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27.10.2012 Official
Journal
of
the
European
Union
L
299/1
I
(Legislative acts)
DIRECTIVES
DIRECTIVE 2012/26/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 25 October 2012
amending Directive 2001/83/EC as regards pharmacovigilance
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
(2) In
addition,
voluntary
action
by
the
marketing
authori
EUROPEAN UNION,
sation holder should not lead to a situation where
concerns relating to the risks or benefits of a medicinal
product authorised in the Union are not properly
Having regard to the Treaty on the Functioning of the European
addressed in all Member States. Therefore, the
Union, and in particular Article 114 and Article 168(4)(c)
marketing authorisation holder should be obliged to
thereof,
inform the relevant competent authorities and the
European Medicines Agency of the reasons for with
drawing or interrupting the placing on the market of a
Having regard to the proposal from the European Commission,
medicinal product, for requesting that a marketing auth
orisation be revoked, or for not renewing a marketing
authorisation.
After transmission of the draft legislative act to the national
parliaments,
(3) It
is
appropriate
to
further
clarify
and
strengthen
the
Normal Procedure and the Urgent Union Procedure in
Having regard to the opinion of the European Economic and
order to ensure coordination, swift assessment in case of
Social Committee ( 1 ),
urgency and the possibility to take immediate action,
where necessary to protect public health, before a
decision is taken at Union level. The Normal Procedure
After consulting the Committee of the Regions,
should be initiated for matters concerning quality, safety
or efficacy of medicinal products where the interests of
the Union are involved. The Urgent Union Procedure
should be initiated when there is a need to swiftly
Acting in accordance with the ordinary legislative procedure ( 2 ),
assess concerns resulting from the evaluation of data
from pharmacovigilance activities. Regardless of
whether the Urgent Union Procedure or the Normal
Whereas:
Procedure is applied, and regardless of the procedure
by means of which the medicinal product was auth
orised, be it centralised or otherwise, the Pharmaco
(1) Recent
pharmacovigilance
incidents
in
the
Union
have
vigilance Risk Assessment Committee should always
shown the need for an automatic procedure at Union
give its recommendation when the reason for taking
level in cases of specific safety issues to ensure that a
action is based on pharmacovigilance data. It is appro
matter is assessed and addressed in all Member States
priate that the coordination group and the Committee
where the medicinal product is authorised. The scope
for Medicinal Products for Human Use rely on that
of different Union procedures concerning products auth
recommendation when carrying out the assessment of
orised at national level, as laid down in Directive
the issue.
2001/83/EC of the European Parliament and of the
Council of 6 November 2001 on the Community code
relating to medicinal products for human use ( 3 ), should
be clarified.
(4) It
is
appropriate
that
Member
States
bring
cases
concerning new contraindications, reductions in the
recommended dose or restrictions to the indication for
( 1 ) OJ C 181, 21.6.2012, p. 201.
medicinal products authorised in accordance with the
( 2 ) Position of the European Parliament of 11 September 2012 (not yet
decentralised procedure and the mutual recognition
published in the Official Journal) and decision of the Council of
4 October 2012.
procedure to the attention of the coordination group
( 3 ) OJ L 311, 28.11.2001, p. 67.
when the Urgent Union Procedure is not initiated. In

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L 299/2
EN
Official Journal of the European Union
27.10.2012
order to ensure harmonisation for those products, the
accordance with Regulation (EC) No 726/2004 which
coordination group may discuss whether any action is
belong to that range or class shall also be included in
necessary in the event that no Member State has
the procedure.
triggered the Normal Procedure.
3. Without
prejudice
to
paragraph
1,
a
Member
(5) Since
the
objective
of
this
Directive,
namely
to
harmonise
State may, where urgent action is necessary to
the rules on pharmacovigilance across the Union, cannot
protect public health at any stage of the procedure,
be sufficiently achieved by the Member States and can
suspend the marketing authorisation and prohibit the
therefore be better achieved at Union level, the Union
use of the medicinal product concerned on its territory
may adopt measures, in accordance with the principle of
until a definitive decision is adopted. It shall inform
subsidiarity as set out in Article 5 of the Treaty on
the Commission, the Agency and the other Member
European Union. In accordance with the principle of
States, no later than the following working day, of the
proportionality, as set out in that Article, this Directive
reasons for its action.
does not go beyond what is necessary in order to achieve
that objective.
4. Where the scope of the procedure initiated under
this Article, as determined in accordance with
(6) Directive
2001/83/EC
should
therefore
be
amended
accordingly,
paragraph 2, includes medicinal products authorised

in accordance with Regulation (EC) No 726/2004,
the Commission may, where urgent action is
HAVE ADOPTED THIS DIRECTIVE:
necessary to protect public health, at any stage of
the procedure, suspend the marketing authorisations
Article 1
and prohibit the use of the medicinal products
concerned until a definitive decision is adopted. The
Directive 2001/83/EC is hereby amended as follows:
Commission shall inform the Agency and the Member
States no later than the following working day of the
(1) in Article 23a, the second paragraph is replaced by the
reasons for its action.’;
following:
(3) in Article 34(3), the following subparagraph is added:
‘If the product ceases to be placed on the market of a
Member State, either temporarily or permanently, the
marketing authorisation holder shall notify the
‘Where the scope of the procedure initiated under
competent authority of that Member State. Such notifi
Article 31 includes medicinal products authorised in
cation shall, other than in exceptional circumstances, be
accordance with Regulation (EC) No 726/2004 pursuant
made no less than two months before the interruption in
to the third subparagraph of Article 31(2) of this Directive,
the placing on the market of the product. The marketing
the Commission shall, where necessary, adopt decisions to
authorisation holder shall inform the competent authority
vary, suspend or revoke the marketing authorisations or to
of the reasons for such action in accordance with
refuse the renewal of the marketing authorisations
Article 123(2).’;
concerned.’;
(2) Article 31 is amended as follows:
(4) in Article 37, the words ‘Articles 35 and 36 shall apply’
are replaced by the words ‘Article 35 shall apply’;
(a) in paragraph 1, the third subparagraph is replaced by
the following:
(5) Article 63 is amended as follows:
‘However, where one of the criteria listed in
Article 107i(1) is met, the procedure laid down in
(a) in paragraph 1, the first subparagraph is replaced by
Articles 107i to 107k shall apply.’;
the following:
(b) paragraph 2 is replaced by the following:
‘1. The
particulars
for
labelling
listed
in
Articles
54,
59 and 62 shall appear in an official language or
official languages of the Member State where the
‘2. Where the referral to the Committee concerns a
medicinal product is placed on the market, as spec
range of medicinal products or a therapeutic class, the
ified, for the purposes of this Directive, by that
Agency may limit the procedure to certain specific
Member State.’;
parts of the authorisation.
In that event, Article 35 shall apply to those medicinal
(b) in paragraph 2, the first subparagraph is replaced by
products only if they were covered by the authori
the following:
sation procedures referred to in this Chapter.
‘2. The
package
leaflet
must be written
and
Where the scope of the procedure initiated under this
designed in such a way as to be clear and under
Article concerns a range of medicinal products or a
standable, enabling users to act appropriately, when
therapeutic class, medicinal products authorised in
necessary with the help of health professionals. The

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EN
27.10.2012 Official
Journal
of
the
European
Union
L
299/3
package leaflet must be clearly legible in an official
(c) it considers refusing the renewal of a marketing auth
language or official languages of the Member State
orisation; or
where the medicinal product is placed on the
market, as specified, for the purposes of this Directive,
by that Member State.’;
(d) it is informed by the marketing authorisation holder
that, on the basis of safety concerns, the holder has
interrupted the placing on the market of a medicinal
(c) paragraph 3 is replaced by the following:
product or has taken action to have a marketing auth
orisation withdrawn, or intends to take such action or
‘3. Where
the
medicinal
product
is
not
intended
to
has not applied for the renewal of a marketing auth
be delivered directly to the patient, or where there are
orisation.
severe problems in respect of the availability of the
medicinal product, the competent authorities may,
subject to measures they consider necessary to
1a. A Member State or the Commission, as appropriate,
safeguard human health, grant an exemption to the
shall, on the basis of concerns resulting from the
obligation that certain particulars should appear on
evaluation of data from pharmacovigilance activities,
the labelling and in the package leaflet. They may
inform the other Member States, the Agency and the
also grant a full or partial exemption to the obligation
Commission where it considers that a new contraindi
that the labelling and the package leaflet must be in an
cation, a reduction in the recommended dose or a
official language or official languages of the Member
restriction to the indications of a medicinal product is
State where the medicinal product is placed on the
necessary. The information shall outline the action
market, as specified, for the purposes of this Directive,
considered and the reasons therefor.
by that Member State.’;
Any Member State or the Commission, as appropriate,
(6) Article 85a is replaced by the following:
shall, when urgent action is considered necessary, initiate
the procedure provided for in this section in any of the
‘Article 85a
cases referred to in this paragraph.
In the case of wholesale distribution of medicinal products
to third countries, Article 76 and point (c) of the first
Where the procedure provided for in this section is not
paragraph of Article 80 shall not apply. Moreover,
initiated, for medicinal products authorised in accordance
points (b) and (ca) of the first paragraph of Article 80
with the procedures laid down in Chapter 4 of Title III, the
shall not apply where a product is directly received from
case shall be brought to the attention of the coordination
a third country but not imported. However, in that case
group.
wholesale distributors shall ensure that the medicinal
products are obtained only from persons who are auth
orised or entitled to supply medicinal products in
Article 31 shall be applicable where the interests of the
accordance with the applicable legal and administrative
Union are involved.
provisions of the third country concerned. Where
wholesale distributors supply medicinal products to
1b. Where
the
procedure
provided
for
in
this
section
is
persons in third countries, they shall ensure that such
initiated, the Agency shall verify whether the safety
supplies are only made to persons who are authorised or
concern relates to medicinal products other than the one
entitled to receive medicinal products for wholesale
covered by the information, or whether it is common to
distribution or supply to the public in accordance with
all products belonging to the same range or therapeutic
the applicable legal and administrative provisions of the
class.
third country concerned. The requirements set out in
Article 82 shall apply to the supply of medicinal
products to persons in third countries authorised or
Where the medicinal product involved is authorised in
entitled to supply medicinal products to the public.’;
more than one Member State, the Agency shall without
undue delay inform the initiator of the procedure of the
(7) in Article 107i, paragraph 1 is replaced by the following:
outcome of this verification, and the procedures laid down
in Articles 107j and 107k shall apply. Otherwise, the
safety concern shall be addressed by the Member State
‘1. A Member State or the Commission, as appropriate,
concerned. The Agency or the Member State, as applicable,
shall, on the basis of concerns resulting from the
shall make the information that the procedure has been
evaluation of data from pharmacovigilance activities,
initiated available to marketing authorisation holders.’;
initiate the procedure provided for in this section by
informing the other Member States, the Agency and the
Commission where:
(8) in Article 107i(2) the words ‘paragraph 1 of this Article’
are replaced by the words ‘paragraphs 1 and 1a of this
(a) it considers suspending or revoking a marketing auth
Article’;
orisation;
(9) in the second subparagraph of Article 107i(3) the words
(b) it considers prohibiting the supply of a medicinal
‘in accordance with paragraph 1’ are replaced by the words
product;
‘in accordance with paragraphs 1 and 1a’;

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L 299/4
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Official Journal of the European Union
27.10.2012
(10) in Article 107i(5) the words ‘in paragraph 1’ are replaced
‘4. Each
year,
the
Agency
shall
make
public
a
list
of
by the words ‘in paragraphs 1 and 1a’;
the medicinal products for which marketing authori
sations have been refused, revoked or suspended in the
Union, whose supply has been prohibited or which
(11) in the first subparagraph of Article 107j(1) the words ‘in
have been withdrawn from the market, including the
Article 107i(1)’ are replaced by the words ‘in paragraphs 1
reasons for such action.’.
and 1a of Article 107i’;
Article 2
(12) Article 123 is amended as follows:
1. Member
States
shall
adopt
and
publish
the
laws,
regu
lations and administrative provisions necessary to comply
(a) paragraph 2 is replaced by the following:
with this Directive by 28 October 2013 at the latest. They
shall forthwith communicate to the Commission the text of
those provisions.
‘2. The
marketing
authorisation
holder
shall
be
obliged to notify the Member States concerned
forthwith of any action taken by the holder to
They shall apply those provisions from 28 October 2013.
suspend the marketing of a medicinal product, to
withdraw a medicinal product from the market, to
When Member States adopt those provisions, they shall contain
request the withdrawal of a marketing authorisation
a reference to this Directive or be accompanied by such a
or not to apply for the renewal of a marketing auth
reference on the occasion of their official publication. Member
orisation, together with the reasons for such action.
States shall determine how such reference is to be made.
The marketing authorisation holder shall in particular
declare if such action is based on any of the grounds
set out in Article 116 or Article 117(1).
2. Member
States
shall
communicate
to
the
Commission
the
text of the main provisions of national law which they adopt in
the field covered by this Directive.
2a. The
marketing
authorisation
holder
shall
also
make the notification pursuant to paragraph 2 of
Article 3
this Article in cases where the action is taken in a
third country and where such action is based on any
This Directive shall enter into force on the twentieth day
of the grounds set out in Article 116 or
following that of its publication in the Official Journal of the
Article 117(1).
European Union.
2b. The marketing authorisation holder shall
Article 4
furthermore notify the Agency where the action
This Directive is addressed to the Member States.
referred to in paragraph 2 or 2a of this Article is
based on any of the grounds referred to in Article 116
or Article 117(1).
Done at Strasbourg, 25 October 2012.
2c. The
Agency
shall
forward
notifications
received
in accordance with paragraph 2b to all Member States
without undue delay.’;
For the European Parliament
For the Council
The President
The President
(b) paragraph 4 is replaced by the following:
M. SCHULZ
A. D. MAVROYIANNIS

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