CELEX: 52014PC0557
Language: en
Date: 2014-09-10
Title: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

|
			
		
		
		52014PC0557
		
			Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency /* COM/2014/0557 final - 2014/0256 (COD) */
			
				
		
		
			
			   	EXPLANATORY MEMORANDUM
1.           CONTEXT OF THE PROPOSAL
Justification and objectives
Following the proposal that will repeal and
replace Directive 2001/82/EC on veterinary medicinal products, Regulation (EC)
No 726/2004 laying down Community procedures for the authorisation and
supervision of medicinal products for human and veterinary use and establishing
a European Medicines Agency must be amended to take account of the fact that
centralised marketing authorisation for veterinary products is being decoupled from
that for medicines for humans. 
Legal basis
The legal basis for legislative measures on
animal health, which are essential to public and animal health, environmental
protection, trade and single market policy are:
·                        
Article 114 of the Treaty on the Functioning of
the European Union (TFEU), which provides for the establishment and functioning
of the internal market and the approximation of relevant legal, regulatory and
administrative provisions; and
·                        
Article 168(4)(c) TFEU, which covers measures setting
high standards of quality and safety for medicinal products and devices for
medical uses.
2.           RESULTS OF CONSULTATIONS
WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS
Better regulation of veterinary
pharmaceuticals: how to put in place a simpler legal framework, safeguarding
public and animal health while increasing the competitiveness of companies, a public consultation on the key issues of the envisaged legal
proposal, was launched on the Commission’s website on 13 April 2010 and was
available through the interactive policy-making (IPM) tool until 15 July
2010.[1]
The consultation and a study, An
assessment of the impact of the revision of veterinary pharmaceutical
legislation, formed the basis of an impact assessment carried out for the
Commission between November 2009 and June 2011.[2]
The Commission’s Impact Assessment Board
(IAB) released its final opinion in September 2013.
3.           LEGAL ELEMENTS OF THE
PROPOSAL
Provisions regarding granting and
maintaining marketing authorisations for veterinary medicinal products are
deleted from Regulation (EC) No 726/2004. The rules on marketing authorisations
valid in all EU Member States are part of the proposal for a Regulation on
veterinary medicinal products. The new Regulation on veterinary medicinal
products will cover all routes granting marketing authorisations for veterinary
medicinal products in the Union – both at centralised and national level. 
The costs of the procedures and services
associated with the operation of this Regulation need to be recovered from those
making medicinal products available on the market and from those seeking
authorisation. Therefore, it is appropriate to establish certain principles
applicable to fees payable to the Agency, including the need to take into
account, as appropriate, the specific needs for SMEs. The provisions regulating
fees should be brought into line with the Treaty of Lisbon.
As a consequence of the entry into force of
the Treaty of Lisbon, the powers conferred on the Commission under Regulation
(EC) No 726/2004 should be aligned to Articles 290 and 291 of the Treaty on the
Functioning of the European Union. In order to supplement or amend certain
non-essential elements of Regulation (EC) No 726/2004, the power to adopt acts
in accordance with Article 290 of the Treaty should be delegated to the
Commission in respect of amending the Annex to
technical and scientific progress, determining the situations in which
post-authorisation efficacy studies may be required, laying down provisions and
requirements for granting marketing authorisations subject to certain specific
obligations, establishing procedures for the examination of applications for
variations to the terms of marketing authorisations and for the examination of
applications for the transfer of marketing authorisations and laying down the
procedure for investigating the infringements and the imposition of fines or
periodic penalty payments to the holders of marketing authorisations granted
under this Regulation, the maximum amounts of these penalties as well as the
conditions and methods for their collection.
The entry into force and application of
this Regulation should be on the same date as of the new Regulation on
veterinary medicinal products.
4.           BUDGETARY IMPLICATION 
It is planned that the costs for the EMA for
implementing and applying the new rules are entirely covered by fees charged to
industry. 
Therefore, the proposal is not expected to
have any financial impact on the budget of the EU.
As set out in the legislative financial
statement the additional resource needs for EMA are approximately 8 staff plus
expenditure for meetings, translation, IT, etc. 
The level of fees, their structure and
modalities and exceptions will be set at a later stage by the Commission by way
of implementing acts. This holds not only for the fees for new tasks for the
EMA set out in this proposal, but for all fees in general.
5.           OPTIONAL ELEMENTS
2014/0256 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
amending Regulation (EC) No 726/2004
laying down Community procedures for the authorisation and supervision of
medicinal products for human and veterinary use and establishing a European
Medicines Agency
(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,
After transmission of the draft legislative
act to the national Parliaments,
Having regard to the opinion of the
European Economic and Social Committee[3],
Having regard to the opinion of the
Committee of the Regions[4],

Acting in accordance with the ordinary
legislative procedure,
Whereas:
(1)       Directive 2001/82/EC of
the European Parliament and of the Council[5]
and Regulation (EC) 726/2004 of the European Parliament and of the Council[6] constituted the Union
regulatory framework for the manufacture, authorisation and distribution of
veterinary medicinal products. In the light of the experience acquired and
following the assessment by the Commission of the functioning of the internal market
for veterinary medicinal products, the regulatory framework for veterinary
medicinal products has been reviewed, and Regulation (EU) No […] of the European
Parliament and of the Council[7]
laying down procedures for the authorisation and supervision of veterinary
medicinal products has been adopted. 
(2)       Regulation (EU) No […]
also provides for centralised marketing authorisations for veterinary medicinal
products. The parts of Regulation (EC) 726/2004 relating to procedures for
those marketing authorisation should therefore be repealed.
(3)       The costs of the
procedures and services associated with the operation of this Regulation need
to be recovered from those making medicinal products available on the market
and from those seeking authorisation. It is appropriate to establish certain
principles applicable to fees payable to the Agency, including the need to take
into account, as appropriate, the specific needs for SMEs. The provisions
regulating fees should be brought into line with the Treaty of Lisbon.
(4)       As a consequence of the
entry into force of the Treaty of Lisbon, the powers conferred on the
Commission under Regulation (EC) No 726/2004 should be aligned to Articles 290
and 291 of the Treaty on the Functioning of the European Union In order to
supplement or amend certain non-essential elements of Regulation (EC) No
726/2004, the power to adopt acts in accordance with Article 290 of the Treaty
should be delegated to the Commission in respect of amending
the Annex to technical and scientific progress, determining the situations in
which post-authorisation efficacy studies may be required, laying down
provisions and requirements for granting marketing authorisations subject to
certain specific obligations, establishing procedures for the examination of
applications for variations to the terms of marketing authorisations and for
the examination of applications for the transfer of marketing authorisations
and laying down the procedure for investigating the infringements and the
imposition of fines or periodic penalty payments to the holders of marketing
authorisations granted under this Regulation, the maximum amounts of these
penalties as well as the conditions and methods for their collection.
(5)       It is of particular
importance that the Commission carries out appropriate consultations during its
preparation of delegated acts, including at expert level. The Commission, when preparing and drawing-up delegated
acts, should ensure a simultaneous, timely and appropriate transmission of
relevant documents to the European Parliament and Council. 
(6)       In order to ensure uniform
conditions for the implementation of Regulation (EC) No 726/2004, implementing
powers should be conferred on the Commission to adopt implementing acts in
relation to marketing authorisations for medicinal products for human use.
Those powers should be exercised in accordance with Regulation (EU) No 182/2011
of the European Parliament and of the Council[8].
(7)       Regulation (EC) No
726/2004 should therefore be amended accordingly, 
HAVE ADOPTED THIS REGULATION:
Article 1
Regulation (EC) No 726/2004 is amended as
follows:
(1)                   
the title is replaced by the following:
‘Regulation (EC) No 726/2004 of the European
Parliament and of the Council of 31 March 2004 laying down Union procedures for
the authorisation and supervision of medicinal products for human use and
establishing a European Medicines Agency’;
(2)                   
in Article 1, the first paragraph is replaced by
the following:
‘The purpose of this Regulation is to lay down
Union procedures for the authorisation, supervision and pharmacovigilance of
medicinal products for human use and to establish a European Medicines Agency
(hereinafter referred to as ‘the Agency’).’
(3)                   
in Article 2, the first paragraph is replaced by
the following:
‘The definitions laid down in Article 1 of
Directive 2001/83/EC shall apply for the purposes of this Regulation.’
(4)                   
Article 3 is amended as follows:
(a)         
in paragraph 2, point (b) is replaced by the
following:
 ‘(b)   the applicant shows that the medicinal
product constitutes a significant therapeutic, scientific or technical
innovation or that the granting of authorisation in accordance with this
Regulation is in the interests of patients health at Union level.’,
(b)         
in paragraph 3, the introductory phrase and
point (a) are replaced by the following:
‘A generic medicinal
product of a reference medicinal product authorised by the Union may be
authorised by the competent authorities of the Member States in accordance with
Directive 2001/83/EC under the following conditions: 
(a) the application for authorisation is
submitted in accordance with Article 10 of Directive 2001/83/EC;’ ,
(c)         
paragraph 4 is replaced by the following: 
‘The Commission shall
be empowered to adopt delegated acts in accordance with Article 87b in order to
amend the Annex to technical and scientific progress without extending the
scope of the centralised procedure.’;
(5)                   
Article 4(3) is deleted;
(6)                   
Article 10 is amended as follows:
(a)         
paragraph 2 is replaced by the following:
‘2. The Commission shall, by means of
implementing acts, take a final decision within 15 days after obtaining the
opinion of the Standing Committee on Medicinal Products for Human Use. Those
implementing acts shall be adopted in accordance with the examination procedure
referred to in Article 87(2). ’,
(b)         
paragraph 5 is replaced by the following:
‘5. The Commission shall adopt detailed rules
for the implementation of paragraph 4 which specify the applicable time limits
and procedures, by means of implementing acts. Those implementing acts shall be
adopted in accordance with the examination procedure referred to in Article
87(2). ’ ;
(7)                   
Article 10b(1) is replaced by the following:
‘The Commission shall
be empowered to adopt measures, by means of delegated acts in accordance with
Article 87b, to determine the situations in which post-authorisation efficacy
studies may be required under point (cc) of Article 9(4) and point (b) of
Article 10a(1).’;
(8)                   
Article 14(7) is replaced by the following:
 ‘7. In the interests of public health a
marketing authorisation may be granted subject to certain specific obligations,
to be reviewed annually by the Agency. Those obligations and, where
appropriate, the time limit for compliance shall be specified in the conditions
to the marketing authorisation. The summary of product characteristics and the
package leaflet shall clearly mention that the marketing authorisation for the
medicinal product has been granted subject to those obligations. 
By way of derogation from paragraph 1, such
authorisation shall be valid for one year, on a renewable basis.
The Commission shall be empowered to adopt
delegated acts in accordance with Article 87b in order to lay down provisions
and requirements for granting such marketing authorisation and for its renewal.’
;
(9)                   
Article 16(4) is replaced by the following:
‘4. The Commission shall be empowered to adopt
delegated acts in accordance with Article 87b establishing procedures for the
examination of applications for variations to the terms of marketing
authorisations and for the examination of applications for the transfer of
marketing authorisations.’; 
(10)               
Article 20 is amended as follows:
(a)         
paragraph 3 is replaced by the following:
‘3. At any stage of the procedure laid down in
this Article the Commission may take temporary measures. Those temporary
measures shall be applied immediately. 
The Commission shall, by means of implementing
acts, adopt a final decision concerning the measures to be taken in respect of
the medicinal product concerned. Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 87(2).
The Commission may also adopt a decision
addressed to the Member States pursuant to Article 127a of Directive
2001/83/EC.’,
(b)         
paragraph 6 is replaced by the following:
‘6.      The suspensive measures referred to in
paragraph 4 may be maintained in force until such time as a final decision has
been reached in accordance with paragraph 3.’;
(11)               
The first subparagraph of Article 57(2) is
replaced by the following:
‘2. The database provided for in paragraph 1(l)
shall include the summaries of product characteristics, the patient or user
package leaflet and the information shown on the labelling. The database shall
be developed in stages, priority being given to medicinal products authorised
under this Regulation and those authorised under Chapter 4 of Title III of
Directive 2001/83/EC. The database shall subsequently be extended to include
any medicinal product authorised in the Union.’;
(12)               
Article 59(4) is replaced by the following:
‘4. Save as otherwise provided in this
Regulation, in Regulation (EU) No […] or in Directive 2001/83/EC, where there
is a fundamental conflict over scientific points and the body concerned is a
body in a Member State, the Agency and the national body concerned shall work
together either to resolve the conflict or to prepare a joint document
clarifying the scientific points of conflict. This document shall be published
immediately after its adoption.’;
(13)               
Article 61(1) is replaced by the following:
‘1. Each Member State shall, after consultation
of the Management Board, appoint, for a three-year term which may be renewed,
one member and one alternate to the Committee for Medicinal Products for Human.

The alternates shall represent and vote for the
members in their absence and may act as rapporteurs in accordance with Article
62. 
Members and alternates shall be chosen for
their role and experience in the evaluation of medicinal products for human use
as appropriate and shall represent the competent national authorities.’
(14)               
in Article 62(3), the second subparagraph is deleted;
(15)               
the first subparagraph of Article 67(3) is
replaced by the following:
‘The Agency’s revenue shall consist of a
contribution from the Union, fees paid by undertakings for obtaining and
maintaining Union marketing authorisations and for other services provided by
the Agency, or by the coordination group as regards the fulfilment of its tasks
in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC
and charges for other services provided by the Agency.’;
(16)               
Article 70 is replaced by the following: 
‘Article 70
1.         The
Commission shall, on the basis of the principles set out in paragraph 2, adopt implementing
acts in accordance with the procedure laid down in Article 87(2) specifying:
(a)         
the structure and the level of the fees and
charges referred to in Article 67(3);
(b)         
the services for which charges may be collected;
(c)         
the conditions under which small and
medium-sized enterprises may pay reduced fees, defer payment of fees or receive
administrative assistance;
(d)        
the rules defining the remuneration for work
carried out by the member of the relevant committee or the coordination group
who acts as a rapporteur; and
(e)         
the conditions for payment and remuneration.
The fees shall be
set at such a level as to avoid a deficit or a significant accumulation of
surplus in the budget of the Agency and be revised when this is not the case.
2.           When adopting the implementing acts referred
to in paragraph 1, the Commission shall take the following into account: 
(a)         
fees shall be set at such a level as to ensure
that the revenue derived from them is, in principle, sufficient to cover the
costs of the services delivered and shall not exceed what is necessary to cover
the costs;
(b)         
the level of the fees shall take into account
the results of a transparent and objective evaluation of the costs of the
Agency and the costs of the tasks carried out by the national competent
authorities;
(c)         
the specific needs of SMEs shall be taken into
account, as appropriate, including the possibility of splitting payments into
several instalments and phases;
(d)        
on public health grounds the fee may be totally
or partially waived for a particular category of medicinal products;
(e)         
the structure and amount of fees shall take into
account whether information has been submitted jointly or separately;
(f)          
under exceptional and duly justified
circumstances and upon acceptance by the Agency, the whole fee or part of it
may be waived;
(g)         
the remuneration for the work of the rapporteur
shall be paid in principle  to the national competent authority employing the
rapporteur or, where the rapporteur is not employed by the national  competent
authority, the Member State that nominated him;
(h)         
the time of payment for the fees and charges shall
be fixed taking due account of the time limits under the provisions of this
Regulation and Regulation (EU) No […]’;
(17)               
Article 84(3) is replaced by the following: 
‘3. The Commission may impose financial
penalties on the holders of marketing authorisations granted under this
Regulation if they fail to observe obligations laid down in connection with the
marketing authorisations granted in accordance with this Regulation. 
The Commission shall be empowered to adopt
delegated acts in accordance with Article 87b laying down:
(a)         
a list of obligations under this Regulation, the
infringement of which may be subject to financial penalties;
(b)         
procedures for the exercise of powers to impose
fines or periodic penalty payments, including rules on the initiation of the procedure,
measures of inquiry, rights of the defence, access to file, legal
representation and confidentiality;
(c)         
rules on duration of procedure and limitation
periods;
(d)        
elements to be taken into account by the
Commission when setting the level of and imposing fines and periodic penalty
payments, their maximum amounts as well as the conditions and methods for their
collection.
For the conduct of the investigation the
Commission may cooperate with national competent authorities and rely on
resources provided by the Agency.
Where the Commission adopts a decision imposing
a financial penalty, it shall publish a concise summary of the case, including
the names of the marketing authorisation holders involved and the amounts of
and reasons for the financial penalties imposed, having regard to the
legitimate interest of the marketing authorisation holders in the protection of
their business secrets.
The Court of Justice shall have unlimited
jurisdiction to review decisions whereby the Commission has imposed financial
penalties. It may cancel, reduce or increase the fine or periodic penalty
payment imposed.’
(18)               
Article 86 is replaced by the following:
‘Article
86 
At least every ten years, the Commission shall
publish a general report on the experience acquired as a result of the
operation of the procedures laid down in this Regulation and in Chapter 4 of
Title III of Directive 2001/83/EC.’;
(19)               
Article 87 is replaced by the following:
‘Article
87
1. The Commission shall be assisted by the
Standing Committee on Medicinal Products for Human Use established by Article
121 of Directive 2001/83/EC. The Committee shall be a committee within the
meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph,
Article 5 of Regulation (EU) No 182/2011 shall apply.’
(20)               
Article 87b is replaced by the following:
‘Article
87b
1. The power to adopt delegated acts is
conferred on the Commission subject to the conditions laid down in this
Article.
2. The delegation of power referred to in
Articles 3(4), 10b (1), 14(7), 16(4) and 84(3) shall be conferred on the
Commission for an indeterminate period of time from the date of entry into
force of this Regulation.
3. The delegation of power referred to in
Articles 3(4), 10b (1), 14(7), 16(4) and 84(3) may be revoked at any time by the
European Parliament or by the Council. A decision to revoke shall put an end to
the delegation of the power specified in that decision. It shall take effect
the day following the publication of the decision in the Official Journal of
the European Union or at a later date specified therein. It shall not
affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the
Commission shall notify it simultaneously to the European Parliament and to the
Council.
5. A delegated act adopted pursuant to Articles
3(4), 10b (1), 14(7), 16(4) and 84(3) shall enter into force only if no
objection has been expressed either by the European Parliament or the Council
within a period of two months of notification of that act to the European
Parliament and the Council or if, before the expiry of that period, the
European Parliament and the Council have both informed the Commission that they
will not object. That period shall be extended by two months at the initiative
of the European Parliament or of the Council.’;
(21)               
Articles 30 to 54, Articles 79, 87c and 87d and
point 2 of the Annex are deleted.
Article 2
This Regulation shall enter into force on
the  day following that of its publication in the Official Journal of the
European Union.
[the entry into force and application
should be on the same date as of the new Regulation on veterinary medicinal
products]
This Regulation shall be binding
in its entirety and directly applicable in all Member States..
Done at Brussels,
For the European Parliament                        For
the Council
The President                                                 The
President
[1]        For a summary of the responses, see:
http://ec.europa.eu/health/files/veterinary/vet_pubcons_rep2011.pdf 
[2]        Study carried out by GHK Consulting,
a member of the European Policy Evaluation Consortium (EPEC), assisted by
Triveritas              
[3]               OJ C , , p. .
[4]               OJ C , , p. .
[5]               Directive 2001/82/EC of the European Parliament and
of the Council of 6 November 2001 on the Community code relating to veterinary
medicinal products (OJ L 311, 28.11.2001, p. 1).
[6]               Regulation (EC) No 726/2004 of the European
Parliament and of the Council of 31 March 2004 laying down Community procedures
for the authorisation and supervision of medicinal products for human and
veterinary use and establishing a European Medicines Agency (OJ L 136,
30.4.2004, p. 1).
[7]               Regulation … of the European Parliament and of the
Council of … … … on veterinary medicinal products (OJ L …, … … …, p. …).
[8]               Regulation (EU) No 182/2011 of the European
Parliament and of the Council of 16 February 2011 laying down the rules and
general principles concerning mechanisms for control by Member States of the
Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).