2014/0256(COD) | [ParlTrack]

Proposal for a regulation
Recital 4

(4) As a ~~consequence~~result 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 with regard 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.

Amendment 14 #

Proposal for a regulation
Recital 5

(5) It is of ~~particular~~fundamental 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.

Amendment 15 #

Proposal for a regulation
Recital 6

(6) In ~~order to~~the interests of ensureing 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 Council8. ___________ 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).

Amendment 16 #

Proposal for a regulation
Recital 6

(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 and veterinary use. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council8. ___________ 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).

Amendment 17 #

Proposal for a regulation
Article 1 – paragraph 1 – point 3

Regulation (EC) No 726/2004
Article 2 – point 1

The definitions laid down in Article 1 of Directive 2001/83/EC and in Regulation (EU) ... of the European Parliament and of the Council on veterinary medicinal products (2014/0257(COD) shall apply for the purposes of this Regulation.

Amendment 18 #

Proposal for a regulation
Article 1 – paragraph 1 – point 4 – point c

Regulation (EC) No 726/2004
Article 3 – paragraph 4

‘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 procedureAnnex may not be amended without the approval of the competent health authorities of the Member States.’;

Amendment 19 #

Proposal for a regulation
Article 1 – paragraph 1 – point 6 – point b – introductory part

Regulation (EC) No 726/2004
Article 10 – paragraph 5

(b) paragraph 5 is replaced by the following: (Linguistic change not affecting the English version.)

Amendment 20 #

Proposal for a regulation
Article 1 – paragraph 1 – point 9

Regulation (EC) No 726/2004
Article 16 – paragraph 4

(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.’;deleted

Amendment 21 #

Proposal for a regulation
Article 1 – paragraph 1 – point 10 a (new)

Regulation (EC) No 726/2004
Article 55 – paragraph 2

(10a) Article 55(2) is replaced by the following: ‘The Agency shall be responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products for human and veterinary use.’

Amendment 22 #

Miguel VIEGAS

Proposal for a regulation
Article 1 – paragraph 1 – point 10 a (new)

Regulation (EC) No 726/2004
Article 56 – paragraph 1

(10a) Article 56(1) is replaced by the following: ‘1. The Agency shall comprise: (a) the Committee for Medicinal Products for Human Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for human use; (b) the Committee for Medicinal Products for Veterinary Use, which shall be responsible for preparing the opinion of the Agency in accordance with Regulation (EU) No ... [Regulation on veterinary medicinal products, 2014/0257(COD)]; (c) the Committee on Orphan Medicinal Products; (d) the Committee on Herbal Medicinal Products; (e) a Secretariat, which shall provide technical, scientific and administrative support for the committees and ensure appropriate coordination between them; (f) an Executive Director, who shall exercise the responsibilities set out in Article 64; (g) a Management Board, which shall exercise the responsibilities set out in Articles 65, 66 and 67.’;

Amendment 23 #

Molly SCOTT CATO

Proposal for a regulation
Article 1 – paragraph 1 – point 10 a (new)

Regulation (EC) No 726/2004
Article 57 – paragraph 1 – points u, v and w (new)

(10a) In Article 57(1) the following points are added: "(u) co-ordination of the provision of information on active substances of veterinary medicinal products authorised under Union procedures, for the purpose of implementing a review system (Monograph system); (v) assisting Member States in providing information on active substances of veterinary medicinal products authorised under procedures other than the Union procedures, for the purpose of implementing a review system (Monograph System); (w) setting up a free of charge public database that lists information on active substances of veterinary medicinal products according to the review system (Monograph System), and updating on a regular basis. The respective information shall be presented in an easily understandable manner.".

Amendment 24 #

Proposal for a regulation
Article 1 – paragraph 1 – point 11

Regulation (EC) No 726/2004
Article 57 – paragraph 2 – subparagraph 1

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 for human use authorised in the Union.’;

Amendment 25 #

Molly SCOTT CATO

Proposal for a regulation
Article 1 – paragraph 1 – point 11 a (new)

Regulation (EC) No 726/2004
Article 57 – paragraph 3 (new)

(11a) In Article 57, the following paragraph is added: '(3) The database according to point (w) paragraph 1 of this Article, shall contain data on physico-chemical, ecotoxicological and behavioural properties of the active substance and its respective metabolites. The database shall list information on all veterinary medicines marketed in the Union. The Agency shall prepare a list of all veterinary medicines and active substances marketed in the Union in accordance with Article 51 of Regulation (EU) No .../... of the European Parliament and of the Council of ... on veterinary medicinal products (2014/0257(COD)).'.

Amendment 26 #

Proposal for a regulation
Article 1 – paragraph 1 – point 13

Regulation (EC) No 726/2004
Article 61 – paragraph 1 – subparagraph 1

Each Member State shall, after consultation of the Management Board, appoint, for a three-year ~~term which may be renewed~~renewable term, one member and one alternate apiece to the Committee for Medicinal Products for Human Use.

Amendment 27 #

Proposal for a regulation
Article 1 – paragraph 1 – point 13

Regulation (EC) No 726/2004
Article 61 – paragraph 1 – subparagraph 2

The alternates shall represent and vote for the members in their absence and may also act as rapporteurs in accordance with Article 62.

Amendment 28 #

Proposal for a regulation
Article 1 – paragraph 1 – point 15

Regulation (EC) No 726/2004
Article 67 – paragraph 3 – subparagraph 1

(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.’;deleted

Amendment 29 #

Proposal for a regulation
Article 1 – paragraph 1 – point 15

Regulation (EC) No 726/2004
Article 67 – paragraph 3 – subparagraph 1

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~~for medicinal products for human and veterinary use, and for other services provided by the Agency under this Regulation or Regulation (EU) ... of the European Parliament and of the Council on veterinary medicinal products (2014/0257 (COD), 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.

Amendment 30 #

Tibor SZANYI

Proposal for a regulation
Article 1 – paragraph 1 – point 16

Regulation (EC) No 726/2004
Article 70

~~[...]~~deleted

Amendment 31 #

Proposal for a regulation
Article 1 – paragraph 1 – point 16

Regulation (EC) No 726/2004
Article 70

~~[...]~~deleted

Amendment 32 #

Proposal for a regulation
Article 1 – paragraph 1 – point 16

Regulation (EC) No 726/2004
Article 70 – paragraph 1 – introductory part

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~~submit proposals to the Member States on:

Amendment 33 #

Proposal for a regulation
Article 1 – paragraph 1 – point 16

Regulation (EC) No 726/2004
Article 70 – paragraph 2 – introductory part

2. ~~When adopting the implementing acts referred to in paragraph 1~~In its proposals, the Commission shall take the following into account:

Amendment 34 #

Proposal for a regulation
Article 1 – paragraph 1 – point 17

Regulation (EC) No 726/2004
Article 84 – paragraph 3 – subparagraph 1

~~The Commission may~~3. Member States alone shall be empowered to 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.

Amendment 35 #

Proposal for a regulation
Article 1 – paragraph 1 – point 17

Regulation (EC) No 726/2004
Article 84 – paragraph 3 – subparagraph 3

For the conduct of the investigation the Commission ~~may~~shall cooperate with national competent authorities and rely on resources provided by the Agency.

Amendment 36 #

Proposal for a regulation
Article 1 – paragraph 1 – point 17

Regulation (EC) No 726/2004
Article 84 – paragraph 3 – subparagraph 4

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.deleted

Amendment 37 #

Ivan JAKOVČIĆ

Proposal for a regulation
Article 1 – paragraph 1 – point 18

Regulation (EC) No 726/2004
Article 86

Amendment 38 #

Proposal for a regulation
Article 1 – paragraph 1 – point 20

Regulation (EC) No 726/2004
Article 87b

(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.’;deleted

Amendment 39 #

Proposal for a regulation
Article 1 – paragraph 1 – point 20

Regulation (EC) No 726/2004
Article 87 b – paragraph 4

4. As soon as it adopts a delegated act, the Commission shall ~~notify~~announce it simultaneously to the European Parliament and to the Council.

source: 557.072

2015/06/17 ENVI 38 amendments...

Amendment 16 #

Proposal for a regulation
Recital 3

(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 fees payable to the Agency should ensure that it functions normally and independently. The provisions regulating fees should be brought into line with the Treaty of Lisbon.

Amendment 17 #

Piernicola PEDICINI, Eleonora EVI, Marco AFFRONTE

Proposal for a regulation
Recital 5

(5) ~~It is of particular importance that the Commission carries out appropriate consultations during its preparation of delegated acts, including at expert level~~During the initial stage of the preparatory work, the Commission is requested to carry out consultations with panels of experts, who should be as independent as possible. The appointment of these experts should also secure the consent of the European Parliament. 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 and should examine any feedback.

Amendment 18 #

Proposal for a regulation
Recital 5 a (new)

(5a) The Commission should be able to include, in its general report on the experience acquired as a result of the application of the procedures laid down in this Regulation, information concerning a proposal to revise Council Regulation No (EC) 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products;

Amendment 19 #

Proposal for a regulation
Recital 6 a (new)

(6a) Advances in alternative testing require the creation of a validation framework capable of adapting to new developments in this field, particularly in relation to the recognition and evaluation of in silico testing.

Amendment 20 #

Proposal for a regulation
Recital 6 b (new)

(6b) Animal testing currently plays a key regulatory and scientific role in the development of medicines, and is subject to Directive 2010/63/EU relating to the replacement, reduction or refinement of animal testing.

Amendment 21 #

Proposal for a regulation
Recital 7 a (new)

(7a) 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, and taking into consideration cost-effectiveness of the medicinal product concerned.

Amendment 22 #

Proposal for a regulation
Recital 7 b (new)

(7b) 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 both the risk-benefit balance and the cost-effectiveness 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.

Amendment 23 #

Proposal for a regulation
Recital 7 c (new)

(7c) Member States have developed an evaluation of the 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, adopted on 29 June 2000, emphasised the importance of identifying medicinal products that presented an added therapeutic value. This evaluation should be conducted in the context of the marketing authorisation, in order to provide Member States with a non-binding assessment of comparative efficacy and cost- effectiveness, to be used as a reference assessment by the competent reimbursement agencies of the Member States.

Amendment 24 #

Proposal for a regulation
Article 1 – point 2 a (new)

Regulation (EC) No 726/2004
Article 1 – paragraph 2

(2a) In Article 1, the second paragraph is replaced by the following: "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, provided that Member States take in due consideration the reference comparative efficacy and reference cost-effective evaluation of medicinal product as per the provisions stated in Article 9(4). In particular, Member States shall be free to choose from the particulars shown in the marketing authorisation those therapeutic indications and pack sizes which will be covered by their social security bodies."

Amendment 25 #

Proposal for a regulation
Article 1 – point 5 a (new)

Regulation (EC) No 726/2004
Article 6 – paragraphs 4 a and 4 b (new)

(5a) In Article 6, the following paragraphs are added: "4a. The Agency shall verify that applicants for marketing authorisations have acted in accordance with Article 13(1) of Directive 2010/63/EU. 4b. The Agency shall develop a framework for the validation of in silico models and take into consideration the opportunities presented by in silico concepts developed in toxicology aiming for predictive medicine. These can be based on human-relevant computer or cellular models, pathways of toxicity, or adverse outcome pathways."

Amendment 26 #

Sylvie GODDYN, Jean-François JALKH, Mireille D'ORNANO

Proposal for a regulation
Article 1 – point 5 a (new)

Regulation (EC) No 726/2004
Article 9 – paragraph 1 – point d a (new)

(5a) In Article 9(1) the following point is added: "(da) the reference comparative efficacy and cost-effective evaluation of the medicinal product."

Amendment 27 #

Proposal for a regulation
Article 1 – point 7

Regulation (EC) No 726/2004
Article 10b– paragraph 1

The Commission shall ~~be empowered to adopt measures, by means of delegated acts in accordance with Article 87b,~~propose acts to Parliament and the Council 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).

Amendment 28 #

Sylvie GODDYN, Jean-François JALKH, Mireille D'ORNANO

Proposal for a regulation
Article 1 – paragraph 1 – point 8

Regulation (EC) No 726/2004
Article 14 – paragraph 7 – subparagraph 3

The Commission shall ~~be empowered to adopt delegated acts in accordance with Article 87b~~propose acts to Parliament and the Council in order to lay down provisions and requirements for granting such marketing authorisation and for its renewal.

Amendment 29 #

Proposal for a regulation
Article 1 – point 10 a (new)

Regulation (EC) No 726/2004
Article 57 – paragraph 1 – subparagraph 1

(10a) In Article 57(1), subparagraph 1 is replaced by the following: "1. The Agency shall provide the Member States and the institutions of the Community with the best possible scientific advice on any question relating to the evaluation of the quality, safety ~~and efficacy~~, efficacy and cost effectiveness of medicinal products for human or veterinary use which is referred to it in accordance with the provisions of Community legislation relating to medicinal products."

Amendment 30 #

Proposal for a regulation
Article 1 – point 10 b (new)

Regulation (EC) No 726/2004
Article 57 – paragraph 1 – subparagraph 2 – point i a (new)

(10b) In subparagraph 2 of Article 57(1), the following point is inserted after point (i): "(ia) in the framework of the market authorisation, providing a framework health technology assessment evaluation of medicinal products, in cooperation with Member States national HTA assessment bodies;"

Amendment 31 #

Proposal for a regulation
Article 1 – point 10 a (new)

Regulation (EC) No 726/2004
Article 57 – paragraph 1– subparagraph 2 – points t a, t b and t c (new)

(10a) In subparagraph 2 of Article 57(1), the following points are added: "(ta) co-ordination of the provision of information on active substances of veterinary medicinal products authorised under community procedures, for the purpose of implementing a review system (Monograph system); (tb) assisting Member States in providing information on active substances of veterinary medicinal products authorised under procedures other than the community procedures, for the purpose of implementing a review system (Monograph System); (tc) setting up a free of charge public database that lists information on active substances of veterinary medicinal products according to the review system (Monograph System), and updating on a regular basis. The respective information should be presented in an easily understandable manner."

Amendment 32 #

Fredrick FEDERLEY

Proposal for a regulation
Article 1 – point 10 a (new)

Regulation (EC) No 726/2004
Article 57 – paragraph 1 – subparagraph 2 – point t a (new)

(10a) In subparagraph 2 of Article 57(1), the following point is added: "(ta) in cooperation with EFSA and ECDC annually publish a report on the use of antimicrobials for human and veterinary medicine as well as the current situation on the antimicrobial resistance in the Union."

Amendment 33 #

Proposal for a regulation
Article 1 – point 10 a (new)

Regulation (EC) No 726/2004
Article 57 – paragraph 1 – subparagraph 2 – point t a (new)

(10a) In subparagraph 2 of Article 57(1), the following point is added: "(ta) cooperating with health technology assessment bodies and other national authorities involved in market access, in particular to facilitate their assessment."

Amendment 34 #

Sylvie GODDYN, Jean-François JALKH, Mireille D'ORNANO

Proposal for a regulation
Article 1 – point 11 a (new)

Regulation (EC) No 726/2004
Article 57 – paragraph 2 a (new)

(11a) In Article 57, the following paragraph is added: "2a. The database according to point (tc) of paragraph 1 of this Article contains data on physico-chemical, ecotoxicological and behavioural properties of the active substance and its respective metabolites. The database lists information of all veterinary medicines marketed in the Union. Therefore, the Agency shall prepare a list of all veterinary medicines and active substances marketed in the Union in accordance with Article 51 of Regulation (EU) 2015/xxx of the European Parliament and of the Council1a+. ___________________________ 1aRegulation (EU) 2015/xxx of the European Parliament and of the Council of ... on veterinary medicinal products (OJ L ...). ' + OJ: please insert the number and in the footnote, the number, date and OJ reference of Regulation in document COD 2014/0257."

Amendment 35 #

Proposal for a regulation
Article 1 – point 13

Regulation (EC) No 726/2004
Article 61– paragraph 1 – subparagraph 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 Use. Full and alternate members may be dismissed ad nutum by the appointing Member State and dismissed where there is a conflict of interest.

Amendment 36 #

Proposal for a regulation
Article 1 – point 13 a (new)

Regulation (EC) No 726/2004
Article 62 – paragraph 2

(13a) Article 62(2) is amended as follows: "2. Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products ~~for human use~~ who, taking into account Article 63(2), would be available to serve on working parties or scientific advisory groups of any of the Committees referred to in Article 56(1), together with an indication of their qualifications and specific areas of expertise. The Agency shall keep an up-to-date list of accredited experts. The list shall include the experts referred to in the first subparagraph and any other experts appointed ~~directly~~ by the Agency or the Commission. The list shall be updated."

Amendment 37 #

Proposal for a regulation
Article 1 – point 14

Regulation (EC) No 726/2004
Article 62 – paragraph 3 – subparagraph 2

~~(14) in Article 62(3), the second subparagraph is~~ deleted;

Amendment 38 #

Sylvie GODDYN, Jean-François JALKH, Mireille D'ORNANO

Proposal for a regulation
Article 1 – point 14 a (new)

Regulation (EC) No 726/2004
Article 64 – paragraph 1

(14a) Article 64(1) is amended as follows: "1. The Executive Director shall be appointed by the Management Board, on a proposal from the Commission, for a period of five years on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and elsewhere. Before appointment, the candidate nominated by the Management Board shall be invited forthwith to make a statement to the European Parliament and to answer any questions put by its Members. His mandate may be renewed once by the Management Board, in consultation with the Commission. The Management Board may, upon a proposal from the Commission, remove the Executive Director from his post."

Amendment 39 #

Soledad CABEZÓN RUIZ

Proposal for a regulation
Article 1 – point 14 a (new)

Regulation (EC) No 726/2004
Article 66 – point j

(14a) In Article 66, point (j) is amended as follows: (j) adopt provisions for providing ‘assistance to small and medium-sized pharmaceutical companies (Article 79)’;

Amendment 40 #

Proposal for a regulation
Article 1 – point 15

Regulation (EC) No 726/2004
Article 67 – paragraph 3 – subparagraph 1

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 Agencyme from the general budget of the Union.

Amendment 41 #

Proposal for a regulation
Article 1 – point 15 a (new)

Regulation (EC) No 726/2004
Article 67 – paragraph 3 – subparagraph 1 a (new)

~~It is necessary to ensure that the Agency can deliver the services required by the legislation. A reserve fund could help to deal with potential unpredicted shortfalls in fee revenue.~~(15a) In Article 67(3), the following subparagraph is inserted after subparagraph 1: "In order to safeguard fluctuations in fee revenue, any positive budget outturn of a financial year (N) shall be set aside as assigned revenue and serve as a reserve should actual fee revenue be below budgeted appropriations. The total amount of such safeguard fund shall not exceed the Agency's appropriations for the fee revenue of the past year." Or. en Justification

Amendment 42 #

Proposal for a regulation
Article 1 – point 15 b (new)

Regulation (EC) No 726/2005
Article 67 – paragraph 6 – subparagraph 1 a (new)

(15b) In Article 67(6), the following subparagraph is added: "The draft establishment plan shall contain the number of staff required by the Agency to provide the services financed through fees and the number of staff financed by the Union budget."

Amendment 43 #

Proposal for a regulation
Article 1 – point 15 c (new)

Regulation (EC) No 726/2004
Article 67 – paragraph 8

(15c) Article 67(8) is amended as follows: "8. On the basis of the estimate, the Commission shall enter in the preliminary draft general budget of the European Union the estimates it deems necessary for the establishment plan concerning the staff financed by the Union budget and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty."

Amendment 44 #