Classification for the supply of medicinal products for human use - Commission report to the Council on the application of Directive 92/26/EEC
Date: 1997-11-14
Institutions: European Commission
Subjects: consumer protection, drugs classification, health policy, medicinal product, single market

COMMISSION OF THE EUROPEAN  COMMUNITIES 

Brussels,  14.11.1997 
COM(97) 581 final 

Classification for the supply of medicinal products for human use 

Commission Report to the Council on the application of Directive 
92/26/EEC 

Classification for the supply of medicinal products for human use 

Commission Report to the Council on the application of Directive 
92/26/EEC 

1. Introduction 
The  1985 White  Paper  identified  the  harmonisation  of  conditions  for  the  supply  of 
medicinal  products  to patients,  as being  necessary  for  the completion  of  the  internal 
market  in  the  pharmaceutical  sector.  In  this  context  Directive  92/26/EEC  was 
proposed  by  the  Commission  in  1989  and  adopted  by  the  Council  in  March  1992. 
During the discussions which took place prior to its adoption, it was recognised that a 
progressive approach would be required  to clearly  identify  the fundamental  principles 
which  should  govern  the role  of  the  Community  in  this  area,  while  recognising  that 
the legislation would need to be refined  and developed over time. 

To enable account  to be taken of the progress  achieved  following  its  implementation 
and to provide a means for refining  and developing  the legislation, Article 6 provides 
for a report (accompanied  if necessary by appropriate proposals) on the application of 
this Directive, within 4 years of its adoption, (i.e. by March 1996). 

The deadline for its implementation by the Member States was 1 January  1993 but this 
was  delayed  in  many  Member  States  such  that  its  implementation  was  spread  from 
December  1992  through  to  December  1994.  Consequently,  this  report  was  also 
delayed. 

In  1994, in preparation for this report, Informations  Médicales Statistiques S.A.  (IMS) 
were contracted  to carry  out  a study  which  would  analyse the degree of  convergence 
of national decisions  following  the implementation  of the Directive  on the one  hand, 
and  on  the  other  hand,  the  analysis  of  the  persistent  obstacles  which  go  against  the 
adoption  of  coherent  decisions  and  thus  hinder  the  proper  functioning  of  the  single 
market. 

1 Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of 
medicinal products for human use, O.J. L 113,30.4.1992 p.S 

2. Application of Directive 92/26/EEC 
The  Directive's  implementation  into  national  law  has  been  carried  out  by  all  the 
Member  States. They all use the classification  system  set  out  in the  Directive  which 
consists  of  two  main  categories,  non-prescription  and  prescription-only.  However 
within each of these main categories there are optional sub-categories which vary  from 
one Member State to the next. 

Non prescription medicines 
The  notion  of  non-prescription  medicines  is  univocal.  Within  this  category  certain 
Member  States  have  created  the  sub-category  of  medicinal  products  for  self-
medication.  However,  certain  Member  States,  (for  example  Austria),  do  not 
acknowledge the notion of  self-medication. 

The  Directive  is  silent  with  regard  to  the  outlets  through  which  non-prescription 
medicines  are available.  Finland,  Austria,  Denmark,  Germany,  Ireland,  Sweden  and 
The  U.K.  distinguish  between  the  outlets:  i.e.  availability  for  general  sale  and  the 
availability  in  pharmacies  only.  Availability  for  general  sale,  only  relates  to  certain 
non-prescription  medicines. In The  Netherlands  there  are  two  outlets  for  the  sale  of 
non-prescription  medicines:  pharmacies  and  authorised  druggists. In  the  other  seven 
Member States ^all medicines are available only in pharmacies. 

There  is  nothing  to  prevent  any  medicinal  product  which  is  non-prescription  from 
being prescribed, although it may not necessarily be reimbursed. 

Prescription-only medicines 
The notion of prescription medicines is also univocal. Nevertheless, differences  can be 
noted when considering the prescriber's right to prescribe all or only certain  medicinal 
products. The  criteria  applicable  to  this  classification  have been  implemented  in  all 
Member States. 

The  sub-categories  for  prescription-only  medicines  in  Article  2(2)  are  optional.  The 
Directive  provides  that  -  'The  competent  authorities  may  fix  sub-categories  for 
medicinal products which are available on medical prescription only.  In that case, 
they shall refer to the following classification: 

(a) medicinal products on renewable or non-renewable prescription 
(b) medicinal products subject to special medical prescription 
(c) medicinal products on restricted medical prescription reserved for  use in 

certain specialised areas'. 

Implementation  of  these  sub-categories  has  only  been  carried  out  only  to  the  extent 
that it was deemed necessary in terms of national health services or the rational use of 
medicines. The  nature  of  the  State  funded  health  services  in  certain  Member  States 
has  significantly  influenced  the  implementation  of  the  first  sub-category.  In  this 
context,  certain  medicinal  products  have  been  subjected  to  a renewable  prescription 
;i'  . iikation which enables the pharmacist  to repeat the supply  of certain  prescribed 
medicines.  When  the  implementation  is  examined  in  relation  to  the  national 
regulations  in  force  and  their  interpretation  through  national  practices,  it  becomes 
evident that the situation  in each Member  State differs  for these optional parts  of  the 
Directive :-

(France, Spain, Italy, Greece, Portugal, Belgium & Luxembourg) 

-  All  Member  States  have  legislative  provisions  for  making  certain  medicinal 
products available only on * special medical prescription'; within the meaning of the 
second sub-category, at least with regard to psychotropic substances. 

-  Eleven Member States3 have implemented the 'renewable' sub-category; Germany, 

U.K, The Netherlands and Portugal have not. 

-  Eleven  Member  States^ have  implemented  the  third sub-category  of  €restricted'; 

Austria, Sweden, The Netherlands and The U.K. have not. 

So  far,  the  operation  of  the  centralised  Community  procedure  (Council  Regulation 
2309/93)  has  not  brought  about  the  implementation  of  these  sub-categories  in  all 
Member States. 

National lists 
Articles 5(1) and 6(1) provide for these lists:-

Article  5(1)  -  "The  competent authorities  shall  draw  up  a  list  of  the medicinal 
products subject on their territory to medical prescription,  specifying, 
if necessary, the category of classification.  They shall update this list 
annually. ' 

Article 6(1) - 'Within two years of adoption of this Directive, the Member States shall 
communicate  the list referred to in Article 5(1) to the Commission and 
to the other Member States, when requested by the latter' 

These lists do not exist in all the Member States. Substance lists or lists of exemption 
according to pharmaceutical form or dosage are used in certain countries even if they 
do not correspond to the same end. However the majority of the 15 Member States (in 
accordance  with  Articles  5(1)  and  6(1))  have  sent  lists,  to  the  Commission,  of 
medicinal  products which  are prescription-only  medicines.  Although  such lists  have 
been  sent,  the  presentation  format  is  not  necessarily  analogous  and  does  not 
necessarily contain the same rubrics. 

As  outlined  in the paragraph entitled  'Annual Lists' on page  8,  the  format  for  these 
lists  needs  to be  standardised  and they  could  be  used  to draw  up a list  of  products 
restricted to prescription-only throughout the Community. 

3. Non-prescription/Self-medication 
Following a long historical period during which the evolution of professional  medical 
services  sometimes  appeared to be rendering  self-medication  superfluous,  at least  in 
developed  countries,  there  is  now  a  growing  trend  towards  self-medication. 
Recognition of the responsibility of the individual for his or her own health, and of the 
fact  that  recourse  to  medical  care  for  minor  ailments  is  often  unnecessary,  has 
contributed  to  this  development.  More  recently,  the  actions  of  governments 
everywhere to curtail the costs of state-funded treatment is seen as a factor which may 
result in increased self-medication. 

The Commission  in  its  Communication  on the  framework  for  action  in the  field  of 
public  health,  published  in  November  1993,  states  that  this  trend  towards  self-
medication must be accompanied by a strengthening of information measures, if  it is 
not to have an adverse effect on people's health. It considers further that giving people 
more choice  and responsibility  must also  involve  ensuring  that they  are equipped to 
make sensible choices. 

3 (Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Spain, Sweden) 
4 (Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Spain,) 
3 

For  the  medicinal  products  switched  from  prescription-only  to  non-prescription  (i.e. 
for  self-medication)  the  provision  of  patient  information  is  particularly  important. 
Council Directive 92/27/EEC5 requires "the use of clear and understandable terms  for 
the  patient  which  are  legible  and  which  are  in  the  official  language  of  the  Member 
State  where  the  product  is  placed  on  the  market".  Furthermore  the  Commission  has 
recently drafted  guidelines, (as provided  for  in article  12 of Directive 92/27/EEC), on 
the readability and excipients in the label and package leaflet. 

The  Communication  also  states  that  self-medication  is  of  particular  benefit  in  the 
treatment of minor ailments.  It emphasises that the public must be made aware of the 
need  to  consult  a  doctor  if  symptoms  persist  or  doubts  exist.  It  outlines  how,  after 
initial  diagnosis  and  prescription,  self-medication  becomes  possible  with  the  doctor 
delegating  control  while  retaining  an  advisory  role.  The  Communication  considers 
that  information  in  all  these  cases  must  be  easily  accessible  and  understandable  and 
that  both  pharmacists  and  doctors  have  an  important  role  to  play  as  far  as  self-
medication is concerned. 

•  There  is  still  considerable  variation  throughout  the EU  as  to  the  non-prescription 
status  of  many  medicinal  products,  with  the  result  that  some  medicines  are 
prescription-only  in  one  Member  State  and  available  without  prescription  in 
another Member State. Directive 92/26/EEC clearly states the criteria to be used to 
classify  a medicinal product  within  the  non-prescription  class. These criteria make 
clear that a prescription shall only be necessary if the product: 
•  Is likely to present a danger if used without medical supervision; 
•  Is frequently,  and to a wide extent, incorrectly used; 
•  may cause an action or a side effect  which needs to be investigated; 
•  Is normally prescribed by a doctor to be administered parenterally. 

These criteria were expected  to bring the classification,  of medicinal products, in the 
Member States closer to each other. This expectation was reinforced  by the obligation 
on  national  authorities  to  examine,  as  appropriate,  the  classification  of  a  medicinal 
product at least on the occasion of the five-year  renewal of the marketing authorisation 
(as  required  by  Article  5(2)  of  Directive  92/26/EEC).  This  examination  of  the 
classification,  by the competent authorities on the occasion of the five-yearly  renewal, 
is usually provoked by proposals made by the marketing authorisation holder. In some 
Member States the marketing authorisation  holders are cautious about switching legal 
status  from  prescription-only  to  non-prescription  because  of  the  possibility  that  the 
medicinal  product  concerned  will  lose  its  reimbursement  status  in  the  State  funded 
health service. 

Differences,  between Member States, in the classification  of medicinal products have 
decreased since the adoption of Directive 92/26/EEC. However, it is generally felt that 
the level of harmonisation  achieved is not yet satisfactory. This may be due to the  fact 
that Member States have been late in implementing this Directive, but it also probably 
reflects more fundamental  differences  in their approaches to  self-medication. 

4. Switching legal status 
At present each Member State has different  procedures for considering the switch of a 
medicinal product from prescription-only to non-prescription. 

5Council Directive 92/27/EEC on the labelling of medicinal products for human use and on package 
leaflets of 31 March  1992, O.J. No. L  113  30. 4.  1992  p.8 

4 

Following  the  adoption  of  the  Directive  92/26/EEC,  efforts  have  been  made  at 
national  level  to  improve  the  procedures  for  change  of  the  legal  status  from 
prescription to non-prescription, (i.e.  switching). In several Member States, however, 
the  impact  of  this  Directive  has  been  minor.  In  these  Member  States,  neither  the 
authorities  nor the  marketing  authorisation  holders  changed  their previous  practices 
significantly, therefore there has been hardly any change with regard to the legal status 
of the medicinal products. As mentioned already, the risk of losing reimbursement by 
the  State  funded  health  service  is  frequently  a  factor  which  discourages  marketing 
authorisation  holders  from  applying  to  switch  legal  status  from  prescription-only  to 
non-prescription. 

On  the  28  March  1996,  the  Council  of  Ministers  adopted  a  'Council  Resolution 
designed  to  implement  the  outlines  of  an  industrial  policy  for  the  pharmaceutical 
sector in the European Union'6. This Resolution states that it would be appropriate to 
tighten the common classification  system  in  Directive  92/26/EEC,  so that there is  a 
clearer distinction between prescription and non-prescription medicinal products. 

The  European  Parliament  adopted  a  resolution  on  industrial  policy  for  the 
pharmaceutical  sector on  16 April  19967. It calls for the establishment of transparent 
procedures  which  define  the  method  by  which  prescription  medicines  can  be 
transferred (i.e. switched) to non-prescription status. 

Therefore to move forward with EU harmonisation of medicinal products restricted to 
prescription-only  and of  medicinal  products  available without prescription,  it is now 
necessary  to  establish  criteria  and  procedures  for  switching  prescription-only 
medicinal  products  to  supply  without  a prescription.  These  criteria  and procedures 
should  take  the  form  of  a  Commission  guideline  (to  be  approved  by  the 
Pharmaceutical  Committee).  Within  the  framework  of  the criteria already  set  out in 
the  Directive  for  non-prescription  and  prescription-only  medicines,  the  guideline 
would outline the supporting  scientific  data required to demonstrate that the product 
(at a specified  dosage and for specific  indications)  may safely  be supplied without a 
prescription  and  thus  be  available  for  self-medication.  The  guideline  would  also 
outline the administrative procedures and timetables which would apply. 

Some  Member  States  (e.g.  Portugal  and  Spain)  require  the  name  of  the  medicinal 
product  to  be  changed  when  a  product,  which  was  previously  prescription-only, 
becomes  available  without  a  prescription.  It  appears  that  this  requirement  is  not 
entirely based on safety, quality or efficacy  considerations but is sometimes linked to 
concerns that advertising of a non-prescription medicine which has the same name as 
a prescription medicine may increase the prescribing of the prescription-only product 
and  this  impacts  on  the  state  funded  health  service.  Data  available,  so  far,  from 
industry, does not support this concern 

5. Prescription-only  medicines 
Article  3 of Directive  92/26/EEC  sets  out the criteria for restricting  the  supply/legal 
status of  a medicinal  product  to prescription-only.  A  medicinal  product classified  as 
prescription-only  may be  available  on  prescription,  without  further  restriction,  or it 
may be available on prescription with further restriction, as provided for by the sub 
categories for prescription-only (in Article 2(2)). 

The three sub-categories:-

6 O.J. C 136 8 May  1996 p.4 
7O J . C 1 41  13 May  1996 p.63 

"medicinal products on renewable or non-renewable medical prescription" 
"medicinal products subject to special medical prescription" 
"medicinal products  on  restricted medical prescription,  reserved for  use  in  certain 
specialised areas", 
are  optional  and  this  means  that  whatever  the  level  of  harmonisation  achieved  for 
prescription-only  products  this  will  be  limited  by  the  extent  to  which  the  sub 
categories  are  used.  However  all  of  the  Member  States  have  legal  provisions  which 
give effect  to the second sub-category  "medicinal products subject to special medical 
prescription", at least with regard to psychotropic substances. 

The  third  sub-category,  "medicinal products  on  restricted  medical  prescription, 
reserved for  use  in  certain  specialised  areas",  must  remain  optional,  at  present, 
because  four  Member  States (Austria, The Netherlands  Sweden  and The UK)  do  not 
use  it.  However,  for  medicinal  products  authorised  by  the  Community,  in  line  with 
article  13.3 of Council  Regulation No. 2309/93  %, which  states: "Some products may 
be  authorised  only  for  use  in  hospitals  or  for  prescription  by  some  specialists",  the 
following  interpretations are used:-

use in hospital/use in certain specialised areas, may be taken to include use within a 
framework  providing hospital-type care; 
prescription  by  some  specialists/restricted  medical  prescription,  may  be  taken  to 
include:-  that  the  prescription,  or  the  initial  prescription  only  must  be  by  a 
specialist. 

The  designation  of  the  specialist  shall  take  into  account  the  progress  made  under 
Directive  93/16/EEC9  in  harmonising  Member  States'  terminology  for  medical 
specialists. 

The  first  sub-category,  "medicinal products  on  renewable/non-renewable medical 
prescription",  must  also  remain  optional,  at  present,  because  four  Member  States 
(Germany,  The Netherlands,  Portugal  and  The  U.K.)  do  not  have  this  sub-category; 
although  in  The  U.K.  there  is  the  possibility  to  repeat  the  supply,(for  prescriptions 
issued  outside  the  scope  of  the  State  funded  health  service).  This  sub-category  has 
different  interpretations  in the Member  States who have  it, as illustrated  in  the  table 
overleaf. 

8 Council Regulation No. (EEC) 2309/93 of 22 July  1993 laying down Community procedures for the 
authorisation and supervision of medicinal products for human and veterinary use and establishing a 
European Agency for the Evaluation of Medicinal Products, O.J. No. L 214  24. 8. 1993  p.l 
9  Council Directive 93/16/EEC of 5 April  1993 to facilitate the free movement of doctors and the 
mutual recognition of their diplomas, certificates  and other evidence of formal  qualifications, O.J. L 
165 of 7.7.1993  p.l 

Member States5 interpretations of the sub-category  renewable/non-renewable 

Renewable10 

Non-renewable 

On the basis of one medical 
prescription the supply of the 
quantity prescribed may be 
repeated, unless the prescriber 
has specified  to the contrary on 
the prescription. 

On the basis of one medical 
prescription the supply of the 
quantity prescribed may only be 
repeated for the number of 
times/over the period of time 
specified by the prescriber on the 
prescription. 

On the basis of one medical 
prescription the supply of the 
quantity prescribed may not 
be repeated unless the 
prescriber has specified to the 
contrary. 

On the basis of one medical 
prescription the supply of the total 
quantity prescribed may not be 
repeated. 

Austria 

France 

Ireland 

Italy11 

Belgium 

Denmark 

Finland 

Greece 

Luxembourg 

Spain 

Sweden 

U.K. 

Austria 

France 

Ireland 

Sweden 

Belgium 

Denmark 

Italy 

Luxembourg 

Spain 

Portugal 

Greece 

10 In Portugal renewable prescription is provided for by the legislation but has not yet been put into operation 
1 '  In Italy prescriptions do not include any statement concerning renewable or non-renewable 

+> 

6- Annual Lists 
According to Articles  5 and 6 of Directive 92/26/EEC, each Member  State is obliged 
to  provide,  annually,  a  list  of  the  medicinal  products  which  they  have  classified  as 
prescription-only.  These  lists  should  be  used  to  draw  up,  in  consultation  with  the 
Pharmaceutical  Committee,  a  Community  list  of  medicinal  products  which  are 
restricted to prescription-only  throughout the Community. This Community list could 
then,  in consultation  with the Pharmaceutical  Committee, be revised  annually,  in the 
light of the lists submitted annually by the Member States. There should be a standard 
format  to  be  followed  by  Member  States  when  submitting  these  annual  lists  of 
medicinal  products  which  are  restricted  to  prescription-only.  The  Commission  will 
draw  up  a  guideline  for  the  presentation  and  submission  of these  lists,  by  telematic 
means. 

7. The centralised procedure for a Community marketing  authorisations 
The  Community  decision  (in  accordance  with  Council  Regulation  2309/93) 
concerning  the  marketing  authorisation  for  a  medicinal  product  contains:  the  legal 
status  in  Annex  2,  the  label  text  in  Annex  3  and  the  summary  of  product 
characteristics in Annex 1. 

For  a medicinal  product  authorised  by  the  Community  the  legal  status  is  elaborated 
having regard to this Directive (which is invoked in Council Regulation No. 2309/93) 
and to article  13.3 of Council Regulation No.  2309/93. The legal status thus elaborated 
forms part of the Commission Decision. Due to the disharmony  amongst the Member 
States  in their national provisions  for  legal  status  (in particular  for the  sub-categories 
of  prescription-only  medicines)  the  expression  of  the  legal  status,  for  restricting  the 
supply  of  a medicinal  product  authorised  by the  Community,  in the  label  text  in the 
Commission Decision  (and thus on the label  of medicinal products authorised  by the 
Community)  is  limited  at  present  to  the  main  category  in  Article  2(1)  of  Directive 
92/26/EEC, i.e. prescription-only. 

It would make the Commission decision more transparent if, the additional restrictions 
to  supply,  beyond  prescription-only,  which  appear  in  annex  2  of  the  decision  but 
which  do not appear  on the Community  label text  (in annex 3), were included  in the 
summary  of  product  characteristics  (viz.  Directive  65/65/EEC12  article  4a  (5.4)  as 
introduced by Directive 83/570/EEC13). 

Nevertheless  Member  States  have  to  find  suitable  ways  to  allow  the  marketing 
authorisation holder of a centrally authorised product to fulfil  all of the conditions laid 
down  in the Commission  Decision  granting the marketing  authorisation.  Thus,  when 
the  legal  status  in  the  Commission  Decision  includes  one  of  the  optional  sub 
categories, then the Member  States who have not implemented this sub-category  must 
provide  an administrative,  legal  or practical  framework  that will  allow the  marketing 
authorisation  holder  to  put  the  medicinal  product(s)  (concerned  by this  Decision)  on 
their  market  under  the  specific  condition(s)  provided  for  by  the  legal  status  in  the 
Decision. 

In accordance  with article  5.2  of Directive  92/27/EEC14, Member  States may  require 
the legal status for supply to the patient, (in accordance with Directive 92/26/EEC), to 

12 Council 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, O.J. L 22 of 9.2.1965  p.369/65 

13 Council Directive 83/570/EEC of 26 October  1983 amending Directives 65/65/EEC, 75/318/EEC 
and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative 
action relating to proprietary medicinal products, O.J. L 332 of 28.11.83 p. 
14 Council Directive 92/27/EEC of 31 March  1992 on the labelling of medicinal products for human 
use and on package leaflets, O.J. L 113 of 30.4.1992 p.8 

8 

appear  on  the  label.  So,  for  a  medicinal  product  authorised  by  the  Community,  a 
Member State may require further  information  concerning the legal status, in addition 
to the main category, to appear on the label; e.g. mention of the sub-categories, where 
relevant.  Any  further  information  concerning  the  legal  status  must  be  in  accordance 
with annex 2 of the decision. 

Subject  to  approval  by  the  Community  competent  authority  which  is  normally  the 
European Commission, this further  information  is to be accommodated on the label in 
a boxed area ("blue box') which is used for other optional  labelling items, not relevant 
to all Member States. 

8. The mutual recognition procedures for national marketing  authorisations 
Council  Directive  75/319/EEC  provides  that  an  application  can  be  made  for  the 
mutual  recognition  of national  marketing  authorisations  and Articles  10,11,12,13 and 
14  of  this  Directive  provide  a  means  for  harmonisation  (including  arbitration  if 
necessary)  at  Community  level  of  national  marketing  authorisations  leading  to  a 
Community Decision. To date the legal status of the medicinal product concerned  has 
not been included, however, there seems to be no legislative obstacle to doing so. 

The exclusion of legal status from  the mutual recognition  procedures  is due firstly  to 
the fact that the sub-categories for prescription-only  are optional in the Member  States 
and  secondly,  these  optional  sub-categories  for  prescription-only  are  sometimes 
interpreted differently  in each Member State, due to the absence of clear definitions. 

The  proposals  concerning  guidelines  for  switching,  could,  given  time,  facilitate  the 
inclusion of legal status in the mutual recognition procedures. 

9. General Conclusions and Proposals 
The  implementation  of  Directive  92/26/EEC  was  spread  from  December  1992  to 
December  1994.  These  delays  in  implementation,  together  with  the  fact  that  the 
optional  parts  of  the  Directive  were  not  implemented  in  all  Member  States,  account 
for some of the non-convergence which still exists. 

Although  individual  market  profiles  have  changed  in  the  period  1992-95, the  effect 
has been relatively small in overall terms and further  initiatives should be considered:-
EU harmonisation of medicinal products restricted to prescription-only 
and 
EU  harmonisation  of  medicinal  products  available  without  prescription  i.e.  for  self-
medication. 

National  procedures  need  to  be  adapted  and  aligned  with  the  Directive's  overall 
strategy,  which  is  to  provide  uniform  criteria  for  the  supply  of  medicinal  products 
throughout the Community. 

The optional  nature of the sub-categories, for  prescription-only  medicines  need  to be 
addressed. The interpretation of these sub-categories also needs to be harmonised. 

The Directive's provision  for  monitoring  harmonisation,  which  is the Member  State's 
lists of medicinal products restricted to prescription-only, should be retained  and used 
to  draw  up  a  Community  list  of  prescription-only  medicines.  The  Commission  will 
provide  guidance  on  the  presentation  and  submission  of  these  lists  by  telematic 
means.  As  part  of  the  inevitable  ongoing  review  of  the  guidelines  on  switching,  it 
would  also  be  useful  if  Member  States  were  to  draw  up  similar  lists  for  non 
prescription  products which could  then be used to draw up a Community  list  of non-

15 Council Directive 75/319/EEC of 20 May  1975 on the approximation of provisions laid down by 
law, regulation or administrative action relating to medicinal products, O.J.No. L 147  9. 6.  1975 p. 13 

prescription  products.  As  a  first  step  towards  achieving  this,  it  is  proposed  that  the 
Commission  draw up guidelines to improve the comparability  of the Member  States' 
lists and thus within four years this should allow a Community list of non-prescription 
medicinal products to be drawn up. 

Article  71 of Council  Regulation  2309/93  provides  for  a general report  (in 2001)  on 
the  experience  acquired  as  a  result  of  the  operation  of  the  centralised  and  mutual 
recognition  procedures.  In  view  of  the  anticipated  progress  towards  harmonisation 
(e.g. the development of 'switching' guidelines), it is reasonable to expect that within 
four  years (i.e. by 2001) it should be possible to include legal status for all  medicinal 
products in the mutual recognition procedures. 

This report could be updated at the time of publication of the general report (in 2001), 
referred  to above, so that the progress towards the harmonisation of the legal status of 
medicinal products throughout the Community could continue to be monitored. 

10 

ISSN 0254-1475 

COM(97) 581 final 

DOCUMENTS 

EN 

05  15  17 

Catalogue number  :  CB-C0-97-599-EN-C 

ISBN 92-78-27385-6 

Office  for Official  Publications of the European Communities 

L-2985 Luxembourg 

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