No C 330/18 Official Journal of the European Communities 31. 12. 90 
Proposal for a Council Directive amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC 
in respect of medicinal products 
COM(90) 283 final — SYN 310 
(Submitted by the Commission on 14 November 1990) 
(90/C 330/02) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100a 
thereof, 
Having regard to the proposal from the Commission, 
In cooperation with the European Parliament, 
Having regard to the opinion of the Economic and Social 
Committee, 
Whereas it is important to adopt measures with the aim of 
progressively establishing the internal market over a period 
expiring on 31 December 1992; whereas the internal market 
shall comprise an area without internal frontiers in which the 
free movement of goods, persons, services and capital is 
ensured; 
Whereas Article 15 (2) of Second Council Directive 
75/319/EEC of 20 May 1975 on the approximation of 
provisions laid down by law, regulation or administrative 
action relating to proprietary medicinal products (1), as last 
amended by Directive 89/381/EEC (2), provides that the 
Commission shall submit to the Council a proposal 
containing appropriate measures leading towards the 
abolition of any remaining barriers to the free movement of 
proprietary medicinal products; 
Whereas in the interests of public health it is necessary that 
decision 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 (3), as last amended by Directive 
89/381/ECC, 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 (4), as last amended by Directive 89/341 /EEC (5); 
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; 
(») OJNoL147, 9. 6. 1975, p. 13. 
(2) OJ No L 181, 28. 6. 1989, p. 44. 
(3) OJ No 22, 9. 2. 1965, p. 369/65. 
(4) OJ No L 147, 9. 6. 1975, p. 1. 
(5) OJ No L 142, 25. 5. 1989, p. 11. Whereas, with the exception of those medicinal products 
which are subject to the centralized Community 
authorization established by Council Regulation (EEC) 
No . . . of . . . laying down Community procedures for the 
authorization and supervision of medicinal products for 
human and veterinary use and establishing a European 
Agency for the Evaluation of Medicinal Products (6), an 
authorization to place a medicinal product on the market in 
one Member State ought in principle to be recognized by the 
competent authorities of the other Member States unless 
there are serious grounds for supposing that the 
authorization of the medicinal product concerned may 
present a risk to public health; whereas, in the event of a 
disagreement between Member States about the quality, the 
safety or the efficacy of a medicinal product, a scientific 
evaluation of the matter should be undertaken by the 
Committee for Proprietary Medicinal Products attached to 
the European Agency for the Evaluation of Medicinal 
Products, leading to a single decision on the area of 
disagreement, binding on the Member States concerned; 
whereas this Decision should be adopted by a rapid 
procedure ensuring close cooperation between the 
Commission and the Member States, in particular through 
the Standing Committee on Medicinal Products for Human 
Use created by Article 2b of Directive 75/318/EEC; 
Whereas in order better to protect public health and avoid 
any unnecessary duplication of effort during the examination 
of application for authorization to place medicinal products 
on the market, Member States should systematically prepare 
assessment reports in respect of each medicinal product 
which is authorized by them, and exchange the reports upon 
request; whereas, furthermore, a Member State should be 
able to suspend the examination of an application for 
authorization to place a medicinal product on the market 
which is currently under active consideration in another 
Member State with a view to recognizing the Decision 
reached by the latter Member State; 
Whereas following the establishment of the internal market, 
specific controls to guarantee the quality of medicinal 
products imported from third countries can only be waived if 
appropriate arrangements have been made by the 
Community to ensure that the necessary controls are carried 
out in the exporting country; 
Whereas it is desirable to codify and improve the cooperation 
and exchange of information between Member States 
relating to the supervision of medicinal products and in 
particular the monitoring of adverse reactions under 
(*) See page 1 of this Official Journal. 
31. 12. 90 Official Journal of the European Communities No C 330/19 
practical conditions of use through the national 
pharmacovigilance centres, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Directive 65/65/EEC is hereby amended as follows: 
1. Article 3 is replaced by the following: 
'Article 3 
No 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.' 
2. Article 4 (2), points 6 and 11 are replaced by the 
following: 
'6. Posology, pharmaceutical form, method and 
route of administration and expected shelf life. 
If applicable, reasons for any precautionary and safety 
measures to be taken for the storage of the product, its 
administration to patients and for the disposal of waste 
products, together with an indication of any potential 
risks presented by the product for the environment.' 
'11. Copy of any authorization obtained in another 
Member State or in a third country to place the relevant 
medicinal product on the market, together with a list of 
those Member States in which an application for 
authorization submitted in accordance with this 
Directive is under examination and copies of the 
summary of product characteristics proposed by the 
applicant in accordance with Article 4a or approved by 
the competent authorities in accordance with Article 4b, 
as appropriate, in respect of each Member State 
concerned. Details of any Decision to refuse 
authorization, whether in the Community or a third 
country and the reasons for that Decision. 
This information shall be updated at regular 
intervals.' 
3. Article 4b is replaced by the following: 
'Article 4b 
When the marketing authorization referred to in 
Article 3 is issued, the person responsible for placing that 
product on the market shall be informed, by the 
competent authorities of the Member State concerned, of 
the summary of the product characteristics as approved 
by them. The competent authorities shall take all 
necessary measures to ensure that the information given 
in the summary is in conformity with that accepted when 
the marketing authorization is issued or subsequently. 
The competent authorities shall forthwith forward a 
copy of the summary to the European Agency for the 
Evaluation of Medicinal Products established by Council 
Regulation (EEC) No .../.. (*) Furthermore, the competent authorities shall draw up an 
assessment report and comments on the dossier as 
regards the results of the analytical, 
pharmaco-toxicological tests and the clinical trials of the 
medicinal product concerned. The assessment report 
shall be updated whenever new information becomes 
available which is of importance for the evaluation of the 
quality, safety or efficacy of the medicinal product 
concerned. 
(*) OJNoL...' 
4. Article 6 is replaced by the following: 
'Article 6 
This Directive shall not affect the application of national 
legislation prohibiting or restricting the use of medicinal 
products as contraceptives or abortifacients. The 
Member States shall communicate the national 
legislation concerned to the Commission.' 
5. Article 7 is replaced by the following: 
'Article 7 
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. 
2. Where a Member State notes that an application 
for authorization submitted after 1 January 1993 is 
already under active examination in another Member 
State, the former Member State may decide to suspend 
the detailed examination of the application in order to 
await the assessment report prepared by the first 
Member State in accordance with Article 4b. 
The Member State concerned shall inform the first 
Member State and the applicant of its Decision to 
suspend detailed examination of the application in 
question. As soon as it has completed the examination of 
the application and reached a Decision, the first Member 
State shall forward a copy of its assessment report to the 
Member State concerned. 
Within 90 days of the receipt of the assessment report, 
the Member State concerned shall recognize the Decision 
of the first Member State. However, if the Member State 
concerned considers that there are serious grounds for 
supposing that the authorization of the medicinal 
product may present a risk to public health, it shall 
inform the first Member State, the Committee for 
Proprietary Medicinal Products and the applicant within 
the time limit referred to above, stating its reason in 
detail, and apply the procedures laid down in Chapter III 
of Directive 75/319/EEC 
6. The following Article 7a is inserted: 
'Article 7a 
1. With effect from 1 January 1996, where a Member 
State is informed in accordance with point 11 of Article 4 
(2) that another Member State has authorized a 
No C 330/20 Official Journal of the European Communities 31. 12. 90 
medicinal product which is the subject of an application 
for authorization in the Member State concerned, that 
Member State shall forthwith request the authorities of 
the Member State which has granted the authorization of 
the Member State which has granted the authorization to 
forward to it the assessment report referred to in 
Article 4b (2). Within 90 days of the receipt of the 
assessment report, the competent authorities of the 
Member State concerned shall recognize the 
authorization granted by the other Member State. 
2. Notwithstanding paragraph 1, if the Member 
State concerned considers that there are serious grounds 
for supposing that the authorization of the medicinal 
product may present a risk to public health, it shall 
inform the Member State which granted the initial 
authorization, any other Member States concerned by 
the application, and the Committee for Proprietary 
Medicinal Products and the applicant within the time 
limit referred to in paragraph 1, stating its reasons in 
detail, and apply the procedures laid down in Chapter III 
of Directive 75/319/EEC 
7. Article 9a is replaced by the following: 
'Article 9a 
After an authorization has been issued, the person 
responsible for placing the product on the market must, 
in respect of the methods of production and control 
provided for in points 4 and 7 of Article 4 (2), take 
account of technical and scientific progress and 
introduce any changes that may be required to enable the 
medicinal product to be manufactured and checked by 
means of generally accepted scientific methods. These 
changes must be accepted by the competent authorities of 
the Member State concerned.' 
8. Article 10 is replaced by the following: 
'Article 10 
1. Authorization shall be valid for five years and shall 
be renewable for five-year periods, on application by the 
holder at least three months before the expiry date. 
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.' 
Article 2 
In Directive 75/318/EEC, the Committee referred to in 
Article 2b is hereby renamed 'the Standing Committee on 
Medicinal Products for Human Use'. 
Article 3 
Directive 75/319/EEC is hereby amended as follows: 1. Chapter III is replaced by the following: 
'CHAPTER III 
Committee for Proprietary Medicinal Products 
Article 8 
1. In order to facilitate the adoption of common 
Decisions by Member States on the authorization of 
medicinal products for human use on the basis of the 
scientific criteria of quality, safety and efficacy, and to 
achieve thereby the free movement of medicinal 
products, within the Community, a Committee for 
Proprietary Medicinal Products, hereinafter referred to 
as 'the Committee', is hereby set up. The Committee shall 
be attached to the European Agency for the Evaluation 
of Medicinal Products established by Council Regulation 
(EEC) No .../...(*), hereinafter referred to as the 
Agency. 
2. In addition to the other responsibilities conferred 
upon it by Community law, the Committee shall 
examine any question relating to the grant, amendment, 
suspension or withdrawal of authorization for a 
medicinal product which is submitted to it in accordance 
with the provisions of this Directive. 
3. The Committee shall adopt its own rules of 
procedure. 
Article 9 
1. In order to obtain the recognition in one or more of 
the Member States of an authorization issued by a 
Member State in accordance with Article 3 of Directive 
65/65/EEC, the holder of the authorization shall 
submit an application to the competent authorities of the 
Member State or Member States concerned, together 
with the information and particulars referred to in 
Articles 4,4a and 4b of Directive 65/65/EEC. He shall 
testify to the identity of the dossier with that accepted by 
the first Member State, or shall identify any additions or 
modifications it may contain. In the latter case, he shall 
certify that the summary of product characteristics 
proposed by him in accordance with Article 4a of 
Directive 65/65/EEC is identical to that accepted by the 
first Member State in accordance with Article 4b of 
Directive 65 / 65 /EEC. Moreover, he shall certify that all 
the dossiers filed as part of this procedure are 
identical. 
2. The holder of the marketing authorization shall 
notify the Committee of this application, inform it of the 
Member States concerned and of the dates of submission 
of the application and send it a copy of the authorization 
granted by the first Member State. He shall also send the 
Committee copies of any marketing authorization which 
may have been granted by the other Member States in 
respect of the product concerned, and shall indicate 
whether any application for authorization is currently 
under consideration in any Member States. 
31. 12. 90 Official Journal of the European Communities No C 330/21 
3. The holder of the authorization shall also inform 
the Member State which granted the initial authorization 
that an application is being made in accordance with this 
Directive and shall notify it of any additions to the 
original dossier; that Member State may require the 
applicant to provide it with all the particulars and 
documents necessary to enable it to check the identify of 
the dossiers filed with the dossiers on which it took its 
Decision. In addition that Member State shall forward to 
the Member State or Member States concerned by the 
application a copy of the assessment report established in 
accordance with the second paragraph of Article 4b of 
Directive 65/65/EEC. 
4. Each Member State concerned shall recognize the 
marketing authorization granted by the first Member 
State within 90 days of receipt of the application. It shall 
inform the Member State which granted the initial 
authorization, the other Member States concerned by the 
application, the Committee, and the person responsible 
for marketing thereof. 
Article 10 
1. Notwithstanding Article 9 (4), where a Member 
State considers that there are serious grounds for 
supposing that the authorization of the medicinal 
product concerned may present a risk to public health, it 
shall forthwith inform the applicant, the Member State 
which granted the initial authorization, any other 
Member States concerned by the application and the 
Committee. The Member State shall state its reasons in 
detail and shall indicate what action may be necessary to 
correct any defect in the application. 
2. All the Member States concerned shall use their 
best endeavours to reach agreement on the action to be 
taken in respect of the application. They shall provide the 
applicant with the possibility to make his point of view 
known orally or in writing. However, if within 60 days 
of the expiry of the time limit referred to in Article 9(4), 
the Member States have not been able to reach agreement 
they shall forthwith refer the matter to the Committee for 
the application of the procedure laid down in 
Article 13. 
3. Within the time limit referred to in paragraph 2, 
the Member States concerned shall provide the 
Committee with a detailed statement of the matters on 
which they have been unable to reach agreement and the 
reasons for their disagreement. A copy of this 
information shall be provided to the applicant. 
4. As soon as he is informed that the matter has been 
referred to the Committee, the applicant shall forthwith 
forward to the Committee a copy of the information and 
particular referred to in Article 9 (1). 
Article 11 
If several applications submitted in accordance with 
Articles 4 and 4a of Directive 65/65/EEC have been made for marketing authorization for a particular 
medicinal product, and Member States have adopted 
divergent Decisions concerning the authorization of the 
medicinal product, or its suspension or withdrawal from 
the market, any Member State, or the Commission, or 
the person responsible for marketing may refer the 
matter to the Committee for application of the procedure 
laid down in Article 13. 
The Member State concerned, the person responsible for 
marketing or the Commission shall clearly identify the 
question which is referred to the Committee for 
consideration and, if necessary, shall inform the person 
responsible for marketing. 
The Member States and the person responsible for 
marketing shall forward to the Committee all available 
information relating to the matter in question. 
Article 12 
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 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. 
The Member State concerned or the Commission shall 
clearly identify the questions which is referred to the 
Committee for consideration and shall inform the person 
responsible for marketing. 
The Member States and the person responsible for 
marketing shall forward to the Committee all available 
information relating to the matter in question. 
Article 13 
1. When reference is made to the procedure described 
in this Article, the Committee shall consider the matter 
concerned and issue a reasoned opinion within 90 days of 
the date on which the matter was referred to it. 
In case of urgency, on a proposal from its chairman, the 
Committee may agree to impose a shorter deadline. 
2. In order to consider the matter, the Committee 
may appoint one of its members to act as rapporteur. The 
Committee may also appoint individual experts to advise 
it on specific questions. When appointing experts, the 
Committee shall define their tasks and specify the time 
limit for the completion of these tasks. 
3. In the cases referred to in Article 10 and 11, before 
issuing its opinion, the Committee shall provide the 
person responsible for marketing with an opportunity to 
present written or oral explanations. 
^oC330B22 COfficial journal of the European Communities 31.12.^0 
In the case referred to in Articled the person 
responsiblefor placing themedicinalproductonthe 
market may he asked to explain himself orally or in 
writing. 
If it considers it appropriate, the Committee may invite 
any other person to provide information relating to the 
matter before itD 
^beCommitteemaysuspendthetimelimitreferredtoin 
paragraphiinordertoallowthe person responsible for 
marketing to prepare explanations' 
^. Where the opinion of the Committee is that^ 
— the application does not satisfy the criteria for 
authorisation set out in this Directive, or 
— the summary of product characteristics proposed by 
the applicant in accordance with Article ^a of 
Directive 6^B6^L^C should be amended, or 
— thelabellingorpackageleafletoftheproductisnotin 
compliance with Directive..g..^^C,or 
— the authorisation should granted subject to 
conditions, or 
— an existing marketing authorisation should be 
suspended amended or withdrawn, 
theAgencyshallforthwithinformthepersonresponsible 
for marketing. Within todays of the receiptof the 
opinion, the person responsible for marketing may 
provide written notice to the Agency that he wishes to 
appeal.Within 60 days of the receipt ofthe grounds for 
appeal,theCommitteeshallconsiderwhetheritsopinion 
should be revised, and the reasons for the conclusions 
reached on the appeal shall be annexed to the assessment 
report referred to in paragraphs 
^ Within 30 days of its adoption, the Agency shall 
forward the final opinion of the Committee to the 
Commission, the member states and the person 
responsible for marketing together with a report, 
describing the assessment of the medicinal product and 
the reasons for its conclusions. 
In the event of an opinion in favour of grantingor 
maintaining an authorisation to market the medicinal 
productconcemed, the followingdocuments shall be 
annexed to the opinions 
^d adraft summary of the product characteristics,as 
referred to in Article ^a of Directive 6^B6^^C^ 
^ details of any conditions or restrictions which 
should be imposed on the supply or use of the 
medicinal product concerned, included tbe 
conditions under which the medicinal product may 
be made available to patients, having regard to the criteria laid down in Directive ...g..B^C 
concerning the legal status for the supply of 
medicinal products for human use^ 
^ the draft te^t of the labelling and package leaflet, 
proposed by the applicant presented in accordance 
with Directive...B.,.BL^C on the labelling of 
medicinal products for human use and on package 
leaflets. 
i. Within 30 days ofthe receipt of the opinion ofthe 
Committee,the Commission shall prepareadraft of the 
Decision to be taken in respect ofthe application taking 
into account the objectives of Community policies and 
considering all relevant information. In the event ofa 
draft Decision which envisages the granting of a 
marketing authorisation, the documents referred to in 
points ^,d^and^of Article 13^shall be annexed. 
I^he Commission shall transmitthe 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. 
2. I^he Commission shall adopt the Decision to be 
takeninrespectoftheapplication unless, within30days, 
ithasreceivedareasonedrequestfroma^iember^tateto 
reconsider the matter. Lhe member ^tate concerned 
shallalsotransmitacopyof its request to the other 
member states and the applicant within the same time 
limit. 
3. Within the time limit referred to in paragraph 2, 
the applicant may submit written observations on the 
draft Decision for consideration by the commission. 
^. l^he Commission shall examine any reasoned 
request received in accordance with paragraph 2, in 
consultation with the Agency, and after consideration of 
any further observations submitted by the applicant. 
If the Commission considers that the request raises 
questions of ascientific or technicalnaturerequiring 
further examination, it may remit thematter to the 
Agency.In this case the Committee shall giveasecond 
opinion withinatime limit of60days.Within30daysof 
the receipt of the opinion, the Commission shall adopt 
the Decision to be taken in respect of the application. 
C^therwisetheDecisionshallbetakeninaccordancewith 
theprocedurelaiddowninArticle2band2cofDirective 
^^31^E^C 
^. ADecisionadoptedin accordance with thisArticle 
shall beaddressedtothe^iember^tatesconcemedbythe 
matter and to thepersonresponsibleformarketing.^fbe 
^viember^tates shall either grant orwithdrawmarketing 
authorisation,or make any adjustment to the terms ofa 
31. 12. 90 Official Journal of the European Communities No C 330/23 
marketing authorization which may be necessary to 
comply with the Decision within 30 days of its 
notification. They shall inform the Commission and the 
Committee thereof. 
Article 15 
Any application by the person responsible for marketing 
to amend the terms of a marketing authorization which 
has granted in accordance with the provisions of this 
Chapter shall be submitted to all the Member States 
which have previously authorized the medicinal product 
concerned. 
The Agency shall, in consultation with the Commission, 
adopt appropriate arrangements for the examination by 
the Committee of amendments or variations to a 
marketing authorization which has been granted in 
accordance with the provisions of this Chapter. 
The procedures laid down in Articles 13 and 14 shall 
apply by analogy to variations and amendments of 
marketing authorizations. 
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. 
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 on its territory. It 
shall inform the Commission no later than the following 
working day of the reasons for its action. 
Article 15b 
Articles 15 and 15a shall apply by analogy to medicinal 
products authorized by Member States following an 
opinion of the Committee given in accordance with 
Article 4 of Directive 87/22/EEC before 1 January 
1993. 
Article 15c 
1. The Agency shall publish an annual report on the 
operation of the procedures laid down in this 
Chapter. 
2. Within six years of the date referred to in the first 
subparagraph of Article 4(1), the Commission shall 
publish a detailed review of the operation of the 
procedures laid down in this chapter and shall propose 
any amendments which may be necessary to improve the 
operation of these procedures. 
The Council shall decide on the Commission proposal 
within one year of its submission. 
(*) OJNoL...' 
2. The third subparagraph of Article 22 (1) is replaced by 
the following: 
'In the case of medicinal products imported from a third 
country, where appropriate arrangements have been made by the Community with the exporting country to 
ensure that the manufacturer of the medicinal product 
applies standards of good manufacturing practice at least 
equivalent to those laid down by the Community and to 
ensure that the controls referred to under (b) have been 
carried out in the exporting country, the qualified person 
may be relieved of responsibility for those controls.' 
3. The following Chapter Va is inserted after Article 29: 
'CHAPTER Va 
Pharmacovigilance 
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, 
the 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. 
Article 29b 
For the purpose of this Directive, the following 
definitions shall apply: 
— 'adverse reaction' shall mean a reaction which is 
noxious and unintended and which occurs at doses 
normally used in man for the prophylaxis, diagnosis 
or therapy of disease or for the modification of 
physiological function, 
— 'serious adverse reaction' shall mean an adverse 
reaction which is fatal, life-threatening, disabling, 
incapacitating, or which results in hospizalization or 
prolonged hospitalization. 
Article 29c 
The person responsible for marketing shall have 
permanently and continuously at his disposal a person 
responsible for pharmacovigilance. This person shall be 
responsible for: 
(a) the establishment and maintenance of a system 
which ensures that information about all adverse 
reactions which are reported to the personnel of the 
No C 330/24 Official Journal of the European Communities 31. 12. 90 
company, including its sales personnel and 
medicinal representatives, is collected and collated 
at a single point; 
(b) the preparation and submission to the competent 
authorities of the reports referred to in Article 29d, 
in such form as may be laid down by those 
authorities; 
(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 is 
answered fully and promptly, including the 
provision of information about the volume of sales 
or prescriptions for the medicinal product 
concerned, where relevant. 
Article 29d 
1. The person responsible for marketing shall be 
required to record and to report all suspected serious 
adverse reactions which are brought to his attention by a 
qualified health care professional to the competent 
authorities within 15 days of their receipt. 
2. In addition, the person responsible for marketing 
shall be required to maintain detailed records of all other 
adverse reactions which are reported to him by a 
qualified health care professional. Unless other 
requirements have been laid down as a condition of the 
granting of authorization, these records shall be 
submitted to the competent authorities immediately 
upon request or at least every six month during the first 
two years following authorization, and once a year for 
the following three years. Thereafter, the records shall be 
submitted at five yearly intervals together with the 
application for renewal of the authorization, or 
immediately upon request. 
Article 29e 
The Member States shall take all appropriate measures 
to encourage doctors and other health care professionals 
to report adverse reactions to the competent 
authority. 
The Member States may impose specific requirements on 
medical practitioners, in particular in respect of the 
reporting of serious or unexpected adverse reactions, or 
where such reporting is a condition of the marketing 
authorization. Article 29f 
The Member States shall ensure that, report of serious 
adverse reactions are brought to the attention of the 
Agency and the person responsible for marketing within 
15 days of their receipt. 
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 interested parties, draw up detailed 
guidance on the collection, verification and presentation 
of adverse reaction reports. 
Article 29b 
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 suspensions 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.' 
Article 4 
Member States shall take all appropriate measures to comply 
with the provisions of this Directive, with the exception of 
Article 1 (6), before 1 January 1993. They shall forthwith 
inform the Commission thereof. 
Member States shall take all appropriate measures to comply 
with Article 1 (6) of this Directive before 1 January 1996. 
They shall forthwith inform the Commission thereof. 
When Member States adopt these provisions, these shall 
contain a reference to this Directive or shall be accompanied 
by such reference at the time of their official publication. The 
procedure for such reference shall be adopted by Member 
States. 
Article 5 
This Directive is addressed to the Member States.