Information to patients - New developments

9/07/2012
Information to patients and Pharmacovigilance - New developments

On 28 June 2012, the Commission adopted a corrigendumpdf(402 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) Gaeilge (ga) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) to the amended Commission proposal for a Regulation as regards information to the general public on medicinal products subject to medical prescription
This corrigendumpdf(402 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) Gaeilge (ga) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) rectifies mistake in the cross references of Article 2, paragraph 2 of the Regulation.

10/02/2012
Information to patients and Pharmacovigilance - New developments

On 10 February 2012, the Commission adopted:

The adoption of these proposals follows Commissioner Dalli' s announcement on 2 December 2011 at the Council on Employment, Social Policy, Health and Consumer Affairs (EPSCO) of the split of the amended proposals on information to patients, which were adopted on 11 October 2011, into two parts relating to "Information to Patients" and "Pharmacovigilance" respectively. The split of the proposals aims to facilitate the discussion of the proposals by the co-legislators. The four proposals will be now discussed by the European Parliament and the Council of Ministers.

11/10/2011
The European Commission adopts revised proposals setting out clearer rules on information on prescription-only medicines

The revised proposals amend the original Commission proposals of 2008 and take into account the European Parliament's amendments to the original proposals for legislation on information to patients.
The revised proposals sets out a clear framework whereby companies with marketing authorisation for a product may – and to some extent must – provide good quality and objective information on their prescription-only medicines to the general public. As a result, the proposals should lead to better empowered patients, more rational use of medicines, whilst, at the same time, maintaining the ban on advertising prescription-only medicines. It also seeks to further strengthen the current system for monitoring the safety of medicines, known as pharmacovigilance.

The revised proposals will now be debated by both the European Parliament and the Council of Ministers.

10/12/2008
The European Commission adopts two legal proposals on the provison of information to patients.

26/5/2008
Outcome of the public consultation on the key elements of a legal proposal on information to patients

DG Enterprise and Industry conducted a public consultation between 5 February and 7 April 2008 on the key ideas of a legal proposal aiming at ensuring that all EU citizens have access to good-quality, objective, reliable and non-promotional information on prescription-only medicinal products.

A summary of the outcome of this consultation is available here.pdf(37 KB)

Responses to the public consultation are available here.

5/02/2008
Commission launches a Public consultation on the key ideas of a legal proposal on information to patients

The 'Report on current practices with regard to the provision of information to patients on medicinal products', published on our website for public consultation in 2007, revealed the need to harmonise the way in which information on medicinal products is made available in the EU in order to ensure that all patients have equal access to information on medicinal products.

With this in mind, DG Enterprise and Industry invites you to give your opinion on the key ideas of a legal proposal aiming at ensuring that all EU citizens have access to good-quality, objective, reliable and non promotional information on prescription-only medicinal products.

Please click here to access the Consultation paperpdf(79 KB) Choose translations of the previous link français (fr) . ( French versionpdf(127 KB) Choose translations of the previous link français (fr) )

All responses to the public consultation should be sent by e-mail to ulla.narhi@ec.europa.eu by 7 April 2008.

20/12/2007
Communication from the Commission concerning the Report on current practices with regard to the provision of information to patients on medicinal products


The Communication from the Commission to the European Parliament and the Council concerning the Report on current practices with regard to the provision of information to patients on medicinal products, in accordance with Article 88a of Directive 2001/83/EC, as amended by Directive 2004/27/EC on the Community code relating to medicinal products for human use COM(2007)862, has been adopted today and transmitted to the European Parliament and the Council.
The Communication is supported by a Commission Staff Working Document SEC(2007)1740.
All linguistic versions of the Communication COM(2007)862pdf are available here

The Commission Staff Working Document SEC(2007)1740 is available herepdf(94 KB) .

19/10/2007
Outcome of the public consultation on a Draft report on current practices with regard to the provision of information to patients on medicinal products

DG Enterprise and Industry conducted a public consultation between 19 April and 30 June 2007 on a Draft report on current practices with regard to the provision of information to patients on medicinal products, as required under Article 88a of Directive 2001/83/EC, as amended by Directive 2004/27/EC on the Community code relating to medicinal products for human use.
A summary of the outcome of this consultation is available herepdf(36 KB) .

19/4/2007
Consultation on the Draft report on current practices with regard to the provision of information to patients on medicinal products

DG Enterprise and Industry launches a public consultation on a Draft report on current practices with regard to the provision of information to patients on medicinal products, as required under Article 88a of Directive 2001/83/EC, as amended by Directive 2004/27/EC on the Community code relating to medicinal products for human use

For the consultation document click herepdf(101 KB) .

We invite comments on the document to be sent to entr-pharmaceuticals@ec.europa.eu until 30 June 2007