# CE2012099EN.01020301.xml

| 3.4.2012 | EN | Official Journal of the European Union | CE 99/203 |
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3.4.2012

EN

Official Journal of the European Union

CE 99/203

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Wednesday 24 November 2010Information on medicinal products (Community procedures for the authorisation and supervision of medicinal products) ***I

P7_TA(2010)0430

European Parliament legislative resolution of 24 November 2010 on the proposal for a regulation of the European Parliament and of the Council amending, as regards information to the general public on medicinal products for human use subject to medical prescription, 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(2008)0662 – C6-0517/2008 – 2008/0255(COD))

2012/C 99 E/49

(Ordinary legislative procedure: first reading)

The European Parliament,

The European Parliament

| — | having regard to the Commission proposal to the European Parliament and the Council (COM(2008)0662), |
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—

having regard to the Commission proposal to the European Parliament and the Council (COM(2008)0662),

| — | having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C6-0517/2008), |
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—

having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C6-0517/2008),

| — | having regard to the communication from the Commission to the European Parliament and the Council entitled: ‘Consequences of the entry into force of the Treaty of Lisbon for ongoing interinstitutional decision-making procedures’ (COM(2009)0665), |
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—

having regard to the communication from the Commission to the European Parliament and the Council entitled: ‘Consequences of the entry into force of the Treaty of Lisbon for ongoing interinstitutional decision-making procedures’ (COM(2009)0665),

| — | having regard to Article 294(3), Article 114 and Article 168(4)(c) of the Treaty on the Functioning of the European Union, |
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—

having regard to Article 294(3), Article 114 and Article 168(4)(c) of the Treaty on the Functioning of the European Union,

| — | having regard to the opinion of 10 June 2009 of the European Economic and Social Committee (1), |
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—

having regard to the opinion of 10 June 2009 of the European Economic and Social Committee (1),

1

| — | having regard to the opinion of 7 October 2009 of the Committee of the Regions (2), |
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—

having regard to the opinion of 7 October 2009 of the Committee of the Regions (2),

2

| — | having regard to Rule 55 of its Rules of Procedure, |
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—

having regard to Rule 55 of its Rules of Procedure,

| — | having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection (A7-0289/2010), |
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—

having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection (A7-0289/2010),

| 1. | Adopts the position at first reading hereinafter set out; |
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1.

Adopts the position at first reading hereinafter set out;

| 2. | Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text; |
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2.

Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text;

| 3. | Instructs its President to forward its position to the Council, to the Commission and to the national parliaments. |
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3.

Instructs its President to forward its position to the Council, to the Commission and to the national parliaments.

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(1)  OJ C 306, 16.12.2009, p. 33.

1

(2)  OJ C 79, 27.3.2010, p. 50.

2

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Wednesday 24 November 2010P7_TC1-COD(2008)0255

Position of the European Parliament adopted at first reading on 24 November 2010 with a view to the adoption of Regulation (EU) No .../2011 of the European Parliament and of the Council amending, as regards information to the general public on medicinal products for human use subject to medical prescription, 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,

Having regard to the opinion of the European Economic and Social Committee (1),

Having regard to the opinion of the Committee of the Regions (2),

Acting in accordance with the ordinary legislative procedure (3),

Whereas:

| (1) | On 20 December 2007, the Commission submitted a Communication entitled ‘Report on current practices with regard to the provision of information to patients on medicinal products’. The report concludes that Member States have adopted divergent rules and practices with regard to the provision of information, resulting in a situation where patients and the public at large have unequal access to information on medicinal products. Experience gained from the application of the current legal framework has also shown disparities in the interpretation of Union rules on advertising, and between national provisions on information
  , highlighting the urgent need for a more precise distinction between advertising and information
  . |
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(1)

On 20 December 2007, the Commission submitted a Communication entitled ‘Report on current practices with regard to the provision of information to patients on medicinal products’. The report concludes that Member States have adopted divergent rules and practices with regard to the provision of information, resulting in a situation where patients and the public at large have unequal access to information on medicinal products. Experience gained from the application of the current legal framework has also shown disparities in the interpretation of Union rules on advertising, and between national provisions on information
  , highlighting the urgent need for a more precise distinction between advertising and information
  .

| (2) | The introduction of a new Title VIIIa in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on a Community code relating to medicinal products for human use (4) addresses those concerns through various provisions intended to ensure the availability of good-quality, objective, reliable and non promotional information on medicinal products for human use subject to prescription
  and to place emphasis on the rights and interests of patients
  . |
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(2)

The introduction of a new Title VIIIa in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on a Community code relating to medicinal products for human use (4) addresses those concerns through various provisions intended to ensure the availability of good-quality, objective, reliable and non promotional information on medicinal products for human use subject to prescription
  and to place emphasis on the rights and interests of patients
  .

| (3) | Disparities in the provision of information on medicinal products for human use are not justified in the case of medicinal products authorised pursuant to Title II of Regulation (EC) No 726/2004 of the European Parliament and of the Council (5) for which a single summary of the products characteristics and package leaflet are approved for the whole Union. Therefore Title VIIIa of Directive 2001/83/EC should also apply to those products. |
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(3)

Disparities in the provision of information on medicinal products for human use are not justified in the case of medicinal products authorised pursuant to Title II of Regulation (EC) No 726/2004 of the European Parliament and of the Council (5) for which a single summary of the products characteristics and package leaflet are approved for the whole Union. Therefore Title VIIIa of Directive 2001/83/EC should also apply to those products.

| (4) | Directive 2001/83/EC provides that certain types of information are subject to control by the Member States’ national competent authorities prior to
  being made available
  . In the case of medicinal products for human use authorised pursuant to Title II of Regulation (EC) No 726/2004, provision should also be made for certain types of information to be subject to prior vetting by the European Medicines Agency (hereinafter the ‘Agency’)
  , and for the Agency to monitor the measures to be taken by the manufacturer and to monitor the updating of the literature following the reporting of adverse reactions
  . |
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(4)

Directive 2001/83/EC provides that certain types of information are subject to control by the Member States’ national competent authorities prior to
  being made available
  . In the case of medicinal products for human use authorised pursuant to Title II of Regulation (EC) No 726/2004, provision should also be made for certain types of information to be subject to prior vetting by the European Medicines Agency (hereinafter the ‘Agency’)
  , and for the Agency to monitor the measures to be taken by the manufacturer and to monitor the updating of the literature following the reporting of adverse reactions
  .

| (5) | To ensure the adequate funding of these activities related to information, provision should be made for the collection of fees charged to marketing authorisation holders by the Agency. |
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(5)

To ensure the adequate funding of these activities related to information, provision should be made for the collection of fees charged to marketing authorisation holders by the Agency.

| (6) | In the event that the additional costs incurred by the Agency as a result of its preliminary checking of certain types of information pursuant to this Regulation are not covered by the fees payable by the marketing authorisation holders for this purpose, the amount of the Union’s contribution to the Agency’s budget should be reviewed. Accordingly, efforts should be initiated at Member State level with a view to the possible amendment of the Union’s contribution to the Agency. |
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(6)

In the event that the additional costs incurred by the Agency as a result of its preliminary checking of certain types of information pursuant to this Regulation are not covered by the fees payable by the marketing authorisation holders for this purpose, the amount of the Union’s contribution to the Agency’s budget should be reviewed. Accordingly, efforts should be initiated at Member State level with a view to the possible amendment of the Union’s contribution to the Agency.

| (7) | Since the objective of this Regulation, namely to provide for specific rules on information on medicinal products for human use subject to prescription authorised pursuant to Regulation (EC) No 726/2004, cannot be sufficiently achieved by Member States and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. |
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(7)

Since the objective of this Regulation, namely to provide for specific rules on information on medicinal products for human use subject to prescription authorised pursuant to Regulation (EC) No 726/2004, cannot be sufficiently achieved by Member States and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

| (8) | Regulation (EC) No 726/2004 should be amended accordingly, |
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(8)

Regulation (EC) No 726/2004 should be amended accordingly,

HAVE ADOPTED THIS REGULATION:

Article 1

Amendments to Regulation (EC) No 726/2004

Regulation (EC) No 726/2004 is amended as follows:

| (1) | In Article 9(4), the following point is added:










  ‘(f) | the summary of the European Public Assessment Report referred to in Article 13(3).’. |
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(1)

In Article 9(4), the following point is added:

‘(f)

the summary of the European Public Assessment Report referred to in Article 13(3).’.

| (2) | The following Articles are inserted:
  ‘Article 20a

  1.   Title VIIIa of Directive 2001/83/EC shall apply to medicinal products which are authorised under this Title and are subject to medical prescription.

  Article 20b

  1.   By way of derogation from Article 100 g(1) of Directive 2001/83/EC, medicinal product-related information referred to in Article 100b(d) of that Directive shall be subject to vetting by the Agency prior to its
  being made available, unless this information appears on a website, the responsibility for monitoring the content of which rests with a Member State in accordance with Article 100h of Directive 2001/83/EC
  .
  2.   For the purposes of paragraph 1, the marketing authorisation holder shall submit to the Agency a mock-up of the information to be
  made available
  .
  3.   The Agency may object to the information submitted or parts thereof on grounds related to non-compliance with the provisions of Title VIIIa of Directive 2001/83/EC within
  90 days
  after receipt of the notification. If the Agency does not object within
  90 days
  , the information shall be deemed accepted and may be published.
  The marketing authorisation holder shall remain fully liable and responsible for the information provided in all cases.




  4.
     
  If the Agency asks for changes to be made to information submitted by the marketing authorisation holder, and if the latter resubmits an improved mock-up of the information within 30 working days, the Agency shall communicate its response to the new proposal within 60 working days.




  The Agency shall charge the marketing authorisation holder an additional fee for this assessment.


  5.   The submission of information to the Agency in accordance with paragraphs 1, 2, 3 and 4 shall be subject to a fee payable in accordance with Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (6). |
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(2)

The following Articles are inserted:

‘Article 20a

1.   Title VIIIa of Directive 2001/83/EC shall apply to medicinal products which are authorised under this Title and are subject to medical prescription.

Article 20b

1.   By way of derogation from Article 100 g(1) of Directive 2001/83/EC, medicinal product-related information referred to in Article 100b(d) of that Directive shall be subject to vetting by the Agency prior to its
  being made available, unless this information appears on a website, the responsibility for monitoring the content of which rests with a Member State in accordance with Article 100h of Directive 2001/83/EC
  .

2.   For the purposes of paragraph 1, the marketing authorisation holder shall submit to the Agency a mock-up of the information to be
  made available
  .

3.   The Agency may object to the information submitted or parts thereof on grounds related to non-compliance with the provisions of Title VIIIa of Directive 2001/83/EC within
  90 days
  after receipt of the notification. If the Agency does not object within
  90 days
  , the information shall be deemed accepted and may be published.
  The marketing authorisation holder shall remain fully liable and responsible for the information provided in all cases.

4.
     
  If the Agency asks for changes to be made to information submitted by the marketing authorisation holder, and if the latter resubmits an improved mock-up of the information within 30 working days, the Agency shall communicate its response to the new proposal within 60 working days.

The Agency shall charge the marketing authorisation holder an additional fee for this assessment.

5.   The submission of information to the Agency in accordance with paragraphs 1, 2, 3 and 4 shall be subject to a fee payable in accordance with Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (6).

| (3) | Article 57 is amended as follows:










  (a) | paragraph 1 is amended as follows:










  (i) | point (l) is replaced by the following:










  ‘(l) | creating a database on medicinal products, to be accessible to the general public, in all official languages of the Union, and ensuring that it is updated and managed independently of the commercial interests of pharmaceutical companies. The database shall facilitate the search for information already authorised for package leaflets, it shall include a section on medicinal products authorised for the treatment of children, and the information provided to the public shall be worded in an appropriate and comprehensible manner designed for non-experts;’. |
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(3)

Article 57 is amended as follows:

(a)

paragraph 1 is amended as follows:

(i)

point (l) is replaced by the following:

‘(l)

creating a database on medicinal products, to be accessible to the general public, in all official languages of the Union, and ensuring that it is updated and managed independently of the commercial interests of pharmaceutical companies. The database shall facilitate the search for information already authorised for package leaflets, it shall include a section on medicinal products authorised for the treatment of children, and the information provided to the public shall be worded in an appropriate and comprehensible manner designed for non-experts;’.

| (ii) | the following points are added:






  ‘(u) | delivering opinions on information to the general public on medicinal products for human use subject to medical prescription; |
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(ii)

the following points are added:

‘(u)

delivering opinions on information to the general public on medicinal products for human use subject to medical prescription;

| (v) | promoting existing sources of independent reliable health information.
  ’. |
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(v)

promoting existing sources of independent reliable health information.
  ’.

| (b) | paragraph 2 is amended as follows:










  (i) | The first subparagraph is replaced by the following:




  ‘2.
     
  The database provided for in point (l) of paragraph 1 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 and Chapter 4 of Title III of Directive 2001/82/EC. The database shall subsequently be extended to include any medicinal product placed on the market within the Union. That database shall be actively promoted to EU citizens.’ |
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(b)

paragraph 2 is amended as follows:

(i)

The first subparagraph is replaced by the following:

‘2.
     
  The database provided for in point (l) of paragraph 1 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 and Chapter 4 of Title III of Directive 2001/82/EC. The database shall subsequently be extended to include any medicinal product placed on the market within the Union. That database shall be actively promoted to EU citizens.’

| (ii) | A fourth subparagraph is added:




  ‘The information submitted by marketing authorisation holders and approved by the national authorities shall be sent to the Agency by those authorities and included in the database referred to in the first subparagraph, which shall be available to the public.’. |
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(ii)

A fourth subparagraph is added:

‘The information submitted by marketing authorisation holders and approved by the national authorities shall be sent to the Agency by those authorities and included in the database referred to in the first subparagraph, which shall be available to the public.’.

Article 2

Entry into force

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at

For the European Parliament

The President

For the Council

The President

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(1)  OJ C 306, 16.12.2009, p. 33.

1

(2)  OJ C 79, 27.3.2010, p. 50.

2

(3)  Position of the European Parliament of 24 November 2010.

3

(4)  OJ L 311, 28.11.2001, p. 67.

4

(5)  OJ L 136, 30.4.2004, p. 1.

5

(6)  OJ L 35, 15.2.1995, p. 1.’

6

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