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 
- 2 -
The Commission has decided to accept: 
- 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 
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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 SYN 309 
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 
Original Text Amendment to the proposal 
Visas and recitals 1-3 unchanged 
Fourth recital Fourth recital 
Whereas in the interests of public 
health 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 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 -
Eighteenth recital 
Whereas the Agency, working in close 
cooperation with the Commission, 
should also be entrusted with the 
task of coordinating the discharge of 
the various supervisory 
responsibilities of Member States and 
in particular monitoring the respect 
of good manufacturing practices, good 
laboratory practices and good 
clinical practices; 17 unchanged 
Eighteenth recital 
Whereas the Agency, working in close 
cooperation with the Commission, 
should also be entrusted with the 
** task of coordinating the discharge 
of the various supervisory 
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 
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Original Text Amendment to the proposal 
Articles 1 - 5 unchanged 
Article 6 Article 6 
Article 6, paragraph 1, unchanged 
Article 6 (2) Article 6 (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 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) 
3. The Agency shall ensure that the opinion of the 
Committee is given within 210 days of the receipt of a valid 
application. Article 6(3) 
3. The application shall also be 
accompanied by the fee payable to 
the Agency for the examination of 
the application. 
2) 
- 7 -
Original Text Amendment to the proposa I 
Article 6 (4) Article 6 (4) 
4. The Agency shall, in consultation with Member States, 4_«_ The Agency shall ensure that 
the Commission and interested parties, draw up detailed the Opinion Of the Committee is 
guidance on the form in which applications for authorization given within 210 day S of the 
are to be presented. receipt of a valid application. 
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 
Article 10 (1) -8 Amendment to the proposal 
Article 10 (1) 
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 tho 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 9(3) shall be annexed. 
The Commission shall transmit the 
draft Decision to the Member States 
and to the applicant. 
The Commission shall explain in 
detail the reasons for any 
differences between the draft 
Decision and the opinion of the 
Committee» 
Article 10 (2) 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 
granting of a marketing 
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. 
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) 
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 State requesting 
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. 
- 9 
Original Text Amendment to the proposal 
Article 12 (1) Article 11 unchanged 
Article 12 (1) 
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 
State in accordance with Article 3 of Directive 
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 (3) Article 12 (2) unchanged 
Article 12 (3) 
A n announcement that 
authorization has been granted shall 
be published for information 
purposes in the Official Journal of 
the European Communities. 3 . Notification of marketing 
authorization shall be published in 
the Official Journal of the European 
Communities, Quoting the number in 
the Community Register. 
Article 13 (1) Article 12 (4) unchanged 
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 
dossier containing up-to-date 
information on pharmacovigilance. 
-10 
Original Text 
Article 13 (2) 
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 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. Amendment to the proposa 
be Article 13 (2) 
2. In exceptional circumstances and 
following consultation with the 
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) 
4. The Agency shall, in consultation 
with the Commission, adopt 
appropriate arrangements for the 
examination of amendments and 
variations to the terms of a 
marketing authorization. 4. The Agency shall, in 
consultation with the Commission, 
adopt appropriate arrangements for 
the examination of amendments and 
variations to the terms of a 
marketing authorization. These 
arrangements shall include a 
notification system o r 
administrative procedures concerning 
minor changes and define precisely 
the concept of 'a minor change*. 
Articles 16 and 17 unchanged 
Original Text 
Article 18 (1) 11 -
Amendment to the proposa I 
Article 18 (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 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 
in Chapter V or Chapter Va of 
Direcitve 75/319/EEC should be 
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 caused by the 
medicinal product cannot await 
the definitive decision of the 
Comrcigaion; 
(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. 
12 -
Original Text Amendment to the proposal 
Article 18 (5) unchanged The Member State in Question shall 
inform the Commission no later than 
the following working day of the 
reasons for its action. It shall 
also Inform the health authorities 
of the other Member States. 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. In such cases the Member State 
in question shall immediately take 
the necessary measures to inform the 
public. 
Article 18 (6). new 
The Agency shall, upon request, 
inform any interested person of the 
contenta of the Committee's opinion 
referred to in paragraph 2. 
Articles 19 - 21 unchanged 
Article 22 paragraphs 1 and 2 unchanged 
Article 22 (3). new 
The person responsible for marketing 
shall accompany the records of 
adverse reactions with an analysis 
of the data regarding such 
reactions, in order to make them 
easier to understand. 
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 Agency and the person 
responsible for marketing within 15 
days of receipt of a report from a 
qualified health care professional. Each Member State shall organize the 
pharmacovlqilance service within its 
territory according to the 
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. The Comm i s s io n shall, 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; 
The Agency 
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 
pharmacovigilance data regarding 
medicinal products marketed in the 
Community. 
Article 25 unchanged 
Article 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) 
2. The application shall also be accompanied by the fee 
payable to the Agency for the examination of the 
application. Article 27 (2) 
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) 
3. The Agency shall ensure that the opinion of the 
Committee is given within 210 days of the receipt of a valid 
application. Article 27 (3) 
3^ The application shall also be 
accompanied by the fee payable to 
the Agency for the examination of 
the application. 
3) 
- 15 -
Original Text 
Article 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. Amendment to the proposal 
Article 27 (4) 
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 
Original Text 16-
Amendment to the proposa 
Article 31 (1) Article 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 Commission shall explain in 
detail the reasons for any 
differences between the draft 
Decision and the opinion of the 
Committee. 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. 
The Member State requesting 
reconsideration shall provide 
detailed juetification based 
scientific 
law. evidence or Community 
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. 
- 17 .. 
Original Text Amendment to the proposal 
Article 33 (1) Article 32 unchanged 
Article 33 (1) 
1. Without prejudice to Article 4 of Council Directive 
.../.. ./EEC extending the scope of Directive 
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. 1. Without prejudice to Article 4 of Council Directive 
.../.. ./EEC extending the scope of Directive 
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 (3) Article 33 (2) unchanged 
Article 33 (3) 
3. Ajn_ a nnouncement that 
authorisation has been granted shall 
be published for information purposes 
in the Official Journal of the 
European Communities. 3. Notification of marketing 
authorization shall be published in 
the Official Journal of the European 
Communities, quoting the number in 
the Community Register of Veterinary 
Medicinal Products. 
Article 34 (l) Article 33 (4) unchanged 
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 containing up-to-date 
information on pharmacovloilance. 
Original Text - 18 -
Amendment to the proposa 
Article 34 (2) 
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 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. Article 34 (2) 
2. In exceptional circumstances, and 
following consultation with the 
aDD)leant, an authorization may be 
granted subject to/ 
certain specific obligations 
defined and reviewed annually by the 
Agency, 
Z to conduct further studies 
following the granting of 
authorization; 
- to report adverse .reactions to 
the veterinary medicinal 
products. 
Article 34 paragraph 3 unchanged 
Article 35 unchanged 
Article 36 paragraphs 1-3 unchanged 
Article 36 (4) Article 36 (4) 
4. The Agency shall, in accordance 
with the Commission, adopt 
appropriate arrangements for the 
examination of amendments and 
variations to the terms of a 
marketing authorization. 4. The Agency shall, in accordance 
with the Commission, adopt 
appropriate arrangements for the 
examination of amendments and 
variations to the terms of a 
marketing authorization. These 
arrangements shall include a system 
of notification 
procedures to or administrative 
take account of 
changes of minor importance. 
Articles 37 and 38 unchanged 
Original Text - 19 -
Amendment to the proposal 
Article 39 (1) Article 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. The sane shall apply 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 
be applied in respect of the 
veterinary medicinal product 
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. 
Articles 40 - 42 unchanged 
Article 43 paragraphs 1 and 2 unchanged 
Article 43 (3). new 
The person responsible for marketing 
shall accompany the records of 
adverse reactions with an analysis 
of the data regarding such 
reactions, in order to make them 
easier to understand. 
Original Text -21} -
Amendment to the proposal 
Article 44 Article 44 
Each Member State shall report any 
suspected serious adverse reaction 
arising within its territory to a 
veterinary 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 . Each Member State shall organize the 
pharmacovigilance service within its 
territory according to the 
provisions of Article 45. It shall 
report any suspected 
serious adverse reaction arising 
within its territory to a 
veterinary 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. 
Article 45 Article 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. The Commi s s i on shal 1 in 
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 -21 -
Amendment to the proposa 
Article 47 unchanged 
Article 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 of Community 
legislation relating to medicinal 
products. 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 
the provisions of Community 
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 -22 -
Amendment to the proposal 
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 
particular . 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 
regi stering al 1 the 
authorizations for medicinal 
products granted in the 
European Community; 
Point (k). new 
the provision to health 
professionals of scientific 
information on the medicinal 
products authorized by this 
Regulation. 
Original Text -23 -
Amendment to the proposal 
Article 49 unchanged 
Article 50 paragraphs 1-3 unchanged 
Article 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) 
a list of medicinal products 
which have been granted 
authorization, those for which 
authorization has been refused 
or withdrawn and those whose 
information records have 
undergone significant changes. 
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) 
1. The management board shall consist of two 
representatives from each Member State and 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. Article 54 (1) 
1. The 
consist 
from 
represen 
and two Manag 
of 
each 
tatives 
repres ement 
two 
Membe 
of 
entat Board 
représenta 
r State, 
the Commi 
ives appo shall 
t ives 
two 
ssion 
inted 
by the European Parliament. One 
icif ic 
to 
use 
inary represen 
responsi 
medicina 
and one 
medicina tative 
bilitie 
1 prod 
relat 
1 produ shal 
s 
ucts 
ing 
cts. 1 have spe< 
relating 
for human 
to veter 
Original Text -24 -
Amendment to the proposal 
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 66 unchanged 
Article 67 
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. 
Article 70 Articles 68 and 69 unchanged 
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. 
Member States shall forthwith inform the Commission of the 
institution of any infringement proceedings. 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. 
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 
-25 -
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 
Original Text Amendment to the proposal 
Visas and recitals 1 and 2 unchanged 
Third recital 
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 amended by Directive 
89/381/EEC, and 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, 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; Third recital 
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 
last amended by Directive 
89/381/EEC, and by Directive 
75/319/EEC, and by Council 
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; 
New recital inserted after 
third recital 
Whereat; _ there already exist in 
Commuait y. law adequate rules for the 
evaluation and monitoring of 
nr.edi çijna 1 products laying 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; 
Remaining recitals unchanged 
Original Text -26 -
Amendment to the proposa I 
Article 1 (1), (Directive 65/65/EEC, Article 3) 
No medicinal product may be placed 
on the market of a Member State 
unless an authorization has been 
Issued bv the competent authority of 
that Member Sfrgf or.—fey—fcfee. 
CommunItVt No medicinal product may be placed 
on the market of a Member State 
unless an authorization has been 
obtained in accordance with 
Community rules. 
Article 1(2) unchanged 
Article 1 (3) (Directive 65/65/EEC, Article 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 
Original Text -27 -
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. 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 
dossier containing up-to-date 
information on pharmacovigilance. 
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 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. 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 of adverse 
reactions to the medicinal 
product. 
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 8-11, 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 
request for 
authorization or 
or revocation of 
or on any other a marketing 
on the suspension 
an authorization, 
amendment to the 
terms of a marketing authorization 
which appears necessary, 1n 
particular to take account of the 
information collected in accordance 
with Chapter Va of this Directive. 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 of the 
procedure laid down in Article 13 
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 Va of this Directive. 
Original Text "28 -
Amendment to the proposal 
Article 12 paragraphs 2 and 3 unchanged 
Article 13 unchanged 
Article 14 paragraphs 1-5 unchanged 
Article 14 paragraph 6, new 
6. The procedure pursuant to 
Articles 8 to 14 shall not apply in 
the instances covered by 
Article 9(21 of Directive ... on 
homeopathic medicinal products 
(COM(90) 0072 final - SYN 251i. 
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 
suspension or withdrawal is 
necessary, the Member State 
concerned shall forthwith refer the 
matter to the Committee for the 
application of the procedures laid 
down in Articles 13 and 14. 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 
suspension or withdrawal is 
necessary, the Member State 
concerned shall forthwith refer the 
matter to the Committee for the 
application of the procedures laid 
down in Articles 13 and 14. 
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 no later than the 
following working day of the reasons 
for its actions. 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 
suspected harm during the 
Commissions deliberations; 
-29 
Original Text Amendment to the proposal 
(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 caused 
by the product itself. 
The Member State concerned shall 
inform the Commission no later than 
the following working day of the 
reasons for its actions. 
Article 15b unchanged 
Article 15c paragraph 1 
1. The Agency shall publish an 
annual report on the operation of 
the procedures laid down in this 
Chapter. 1. The Agency shall publish a 
biennial report on the operation of 
the procedures laid down in this 
Chapter and shall forward it for 
Information to the European 
Parliament and the Council. 
Article 15c paragraph 2 unchanged 
Article 3 (2) unchanged 
Article 3 (3) (Directive 75/319/EEC Article 29a) 
In order to ensure the adoption of 
appropriate regulatory decisions 
concerning the continued 
authorization of medicinal products 
within the Community, having regard 
to information obtained about 
adverse reactions to medicinal 
products under practical conditions 
of use, Member States shall 
establish a pharmacovigilance system 
for collecting information about 
adverse reactions to medicinal 
products in human beings and for the 
scientific evaluation of such 
information. In order to ensure the adoption of 
appropriate regulatory decisions 
concerning the continued 
authorization of medicinal products 
within the Community, having regard 
to information obtained about 
adverse reactions to medicinal 
products under practical conditions 
of use, Member States shall 
establish a pharmacovigilance system 
for collecting information about 
adverse reactions to medicinal 
products in human beings and for the 
scientific evaluation of such 
information, such that the 
information about adverse reactions 
is systematically related to the 
information on the consumption of 
medicinal products. 
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 
provision of additional 
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. (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 medicinal product 1s 
answered fully and promptly, 
Including the provision of 
Information about the volume of 
sales or prescriptions for the 
medicinal product concerned. 
Articles 29d, 29e and 29f unchanged 
Article 29g 
In order to facilitate the exchange 
of information about 
pharmacovigilance within the 
Community, the Agency shall, in 
consultation with Member States, the 
Commission and the interested 
parties, draw up detailed guidance 
on the collection, verification and 
presentation of adverse reaction 
reports. In order to facilitate the exchange 
of information about 
pharmacovigilance within the 
Community, the Commission shall, in 
consultation with the Agency and the 
interested parties, draw up detailed 
guidance on the collection, 
verification and presentation of 
adverse reaction reports. Such 
guidance shall take into account the 
format used by the World Health 
Organization. 
Article 29h 
Where as a result of the evaluation 
of adverse reaction reports, a 
Member State is considering amending 
the terms of a marketing 
authorization or its suspension or 
withdrawal, it shall forthwith 
inform the Agency. 
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.' Where as a result of the evaluation 
of adverse reaction reports, a 
Member State is considering amending 
the terms of a marketing 
authorization or its suspension or 
withdrawal, it shall forthwith 
inform the Agency and the holder of 
the marketing authorization. 
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. - 31 " 
Amendment to the proposal for a 
COUNCIL DIRECTIVE 
anending Directives 81/851/EEC and 81/852/EEC 
in respect of veterinary medicinal products SYN 311 
Original Text Amendment to the proposal 
Visas and recitals unchanged 
Article 1 (1) 
(Directive 81/851/EEC, Article 4 (1), first sub-paragraph) 
No veterinary medicinal product may 
be placed on the market of a Member 
State unless an authorization has 
been issued by the competent 
authority of that Member State or by 
the Community. No veterinary medicinal product may 
be placed on the market of a Member 
State unless an authorization has 
been obtained in accordance with 
Community rules. 
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 
Original Text -32 -
Amendment to the proposal 
Article 1 (8) 
(Directive 81/851/EEC Article 15 paragraph 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 of a 
dossier containing up-to-date 
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 
regueat 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. 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. 
Article 20 paragraphs 2 and 3 unchanged 
Article 21 - 23b unchanged 
Article 23c 
1. The Agency shall publish an 
annual report on the operation of 
the procedures laid down in this 
Chapter. 1. The Agency shall publish a 
biennial report on the operation of 
the procedures laid down in this 
Chapter and shall forward it for 
information to the European 
Parliament and the Council. 
paragraph 2 unchanged 
Article 1 (10) unchanged 
- 33 -
Original Text Amendment to the proposal 
Article 1 (11) 
(Directive 81/851/EEC Chapter Via) 
Article 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 such that the 
Information about adverse reactions 
is systematically related to the 
information on the consumption of 
medicinal products. 
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 
In order to facilitate the exchange 
of information about 
pharmacovigilance within the 
Community, the Agency shall, in 
consultation with Member States, the 
Commission and the Interested 
parties, draw up detailed guidance 
on the collection, verification and 
presentation of adverse reaction 
reports. In order to facilitate the exchange 
of information about 
pharmacovigilance within the 
Community, the Commission shall, in 
consultation with the Agency and the 
interested parties, draw up detailed 
guidance on the collection, 
verification and presentation of 
adverse reaction reports. Such 
guidance shall take into account the 
format used by the World Health 
Organization. 
- 34 -
Original Text Amendment to the proposa 
Article 42h 
Where as a result of the evaluation 
of adverse reaction reports, a 
is considering amending 
of a marketing 
or its suspension or 
it shall forthwith Member State 
the terms 
authorization 
withdrawal, 
inform the Agency. 
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.' Where as a result of the evaluation 
of adverse reaction reports, a 
Member State is considering amending 
the terms of a marketing 
authorization or its suspension or 
withdrawal, it shall forthwith 
inform the Agency and the holder of 
the marketing authorization. 
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 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