State 
concerned  shall  forthwith  refer  the 
matter  to  the  Committee  for  the 
application  of  the  procedures  laid 
down  in Articles  13 and  14. 

withdrawal 

or 
the 

Member 

2.  In  excentional 
cases,  where 
action  is  urgently  necessary  to 
protect  public  health,  until  a 
definitive  decision  is  adopted,  a 
Member  State  may  suspend  the  use  of 
the  medicinal  product  concerned  on 
its  territory.  It  shall  inform  the 
Commission 
later  than  the 
following  working  day  of  the  reasons 
for  its actions. 

no 

2.  In  exceptional 
cases_  where 
action  is  urgently  necessary  to 
protect  public  health,  until  a 
definitive  decision  is  adopted,  a 
Member  State  may  suspend  the  use  of 
the  medicinal  product  concerned  oh 
its  territory  jf it finds  the foil 

(1)  The  severity  of  the  harm  that 
could  be  caused  by  the  medicinal 
product  cannot  await  the  definitive 
decision  of  the  Commission; 

(2) There  is  a  likelihood  that  the 
medicinal  product  will  cause  the 
s u s p e c t ed 
Commissions  deliberations; 

d u r i ng 

h a rm 

the 

Original  Text 

- 29 

Amendment  to  the  proposal 

to  p a t i e n ts 
t he  m e d i c i n al 
the 
the  market 

currently 
(3)  The  r i sk 
product 
t a k i ng 
the 
occasioned  by 
product 
out 
from 
weighed  by  the  degree  of  harm  caused 
i t s e l f. 
by  the  product 

removal 

of 

is 

The  Member  S t a te 
inform  the  Commission  no  l a t er 
following  working  day  of 
the 
i ts  a c t i o n s. 
reasons  for 

concerned 

shall 
than 
the 

A r t i c le  15b  unchanged 

A r t i c le  15c  paragraph  1 

1.  The  Agency 
annual 
the  procedures 
Chapter. 

report  on 

shall 

an 
publish 
the  operation  of 
t h is 

l a id  down 

in 

s h a ll 

publish 

1.  The  Agency 
a 
biennial  report  on  the  operation  of 
t h is 
the  procedures 
Chapter  and 
for 
I n f o r m a t i on 
European 
Parliament  and  the  Council. 

l a id  down 
forward 
t he 

s h a ll 
to 

in 
it 

Article  15c paragraph  2 unchanged 

Article  3  (2) unchanged 

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

o b t a i n ed 

to  ensure 

r e a c t i o ns 

r e g u l a t o ry 

i n f o r m a t i on 

the  adoption  of 
In  order 
decisions 
a p p r o p r i a te 
c o n c e r n i ng 
c o n t i n u ed 
t he 
authorization  of  medicinal  products 
the  Community,  having  regard 
within 
about 
to 
to  medicinal 
adverse 
conditions 
products  under  practical 
of 
s h a ll 
u s e,  Member 
e s t a b l i sh  a  pharmacovigilance  system 
for 
about 
r e a c t i o ns 
adverse 
to  medicinal 
in  human  beings  and  for  the 
products 
s c i e n t i f ic 
such 
information. 

information 

e v a l u a t i on 

c o l l e c t i ng 

S t a t es 

of 

o b t a i n ed 

r e a c t i o ns 

regulatory 

information 

u s e,  Member 

In  order  to  ensure  the  adoption  of 
decisions 
appropriate 
c o n c e r n i ng 
c o n t i n u ed 
t he 
authorization  of  medicinal  products 
within  the  Community,  having  regard 
about 
to 
adverse 
to  medicinal 
products  under  p r a c t i c al  conditions 
of 
s h a ll 
e s t a b l i sh  a  pharmacovigilance  system 
for 
about 
adverse 
to  medicinal 
products  in  human  beings  and  for  the 
e v a l u a t i on 
s c i e n t i f ic 
such 
t he 
s u ch 
i n f o r m a t i o n, 
information  about  adverse  reactions 
is 
the 
information  on 
the  consumption  of 
medicinal  products. 

systematically 

information 

c o l l e c t i ng 

r e a c t i o ns 

of 
t h at 

related 

S t a t es 

to 

Original  Text 

- 30 -
Amendment to the proposal 

Article  29b  unchanged 

Article  29c points  (a) and  (b) unchanged 

Article  29c  point c 

(c)  ensuring  that  any  request  from 
the competent  authority  for the 
p r o v i s i on 
additional 
of 
information  necessary  for  the 
evaluation  of  the  benefits  and 
risks  of a medicinal  product  1s 
answered  fully  and  promptly, 
including 
the  provision  of 
information  about  the volume  of 
sales  or  prescriptions  for  the 
medicinal  product  concerned, 
where  relevant. 

a d d i t i o n al 

(c) ensuring  that  any  request  from 
the  competent  authority  for  the 
p r o v i s i on 
of 
information  necessary  for  the 
evaluation  of  the  benefits  and 
risks  of  a  medicinal  product  1s 
answered  fully  and  promptly, 
Including 
provision  of 
Information  about  the  volume  of 
sales  or  prescriptions  for  the 
medicinal  product  concerned. 

the 

Articles  29d,  29e  and  29f  unchanged 

Article  29g 

to 

w i t h in 

a b o ut 

t he  Agency 

t he  exchange 

f a c i l i t a te 
i n f o r m a t i on 

In  o r d er 
of 
p h a r m a c o v i g i l a n ce 
s h a l l, 
Community, 
c o n s u l t a t i on  w i th  Member  S t a t e s, 
C o m m i s s i on 
and 
p a r t i e s, 
on 
p r e s e n t a t i on 
r e p o r t s. 

t he 
in 
t he 
i n t e r e s t ed 
guidance 
and 
r e a c t i on 

draw  up  d e t a i l ed 

t he  c o l l e c t i o n, 

v e r i f i c a t i on 

a d v e r se 

t he 

of 

w i t h in 

f a c i l i t a te 

i n f o r m a t i on 

t he  Commission  s h a l l, 

t he  exchange 
a b o ut 

In  order  to 
of 
p h a r m a c o v i g i l a n ce 
t he 
in 
Community, 
c o n s u l t a t i on  w i th  t he  Agency  and  t he 
i n t e r e s t ed  p a r t i e s,  draw  up  d e t a i l ed 
c o l l e c t i o n, 
g u i d a n ce 
t he 
of 
v e r i f i c a t i on 
Such 
adverse 
guidance  s h a ll  t a ke 
t he 
format 
t he  World  Health 
O r g a n i z a t i o n. 

p r e s e n t a t i on 
r e p o r t s. 
i n to  account 

and 
r e a c t i on 

used  by 

on 

A r t i c le  29h 

r e a c t i on 

Where  as  a  r e s u lt  of 
of 
a d v e r se 
Member  S t a te 
t e r ms 
t he 
a u t h o r i z a t i on 
w i t h d r a w a l, 
inform  t he  Agency. 

t he  e v a l u a t i on 
a 
r e p o r t s, 
is  c o n s i d e r i ng  amending 
m a r k e t i ng 
or 
f o r t h w i th 

i ts 
s h a ll 

s u s p e n s i on 

of 
or 
it 

a 

Where  as  a  result  of the evaluation 
of  adverse  reaction  reports,  a 
Member State is considering  amending 
the 
authorization  or  its  suspension  or 
withdrawal,  it  shall  forthwith 
inform  the Agency  and  the holder of 
the marketing  authorization. 

marketing 

t e r ms 

of 

a 

In case of  urgency,  the Member State concerned  may 
suspend the marketing of a medicinal product, provided 
the  Agency  is  informed  at the latest  on  the  following 
working day.' 

In case  of  urgency,  the  Member  State concerned  may 
suspend the marketing of a medicinal product, provided 
the Agency  is  informed  at  the  latest  on  the  following 
working day.' 

Articles  4 and  5 unchanged 

3. 

Amendment  to  the  proposal  for a 
COUNCIL  DIRECTIVE 

SYN 311 

anending  Directives  81/851/EEC  and  81/852/EEC 
in respect  of veterinary  medicinal  products 

- 31  " 

Original  Text 

Amendment  to  the  proposal 

Visas  and r e c i t a ls  unchanged 

( D i r e c t i ve  81/851/EEC,  A r t i c le  4  ( 1 ),  f i r st 

A r t i c le  1 (1) 

sub-paragraph) 

No  veterinary  medicinal  product  may 
be  placed  on  the  market  of  a  Member 
S t a te  u n l e ss  an  authorization  has 
competent 
been 
authority  of  that  Member  State  or  by 
the  Community. 

i s s u ed 

t he 

by 

No  veterinary  medicinal  product  may 
be  placed  on  the  market  of  a  Member 
State  unless  an  authorization  has 
in  accordance  with 
been  obtained 
Community  r u l e s. 

Articles  1 (2) and  1 (3) unchanged 

Article  1 (4) Directive  81/851/EEC,  Article  5b 

Third  paragraph,  new 

Before  a  veterinary  medicinal 
product is placed on the market the 
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 give the 
authorized  veterinary  medicinal 
product  a  European  Register  number 
which  shall  be  marked  on  the 
packaging. 

Article  1(5) 
(Directive  81/851/EEC  Article  8,  first  paragraph) 

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  210  days  of  the  date  of 
submitting the 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  of 
submitting the application. 

paragraph  2 unchanged 

Articles  1 (6) and  1 (7) unchanged 

- 32 

-

Original  Text 

Amendment  to  the  proposal 

A r t i c le  1 (8) 
( D i r e c t i ve  81/851/EEC  A r t i c le  15  paragraph  1  ) 

1.  A u t h o r i z a t i on  s h a ll  be  v a l id  f or 
f i ve  years  and  may  be  renewable  f or 
f i v e - y e ar  p e r i o d s,  on  a p p l i c a t i on  by 
t h r ee  months 
l e a st 
the  holder  at 
before  t he  e x p i ry  d a t e. 

1.  A u t h o r i z a t i on  s h a ll  be  v a l id  for 
f i ve  y e a rs  and  may  be  renewable  for 
f i v e - y e ar  p e r i o d s,  on  a p p l i c a t i on  by 
three  months 
l e a st 
the  holder  at 
t he  e x p i ry  date  and  a f t er 
before 
c o n s i d e r a t i on 
of  a 
d o s s i er 
u p - t o - d a te 
c o n t a i n i ng 
information  on  pharmacovigilance. 

paragraph  2 unchanged 

Article  1 (9)  (Directive  81/851/EEC  Chapter  IV) 

Articles  16  - 19 proposal  unchanged 

Article  20  first  paragraph 

The  Member  States or the Commission 
may,  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  21 
before  reaching  a  decision  on  a 
r e g u e at 
authorization  or  on the  suspension 
or  revocation  of an  authorization, 
or  on  any  other  amendment  to the 
terms  of  a  marketing  authorization 
which 
necessary,  in 
particular  to  take  account  of the 
information  collected  in  accordance 
with Chapter Via of this Directive. 

m a r k e t i ng 

f or  a 

appears 

The Member  States, the Commission or 
the  applicant  himself  may,  in 
specific  cases  where  the interests 
of  the  Community  are  involved, 
refer  the matter  to the Comité for 
the  application  of  the  procedure 
laid  down  in  Article  21  before 
reaching a decision on a request for 
a marketing  authorization or on the 
suspension  or  revocation  of  an 
authorization,  or  on  any  other 
amendment  to  the  terms  of  a 
marketing 
authorization  which 
appears  necessary,  in particular to 
take  account  of  the  information 
collected  in  accordance  with 
Chapter Via of this Directive. 

A r t i c le  20  paragraphs  2  and 3  unchanged 

A r t i c le  21  -  23b  unchanged 

A r t i c le  23c 

1.  The  Agency 
annual 
the  procedures 
Chapter. 

shall 

an 
report  on  the  operation  of 
t h is 
laid  down 

publish 

in 

s h a ll 

publish  a 
1.  The  Agency 
biennial  report  on  the  operation  of 
t h is 
the  procedures 
Chapter  and  s h a ll 
for 
European 
to 
i n f o r m a t i on 
Parliament  and  the  Council. 

l a id  down 
forward 
t he 

in 
it 

paragraph  2 unchanged 

Article  1 (10) unchanged 

-  33  -

Original  Text 

Amendment  to  the  proposal 

A r t i c le  1  (11) 
( D i r e c t i ve  81/851/EEC  Chapter  Via) 

A r t i c le  42a 

\ 

In  order  to  ensure  the  adoption  of  appropriate 
regulatory  Decisions  concerning  the  continued 
authorization of veterinary medicinal products within 
the Community, having regard to information obtained 
about  adverse  reactions  to  veterinary  medicinal 
products under practical conditions of use, the Member 
States shall establish a pharmacovigilance system  for 
collecting  information  about  adverse  reactions  to 
veterinary  medicinal  products  and for the  scientific 
evaluation of such information. 

In  order  to  ensure  the  adoption  of  appropriate 
regulatory  Decisions  concerning  the  continued 
authorization of veterinary medicinal products within 
the Community, having regard to information obtained 
about  adverse  reactions  to  veterinary  medicinal 
products under practical conditions of use, the Member 
States shall  establish a pharmacovigilance system for 
collecting  information  about  adverse  reactions  to 
veterinary  medicinal  products  and for the  scientific 
evaluation of such information  s u ch 

t h at 

t he 
r e a c t i o ns 
Information  about  a d v e r se 
is 
t he 
information  on  t he  consumption  of 
m e d i c i n al  p r o d u c t s. 

s y s t e m a t i c a l ly 

r e l a t ed 

to 

Article  42b unchanged 

Article  42c points  (a) and (b) unchanged 

Article  42cpoint (c) 

(c)  ensuring  that  any  request  from  the  competent 
authority  for  the  provision  of  additional 
information  necessary  for the evaluation  of the 
benefits and risks of a veterinary medicinal product 
is  answered  fully  and promptly,  including the 
provision of information about the volume of sales 
for the veterinary  medicinal  product concerned, 
wfrere  relevant. 

(c)  ensuring  that  any request  from  the competent 
authority  for  the  provision  of  additional 
information  necessary  for the evaluation  of the 
benefits and risks of a veterinary medicinal product 
is  answered  fully  and prompdy,  including  the 
provision of information about the volume of sales 
for the veterinary  medicinal  product concerned. 

Articles  42d, 42e, and 42f unchanged 

Article 42g 

w i t h in 

a b o ut 

the  Agency 

the  exchange 

f a c i l i t a te 
i n f o r m a t i on 

In  order  to 
of 
t he 
p h a r m a c o v i g i l a n ce 
in 
Community, 
s h a l l, 
the 
c o n s u l t a t i on  with  Member  S t a t e s, 
Commission 
I n t e r e s t ed 
and 
p a r t i e s,  draw  up  d e t a i l ed  guidance 
on  the  c o l l e c t i o n,  v e r i f i c a t i on  and 
p r e s e n t a t i on 
reaction 
r e p o r t s. 

adverse 

t he 

of 

a b o ut 

w i t h in 

the  exchange 

i n f o r m a t i on 

In  order  to  f a c i l i t a te 
of 
t he 
p h a r m a c o v i g i l a n ce 
Community,  the  Commission  s h a l l, 
in 
c o n s u l t a t i on  with  the  Agency  and  the 
i n t e r e s t ed  p a r t i e s,  draw  up  d e t a i l ed 
c o l l e c t i o n, 
t he 
g u i d a n ce 
v e r i f i c a t i on 
of 
adverse 
Such 
guidance  s h a ll  take  into  account  the 
the  World  Health 
format  used  by 
Organization. 

and  presentation 
reports. 

reaction 

on 

-  34  -

Original  Text 

Amendment  to  the  proposa 

A r t i c le  42h 

Where  as  a  r e s u lt  of  the  evaluation 
of 
a 
reaction 
adverse 
is  considering  amending 
Member  State 
m a r k e t i ng 
t he 
t e r ms 
suspension  or 
authorization 
forthwith 
w i t h d r a w a l, 
inform  the  Agency. 

i ts 
s h a ll 

reports, 

or 
it 

of 

a 

Where as a result of the evaluation 
of  adverse  reaction  reports,  a 
Member State is considering amending 
the 
of  a  marketing 
authorization  or  its  suspension  or 
withdrawal,  it  shall  forthwith 
inform the Agency  and the holder of 
the marketing  authorization. 

t e r ms 

In  case of urgency,  the Member  State  concerned may 
suspend the marketing of a medicinal product, provided 
the  Agency  is informed  at the latest  on the  following 
working day.' 

In case of urgency,  the Member  State  concerned may 
suspend the marketing of a medicinal product, provided 
the  Agency  is informed  at the latest  on the  following 
working day.* 

A r t i c l es  2 -4  unchanged 

-  3s-

ISSN 0254-1475 

COM(91) 382 final 

DOCUMENTS 

EN 

03 

Catalogue number : CB-CO-91-407-EN-C 

ISBN 92-77-75861-9 

Office for Official Publications of the European Communities 

L-2985 Luxembourg