News and updates

10/09/2014
Adoption of proposal by European Commission
On 10 September 2014 the European Commission adopted proposals on veterinary medicinal products and medicated feed. With its proposal on veterinary medicinal products, the Commission aims to tailor legislation on veterinary medicinal products to the needs of the veterinary sector, without jeopardising public and animal health, or a safe environment. The key documents are available here

 

08/09/2014
Eudralex V29
Now, you can consult the whole Pharmaceutical Legislation (Human and Veterinary) with an integrated search engine

The Eudralex V29 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 V29 may be duplicated, shared and the documents may be printed.

03/07/2014
72nd meeting of the Pharmaceutical Committee, 26 March 2014

01/07/2014
New Application Forms for variations and renewals
New application forms for variations and renewals were published on10 June 2014. There is a transitional period of 3 months until the 1st October 2014, after which the new application forms is recommended to be used.

24/06/2014
On 24 June 2014 the European Commission adopted the new common logo through an Implementing Regulation. Member States have one year from this date to ensure that the provisions on the common logo are applied. Therefore, by mid-2015, all online pharmacies or retailers legally operating in the EU should display the logo.

more informations >>>

18/06/2014
Study on the risks of environmental effects of medicinal products
The study on the risks of environmental effects of medicinal products has been financed by the Commission and carried out by an external contractor (BIO Intelligence Service). Its objectives are to characterise the scale of the environmental effects of medicinal products and to identify non-legislative and legislative causes and possible solutions across the entire EU legislative framework.  It constitutes a starting point from which the different aspects need to be further validated by the European Commission based on the contributions from the European Medicines Agency, the European Environment Agency, Member States and stakeholders.

more informations >>>

10/06/2014
Notice to applicants, update of variations and renewal application forms (human and veterinary)
The Notice to Applicants, volumes 2 and 6 have been updated with the publication of the updated application form for the submission of variations and renewal.
Volume 2C : Human medicinal products - Regulatory Guidelines
Volume 6C : Veterinary medicinal products - Regulatory Guidelines

The electronic version of the new variation and renewal application forms are made available by the European Medicines Agency at [http://esubmission.emea.europa.eu/eaf/index.html]

06/06/2014
Annual report on benefits and infringements under the Paediatric Regulationpdf(893 KB)

On an annual basis the European Medicines Agency reports 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 2013 is available herepdf(893 KB)

more informations >>>

27/05/2014
The New Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/ECwas published in the Official Journal on 27 May 2014.

more informations >>>

26/05/2014
Notice to applicants, medicinal products for human use, volume 2A, chapter 3 Union referral procedure
The update of chapter 3 of volume 2A of the notice to applicants is published and available here

12/05/2014
The Commission has uploaded an online questionnaire regarding the application of Regulation (EC) No 470/2009 of the European Parliament and of the Council on Maximum Residue Limits (MRLs).

The aim of this questionnaire is to gather information from authorities and stakeholders on their experiences with the MRL-Regulation. This information is necessary to establish the report on the experiences gained from the application of the MRL Regulation as required by Article 28 of the Regulation. As of today the MRL questionnaire is published on the Europa website "Your Voice" (link provided below).
It would be very much appreciated if you could take the time to respond to the questionnaire as your answers will provide valuable information to the Commission. Please find below some additional information regarding the MRL questionnaire:

  • Questionnaire language: English
  • Number of questions: 22 questions and additional comments (mostly closed-ended questions)
  • Access to questionnaire
  • Deadline for providing answers: May 31 2014 – 20:00 CET

You can only submit/save the questionnaire once it is 100% completed. Therefore, we strongly recommend that you print the questionnaire (pdf format is available online) and prepare the answers in your own time. Once you are ready to submit it you can simply select and copy/paste your answers. You can only stay logged on for a maximum of 60 min.

Should you have any further questions please do not hesitate to contact Alexander Gibbs (e-mail: alexander.gibbs@ext.ec.europa.eu phone: +32 229 13972).

more informations >>>

02/05/2014
One-year report on human medicines pharmacovigilance tasks of the European Medicines Agencypdf(869 KB)

The report on the pharmacovigilance tasks of the European Medicines Agency that were completed the during the first year of application of the EU’s new pharmacovigilance legislation is available herepdf(869 KB)

more informations >>>

02/05/2014
Responses to the public consultation on the Commission guideline on paediatric investigation plans

A public consultation pdf(111 KB)took place from 9 October 2013 to 3 January 2014 on the Commission guideline on paediatric investigation plans.
Overall, the Commission received 26 responses. A summary of the comments as well as the replies arehere.

more informations >>>

16/04/2014
The new Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/ECwas adopted on 16 April 2014

16/04/2014
Substances considered as not falling within the scope of Regulation (EC) No. 470/20091, with regard to residues of veterinary medicinal products in foodstuffs of animal originpdf(95 KB)

01/04/2014
Report on the application of the Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Productspdf(301 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) hrvatski (hr) 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)

The European Commission has adopted a Report on the application of the Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products (“ATMP Regulation”). pdf(301 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) hrvatski (hr) 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) In the report, the Commission takes stock of the situation of advanced therapy medicinal products in the EU and analyses the impact of the Regulation on advanced therapies.

more informations >>>

 01/04/2014
Good Distribution praactice

A "Question and Answer" document (version 1.0 March 2014)pdf(46 KB) responds to frequently asked questions in relation to the guidelines on Good Distribution Practice of medicinal products for human use."

more informations >>>

28/03/2014
Revision of the Guideline on the format and content of applications for designation as orphan medicinal products
On 28 March, the European Commission published the revised EU guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to anotherpdf(85 KB). The European Commission reviewed the guideline to clarify how sponsors should define the medical plausibly of their product in relation to a disease and its significant benefit.  In addition, the electronic submission of an application using the common Food and Drug Administration-European Medicines Agency application form will be possible. During the development of the product, the classification of a disease may change and the designated condition may need to be modified to better reflect the indication that the sponsor intends to request at the time of marketing, therefore, an existing designation can now be amended.
EU guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to anotherpdf(85 KB) (March 2014)

  • Annex to Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another,date [doc fprmatmsw8(117 KB)] - [pdf formatpdf(103 KB)]

more informations >>>

12/02/2014
71th meeting of the Pharmaceutical Committee, 23 October 2013

more informations >>>

06/02/2014
Revision of European Commission Guidelines on Good Manufacturing Practice for Medicinal Products
Today the European Commission has launched the public consultation on the revision of Annex 15: Qualification and Validation.

Stakeholders are invited to comment on this draftpdf(141 KB)by 31 May 2014 at the latest.
Comments should be sent by e-mail to: ADM-GMDP@ema.europa.eu and sanco-pharmaceuticals-D6@ec.europa.eu.

Please consult the privacy statement on this consultationpdf(82 KB).

more informations >>>

29/01/2014
Substances considered as not falling within the scope of Regulation (EC) No. 470/20091, with regard to residues of veterinary medicinal products in foodstuffs of animal originpdf(94 KB)

Maximum Residue Limits >>>

20/12/2013
Updating the Notice to Applicants – Veterinary Medicinal Products - Volume 6B Presentation and content of the dossierpdf(251 KB)

 DG Health and Consumers releases a revised version of the veterinary Volume 6B Presentation and content of the dossier.
(PDF formatpdf(251 KB)) - (Word Formatmsw8(408 KB))

Eudralex Volume 6 >>>

20/12/2013
Health Commissioner, Tonio Borg, welcomes agreement on the revision of EU rules on Clinical Trialspdf(69 KB)

Clinical Trials >>>

10/12/2013
Substances considered as not falling within the scope of Regulation (EC) No. 470/20091, with regard to residues of veterinary medicinal products in foodstuffs of animal origin.

Maximum Residue Limits >>>

10/12/2013
Report on the event ‘Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem’
London, 8 November 2013pdf(92 KB)

28/11/2013
Responses to the public consultation on the revision of Annex 16: Certification by a Qualified Person and Batch Release.

23/11/2013
A new version of the Guidelines on good distribution practice (GDP)pdf of medicinal products was published today
The revised guidelines (OJ C 343/1, 23.11.2013)pdf correct factual mistakes in subchapters 5.5 and 6.3, give more explanations on the rationale for the revision and provide a formal date of coming into operation. These guidelines, which replace the guidelines on GDP published in March 2013, are applicable as of 24 November 2013.

08/11/2013
Responses to public consultations
 

 

04/11/2013
Friday 8 November at EMA  will take place on antibacterials with the title "Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem".

31/10/2013
EC Report highlights the potential of Personalised Medicinepdf(258 KB)

Today, the Commission publishes a report pdf(258 KB)that takes stock of the progress made in personalised medicine, and the opportunities and challenges it presents for healthcare systems.
The report focuses on: 1) the potential for, and issues with, the use of '-omics' technologies in personalised medicine, and the related EU research funding, 2) recent developments in EU legislation for placing medicinal products and devices on the market, and 3) factors affecting the uptake of personalised medicine in health care systems.
The report concludes that personalised medicine has the potential to offer new treatment opportunities for the benefit of patients, including better targeted treatment, avoiding medical errors and reducing adverse reactions to medicines. It also recognises the challenges (e.g. in research) to its successful incorporation into healthcare systems.

30/10/2013
71th meeting of the Pharmaceutical Committee, 23 October 2013

25/10/2013
Responses to the public consultation on the guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another

11/10/2013
Press Release

European Medicines Agency launches a new version of EudraCTpdf(104 KB)

The EudraCT website is available here.

09/10/2013
Public consultation on Commission guideline on paediatric investigation plans

In accordance with the Paediatric Regulation (EC) 1901/2006 the Commission has to draw up detailed arrangements concerning the format and content of paediatric investigation plans. In September 2008 the Commission published a relevant guidelinepdf(184 KB) Choose translations of the previous link 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) , which has been in use for the last five years. In its recent report on the Paediatric Regulationpdf(542 KB) Choose translations of the previous link 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) , the Commission undertook to review the guideline in order to take into account the experience gained.

The Commission therefore requested the European Medicines Agency and its Paediatric Committee to suggest amendments to the current guideline.

In order to further explore which parts of the current guideline should be updated the Commission has prepared a concept paper pdf(111 KB)which is now being rolled out for public consultation with a view of receiving feedback from stakeholders on this issue.

The period of consultation ends on 18 December 2013. All citizens and organisations (public and private) are invited to contribute. For more information on how to contribute, please read the concept paperpdf(111 KB).

Received contributions will be published on the internet. For more information on the processing of personal data in the context of this consultation, read the Specific Privacy Statementpdf(17 KB).

more informations >>>

 

01/10/2013
Medicines undergoing additional monitoring: Video and leaflet to explain new symbol
Since 1 September, a black inverted triangle has started to appear in the product information of medicines that are being monitored particularly closely by regulatory authorities. With this measure, the European Commission aims to improve the safety of medicines and also to highlight to patients, the importance of reporting suspected side effects to the medicines they are taking.

more informations >>> 

EMA website

09/09/2013
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.pdf(426 KB)

First response of EMA on EC's request for advice on the impact on public health and animal health on the use of antibiotics in animals.
This part of the advices discusses the use of "old antibiotics" in the veterinary sector.

Medicinal Products for Veterinary Use >>

  

05 /09/2013
Commission Call for Expression of Interest for the position of member for the Paediatric Committee ('PDCO')

 

17/07/2013
Notice to applicants, update of Guideline on the packaging information of medicinal products for human use authorised by the Union.
pdf(317 KB)
The Notice to applicants, volume 2C Regulatory guidelines have been updated with the publication of the updated guideline on the packaging information of medicinal products for human use authorised by the EU.

Volume 2C : Human medicinal products  - Regulatory Guidelines >>>

05/07/2013
Public consultation on the guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another
Today, the unit in charge of pharmaceuticals launches a public consultation on guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another

Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another (12 June 2013)pdf(76 KB) - Word version with track changesmsw8(133 KB)

Annex: Application form for orphan medicinal product designation (Rev. 4, 22 April 2013)pdf(102 KB) - Word version with track changesmsw8(124 KB)

Comments and suggestions are invited by 30 September 2013 and should be sent by email to:
sanco-pharmaceuticals-d5@ec.europa.eu

05/07/2013
Revision of EU Commission guidelines on Good Manufacturing Practice for Medicinal Products
Today the European Commission launched the public consultation on the revision of the Annex 16: Certification by a Qualified Person and Batch Release.
Stakeholders are invited to comment on this draftpdf(150 KB) by 5 November 2013 at the latest. Comments should be sent by email to: ADM-GMDP@ema.europa.eu and SANCO-pharmaceuticals-D6@ec.europa.eu

04/07/2013 
Notice to applicants, update of variations application forms (human and veterinary) 
The Notice to applicants, volumes 2 and 6 have been updated with the publication of the updated application form for the submission of variations.  The new form reflects the changes in 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.
Volume 2C : Human medicinal products  - Regulatory Guidelines
Volume 6C : Veterinary medicinal products - Regulatory Guidelines
The electronic version of the new variation application forms will be made available by the European Medicines Agency at [http://esubmission.emea.europa.eu/eaf/index.html]

01/07/2013
Update of application form for renewal of marketing authorisation (human and veterinary)
The Notice to applicants, volumes 2C and 6C Regulatory guidelines have been updated with the publication of the updated application form for renewal of marketing authorisation.
The update consists in adding Croatia within the form.
Volume 2C : Human medicinal products  - Regulatory Guidelines
Volume 6C : Veterinary medicinal products - Regulatory Guidelines

In addition, the updated version of the CMDh Best Practice Guide on the processing of renewals in the MRP/DCP from April 2013, which is already available on CMDh website, is published under volume 2C.

27/06/2013
Notice to applicants, medicinal products for human use, volume 2A, chapter 1 marketing authorisation
The update of chapter 1 of volume 2A of the notice to applicants is published and available here.

27/06/2013
Adoption of a legal proposal for fees for pharmacovigilance payable to the European Medicines Agency
The Commission has adopted on 26 June 2013 a Proposal for a Regulation of the European Parliament and of the Council on Fees payable to the European Medicines Agency for the Conduct of Pharmacovigilance Activities in Respect of Medicinal Products for Human use (COM(2013) 472 final).

The text of the proposal can be consulted herepdf(289 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)
The text of the accompanying Impact Assessment Report can be consulted herepdf(410 KB)
The text of the Executive Summary of the Impact Assessment Report can be consulted herepdf(99 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)

24/06/2013
First Commission Report on the Paediatric Regulation
The Commission has published today a progress report on medicines for children covering the five years since the Paediatric Regulation first came into force. This preliminary snapshot points to improvements in the paediatric medicines landscape: better and safer research, more medicines for children on the EU market and more information for parents and health professionals. The report is available herepdf(542 KB) Choose translations of the previous link 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) .

more informations >>>

 

21/06/2013
The Unites States have 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 herepdf.

more informations >>> 

 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 herepdf.

more informations >>> 

 06/06/2013
70th Meeting of the Pharmaceutical Committee, 27 March 2013 : Summary Recordpdf(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.pdf(37 KB)


more informations >>>

 

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.pdf(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.pdf(426 KB)

 

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 procedurespdf(555 KB) Choose translations of the previous link 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) *) Word versionmsw8(2 MB) Choose translations of the previous link 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)

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. 

 *) A clerical error has been identified in the Guidelines.  Specifically, section 2 of the documentation to be provided in connection with variation C.I.8 should be read as “PSMF number (if available)”.   The correction of this error will be reflected in the publication of the Guidelines in the Official Journal.

16 /05/2013
Annual report on benefits and infringements under the Paediatric Regulation  pdf(737 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 herepdf(100 KB).

Eudralex Volume 10 >>>

 

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 countriespdf(29 KB) (may 2013)

Eudralex Volume 10 >>>

 

26/04/2013
Reply of Directorate General Health and Consumers to letters of Pestizid Aktions-Netwerk e.v.pdf(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 herepdf.

 

23/04/2013
Responses to the Public consultation on the template for the qualified person’s declaration concerning GMP compliance of investigational medicinal products manufactured in non-EU countries .

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 consultationpdf(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

 

15/03/2013
Specific implementation measures of the Commission in the context of Directive 2011/62/EU amending Directive 2001/83/EC on falsified medicines Overview (rev.1) (March 2013)pdf(41 KB)

More information is available here

14/03/2013
Overview of the transpostion status of the "Falsified Medicines Directive" in all Member States, together with a reference to the transpoing national law

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 guidelinespdf 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 Regulationpdf(727 KB) Choose translations of the previous link 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 systemspdf(143 KB).

Pharmacovigilance >>>

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.

19/02/2013
Responses to the concept paper submitted for public consultation concerning the implementing act on a common logo for legally-operating online pharmacies/retailers offering medicinal products for human use for sale at a distance to the public.

 

07/02/2013
DG Health and Consumers and the European Medicines Agency renew confidentiality arrangement with Japan.

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:

  • advance drafts of legislation and regulatory guidance documents;
  • scientific advice on medicine development;
  • assessments of applications for marketing authorisations;
  • 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 consultationpdf(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 consultationpdf(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 consultationpdf(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

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  pdf(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 summarypdf(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 Councilpdf(722 KB) Choose translations of the previous link 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)

Eudralex Volume 1 >>>

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

International activities >>>

22/01/2013
Technical guidance on the format of the data fields of result-related information on clinical trials submitted in accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006 pdf(278 KB)

EudraLex, Volume 10 >>>.

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 consultationpdf(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.

Overall, the Commission received 43 responses. The summary of the comments and the comments are   here.

 

15/01/2013
Responses to the public consultation :  guidelines on the details of the various categories of variations

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.

Archives 1997 to 2012 >>>

This call for expressions of interest relates to the appointment by the Commission of members and alternates representing patient associations and health professional organisations at the Paediatric Committee of the European Medicines Agency. More detailed information and application documents are here: [ZIP file]zip(200 KB)