Directive 2010/84 - Directive 2010/84/EU amending, as regards pharmacovigilance, Directive 2001/83/EC on the EC code relating to medicinal products for human use

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Contents

  1. Current status
  2. Key information
  3. Key dates
  4. Legislative text
  5. Original proposal
  6. Sources and disclaimer
  7. Full version
  8. EU Monitor

1.

Current status

This directive has been published on December 31, 2010, entered into force on January 20, 2011 and should have been implemented in national regulation on July 21, 2012 at the latest.

2.

Key information

official title

Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use Text with EEA relevance
 
Legal instrument Directive
Number legal act Directive 2010/84
Original proposal COM(2008)665 EN
CELEX number135 32010L0084

3.

Key dates

Document 15-12-2010
Publication in Official Journal 31-12-2010; Special edition in Croatian: Chapter 13 Volume 056,OJ L 348, 31.12.2010
Effect 20-01-2011; Entry into force Date pub. +20 See Art 4
End of validity 31-12-9999
Transposition 21-07-2012; At the latest

4.

Legislative text

31.12.2010   

EN

Official Journal of the European Union

L 348/74
 

DIRECTIVE 2010/84/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 15 December 2010

amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

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

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

Having regard to the opinion of the European Data Protection Supervisor (3),

Acting in accordance with the ordinary legislative procedure (4),

Whereas:

 

(1)

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (5) lays down harmonised rules for the authorisation, supervision and pharmacovigilance of medicinal products for human use within the Union.
 

(2)

Pharmacovigilance rules are necessary for the protection of public health in order to prevent, detect and assess adverse reactions to medicinal products placed on the Union market, as the full safety profile of medicinal products can only be known after they have been placed on the market.
 

(3)

In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products.
 

(4)

While the fundamental objective of the regulation of medicinal products is to safeguard public health, this aim should nevertheless be achieved by means that do not impede the free movement of safe medicinal products within the Union. It has emerged from the assessment of the Union system of pharmacovigilance that divergent actions by Member States in relation to safety issues pertaining to medicinal products are creating obstacles to the free movement of medicinal products. In order to prevent or eliminate those obstacles the existing pharmacovigilance provisions at Union level should be strengthened and rationalised.
 

(5)

For the sake of clarity, the definition of the term ‘adverse reaction’ should be amended to ensure that it covers noxious and unintended effects resulting not only from the authorised use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorisation, including the misuse and abuse of the medicinal product. The suspicion of an adverse drug reaction, meaning that there is at least a reasonable possibility of there being a causal relationship between a medicinal product and an adverse event, should be sufficient reason for reporting. Therefore, the term ‘suspected adverse reaction’ should be used when referring to reporting obligations. Without prejudice to the existing Union and national provisions and practices on medical confidentiality, Member States should ensure that reporting and processing of personal data related to suspected adverse reactions, including those associated with medication errors is carried out on a confidential basis. This should not affect Member States’ obligations regarding the mutual exchange of information on pharmacovigilance issues or their obligation to make available to the public important information on pharmacovigilance concerns. Furthermore, the principle of confidentiality should not affect the obligations of the persons concerned to provide information under criminal...


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This text has been adopted from EUR-Lex.

5.

Original proposal

 

6.

Sources and disclaimer

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7.

Full version

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8.

EU Monitor

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    OJ L 136, 30.4.2004, p. 1.

     
  • 2. 
    OJ L 311, 28.11.2001, p. 67.

     
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    OJ L 136, 30.4.2004, p. 1.

     
  • 4. 
    See: ec.europa.eu/health/ph_overview/patient_safety

     
  • 5. 
    See: imi.europa.eu/documents_en

     
  • 6. 
    A number of Community projects aim at providing insights to improve pharmacovigilance by analysing, using information technology, the information available in Electronic Health Records, including projects co-funded under the 7th Framework Research Programme.

     
  • 7. 
    Regulation (EC) No 726/2004 is also based on Article 152(4)(b), as regards the regulation of veterinary medicinal products, outside the scope of the current proposals.

     
  • 8. 
    ec.europa.eu/atwork/programmes/docs (see page 20).

     
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    OJ C , , p. .

     
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    OJ C , , p. .

     
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    OJ C , , p. .

     
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    OJ L 136, 30.4.2004, p. 1.

     
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    See: ec.europa.eu/health/ph_overview/patient_safety

     
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    A number of Community projects aim at providing insights to improve pharmacovigilance by analysing, using information technology, the information available in Electronic Health Records, including projects co-funded under the 7th Framework Research Programme.

     
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    OJ L 136, 30.4.2004, p. 1.

     
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    See: ec.europa.eu/health/ph_overview/patient_safety

     
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    OJ L 136, 30.4.2004, p. 1.

     
  • 39. 
    See: ec.europa.eu/health/ph_overview/patient_safety

     
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    A number of Community projects aim at providing insights to improve pharmacovigilance by analysing, using information technology, the information available in Electronic Health Records, including projects co-funded under the 7th Framework Research Programme.

     
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    See: ec.europa.eu/health/ph_overview/patient_safety

     
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    Non-differentiated appropriations hereafter referred to as NDA.

     
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    See: ec.europa.eu/health/ph_overview/patient_safety

     
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    See: imi.europa.eu/documents_en

     
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    A number of Community projects aim at providing insights to improve pharmacovigilance by analysing, using information technology, the information available in Electronic Health Records, including projects co-funded under the 7th Framework Research Programme.

     
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    Regulation (EC) No 726/2004 is also based on Article 152(4)(b), as regards the regulation of veterinary medicinal products, outside the scope of the current proposals.

     
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    ec.europa.eu/atwork/programmes/docs (see page 20).

     
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    OJ C , , p. .

     
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    OJ C , , p. .

     
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    See: ec.europa.eu/health/ph_overview/patient_safety

     
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    See: ec.europa.eu/health/ph_overview/patient_safety

     
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    A number of Community projects aim at providing insights to improve pharmacovigilance by analysing, using information technology, the information available in Electronic Health Records, including projects co-funded under the 7th Framework Research Programme.

     
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    OJ L 136, 30.4.2004, p. 1.

     
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    OJ L 136, 30.4.2004, p. 1.

     
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    See: ec.europa.eu/health/ph_overview/patient_safety

     
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    A number of Community projects aim at providing insights to improve pharmacovigilance by analysing, using information technology, the information available in Electronic Health Records, including projects co-funded under the 7th Framework Research Programme.

     
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    See: ec.europa.eu/health/ph_overview/patient_safety

     
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    OJ L 136, 30.4.2004, p. 1.

     
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    OJ L 136, 30.4.2004, p. 1.

     
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    OJ L 136, 30.4.2004, p. 1.

     
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    OJ L 311, 28.11.2001, p. 67.

     
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    OJ L 136, 30.4.2004, p. 1.

     
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    See: imi.europa.eu/documents_en

     
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    OJ L 136, 30.4.2004, p. 1.

     
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    Non-differentiated appropriations hereafter referred to as NDA.

     
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    Wolters Kluwer
     
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    Deze databank van de Europese Unie biedt de mogelijkheid de actuele werkzaamheden (workflow) van de Europese instellingen (Europees Parlement, Raad, ESC, Comité van de Regio's, Europese Centrale Bank, Hof van Justitie enz.) te volgen. EURlex volgt alle voorstellen (zoals wetgevende en begrotingsdossiers) en mededelingen van de Commissie, vanaf het moment dat ze aan de Raad of het Europees Parlement worden voorgelegd.
     
  • 136. 
    EUR-lex provides an overview of the proposal, amendments, citations and legality.