10 9 90 Official]ournalofthe European Communities ^oC^g^l 
Opinion on the proposal foraCouncil Directive concerning the legal status for the supply of 
medicinal products for human use ^^ 
^O^C^^ll^ 
On8Eebruaryl990 the Council decided to consult the Economic and Social Committee, under 
Article 100a of the Treaty establishing the European Economic Community, on the 
abovementioned proposal 
The Section for protection of the Environment, Public health and Consumer Affairs,v^hichv^as 
responsibleforprepanngtheCommittee^sworl^onthesub^ect,adopteditsopinionon^]unel990^ 
The rapporteur v^as^vir Colombo. 
At its ^8th plenary session ^meeting of^]uly 1990^ the Economic and Social Committee adopted 
the following opinion by 9^ votes tol^,with nine abstentions. 
1. Introduction 
1.1 The Committee notes that the Commission has 
draftedaproposal which tal^es as its base ^ahigh level of 
protection ... concerning health, safety, environmental 
protection and consumerprotection^asenvisagedmArticle 
lOOa^of the Treaty. 
1B^. The present proposal establishing harmonised 
conditions for the issue of medicinal products to patients is 
without doubtafurtherstep towards thecompletionofthe 
internal market 
The proposal is designed to eliminate differences in 
member States^legislation and implementing criteria for 
the supply of medicinal products to patients, and, in 
particular,medicmesnotsub^ectto medical prescription. It 
does not cover matters relatingtowhoe^actlyisauthon^ed 
to prescribe or distribute medicines. 
Plere the Committee suggests the insertion in the preamble 
ofanew recital to read as follows 
whereas the protection of public health requires that 
the dispensing of medicinal products should always be 
supervised by a professionally and legally qualified 
health specialist, given the potential risl^s of these 
products^indiscrnmnateuse,^ 
1.^. The Commission sets two basic preconditions for 
allowingamedicmal product to be sold over the counter 
^OTC^ 
— it is safe to use because its effects and tonicity are well 
l^nown, 
— it is used to treat minor ailments which are easily 
identifiable by theuseranddonotnistifyamedical 
consultation 
^oi^De^,^3^^,D^ 1mA Article^of the proposal lays down the cases where 
aprescnption must be supplied, listing eight possible nsl^ 
factors which mal^e medical control necessary. 
IBo. Among these, the nsl^ factor ^novelty of the active 
pnncipleM^o mentioned in Article^^is of particular 
importance. It is rightly felt thatanew chemical substance 
should not be supplied without prescription until adequate 
information about it is available. 
1.^. Article^of the proposal divides prescription drugs 
into four categories. Eor category ^ products, the 
prescription may be renewed durmgalimitedpenod^for 
category ^ products, the prescription may not be 
renewed^ and category^ covers products on special 
prescription ^containing a psychotropic or narcotic 
substances 
1.^. Category^d^ covers productson restricted prescript 
tion, reserved for use in hospitals or by certain specialists. 
Several^iember States already use this category,as the 
administration of complex or highnsl^ drugs call for 
specific controls by specialist bodies. 
^. Ceneral comments 
^.L On the relevant categories of medicinal products, 
the Committee would mal^e the following comments^ 
^. Some parts of Articled, which deals with prescript 
tion drugs, may prove difficult to interpret, and could be 
interpreted differently by individual member States. This 
No C 225/22 Official Journal of the European Communities 10. 9. 90 
would be at odds with the aims of the Directive, which 
seeks to group products together uniformly. 
2.3. The Committee considers that OTC medicinal 
products perform a practical social function. This being the 
case, the formulation of a single Commmunity-wide 
criterion for defining OTC medicines is to be welcomed. 
2.4. The Committee is concerned at the frequent 
references to decisions to be taken by 'competent 
authorities' at Community level, when there is no 
definition of these authorities (*). 
2.5. In conclusion, the structure of the Directive can be 
endorsed as providing useful clarification for national 
authorities which authorize drugs for marketing. 
2.6. However, the Committee stresses the need for close 
links between the Directives concerning medicinal products 
currently under preparation and, more particularly, with 
the other Directives scheduled in the Commission's 1990 
work programme. 
3. Comments on the individual Articles 
3.1. Article 1 (2) 
The differing situations in the Member States as regards the 
right to prescribe medicinal products could create problems 
here. The Committee therefore asks that efforts be made 
with reasonable speed as warranted by the present 
situation, to clarify and harmonize such rights. 
The Committee also proposes the addition of a third 
indent, to read as follows: 
'— 'Pharmaceutical activity': any act of dispensing 
medicinal products, in accordance with the require­
ments of the legislation of each Member State'. 
3.2. Article 2 
Article 2 (a) and (b) 
While endorsing the aims of this Article, the Committee 
feels that the formula proposed by the Commission could 
prove difficult to implement in practice. A simpler solution 
might be to merge paragraphs (a) and (b), and make a more 
(!) The nature and scope of the competent institutional body have 
still to be determined at Community level. clear-cut division between renewable and non-renewable 
prescriptions. 
However, such a solution is complicated by the existence of 
the Council of Europe lists. 
Article 2 (c) 
Replace 'medicinal products on special prescription' by 
'medicinal products containing a quantity exceeding a 
specific level of a substance classified as a psychotropic ...'. 
3.3. Article 3 
Article 3 (2) 
A clear scientific definition must be given of the term 'new 
chemical entity', to be understood as a new chemical and/ 
or biological entity. 
Article 3 (3) 
The annual list should highlight any medicines being 
transferred from one category to another. 
New paragraph 5 (3) 
A further point should be added to this Article, to read as 
follows: 
'5. Should the legal status for the supply of a medicine 
be determined or altered independently of the 
marketing authorization procedure or its renewal 
every five years, the competent authorities in the 
Member States shall substantiate and publish 
decisions taken on the basis of Article 2 or the 
present Article. Procedures for appeal against such 
decisions shall be established and brought to the 
attention of the persons authorized to market the 
product. 
This procedure is designed to ensure the fullest 
possible information and prior consultation among 
the organizations representing the various interests 
concerned, thereby guaranteeing that it is based on 
sound scientific premises and takes account of 
prevailing social conditions.' 
3.4. Article 4 
Article 4 (1) 
The term 'indirect risk' to human health needs further 
clarification. Moreover, the criteria need to be spelt out in 
10. 9. 90 Official Journal of the European Communities No C 225/23 
more detail to stop Member States interpreting the words 
'safety in use' differently (as they do at present). 
Article 4 (1) (a) 
The term 'preclinical' should be deleted as it is impossible 
at that stage to determine the risks to human health. 
Article 4 (2) 
In order to put the two categories of medicines on a more 
equal footing, the Committee suggests that Article 4 (2) 
form a separate Article: 'Article 5 
Medicinal products which ... a medicinal consultation.' 
The remaining Articles should be renumbered accordingly. 
Done at Brussels, 4 July 1990. 
The Chairman 
of the Economic and Social Committee 
Alberto MASPRONE 
APPENDIX / 
The following amendments were rejected during the debates, but received at least 25 % of the votes cast. 
Point 1.2 — third paragraph 
Delete from 'Here the Committee ...' to the end of the suggested recital. 
Voting 
For: 28; against: 78; abstentions: 8. 
Point 3.1 — Article 1 (2) 
Delete the second paragraph: 'The Committee ... of each Member State'. 
Voting 
For: 28; against: 73; abstentions: 14. 
No C 225/24 Official Journal of the European Communities 10. 9. 90 
APPENDIX II 
The following Members, present or represented, voted in favour of the opinion: 
ALEXOPOULOS, ARENA, ARETS, ATAlDE FERREIRA, BAGLIANO, BERGER, BERNASCONI, BERNS, 
BERTON, BLESER, BODDY, BOISSEREE, BORDES-PAGES, BOS, BREDIMA SAVOPOULOU, BROIC-
HER, Vasco CAL, CALVET CHAMBON, CHRISTIE, COLLAS, COLOMBO, ALVES CONDE, CORELL 
AYORA, CORTOIS, COYLE, van DAM, DECAILLON, DELLA CROCE, VAN DIJK, DOS SANTOS, 
ELSTNER, ETTY, EULEN, FORGAS, FRANDI, GARDNER, GAYETOT, GREDAL, GREEN, HAAS, 
HAGEN, HILKENS, HOUTHUYS, JASCHICK, JENKINS, JESUS SEQUEIRA, KAARIS, KENNA, 
KIRCHFELD, de KNEGT, KROGER, LAPP AS, LARSEN, LIVERANI, LOW, LUCHETTI, MACHADO 
VON TSCHUSI, MADDOCKS, MAINETTI, MANTOVANI, MARGOT, MATTEOLI, MAYAYO BELLO, 
MEYER HORN, MORSELLI, MOURGUES, NIELSEN P., NIERHAUS, NOORDWAL, de NORMANN, 
PARDON, PEARSON, PELLETIER R., PERRIN-PELLETIER, PETERSEN, PROUMENS, QUEVEDO 
ROJO, RANGONI-MACHIAVELLI, RIBIERE, ROBINSON, ROLAO GONgALVES, ROUZIER, 
SALMON, SANTILLAN CABEZA, SCHADE-POULSEN, SCHNITKER, SCHOEPGES, SCHWEITZER, 
SMITH A.R., SMITH L.J., TELLES, TIEMANN, TIXIER, TUKKER, VIDAL, YVERNEAU. 
The following Members, present or represented, voted against the opinion: 
ASPINALL, BEALE, BENTO GONCALVES, FLUM, FRESI, LUSTENHOUWER, MORELAND, MUHR, 
STORIE-PUGH, STRAUSS, TAMLIN, WILLIAMS. 
The following Members, present or represented, abstained: 
CAMPBELL, CEYRAC, DODD, van EEKERT, HOVGAARD JAKOBSEN, NIEUWENHUIZE, PET-
ROPOULOS, VANDEN BROUCKE, WAGNER. 
Opinion on the proposal for a Council Directive on the labelling of medicinal products for human 
use and on package leaflets (*) 
(90/C 225/11) 
On 8 February 1990 the Council decided to consult the Economic and Social Committee, under 
Article 100a of the Treaty establishing the European Economic Community, on the 
abovementioned proposal. 
The Section for Protection of the Environment, Public Health and Consumer Affairs, which was 
responsible for preparing the Committee's work on the subject, adopted its opinion on 5 June 1990. 
The rapporteur was Mr Hilkens. 
At its 278th plenary session (meeting of 4 July 1990), the Economic and Social Committee adopted 
the following opinion by a majority vote, with 10 abstentions. 
The Committee approves the draft Directive subject to the 
following comments. 
1. Introduction 
1.1. It should be pointed out that the Commission's 
proposal to provide the consumer with more complete and 
comprehensible information by means of labelling and 
leaflets is required by Article 100a (3), which states that 
'The Commission in its proposals ... concerning health, 
safety, environmental protection and consumer protection, 
0) OJ No C 58, 8. 3. 1990, p. 21. will take as a base a high level of protection.' The 
Committee is pleased to note that the Commission studied 
this question when drafting its proposal. 
1.2. The Committee notes that the Commission pro­
posal is to be seen in the context of the completion of the 
internal market. For both public health and economic 
reasons a higher degree of regulation is undoubtedly 
required in the medicinal products market than in many 
other sectors of the economy. This applies particularly to 
information for patients with regard to pharmaceutical 
products. 
1.3. The Commission proposal follows on from Direct­
ives 65/65/EEC and 75/319/EEC and the amendments