# EUR-Lex - 52012PC0052 - EN

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# 52012PC0052

**Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2001/83/EC as regards pharmacovigilance /* COM/2012/052 final - 2012/0025 (COD) */**

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EXPLANATORY MEMORANDUM

The Commission presents a proposal for a
Directive of the European Parliament and of the Council amending, as regards
pharmamacovigilance, Directive 2001/83/EC. It is complemented by parallel
changes to Regulation (EC) No 726/2004.

1.
CONTEXT OF THE PROPOSAL

On 15 December 2010, the European Parliament
and the Council adopted Directive 2010/84/EU and Regulation (EU) No 1235/2010
("2010 pharmacovigilance legislation") amending respectively, as
regards pharmacovigilance, Directive 2001/83/EC and Regulation (EC) No
726/2004. The new legislation shall apply in July 2012.

The adopted measures have substantially
strengthened the legal framework for the surveillance of medicinal products,
with provisions that reinforce the coordinating role of the European Medicines
Agency, the possibilities for signal detection, and the operation of
coordinated procedures at European level to respond to safety concerns.

However, recent pharmacovigilance events in the
European Union, in particular the so-called “Mediator case”, have shown the
need for a further improvement of the pharmacovigilance system.

Following an analysis of the Mediator case in
the light of the 2010 pharmacovigilance legislation ("Stress test"),
the Commission has detected certain weaknesses in the pharmacovigilance system
which should be addressed.

In particular, Directive 2001/83/EC provides
for an automatic assessment at Union level when specific serious safety issues
have been identified with regard to nationally authorised products. In the 2010
pharmacovigilance legislation, changes to the Commission's proposal during
co-decision have led to the automatism being lost, as the initiation of the
procedure is linked to an appreciation by the Member State or the Commission as
to whether an urgent action is considered necessary. Thus, when a Member State
considers suspending, revoking or refusing renewal of a marketing
authorisation, but does not consider that urgent action is needed, no
evaluation of the safety concern will be conducted at Union level.

Moreover, marketing authorisation holders are
not required to declare the reasons for the withdrawal of a marketing
authorisation or product. Therefore, it cannot be ruled out that voluntary
withdrawal of a marketing authorisation or product by the marketing
authorisation holder could lead to safety issues being missed, in particular if
the company is not transparent about possible safety concerns.

Finally, the public list of medicinal product
subject to additional monitoring provided for in Article 23 of Regulation (EC)
No 726/2004 will include certain medicinal products subject to
post-authorisation safety conditions. Those products will be included in the
list, following consultation with the Pharmacovigilance Risk Assessment
Committee, only if the Commission or a Member States' competent authorities
make a request. Therefore, competent authorities will have to decide on a
case-by-case basis whether to make public the fact that products are subject to
strengthened surveillance.

2.
OBJECTIVE OF THE COMMISSION'S PROPOSALS

The general policy objectives of the proposals
to amend Directive 2001/83/EC and Regulation (EC) No 726/2004 are in line with
the overall objectives of the EU pharmaceutical legislation. These are intended
to ensure the proper functioning of the internal market for medicinal products
for human use and to better protect health of EU citizens. Following this line,
the proposals aim specifically to address weaknesses identified in the EU
pharmacovigilance system and provide for more transparency and efficiency of
the system in cases where safety concerns are identified.

3.
EXPLANATORY DOCUMENTS ACCOMPANYING THE
NOTIFICATION OF TRANSPOSITION MEASURES AND BUDGETARY IMPLICATION

As the proposed Directive aims to amend only a
very limited number of legal obligations of Directive 2001/83/EC, correlation
tables or other explanatory documents are not required to accompany the
notification of transposition measures by the Member States.

The proposals have no implication for the
budget of the Union.

The proposals only make minor adjustments to
the system set forth by the 2010 pharmacovigilance
legislation. They do not require additional human or
administrative resources for the functioning of the pharmacovigilance system.

2012/0025 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

amending Directive 2001/83/EC as regards
pharmacovigilance

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 114 and Article 168(4)(c)
thereof,

Having regard to the proposal from the
European Commission[1],

Having regard to the opinion of the
European Economic and Social Committee[2],

Having regard to the opinion of the
Committee of the Regions[3],

Acting in accordance with the ordinary
legislative procedure,

Whereas:

(1)       Recent pharmacovigilance events in the
Union have shown the need for an automatic procedure at Union level in the
cases of specific safety issues to ensure that a matter is assessed and
addressed in all Member States where the medicinal product is authorised. The
scope of different Union procedures concerning nationally authorised products
should be clarified.

(2)       In addition, voluntary action by the marketing
authorisation holder should not lead to a situation where concerns related to the
risks or benefits of a medicinal product authorised in the Union are not
properly addressed in all Member States. Therefore, provisions should be made
for the marketing authorisation holder to inform competent authorities of the
reasons for the withdrawal of a medicinal product, for interrupting the placing
on the market of a medicinal product, for requests for revoking a marketing
authorisation, or for not renewing a marketing authorisation.

(3)       Directive 2001/83/EC
should therefore
be amended accordingly.

(4)       Since the objective of
this Directive to harmonise the rules on pharmacovigilance across the Union
cannot be sufficiently achieved by the Member States and can therefore be
better achieved at Union level, the Union may adopt
measures, in accordance with the principle of subsidiarity as set out in
Article 5 of the Treaty. In accordance with the principle of proportionality,
as set out in that Article, this Directive does not go beyond what is necessary
in order to achieve this objective,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 2001/83/EC is amended as follows:

(1)          In Article 23a, the second
subparagraph is replaced by the following:

"The holder shall also notify the
competent authority if the product ceases to be placed on the market of the
Member State, either temporarily or permanently. Such notification shall,
otherwise than in exceptional circumstances, be made no less than two
months before the interruption in the placing on the market of the product. The holder
shall inform the competent authorities of the reasons for such action in
accordance with Article 123."

(2)          Article
31 is replaced by the following:

"Article
31

1. The Member States, the Commission, the
applicant or the marketing authorisation holder shall, in specific cases where
the interests of the Union are involved, refer the matter to the Committee for
application of the procedure laid down in Articles 32, 33 and 34 before any
decision is reached on an application for a marketing authorisation or on the
suspension or revocation of a marketing authorisation, or on any other
variation of the marketing authorisation which appears necessary.

Where the referral results from the evaluation
of data relating to pharmacovigilance of an authorised medicinal product, the
matter shall be referred to the Pharmacovigilance Risk Assessment Committee and
Article 107j(2) may be applied. The Pharmacovigilance Risk Assessment Committee
shall issue a recommendation according to the procedure laid down in Article
32. The final recommendation shall be forwarded to the Committee for Medicinal
Products for Human Use or to the coordination group, as appropriate, and the
procedure laid down in Article 107k shall apply.

However, where one of the criteria listed in
Article 107i(1) is met, the procedure laid down in Articles 107i
to 107k shall apply.

2. Where the referral to the Committee concerns
a range of medicinal products or a therapeutic class, the Agency may limit the
procedure to certain specific parts of the authorisation.

In that event, Article 35 shall apply to those
medicinal products only if they were covered by the authorisation procedures
referred to in this Chapter.

Where the scope of the procedure initiated under this
Article concerns a range of medicinal products or therapeutic class, medicinal
products authorised in accordance with Regulation (EC) No 726/2004 which belong
to that range or class shall also be included in the procedure."

(3)          In
Article 34(3), the following subparagraph is added:

"Where the scope of the procedure includes medicinal
products authorised in accordance with Regulation (EC) No 726/2004 pursuant to
the third subparagraph of Article 31(2) of this Directive, the Commission shall
where necessary adopt decisions to vary, suspend, revoke or refuse renewal of
the marketing authorisations concerned."

(4)          Article 107i(1) is replaced by the
following:

"1. A Member State or the Commission, as
appropriate, shall initiate the procedure provided for in this section, by
informing the other Member States, the Agency and the Commission, in any of the
following cases:

(a) it considers suspending or revoking a
marketing authorisation;

(b) it considers prohibiting the supply of a
medicinal product;

(c) it considers refusing the renewal of a
marketing authorisation;

(d) it is informed by the marketing
authorisation holder that, on the basis of safety concerns, he has interrupted
the placing on the market of a medicinal product or has taken action to have a
marketing authorisation withdrawn, or that he intends to do so or has not applied for the renewal of a marketing
authorisation;

(e) it considers that a new contraindication, a
reduction in the recommended dose, or a restriction to the indications is necessary.

The Agency shall verify whether the safety
concern relates to medicinal products other than the one covered by the
information, or whether it is common to all products belonging to the same
range or therapeutic class.

Where the medicinal product involved is
authorised in more than one Member State, the Agency shall without undue delay
inform the initiator of the procedure of the 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 concerned. The Agency or
the Member State, as applicable, shall make information that the procedure has
been initiated available to marketing authorisation holders."

(5)          Article 123(2) is replaced by the following:

"2. The marketing authorization holder
shall be obliged to notify Member States forthwith of any action taken by him
to suspend the marketing of a medicinal product, to withdraw a medicinal
product from the market, to request the withdrawal of a marketing authorisation or
not to apply for the renewal of a marketing authorisation, together
with the reasons for such action. The marketing authorisation holder shall in
particular declare if such action is linked to any of the grounds set out in
Articles 116 and 117. In such case, Member States shall
ensure that this information is brought to the attention of the Agency."

Article 2

1.           Member States shall bring
into force the laws, regulations and administrative provisions necessary to
comply with this Directive by [12 months after publication in the Official
Journal; exact date inserted at time of publication] at the latest. They
shall forthwith communicate to the Commission the text of those provisions.

When Member States adopt those provisions, they
shall contain a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member States shall
determine how such reference is to be made.

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.

Article 3

This Directive shall enter into force on
the twentieth day following that of its publication in the Official Journal
of the European Union.

Article 4

This Directive is addressed to the Member
States.

Done at Brussels, 10.2.2012

For the European Parliament                       For
the Council

The President                                                 The
President

[1]               OJ C , , p. .

[2]               OJ C , , p. .

[3]               OJ C , , p. .