HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 316/38
EN
Official Journal of the European Union
14.11.2012
REGULATION (EU) No 1027/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 25 October 2012
amending Regulation (EC) No 726/2004 as regards pharmacovigilance
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
pursuant to Regulation (EC) No 726/2004, cannot be
EUROPEAN UNION,
sufficiently achieved by the Member States and can
therefore be better achieved at Union level, the Union
Having regard to the Treaty on the Functioning of the European
may adopt measures, in accordance with the principle of
Union, and in particular Article 114 and Article 168(4)(c)
subsidiarity as set out in Article 5 of the Treaty on
thereof,
European Union. In accordance with the principle of
proportionality as set out in that Article, this Regulation
does not go beyond what is necessary in order to achieve
Having regard to the proposal from the European Commission,
that objective.
After transmission of the draft legislative act to the national
(4) Regulation
(EC)
No
726/2004
should
therefore
be
parliaments,
amended accordingly,
HAVE ADOPTED THIS REGULATION:
Having regard to the opinion of the European Economic and
Social Committee ( 1 ),
Article 1
After consulting the Committee of the Regions,
Regulation (EC) No 726/2004 is hereby amended as follows:
Acting in accordance with the ordinary legislative procedure (
(1) in Article 13(4), the second subparagraph is replaced by the

2 ),
following:
Whereas:
‘The marketing authorisation holder shall notify the Agency
if the product ceases to be placed on the market of a
(1) In
order
to
ensure
transparency
on
the
surveillance
of
Member State, either temporarily or permanently. Such
authorised medicinal products, the list of medicinal
notification shall, other than in exceptional circumstances,
products subject to additional monitoring established
be made no less than two months before the interruption in
by Regulation (EC) No 726/2004 of the European
the placing on the market of the product. The marketing
Parliament and of the Council of 31 March 2004
authorisation holder shall inform the Agency of the reasons
laying down Community procedures for the authori
for such action in accordance with Article 14b.’;
sation and supervision of medicinal products for
human and veterinary use and establishing a European
(2) the following Article is inserted:
Medicines Agency
( 3 ), should systematically include
medicinal products that are subject to certain post-auth
‘Article 14b
orisation safety conditions.
1. The marketing authorisation holder shall notify the
Agency forthwith of any action the holder takes to
(2) In
addition,
voluntary
action
by
the
marketing
authori
suspend the marketing of a medicinal product, to
sation holder should not lead to a situation where
withdraw a medicinal product from the market, to request
concerns relating to the risks or benefits of a medicinal
the withdrawal of a marketing authorisation or not to apply
product authorised in the Union are not properly
for the renewal of a marketing authorisation, together with
addressed in all Member States. Therefore, the
the reasons for such action. The marketing authorisation
marketing authorisation holder should be obliged to
holder shall in particular declare if such action is based
inform the European Medicines Agency of the reasons
on any of the grounds set out in Article 116 or
for withdrawing or interrupting the placing on the
Article 117(1) of Directive 2001/83/EC.
market of a medicinal product, for requesting that a
marketing authorisation be revoked, or for not
renewing a marketing authorisation.
2. The marketing authorisation holder shall also make
the notification pursuant to paragraph 1 of this Article if
the action is taken in a third country and such action is
(3) Since
the
objective
of
this
Regulation,
namely
to
provide
based on any of the grounds set out in Article 116 or
for specific rules on pharmacovigilance and improve the
Article 117(1) of Directive 2001/83/EC.
safety of medicinal products for human use authorised
3. In
the
cases
referred
to
in
paragraphs
1
and
2,
the
( 1 ) OJ C 181, 21.6.2012, p. 202.
Agency shall forward the information to the competent
( 2 ) Position of the European Parliament of 11 September 2012 (not yet
authorities of the Member States without undue delay.’;
published in the Official Journal) and decision of the Council of
4 October 2012.
( 3 ) OJ L 136, 30.4.2004, p. 1.
(3) in Article 20, paragraph 8 is replaced by the following:

---

EN
14.11.2012 Official
Journal
of
the
European
Union L
316/39
‘8. Where the procedure is initiated as a result of the
medicinal product from the list five years after the Union
evaluation of data relating to pharmacovigilance, the
reference date referred to in Article 107c(5) of Directive
opinion of the Agency, in accordance with paragraph 2
2001/83/EC.
of this Article, shall be adopted by the Committee for
Medicinal Products for Human Use on the basis of a recom
In the cases referred to in points (c) and (d) of paragraph 1
mendation from the Pharmacovigilance Risk Assessment
and in paragraph 1a of this Article, the Agency shall remove
Committee and Article 107j(2) of Directive 2001/83/EC
a medicinal product from the list once the conditions have
shall apply.’;
been fulfilled.
(4) Article 23 is replaced by the following:
4. For
medicinal
products
included
in
the
list
referred
to
in paragraph 1, the summary of product characteristics and
the package leaflet shall include the statement "This
‘Article 23
medicinal product is subject to additional monitoring".
1. The
Agency
shall,
in
collaboration
with
the
Member
That statement shall be preceded by a black symbol
States, set up, maintain and make public a list of medicinal
which shall be selected by the Commission by 2 July
products that are subject to additional monitoring.
2013, following a recommendation of the Pharmaco
vigilance Risk Assessment Committee, and shall be
followed by an appropriate standardised explanatory
That list shall include the names and active substances of:
sentence.
(a) medicinal products authorised in the Union that contain
4a. By
5
June
2018,
the
Commission
shall
present
to
the
a new active substance which, on 1 January 2011, was
European Parliament and the Council a report on the use of
not contained in any medicinal product authorised in
the list referred to in paragraph 1 based on the experience
the Union;
and data provided by the Member States and the Agency.
(b) any biological medicinal product not covered by point
The Commission shall, if appropriate, on the basis of that
(a) that was authorised after 1 January 2011;
report, and after consultation with the Member States and
other appropriate stakeholders, present a proposal in order
to adjust the provisions relating to the list referred to in
(c) medicinal products that are authorised pursuant to this
paragraph 1.’;
Regulation, subject to the conditions referred to in point
(cb) of Article 9(4), point (a) of the first subparagraph of
Article 10a(1) or Article 14(7) or (8);
(5) Article 57 is amended as follows:
(a) in the second subparagraph of paragraph 1, points (c)
(d) medicinal products that are authorised pursuant to
and (d) are replaced by the following:
Directive 2001/83/EC, subject to the conditions
referred to in points (b) and (c) of the first paragraph
of Article 21a, Article 22, or point (a) of the first
‘(c) coordinating the monitoring of medicinal products
subparagraph of Article 22a(1) thereof.
which have been authorised within the Union and
providing advice on the measures necessary to
ensure the safe and effective use of those
1a. At the request of the Commission, following consul
medicinal products, in particular by coordinating
tation with the Pharmacovigilance Risk Assessment
the evaluation and implementation of pharmaco
Committee, medicinal products that are authorised
vigilance obligations and systems and the moni
pursuant to this Regulation, subject to the conditions
toring of such implementation;
referred to in points (c), (ca) or (cc) of Article 9(4), point
(b) of the first subparagraph of Article 10a(1) or
(d) ensuring the collation and dissemination of
Article 21(2), may also be included in the list referred to
information on suspected adverse reactions to
in paragraph 1 of this Article.
medicinal products authorised in the Union by
means of a database which is permanently accessible
At the request of a national competent authority, following
to all Member States;’;
consultation with the Pharmacovigilance Risk Assessment
Committee, medicinal products that are authorised
(b) in the second subparagraph of paragraph 2, point (b) is
pursuant to Directive 2001/83/EC, subject to the conditions
replaced by the following:
referred to in points (a), (d), (e) or (f) of the first paragraph
of Article 21a, point (b) of the first subparagraph of
‘(b) marketing authorisation holders shall, by 2 July
Article 22a(1) or Article 104a(2) thereof, may also be
2012 at the latest, electronically submit to the
included in the list referred to in paragraph 1 of this Article.
Agency information on all medicinal products for
human use authorised in the Union, using the
2. The list referred to in paragraph 1 shall include an
format referred to in point (a);’.
electronic link to the product information and to the
summary of the risk management plan.
Article 2
This Regulation shall enter into force on the twentieth day
3. In
the
cases
referred
to
in
points
(a)
and
(b)
of following that of its publication in the Official Journal of the
paragraph 1 of this Article, the Agency shall remove a
European Union.

---

L 316/40
EN
Official Journal of the European Union
14.11.2012
It shall apply from 5 June 2013 with the exception of Article 23(4), points (c) and (d) of the second
subparagraph of Article 57(1) and point (b) of the second subparagraph of Article 57(2) of Regulation (EC)
No 726/2004, as amended by this Regulation, which shall apply from 4 December 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 25 October 2012.
For the European Parliament
For the Council
The President
The President
M. SCHULZ
A. D. MAVROYIANNIS

---

Document Outline

• �

---