30.4.2004
`
`EN
`
`Official Journal of the European Union
`
`L 136/1
`
`I
`
`(Acts whose publication is obligatory)
`
`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
`
`(Text with EEA relevance)
`
`THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
`EUROPEAN UNION,
`
`Having regard to the Treaty establishing the European
`Community,
`and in particular Article 95 and Article
`152(4)(b) thereof,
`
`Having regard to the proposal from the Commission (1),
`
`Having regard to the Opinion of the European Economic and
`Social Committee (2),
`
`(3)
`
`After consulting the Committee of the Regions,
`
`In accordance with the procedure laid down in Article 251 of
`the Treaty (3),
`
`the operation of the authorisation procedures for the
`placing of medicinal products on the market
`in the
`Community
`and to amend certain administrative
`aspects of the European Agency for the Evaluation of
`Medicinal Products.
`In addition,
`the name of
`that
`Agency should be simplified and changed to the
`European Medicines Agency, (hereinafter referred to as
`the ‘Agency’).
`
`It emerges from the conclusions of that report that the
`amendments to be made to the centralised procedure set
`up by Regulation (EEC) No 2309/93 consist of
`corrections to some of the operating procedures and
`adaptations to take account of
`the probable devel-
`opment of
`science and technology and the future
`enlargement of the European Union.
`It also emerges
`from the report that the general principles previously
`established which govern the centralised procedure
`should be maintained.
`
`since the European Parliament and the
`Moreover,
`have
`adopted Directive
`2001/83/EC of
`Council
`6 November 2001 on the Community code relating to
`medicinal products for human use (5) and Directive
`2001/82/EC of 6 November 2001 on the Community
`code relating to veterinary medicinal products (6), all the
`references to the codified Directives in Regulation (EEC)
`No 2309/93 should be updated.
`
`For the sake of clarity, it is necessary to replace the said
`Regulation with a new Regulation.
`
`It is appropriate to preserve the Community mechanism
`set up by the repealed Community legislation for
`concertation prior to any national decision relating to
`a high-technology medicinal product.
`
`Whereas:
`
`(1)
`
`Article 71 of Council Regulation (EEC) No 2309/93 of
`22 July 1993 laying down Community procedures for
`the authorisation and supervision of medicinal products
`for human and veterinary use and establishing a
`European Agency for
`the Evaluation of Medicinal
`Products (4) provides that, within six years of the entry
`into force of
`the Regulation,
`the Commission is to
`publish a general report on the experience acquired as
`a result of the operation of the procedures laid down in
`the Regulation.
`
`(2)
`
`report on the
`the Commission's
`light of
`In the
`experience gained, it has proved necessary to improve
`
`(1) OJ C 75 E, 26.3.2002, p. 189 and OJ C . . . (not yet published in
`the Official Journal).
`(2) OJ C 61, 14.3.2003, p. 1.
`(3) Opinion of the European Parliament of 23 October 2002 (OJ C
`300 E, 11.12.2003, p. 308), Council Common Position of
`29 September 2003 (OJ C 297 E, 9.12.2003, p. 1), Position of
`the European Parliament of 17 December 2003 (not yet
`published in the Official
`Journal) and Council Decision of
`11 March 2004.
`(4) OJ L 214, 24.8.1993, p. 1. Regulation as last amended by Regu-
`lation (EC) No 1647/2003 (OJ L 245, 29.9.2003, p. 19).
`
`(4)
`
`(5)
`
`(6)
`
`(5) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Council
`Directive 2004/27/EC (see p. 34 of this Official Journal).
`(6) OJ L 311, 28.11.2001, p. 1. Directive as amended by Council
`Directive 2004/28/EC (see p. 58 of this Official Journal).
`
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`

`

`L 136/2
`
`EN
`
`Official Journal of the European Union
`
`30.4.2004
`
`(7)
`
`adoption of Council
`the
`Experience gained since
`Directive 87/22/EEC of 22 December 1986 on the
`approximation of national measures relating to the
`placing on the market of high-technology medicinal
`products, particularly those derived from biotech-
`nology (1) has shown that it is necessary to create a
`centralised authorisation procedure that is compulsory
`for high-technology medicinal products, particularly
`those resulting from biotechnical processes, in order to
`maintain the high level of scientific evaluation of these
`medicinal products in the European Union and thus to
`preserve the confidence of patients and the medical
`professions
`in the
`evaluation. This
`is particularly
`important
`in the context of
`the emergence of new
`therapies, such as gene therapy and associated cell
`therapies,
`and
`xenogenic
`somatic
`therapy.
`This
`approach should be maintained, particularly with a
`view to ensuring the effective operation of the internal
`market in the pharmaceutical sector.
`
`(8) With a view to harmonising the internal market for new
`medicinal products, this procedure should also be made
`compulsory for orphan medicinal products and any
`medicinal product
`for human use
`containing an
`entirely new active substance, i.e. one that has not yet
`been authorised in the Community, and for which the
`therapeutic indication is
`the treatment of acquired
`immune deficiency syndrome, cancer, neurodegenerative
`disorder or diabetes. Four years after the date of entry
`into force of this Regulation, the procedure should also
`become compulsory for medicinal products for human
`use containing a new active substance, and for which
`the therapeutic indication is for the treatment of auto-
`immune diseases and other immune dysfunctions and
`viral diseases.
`It
`should be possible to review the
`provisions in point 3 of the Annex via a simplified
`decision-making procedure not earlier than four years
`after the entry into force of this Regulation.
`
`(9)
`
`As regards medicinal products for human use, optional
`access
`to the centralised procedure should also be
`provided for in cases where use of a single procedure
`produces added value for the patient. This procedure
`should remain optional for medicinal products which,
`although
`not
`belonging
`to
`the
`abovementioned
`categories, are nevertheless therapeutically innovative.
`It is also appropriate to allow access to this procedure
`for medicinal products which, although not innovative,
`may be of benefit to society or to patients if they are
`authorised from the outset at Community level, such as
`certain medicinal products which can be supplied
`without a medical prescription. This option may be
`extended to generic medicinal products authorised by
`the Community, provided that
`this
`in no way
`undermines either
`the harmonisation achieved when
`
`(1) OJ L 15, 17.1.1987, p. 38. Directive repealed by Directive
`93/41/EEC (OJ L 214, 24.8.1993, p. 40).
`
`(10)
`
`(11)
`
`(12)
`
`(13)
`
`the reference medicinal product was evaluated or the
`results of that evaluation.
`
`In the field of veterinary medicinal products, adminis-
`trative measures should be laid down in order to take
`account of the specific features of this field, particularly
`those due to the regional distribution of certain diseases.
`It should be possible to use the centralised procedure for
`the authorisation of veterinary medicinal products used
`within the
`framework of Community provisions
`regarding prophylactic measures for epizootic diseases.
`Optional access to the centralised procedure should be
`maintained for veterinary medicinal products containing
`a new active substance.
`
`For medicinal products for human use, the period for
`protection of data relating to pre-clinical
`tests and
`clinical trials should be the same as that provided for
`in Directive 2001/83/EC. For medicinal products for
`veterinary use,
`the period for protection of data
`relating to pre-clinical tests and clinical trials as well
`as safety and residue tests should be the same as that
`provided for in Directive 2001/82/EC.
`
`In order to reduce the cost for small and medium-sized
`enterprises of marketing medicinal products authorised
`via the centralised procedure, provisions
`should be
`adopted to allow for a reduction of fees, deferring the
`payment of fees, taking over responsibility for trans-
`lations and offering administrative assistance in respect
`of these enterprises.
`
`In the interest of public health, authorisation decisions
`under the centralised procedure should be taken on the
`basis of the objective scientific criteria of quality, safety
`and efficacy of the medicinal product concerned, to the
`exclusion of
`economic
`and other
`considerations.
`However, Member States should be able exceptionally
`to prohibit
`the use in their
`territory of medicinal
`products
`for human use which infringe objectively
`defined concepts of public policy and public morality.
`Moreover, a veterinary medicinal product is not to be
`authorised by
`the Community
`if
`its use would
`contravene the rules laid down within the framework
`of the Common Agricultural Policy or if presented for
`a use prohibited under other Community provisions,
`inter alia Directive 96/22/EC (2).
`
`(14)
`
`Provision should be made for the quality, safety and
`efficacy
`criteria
`in Directives
`2001/83/EC
`and
`2001/82/EC to apply to medicinal products authorised
`by the Community and it should be possible to assess
`the risk-benefit balance of all medicinal products when
`they are placed on the market, at
`the time of
`the
`renewal of the authorisation and at any other time the
`competent authority deems appropriate.
`
`(2) Council Directive 96/22/EC of 29 April 1996 concerning the
`prohibition on the use in stockfarming of certain substances
`having a hormonal or thyrostatic action and of β-agonists (OJ L
`125, 23.5.1996, p. 3).
`
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`

`

`30.4.2004
`
`EN
`
`Official Journal of the European Union
`
`L 136/3
`
`(15)
`
`(16)
`
`(17)
`
`(18)
`
`The Community is required, pursuant to Article 178 of
`the Treaty, to take account of the development policy
`aspects of any measure and to promote the creation of
`conditions
`fit
`for human beings worldwide. Phar-
`maceutical law should continue to ensure that only effi-
`cacious, safe and top-quality medicinal products are
`exported,
`and
`the Commission
`should
`consider
`creating further incentives to carry out research into
`medicinal products against widespread tropical diseases.
`
`the ethical
`is also a need to provide for
`There
`requirements of Directive 2001/20/EC of 4 April 2001
`of the European Parliament and of the Council on the
`approximation of
`the laws, regulations and adminis-
`trative provisions of the Member States relating to the
`implementation of good clinical practice in the conduct
`of clinical trials on medicinal products for human use (1)
`to apply to medicinal products authorised by the
`Community. In particular, with respect to clinical trials
`conducted outside
`the Community on medicinal
`products
`destined
`to
`be
`authorised within
`the
`Community, at
`the time of
`the evaluation of
`the
`application for authorisation, it should be verified that
`these trials were conducted in accordance with the prin-
`ciples of
`good clinical practice
`and the
`ethical
`requirements equivalent to the provisions of the said
`Directive.
`
`best possible scientific opinions so as to enable them
`to exercise the powers regarding the authorisation and
`supervision of medicinal products conferred on them by
`Community
`legislation in the
`field of medicinal
`products. Only after
`a
`single
`scientific
`evaluation
`procedure addressing the quality, safety and efficacy of
`high-technology medicinal products has been conducted
`by the Agency, applying the highest possible standards,
`should marketing authorisation be granted by the
`Community, and this should be done by means of a
`rapid procedure ensuring close cooperation between
`the Commission and Member States.
`
`(20)
`
`to ensure close cooperation between the
`In order
`Agency and scientists operating in Member States, the
`composition of the Management Board should be such
`as to guarantee that the competent authorities of the
`Member States are closely involved in the overall
`management of the Community system for authorising
`medicinal products.
`
`(21)
`
`The Agency's budget should be composed of fees paid
`by the private sector and contributions paid out of the
`Community budget to implement Community policies.
`
`The Community should have the means to carry out a
`scientific assessment of the medicinal products presented
`in accordance with the decentralised Community auth-
`orisation procedures. Moreover, with a view to ensuring
`the effective harmonisation of administrative decisions
`taken by Member States with regard to medicinal
`products presented in accordance with decentralised
`authorisation procedures,
`it is necessary to endow the
`Community with the means to resolve disagreements
`between Member States concerning the quality, safety
`and efficacy of medicinal products.
`
`(22)
`
`(23)
`
`the various bodies
`The structure and operation of
`making up the Agency should be designed in such a
`way as to take into account
`the need constantly to
`renew scientific expertise,
`the need for cooperation
`between Community and national bodies, the need for
`adequate involvement of civil society, and the future
`enlargement of
`the European Union. The various
`bodies of
`the Agency should establish and develop
`appropriate contacts with the parties concerned,
`in
`particular
`representatives of patients and health-care
`professionals.
`
`the Interinstitutional Agreement of
`Paragraph 25 of
`6 May 1999 between the European Parliament,
`the
`Council and the Commission on budgetary discipline
`and improvement of budgetary procedure (2) provides
`for the Financial Perspective to be adjusted in order to
`cover the new needs resulting from enlargement.
`
`responsibility for preparing the Agency's
`Exclusive
`on
`all
`questions
`concerning medicinal
`opinions
`for human use
`should be vested in a
`products
`Committee for Medicinal Products for Human Use. As
`far as veterinary medicinal products are concerned, such
`responsibility should be vested in a Committee for
`Medicinal Products
`for Veterinary Use. As
`regards
`orphan medicinal products, the task should fall to the
`Committee on Orphan Medicinal Products set up under
`Regulation (EC) No 141/2000 of
`the
`European
`Parliament and of the Council of 16 December 1999
`on orphan medicinal products (3). Lastly, as regards
`herbal medicinal products, this responsibility should be
`vested in the Committee on Herbal Medicinal Products
`set up under Directive 2001/83/EC.
`
`(19)
`
`the Agency should be to provide
`task of
`The chief
`Community institutions and Member States with the
`
`(24)
`
`The creation of the Agency will make it possible to
`reinforce the scientific role and independence of the
`committees, particularly through the setting-up of a
`permanent technical and administrative secretariat.
`
`(1) OJ L 121, 1.5.2001, p. 34.
`
`(2) OJ C 172, 18.6.1999, p. 1.
`(3) OJ L 18, 22.1.2000, p. 1.
`
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`

`

`L 136/4
`
`EN
`
`Official Journal of the European Union
`
`30.4.2004
`
`(25)
`
`(26)
`
`(27)
`
`(28)
`
`(29)
`
`The field of activity of the Scientific Committees should
`be
`enlarged
`and
`their
`operating methods
`and
`composition modernised. Scientific advice for future
`applicants seeking marketing authorisation should be
`provided more generally and in greater depth. Similarly,
`structures allowing the development of advice for
`companies, in particular small and medium-sized enter-
`prises, should be put in place. The committees should be
`able to delegate some of
`their evaluation duties to
`standing working parties open to experts from the
`scientific world appointed for
`this purpose, whilst
`retaining total responsibility for the scientific opinions
`issued. The
`re-examination procedures
`should be
`amended to provide a better guarantee for applicants'
`rights.
`
`The number of members of the Scientific Committees
`participating in the centralised procedure should be
`established with a view to ensuring that the committees
`remain of an efficient size after the enlargement of the
`European Union.
`
`It is also necessary to reinforce the role of the Scientific
`Committees in such a way as to enable the Agency to
`participate actively in international scientific dialogue
`and to develop certain activities that will be necessary,
`in particular regarding international scientific harmon-
`isation and technical
`cooperation with the World
`Health Organisation.
`
`Furthermore, in order to create greater legal certainty it
`is necessary to define the responsibilities regarding the
`transparency rules for the Agency's work, to set certain
`conditions for the marketing of medicinal products auth-
`orised by the Community, to confer on the Agency
`powers
`to monitor
`the distribution of medicinal
`products authorised by the Community and to specify
`the sanctions and the procedures for implementing them
`in the event of failure to observe the provisions of this
`Regulation and the conditions contained in the author-
`isations granted under the procedures it establishes.
`
`It is also necessary to take measures for the supervision
`of medicinal products authorised by the Community,
`and in particular for the intensive supervision of unde-
`sirable effects of these medicinal products within the
`framework of Community pharmacovigilance activities,
`so as to ensure the rapid withdrawal from the market of
`any medicinal product presenting a negative risk-benefit
`balance under normal conditions of use.
`
`(30)
`
`In order to enhance the efficiency of market surveillance,
`the Agency should be responsible for coordinating
`Member States' pharmacovigilance activities. A number
`of provisions need to be introduced to put in place
`
`(31)
`
`(32)
`
`(33)
`
`stringent and efficient pharmacovigilance procedures,
`to allow the competent authority to take provisional
`emergency measures,
`including the introduction of
`amendments
`to the marketing
`authorisation and,
`finally, to permit a reassessment to be made at any
`time of the risk-benefit balance of a medicinal product.
`
`It is also appropriate to entrust the Commission, in close
`cooperation with the Agency and after consultations
`with the Member States, with the task of coordinating
`the execution of the various supervisory responsibilities
`vested in the Member States, and in particular with the
`tasks of providing information on medicinal products
`and of checking the observance of good manufacturing,
`laboratory and clinical practices.
`
`It is necessary to provide for the coordinated implemen-
`tation of Community procedures for the authorisation of
`medicinal products, and of the national procedures of
`Member States which have already been harmonised to a
`considerable degree by Directives 2001/83/EC and
`2001/82/EC. It is appropriate that the operation of the
`procedures laid down by this Regulation be re-examined
`by the Commission every ten years on the basis of
`experience gained.
`
`in particular, the legitimate expec-
`In order to meet,
`tations of patients
`and to take
`account of
`the
`increasingly rapid progress of science and therapies,
`accelerated assessment procedures should be set up,
`reserved for medicinal products of major therapeutic
`interest, and procedures for obtaining temporary auth-
`orisations
`subject
`to certain annually
`reviewable
`conditions.
`In the field of medicinal products
`for
`human use, a common approach should also be
`followed, whenever possible, regarding the criteria and
`conditions for the compassionate use of new medicinal
`products under Member States' legislation.
`
`the
`(34) Member States have developed an evaluation of
`comparative efficacy of medicinal products aimed at
`positioning a new medicinal product with respect to
`those that already exist in the same therapeutic class.
`Similarly, the Council, in its Conclusions on medicinal
`products and public health (1), adopted on 29 June
`2000,
`emphasised
`the
`importance of
`identifying
`medicinal products that presented an added therapeutic
`value. However this evaluation should not be conducted
`in the context of the marketing authorisation, for which
`it
`is agreed that
`the fundamental criteria should be
`retained.
`It is useful
`in this respect to allow for the
`possibility of gathering information on the methods
`used by the Member States to determine the therapeutic
`benefit obtained by each new medicinal product.
`
`(1) OJ C 218, 31.7.2000, p. 10.
`
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`

`

`30.4.2004
`
`EN
`
`Official Journal of the European Union
`
`L 136/5
`
`(35)
`
`current provisions of Directives
`In line with the
`2001/83/EC and 2001/82/EC, the term of validity of a
`Community marketing authorisation should be limited
`initially to a period of five years, upon the expiry of
`which it should be renewed. Thereafter the marketing
`authorisation should normally be of unlimited validity.
`Furthermore, any authorisation not used for
`three
`consecutive years, that is to say, one which has not
`led to the placing on the market of a medicinal
`product in the Community during that period, should
`be considered invalid, in order,
`in particular, to avoid
`the administrative burden of maintaining such authoris-
`ations. However,
`this
`rule
`should be
`subject
`to
`exemptions when these are justified on public health
`grounds.
`
`(36)
`
`Environmental risks may arise from medicinal products
`containing
`or
`consisting
`of
`genetically modified
`organisms.
`It
`is
`thus necessary
`to subject
`such
`products
`to
`an
`environmental
`risk-assessment
`procedure similar
`to the procedure under Directive
`
`the
`the European Parliament and of
`2001/18/EC of
`Council of 12 March 2001 on the deliberate release
`into
`the
`environment
`of
`genetically modified
`organisms (1),
`to be conducted in parallel with the
`evaluation, under a single Community procedure, of
`the quality, safety and efficacy of the product concerned.
`
`(37)
`
`(38)
`
`The measures necessary for the implementation of this
`Regulation should be adopted in accordance with
`Council Decision 1999/468/EC of 28 June 1999 laying
`down the procedures for the exercise of implementing
`powers conferred on the Commission (2).
`
`The provisions of Regulation (EC) No 1647/2003 (3)
`amending Regulation (EC) No 2309/93 as regards the
`budgetary and financial rules applicable to the Agency
`and access to the Agency's documents should be fully
`incorporated into this Regulation,
`
`HAVE ADOPTED THIS REGULATION:
`
`TITLE I
`
`DEFINITIONS AND SCOPE
`
`Article 1
`
`Article 3
`
`The purpose of this Regulation is to lay down Community
`procedures
`for
`the
`authorisation,
`supervision and phar-
`macovigilance of medicinal products for human and veterinary
`use, and to establish a European Medicines Agency (hereinafter
`referred to as ‘the Agency’).
`
`The provisions of this Regulation shall not affect the powers of
`Member States' authorities as regards setting the prices of
`medicinal products or their inclusion in the scope of
`the
`national health system or social security schemes on the
`basis of health, economic and social conditions. In particular,
`Member States shall be free to choose from the particulars
`shown in the marketing authorisation those therapeutic indi-
`cations and pack sizes which will be covered by their social
`security bodies.
`
`Article 2
`
`No medicinal product appearing in the Annex may be
`1.
`placed on the market within the Community unless a
`marketing authorisation has been granted by the Community
`in accordance with the provisions of this Regulation.
`
`Any medicinal product not appearing in the Annex may
`2.
`be granted a marketing authorisation by the Community in
`accordance with the provisions of this Regulation, if:
`
`(a) the medicinal product contains a new active substance
`which, on the date of entry into force of this Regulation,
`was not authorised in the Community; or
`
`(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 or animal
`health at Community level.
`
`The definitions laid down in Article 1 of Directive 2001/83/EC
`and those laid down in Article 1 of Directive 2001/82/EC shall
`apply for the purposes of this Regulation.
`
`Immunological veterinary medicinal products for the treatment
`of animal diseases that are subject to Community prophylactic
`measures may also be granted such authorisation.
`
`The holder of a marketing authorisation for medicinal products
`covered by this Regulation must be established in the
`Community. The holder shall be responsible for the placing
`on the market of those medicinal products, whether he does
`it himself or via one or more persons designated to that effect.
`
`___________
`(1) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation
`(EC) No 1830/2003 of the European Parliament and of the Council
`(OJ L 268, 18.10.2003, p. 24).
`(2) OJ L 184, 17.7.1999, p. 23.
`(3) OJ L 245, 29.9.2003, p. 19.
`
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`

`L 136/6
`
`EN
`
`Official Journal of the European Union
`
`30.4.2004
`
`A generic medicinal product of a reference medicinal
`3.
`product authorised by the Community may be authorised by
`the competent authorities of the Member States in accordance
`with Directive 2001/83/EC and Directive 2001/82/EC under
`the following conditions:
`
`(a) the application for authorisation is submitted in accordance
`with Article 10 of Directive 2001/83/EC or Article 13 of
`Directive 2001/82/EC;
`
`(b) the summary of the product characteristics is in all relevant
`respects consistent with that of the medicinal product auth-
`orised by the Community except for those parts of the
`summary of product characteristics referring to indications
`or dosage forms which were still covered by patent law at
`the time when the generic medicine was marketed; and
`
`(c) the generic medicinal product is authorised under the same
`name in all the Member States where the application has
`been made. For the purposes of this provision, all the
`linguistic versions of the INN (international non-proprietary
`name) shall be considered to be the same name.
`
`After the competent committee of the Agency has been
`4.
`consulted,
`the Annex may be re-examined in the light of
`technical and scientific progress, with a view to making any
`necessary amendments without extending the scope of
`the
`centralised procedure. Such amendments shall be adopted in
`accordance with the procedure referred to in Article 87(2).
`
`Article 4
`
`Applications for the marketing authorisations referred to
`1.
`in Article 3 shall be submitted to the Agency.
`
`The Community shall grant and supervise marketing
`2.
`authorisations
`for medicinal products
`for human use in
`accordance with Title II.
`
`The Community shall grant and supervise marketing
`3.
`authorisations for veterinary medicinal products in accordance
`with Title III.
`
`AUTHORISATION AND SUPERVISION OF MEDICINAL PRODUCTS FOR HUMAN USE
`
`TITLE II
`
`C h a p t e r 1
`
`Article 6
`
`Submission and examination of applications —
`Authorisations
`
`Article 5
`
`A Committee for Medicinal Products for Human Use is
`1.
`hereby established. The Committee shall be part of the Agency.
`
`2. Without prejudice to Article 56 or to other tasks which
`Community law may confer on it, the Committee for Medicinal
`Products for Human Use shall be responsible for drawing up
`the opinion of
`the Agency on any matter concerning the
`admissibility of
`the files submitted in accordance with the
`centralised procedure, the granting, variation, suspension or
`revocation of an authorisation to place a medicinal product
`for human use on the market
`in accordance with the
`provisions of this Title, and pharmacovigilance.
`
`At the request of the Executive Director of the Agency or
`3.
`the Commission representative, the Committee for Medicinal
`Products for Human Use shall also draw up an opinion on any
`scientific matter
`concerning the
`evaluation of medicinal
`products
`for human use. The Committee shall
`take due
`account of any requests by Member States for an opinion.
`The Committee shall also formulate an opinion whenever
`there is disagreement in the evaluation of medicinal products
`through the mutual recognition procedure. The opinion of the
`Committee shall be made publicly accessible.
`
`Each application for the authorisation of a medicinal
`1.
`product
`for human use shall
`specifically and completely
`include the particulars and documents as
`referred to in
`Articles 8(3), 10, 10a, 10b or 11 of, and Annex I
`to,
`Directive 2001/83/EC. The documents must
`include
`a
`statement to the effect that clinical trials carried out outside
`the European Union meet the ethical requirements of Directive
`2001/20/EC. These particulars and documents
`shall
`take
`account of the unique, Community nature of the authorisation
`requested and, otherwise than in exceptional cases relating to
`the application of the law on trade marks, shall include the use
`of a single name for the medicinal product.
`
`The application shall be accompanied by the fee payable to the
`Agency for the examination of the application.
`
`for human use
`In the case of a medicinal product
`2.
`containing or consisting of genetically modified organisms
`within the meaning of Article 2 of Directive 2001/18/EC, the
`application shall be accompanied by:
`
`(a) a copy of the competent authorities' written consent to the
`deliberate release into the environment of the genetically
`modified organisms for research and development purposes
`where provided for in Part B of Directive 2001/18/EC or in
`Part B of Council Directive 90/220/EEC of 23 April 1990
`on the deliberate
`release
`into the
`environment of
`genetically modified organisms (1);
`
`(1) OJ L 117, 8.5.1990, p. 15. Directive repealed by Directive
`2001/18/EC, but continues to have certain legal effects.
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1050, p. 6 of 33
`
`

`

`30.4.2004
`
`EN
`
`Official Journal of the European Union
`
`L 136/7
`
`(b) the complete technical dossier supplying the information
`required by Annexes III and IV to Directive 2001/18/EC;
`
`(c) the environmental risk assessment in accordance with the
`principles set out in Annex II to Directive 2001/18/EC; and
`
`(d) the results of any investigations performed for the purposes
`of research or development.
`
`Articles 13 to 24 of Directive 2001/18/EC shall not apply to
`medicinal products for human use containing or consisting of
`genetically modified organisms.
`
`the
`the opinion of
`The Agency shall ensure that
`3.
`Committee for Medicinal Products for Human Use is given
`within 210 days after receipt of a valid application.
`
`The duration of the analysis of the scientific data in the file
`concerning the application for marketing authorisation must be
`at least 80 days, except in cases where the rapporteur and
`co-rapporteur
`declare
`that
`they have
`completed
`their
`assessment before that time.
`
`(b) may request that an Official Medicines Control Laboratory
`or a laboratory that a Member State has designated for that
`purpose test
`the medicinal product
`for human use,
`its
`starting materials
`and,
`if need be,
`its
`intermediate
`products or other constituent materials in order to ensure
`that the control methods employed by the manufacturer
`and described in the application documents are satisfactory;
`
`(c) may request that the applicant supplement the particulars
`accompanying the application within a specific time period.
`Where the said Committee avails itself of this option, the
`time-limit laid down in Article 6(3),
`first subparagraph,
`shall be suspended until such time as the supplementary
`information requested has been provided. Likewise,
`this
`time-limit shall be suspended for the time allowed for the
`applicant to prepare oral or written explanations.
`
`Article 8
`
`Upon receipt of a written request from the Committee for
`1.
`Medicinal Products for Human Use, a Member State shall
`forward the information showing that the manufacturer of a
`medicinal product or the importer from a third country is able
`to manufacture the medicinal product concerned and/or carry
`out
`the necessary control
`tests
`in accordance with the
`particulars and documents supplied pursuant to Article 6.
`
`On the basis of a duly reasoned request, the said Committee
`may call for the duration of the analysis of the scientific data in
`the file concerning the application for marketing authorisation
`to be extended.
`
`2. Where it considers it necessary in order to complete its
`examination of an application, the said Committee may require
`the applicant to undergo a specific inspection of the manu-
`facturing site of
`the medicinal product concerned. Such
`inspections may be made unannounced.
`
`In the case of a medicinal product for human use containing or
`consisting of genetically modified organisms, the opinion of the
`said Committee
`shall
`respect
`the
`environmental
`safety
`requirements laid down by Directive 2001/18/EC. During the
`process of evaluating applications for marketing a