HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 174/74
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Official Journal of the European Union
1.7.2011
DIRECTIVE 2011/62/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 8 June 2011
amending Directive 2001/83/EC on the Community code relating to medicinal products for human
use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
medicinal products from other illegal medicinal products,
EUROPEAN UNION,
as well as from products infringing intellectual property
rights. Furthermore, medicinal products with uninten
Having regard to the Treaty on the Functioning of the European
tional quality defects resulting from manufacturing or
Union, and in particular Article 114, and point (c) of
distribution errors should not be confused with falsified
Article 168(4), thereof,
medicinal products. To ensure uniform application of
this Directive, the terms ‘active substance’ and ‘excipient’
Having regard to the proposal from the European Commission,
should also be defined.
Having regard to the opinion of the European Economic and
Social Committee (
(6) Persons
procuring,
holding,
storing,
supplying
or

1 ),
exporting medicinal products are only entitled to
Having regard to the opinion of the Committee of the
pursue their activities if they meet the requirements for
Regions (
obtaining a wholesale distribution authorisation in

2 ),
accordance with Directive 2001/83/EC. However,
Acting in accordance with the ordinary legislative procedure (
today’s distribution network for medicinal products is

3 ),
increasingly complex and involves many players who
Whereas:
are not necessarily wholesale distributors as referred to
in that Directive. In order to ensure the reliability of the
(1) Directive
2001/83/EC
of
the
European
Parliament
and
of
supply chain, legislation in relation to medicinal products
the Council (
should address all actors in the supply chain. This

4 ) lays down the rules for, inter alia, manu
facturing, importing, placing on the market, and the
includes not only wholesale distributors, whether or
wholesale distribution of medicinal products in the
not they physically handle the medicinal products, but
Union as well as rules relating to active substances.
also brokers who are involved in the sale or purchase of
medicinal products without selling or purchasing those
(2) There
is
an
alarming
increase
of
medicinal
products
products themselves, and without owning and physically
detected in the Union which are falsified in relation to
handling the medicinal products.
their identity, history or source. Those products usually
contain sub-standard or falsified ingredients, or no
(7) Falsified
active
substances
and
active
substances
that
do
ingredients or ingredients, including active substances,
not comply with applicable requirements of Directive
in the wrong dosage thus posing an important threat
2001/83/EC pose serious risks to public health. Those
to public health.
risks should be addressed by strengthening the verifi
cation requirements applicable to the manufacturer of
(3) Past
experience
shows
that
such
falsified
medicinal
the medicinal product.
products do not reach patients only through illegal
means, but via the legal supply chain as well. This
poses a particular threat to human health and may lead
(8) There
is
a
range
of
different
good
manufacturing
to a lack of trust of the patient also in the legal supply
practices that are suitable for being applied to the manu
chain. Directive 2001/83/EC should be amended in order
facturing of excipients. In order to provide for a high
to respond to this increasing threat.
level of protection of public health, the manufacturer
of the medicinal product should assess the suitability of
(4) The
threat
to
public
health
is
also
recognised
by
the
excipients on the basis of appropriate good manufac
World Health Organisation (WHO), which set up the
turing practices for excipients.
International Medical Products Anti-Counterfeiting
Taskforce (‘IMPACT’). IMPACT developed Principles and
(9)
In order to facilitate enforcement of and control of
Elements for National Legislation against Counterfeit
compliance with Union rules relating to active
Medical Products, which were endorsed by the IMPACT
substances, the manufacturers, importers or distributors
General Meeting in Lisbon on 12 December 2007. The
of those substances should notify the competent
Union participated actively in IMPACT.
authorities concerned of their activities.
(5) A
definition
of
‘falsified
medicinal
product’
should
be
introduced in order to clearly distinguish falsified
(10) Medicinal
products
may
be
introduced
into
the
Union
while not being intended to be imported, i.e. not
intended to be released for free circulation. If those
( 1 ) OJ C 317, 23.12.2009, p. 62.
medicinal products are falsified they present a risk to
( 2 ) OJ C 79, 27.3.2010, p. 50.
public health within the Union. In addition, those
( 3 ) Position of the European Parliament of 16 February 2011 (not yet
falsified medicinal products may reach patients in third
published in the Official Journal) and decision of the Council of
27 May 2011.
countries. Member States should take measures to
( 4 ) OJ L 311, 28.11.2001, p. 67.
prevent these falsified medicinal products, if introduced

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into the Union, from entering into circulation. When
orisation. In order for the safety features to be effective, a
adopting provisions supplementing this obligation on
manufacturing authorisation holder who is not himself
Member States to take those measures, the Commission
the original manufacturer of the medicinal product
should take account of the administrative resources
should only be permitted to remove, replace or cover
available and the practical implications, as well as the
those safety features under strict conditions. In particular,
need to maintain swift trade flows for legitimate
the safety features should be replaced in the case of
medicinal products. Those provisions should be without
repackaging by equivalent safety features. To this end,
prejudice to customs legislation, to the distribution of
the meaning of the term ‘equivalent’ should be clearly
competences between the Union and the Member
specified. Those strict conditions should provide
States and to the distribution of responsibilities within
adequate safeguards against falsified medicinal products
Member States.
entering the supply chain, in order to protect patients as
well as the interests of marketing authorisation holders
(11) Safety features for medicinal products should be
and manufacturers.
harmonised within the Union in order to take account
of new risk profiles, while ensuring the functioning of
the internal market for medicinal products. Those safety
(13) Manufacturing authorisation holders who repackage
features should allow verification of the authenticity and
medicinal products should be liable for damages in the
identification of individual packs, and provide evidence of
cases and under the conditions set out in Council
tampering. The scope of these safety features should take
Directive 85/374/EEC of 25 July 1985 on the approxi
due account of the particularities of certain medicinal
mation of the laws, regulations and administrative
products or categories of medicinal products, such as
provisions of the Member States concerning liability for
generic medicinal products. Medicinal products subject
defective products ( 2 ).
to prescription should as a general rule bear the safety
features. However, in view of the risk of falsification and
the risk arising from falsification of medicinal products
(14) In
order to increase reliability in the supply chain,
or categories of medicinal products there should be the
wholesale distributors should verify that their supplying
possibility to exclude certain medicinal products or
wholesale distributors are holders of a wholesale
categories of medicinal products subject to prescription
distribution authorisation.
from the requirement to bear the safety features by way
of a delegated act, following a risk assessment. Safety
features should not be introduced for medicinal
(15) The
provisions
applicable
to
the
export
of
medicinal
products or categories of medicinal products not
products from the Union and those applicable to the
subject to prescription unless, by way of exception, an
introduction of medicinal products into the Union with
assessment shows the risk of falsification, which leads to
the sole purpose of exporting them need to be clarified.
serious consequences. Those medicinal products should
Under Directive 2001/83/EC a person exporting
accordingly be listed in a delegated act.
medicinal products is a wholesale distributor. The
provisions applicable to wholesale distributors as well
as good distribution practices should apply to all those
The risk assessments should consider aspects such as the
activities whenever they are performed on Union
price of the medicinal product; previous cases of falsified
territory, including in areas such as free trade zones or
medicinal products being reported in the Union and in
free warehouses.
third countries; the implications of a falsification for

public health, taking into account the specific char
acteristics of the products concerned; and the severity
(16) In
order
to
ensure
transparency,
a
list
of
wholesale
of the conditions intended to be treated. The safety
distributors for whom it has been established that they
features should allow the verification of each supplied
comply with applicable Union legislation by means of an
pack of the medicinal products, regardless of how they
inspection by a competent authority of a Member State,
are supplied including through sale at a distance. The
should be published in a database that should be estab
unique identifier as well as the corresponding repositories
lished at Union level.
system should apply without prejudice to Directive
95/46/EC of the European Parliament and of the
Council of 24 October 1995 on the protection of indi
(17) The
provisions
on
inspections
and
controls
of
all
actors
viduals with regard to the processing of personal data
involved in the manufacturing and supply of medicinal
and on the free movement of such data ( 1 ) and should
products and their ingredients should be clarified and
retain clear and effective safeguards whenever personal
specific provisions should apply to different types of
data is processed. The repositories system containing
actors. This should not prevent Member States from
information on safety features might include
performing additional inspections, where considered
commercially sensitive information. This information
appropriate.
must be appropriately protected. When introducing the
obligatory safety features, due account should be taken of
the particular characteristics of the supply chains in
(18) In order to ensure a similar level of protection of human
Member States.
health throughout the Union, and to avoid distortions in
the internal market, the harmonised principles and
(12) Any
actor
in
the
supply
chain
who
packages
medicinal
guidelines for inspections of manufacturers and
products has to be a holder of a manufacturing auth
wholesale distributors of medicinal products as well
( 1 ) OJ L 281, 23.11.1995, p. 31.
( 2 ) OJ L 210, 7.8.1985, p. 29.

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Official Journal of the European Union
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as of active substances should be strengthened. Such
(24) Therefore, and in the light of the case-law of the Court of
harmonised principles and guidelines should also help
Justice, Member States should be able to impose
to ensure the functioning of existing mutual recognition
conditions justified by the protection of public health
agreements with third countries whose application
upon the retail supply of medicinal products offered
depends on efficient and comparable inspection and
for sale at a distance by means of information society
enforcement throughout the Union.
services. Such conditions should not unduly restrict the
functioning of the internal market.
(19) Manufacturing
plants of active substances should be
subject not only to inspections carried out on the
grounds of suspected non-compliance but also on the
(25) The
public
should
be
assisted
in
identifying
websites
basis of a risk-analysis.
which are legally offering medicinal products for sale at

a distance to the public. A common logo should be
established, which is recognisable throughout the
(20) The
manufacture
of
active
substances
should
be
subject
Union, while allowing for the identification of the
to good manufacturing practice regardless of whether
Member State where the person offering medicinal
those active substances are manufactured in the Union
products for sale at a distance is established. The
or imported. With regard to the manufacture of active
Commission should develop the design for such a logo.
substances in third countries, it should be ensured that
Websites offering medicinal products for sale at a
the legislative provisions applicable to the manufacturing
distance to the public should be linked to the website
of active substances intended for export to the Union, as
of the competent authority concerned. The websites of
well as inspections of facilities and enforcement of the
the competent authorities of Member States, as well as
applicable provisions, provide for a level of protection of
that of the European Medicines Agency (‘the Agency’),
public health equivalent to that provided for by Union
should give an explanation of the use of the logo. All
law.
those websites should be linked in order to provide
comprehensive information to the public.
(21) The
illegal
sale
of
medicinal
products
to
the
public
via
the Internet is an important threat to public health as
falsified medicinal products may reach the public in this
(26) In
addition,
the
Commission
should,
in
cooperation
with
way. It is necessary to address this threat. In doing so,
the Agency and Member States, run awareness campaigns
account should be taken of the fact that specific
to warn of the risks of purchasing medicinal products
conditions for retail supply of medicinal products to
from illegal sources via the Internet.
the public have not been harmonised at Union level
and, therefore, Member States may impose conditions
for supplying medicinal products to the public within
(27) Member States should impose effective penalties for acts
the limits of the Treaty on the Functioning of the
involving falsified medicinal products taking into account
European Union (TFEU).
the threat to public health posed by those products.
(22) When
examining
the
compatibility
with
Union
law
of
the
(28) The falsification of medicinal products is a global
conditions for the retail supply of medicinal products, the
problem, requiring effective and enhanced international
Court of Justice of the European Union (‘the Court of
coordination and cooperation in order to ensure that
Justice’) has recognised the very particular nature of
anti-falsification strategies are more effective, in particular
medicinal products, whose therapeutic effects distinguish
as regards sale of such products via the Internet. To that
them substantially from other goods. The Court of Justice
end, the Commission and the Member States should
has also held that health and life of humans rank
cooperate closely and support ongoing work in inter
foremost among the assets and interests protected by
national fora on this subject, such as the Council of
the TFEU and that it is for Member States to determine
Europe, Europol and the United Nations. In addition,
the level of protection which they wish to afford to
the Commission, working closely with Member States,
public health and the way in which that level has to
should cooperate with the competent authorities of
be achieved. Since that level may vary from one
third countries with a view to effectively combating the
Member State to another, Member States must be
trade in falsified medicinal products at a global level.
allowed discretion ( 1 ) as regards the conditions for the
supply on their territory of medicinal products to the
public.
(29) This Directive is without prejudice to provisions
concerning intellectual property rights. It aims specifically
(23) In particular, in the light of the risks to public health and
to prevent falsified medicinal products from entering the
given the power accorded to Member States to determine
legal supply chain.
the level of protection of public health, the case-law of
the Court of Justice has recognised that Member States
may, in principle, restrict the retail sale of medicinal
(30) The Commission should be empowered to adopt
delegated acts in accordance with Article 290 TFEU in
products to pharmacists alone ( 2 ).
order to supplement the provisions of Directive
2001/83/EC, as amended by this Directive, concerning
( 1 ) Judgment of the Court of 19 May 2009 in Joined Cases C-171/07
good manufacturing and distribution practices for
and C-172/07 Apothekerkammer des Saarlandes and Others v Saarland
active substances, concerning detailed rules for
ECR [2009] I-4171, paragraphs 19 and 31.
medicinal products introduced into the Union without
( 2 ) Judgment of the Court of 19 May 2009 in Joined Cases C-171/07
and C-172/07 Apothekerkammer des Saarlandes and Others v Saarland
being imported and concerning safety features. It is of
ECR [2009] I-4171, paragraphs 34 and 35.
particular importance that the Commission carry

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out appropriate consultations during its preparatory
(35) In
accordance
with
point
34
of
the
Interinstitutional
work, including at expert level. The Commission, when
Agreement on better law-making ( 2 ), Member States are
preparing and drawing up delegated acts, should ensure a
encouraged to draw up, for themselves and in the
simultaneous, timely and appropriate transmission of
interests of the Union, their own tables illustrating, as
relevant documents to the European Parliament and
far as possible, the correlation between this Directive
Council.
and the transposition measures, and to make them
public.
(31) In
order
to
ensure
uniform
conditions
for
implemen
(36) Directive
2001/83/EC
was
recently
amended
by
Directive
tation, implementing powers should be conferred on
2010/84/EU ( 3 ) as regards pharmacovigilance. That
the Commission as regards the adoption of measures
Directive, inter alia, amended Article 111 with regard
for the assessment of the regulatory framework
to inspections and Article 116 with regard to the
applicable to the manufacturing of active substances
suspension and revocation and variation of marketing
exported from third countries to the Union and as
authorisations under certain circumstances. Furthermore,
regards a common logo that identifies websites which
it inserted provisions on delegated acts in Articles 121a,
are legally offering medicinal products for sale at a
121b and 121c of Directive 2001/83/EC. This Directive
distance to the public. Those powers should be
requires some further and complementary changes to
exercised in accordance with Regulation (EU) No
those Articles of Directive 2001/83/EC.
182/2011 of the European Parliament and of the
Council of 16 February 2011 laying down the rules
(37) Directive
2001/83/EC
should
be
amended
accordingly,
and general principles concerning mechanisms for
control by Member States of the Commission’s exercise
of implementing powers (
HAVE ADOPTED THIS DIRECTIVE:

1 ).
Article 1
(32) The
safety
features
for
medicinal
products
introduced
Directive 2001/83/EC is hereby amended as follows:
under this Directive require substantial adaptations to
manufacturing processes. In order to enable manu
facturers to make those adaptations, the time limits for
(1) Article 1 is amended as follows:
the application of the provisions on the safety features
should be sufficiently long and should be calculated as
(a) the following points are inserted:
from the date of publication in the Official Journal of the
European Union of the delegated acts setting out detailed
‘3a. Active substance:
rules in relation to those safety features. It should also be
taken into account that some Member States already have
Any substance or mixture of substances intended
a national system in place. Those Member States should
to be used in the manufacture of a medicinal
be granted an additional transitional period for adapting
product and that, when used in its production,
to the harmonised Union system.
becomes an active ingredient of that product
intended to exert a pharmacological, immuno
logical or metabolic action with a view to
(33) Since
the
objective
of
this
Directive,
namely
to
safeguard
restoring, correcting or modifying physiological
the functioning of the internal market for medicinal
functions or to make a medical diagnosis.
products, whilst ensuring a high level of protection of
public health against falsified medicinal products, cannot
3b. Excipient:
be sufficiently achieved by the Member States, and can,
by reason of the scale of the measure, be better achieved
Any constituent of a medicinal product other
at Union level, the Union may adopt measures, in
than the active substance and the packaging
accordance with the principle of subsidiarity as set out
material.’;
in Article 5 of the Treaty on European Union. In
accordance with the principle of proportionality, as set
out in that Article, this Directive does not go beyond
(b) the following point is inserted:
what is necessary in order to achieve that objective.
‘17a. Brokering of medicinal products:
(34) It is important that the competent authorities of the
All activities in relation to the sale or purchase
Member States, the Commission and the Agency
of medicinal products, except for wholesale
cooperate to ensure the exchange of information on
distribution, that do not include physical
measures taken to combat the falsification of medicinal
handling and that consist of negotiating inde
products and on the penalties systems that are in place.
pendently and on behalf of another legal or
Currently, such exchange takes place through the
natural person.’;
Working Group of Enforcement Officers. Member
States should ensure that patients’ and consumers’
(c) the following point is added:
organisations are kept informed about enforcement
activities to the extent that this is compatible with oper
‘33. Falsified medicinal product:
ational needs.
( 2 ) OJ C 321, 31.12.2003, p. 1.
( 1 ) OJ L 55, 28.2.2011, p. 13.
( 3 ) OJ L 348, 31.12.2010, p. 74.

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Any medicinal product with a false representation
holder of the manufacturing authorisation shall
of:
verify such compliance either by himself or, without
prejudice to his responsibility as provided for in this
(a) its identity, including its packaging and
Directive, through an entity acting on his behalf under
labelling, its name or its composition as
a contract.
regards any of the ingredients including
excipients and the strength of those
The holder of the manufacturing authorisation shall
ingredients;
ensure that the excipients are suitable for use in
medicinal products by ascertaining what the appro
(b) its source, including its manufacturer, its
priate good manufacturing practice is. This shall be
country of manufacturing, its country of
ascertained on the basis of a formalised risk
origin or its marketing authorisation holder;
assessment in accordance with the applicable
or
guidelines referred to in the fifth paragraph of
Article 47. Such risk assessment shall take into
(c) its history, including the records and
account requirements under other appropriate
documents relating to the distribution
quality systems as well as the source and intended
channels used.
use of the excipients and previous instances of
This definition does not include unintentional
quality defects. The holder of the manufacturing auth
quality defects and is without prejudice to
orisation shall ensure that the appropriate good
infringements of intellectual property rights.’;
manufacturing practice so ascertained, is applied.
The holder of the manufacturing authorisation shall
(2) in Article 2, paragraph 3 is replaced by the following:
document the measures taken under this paragraph;
‘3. Notwithstanding
paragraph
1
of
this
Article
and
(g) to inform the competent authority and the marketing
Article 3(4), Title IV of this Directive shall apply to the
authorisation holder immediately if he obtains
manufacture of medicinal products intended only for
information that medicinal products which come
export and to intermediate products, active substances
under the scope of his manufacturing authorisation
and excipients.
are, or are suspected of being, falsified irrespective
of whether those medicinal products were distributed
4. Paragraph
1
shall
be
without
prejudice
to
Articles
within the legal supply chain or by illegal means,
52b and 85a.’;
including illegal sale by means of information
society services;
(3) in Article 8(3), the following point is inserted:
(h) to verify that the manufacturers, importers or
‘(ha) A written confirmation that the manufacturer of the
distributors from whom he obtains active substances
medicinal product has verified compliance of the
are registered with the competent authority of the
manufacturer of the active substance with principles
Member State in which they are established;
and guidelines of good manufacturing practice by
conducting audits, in accordance with point (f) of
Article 46. The written confirmation shall contain
(i) to verify the authenticity and quality of the active
a reference to the date of the audit and a declaration
substances and the excipients.’;
that the outcome of the audit confirms that the
manufacturing complies with the principles and
(6) the following Article is inserted:
guidelines of good manufacturing practice.’;
‘Article 46b
(4) in Article 40, paragraph 4 is replaced by the following:
1. Member
States
shall
take
appropriate
measures
to
‘4. Member
States
shall
enter
the
information
relating
to
ensure that the manufacture, import and distribution on
the authorisation referred to in paragraph 1 of this Article
their territory of active substances, including active
in the Union database referred to in Article 111(6).’;
substances that are intended for export, comply with
good manufacturing practice and good distribution
(5) in Article 46, point (f) is replaced by the following:
practices for active substances.
‘(f) to comply with the principles and guidelines of good
2. Active
substances
shall
only
be
imported
if
the
manufacturing practice for medicinal products and to
following conditions are fulfilled:
use only active substances, which have been manu
factured in accordance with good manufacturing
practice for active substances and distributed in
(a) the active substances have been manufactured in
accordance with good distribution practices for
accordance with standards of good manufacturing
active substances. To this end, the holder of the
practice at least equivalent to those laid down by the
manufacturing authorisation shall verify compliance
Union pursuant to the third paragraph of Article 47;
by the manufacturer and distributors of active
and
substances with good manufacturing practice and
good distribution practices by conducting audits at
(b) the active substances are accompanied by a written
the manufacturing and distribution sites of the manu
confirmation from the competent authority of the
facturer and distributors of active substances. The
exporting third country of the following:

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(i) the standards of good manufacturing practice
(a) the manufacturing authorisation holder verifies, prior
applicable to the plant manufacturing the
to partly or fully removing or covering those safety
exported active substance are at least equivalent
features, that the medicinal product concerned is
to those laid down by the Union pursuant to
authentic and that it has not been tampered with;
the third paragraph of Article 47;
(b) the manufacturing authorisation holder complies with
(ii) the manufacturing plant concerned is subject to
point (o) of Article 54 by replacing those safety
regular, strict and transparent controls and to
features with safety features which are equivalent as
the effective enforcement of good manufacturing
regards the possibility to verify the authenticity, identi
practice, including repeated and unannounced
fication and to provide evidence of tampering of the
inspections, so as to ensure a protection of
medicinal product. Such replacement shall be
public health at least equivalent to that in the
conducted without opening the immediate packaging
Union; and
as defined in point 23 of Article 1.
(iii) in the event of findings relating to non-
Safety features shall be considered equivalent if they:
compliance, information on such findings is
supplied by the exporting third country to the
(i) comply with the requirements set out in the
Union without any delay.
delegated acts adopted pursuant to Article 54a(2);
and
This written confirmation shall be without prejudice to the
obligations set out in Article 8 and in point (f) of
(ii) are equally effective in enabling the verification of
Article 46.
authenticity and identification of medicinal
products and in providing evidence of tampering
3. The
requirement
set
out
in
point
(b)
of
paragraph
2
with medicinal products;
of this Article shall not apply if the exporting country is
included in the list referred to in Article 111b.
(c) the replacement of the safety features is conducted in
accordance with applicable good manufacturing
4. Exceptionally
and
where
necessary
to
ensure
the
practice for medicinal products; and
availability of medicinal products, when a plant manufac
turing an active substance for export has been inspected
(d) the replacement of the safety features is subject to
by a Member State and was found to comply with the
supervision by the competent authority.
principles and guidelines of good manufacturing practice
laid down pursuant to the third paragraph of Article 47,
2. Manufacturing
authorisation
holders,
including
those
the requirement set out in point (b) of paragraph 2 of this
performing the activities referred to in paragraph 1 of this
Article may be waived by any Member State for a period
Article, shall be regarded as producers and therefore held
not exceeding the validity of the certificate of Good Manu
liable for damages in the cases and under the conditions
facturing Practice. Member States that make use of the
set forth in Directive 85/374/EEC.’;
possibility of such waiver, shall communicate this to the
Commission.’;
(9) in Article 51(1), the following subparagraph is inserted
(7) in Article 47, the third and fourth paragraphs are replaced
before the second subparagraph:
by the following:
‘The qualified person referred to in Article 48 shall in the
‘The Commission shall adopt, by means of delegated acts
case of medicinal products intended to be placed on the
in accordance with Article 121a and subject to the
market in the Union, ensure that the safety features
conditions laid down in Articles 121b and 121c, the prin
referred to in point (o) of Article 54 have been affixed
ciples and guidelines of good manufacturing practice for
on the packaging.’;
active substances referred to in the first paragraph of point
(f) of Article 46 and in Article 46b.
(10) the following Articles are inserted:
The principles of good distribution practices for active
‘Article 52a
substances referred to in the first paragraph of point (f)
1. Importers,
manufacturers
and
distributors
of
active
of Article 46 shall be adopted by the Commission in the
substances who are established in the Union shall
form of guidelines.
register their activity with the competent authority of the
Member State in which they are established.
The Commission shall adopt guidelines on the formalised
risk assessment for ascertaining the appropriate good
2. The registration form shall include, at least, the
manufacturing practice for excipients referred to in the
following information:
second paragraph of point (f) of Article 46.’;
(8) the following Article is inserted:
(i) name or corporate name and permanent address;
‘Article 47a
(ii) the active substances which are to be imported, manu
factured or distributed;
1. The safety features referred to in point (o) of
Article 54 shall not be removed or covered, either fully
(iii) particulars regarding the premises and the technical
or partially, unless the following conditions are fulfilled:
equipment for their activity.

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L 174/80
EN
Official Journal of the European Union
1.7.2011
3. The
persons
referred
to
in
paragraph
1
shall
submit
— verify the authenticity of the medicinal product,
the registration form to the competent authority at least
and
60 days prior to the intended commencement of their
activity.
— identify individual packs,
4. The
competent
authority
may,
based
on
a
risk
as well as a device allowing verification of whether
assessment, decide to carry out an inspection. If the
the outer packaging has been tampered with.’;
competent authority notifies the applicant within 60
(12) the following Article is inserted:
days of the receipt of the registration form that an
inspection will be carried out, the activity shall not begin
‘Article 54a
before the competent authority has notified the applicant
that he may commence the activity. If within 60 days of
1. Medicinal
products
subject
to
prescription
shall
bear
the receipt of the registration form the competent
the safety features referred to in point (o) of Article 54,
authority has not notified the applicant that an inspection
unless they have been listed in accordance with the
will be carried out, the applicant may commence the
procedure pursuant to point (b) of paragraph 2 of this
activity.
Article.
5. The
persons
referred
to
in
paragraph
1
shall
Medicinal products not subject to prescription shall not
communicate annually to the competent authority an
bear the safety features referred to in point (o) of
inventory of the changes which have taken place as
Article 54, unless, by way of exception, they have been
regards the information provided in the registration
listed in accordance with the procedure pursuant to point
form. Any changes that may have an impact on the
(b) of paragraph 2 of this Article, after having been
quality or safety of the active substances that are manu
assessed to be at risk of falsification.
factured, imported or distributed must be notified
immediately.
2. The
Commission
shall
adopt,
by
means
of
delegated
acts in accordance with Article 121a and subject to the
conditions laid down in Articles 121b and 121c, measures
6. Persons
referred
to
in
paragraph
1
who
had
supplementing point (o) of Article 54 with the objective of
commenced their activity before 2 January 2013 shall
establishing the detailed rules for the safety features
submit the registration form to the competent authority
referred to in point (o) of Article 54.
by 2 March 2013.
Those delegated acts shall set out:
7. Member
States
shall
enter
the
information
provided
in accordance with paragraph 2 of this Article in the
(a) the characteristics and technical specifications of the
Union database referred to in Article 111(6).
unique identifier of the safety features referred to in
point (o) of Article 54 that enables the authenticity of
8. This Article shall be without prejudice to
medicinal products to be verified and individual packs
Article 111.
to be identified. When establishing the safety features
due consideration shall be given to their cost-effec
Article 52b
tiveness;
1. Notwithstanding
Article
2(1),
and
without
prejudice
(b) the lists containing the medicinal products or product
to Title VII, Member States shall take the necessary
categories which, in the case of medicinal products
measures in order to prevent medicinal products that are
subject to prescription shall not bear the safety
introduced into the Union, but are not intended to be
features, and in the case of medicinal products not
placed on the market of the Union, from entering into
subject to prescription shall bear the safety features
circulation if there are sufficient grounds to suspect that
referred to in point (o) of Article 54. Those lists
those products are falsified.
shall be established considering the risk of and the
risk arising from falsification relating to medicinal
2. In
order
to
establish
what
the
necessary
measures
products or categories of medicinal products. To this
referred to in paragraph 1 of this Article are, the
end, at least the following criteria shall be applied:
Commission may adopt, by means of delegated acts in
accordance with Article 121a, and subject to the
(i) the price and sales volume of the medicinal
conditions laid down in Articles 121b and 121c,
product;
measures supplementing paragraph 1 of this Article as
regards the criteria to be considered and the verifications
(ii) the number and frequency of previous cases of
to be made when assessing the potential falsified character
falsified medicinal products being reported
of medicinal products introduced into the Union but not
within the Union and in third countries and the
intended to be placed on the market.’;
evolution of the number and frequency of such
cases to date;
(11) in Article 54, the following point is added:
(iii) the specific characteristics of the medicinal
products concerned;
‘(o) for medicinal products other than radiophar
maceuticals referred to in Article 54a(1), safety
(iv) the severity of the conditions intended to be
features enabling wholesale distributors and persons
treated;
authorised or entitled to supply medicinal products to
the public to:
(v) other potential risks to public health;

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EN
1.7.2011 Official
Journal
of
the
European
Union L
174/81
(c) the procedures for the notification to the Commission
device referred to in point (o) of Article 54 to any
provided for in paragraph 4 and a rapid system for
medicinal product.’;
evaluating and deciding on such notification for the
purpose of applying point (b);
(13) in Article 57, the fourth indent of the first paragraph is
replaced by the following:
(d) the modalities for the verification of the safety features
referred to in point (o) of Article 54 by the manu
‘— authenticity and identification in accordance with
facturers, wholesalers, pharmacists and persons auth
Article 54a(5).’;
orised or entitled to supply medicinal products to the
public and by the competent authorities. Those
(14) the heading of title VII is replaced by the following:
modalities shall allow the verification of the auth
enticity of each supplied pack of the medicinal
‘Wholesale distribution and brokering of medicinal
products bearing the safety features referred to in
products’;
point (o) of Article 54 and determine the extent of
such verification. When establishing those modalities,
(15) in Article 76, paragraph 3 is replaced by the following:
the particular characteristics of the supply chains in
Member States, and the need to ensure that the
‘3. Any
distributor,
not
being
the
marketing
authori
impact of verification measures on particular actors
sation holder, who imports a medicinal product from
in the supply chains is proportionate, shall be taken
another Member State shall notify the marketing authori
into account;
sation holder and the competent authority in the Member
State to which the medicinal product will be imported of
(e) provisions on the establishment, management and
his intention to import that product. In the case of
accessibility of the repositories system in which
medicinal products which have not been granted an auth
information on the safety features, enabling the verifi
orisation pursuant to Regulation (EC) No 726/2004, the
cation of the authenticity and identification of
notification to the competent authority shall be without
medicinal products, as provided for in point (o) of
prejudice to additional procedures provided for in the
Article 54, shall be contained. The costs of the reposi
legislation of that Member State and to fees payable to
tories system shall be borne by the manufacturing
the competent authority for examining the notification.
authorisation holders of medicinal products bearing
the safety features.
4. In
the
case
of
medicinal
products
which
have
been
granted an authorisation pursuant to Regulation (EC) No
3. When adopting the measures referred to in
726/2004, the distributor shall submit the notification in
paragraph 2, the Commission shall take due account of
accordance with paragraph 3 of this Article to the
at least the following:
marketing authorisation holder and the Agency. A fee
shall be payable to the Agency for checking that the
(a) the protection of personal data as provided for in
conditions laid down in Union legislation on medicinal
Union law;
products and in the marketing authorisations are
observed.’;
(b) the legitimate interests to protect information of a
commercially confidential nature;
(16) Article 77 is amended as follows:
(c) the ownership and confidentiality of the data generated
(a) paragraph 1 is replaced by the following:
by the use of the safety features; and
‘1. Member States shall take all appropriate
(d) the cost-effectiveness of the measures.
measures to ensure that the wholesale distribution of
medicinal products is subject to the possession of an
4. The
national
competent
authorities
shall
notify
the
authorisation to engage in activity as a wholesaler in
Commission of non-prescription medicinal products which
medicinal products, stating the premises located on
they judge to be at risk of falsification and may inform the
their territory for which it is valid.’;
Commission of medicinal products which they deem not
to be at risk according to the criteria set out in point (b) of
(b) paragraphs 4 and 5 are replaced by the following:
paragraph 2 of this Article.
‘4. Member
States
shall
enter
the
information
5. Member
States
may,
for
the
purposes
of
reim
relating to the authorisations referred to in paragraph
bursement or pharmacovigilance, extend the scope of
1 of this Article in the Union database referred to in
application of the unique identifier referred to in point
Article 111(6). At the request of the Commission or
(o) of Article 54 to any medicinal product subject to
any Member State, Member States shall provide all
prescription or subject to reimbursement.
appropriate information concerning the individual
authorisations which they have granted under
Member States may, for the purposes of reimbursement,
paragraph 1 of this Article.
pharmacovigilance or pharmacoepidemiology, use the
information contained in the repositories system referred
5. Checks
on
the
persons
authorised
to
engage
in
to in point (e) of paragraph 2 of this Article.
activity as a wholesaler in medicinal products, and the
inspection of their premises, shall be carried out under
Member States may, for the purposes of patient safety,
the responsibility of the Member State which granted
extend the scope of application of the anti-tampering
the authorisation for premises located on its territory.’;

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L 174/82
EN
Official Journal of the European Union
1.7.2011
(17) Article 80 is amended as follows:
(18) in the first paragraph of Article 82, the following indent is
added:
(a) the following point is inserted:
‘— batch number of the medicinal products at least for
‘(ca) they must verify that the medicinal products
products bearing the safety features referred to in
received are not falsified by checking the safety
point (o) of Article 54;’;
features on the outer packaging, in accordance
with the requirements laid down in the
delegated acts referred to in Article 54a(2);’;
(19) the following Articles are inserted:
(b) point (e) is replaced by the following:
‘Article 85a
In the case of wholesale distribution of medicinal products
‘(e) they must keep records either in the form of
to third countries, Article 76 and point (c) of Article 80
purchase/sales invoices or on computer, or in
shall not apply. Moreover, points (b) and (ca) of Article 80
any other form, giving for any transaction in
shall not apply where a product is directly received from a
medicinal products received, dispatched or
third country but not imported. The requirements set out
brokered at least the following information:
in Article 82 shall apply to the supply of medicinal
products to persons in third countries authorised or
— date,
entitled to supply medicinal products to the public.
— name of the medicinal product,
Article 85b
— quantity received, supplied or brokered,
1. Persons
brokering
medicinal
products
shall
ensure
that the brokered medicinal products are covered by a
marketing authorisation granted pursuant to Regulation
— name and address of the supplier or consignee,
(EC) No 726/2004 or by the competent authorities of a
as appropriate,
Member State in accordance with this Directive.
— batch number of the medicinal products at
least for products bearing the safety features
Persons brokering medicinal products shall have a
referred to in point (o) of Article 54;’;
permanent address and contact details in the Union, so
as to ensure accurate identification, location, communi
cation and supervision of their activities by competent
(c) the following points are added:
authorities.
‘(h) they must maintain a quality system setting out
responsibilities, processes and risk management
The requirements set out in points (d) to (i) of Article 80
measures in relation to their activities;
shall apply mutatis mutandis to the brokering of medicinal
products.
(i) they must immediately inform the competent
authority and, where applicable, the marketing
2. Persons
may
only
broker
medicinal
products
if
they
authorisation holder, of medicinal products they
are registered with the competent authority of the Member
receive or are offered which they identify as
State of their permanent address referred to in paragraph
falsified or suspect to be falsified.’;
1. Those persons shall submit, at least, their name,
corporate name and permanent address in order to
(d) the following paragraphs are added:
register. They shall notify the competent authority of any
changes thereof without unnecessary delay.
‘For the purposes of point (b), where the medicinal
product is obtained from another wholesale
Persons brokering medicinal products who had
distributor, wholesale distribution authorisation
commenced their activity before 2 January 2013 shall
holders must verify compliance with the principles
register with the competent authority by 2 March 2013.
and guidelines of good distribution practices by the
supplying wholesale distributor. This includes
verifying whether the supplying wholesale distributor
The competent authority shall enter the information
holds a wholesale distribution authorisation.
referred to in the first subparagraph in a register that
shall be publicly accessible.
Where the medicinal product is obtained from the
manufacturer or importer, wholesale distribution auth
3. The
guidelines
referred
to
in
Article
84
shall
include
orisation holders must verify that the manufacturer or
specific provisions for brokering.
importer holds a manufacturing authorisation.
4. This Article shall be without prejudice to
Where the medicinal product is obtained through
Article 111. Inspections referred to in Article 111 shall
brokering, the wholesale distribution authorisation
be carried out under the responsibility of the Member
holders must verify that the broker involved fulfils
State where the person brokering medicinal products is
the requirements set out in this Directive.’;
registered.

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EN
1.7.2011 Official
Journal
of
the
European
Union L
174/83
If a person brokering medicinal products does not comply
(ii) a hyperlink to the website referred to in paragraph
with the requirements set out in this Article, the
4 of the Member State of establishment;
competent authority may decide to remove that person
from the register referred to in paragraph 2. The
(iii) the common logo referred to in paragraph 3
competent authority shall notify that person thereof.’;
clearly displayed on every page of the website
that relates to the offer for sale at a distance to
(20) the following Title is inserted before Title VIII:
the public of medicinal products. The common
logo shall contain a hyperlink to the entry of
‘TITLE VIIA
the person in the list referred to in point (c) of
SALE AT A DISTANCE TO THE PUBLIC
paragraph 4.
Article 85c
2. Member
States
may
impose
conditions,
justified
on
1. Without
prejudice
to
national
legislation
prohibiting
grounds of public health protection, for the retail supply
the offer for sale at a distance of prescription medicinal
on their territory of medicinal products for sale at a
products to the public by means of information society
distance to the public by means of information society
services, Member States shall ensure that medicinal
services.
products are offered for sale at a distance to the public
by means of information society services as defined in
3. A
common
logo
shall
be
established
that
is
recog
Directive 98/34/EC of the European Parliament and of
nisable throughout the Union, while enabling the identifi
the Council of 22 June 1998 laying down a procedure
cation of the Member State where the person offering
for the provision of information in the field of technical
medicinal products for sale at a distance to the public is
standards and regulations and of rules on Information
established. That logo shall be clearly displayed on
Society services (*) under the following conditions:
websites offering medicinal products for sale at a
distance to the public in accordance with point (d) of
(a) the natural or legal person offering the medicinal
paragraph 1.
products is authorised or entitled to supply medicinal
products to the public, also at a distance, in
In order to harmonise the functioning of the common
accordance with national legislation of the Member
logo, the Commission shall adopt implementing acts
State in which that person is established;
regarding:
(b) the person referred to in point (a) has notified the
(a) the technical, electronic and cryptographic
Member State in which that person is established of
requirements for verification of the authenticity of
at least the following information:
the common logo;
(i) name or corporate name and permanent address
(b) the design of the common logo.
of the place of activity from where those
medicinal products are supplied;
Those implementing acts shall, where necessary, be
(ii) the starting date of the activity of offering
amended to take account of technical and scientific
medicinal products for sale at a distance to the
progress. Those implementing acts shall be adopted in
public by means of information society services;
accordance with the procedure referred to in
Article 121(2).
(iii) the address of the website used for that purpose
and all relevant information necessary to identify
4. Each
Member
State
shall
set
up
a
website
providing
that website;
at least the following:
(iv) if applicable, the classification in accordance with
(a) information on the national legislation applicable to
Title VI of the medicinal products offered for sale
the offering of medicinal products for sale at a
at a distance to the public by means of
distance to the public by means of information
information society services.
society services, including information on the fact
that there may be differences between Member States
Where appropriate, that information shall be updated;
regarding classification of medicinal products and the
(c) the medicinal products comply with the national legis
conditions for their supply;
lation of the Member State of destination in
accordance with Article 6(1);
(b) information on the purpose of the common logo;
(d) without prejudice to the information requirements set
(c) the list of persons offering the medicinal products for
out in Directive 2000/31/EC of the European
sale at a distance to the public by means of
Parliament and of the Council of 8 June 2000 on
information society services in accordance with
certain legal aspects of information society services,
paragraph 1 as well as their website addresses;
in particular electronic commerce, in the Internal
Market (Directive on electronic commerce) (**), the
(d) background information on the risks related to
website offering the medicinal products contains at
medicinal products supplied illegally to the public by
least:
means of information society services.
(i) the contact details of the competent authority or
This website shall contain a hyperlink to the website
the authority notified pursuant to point (b);
referred to in paragraph 5.

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L 174/84
EN
Official Journal of the European Union
1.7.2011
5. The
Agency
shall
set
up
a
website
providing
the
by inspections at an appropriate frequency based on
information referred to in points (b) and (d) of
risk, at the premises of the manufacturers, importers,
paragraph 4, information on the Union legislation
or distributors of active substances, located on its
applicable to falsified medicinal products as well as
territory, and effective follow-up thereof.
hyperlinks to the Member States’ websites referred to in
paragraph 4. The Agency’s website shall explicitly mention
Whenever it considers that there are grounds for
that the Member States’ websites contain information on
suspecting non-compliance with the legal requirements
persons authorised or entitled to supply medicinal
laid down in this Directive, including the principles
products at a distance to the public by means of
and guidelines of good manufacturing practice and
information society services in the Member State
good distribution practices referred to in point (f) of
concerned.
Article 46 and in Article 47, the competent authority
may carry out inspections at the premises of:
6. Without
prejudice
to
Directive
2000/31/EC
and
the
requirements set out in this Title, Member States shall take
(a) manufacturers or distributors of active substances
the necessary measures to ensure that other persons than
located in third countries;
those referred to in paragraph 1 that offer medicinal
products for sale at a distance to the public by means of
(b) manufacturers or importers of excipients.
information society services and that operate on their
territory are subject to effective, proportionate and
1c. Inspections referred to in paragraphs 1a and 1b
dissuasive penalties.
may also be carried out in the Union and in third
countries at the request of a Member State, the
Article 85d
Commission or the Agency.
Without prejudice to the competences of the Member
States, the Commission shall, in cooperation with the
1d. Inspections
may
also
take
place
at
the
premises
Agency and Member State authorities, conduct or
of marketing authorisation holders and of brokers of
promote information campaigns aimed at the general
medicinal products.
public on the dangers of falsified medicinal products.
Those campaigns shall raise consumer awareness of the
1e. In
order
to
verify
whether
the
data
submitted
in
risks related to medicinal products supplied illegally at a
order to obtain a conformity certificate comply with
distance to the public by means of information society
the monographs of the European Pharmacopoeia, the
services and of the functioning of the common logo, the
standardisation body of the nomenclatures and the
Member States’ websites and the Agency’s website.
quality norms within the meaning of the Convention
relating to the elaboration of the European Phar
___________
macopoeia (the European Directorate for the Quality
(*) OJ L 204, 21.7.1998, p. 37.
of Medicines and Healthcare) may ask the Commission
(**) OJ L 178, 17.7.2000, p. 1.’;
or the Agency to request such an inspection when the
starting material concerned is the subject of a
European Pharmacopoeia monograph.
(21) Article 111 is amended as follows:
1f. The
competent
authority
of
the
Member
State
concerned may carry out inspections of starting
(a) paragraph 1 is replaced by the following:
material manufacturers at the specific request of the
manufacturer.
‘1. The
competent
authority
of
the
Member
State
concerned shall, in cooperation with the Agency,
1g. Inspections
shall
be
carried
out
by
officials
ensure that the legal requirements governing
representing the competent authority who shall be
medicinal products are complied with, by means of
empowered to:
inspections, if necessary unannounced, and, where
appropriate, by asking an Official Medicines Control
(a) inspect the manufacturing or commercial estab
Laboratory or a laboratory designated for that
lishments of manufacturers of medicinal products,
purpose to carry out tests on samples. This coop
of active substances or of excipients, and any
eration shall consist in sharing information with the
laboratories employed by the holder of the manu
Agency on both inspections that are planned and that
facturing authorisation to carry out checks
have been conducted. Member States and the Agency
pursuant to Article 20;
shall cooperate in the coordination of inspections in
third countries. The inspections shall include but not
(b) take samples including with a view to independent
be limited to the ones mentioned in paragraphs 1a to
tests being carried out by an Official Medicines
1f.
Control Laboratory or a laboratory designated for
that purpose by a Member State;
1a. Manufacturers, located in the Union or in third
countries, and wholesale distributors of medicinal
(c) examine any documents relating to the object of
products shall be subject to repeated inspections.
the inspection, subject to the provisions in force in
the Member States on 21 May 1975 placing
1b. The
competent
authority
of
the
Member
State
restrictions on these powers with regard to the
concerned shall have a system of supervision including
description of the manufacturing method;

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EN
1.7.2011 Official
Journal
of
the
European
Union L
174/85
(d) inspect the premises, records, documents and phar
(d) in the first subparagraph of paragraph 8, the words
macovigilance system master file of the marketing
‘paragraph 1(d)’ are replaced by the words ‘point (d) of
authorisation holder or any firms employed by the
paragraph 1g’;
marketing authorisation holder to perform the
activities described in Title IX.
(22) the following Articles are inserted:
1h. Inspections
shall
be
carried
out
in
accordance
with the guidelines referred to in Article 111a.’;
‘Article 111a
The Commission shall adopt detailed guidelines laying
(b) paragraphs 3 to 6 are replaced by the following:
down the principles applicable to inspections referred to
in Article 111.
‘3. After every inspection as referred to in
paragraph 1, the competent authority shall report on
whether the inspected entity complies with the prin
Member States shall, in cooperation with the Agency,
ciples and guidelines of good manufacturing practice
establish the form and content of the authorisation
and good distribution practices referred to in Articles
referred to in Articles 40(1) and 77(1), of the reports
47 and 84, as applicable, or on whether the marketing
referred to in Article 111(3), of the certificates of good
authorisation holder complies with the requirements
manufacturing practice and of the certificates of good
laid down in Title IX.
distribution practices referred to in Article 111(5).
The competent authority which carried out the
Article 111b
inspection shall communicate the content of those
reports to the inspected entity.
1. At the request of a third country, the Commission
shall assess whether that country’s regulatory framework
applicable to active substances exported to the Union and
Before adopting the report, the competent authority
the respective control and enforcement activities ensure a
shall give the inspected entity concerned the oppor
level of protection of public health equivalent to that of
tunity to submit comments.
the Union. If the assessment confirms such equivalence,
the Commission shall adopt a decision to include the third
4. Without
prejudice
to
any
arrangements
which
country in a list. The assessment shall take the form of a
may have been concluded between the Union and
review of relevant documentation and, unless
third countries, a Member State, the Commission or
arrangements as referred to in Article 51(2) of this
the Agency may require a manufacturer established in
Directive are in place that cover this area of activity, that
a third country to submit to an inspection as referred
assessment shall include an on-site review of the third
to in this Article.
country’s regulatory system and, if necessary, an
observed inspection of one or more of the third
5. Within
90
days
of
an
inspection
as
referred
to
in
country’s manufacturing sites for active substances. In
paragraph 1, a certificate of good manufacturing
the assessment particular account shall be taken of:
practice or good distribution practices shall, when
applicable, be issued to the inspected entity if the
(a) the country’s rules for good manufacturing practice;
outcome of the inspection shows that it complies
with the principles and guidelines of good manufac
turing practice or good distribution practices as
(b) the regularity of inspections to verify compliance with
provided for by Union legislation.
good manufacturing practice;
If inspections are performed as part of the certification
(c) the effectiveness of enforcement of good manufac
procedure for the monographs of the European Phar
turing practice;
macopoeia, a certificate shall be drawn up.
6. Member
States
shall
enter
the
certificates
of
good
(d) the regularity and rapidity of information provided by
manufacturing practice and good distribution practices
the third country relating to non-compliant producers
which they issue in a Union database managed by the
of active substances.
Agency on behalf of the Union. Pursuant to
Article 52a(7), Member States shall also enter
2. The
Commission
shall
adopt
the
necessary
imple
information in that database regarding the registration
menting acts to apply the requirements set out in points
of importers, manufacturers and distributors of active
(a) to (d) of paragraph 1 of this Article. Those imple
substances. The database shall be publicly accessible.’;
menting acts shall be adopted in accordance with the
procedure referred to in Article 121(2).
(c) paragraph 7 is amended as follows:
3. The Commission shall verify regularly whether the
(i) the words ‘paragraph 1’ are replaced by the words
conditions laid down in paragraph 1 are fulfilled. The
‘paragraph 1g’;
first verification shall take place no later than 3 years
after the country has been included in the list referred to
(ii) the words ‘used as starting materials’ are deleted;
in paragraph 1.

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L 174/86
EN
Official Journal of the European Union
1.7.2011
4. The
Commission
shall
perform
the
assessment
and
Those penalties shall not be inferior to those applicable to
verification referred to in paragraphs 1 and 3 in coop
infringements of national law of similar nature and
eration with the Agency and the competent authorities
importance.
of the Member States.’;
2. The
rules
referred
to
in
paragraph
1
shall
address,
(23) in Article 116, the following paragraph is added:
inter alia, the following:
(a) the manufacturing, distribution, brokering, import and
‘The second paragraph of this Article also applies in cases
export of falsified medicinal products, as well as the
where the manufacture of the medicinal product is not
sale of falsified medicinal products at a distance to the
carried out in compliance with the particulars provided
public by means of information society services;
pursuant to point (d) of Article 8(3), or where controls
are not carried out in compliance with the control
(b) non-compliance with the provisions laid down in this
methods described pursuant to point (h) of Article 8(3).’;
Directive on manufacturing, distribution, import and
export of active substances;
(24) the following Article is inserted:
(c) non-compliance with the provisions laid down in this
‘Article 117a
Directive on the use of excipients.
1. Member
States
shall
have
a
system
in
place
which
Where relevant, the penalties shall take into account the
aims at preventing medicinal products that are suspected
risk to public health presented by the falsification of
to present a danger to health from reaching the patient.
medicinal products.
2. The
system
referred
to
in
paragraph
1
shall
cover
the
3. The Member States shall notify the national
receipt and handling of notifications of suspected falsified
provisions adopted pursuant to this Article to the
medicinal products as well as of suspected quality defects
Commission by 2 January 2013 and shall notify any
of medicinal products. The system shall also cover recalls
subsequent amendment of those provisions without delay.
of medicinal products by marketing authorisation holders
or withdrawals of medicinal products from the market
By 2 January 2018, the Commission shall submit a report
ordered by national competent authorities from all
to the European Parliament and to the Council giving an
relevant actors in the supply chain both during and
overview of the transposition measures of Member States
outside normal working hours. The system shall also
as regards this Article, together with an evaluation of the
make it possible to recall, where necessary with the
effectiveness of those measures.
assistance of health professionals, medicinal products
from patients who received such products.
Article 118b
Member States shall organise meetings involving patients
3. If the medicinal product in question is suspected of
“and consumers” organisations and, as necessary, Member
presenting a serious risk to public health, the competent
States’ enforcement officers, in order to communicate
authority of the Member State in which that product was
public information about the actions undertaken in the
first identified shall, without any delay, transmit a rapid
area of prevention and enforcement to combat the falsifi
alert notification to all Member States and all actors in the
cation of medicinal products.
supply chain in that Member State. In the event of such
medicinal products being deemed to have reached patients,
Article 118c
urgent public announcements shall be issued within 24
hours in order to recall those medicinal products from
Member States, in applying this Directive, shall take the
the patients. Those announcements shall contain sufficient
necessary measures to ensure cooperation between
information on the suspected quality defect or falsification
competent authorities for medicinal products and
and the risks involved.
customs authorities.’;
4. Member
States
shall
by
22
July
2013
notify
the (26) in Article 121a(1), the words ‘Article 22b’ are replaced by
Commission of the details of their respective national
the words ‘Articles 22b, 47, 52b and 54a’;
systems referred to in this Article.’;
(27) in Article 121b(1), the words ‘Article 22b’ are replaced by
the words ‘Articles 22b, 47, 52b and 54a’;
(25) the following Articles are inserted:
Article 2
‘Article 118a
1. Member
States
shall
bring
into
force
the
laws,
regulations
1. The
Member
States
shall
lay
down
the
rules
on and administrative provisions necessary to comply with this
penalties applicable to infringements of the national
Directive by 2 January 2013. They shall forthwith inform the
provisions adopted pursuant to this Directive and shall
Commission thereof.
take all necessary measures to ensure that those penalties
are implemented. The penalties must be effective, propor
2. Member States shall apply those measures from
tionate and dissuasive.
2 January 2013.

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EN
1.7.2011 Official
Journal
of
the
European
Union L
174/87
However, the Member States shall apply:
(b) an evaluation of the contribution of the measures provided
for in this Directive regarding the prevention of the entry of
(a) the provisions necessary to comply with point 6 of
falsified medicinal products in the legal supply chain. That
Article 1 of this Directive in so far as it relates to
evaluation shall in particular assess point (o) of Article 54
Article 46b(2)(b) and Article 46b(3) and (4) of Directive
and Article 54a of Directive 2001/83/EC as inserted by this
2001/83/EC as inserted by this Directive from 2 July 2013;
Directive.
(b) the provisions necessary to comply with points 8, 9, 11 and
12 of Article 1 of this Directive from 3 years after the date
Article 4
of publication of the delegated acts referred to in point 12
In order to adopt the delegated acts referred to in Article 54a(2)
of Article 1 of this Directive.
of Directive 2001/83/EC as inserted by this Directive, the
Nevertheless, Member States which, on 21 July 2011, have
Commission shall perform a study assessing at least the
systems in place for the purpose referred to in point 11 of
following aspects:
Article 1 of this Directive shall apply the provisions
necessary to comply with points 8, 9, 11 and 12 of
(a) the technical options for the unique identifier of the safety
Article 1 of this Directive at the latest from 6 years after
features referred to in point (o) of Article 54 of Directive
the date of application of the delegated acts referred to in
2001/83/EC as inserted by this Directive;
point 12 of Article 1 of this Directive;
(b) the options for the extent and the modalities of verification
(c) the provisions necessary to comply with point 20 of
of the authenticity of the medicinal product bearing the
Article 1 of this Directive in so far as it relates to
safety features. This assessment shall take into account the
Article 85c of Directive 2001/83/EC as inserted by this
particular characteristics of the supply chains in the Member
Directive at the latest from 1 year after the date of publi
States;
cation of the implementing acts referred to in Article 85c(3)
as inserted by this Directive.
(c) the technical options for establishing and managing the
repositories system, referred to in point (e) of
3. When
Member
States
adopt
the
measures
referred
to
in
Article 54a(2) of Directive 2001/83/EC as inserted by this
paragraph 1, they shall contain a reference to this Directive or
Directive.
be accompanied by such a reference on the occasion of their
official publication. The methods of making such references
The study shall, for each of the options, assess benefits, costs
shall be laid down by Member States.
and cost-effectiveness.
4. Member
States
shall
communicate
to
the
Commission
the
Article 5
text of the main provisions of national law which they adopt in
the field covered by this Directive.
This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.
Article 3
Article 6
At the latest 5 years after the date of application of the
delegated acts referred to in Article 54a(2) of Directive
This Directive is addressed to the Member States.
2001/83/EC as inserted by this Directive, the Commission
shall submit a report to the European Parliament and to the
Council containing the following:
Done at Strasbourg, 8 June 2011.
(a) a description, where possible including quantitative data, of
the trends in the falsification of medicinal products in terms
of: categories of medicinal products affected, distribution
channels including sale at a distance to the public by
For the European Parliament
For the Council
means of information society services, the Member States
concerned, the nature of the falsifications, and the regions
The President
The President
of provenance of these products; and
J. BUZEK
GYRI E.

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