Communication from the Commission - Commission Communication on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted
Date: 2003-12-30
Institutions: European Commission
Subjects: common commercial policy, free movement of goods, import, market approval, medicinal product, pharmaceutical product

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 30.12.2003
COM(2003) 839 final

COMMUNICATION FROM THE COMMISSION

Commission Communication on parallel imports of proprietary medicinal products for
which marketing authorisations have already been granted

EN

  EN

TABLE OF CONTENTS

1.

2.

3.

4.

5.

5.1.

5.2.

5.3.

5.4.

5.5.

5.6.

6.

Summary ...................................................................................................................... 3

Introduction .................................................................................................................. 4

Parallel imports and free movement of goods.............................................................. 6

Protection of human health and life - marketing authorisations .................................. 7

Protection and exhaustion of industrial and commercial property rights................... 10

Protection of trade marks and repackaging................................................................ 11

Artificial partitioning of the Internal Market ............................................................. 13

Adverse effects on the original condition of the product ........................................... 14

Indication on who repackaged and manufactured the product................................... 14

Presentation of the repackaged product ..................................................................... 15

Prior notice to the proprietor of the trade mark.......................................................... 15

Authorisation at Community level ............................................................................. 16

Conclusions ................................................................................................................ 17

ANNEX...................................................................................................................... 19

2

 
Summary

This  communication  updates  the  1982  Commission  Communication  on  the  same  subject
and aims at giving some guidance on the practical application of the jurisprudence of the
European  Court  of  Justice  to  national  measures  relating  to  parallel  imports,  from  one
Member  State  to  another,  of  proprietary  medicinal  products  for  which  marketing
authorisations have already been granted in the Member State of destination.

Parallel importation of a medicinal product is a lawful form of trade within the Internal
Market based on article 28 of the EC Treaty and subject to the derogations regarding the
protection  of  human  health  and  life  and  the  protection  of  industrial  and  commercial
property, provided by article 30 of the EC Treaty.

When  the  information  necessary  for  the  purposes  of  protecting  public  health  is  already
available to the competent authorities of the Member State of destination as a result of the
first marketing of a product in this Member State, a parallel imported medicinal product
is  subject  to  a  licence  granted  on  the  basis  of  a  proportionally  "simplified"  procedure
(compared to marketing authorisation procedure) provided:

(cid:1)  the imported product has been granted a marketing authorisation in the Member State

of origin;

(cid:1)  the  imported  product  is  essentially  similar  to  a  product  that  has  already  received

marketing authorisation in the Member State of destination;

Parallel  importation  of  a  medicinal  product  is  still  possible  even  when  the  reference
authorisation  has  been  withdrawn  and  the  parallel  imports  licence  may  not  be  revoked
unless such a measure is justified by reasons relating to the protection of public health.

Regarding  industrial  and  commercial  property  rights  protected  by  Member  State
legislation, that legislation may not be used to oppose the importation of a product which
has been lawfully placed on the market in another Member State by, or with the consent
of, the proprietor of that right. Moreover, the trade mark proprietor may not use his right
in order to prevent repackaging of a product imported in parallel when:

(cid:1)  the use of  the  trade-mark  right  by  the  owner,  having  regard  to  the  marketing  system
which  he  has  adopted,  will  contribute  to  the  artificial  partitioning  of  the  markets
between Member States;

(cid:1)  the repackaging cannot adversely affect the original condition of the product;

(cid:1)  it is stated on the new packaging by whom the product has been repackaged;

(cid:1)  the  presentation  of  the  repackaged  product  is  not  such  as  to  be  liable  to  damage  the

reputation of the trade mark and of its owner; and

(cid:1)  the proprietor of the trade mark receives prior notice before the repackaged product is

put on sale

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1.

INTRODUCTION

in  general.  It  updates 

This  communication  is  mainly  addressed  to  national  administrations,  economic
operators who trade in parallel imports of proprietary medicinal products1, enterprises
and  pharmaceuticals  operators 
the  1982  Commission
Communication on the same subject2 and its overall aim is to give some guidance on
practical  applications  of  the  principle  of  the  free  movement  of  goods  to  national
measures relating to parallel imports, from one Member State to another, of proprietary
medicinal products for which marketing authorisations have already been granted in the
Member State of destination. Particular reference is made to the rights and obligations
of the parties concerned and to the guarantees to which they are entitled according to
Community law.

Since  the  adoption  of  the  1982  Communication,  the  European  Court  of  Justice  has
developed  significantly  its  jurisprudence  on  the  field  and  has  clarified  a  number  of
issues  regarding  the  requirements  and  procedures  for  licensing  parallel  imports3,  the
use  of  national  patent  rights4  and  regarding  repackaging,  re-labelling  and  the  use  of
national  trade-marks5.  At  the  same  time,  further  developments  at  the  level  of
Community law, have had a considerable technical and economic impact on the trade
of  proprietary  medicinal  products  while  EU  enlargement  is  expected  to  pose  further
challenges.

This  communication,  based  mainly  on  the  development  of  the  jurisprudence  of  the
Court,  does  not  address  issues  dealt  with  by  other  Community  legislation,  especially
regarding the marketing for the first time of a medicinal product6, competition or issues
dealt  with  by  the  1998  Commission  Communication  on  the  Single  Market  in
Pharmaceuticals7,  unless  such  issues  have  been  addressed  by  the  Court  in  its
jurisprudence  regarding  parallel  imports.  Specific  reference  is  made  to  more  recent
judgements  that  clarify  the  conditions  where  repackaging  of  the  medicinal  product,

1

2

3

4

5

6

7

Proprietary  medicinal  product  is  any  ready-prepared  medicinal  product  placed  on  the  market  under  a
special  name  and  in  a  special  pack;  medicinal  product  is  any  substance  or  combination  of  substances
presented for treating or preventing disease in human beings. Any substance or combination of substances
which may be administered to human beings with a view to making a  medical diagnosis or to restoring,
correcting  or  modifying  physiological  functions  in  human  beings  is  likewise  considered  a  medicinal
product. Directive 2001/83/EC (OJ No L 311, 28/11/2001 p.67-128). The same definitions, in relation to
animals,  apply  for  veterinary  medicinal  products,  Directive  2001/82/EC  (OJ  No  L  311,  28/11/2001,
p.1-66).
OJ C 115 of 6.5.1982, p.5
Case 247/81 Commission v Germany (1984) ECR 1111, C-201/94 Smith & Nephew (1996) ECR I-5819,
C-94/98 Rhône-Poulenc (1999) ECR I-8789, C-172/00 Ferring (2002) ECR I-6891.
Case  434/85  Allen  &  Hansburys  (1988)  ECR  1245,  C-191/90  Generics  (1992)  ECR  5335,  joined  cases
C-267 and 268/95 Merck v Primecrown (1996) ECR I-6285.
Joined  cases  C-427,  429  &  436/93  Bristol-Myers  Squibb  (1996)  ECR  I-3457,  case  C-232/94  Rhône-
Poulenc (1996) ECR I-3671, C-379/97 Pharmacia & Upjohn (1999) ECR I-6927, C-143/00 Boehringer etc
(2002) ECR I-3759, C-443/99 Merck, Sharp and Dohme vs Paranova (2002) ECR I-3703.
Directive  2001/83/EC  (OJ  No  L  311,  28/11/2001  p.67-128)  as  last  amended  by  Directive  2003/63/EC
(OJ L 159, 27/06/2003 p.46-94); Directive 2001/82/EC (OJ No L 311, 28/11/2001, p.1-66).
COM (1998) 588 final - 25.11.1998

4

 
                                                
imported in parallel, is objectively necessary so that it can gain access to the Member
State of destination. The significance of that jurisprudence of the Court is underlined by
the  explanation  of  those  conditions  and  their  application  in  the  fifth  part  of  this
communication.

Finally,  the  term  "import"  is  used,  when  referring  to  intra-community  trade,  for
practical  reasons  even  though  it  could  be  argued  that  the  term  has  lost  most  of  its
relevance due to the development of the Internal Market.

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2.

PARALLEL IMPORTS AND FREE MOVEMENT OF GOODS

Parallel  importation  of  a  medicinal  product  is  a  lawful  form  of  trade  within  the  Internal
Market based on article 28 of the EC Treaty and subject to the derogations provided by article
30 of the EC Treaty

Parallel  trade  is  a  lawful  form  of  trade  in  goods  between  Member  States  of  the
European Union. It is known as "parallel" to the extent that it takes place outside and –
in  most  cases-  in  parallel  with  the  distribution  network  that  the  manufacturers  or
original  suppliers  have  established  for  their  products  at  a  Member  State,  while  it
concerns  products  which  are  in  every  respect  similar  to  the  ones  marketed  by  the
distribution networks.

Parallel  trade  is  based  on  the  principle  of  the  free  movement  of  goods  within  the
Internal  Market  (articles  28-30  of  the  EC  Treaty).  In  the  pharmaceutical  sector,  it
benefits  from  price  divergence  as  Member  States  set  or,  by  other  means,  control  the
price of medicinal products sold within their respective markets8. The European Court
of Justice has repeatedly confirmed that medicinal products are not exempted from the
rules  of  the  Internal  Market9  and  has  condemned  State  measures10  which  restrict,
without  appropriate  justification,  parallel  imports  of  medicines.  The  Court  has  ruled
that certain Member State measures restricting parallel imports may be justified on the
grounds  of  protection  of  industrial  and  commercial  property  and  the  protection  of
human health and life, according to article 30 of the EC Treaty.

8

9

10

Member  States  may  resort  to  direct  price  setting  or  indirect  price  setting  by  means  of  reimbursement
policies,  in  order  to  guarantee  to  all  citizens  equal  access  to  medicinal  products  and  to  safeguard  the
financial  stability  of  their  social  security  services.  The  Court  has  acknowledged  that,  in  the  absence  of
harmonisation,  Member  States  are  entitled  to  set  the  prices  of  pharmaceutical  products  in  order  to  meet
such  legitimate  concerns  provided  that  such  an  intervention  does  not  discriminate  de  jure  or  de  facto
between  national  or  imported  products  and  the  price  indicated  is  remunerative  –  Case  181/82  Roussel
Laboratoria (1983) ECR 3849 and Case 249/88 Commission v. Belgium (1991) ECR I-1275. As regards,
in particular, the market of prescription medicines, State intervention may take the form of exclusion of a
medicinal product from a reimbursement scheme. Such a restriction may be justified only if: (a) there is no
discrimination based on the origin of the product, (b) it is based on objective and verifiable criteria and (c)
it provides for procedures to remedy any distortion as it may arise - Case 238/82 Duphar (1984) ECR 523.
Additional  procedural  requirements  are  laid  down  in  Directive  89/105/EEC  (OJ  No  L  40,  11/2/1989
p.8-11).
The  Court  has  noted  that  to  this  effect  it  is  "a  matter  of  no  significance  that  there  exist  as  between  the
exporting and importing Member States, price differences resulting from governmental measures adopted
in  the  exporting  State  with  a  view  to  controlling  the  price  of  the  product"  –  Case  15/74  Centrafarm  v.
Sterling (1974) ECR 1147. This principle was confirmed in joined cases C-267/95 and C-268/95, Merck v
Primecrown, (1996) ECR I-6285, paragraph 47; see also case C-436/93 Bristol-Myers Squibb v. Paranova,
(1996) ECR I-3457, case 16/74, Centrafarm and De Peijper v. Winthrop (1974) ECR 1183.
When  a  restriction  on  parallel  trade  is  due  to  measures  taken  by  undertakings,  such  as  dual  pricing  or
limiting  supplies  to  wholesalers,  this  is  subject  to  examination  under  the  Community  competition  rules
(articles 81-82 of the EC Treaty).

6

 
                                                
3.

PROTECTION OF HUMAN HEALTH AND LIFE - MARKETING AUTHORISATIONS

A medicinal product may be imported in parallel on the basis of a licence granted according
to a ‘simplified’ procedure under which the applicant needs to provide less information than
is required for an application for a marketing authorisation

In general, a medicinal product cannot be put on the market of a Member State without
a marketing authorisation, the primary purpose of which is to safeguard public health.
Marketing authorisations are granted either at national or Community level11.

According  to  the  jurisprudence  of  the  Court12,  however,  these  rules  are  subject  to
exceptions resulting from the rules of the EC Treaty  relating to the free movement of
goods.  National  authorities  may  not  obstruct  parallel  imports  by  requiring  parallel
importers  to  satisfy  the  same  requirements  as  those  which  are  applicable  to
undertakings  applying  for  the  first  time  for  a  marketing  authorisation  for  a  medicinal
product13,  provided  that  an  exception  of  that  kind  to  the  rules  normally  applicable  to
marketing authorisations for medicinal products does not undermine the protection of
public health.

In  particular,  when  the  information  necessary  for  the  purposes  of  protecting  public
health  is  already  available  to  the  competent  authorities  of  the  Member  State  of
destination  as  a  result  of  the  first  marketing  of  a  product  in  this  Member  State,  a
parallel imported medicinal product is subject to  a licence  granted14 on the basis  of a
proportionally simplified procedure15 provided:

11

12

13

14

15

Directive 2001/83/EC, article 6.1: No medicinal product may be placed on the market of a Member State
unless  a  marketing  authorization  has  been  issued  by  the  competent  authorities  of  that  Member  State  in
accordance with this Directive or an authorization has been granted in accordance with Regulation (EEC)
No 2309/93. Article 8 of the Directive details the information which must be submitted to the competent
authority in order to have a marketing authorisation issued. The Directive has been amended by Directive
2002/98/EC (OJ L 33, 8/2/2003, p.30-40) and by Directive 2003/63/EC (OJ No L 159, 27/06/2003 p. 46-
94). The equivalent provisions in Directive 2001/82/EC are articles 5 and 12.
Cases  104/75  De  Peijper  (1976)  ECR  613,  C-201/94  Smith  &  Nephew  and  Primecrown  (1996)  ECR
I-5819, C-94/98 Rhone Poulenc (1999) ECR I-08789 and C-172/00 Ferring (2002) ECR I-6891
This  in  practice  means  that  the  parallel  importer  does  not  need  to  submit  documents  relating  to  the
medicinal product in general or to a specific batch, that could be obtained only by the manufacturer of the
medicinal product or his licensee. Otherwise the manufacturer or his licensee could have impeded parallel
imports  simply  by  refusing  to  produce  the  necessary  documents  –  Case  104/75  De  Peijper  (1976)
ECR 613.
Time related issues, such as the  time  limits  within  which  national  authorities  must  respond  to  a  parallel
import  license  applicant  and  the  duration  of  such  licence,  remain  to  be  further  clarified.  Regarding  the
former,  it  must  be  noted  that  article  18  of  Dir.2001/83  provides  for  a  90  days  period  within  which  a
Member  State  may  decide  on  the  recognition  of  a  marketing  authorisation  issued  by  another  Member
State;  it  may  therefore  be  argued  that  45  days  is  a  reasonable  time  limit  for  applying  a  simplified
procedure  to  decide  on  a  parallel  imports  licence  application.  As  for  the  duration  of  the  licence  see
note 21.
"If the public health authorities of the Member State of importation already have in their possession, as a
result of importation on  a  previous  occasion,  all  the  pharmaceutical  particulars  relating  to  the  medicinal
product in question and considered to be absolutely necessary for the purpose of checking that the product
is effective and not harmful, it is clearly unnecessary, in order to protect the health and life of humans, for
those authorities to require a second trader who has imported a medicinal product which is in every respect

7

 
                                                
(cid:1)  the  imported  product  has  been  granted  a  marketing  authorisation  in  the  Member

State of exportation;

(cid:1)  the  imported  product  is  sufficiently  similar  to  a  product  that  has  already  received
marketing  authorisation  in  the  Member  State  of  destination  even  if  there  are
differences relating to the excipients16.

The Court has clarified the issue of similarity, ruling that the two products do not have
to be identical in all respects but they should have at least been manufactured according
to the same formulation, using the same active ingredient, and that they also have the
same therapeutic effects17.

That a medicinal product sufficiently similar to the parallel import has already received
marketing authorisation in the Member State of destination does not necessarily imply
that this "reference" authorisation is still valid at the time of importation. In particular,
the Court has ruled that parallel importation of a medicinal product is still possible even
when  the  reference  authorisation  has  been  withdrawn  and  that  the  parallel  imports
licence may not be revoked unless such a measure is justified by reasons relating to the
protection of public health, in accordance with the provisions of Article 30 EC18. It may
reasonably  be  assumed  that  the  same  principles  apply  when  the  reference  marketing
authorisation  of  a  medicinal  product  is  still  valid  in  the  Member  State  of  exportation
but  is  left  to  expire19  in  the  Member  State  of  importation  so  that  a  new  version  is
marketed.

The  issue  arises  of  when  a  marketing  authorisation  of  reference  is  withdrawn  in  the
Member State of importation for reasons other than the protection of public health and
the  imported  product  continues  to  be  lawfully  marketed  in  the  Member  State  of
exportation  under  the  marketing  authorisation  issued  in  that  State.  This  is  the  case
where,  for  example,  a  new  version  of  a  medicinal  product  is  marketed  in  a  Member
State while the old version continues to be imported from another Member State.

16

17

18

19

the  same  or  whose  differences  have  no  therapeutic  effect,  to  produce  these  particulars  again",  Case
C-201/94 Smith & Nephew and Primecrown (1996) ECR I-5819
The fact that the manufacturer of the imported product and of the product already marketed in the Member
State  of  destination  is  either  the  same  or  they  belong  to  the  same  group  or,  in  case  of  independent
companies,  they  have  concluded  agreements  with  the  same  licensor  was  also  taken  into  account  by  the
Court in cases 104/75 De Peijper (1976) ECR 613 and C-201/94 Smith & Nephew and Primecrown (1996)
ECR I-5819 when addressing the issue of similarity.
Case C-201/94 Smith & Nephew and Primecrown (1996) ECR I-5819 - As for the condition regarding the
formulation of  a  product  the  Court  went  on  to  rule  that  national  authorities  are  required  to  authorise,  in
accordance with the rules relating to parallel imports, a medicinal product imported as a parallel product
where they are convinced that that product, in spite of differences relating to the excipients, does not pose
a problem for public health – Case C-94/98 Rhone Poulenc (1999) ECR I-08789
Cases C-172/00 Ferring (2002) ECR I-6891 and C-15/01 Paranova (2003) ECR
Article 24 of Directive 2001/83/EC provides that: "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
and after consideration by the competent authority of a dossier containing in particular details of the data
on  pharmacovigilance  and  other  information  relevant  to  the  monitoring  of  the  medicinal  product"  -
OJ L 311, 28/11/2001 p. 67-128. The equivalent provision in Directive 2001/82/EC is article 28.

8

 
                                                                                                                                                           
The  Court  has ruled20 that the withdrawal of such  a marketing  authorisation  does  not
mean  in  itself  that  the  quality,  efficacy  and  safety  of  the  old  version  are  called  into
question. It has been acknowledged that the competent authorities of the Member State
of  importation  must  adopt  the  measures  necessary  for  the  purpose  of  verifying  the
quality,  efficacy  and  safety  of  the  old  version  of  the  medicinal  product  and  that  this
objective must nevertheless be attained by measures having a less restrictive effect on
the  import  of  medicinal  products  than  the  automatic  cessation  of  the  validity  of  the
parallel  import  licence.  A  possible  way  of  attaining  such  an  objective  is  through
cooperation  with  the  national  authorities  of  the  other  Member  States  by  means  of
access to the documents and data produced by the manufacturer or other companies in
the same group, relating to the old version in the Member States in which that version
is still marketed on the basis of a marketing authorisation still in force21.

Moreover the Court has held that restrictions on the importation of the old version may
be justified if it can be demonstrated that there is in fact a risk to public health arising
from the coexistence of the two versions in the same market. The question, however, of
the existence and the reality of the risk is a matter which is primarily for the competent
authorities of the Member State of destination to determine, and the mere assertion by
the holder of the marketing authorisation for the new and old versions that there is such
a risk is not sufficient to justify a prohibition of the importation of the old version.

When  a  medicinal  product  has  been  authorised  at  Community  level22  the  marketing
authorisation  is  valid  throughout  the  Community.  Centrally  authorised  medicines
distributed in parallel which are identical23 to those distributed by the manufacturer are
covered  by  one  and  the  same  marketing  authorisation.  The  parallel  distributor  may
therefore  under  Community  pharmaceutical  law  directly  place  on  the  market  the
medicine and distribute it in parallel. He may also do so if the marketing authorisation

20

21

22

23

Cases C-172/00 Ferring (2002) ECR I-6891 and C-15/01 Paranova (2003) ECR
The Court referred to the principle of co-operation of the authorities of Member States in joint cases 87
and  88/85  Legia  and  Gyselinx  (1986)  ECR  1707.  On  the  basis  of  this  principle  it  may  be  argued  that
national  authorities,  when  granting  a  parallel  imports  licence,  may  not,  as  a  general  rule,  restrict  its
duration until the expiry date of the original marketing authorisation. In any event, if the health authorities
of the Member State concerned consider, in specific cases and for clearly identified reasons, that the lack
of  pharmacovigilance  obligations  on  the  holder  of  the  withdrawn  marketing  authorisation  could
compromise  the  safeguarding  of  public  health,  they  must  be  able  to  adopt  the  appropriate  measures,
namely,  where  necessary,  to  restrict  the  duration  of  the  import  licence  to  the  validity  of  the  marketing
authorisation  (C-223/01,  AstraZeneca  A/S,  judgement  of  16/10/2003,  not  yet  reported).  The  case
concerned the granting of an authorisation for a generic product and not an import licence. It remains to be
decided by the Court whether this principle also applies to parallel imports.
Authorisation at Community level is granted according to the centralised procedure provided by Council
Regulation (EEC) 2309/93 OJ 1993 L 214, 1-21. Regulation 2309/93 has been the subject of Commission
Communication on the Community Marketing Authorisation Procedures for Medicinal Products of 1998
(98C  229/03).  The  Communication  also  provides  guidance  on  the  mutual  recognition  procedure  of
Directives 2001/83/EC and 2001/82/EC.
The Court held in Case T-123/00, Thomae/Commission (2002) ECR II-5193, that considerations deriving
from  the  unitary  nature  of  the  Community  MA  and  the  fundamental  principle  of  the  free  movement  of
goods  suggest  that  a  medicinal  product  which  is  the  subject  of  an  application  for  a  Community  market
authorisation must, as a general rule, have a single package layout such as colour, logo, format and general
layout. It went on however to declare that under exceptional circumstances the package layout may vary.
The case concerned the holder of the marketing authorisation and not a parallel distributor.

9

 
                                                
holder,  for  one  reason  or  another,  has  not  yet  placed  the  relevant  product  on  a  given
national market.

4.

PROTECTION AND EXHAUSTION OF INDUSTRIAL AND COMMERCIAL PROPERTY RIGHTS

The  owner  of  an  industrial  and  commercial  property  right  protected  by  Member  State
legislation may not rely on that legislation to oppose the importation of a product which has
been lawfully placed on the market in another Member State by, or with the consent of, the
proprietor of that right

Medicinal products are generally covered by industrial and commercial property rights,
namely patents and trademarks, which are essentially national in nature24. They can be
invoked before the national authorities and the national  courts in order to prevent the
sale on the national market of imported medicinal products infringing these rights.

The  existence  of  industrial  and  commercial  property  rights  is  not  affected  by  the  EC
Treaty;  their  exercise  may  however  be  affected  when  it  is  repugnant  to  the  essential
purpose  of  the  Treaty,  which  is  to  unite  national  markets  into  a  single  market.  The
Court  has  ruled25  that  the  derogation  to  the  free  movement  of  goods  justified  on  the
grounds of protection of industrial and commercial property is only admissible when it
is justified for the purpose of safeguarding rights, which constitute the specific subject
matter of the property26.

This rule is known as the principle of exhaustion of industrial and commercial property
rights27.  According  to  this  principle,  the  owner  of  an  industrial  and  commercial
property right protected by Member State legislation may not rely on that legislation to
oppose the importation of a product which has been lawfully placed on the market in
another Member State by, or with the consent of, the proprietor of that right. The right
is  considered  to  have  been  exhausted  once  the  product  has  been  put  on  the  market
somewhere in the Community.

24

25

26

27

See  however  Council  Regulation  (EC)  No  40/94  of  29  December  1993  on  the  Community  trademark,
OJ L 11, 14.1.1994, p.1, and proposal for a Council Regulation on the Community patent, OJ No C 337E,
28.11.2000, p. 278.
See  among  others  case  78/70  Deutsche  Grammophon  v.  Metro  (1971)  ECR  487  and  case  102/77
Hoffmann-La Roche (1978) ECR 1139.
"The  specific  subject  matter  of  the  industrial  property  is  the  guarantee  that  the  patentee,  to  reward  the
creative effort of the inventor, has  the  exclusive  right  to  use  an  invention  with  a  view  to  manufacturing
industrial  products  and  putting  them  into  circulation  for  the  first  time,  either  directly  or  by  the  grant  of
licenses to third parties, as well as the right to oppose infringements", Case 15/74 Centrafarm  v Sterling
Drug (1974) ECR 1147 as confirmed by joint cases C267/95 and C-268/95 Merck v. Primecrown (1996)
ECR I-6285.
This general principle, based on the distinction between the existence and the exercise of patent rights, has
been enshrined in EC legislation on industrial property. See article 7 of Council Directive 89/104/EEC of
21  December  1988  to  approximate  the  laws  of  the  Member  States  relating  to  trademarks  (OJ  L  40,
11.12.1989, p. 1) which reiterates the case-law of the Court, in particular case 15/74 Centrafarm v Sterling
(1974)  ECR  1147,  case  C-10/89  CNL-SUCAL  v  HAG  GF  (1990)  ECR  I-3711  and  case  C-9/93  IHT
Internationale Heiztechnik v Ideal Standard (1994) ECR I-2789.

10

 
                                                
An industrial property right will be exhausted even in the case of a product which the
owner  of  the  industrial  property  right  first  markets  in  one  Member  State  where
protection  exists,  then  markets  it  in  another  Member  State  where  there  is  no  such
protection: the owner of the right cannot prevent the parallel importation of the product
from the latter Member State to the former28.

An important, even if temporary, exception to this rule has emerged, during discussions
on  the  G10  Medicines  initiative29,  with  the  accession  of  the  new  Member  States  in
2004  and,  in  particular,  the  Czech  Republic,  Estonia,  Latvia,  Lithuania,  Hungary,
Poland,  Slovenia  and  Slovakia30.  The  Treaty  of  Accession  provides31  for  a  specific
mechanism  whereby  parallel  imports  from  the  above  mentioned  new  Member  States
are  prevented  until  the  patent  or  supplementary  protection  of  the  medicinal  product
concerned expires in these Member States32.

5.

PROTECTION OF TRADE MARKS AND REPACKAGING

The  proprietor  of  the  trade  mark  may  not  use  his  trade  mark  right  in  order  to  prevent
repackaging  when:  (1)  the  use  of  the  trade-mark  right  by  the  owner  will  contribute  to  the
artificial  partitioning  of  the  markets  between  Member  States,  (2)  the  repackaging  cannot
adversely affect the original condition of the product, (3) it is stated on the new packaging by
whom  the  product  has  been  repackaged  and  manufactured,  (4)  the  presentation  of  the
repackaged product is not such as to be liable to damage the reputation of the trade mark and
of  its  owner  and  (5)  the  proprietor  of  the  trade  mark  receives  prior  notice  before  the
repackaged product is put on sale

In  certain  circumstances33,  repackaging  the  product  and  reaffixing  the  trade  mark  or
replacing it with a different trade mark used for the same product in the Member State
of destination is necessary to allow the product imported in parallel to be marketed in a
Member State. The issue has been addressed by the Court and a number of conditions

28

29

30

31

32

33

Cases 187/80 "Merck v. Stephar" (1981) ECR 2603, C-10/89 HAG (1990) ECR 3711, C-191/90 Generics
and Harris Pharmaceutical (1992) ECR 5335, joined cases C-267/95 and C-268/95 Merck v. Primecrown
(1996) ECR I-6285.
See recent Commission Communication on "A stronger  European-based  pharmaceutical  industry  for  the
benefit of the patient – A call for action", COM (2003) 383.
Patent  or  supplementary  protection  could  be  obtained  in  the  other  two  new  Member  States,  Malta  and
Cyprus, and they are therefore not included in the list.
"With regard to the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia and Slovakia,
the  holder,  or  his  beneficiary,  of  a  patent  or  supplementary  protection  certificate  for  a  pharmaceutical
product  filed  in  a  Member  State  at  a  time  when  such  protection  could  not  be  obtained  in  one  of  the
abovementioned  new  Member  States  for  that  product,  may  rely  on  the  rights  granted  by  that  patent  or
supplementary  protection  certificate  in  order  to  prevent  the  import  and  marketing  of  that  product  in  the
Member  State  or  States  where  the  product  in  question  enjoys  patent  protection  or  supplementary
protection, even if the product was put on the market in that new Member State for the first time by him or
with  his  consent",  Accession  Treaty,  Part  three,  Title  II,  Annex  IV,  Section  2  "Company  Law",
AA2003/ACT/Annex IV/en p.2499, signed in Athens on 16 April, 2003.
These new Member States introduced patent protection rights in the period between 1991and 1994.
For example, requirements relating to the language of the labelling and the instructions or national rules
relating to the size of packaging.

11

 
                                                
have  emerged  regarding  the  necessity  and  the  extent  of  changes  to  the  original
packaging.

According to Article 7, paragraph 2 of Directive 89/10434, the principle of exhaustion
of the rights conferred by a trade mark does not apply where the proprietor of a trade
mark  has  legitimate  reasons  to  oppose  further  commercialisation  of  the  goods,
especially where the condition of the goods is changed or impaired after they have been
put  on  the  market.  The  Court  has  accepted  that  Article  7  of  the  directive
comprehensively  regulates  the  question  of  the  exhaustion  of  trade  mark  rights  for
products traded in the Community noting however that, like any secondary legislation,
the  directive  must  be  interpreted  in  the  light  of  the  EC  Treaty  rules  on  the  free
movement of goods and in particular Article 3035. This is explained on the grounds that
a directive cannot justify obstacles to intra-Community trade save within the bounds set
by the Treaty rules36.

It  has  been  already  mentioned  that  the  derogation  to  the  free  movement  of  goods
principle based on the grounds of protection of industrial and commercial property37 is
only  admissible  when  it  is  justified  for  the  purpose  of  safeguarding  rights,  which
constitute  the  specific  subject  matter  of  the  property.  The  Court  has  ruled  that  the
specific subject-matter of a trade mark is in particular to guarantee to the owner that he
has the exclusive right to use that trade mark for the purpose of putting a product on the
market  for  the  first  time  and  therefore  to  protect  him  against  competitors  wishing  to
take  advantage  of  the  status  and  reputation  of  the  trade  mark  by  selling  products
bearing  it  illegally38.  Accordingly,  the  essential  function  of  the  trade  mark  is  to
guarantee  to  the  consumer  the  identity  of  the  product's  origin  by  enabling  him  to
distinguish it without any risk of confusion from products of different origin; it is also
to assure the consumer that the product has not been subject to interference by a third
person, without the authorization of the trade mark owner, in such a way as to affect the
original condition of the product39.

It follows that the proprietor of the trade mark may not use his trade mark right in order
to prevent repackaging when:

(cid:1)  the use of the trade-mark right by the owner, having regard to the marketing system
which  he  has  adopted,  will  contribute  to  the  artificial  partitioning  of  the  markets
between Member States;

(cid:1)  the repackaging cannot adversely affect the original condition of the product;

34

35

36

37

38

39

OJ L 40, 11.12.1989, p. 1
Joined cases C-427/93, C-429/93 and C-436/93 Bristol-Myers Squibb and Others (1996) ECR I-3457
According  to  the  jurisprudence  of  the  Court,  case  C-51/93  Meyhui  v  Schott  Zwiesel  Glaswerke  (1994)
ECR I-3879, the prohibition on quantitative restrictions and measures having equivalent effect –art.28 EC-
applies not only to national measures but also to those emanating from Community institutions.
Art. 30 EC Treaty
See  among  others  cases  16/74  Centrafarm  v  Winthrop  (1974)  ECR  1183,  102/77  Hoffmann-La  Roche
(1978) ECR 1139 and 1/81 Pfizer v Eurim-Pharm (1981) ECR 2913 confirmed by joined cases C-427/93,
C-429/93 and C-436/93 Bristol-Myers Squibb and Others (1996) ECR I-3457.
note 38

12

 
                                                
(cid:1)  it  is  stated  on  the  new  packaging  by  whom  the  product  has  been  repackaged  and

manufactured;

(cid:1)  the presentation of the repackaged product is not such as to be liable to damage the

reputation of the trade mark and of its owner; and

(cid:1)  the proprietor of the trade mark receives prior notice before the repackaged product

is put on sale40.

On  the  other  hand,  the  Court  has  ruled  that  the  condition  of  necessity  will  not  be
satisfied if the parallel importer wishes to repackage the product and reaffix or replace
the  trade  mark  solely  in  order  to  secure  a  commercial  advantage.  In  that  case  the
proprietor of the trade mark may lawfully use his right to prevent the actions mentioned
above.

Whether  repackaging  is  objectively  necessary  according  to  the  conditions  explained
below is, in any case, to be assessed on the basis of the circumstances prevailing at the
time of marketing of the medicinal product in the Member State of destination.

5.1.

Artificial partitioning of the Internal Market

This is the case where the trade mark proprietor has placed an identical pharmaceutical
product on the market in several Member States in various forms of packaging and/or
under a different trade mark41 and the size of the packet marketed in the Member State
of  exportation  may  not  be  marketed  in  the  Member  State  of  destination  for  various
reasons42. Furthermore, the Court also ruled that even when one of the  many sizes of
the  product  marketed  in  the  Member  State  of  destination  is  also  marketed  in  the
Member  State  of  exportation,  this  is  not  enough  to  justify  the  conclusion  that
repackaging is unnecessary. Partitioning of the markets would still exist if the importer
were able to sell the product in only part of his market.

It  must  be  noted  that,  in  all  circumstances,  repackaging  is  permitted  only  if  it  is
necessary.  If,  for  example,  the  imported  product  may  have  effective  access  to  the
market a Member State simply by having new labels affixed to the original packaging
or new user instructions and information  added, then the proprietor of  the trade  mark
may indeed oppose repackaging to the extent that it is not objectively necessary.

40

41

42

These conditions were clarified by the Court in a series of judgements since the case 102/77 Hoffmann-La
Roche  (1978)  ECR  1139.  See  in  particular,  case  1/81  Pfizer  v  Eurim-Pharm  (1981)  ECR  2913,  joined
cases  C-427/93,  C-429/93  and  C-436/93  Bristol-Myers  Squibb  and  Others  (1996)  ECR  I-3457,  case
C-379/97  Upjohn  (1999)  ECR  I-6927,  case  C-443/99  Merck,  Sharp  &  Dohme  (2002)  ECR  I-3703  and
case C-143/00 Boehringer (2002) ECR I-03759
The  issue  of  replacing  the  trade  mark  with  the  one  used  for  the  same  product  in  the  Member  State  of
destination was addressed by the Court in case C-379/97 Upjohn (1999) ECR I-6927.
The artificial partitioning of the market may not necessarily be directly attributed to and intended by the
proprietor  of  the  trade  mark  but  to  such  factors  as  the  ones  mentioned  by  the  Court:  a  rule  authorizing
packaging only of a certain size or a national practice to the same effect, sickness insurance rules making
the reimbursement of medical expenses depend on the size of the packaging, or well-established medical
prescription  practices  based,  inter  alia,  on  standard  sizes  recommended  by  professional  groups  and
sickness insurance institutions.

13

 
                                                
The  Court  has clarified  the term  "effective access", ruling43 that  there may exist on a
market,  or  on  a  substantial  part  of  it,  such  strong  resistance  from  a  significant
proportion of consumers to relabelled medicinal products that there must be held to be
a  hindrance  to  effective  market  access.  Therefore,  in  those  circumstances,  the
proprietor of the trade mark may not oppose repackaging.

5.2.

Adverse effects on the original condition of the product

The  concept  of  adverse  effects  on  the  original  condition  of  the  product  refers  to  the
condition  of  the product  inside  the  packaging.  It  is  accepted  that  the  condition  of  the
product is not adversely affected

(cid:1)  when repackaging affects only the external layer, leaving the inner packaging intact,

or

(cid:1)  where the repackaging is carried out under the supervision of a  public  authority in

order to ensure that the product remains intact.

It follows from the jurisprudence of the Court that the mere removal of blister packs,
flasks,  phials,  ampoules  or  inhalers  from  their  original  external  packaging  and  their
replacement  in  new  external  packaging  cannot  affect  the  original  condition  of  the
product inside the packaging. The same applies to operations consisting in the fixing of
self-stick labels to flasks, phials, ampoules or inhalers, the addition to the packaging of
new  user  instructions  or  information  in  the  language  of  the  Member  State  of
importation,  or  the  insertion  of  an  extra  article,  such  as  a  spray,  from  a  source  other
than the trade mark owner.

On  the  other  hand,  the  Court  has  acknowledged  that  the  original  condition  of  the
product inside the packaging might be indirectly affected where, for example:

(cid:1)  the  external  or  inner  packaging  of  the  repackaged  product,  or  a  new  set  of  user
instructions or information, omits certain important information or gives inaccurate
information  concerning  the  nature,  composition,  effect,  use  or  storage  of  the
product, or

(cid:1)  an  extra  article  inserted  into  the  packaging  by  the  importer  and  designed  for  the
ingestion and dosage of the product does not comply with the method of use and the
doses envisaged by the manufacturer.

5.3.

Indication on who repackaged and manufactured the product

Since  it  is  in  the  trade  mark  owner's  interest  that  the  consumer  should  not  be  led  to
believe that the owner is responsible for the repackaging, an indication must be clearly
shown on the external packaging of who repackaged the product. That indication must
be  printed  in  such  a  way  as  to  be  understood  by  a  person  with  normal  eyesight,
exercising a normal degree of attentiveness. Moreover, where the parallel importer has

43

Case C-443/99 Merck, Sharp & Dohme (2002) ECR I-3703

14

 
                                                
added to the packaging an extra article from a source other than the trade mark owner,
he must ensure that the origin of the extra article is clearly indicated in such a way as to
dispel any impression that the trade mark owner is responsible for it.

It is, nevertheless, not necessary to require that the further express statement be made
on the packaging that the repackaging was carried out without the authorization of the
trade mark owner, since such a statement could give the misleading impression that the
repackaged product is not entirely legitimate.

5.4.

Presentation of the repackaged product

The Court has acknowledged that even if the person who carried out the repackaging is
indicated  on  the  packaging  of  the  product,  there  remains  the  possibility  that  the
reputation  of  the  trade  mark,  and  thus  of  its  owner,  may  nevertheless  suffer  from  an
inappropriate  presentation  of  the  repackaged  product.  In  such  a  case,  the  trade  mark
owner has a legitimate interest, related to the specific subject-matter of the trade mark
right,  in  being  able  to  oppose  the  marketing  of  the  product.  In  assessing  whether  the
presentation of the  repackaged product is liable to damage the  reputation  of the trade
mark, account must be taken of the nature of the product and the market for which it is
intended44.

5.5.

Prior notice to the proprietor of the trade mark

The  proprietor  of  the  trade  mark  must  be  given  advance  notice  of  the  repackaged
product being put on sale. The proprietor may also require the importer to supply him
with  a  specimen  of  the  repackaged  product  before  it  goes  on  sale,  to  enable  him  to
check that the repackaging is not carried out in such a way as directly or indirectly to
affect the original condition of the product and that the presentation after repackaging
is not likely to damage the reputation of the trade mark45. If the parallel importer46 does
not satisfy that requirement, the trade mark proprietor may oppose the marketing of the
repackaged pharmaceutical product.

Both parties, nevertheless, must make sincere efforts to respect each other's legitimate
interests.  Accordingly,  the  proprietor  is  expected  to  be  given  a  reasonable  time  to
examine  the  product  before  reacting  to  the  notice  while  consideration  must  also  be
given to the parallel importer's interest in proceeding to market the product as soon as
possible  after  obtaining  the  necessary  licence  from  the  competent  authority.  In  the

44

45

46

The  public  is  particularly  demanding  as  to  the  quality  and  integrity  of  pharmaceutical  products,  and
defective,  poor  quality  or  untidy  packaging  could  damage  the  trade  mark's  reputation.  However,  the
requirements  to  be  met  by  the  presentation  of  a  repackaged  pharmaceutical  product  vary  according  to
whether  the  product  is  sold  to  hospitals  or,  through  pharmacies,  to  consumers.  In  the  former  case,  the
products are administered to patients by professionals, for whom the presentation of the product is of little
importance. In the latter case, the presentation of the product is of greater importance for the consumer.
Such  a  requirement  also  affords  the  trade  mark  owner  a  better  possibility  of  protecting  himself  against
counterfeiting.
It  is  not  sufficient  that  the  proprietor  be  notified  by  other  sources,  such  as  the  authority  which  issues  a
parallel import licence to the importer - case C-143/00 Boehringer (2002) ECR I-03759

15

 
                                                
Boehringer case47 the Court suggested that a period of 15 working days seems likely to
constitute such a reasonable time where the parallel importer has chosen to give notice
to  the  trade  mark  proprietor  by  supplying  it  simultaneously  with  a  sample  of  the
repackaged  pharmaceutical  product.  The  Court  added  that,  that  period  being  purely
indicative,  it  remains  open  to  the  parallel  importer  to  allow  a  shorter  time  and  to  the
proprietor to ask for a longer time to react than that allowed by the parallel importer.

It must be noted that, regarding parallel imports of medicinal products covered by the
exception provided in the Accession Treaty 2003, the rule is that the parallel importer
must give one month's prior notification48.

5.6.

Authorisation at Community level

When  a  medicinal  product  has  been  authorised  at  Community  level49  the  marketing
authorisation  issued  in  accordance  with  Regulation  2309/93  relates  to  the  specific
packaging prescribed for the medicinal product in the application for authorisation. The
authorisation determines the pack sizes and the immediate packaging to be used for the
medicinal product, as well as the information to be included on the immediate or outer
packaging50. The Court has held that the detailed and specific requirements regarding
the  packaging,  which  are  intended  to  prevent  consumers  from  being  misled  and,
thereby,  to  protect  public  health  preclude  the  joining  together  and  re-labelling  of
packages  of  that  medicinal  product51.  The  Court  added,  however,  that  the  creation  of
new  packaging  may  be  possible  if  that  repackaging  is  objectively  necessary52  so  that
the imported product gains effective access to the market of a Member State.

Although no further authorisation is required, the Community (in practice the European
Agency for the Evaluation of Medicinal Products –EMEA) and national authorities of
the Member States in which the medicinal product will be distributed in parallel shall
be informed that such parallel distribution will take place in order to enable the EMEA
to check compliance with the terms of the Community marketing authorisation and the
national  authorities  to  monitor  the  market  (batch  identification,  pharmacovigilance,
etc.) and to carry out post-marketing surveillance (Commission Communication on the

47

48

49

50

51

52

Case C-143/00 Boehringer (2002) ECR I-03759
"Any person intending to import or market a pharmaceutical product covered by the above paragraph in a
Member  State  where  the  product  enjoys  patent  or  supplementary  protection  shall  demonstrate  to  the
competent authorities in the application regarding that import that one month's prior notification has been
given to the holder or beneficiary of such protection". (Accession Treaty, Part three, Title II, Annex IV,
Section 2 "Company Law" AA2003/ACT/Annex IV/en p.2499, signed in Athens on 16 April, 2003
Authorisation at Community level is granted according to the centralised procedure provided by Council
Regulation (EEC) 2309/93 OJ 1993 L 214 , 1-21
Pursuant to Articles 9(3) and 10(1) and the second sub-paragraph of Article 11 of Regulation No 2309/93,
the  authorisation  will  include,  in  annex,  the  draft  text  of  the  labelling  and  package  leaflet,  presented  in
accordance  with  Directive  92/27/EEC  (now  Directive  2001/83/EC,  articles  54-69).  Accordingly,  the
particulars and information to be printed on the product packaging are specific to those packagings, since
they are based on the pack size and immediate packaging used, as specified in the application pursuant to
Article 6(1) of that regulation.
Case C-433/00 Aventis Pharma Deutschland (2002) ECR I-7761
The  circumstances  prevailing  at  the  time  of  marketing  in  the  Member  State  of  importation  are  again
assessed according to the criteria set in the jurisprudence of the Court, see note 38.

16

 
                                                
Community  marketing  authorisation  procedures  for  medicinal  products,  OJ  C  229,
22/7/1998, p.4-17)53.

6.

CONCLUSIONS

Since the adoption of the 1982 Commission Communication, the Court has addressed a
great  number  of  issues  regarding  parallel  imports  of  medicinal  products  and  has
confirmed that a parallel imported medicinal product is subject to a licence granted on
the basis of a simplified procedure when the information necessary for the purpose of
protecting public health is already available to the  authorities  of the  Member State of
destination.  This  is  the  case  when  the  product  in  question  has  already  received  a
marketing authorisation in the Member State of exportation and is sufficiently similar
to a product that has already received authorisation in the Member State of destination.
Accordingly, the Court has ruled that when the marketing authorisation in the Member
State of destination has been withdrawn for reasons other than the protection of public
health, this does not affect the validity of the parallel imports licence.

A further development that has significantly contributed to legal certainty and thus to
the smooth functioning of the internal market, is the series of rulings delivered by the
Court regarding repackaging of a product imported in parallel. The Court has clarified
that the protection of a trade-mark right is not without limits, noting in particular that it
may  not  contribute  to  the  artificial  partitioning  of  the  internal  market.  Therefore,  the
parallel importer may repackage a proprietary medicinal product and reaffix the trade-
mark  or  indeed  replace  it  with  the  trade-mark  used  in  the  market  of  destination,
provided  that  repackaging  does  not  adversely  affect  the  original  condition  of  the
product or the reputation of the trade-mark and its owner. Further conditions confirmed
by  the  Court  are  that  the  new  packaging  states  by  whom  the  product  has  been
repackaged  and  also  that  the  trade-mark  proprietor  receives  notice  before  the
repackaged product is put on sale.

53

The  Commission  is  proposing  to  make  this  system  compulsory  in  the  on-going  review  of  the
pharmaceutical legislation (articles 76(3) of Directive 2001/83/EC and 57(1)(n) of the proposed regulation
replacing  Regulation  (EEC)  No  2309/93).  The  Commission  proposed,  in  November  2001,  a  legislative
package  for  the  review  of  the  pharmaceutical  legislation  comprising  a  regulation  intended  to  replace
Regulation  (EEC)  No  2309/93  and  two  directives  amending  Directives  2001/83/EC  and  2001/82/EC
(COM  (2001)  404  final).  The  package  is  currently  in  its  second  reading  in  the  European  Parliament
(2001/0252 (COD), 2001/0253 (COD) and 2001/0254 (COD)).

17

 
                                                
Nevertheless,  not  every  issue  regarding  parallel  imports  has  been  addressed  by  the
Court. As the internal market develops, new questions keep emerging and old answers
need  further  clarification.  While  all  parties  pursue  their  legitimate  interests  in  the
framework of the internal market, respect of what has already been achieved and close
cooperation  among  Community  institutions,  national  authorities  and  economic
operators  continues  to  provide  the  solid  basis  for  the  resolution  of  all  outstanding
issues.

18

 
ANNEX

Questions and Answers

Who is this communication addressed to?

It is addressed to national administrators as well as to companies or individuals dealing with the
marketing of medicinal products.

How can it help me?

Policy  makers  and  national  administrators  handling  parallel  imports  applications  can  find
solutions  to  complex  problems  by  referring  to  the  relevant  jurisprudence  of  the  Court  while
market operators can clarify their respective rights and obligations deriving from the principle of
the free movement of goods.

Are parallel imports legal?

Parallel  imports  are  legal  and  have  been  a  direct  consequence  of  price  divergence  and  the
development  of  the  Internal  Market  which  guarantees  the  free  movement  of  goods;  certain
conditions  must,  as  in  all  cases,  be  respected,  namely  those  derived  from  the  need  to  protect
public health.

Doesn’t the word "parallel" indicate something not quite proper, though?

This is clearly not the case. It simply indicates that the marketing of a medicinal product takes
place outside the distribution network of the manufacturer or his licensee. In any  case it is the
same or a sufficiently similar product.

Isn’t this "similarity" rather ambiguous, then?

On the contrary, it has been clarified by the Court for the benefit of patients as well as national
public  health  authorities.  In  particular,  the  product  imported  in  parallel  (i.e.  after  a  first
marketing authorisation has been granted by the Member State of destination) does not have to
be  identical  in  all  respects  to  the  product  already  marketed  by  the  manufacturer  but  it  should
have  at  least  been  manufactured  according  to  the  same  formulation,  using  the  same  active
ingredient, and should have the same therapeutic effects.

Can't the Member State of destination nevertheless stop or restrict parallel imports?

Indeed they can, provided they can establish that any restrictive measure aims at the protection
of human health and life or the protection of industrial and commercial property (i.e. patents and
trademarks).  National  authorities  must  also  show  that  such  measures  are  necessary  and
proportionate.

How can human health and life be effectively protected?

Member States have at their disposal several tools and procedures in order to safeguard public
health and, in the case of medicinal products, a marketing authorisation is granted only after the

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product  has  been  thoroughly  checked.  The  marketing  of  a  medicinal  product  having  been
authorised,  it  would  be  unnecessary,  disproportionate,  time  consuming  and  costly  to  apply
exactly the same procedure all over again. Therefore, national authorities are entitled to confirm
that  a  product  imported  in  parallel  is  the  same  or  sufficiently  similar  to  the  one  already
authorised for circulation in their market. The parallel importer is accordingly required to submit
all relevant information, fulfilling the conditions described above, in the framework of a much
simpler procedure. For the same reasons, when the first authorisation is withdrawn on grounds
other than the protection of public health, that does not automatically result to the withdrawal of
the parallel imports licence.

Can't a manufacturer stop or restrict parallel imports?

The manufacturer or in general the owner of an industrial or commercial right may indeed ask
national authorities or courts of the Member State of destination to protect the specific subject-
matter of these rights. In other words, a patent holder may seek protection of his exclusive right
to  use  an  invention  with  a  view  to  manufacturing  industrial  products  and  putting  them  into
circulation  for  the  first  time,  either  directly  or  by  the  grant  of  licenses  to  third  parties.
Consequently, as soon as he markets his product for the first time his exclusive marketing right
is exhausted within the Internal Market, i.e. the parallel importer may indeed buy the product at
one place and market it at another.

Can the parallel importer go further than that and interfere with the product itself?

Parallel  importers  cannot  alter  the  essential  characteristics  of  the  product  itself;  that  would
possibly result to a different product which consequently would not fall under the definition of
products imported in  parallel.  There  are  circumstances,  however  (e.g.  difference  in  language),
whereby certain alterations in the form of packaging are considered necessary for the marketing
of the medicinal product in the Member State of destination, in other words, in order to avoid
the  artificial  partitioning  of  the  Internal  Market.  For  this  purpose,  the  parallel  importer  may
change the packaging and may re-affix the trade mark on the new packaging or even replace it
with the trade mark used for the same product in the Member State of destination provided that
this  does  not  adversely  affect  the  original  condition  of  the  product,  it  is  stated  on  the  new
packaging by whom the product has been repackaged and manufactured, the presentation of the
repackaged product is not such as to be liable to damage the reputation of the trade mark and of
its  owner  and  the  proprietor  of  the  trade  mark  receives  prior  notice  before  the  repackaged
product is put on sale. The Court has provided guidelines for each of these conditions.

So, have all problems been finally resolved?

Not  quite.  Even  though  the  Court  has  addressed  a  great  number  of  issues  and  despite  the
Community  legislation  that  deals  with  general  issues  regarding  the  marketing  of  medicinal
products,  there  can  by  no  means  be  any  "definitive"  guide  to  parallel  imports.  New  questions
keep  emerging  and  old  answers  need  more  clarification.  Respect  of  what  has  already  been
achieved  and  continuous  cooperation  among  Community  institutions,  national  authorities  and
economic  operators  has  been  and  still  is  a  solid  basis  for  the  resolution  of  all  remaining
problems.

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