(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.

(1)

Directive 2001/82/EC of the European Parliament and of the Council (5) and Regulation (EC) No 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 , with a view to harmonisation of the laws of the Member States .

(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.

(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 with regard to technical and scientific progress so as to facilitate the placing on the market of new medicinal products , 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.

(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 (2).

(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 Council (3).

(6a)

Advances in alternative testing require the creation of a regulatory framework capable of adapting to new developments in this field, including for example the recognition and evaluation of modeling and simulation technologies.

(6b)

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

(6c)

In the interest of public health, authorisation decisions adopted under the centralised procedure should be taken on the basis of the objective scientific criteria of quality, safety and efficacy.

(6d)

Provision should be made for the quality, safety and efficacy criteria laid down in Directives 2001/83/EC and 2001/82/EC to apply to medicinal products authorised by the Union 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.

(6e)

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. That evaluation should be conducted in the context of the marketing authorisation.

(2a)

(a)

in paragraph 2, point (b) is replaced by the following:

(a)

paragraph 2 is replaced by the following:

‘2.    Any medicinal product not appearing in the Annex may be granted a marketing authorisation by the Union in accordance with this Regulation, if:

(5a)

‘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 regulatory acceptance of alternative models and shall take into consideration the opportunities presented by these new concepts which aim at providing for more predictive medicines. These concepts may be based on human-relevant computer or cellular models, pathways of toxicity, or adverse outcome pathways.’

(5b)

(10a)

(10b)

(10c)

(10d)

(10e)

(13a)

(14)

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

(14)

Article 62 is amended as follows:

(14a)

(14b)

(a)

point (a) is replaced by the following:

(a)

adopt an opinion on the rules of procedures of the Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use (Article 61);

(15)

the first subparagraph of Article 67(3) is replaced by the following:

(15)

Article 67(3) is replaced by the following:

(a)

a contribution from the Union;

(b)

a contribution from any European third country with which the Union has concluded agreements;

(c)

the fees paid by undertakings for obtaining and maintaining Union marketing authorisations for human and veterinary medicinal products and for other services provided by the Agency, as provided for in this Regulation and in Regulation (EU) …/…  (*5) , or by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107 g, 107k and 107q of Directive 2001/83/EC;

(d)

charges for any other services provided by the Agency ; and

(e)

other sources of income, including any ad-hoc grants within the scope of Title VI of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council  (1a) .

(15a)

‘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 in the event that actual fee revenue be below budgeted appropriations. The total amount of such a safeguard fund shall not exceed the Agency's appropriations for the fee revenue of the past year .’

(15b)

‘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 .’

(15c)

(15d)

(15e)

(16)

(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.

(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 […]’;

(16a)

‘ Article 70a

With regard to the level and the structure of the fees referred to in Article 67(3) of this Regulation, Regulation (EC) No 297/95 and Regulation (EU) No 658/2014 shall be applicable until an amendment of Regulation (EC) No 297/95 or any other relevant provisions on fees are adopted and become applicable. ’

(16b)