5. 11. 84 ( Official Journal of the European Communities No C 293/1 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive on the approximation of national measures relating to 
the placing on the market of high-technology medicinal products, particularly those 
derived from biotechnology 
COM(84) 437final 
(Submitted by the Commission to the Council on 3 October 1984) 
(84/C 293/01) 
THE COUNCIL OF THE EUROPEAN 
COMMUNITIES, 
Having regard to the Treaty establishing the Euro­
pean Economic Community, and in particular 
Article 100 thereof, 
Having regard to the proposal from the Commis­
sion, 
Having regard to the opinion of the European Par­
liament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas 'high-technology' medicinal products 
requiring lengthy periods of costly research will con­
tinue to be developed in Europe only if they benefit 
from a favourable regulatory environment, particu­
larly identical conditions governing their placing on 
the market throughout the Community; 
Whereas 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 ('), as last 
amended by Directive 83/570/EEC (2), makes prov­
ision for certain procedures for coordinating national decisions relating to the placing on the 
market of proprietary medicinal products for human 
use; whereas pharmaceutical firms may, according 
to these provisions, request a Member State to take 
due account of an authorization already issued by 
another Member State; 
Whereas Council Directive 81/851 /EEC of 28 Sep­
tember 1981 on the approximation of the laws of the 
Member States relating to veterinary medicinal 
products (3) makes provision for a procedure for 
coordinating national decisions relating to veteri­
nary medicines; 
Whereas, however, these procedures are not suffi­
cient to open up to high-technology medicinal prod­
ucts the large Community-wide single market which 
they require; 
Whereas, in this technically advanced sector, the 
scientific expertise available to each of the national 
authorities is not always sufficient to resolve prob­
lems posed by high-technology medicinal products; 
Whereas it is consequently important to provide for 
a Community mechanism for concertation, prior to 
any national decision relating to a high-technology 
medicinal product, with a view to arriving at uni­
form decisions throughout the Community; 
(>) OJ No L 147, 9. 6. 1975, p. 13. 
0 OJNoL332, 28. 11. 1983, p. 1. (3) OJ No L 317, 6. 11. 1981, p. 1. 
No C 293/2 Official Journal of the European Communities 5. 11. 84 
Whereas it is desirable to extend this Community 
concertation to immunological products and substi­
tutes for blood constituents developed by means of 
new biotechnological processes, and to new prod­
ucts based on radioisotopes, the development of 
which in Europe can only take place if a sufficiently 
large and homogeneous market exists; 
Whereas the necessity for the adoption of new tech­
nical rules applying to high-technology medicinal 
products or for the amendment of existing rules 
must be examined during a preliminary concertation 
between the Member States and the Commission 
within the competent Committees so as not to 
endanger the advance of pharmaceutical research 
whilst at the same time ensuring optimal protection 
of public health within the Community, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
1. The Member States shall intensify coordination 
in respect of national measures relating to the plac­
ing on the market of medicinal products within the 
meaning of Article 1 of Council Directive 65/65/ 
EEC of 26 January 1965 on the approximation of 
provisions laid down by law, regulation or adminis­
trative action relating to proprietary medicinal prod­
ucts (') in order to create a regulatory environment 
favourable to the development of pharmaceutical 
research in Europe, particularly in the field of bio­
technology. 
2. Before taking a decision on the authorization, 
suspension or withdrawal from the market of a 
'high-technology' medicinal product, the authorities 
of the Member States shall, in accordance with the 
provisions of Articles 2 to 5, refer the matter for an 
opinion to the Committees mentioned in Article 12 
of Directive 75/319/EEC and Article 22 of Direc­
tive 81/851/EEC. 
3. The provisions of paragraph 2 shall apply to the 
medicinal products listed in the Annex. 
Article 2 
1. As soon as they receive an application for mar­
keting authorization relating to a medicinal product 
(>) OJ No 22, 9. 6. 1965, p. 369/65. developed by means of the new biotechnological 
processes mentioned in part A of the Annex, the 
competent authorities shall be required to bring the 
matter before either the Committee for Proprietary 
Medicinal Products or the Committee for Veterinary 
Medicinal Products, as appropriate, for an opinion. 
This requirement shall also apply for the other 
high-technology medicinal products listed in part B 
of the Annex, provided that the person responsible 
for placing the product on the market has expressly 
requested the competent authority concerned to 
refer the matter and has sent a copy of the request to 
the Committee concerned. 
2. Where the Committee has, in accordance with 
the provisions of this Directive, issued an opinion 
favourable to the placing on the market of a high-
technology medicinal product, the competent 
authorities shall bring the matter before the Com­
mittee for a new opinion before deciding on the sus­
pension or withdrawal of the marketing authoriza­
tion for the medicinal product in question. 
3. Questions relating to medicinal products for 
human use, including the medicinal products 
referred to in the second paragraph of Article 34 of 
Directive 75/319/EEC, shall be brought before the 
Committee for Proprietary Medicinal Products set 
up by that Directive. 
Questions relating to veterinary medicinal products, 
including those referred to in the second and third 
indents of Article 2 (2) of Directive 81/851/EEC 
shall be brought before the Committee for Veteri­
nary Medicinal Products set up by that Directive. 
Article 3 
1. The representative of the Member State which 
initiated the procedure referred to in Article 2 shall 
act as rapporteur throughout the procedure. In this 
capacity, he shall ensure that there is close liais.on 
between the Committee in question and the com­
petent authorities concerned and shall provide all 
information relevant to the evaluation of the medi­
cinal product. The information thus disclosed shall 
be strictly confidential. 
2. When placing the matter before the Committee, 
the Member State concerned must forward to it at 
least: 
— a summary of the product characteristics, as 
described in Article 4a of Directive 65/65/EEC, 
or an equivalent document provided by the 
applicant if a medicinal product referred to in 
the second paragraph of Directive 75/319/EEC 
or a veterinary medicinal product is involved, 
5. 11.84 Official Journal of the European Communities No C 293/3 
— a summary of the documents contained in the 
file on the marketing authorization for the medi­
cinal product in question. 
3. Where they exist, evaluation reports and drug-
monitoring reports relating to the same medicinal 
product shall be forwarded to the Committee by the 
authorities of the Member States which drew them 
up. 
4. The person responsible for placing the medi­
cinal product in question on the market shall 
immediately be informed of the referral to the Com­
mittee. He may, at his own request, provide the 
Committee with oral or written explanations and 
forward to it any documents that he judges to be rel­
evant. 
5. In order to speed up the examination of scien­
tific and technical questions, the Committee, in 
agreement with the Commission, may assign certain 
preparatory tasks to an ad hoc group of experts or to 
highly qualified outside consultants. The members 
of the Committee, the experts and the outside con­
sultants shall be obliged, even after their duties have 
ceased, not to disclose information which, by its 
nature, is covered by the obligation of professional 
secrecy. 
Article 4 
1. When the questions referred to it relate to an 
application for marketing authorization, the Com­
mittee shall issue its opinion 30 days before the 
expiry of the time limits provided for in Article 7 of 
Directive 65/65/EEC and Article 4 (c) of Directive 
75/319/EEC, or in Articles 8 and 9 (3) of Directive 
81/851/EEC, as appropriate. To this end, the Mem­
ber State which referred the matter shall inform the 
Committee without delay of any extension and of 
the beginning and end of any suspension of the time 
limits concerned. 
2. When a proposal to suspend or withdraw a mar­
keting authorization is referred to it, the Committee 
shall fix an appropriate time limit for issuing its rea­
soned opinion, having regard to the requirements 
for the protection of public health. However, in 
cases of urgency, the Member States may suspend 
the marketing authorization in question without waiting for the opinion of the Committee provided 
that they forthwith inform the Committee thereof, 
indicating the reasons for the suspension and justi­
fying the urgency of this measure. 
3. The opinion of the Committee, which shall be 
adopted by an absolute majority of the members 
present, shall concern the conditions under which 
the marketing authorization should be granted or 
the reasons for which that authorization may be 
refused, suspended or withdrawn. 
4. The Committee shall forthwith inform the Mem­
ber State concerned and the person responsible for 
placing the product on the market of its opinion 
and, if necessary, of any dissenting opinions 
expressed. 
5. The Member State concerned shall reach a deci­
sion on the action it intends to take following the 
Committee's opinion not later than 30 days after 
receipt of the information provided for in para­
graph 4. It shall forthwith inform the Committee of 
its decision. 
Article 5 
Subject to the application of other Community 
provisions, the Member States shall communicate to 
the Commission and delay the adoption of draft 
technical regulations relating to the production, 
marketing or use of the medicinal products referred 
to in Article 1 of this Directive, in accordance with 
the provisions of Articles 8 and 9 of Council Direc­
tive 83/189/EEC of 28 March 1983 laying down a 
procedure for the provision of information in the 
field of technical standards and regulations ('). 
Article 6 
Member States shall take the measures necessary to 
comply with this Directive no later than 1 July 
1985. They shall forthwith inform the Commission 
thereof. 
Article 7 
This Directive is addressed to the Member States. 
(') OJNoL109, 24. 4. 1983, p. 8. 
No C 293/4 Official Journal of the European Communities 5. 11. 84 
ANNEX 
LIST OF HIGH-TECHNOLOGY' MEDICINAL PRODUCTS 
A. Medicinal products developed by means of new biotechnological processes 
which make use of genetic recombination, hybridoma technology, aneuploid cell strains and 
enzyme bioreactors. 
For example: 
— new vaccines, particularly synthetic vaccines, 
— new antibiotics, 
— interferons, 
— immunotoxins, 
— hormones, particularly peptide hormones (human insulin; growth hormone), 
— monoclonal antibodies and DNA hybridization probes used in vivo, 
— enzymes such as urokinase, 
— blood proteins or substitutes thereof: alpha I, antitrypsin, human seralbumin, factor 
VIII, etc. 
B. Other high-technology medicinal products 
— Medicinal products administered by means of new delivery systems which constitute a 
major innovation: transcutaneous systems, encapsulation in liposomes or polymers, 
drug targeting systems, etc. 
— Medicinal products containing a new substance claimed to be of major therapeutic 
interest. 
— New medicinal products based on radioisotopes. 
— Medicinal products the manufacture of which is based upon an advanced technique 
such as two-dimensional electrophoresis under gravity or microgravity. 
Proposal for a Council Directive amending Directive 75/318/EEC on the approximation 
of the laws of Member States relating to analytical, pharmaco-toxicological and clinical 
standards and protocols in respect of the testing of proprietary medicinal products 
COM(84) 437final 
(Submitted by the Commission to the Council on 3 October 1984) 
(84/C 293/02) 
THE COUNCIL OF THE EUROPEAN Having regard to the opinion of the Economic and 
COMMUNITIES, Social Committee; 
Having regard to the Treaty establishing the Euro­
pean Economic Community, and in particular 
Article 100 thereof; 
Having regard to the proposal from the Commis­
sion; Whereas the testing of proprietary medicinal prod­
ucts must regularly be adapted to scientific and 
Having regard to the opinion of the European Par- technical progress in order to ensure optimum pro-
liament; tection of public health in the Community;