Pharmaceuticals Archives - 2006

18/12/2006

Updating the NOTICE TO APPLICANTS Volume 2B - eCTD
- Electronic Common Technical Document (eCTD)
- Change Control Process for European eCTD Standarts 15/12/2006 GMP Annex 3 "Manufacture of Radiopharmaceuticals" : Draft revision for public consultationpdf(179 KB)

The annex has been revised in the light of new GMP requirements for actives substances used as starting materials (GMP Part II). It specifies application of Part II for the manufacture of radiopharmaceuticals.

Public comments should be sent to entr-gmp@ec.europa.eu and david.cockburn@emea.europa.eu by 30 March 2007. Public comments are particularly invited on the application of GMP to short-lived Positron Emission Tomography (PET) radiopharmaceuticals. We would highly appreciate to receive comments in the attached comment format (PDF formatpdf(86 KB) - Word formatmsw8(48 KB) ).

11/12/2006

Pharmaceutical Committee - Meeting Report of the 61st meetingpdf(25 KB) , 5 December 2006

24/10/2006

Update of the annex to Guideline on format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to anotherpdf(243 KB)
In preparation of the coming enlargement, the annex to Guideline on format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another has been updated
Annex (word format)msw8(121 KB) revision October 2006 20/10/2006 Meeting of the Veterinary Standing Committee on 10 October 2006 - 2 veterinary legal acts adopted

At the meeting of the Veterinary Standing Committee on 10 October 2006 two important veterinary legal acts have received a favourable opinion:

"Draft Commission Regulation establishing, in accordance with Directive 2001/82/EC of the European Parliament and the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidaepdf(141 KB) ".

"Draft Commission Directive implementing Directive 2001/82/EC of the European Parliament and the Council as regards the establishment of criteria for exempting certain veterinary medicinal products for food-producing animals from the requirement of a veterinary prescriptionpdf(19 KB) ".

Both texts have been forwarded to the European Parliament for the 30 days scrutiny period. The adoption by the Commission is awaited in December 2006. We will publish the final adopted texts on our website as soon as they have published in the Official Journal. You might address further question to Dr. Karin Krauss (Tel.: +32 2 29 91511)

20/10/2006

An up-to-date list of substances considered as not falling within the scope of Council Regulation (EEC) No 2377/90. is now available (revision 9, October 2006)pdf(13 KB)

4/10/2006

Consultation on the draft document on "Ethical Considerations for Clinical Trials Performed in Children - Recommendations of the Ad Hoc Group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human usepdf(134 KB) ".

DG Enterprise and Industry releases a draft document on 'Ethical Considerations for Clinical Trials Performed in Children - Recommendations of the Ad Hoc Group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use.
This document provides recommendations on various ethical aspects of clinical trials performed in children, intending to contribute to their protection as the subject of clinical trials as well as to facilitate a harmonised approach to clinical trials across the EU Member States, considering that the approval of clinical trials, including ethical approval, is primarily a national competence, thereby facilitating the conduct of clinical trials in the European Union.

We invite comments on the draft document to be provided using this templatemsw8(305 KB) to entr-pharmaceuticals@ec.europa.eu until 31 January 2007.

29/09/2006

NOTICE TO APPLICANTS Volume 2C
Draft "Guideline on the readability of the label and package leaflet of medicinal products for human usepdf(72 KB)" - update 2006 according to Directive 2001/83/EC as amended by Directive 2004/27/EC. Consultation on new sections.

Directive 2004/27/EC amending Directive 2001/83/EC includes changes to the package leaflet and labelling requirements. It is therefore necessary to update the "Guideline on the readability of the label and package leaflet for medicinal products for human use".

The attached draft revised guideline contains the following elements:
Chapter 1: information regarding the readability of the label and the package leaflet updated in the view of experience gained after the first publication of the guideline in 1999.
Chapter 2: specific recommendations for blind and partially sighted patients already published on 13/04/2005.
Chapter 3: guidance concerning consultations with target patient groups for the package leaflet already published on 22/05/2006.
Annex 1 gives an illustration on a possible way of undertaking a test of a package leaflet.

Interested parties are invited to send any comments on the new sections (Chapter 1 and Annex 1) by 30 November 2006 to entr-pharmaceuticals@ec.europa.eu25/09/2006

Implementation of the Paediatric Regulation
Today DG Enterprise and Industry makes public its priorities for implementation of the Regulation on medicinal products for paediatric use (the paediatric regulation). The priorities document has been developed and agreed with the European Medicines Agency (EMEA). It should be noted that the precise dates of adoption, publication and entry into force of the paediatric regulation are not known at the present time, however, based on our best estimates, the prioritisation document assumes entry into force in January 2007. The joint Commission and EMEA document can be found herepdf(15 KB) .

7/09/2006

Inventory of Community and Member States' incentive measures to aid the research, marketing, development and availability of orphan medicinal products. Revision 2005pdf(262 KB)
The Regulation on Orphan Medicinal Products adopted in 2000 requires Member States to communicate to the Commission detailed information concerning any measure that they have enacted to support research into, and the development and availability of, orphan medicinal products or medicinal products that may be designated as such. On the basis of this information, the Commission prepared and published on 1 January 2001 a first detailed inventory of all incentives made available by the Community and the Member States to support research into and availability of orphan medicinal products, thus meeting its obligations according to the regulation. This inventory has been updated in 2006 for the second time.

25/8/2006

Updating the Notice to Applicants - Veterinary Medicinal Products - Volume 6A Chapter 7 "General Information"pdf(353 KB)
DG Enterprise and Industry releases an updated version of Chapter 7 "General Information" of the veterinary Notice to Applicants Volume 6A. The revised version provides specific information required by national authorities of Member States and EFTA States. Several changes of addresses, procedure on fee payments, languages required and on the National procedures following a Commission decision in case of a referral were introduced.
Volume 6A

28/7/2006

Consultation on 'Draft guidance on 'specific modalities' for non-commercial clinical trials referred to in Commission Directive 2005/28/EC laying down the principles and detailed guidelines for good clinical practice'pdf(53 KB)

DG Enterprise and Industry releases 'Draft guidance on 'specific modalities' for non-commercial clinical trials referred to in Commission Directive 2005/28/EC laying down the principles and detailed guidelines for good clinical practice'.
This guidance includes information regarding the definition of non commercial clinical trial and the specific modalities, labelling and documentation, concerning the investigational medicinal product.
DG Enterprise and Industry has also been considering the issue of the monitoring of non-commercial clinical trials. However, specific modalities on monitoring have not been included in this draft guidance since they would go beyond the provisions of Directive 2005/28/EC. Nevertheless, if stakeholders want to make comments or proposals in relation to the monitoring of non-commercial clinical trials, they are welcome to do so in the framework of this consultation.

We invite comments on the draft proposal to be sent to birka.lehmann@ec.europa.eu and rui.santos-ivo@ec.europa.eu until 1 October 2006.

28/7/2006

Consultation on a proposal for a guidance on the 'Definition of Investigational Medicinal Products (IMPs) and definition of Non Investigational Medicinal Products (NIMPs)'pdf(51 KB)

DG Enterprise and Industry releases a proposal for a guidance on the of 'Definition of Investigational Medicinal Product (IMP) and definition of Non Investigational Medicinal Products (NIMPs).This guidance is intended to reflect a common understanding between Member States and DG Enterprise and Industry, with the view to facilitating the conduct of multi-centre clinical trials.

We invite comments on the draft proposal to be sent to birka.lehmann@ec.europa.eu and rui.santos-ivo@ec.europa.eu until 1 October 2006. 27/7/2006 EudraLex - The Rules Governing Medicinal Products in the European Union
Volume 10 - Clinical trials
Medicinal Products for human use in clinical trials (investigational medicinal products).

20/7/2006

Updating the Notice to Applicants Volume 2C and 6C: Application form for renewal of a marketing authorisation for human and veterinary medicinal products.pdf(51 KB)
DG Enterprise and Industry releases an updated version of the Volume 2C and 6C: Application form for renewal of a marketing authorisation for human and veterinary medicinal products. The new application form is valid for national and Community procedures. The list of documents to be appended are harmonised for national and Community procedures, for both human and veterinary applications.

PDF Formatpdf(51 KB)
Word Formatmsw8

13/7/2006

Notice to Applicants Volume 6C - Guidelines on the Summary of Product Characteristics for pharmaceutical pharmaceuticalpdf(328 KB) and immunological immunologicalpdf veterinary medicinal products
DG Enterprise and Industry publishes the revised Guidelines on the Summary of Product Characteristics for pharmaceuticalpdf(328 KB) and immunologicalpdf veterinary medicinal products in Volume 6C Regulatory Guidelines of the Notice to Applicants for Veterinary Medicinal Products. The updates reflect the amendments introduced by Directive 2004/28/EC amending Directive 2001/82/EC. The opportunity was also taken to review all sections following consultation of the Committee for Medicinal Products for Veterinary Use (CVMP), its Working Parties and the Veterinary Committee for Mutual Recognition and Decentralised Procedures (CMD(v)), and following comments from public consultation. 11/7/2006 Pharmaceutical Committee - Summary record of the 60th meeting, 2 May 2006pdf(169 KB) 3/7/2006 NOTICE TO APPLICANTS, VOLUME 2B, COMMON TECHNICAL DOCUMENT (CTD)
DG Enterprise and Industry releases an updated version of the introduction of the Notice to Applicants Volume 2B incorporating the Common Technical Document.
The revised version provides information required by the competent authorities in the Community according to Directive 2001/83/EC as amended by Directive 2004/27/EC.

27/6/2006

The report on the experience acquired as a result of the application of Regulation (EC) 141/2000 on orphan medicinal products has been adoptedpdf(555 KB)

27/6/2006

Updating the Notice to Applicants - Human and Veterinary Medicinal Products - Volume 2C and 6C
Guideline on the dossier requirements for type IA and type IB notifications for minor variations to the terms of marketing authorisations in the mutual recognition and the centralised procedure - Revision 1pdf(302 KB)
DG Enterprise and Industry releases an update of the Guideline on dossier requirements for type IA and IB notifications for variations to the terms of marketing authorisations granted following the mutual recognition procedure or the centralised procedure. In variation 7, 8, 14 and 15 the requirement for a declaration by the qualified person is added according to Article 41 of Directive 2001/83/EC, Article 45 of Directive 2001/82/EC and Directive 2003/94/EC. In Variation 42 a footnote is added for clarification of the acceptance of pilot scale batches.

8/6/2006

Guideline on the Definition of a Potential Serious Risk to Public Health and Guideline on the Definition of a Serious Risk to Human or Animal Health or for the Environment
During the Review of the human and veterinary pharmaceutical legislation, Article 29(2) of Directive 2001/83/EC, as amended by Directive 2004/27/EC, and Article 33(2) of Directive 2001/82/EC, as amended by Directive 2004/28/EC, have been introduced calling upon the Commission to adopt guidelines defining a "potential serious risk to human health" as well as a "potential serious risk to human or animal health or for the environment". These Guidelines were drafted in cooperation with Member States and industry and have now been published in Official Journal C 133 (08.06.2006) and Official Journal C 132 (07.06.2006).
DG Enterprise and Industry is additionally publishing these guidelines in Volumes 1 and 5. The English versions and the annexes including examples related to the definitions of issues which normally would not be considered as grounds for a "potential serious risk to human health" or a "potential serious risk to human or animal health or for the environment" are published in Notice to Applicants Volume 2C and Volume 6C.

8/6/2006

New updates EudraLex
Notice to Applicants, Volume 2B - Electronic Common Technical Document (eCTD)

22/5/2006

UPDATING THE NOTICE TO APPLICANTS Volume 3B (C7A)
Excipients in the Label and Package leaflet of Medicinal Products for Human Use

DG Enterprise and Industry releases the translation of the Annex to the Excipients Guideline in all EEA languages in order to ensure a harmonised use of the excipients statements in the product information of medicinal products.

22/5/2006

NOTICE TO APPLICANTS Volume 2Cpdf(29 KB)
The Commission services present the final Guidance concerning consultation with target patient groups for the package leaflet. This Guidance sets out detailed explanation of the requirement ofArticle 59(3) and Article 61(1) of Directive 2001/83/EC° as amended by Directive 2004/27/EC according to which the package leaflet shall reflect consultations with target patient groups.
The Guidance will be integrated in the Guideline on the readability of the label and package leaflet of medicinal products for human use, once finalised.
OJ L 331, 28.11.2001, p.67 Directive last amended by Directive 2004/27/EC, OJ L 136, 30.4.2004, p. 334

19/5/2006

UPDATING THE NOTICE TO APPLICANTS Volume 2A Chapter 7 "General Information"
DG Enterprise and Industry releases an updated version of Chapter 7 "General Information" of the Notice to Applicants Volume 2A.
The revised version provides specific information required by national authorities of Member States and EFTA States. In addition, changes of addresses, procedure on fee payments and languages required were made to reflect the situation for some Member States.
In section 6 "National procedure after a Commission decision on a referral" and section 10 "Blue-box requirements" the requirements for Spain, Ireland, Italy and Portugal are updated.

19/5/2006

Updating the Notice to Applicants -Veterinary Medicinal Products - Volume 6A Chapter 4 "Centralised procedure"
DG Enterprise and Industry releases an updated version Chapter 4 "Centralised procedure" of the Notice to Applicants veterinary Volume 6A. The revised version reflects the amendments introduced by Directive 2001/82/EC, as amended by Directive 2004/28/EC and Regulation (EC) No 726/2004.

16/5/2006

NOTICE TO APPLICANTS, VOLUME 2B, COMMON TECHNICAL DOCUMENT (CTD)
DG Enterprise and Industry releases an update of the Questions and Answers document related to the Common Technical Document (CTD).
The revision concerns an update of question and answer 4a regarding Type II variations, a new question and answer 4c regarding Type IA/B variations, a new question and answer 18 for Follow-up measure and a new question and answer 19 regarding Periodic Safety Update Reports.
The question and answers No 10, 11 and 15 have been deleted because these questions dealt with the transitional period, which already ended.

14/5/2006

Volume 9a of the Rules Governing Medicinal Products in the European Union: Supplementary consultation on the Guideline on the handling of direct healthcare professional communications
The European Commission today launches a public consultation on the "Guideline on the handling of direct healthcare professional communications on the safe and effective use of medicinal products for human use". Following the consultation the final guideline will be included in Volume 9a of the Rules Governing Medicinal Products in the European Union. Please note that the analysis of the responses to the consultations on other sections on Volume 9a is ongoing.

The draft guideline can be found herepdf(70 KB) .

The template for comments can be found heremsw8(34 KB) .

Comments are invited by 14 July 2006 and should be sent, preferably by email to Dr Peter Arlett

03/5/2006

NOTICE TO APPLICANTS, VOLUME 2B, COMMON TECHNICAL DOCUMENT (CTD)
DG Enterprise and Industry releases an updated version of Module 1 Administrative Information and Prescribing Information of the Notice to Applicants Volume 2B incorporating the Common Technical Document.
The revised version provides information required by the competent authorities in the Community according to Directive 2001/83/EC* as amended by Directive 2004/27/EC.
In section 1.3 Product Information a reference is included to the 'Consultation with Target Patient Groups' according to Article 59(3) and 61(1) of Directive 2001/83/EC and 'Braille' according to Article 56a of Directive 2001/83/EC.
New sections 1.8 "Information relating to Pharmacovigilance' and 1.9 'Information relating to Clinical Trials' have been introduced.
*OJ L 331, 28.11.2001, p.67 Directive last amended by Directive 2004/27/EC, OJ L 136, 30.4.2004, p. 334

03/5/2006

GMP Annex 7 "Manufacture of Herbal Medicinal Products" : Draft revision for public consultationpdf(28 KB)
The annex has been revised in the light of new GMP requirements for actives substances used as starting materials (GMP Part II). It specifies application of Part II for the manufacture of herbal medicinal products. Additional changes are in particular related to the new Directive 2004/24/EC on traditional herbal medicinal products.
Public comments should be sent to sabine.atzor@ec.europa.eu and gmp@emea.eu.int by 31 July 2006.

11/4/2006

Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human usepdf(89 KB)
DG Enterprise and Industry releases an update of the Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use as foreseen in Article 18 of Directive 2001/20/EC. This update includes new information regarding reporting of suspected unexpected serious adverse reactions with authorised investigational medicinal products.

11/4/2006

Updating the "Notice to applicants" Volume 2A Chapter 4 "Centralised Procedure"
DG Enterprise and Industry releases updated versions of the Notice to Applicants Volume 2A Chapter 4 'Centralised Procedure' The updates reflect the amendments introduced by Directive 2001/83/EC, as amended by Directive 2004/27/EC and Directive 2004/24/EC and Regulation (EC) No 726/2004.

11/4/2006

DG Enterprise and Industry releases an update 'Question and Answer' document for clinical trials
In order to give more and detailed information to requirements set out in the legislation on clinical trials the document "QUESTIONS AND ANSWERS"pdf(48 KB) has been updated. It concerns the interpretation of the definition of a clinical trial (algorithm/decision tree).

3/4/2006

Orphan Medicinal Products: Outcome of consultation on a general report on the experience acquired as a result of the application of Regulation (EC) 141/2000 on orphan medicinal products and account of the public health benefits obtained
As required by Article 10 of Regulation (EC) 141/2000 on orphan medicinal products, the European Commission has drafted a Commission Staff Working Document on the experience acquired as a result of the application of Regulation (EC) 141/2000 on orphan medicinal products and account of the public health benefits obtained.
All interested parties were invited to comment on the draft Commission Staff Working Document until 8 March. The outcome of the consultation is now published until publication of final documentpdf(19 KB)

29/3/2006

Commission adopts Regulation on conditional marketing authorisations

Article 14 (7) of Regulation (EC) No 726/2004 directs the Commission to adopt a regulation on the provisions for granting Conditional Marketing Authorisations for applications submitted via the centralised (Community) procedure.

The regulation, adopted today, is available here in all 20 official languages of the EU.

The Commission conducted a public consultation on draft proposals at the end of 2004 and a summary of the consultation responses can be found here.

Any enquiries about the new regulation should be sent to Dr Peter Arlett at entr-pharmaceuticals@ec.europa.eu.

16/3/2006

Commission Public Consultation: An Assessment of the Community System of Pharmacovigilance

The Commission today launches a public consultation on the Community system of pharmacovigilance. The objective of the consultation is to collect the views of stakeholders on the community system, including comments on the current functioning of the system and how it might be further strengthened.

A document to explain the consultation and its background is available herepdf.
A template for your consultation responses is available here.pdf

Electronic consultation responses are preferred and should be sent to entr-pharmaceuticals@ec.europa.eu. Please note that your consultation response will be made public.

The Commission will be holding two workshops in April or May 2006 as part of the public consultation. One will be for patient groups and healthcare professionals, the other for the pharmaceutical industry. Places will be limited and we cannot guarantee to accommodate everyone that would like to attend but if you would like an invitation please email your name, the organisation you represent and all relevant contact details to peter.arlett@ec.europa.eu. As places are limited priority will be given to European organisations. All requests for the workshops should be sent by 31 March 2006.

This consultation is one key way that we can ensure that we strengthen pharmacovigilance, making it fit for the enlarged Community for decades to come and hence effectively protecting the health of citizens in the EU and beyond.

15/3/2006

Medicines for Children: Commission Communication regarding the Council Common Position on the paediatric regulation
On 13 March 2006 the European Commission adopted a Communication concerning the common position of the Council with a view to the adoption of a regulation on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. The Communication, together with both the original and modified proposals of the Commission can be found by clicking here.

14/3/2006

EU-FDA confidentiality arrangement
EU-FDA confidentiality arrangement. The joint press release from the 13 March meeting of the European Commission, the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA)pdf(27 KB) is available.

14/3/2006

Draft guideline on monitoring of compliance with pharmacovigilance regulatory obligations and pharmacovigilance inspections - consultation
The draft guideline on "monitoring of compliance with pharmacovigilance regulatory obligations and pharmacovigilance inspections" is released today for consultation. This draft guideline covers both human and veterinary medicinespdf(83 KB) .
For human medicines, following the consultation the guideline will be included in Volume 9a of the Rules Governing Medicinal Products in the European Union.
For veterinary medicines, following the consultation the guideline will be included in Volume 9b of the Rules Governing Medicinal Products in the European Union.

Comments and suggestions are invited by 12 May 2006 and should be sent, preferably by email, to Dr Peter Arlett - entr-pharmaceuticals@ec.europa.eu

14/3/2006

Updating the Notice to Applicants - Veterinary Medicinal Products - Volume 6C
Guidance on environmental risk assessment for veterinary medicinal products consisting of or containing genetically modified organisms (GMOs) as or in products
This updated guidance combines the three existing guidelines as recorded in Volume 6B "Annex I - Guidance for environmental risk assessment for GMOs" (p. 168-189) for clarity in addition to changes further to consultation of the competent authorities being responsible for Directive 2001/18/EC on the deliberate re-lease into the environment of genetically modified organisms. There are few changes to the existing guidance: the aim being to create easier-to-follow guidance but not to change any data requirements. This up-date includes reference to Regulation (EC) No. 726/2004.

14/3/2006

Updating the Notice to Applicants - Veterinary Medicinal Products - Volume 6B
Presentation and content of the dossier - Part 1: Summary of the dossier - Part 1A Application formpdf
DG Enterprise and Industry releases a revised version of the veterinary Volume 6B Presentation and content of the dossier - Part 1: Summary of the dossier - Part 1A Application form - Administrative data. The revision contains some corrections and aims at improving the format to facilitate the practicability and usage of this template.

10/3/2006

DG Enterprise and Industry releases an updated version of Chapter 7 "General Information" of the Notice to Applicants Volume 2A.
The revised version provides specific information required by national authorities of Member States and EFTA States. In addition, changes of addresses, procedure on fee payments and languages required were made to reflect the situation for some Member States.
A new section 6 "National procedure after a Commission decision on a referral" and a new section 10 "Blue-box requirements" have been introduced.

23/02/2006

Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human usepdf(137 KB)
DG Enterprise and Industry releases an update of the: 'Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use as foreseen in Article 8 of Directive 2001/20/EC. This update includes new information regarding the update dossier requirements for Spain, Luxemburg, Portugal and Poland.

9/02/2006

Draft Commission Decision establishing criteria for granting exemptions to the prescription only principle for veterinary medicinal products for food-producing animalspdf(18 KB)
Article 67 first paragraph point aa) of Directive 2001/82/EC, as amended by Directive 2004/28/EC, includes the specific provision that a prescription shall be required for veterinary medicinal products for food-producing animals. However, the Commission may establish criteria upon which Member States may grant exemptions from this general requirement. The decision has to be adopted by Comitology. In case the decision is not adopted prior to 31 December 2006 all veterinary medicinal products for food producing animals authorised in the European Community will be prescription only medicines (POM) from 1st January 2007 onwards.
Drawing your attention to our Background Notepdf(14 KB) , DG Enterprise and Industry invites comments on the draft Commission Decision establishing criteria for granting exemptions to the prescription only principle for veterinary medicinal products for food-producing animals to be sent to Dr. Karin Krauss (Karin.Krauss@ec.europa.eu) until 17.03.2006 at the latest.

9/02/2006

Update of the "Guideline on the processing of renewals in the mutual recognition and decentralised procedurepdf(44 KB)"
DG Enterprise and Industry releases an updated version of the Notice to Applicants Volume 6C "Guideline on the processing of renewals in the mutual recognition and decentralised procedurepdf(44 KB)". The update reflects the amendments introduced by Directive 2001/82/EC, as amended by Directive 2004/28/EC.

8/02/2006

Updating the Notice to Applicants - Veterinary Medicinal Products - Volume 6A Chapter 7 "General Information"
DG Enterprise and Industry releases an updated version of Chapter 7 "General Information"pdf of the Notice to Applicants veterinary Volume 6A. The revised version provides specific information required by national authorities of Member States and EFTA States. In addition, changes of addresses, procedure on fee payments and languages required were made to reflect the situation for some Member States. A new section 6 "National procedure after a Commission decision on a referral" and a new section 10 "Blue-box requirements" have been introduced.

8/02/2006

Consultation on a general report on the experience acquired as a result of the application of Regulation (EC) No 141/2000 on orphan medicinal products and account of the public health benefits obtained as required by Article 10 of Regulation (EC) No 141/2000 on orphan medicinal products, the European Commission has drafted a Commission report on the experience acquired as a result of the application of Regulation (EC) No 141/2000 on orphan medicinal products and account of the public health benefits obtained. All interested parties are invited to comment on the attached draft Commission Staff Working Documentpdf(414 KB) .Comments should be sent to Elena Prats, European Commission, BREY 10/130, 1049 Brussels, Belgium.
E-mail submissions are preferred and should be sent to elena.prats@ec.europa.eu The consultation will be closed on 8 March 2006.

07/02/2006

Implementation of Article 10 of Regulation (EC) No 726/2004 - Updated versionpdf(14 KB)
Article 10 of Regulation 726/2004 shortens the current timelines for the decision making process. This document sets out how to apply these shortened timelines in practice. This updated version supersedes the version published in August 2005 and includes the link to the detailed document published on the EMEA website.

07/02/2006

Rules of procedure for the standing committee on medicinal products for human use and the standing committee on veterinary medicinal products
The standing committee on medicinal products for human use and the standing committee on veterinary medicinal products, set up respectively by the amended Articles 121(4) of Directive 2001/83/EC and 89(4) of Directive 2001/82/EC, adopted their new rules of procedure in June 2005. These are available in a new section of this website: Standing Committee.

02/02/2006

Substances considered as not falling within the scope of Council Regulation (EEC) No 2377/90pdf(13 KB)
An up-to-date list of substances considered as not being within the scope of Council Regulation (EEC) No 2377/90 is now available. (Revision 7 of January 2006)

02/02/2006

NOTICE TO APPLICANTS Volume 2B - Electronic Common Technical Document (eCTD)

New Version

26/01/2006

NOTICE TO APPLICANTS Volume 2C
The Commission services present the final update of the 'Guideline on changing the classification for the supply of medicinal productspdf(45 KB)' after public consultation.
This guidance outlines definition for the data exclusivity for data provided in a 'switch' application to describe the extent of data exclusivity in relation to significant pre-clinical tests or clinical trials according to Article 74a of Directive 2001/83/EC as amended by Directive 2004/27/EC and outlines the principles and procedure to claim for one-year data exclusivity based on Article 74a of Directive 2001/83/EC.
In the update of the guideline a new part 3 and part 4 is included reflecting the provisions set out by Directive 2001/83/EC and the requirements for Article 74a.
Part 1 and 2 of the guideline are unchanged except of the references to the new legislation. The necessary update for part 1 and part 2 in respect to the technical and scientific progress will be started this year.

OJ L 331, 28.11.2001, p.67 Directive last amended by Directive 2004/27/EC, OJ L 136, 30.4.2004, p. 334