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News and updates
12/06/2013
Japan has been added to the "list of third countries" as regards standards of manufacture and supervision of active pharmaceutical ingredients equivalent to those of the EU. The Commission Decision is here
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06/06/2013
70th Meeting of the Pharmaceutical Committee, 27 March 2013 : Summary Record(54 KB)
Human Pharmaceutical Committee >>>
31/05/2013
Notice to applicants, medicinal products for human use, volume 2B, module 1.2 administrative information application form
The electronic version of the revised version of the application form is available (revision 10.1). The external link has been added on the website.
As from Monday 3 June 2013, applicants shall use the revision 10.1 (in electronic or paper form).
27/05/2013
International activities
Agreement between Israel and the EU on conformity assessment and acceptance of industrial products : Questions and answers.(37 KB)
24/05/2013
Notice to applicants, medicinal products for human use, volume 2B, module 1.2 administrative information application form
Publication of revision 10.1 of the application form - correction of a typographical error in the numbering of the annexes in the end of section 2.5.3 regarding the ASMF (annexes should read 5.10 and 5.11 instead of 5.11 and 5.12
The electronic version of this application form is currently prepared and should be available in May 2013.
Information will be published when the updated electronic application form version will be available together with hyperlink to it.
22/05/2013
Summary of the responses to the public consultation on the Regulation on Advanced Therapies.(92 KB)
A summary of the responses to the public consultation on the Regulation on Advanced Therapies as well as the responses can be found here.
21/05/2013
Medicinal Products for Veterinary Use
Terms of reference for advice on the impact on public health and animal health of the use of antibiotics in animals.(426 KB)
Medicinal Products for Veterinary Use >>
16/5/2013
Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures(898 KB) 
български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) svenska (sv)
The Commission has adopted the Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures ("Guidelines").
The Guidelines replace the Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products as well as the Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products.
The new Guidelines reflect the changes in the procedures for the variation of the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products introduced by Commission Regulation 712/2012. The Guidelines have also been updated with new classifications to reflect adaptation to technical progress, changes introduced in the basic legislation, and the experience acquired in the application of variation classifications.
The Guidelines will also be published in the Official Journal coinciding with the entry into force on 4 August 2013 of all changes introduced in Regulation 1234/2008 by Commission Regulation 712/2012. The purpose of the earlier publication on our website is to enable marketing authorisation holders to make the necessary preparations so that the submission of variations can be done in accordance with the procedures and classifications explained in the Guidelines by 4 August 2013.
16 /05/2013
Annual report on benefits and infringements under the Paediatric Regulation (771 KB)
15/05/2013
Eudralex Volume 10 : Clinical Trials - Chapter V
Guidance documents applying to clinical trials - Questions & Answers Document, Version 11.0 (May 2013)
The Questions and Answers document in the EudraLex chapter on clinical trials has been revised. The version 11.0 of this document is available here(100 KB).
03/05/2013
Eudralex Volume 10 : Clinical Trials - Chapter III: Quality of the Investigational Medicinal Product
Template for the qualified person's declaration equivalence to EU GMP for Investigational Medicinal Products manufactured in third countries(29 KB) (may 2013)
26/04/2013
Reply of Directorate General Health and Consumers to letters of Pestizid Aktions-Netwerk e.v.(31 KB)
25/04/2013
Australia has been added to the "list of third countries" as regards standards of manufacture and supervision of active pharmaceutical ingredients equivalent to those of the EU. The Commission Decision is here.
15/04/2013
Notice to applicants, medicinal products for human use, volume 2B, module 1.2 administrative information application form
The revised version of the application form is published (version 10 from April 2013). Applicants shall use it as from Monday 3 June 2013, but may use it before.
The electronic version of this application form is currently prepared and should be available in May 2013.
Information will be published when the updated electronic application form version will be available together with hyperlink to it.
12/04/2013
Importation of active substances for medicinal products for human use
More information is available here.
02/04/2013
70th meeting of the Pharmaceutical Committee, 27 March 2013
15/03/2013
Responses to the public consultation on the delegated act on post-authorisation efficacy studies
A public consultation(64 KB)took place from 28 November 2012 to 18 February 2013 on post-authorisation efficacy studies.Overall, the Commission received 33 responses. A summary of the comments as well as the replies are here
More information is available here.
08/03/2013
Revised rules on the distribution of medicinal products in the EU
It is of key importance that the quality and the integrity of the medicinal products are maintained during the entire supply chain from the manufacturer to the patient.
Today’s distribution network for medicinal products is increasingly complex and involves many players. The revised guidelines, published today, lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain.
The revised guidelines will enter into force in six months from the date of publication, on 8 Septembre 2013.
More information is available here.
07/03/2013
Adoption and Publication of Commission implementing regulation introducing a Black Symbol to identify medicinal products that are subject to additional monitoring.
On 7 March 2013, the Commission adopted an Implementing Regulation(727 KB) български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) 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) introducing a Black Symbol to identify medicinal products that are subject to additional monitoring.
The black symbol will allow patients and healthcare professionals to identify these products, and the accompanying text will encourage them to report unexpected adverse reactions through national reporting systems(143 KB).
23/02/2013
EudraLex Version 27 - February 2013
Now, you can consult the whole Pharmaceutical Legislation (Human and Veterinary) with an integrated search engine.
The Eudralex V27 is similar to the EudraLex section of this web site, but it can be used off-line with the search engine. All the documents are in.pdf format and without protection.
For a non-commercial use, Eudralex V27 may be duplicated, shared and the documents may be printed.
The DG Health and Consumers and the European Medicines Agency have renewed their confidentiality arrangement with the Japanese medicines regulatory authorities for a further 5-year period.
The renewal of this arrangement allows to continue the exchange of confidential information on the regulation of human medicines with Japan's Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) until February 2018, with the possibility of further extensions for five-year periods.
The renewal builds on the success of the original 2007 confidentiality arrangement as a tool for enhanced regulatory collaboration between the EU and Japanese authorities.
It provides for the international exchanges in areas such as the following:
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advance drafts of legislation and regulatory guidance documents;
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scientific advice on medicine development;
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assessments of applications for marketing authorisations;
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information about the safety of marketed medicines.
06/02/2013
Template for the qualified person’s declaration concerning GMP compliance of investigational medicinal products manufactured in non-EU countries - draft submitted for public consultation(35 KB).
Stakeholders are invited to comment on this draft by 2 April 2013 at the latest. Responses should be sent preferably by e-mail to sanco-pharmaceuticals-d6@ec.europa.eu, or by post to Unit SANCO/D/6, DM24 02/050, BE-1049 Brussels.
06/02/2013
Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use - draft submitted for public consultation(32 KB).
Stakeholders are invited to comment on this draft by 30 April 2013 at the latest. Responses should be sent preferably by e-mail to sanco-pharmaceuticals-d6@ec.europa.eu, or by post to Unit SANCO/D/6, DM24 02/050, BE-1049 Brussels.
06/02/2013
Guidelines on the principles of good distribution practices for active substances for medicinal products for human use - draft submitted for public consultation(45 KB).
Stakeholders are invited to comment on this draft by 30 April 2013 at the latest. Responses should be sent preferably by e-mail to sanco-pharmaceuticals-d6@ec.europa.eu, or by post to Unit SANCO/D/6, DM24 02/050, BE-1049 Brussels.
28/01/2013
Importation of active substances for medicinal products for human use
- Version 3.0 of the "questions and answers(49 KB)" document
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Amended template for "written confirmation"(487 KB)
24/01/2013
Responses to the public consultation on phasing-in requirements on a black symbol identifying medicinal products subject to additional monitoring
A public consultation (33 KB)took place from 21 November 2012 to 10 January 2013 on phasing-in requirements on a black symbol identifying medicinal products subject to additional monitoring.
Overall, the Commission received 14 responses. A summary(35 KB) of the comments as well as the replies are here
24/01/2013
Commission Implementing Decision of 23 January 2013 on the assessment of a third country’s regulatory framework applicable to active substances of medicinal products for human use and of the respective control and enforcement activities pursuant to Article 111b of Directive 2001/83/EC of the European Parliament and of the Council(722 KB) български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) 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)
24/01/2013
The amendment to the Australia-EU Mutual Recognition Agreement has entered into force on 1 January 2013
The EU – Israel Mutual Recognition Agreement has entered into force on 19 January 2013
22/01/2013
Responses to the concept paper submitted for public consultation concerning the delegated act on the criteria to be considered and the verifications to be made when assessing the potential falsified character of medicinal products introduced in the Union but not intended to be placed on the market.
The responses are available here.
17/01/2013
Revision of EU Commission guidelines on Good manufacturing Practice Medicinal Products
Today, the European Commission launches the public consultation of the following revised guidelines on good manufacturing practices:
Chapter 3: Premises and Equipment, Chapter 5: Production, Chapter 6: Quality Control, Chapter 8: Complaints, Quality Defects and Product Recalls.
Comments and suggestions are invited by 18 July 2013 and should be sent by email to: ADM-GMDP@ema.europa.eu and SANCO-pharmaceuticals-D6@ec.europa.eu
- More informations here
16/01/2013
Responses to the public consultation on the experience acquired with the Paediatric Regulation
A public consultation(67 KB) took place from 19 September to 28 November 2012 on the experience acquired with the Paediatric Regulation (Regulation (EC) No 1901/2006) in preparation of a Commission report on this legislative instrument which is due for 2013.
In June 2012 the Directorate General for Health and Consumers consulted stakeholders on a contribution to review the guidelines on the details of the various categories of variations. This contribution took into account scientific and technical progress and the recommendations delivered in accordance with Article 5 of the Variations Regulation, since the entry into force of the Regulation in January 2010. In addition, it took into account the necessary update required by the implementation of the new Pharmacovigilance legislation, which entered into force in July 2012.
Once a year the European Medicines Agency prepares a report on companies and products that have benefitted from the rewards and incentives provided by the Paediatric Regulation No 1901/2006 as well as on companies that have failed to comply with any of the obligations in that Regulation. This report is published by the Commission in accordance with Article 50(1) of the Regulation.
The report covering the year 2012 is available here(771 KB). As a new element it analyses for the first time the obligation of reporting annually on deferred studies. Additionally, it gives an overview of the completion of paediatric investigation plans so far.
06/06/2013
70th meeting of the Pharmaceutical Committee, 27 March 2013