Pharmaceuticals Archives - 2007

20/12/2007

Update List of medicinal products authorised under Article 126a of Directive 2001/83/EC
The List of medicinal products authorised under Article 126a of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use has been updated.
113 products for Cyprus have been added, 6 products for Cyprus have been withdrawn.

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) .

20/12/2007

Substances considered as not falling within the scope of Council Regulation (EEC) No 2377/90
An up-to-date list of substances considered as not being within the scope of Council Regulation (EEC) No 2377/90 is now availablepdf(12 KB) . (Revision 11 of December 2007) - See also section MRL

19/12/2007

63rd Pharmaceutical Committee - Meeting Reportpdf(23 KB)
The 63rd meeting of the Pharmaceutical Committee (Human) took place on 10 December 2007 (morning) in Brussels.
In addition a joint meeting of the Pharmaceutical Committee (Human) and the Veterinary Pharmaceutical Committee dealing specifically with the revision of the Variations Regulations took place on 10 December 2007 (afternoon).

13/12/2007

Update 13.12.2007: Implementation Plan for the Regulation on Advanced Therapies
The Regulation on advanced therapy medicinal products (Regulation (EC) No 1394/2007) has been published in the Official Journal on 10/11/2007 and will apply from 30 December 2008.
Today DG Enterprise and Industry makes public its priorities for the implementation of this Regulation. The implementation plan has been developed and agreed with the European Medicines Agency (EMEA).
The joint Commission and EMEA document can be found here.pdf(64 KB)The EMEA website on advanced therapies is available here.

10/12/2007

Publication of the Regulation on Advanced Therapies
The Regulation on advanced therapy medicinal products has been published today in the Official Journal of the European Union. It will apply from 30 December 2008.
All linguistic versions are available here

5/12/2007

Commission Pharmacovigilance Strategy: Public consultation on draft legislative proposals (5 December 2007 - 1 February 2008)
DG Enterprise and Industry of the European Commission wishes to consult stakeholders on legislative proposals to strengthen and rationalise the EU system of pharmacovigilance. All comments should be sent electronically to Dr Peter Arlett (entr-pharmaceuticals@ec.europa.eu) by 1 February 2008. The consultation document can be found here.pdf

30/11/2007

Transatlantic Cooperation in Pharmaceutical Regulation: Identifying Opportunities for Administrative Simplification
In Brussels on 28 November 2007, in the field of pharmaceutical regulation, the European Commission hosted the Transatlantic Administrative Simplification Workshop which was co-chaired by the European Commission and the United States (U.S.) Food and Drug Administration (FDA) and organised in collaboration with the European Medicines Agency (EMEA) and the Heads of the EU National Medicines Agencies (HMA). For more information click herepdf(34 KB) .

30/11/2007

Report on the European Commission-EMEA clinical trials conference Published

30/11/2007

On 3 October 2007, the 'European Commission-EMEA Conference on the Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future' was held at the EMEA.

A wide range of interested parties attended the conference to discuss their experience to date with the implementation of this legislation and provide recommendations for the future.

A report on the conference has now been published, together with the collected presentations and written submissions of participating organisations.

The conference report and its annexes are available herepdf

30/11/2007

Notice to Applicants: New guidance on a new therapeutic indication for a well established substance
Following detailed discussions with the European Medicines Agencies, as well as a period of public consultation and discussions with the Pharmaceutical Committee, new guidance is included in Eudralex Volume 2 - Notice to Applicants (Volume 2C Regulatory Guidelines) on "Guidance on a new therapeutic indication for a well established substance"

The new guidance can be found herepdf
A summary of the public consultation response can be found herepdf(20 KB)

30/11/2007

Notice to Applicants: New guideline on significant clinical benefit to obtain an extended 11 years marketing protection period
Following detailed discussions with the European Medicines Agencies, as well as a period of public consultation and discussions with the Pharmaceutical Committee, new guidance is included in Eudralex Volume 2 - Notice to Applicants (Volume 2C Regulatory Guidelines) on "Guidance on elements required to support the significant benefit in comparison with existing therapies of a new therapeutic indication in order to benefit from an extended (11 years) marketing protection period".

The new guidance can be found herepdf(48 KB)
A summary of the public consultation response can be found herepdf(24 KB)

27/11/2007

Simplification of orphan medicines designation through transatlantic cooperation
The European Commission, the European Medicines Agency (EMEA) and the United States (US) Food and Drug Administration (FDA) have adopted a common application form for sponsors seeking orphan designation of medicines in the EU and U.S. This initiative is aimed at simplifying the process of obtaining orphan status for medicines intended for rare diseases in both jurisdictions. Details can be found herepdf(24 KB)

30/10/2007

Formal adoption of the Regulation on advanced therapies

On 30 October 2007, the Council has formally adopted the Regulation on advanced therapy medicinal products. All documents related to this adoption (all linguistic versions of the Regulation, results of voting, video of the Council debate etc.) are available here

25/10/2007

Commission launches a Public Consultation on the comitology part of the revision of the Variations Regulations, on the basis of two documents:
-The draft legal proposal is available herepdf(230 KB)
-The Consultation paper, which gives detailed explanations on the consultation process as well as on the content of the draft legal proposal, is available herepdf(72 KB) .
This public consultation only addresses the 'comitology' part of this Better Regulation initiative. It does not address the aspects of the review which require 'co-decision'. These aspects have already been adressed in a previous consultation.
Comments on the draft legal proposal and on the Consultation paper should be sent by e-mail to entr-pharmaceuticals@ec.europa.eu before Friday 4 January 2008.

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) .

5/10/2007

Revision of the Variations Regulations: Outcome of the Public Consultation (co-decision part)

A public consultation was conducted in July-September 2007 on the co-decision aspects of the review of the Variations Regulations.
A summary of the outcome of this consultation is available herepdf(20 KB) .
Comments from stakeholders are available here.
For any questions, please contact entr-pharmaceuticals@ec.europa.eu

03/10/2007

Notice to Applicants: Update of Volumes 2A and 6A, Chapter 3 - Community Referral Procedures

DG Enterprise and Industry releases updated versions of Chapter 3 - Community Referral Procedures - of the Notice to Applicants Volumes 2A and 6A. The revised versions reflect the current legal framework for referral procedures for both human and veterinary medicinal products.

Volume 2A, Chapter 3 - Community Referral Procedures : Pdf Versionpdf(117 KB) - Word Versionmsw8(211 KB)
Volume 6A, Chapter 3 - Community Referral Procedures : Pdf Versionpdf(97 KB) - Word Versionmsw8(210 KB)

26/9/2007

When will the Regulation on advanced therapy medicinal products be published?
The current, provisional timeline for the formal adoption, publication and entry in application of the Regulation on advanced therapies is the following:
-On substance, the file is closed since the Council agreement on 31 May 2007 (see below);
-The Regulation now needs to be checked in all languages and formally adopted (without any discussion) by the Council. Given the average delays, this means the formal adoption by the Council will most likely occur in end October-mid November;
-The Regulation should then be published in the Official Journal, probably in end November/beginning of December. It will then enter into force 20 days after publication (i.e. most likely by the end of the year), and will apply 1 year after entry into force (i.e. most likely end of 2008).
In practice, this means that the date of entry in application for economic operators will most likely be the end of 2008.
Once formally adopted and published, the final text will be posted on this website.

13/9/2007

Good Manufacturing Practice (GMP) Annex2 "Manufacture of Biological Products" : Draft revision for public consultationpdf(88 KB)

Annex 2 of the GMP Guide has been revised as a consequence of the restructuring of the GMP Guide and the introduction of GMP for active substances used as starting materials. Further revision was necessary due to an increase of breadth of biological products. In addition, with the agreement on the new regulation on advanced therapies (formal adoption and publication pending) the Commission is asked to draw up specific GMP guidelines for advanced therapy medicinal products, including gene therapy, somatic cell therapy medicinal products and tissue engineered products as defined in the regulation. Input from organizations with particular experience in advanced therapies is expected though this public consultation. The relevant section of Annex 2 on tissue engineered products will be developed subsequently.

Comments should be sent by 14 March 2008 to entr-gmp@ec.europa.eu and GMP@emea.europa.eu (Please note: original deadline 31 December 2007 has been extended.)

13/9/2007

Notice to Applicants: Volume 2C, Guideline on the packaging information of medicinal products for human use authorised by the Community
The annex to the Guideline on the packaging information of medicinal products for human use authorised by the Community has been correctedpdf(230 KB) in relation to the requirements by Italy.
- Eudralex Volume 2C >>>

31/7/2007

European Commission and EMEA to hold conference on EU clinical trials legislation
A joint conference of the European Commission and the European Medicines Agency (EMEA) will be held on 3 October 2007 to discuss the current legislation on clinical trials for medicinal products and its implementation in the European Union.
The conference, which will be attended by invited representatives of major stakeholder groups, will focus on evaluating the operation of the Clinical Trials Directive and providing recommendations for its future development.
Further information on this conference is available here

31/7/2007

Pharmaceutical Committee - Summary record of the 62nd meeting, 21 May 2007pdf(40 KB)

31/7/2007

GMP Annex 6 "Manufacture of Medicinal Gases" : Draft revision for public consultationpdf
Annex 6 of the GMP Guide has been revised as a consequence of the restructuring of the GMP Guide and the need to review requirements of Part II of the Guide for the applicability to medicinal gases. The opportunity has also been taken to update the annex. Comments should be sent by the 31 December 2007 to entr-gmp@ec.europa.eu and GMP@emea.europa.eu

22/7/2007

Notice to Applicants:
Volume 2A, Chapter 7 - General Informationpdf
Volume 2C,Guideline on the packaging information of medicinal products for human use authorised by the Communitypdf

An updated version of Chapter 7- General Information of Volume 2A of the Notice to Applicants is now available. It reflects the inclusion of updates from Cyprus, Denmark, Italy, Lithuania, Netherlands, Portugal , Slovak Republic, Sweden, United Kingdom, Norway and the EMEA. It also contains a major update of section 3.2 regarding the additional data requested by Member States in National, Mutual Recognition and Decentralised procedures.
The annex to the Guideline on the packaging information of medicinal products for human use authorised by the Community has also been amended to include updates requested by Italy and Sweden.

22/7/2007

Veterinary Pharmaceutical Committee - Summary record of the 18th meeting, 20 March 2007pdf(24 KB)

19/7/2007

Have your say! ENpdf(29 KB) Choose translations of the previous link Deutsch (de) français (fr) (ENpdf(29 KB) Choose translations of the previous link Deutsch (de) français (fr) - DEpdf(35 KB) Choose translations of the previous link Deutsch (de) français (fr) DeutschбългарскиčeštinadanskeestiελληνικάespañolfrançaisitalianolatviešulietuviųmagyarNederlandspolskiportuguêsromânăslovenčinaslovenščinasuomisvenska - FRpdf(33 KB) Choose translations of the previous link Deutsch (de) français (fr) françaisбългарскиčeštinadanskDeutscheestiελληνικάespañolitalianolatviešulietuviųmagyarNederlandspolskiportuguêsromânăslovenčinaslovenščinasuomisvenska) Commission launches a public consultation on the future of pharmaceuticals for human use in Europe
The pharmaceutical sector has been and remains a key strategic sector in Europe. The future of this sector is a crucial matter for the EU.


Today, the Commission launches a broad public debate on the future of pharmaceuticals for human use in the Community. All stakeholders dealing with medicines for human use are invited to participate. The Consultation Paper which forms the basis for the public consultation is availableherepdf(29 KB) Choose translations of the previous link Deutsch (de) français (fr) . Contributions should be sent by e-mail to nicolas.rossignol@ec.europa.eu before 12 October 2007. Details on the consultation process are outlined in the Consultation Paper.
Following this public debate, the Commission intends to address a Communication to the Council of the European Union and to the European Parliament on the future of the EU single market in pharmaceuticals for human use, outlining its vision and strategy for the sector, as well as concrete action items. The Communication will build on this public consultation and will outline how its outcome was taken into account.

For any questions, please contact:
Nicolas Rossignol: Nicolas.rossignol@ec.europa.eu (tel.: +32 2 298 73 54) or
Thomas Heynisch: Thomas.heynisch@ec.europa.eu (tel.: +32 2 295 39 46)

11/7/2007

Update of the "guideline on format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to anotherpdf(65 KB) "

The "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: sponsors will from now on be required to provide only ONE paper version of their application (instead of three paper versions); instead, an additional electronic version (CD Rom) will be requested.

10/7/2007

Better regulation of pharmaceuticals: towards a simpler, clearer and more flexible framework on variations: Public Consultation (co-decision part)

Commission launches a Public Consultation on the co-decision part of the revision of the Variations Regulations. The consultation paper, together with detailed explanations on the consultation process, is available herepdf(61 KB) . This public consultation only addresses the 'co-decision' part of this Better Regulation initiative. It does not address the aspects of the review which can be implemented through 'comitology'. These aspects will be addressed in another round of consultation.
Comments should be sent by e-mail to entr-pharmaceuticals@ec.europa.eu before 21 September 2007.

18/6/2007

Notice to Applicants Volume 6C - Guideline on the Summary of Product Characteristics for immunological veterinary medicinal productspdf(68 KB)

DG Enterprise and Industry publishes the revised Guideline on the Summary of Product Characteristics for immunological veterinary medicinal products in Volume 6C Regulatory Guidelines of the Notice to Applicants for Veterinary Medicinal Products. The update, which has been endorsed by NTA, reflects the amendment of point 4.8 as proposed by CVMP and its Immunological Working Party.

18/6/2007

New provisions on the enforcement of obligations linked to marketing authorisations granted through the centralised procedure: Commission penalties regulation adopted
On Thursday 14 June, the European Commission adopted a regulation concerning the imposition by the Commission of financial penalties on the holders of marketing authorisations in order to ensure the enforcement of certain obligations connected with marketing authorisations granted in accordance with the centralised procedure. The Regulation, which implements Article 84(3) of Regulation (EC) No 726/2004, was published in the Official Journal on 15 June and will enter into force on 5 July.
The Regulation lists the obligations linked to marketing authorisations and the conditions which may lead to Community enforcement, and provides for the maximum amount for penalties, the criteria for the imposition of penalties and the elements of the infringement procedure.
These new provisions are expected to contribute to the strategic goals of the Community framework for the authorisation and surveillance of medicinal products, i.e.: ensuring that public health is adequately protected across the Community, and supporting the achievement of the internal market for the pharmaceutical sector.
To that effect, the Regulation aims at strengthening the application of the Community pharmaceutical rules through a stronger involvement of the Agency and the Commission in the area of marketing authorisations granted through the centralised procedure. The Regulation will raise the deterrent effect of the Community rules and will increase the efficiency of the enforcement system for marketing authorisations granted through the centralised procedure, by providing for a single mechanism for the enforcement of obligations linked to these authorisations where the infringement has a Community dimension or effect.

All language versions of the Regulation can be found here.

18/6/2007

Transatlantic cooperation on medicines regulation expanded
On 14 and 15 June the bilateral meeting between the European Commission and European Medicines Agency and the United States Food and Drug Administration made important progress on expanding transatlantic regulatory cooperation.
The joint press release can be accessed here.pdf(30 KB)
The 'Principles for Interaction' on medicines for children can be accessed herepdf(42 KB) .
The revised implementation plan can be accessed here.pdf(48 KB)

12/6/2007

Paediatric Committee: Commission call for expressions of interest
Today the Commission launches a call for expressions of interest as Commission appointees to the European Medicines Agency Paediatric Committee. The deadline for expressions of interest is 31 August 2007 which should be sent to Peter Arlett at the European Commission in electronic form (entr-pharmaceuticals@ec.europa.eu). Further details, including the criteria for selection can be found by clicking herepdf(34 KB) .

31/5/2007

Following the opinion of the European Parliament on 25 April, the Council of Ministers approved today the Regulation on advanced therapies, in first-reading.

All Member States supported the Regulation. A first-reading agreement is therefore achieved. The Council debate held this morning is publicly available on the web.
An informal version of the final text, as discussed this morning in the Council, is available herepdf(29 KB) .

Next steps: the Regulation now needs to be translated in all EU official languages, checked by the linguistic revisers of the Council/European Parliament, and formally adopted, signed and published. This purely formal and administrative procedure should take a couple of months.

The Commission will start now the implementation work, together with the European Medicines Agency.

30/5/2005

Consultation on a draft report on the experience acquired as a result of the application of the specific provisions applicable to traditional herbal medicinal products

DG Enterprise and Industry launches a public consultation on a draft report on the experience acquired as a result of the application of the provisions of Chapter 2a of Directive 2001/83/EC (introduced by Directive 2004/24/EC) on specific provisions applicable to traditional herbal medicinal products, as required under Article 16i of Directive 2001/83/EC.

For the consultation document click herepdf(57 KB).

We invite comments on the document to be sent to entr-pharmaceuticals@ec.europa.eu until 10 August 2007.

29/5/2007

Pharmaceutical Committee - Meeting Report of the 62nd meeting, 21 May 2007pdf(24 KB)

24/5/2007

Updating the Notice to Applicants - Veterinary Medicinal Products - Volume 6A Chapter 7 "General Information"pdf
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 as well as data for Bulgaria and Romania were introduced.

14/5/2007

Substances considered as not falling within the scope of Council Regulation (EEC) No 2377/90

An up-to-date listpdf(12 KB) of substances considered as not being within the scope of Council Regulation (EEC) No 2377/90 is now available. (Revision 10 of May 2007)

8/5/2007

Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trialspdf(40 KB)
This document intends to clarify and provide additional guidance on the definition of investigational medicinal products and to provide specific guidance about the use of non-investigational medicinal products, in accordance with the applicable EU legislation. It complements the "Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial " and 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 usepdf(135 KB)".

24/4/2007

Vote in the European Parliament on the Commission proposal for a Regulation on advanced therapy medicinal products.

On 25.4.2007, the European Parliament voted in first reading on the Commission proposal for a Regulation on advanced therapy medicinal products. The final EP opinion was adopted with a very large majority.
The adopted amendments (amendments 82 to 156) can be found herepdf(262 KB) . More information from the European Parliament, including a summary of the plenary debate, can be found here

The Press Release of the European Commission on the subject can be found here: ENpdf(93 KB) Choose translations of the previous link Deutsch (de) français (fr) Deutschfrançais - DEpdf(98 KB) Choose translations of the previous link Deutsch (de) français (fr) Deutschfrançais - FRpdf(89 KB) Choose translations of the previous link Deutsch (de) français (fr) françaisDeutsch.

This 1st reading opinion of the European Parliament goes now formally to the Council of Ministers.

See also the section Advanced therapies

20/4/2007

Important simplification steps for the approval of veterinary medicines

On Tuesday 17 April the European Commission adopted a proposal to amend the Regulation on Maximum Residue Limits which aims at simplifying existing provisions for establishing the maximum amount of residues of veterinary medicinal products legally accepted in foodstuffs. These new provisions are expected to stimulate innovation and improve availability of veterinary medicinal products.

For more information click here.

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

10/4/2007

Volume 9A of the Rules Governing Medicinal Products in the European Union: Pharmacovigilance for medicinal products for human use

Volume 9A was made public in January 2007 and it is now updated with the following changes:

- On page 77 and 82 the request for Periodic Safety Update Report (PSUR) annexes of line-listings of Individual Case Safety Reports from post authorisation safety studies on non-serious adverse reactions has been removed. Instead the guideline emphasises (on page 91) that such reports should be summarised in frequency tables in the final study report. Page 179 is updated for consistency.

- To promote international harmonisation, on page 194 in the glossary, the explanatory note on the term "response" in the definition of adverse reaction has been replaced with the exact text of ICH guideline E2D.

- For completeness the reporting arrangements of Malta and Iceland have been included in Annex 6.

Volume 9A can be found by clicking here.

4/4/2007

Volume 9 B - GUIDELINE on monitoring of compliance with pharmacovigilance regulatory obligations and pharmacovigilance inspections for veterinary medicinal productspdf

Following the public consultation held in 2006, and awaiting the publication of Volume 9B of the Rules governing medicinal products in the European Union , which will contain the guidelines on pharmacovigilance for veterinary medicinal products, the guideline on monitoring of compliance with pharmacovigilance regulatory obligations and pharmacovigilance inspections for veterinary medicinal product,pdf containing specifically the veterinary regulatory provisions, is added to the set of guidelines on pharmacovigilance for veterinary medicinal products currently provided for in Volume 9 (Version June 2004). The Guideline can be found by clicking here

30/3/2007

Notice to Applicants, Volume 2C, Guideline on the Packaging Information of Medicinal Products for Human Use Authorised by the Community
Update of the Guideline on the Packaging Information of Medicinal Products for Human Use Authorised by the Community (Volume 2C of Notice to Applicants) to include information requirements by the new Member States and updates from Italy and Sweden.

30/3/2007

Veterinary Pharmaceutical Committee - 18th Meeting - 20 March 2007pdf(24 KB)
The Veterinary Pharmaceutical Committee held its 18th meeting on 20 March 2007 in Brussels. The meeting was chaired by Martin Terberger, Head of Unit of ENTR/F/2, Pharmaceuticals. This meeting report intends to provide a brief summary of the outcome on the different topics on the agenda. It will be complemented by the publication of a summary record of the meeting.

30/3/2007

Pharmaceuticals news now also with RSS !

A RSS flux has now been installed. You may consult the latest news now with your favorite flux software. Note that this option is not available with Internet Explorer 6, if you want to use this option use Mozilla Firefox, Opera, Internet Explorer 7 and Safari (Apple) and of course all other RSS applications.
For more information about RSS see here.

27/03/2007

Revision of Guidelines and Procedures for Official Batch Protocol Review and Official Control Authority Batch Release of veterinary vaccine
At its 18th meeting the Veterinary Pharmaceutical Committee endorsed revised guidelines and procedures on the implementation on the implementation of Article 81 and Article 82 of Directive 2001/82/EC, as amended by Directive 2004/28/EC. The revisions are meant to lead to a reduction of administrative burden when competent authorities/ Official Medicines Control Laboratories ask companies for information on their veterinary vaccines for Official Batch Protocol Review. The revisions were elaborated jointly between the OMCL network and industry. In addition, it should be noted that the revised procedure on Article 82 supersedes the Commission Guideline III/5372/93.

As in the past, the European Directorate for the Quality of Medicines will make the revised guidelines public on its website http://www.edqm.eu/site/page_634.php ():
Vet OBPR: Article 81 Procedure (PA/PH/OMCL (07) 16)
Vet OCABR: Article 82 (PA/PH/OMCL (07)15)
Vet OCABR: Inactivated Bacterial Vaccines (PA/PH/OMCL (06)118 2R)
Vet OCABR: Live Bacterial Vaccines (PA/PH/OMCL (06) 119 R)
Vet OCABR: Live Viral Vaccines (PA/PH/OMCL (06) 120 2R)
Vet OCABR: Tuberculin PPD/ Brucellin Preparations (PA/PH/OMCL (06) 121 2R)
Vet OCABR: Inactivated Viral Vaccines (PA/PH/OMCL (06) 122 2R)

27/03/2007

Recommendations on the Implementation of Official Control Authority Batch Release for Immunological Veterinary Medicinal Products
Following endorsement by the Veterinary Pharmaceutical Committee at its 18th meeting, DG Enterprise and Industry publishes the "Recommendations on the Implementation of Article 82 of Directive 2001/82/EC, as amended by Directive 2004/28/EC for Official Control Authority Batch Releasepdf(46 KB) " for immunological veterinary medicinal products.
The recommendations summarise the conclusions following discussions of the joint industry/ regulatory working group and the OMCL/ competent authorities' network on this topic based on an assessment of possible impacts. Annex 5 of the recommendations includes the conclusions on the restricted list of products to be re-tested and the list of tests to be repeated. For further information reference is made to the attached note to the Veterinary Pharmaceutical Committee and stakeholderspdf(20 KB) .

The annexes to the recommendations are published separately:
Annex 1 - Risk Assessmentpdf(173 KB)
Annex 2 - Economic Assessmentpdf(37 KB)
Annex 3 - Trend Analysispdf(12 KB)
Annex 4 - Out of Specification Resultspdf(139 KB)
Annex 5 - Restricted List of Products to be retested and restricted list of testspdf(12 KB)

22/03/2007

In preparation of a Directive on GMP for certain excipients following Article 46 (f) of Directive 2001/83/EC, as amended by Directive 2004/27/EC, DG Enterprise and Industry asks excipient manufacturers and manufacturers/ importers of medicinal products for human use (excipient users) to contribute to an online consultation on possible impacts of different policy options. Excipient distributors may also participate in this consultation. With the questionnaires for excipient manufacturers and excipient users we also publish the draft "Specific Conditions of the Application of the Principles and Guidelines of GMP for Certain Excipients"pdf(23 KB) as a possible basis for a GMP Directive. Before responding, please carefully read the attached instruction notemsw8(884 KB) . For separate comments to the draft specific GMP conditions please use the template for comments as attached to the instruction note.

Excipient manufacturers and excipient users are asked to respond by 30 July 2007. Small and medium size enterprises are specifically encouraged to contribute to this consultation.

13/03/2007

Updating the NOTICE TO APPLICANTS Volume 2

An updated version of Chapter 7 - General Information of Volume 2A of the Notice to Applicants is now available. The update reflects the inclusion of information requirements by the new Member States and updates from Austria, Belgium, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom, Iceland, Norway and the EMEA.

The forms for application for a new marketing authorisation contained in Volume 2B were also amended to include reference to the new Member States and to update website addresses and are now available. The same occurs with application forms for renewal and variation contained in Volume 2C.

Note that the structure of Volume 2B was updated to eliminate the old format for submitting marketing authorisation applications. The CTD format is now the only one available under Volume 2B. The presentation of this volume has also been updated in order to make it more user-friendly.

07/03/2007

Consultation on a draft "Guideline on aspects of the application of Article 8(2) of Regulation (EC) No 141/2000: Review of the period of market exclusivity of orphan medicinal products"pdf(44 KB)
Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products lays down a Community procedure for the designation of medicinal products as orphan medicinal products and provides incentives for the research, development and placing on the market of such products. In particular, Article 8(1) provides for a period of ten years of market exclusivity where a marketing authorisation in respect of an orphan medicinal product is authorised throughout the Community. In turn, Article 8(2) provides that this period may be reduced to six years if it is established that the designation criteria are no longer met. In this respect, this draft guideline sets out the general principles and procedures by which the period of market exclusivity of orphan medicinal products is reviewed and may be reduced to six years.

We invite comments on the draft guideline, to be sent to claire.scharf-kroener@ec.europa.eu until 7 May 2007.

05/03/2007

Pharmaceutical Committee - Summary record of the 61sh meeting, 5 December 2006pdf

26/02/2007

Strengthening Human Medicines Safety Monitoring
Commission Vice-President Günter Verheugen has announced a strengthening of the EU pharmacovigilance system. Today's announcement is based on the results of the 2006 public consultation and includes both better implementation of the current system and proposals to change the legal framework for pharmacovigilance in the EU. The change to the legal framework will involve an impact assessment during the course of 2007 with a view to a legal proposal in 2008. For:

· the press release from the Vice-President,

· details of the strategy

· a detailed analysis of the public consultation and

· the individual consultation responses

click here.

19/02/2007

Advanced Therapies : Update 30/`01/2007
The Environment, Public Health and Food Safety Committee of the European Parliament adopted on 30 January 2007 a report on the Commission proposal for a Regulation on advanced therapy medicinal products. The report, which was adopted by 55 votes to 6 with 3 abstentions, can be found here .

16/02/2007

Chapter 2 - Mutual Recognition of Volume 2A of the Notice to Applicantspdf(526 KB)
An updated version of Chapter 2 - Mutual Recognitionpdf(526 KB) of Volume 2A of the Notice to Applicants is now available. The update reflects the inclusion of references to the new Member States and precisions in the numbering system for the procedures for Mutual Recognition and Decentralised Procedure as well as the new website of Heads of Agencies address.

5/02/2007

Confidentiality arrangements finalised with Japan

The European Commission's Directorate-General Enterprise and Industry, the European Medicines Agency (EMEA), the Japanese Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) have concluded confidentiality arrangements in the area of human medicine regulation during their bilateral meeting of 2 February 2007 in Tokyo.

The joint EC / EMEA press release can be found here in:

The letter from EC/EMEA to MHLW/PMDA can be found herepdf(415 KB) .

The letter from MHLW/PMDA to EC/EMEA can be found here Choose translations of the previous link euskara (eu) .

Enquiries on the bilateral arrangements with Japan should be directed to Peter Arlett (entr-pharmaceuticals@ec.europa.eu).

31/01/2007

Updating the Notice to Applicants Guidelines - Veterinary Medicinal Products - Volume 6A - Chapter 1 "Marketing Authorisationspdf(151 KB)

DG Enterprise and Industry releases an updated version of the Notice to Applicants Volume 6A Chapter 1 "Marketing Authorisations". The update reflects a correction of point 6.1.2 concerning the data exclusivity for applications submitted before the implementation of the amended legislation in Italy.

31/01/2007

Implementation of the paediatric regulation: Consultation on draft Commission guideline
The paediatric regulation (Regulation (EC) No 1901/2006) entered into force on 26 January 2007. Today DG ENTR launches a public consultation on its draft implementing guideline entitled: "Commission guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies".
Comments are invited, particularly from small and medium sized enterprises, and should be e-mailed by 30 March 2007 as word documents using the template to Peter Arlett at the European Commission (entr-pharmaceuticals@ec.europa.eu).

Click here for the draft guideline.pdf(76 KB)

Click here for the template for responses (PDF document)pdf(62 KB) - word documentmsw8(34 KB)

31/01/2007

GMP Chapter 1 "Quality Management" : Draft revision for public consultationpdf(146 KB)

Chapter 1 of the GMP Guide has been amended to include reference to the quality risk management principles as described in the ICH Q9 guideline. The amendment is part of the EC implementation measures for the ICH Q9 guideline on quality risk management. The changes made are restricted to the principle and a new section 1.5. Unrelated changes have been made to the numbering and in section 1.1(i).

While the risk management principles will be included in Chapter 1, the most appropriate way to fully integrate the ICH Q9 guideline to provide risk management methodology and tools to be used at the discretion of the manufacturer is currently under discussion. An integration into the GMP guide is currently being considered.

Comments are invited, particularly from small and medium sized enterprises, and should be sent to entr-gmp@ec.europa.eu and gmp@emea.europa.eu by 30 April 2007.

29/01/2007

Draft Commission regulation on financial penalties receives a positive opinion from the Standing Committee on Medicinal Products for Human Use and the Standing Committee on Veterinary Medicinal Products
Article 84(3) of European Parliament and Council Regulation (EC) No 726/2004 empowers the Commission to impose financial penalties on the holders of marketing authorisations for medicinal products granted in accordance with the centralised procedure, to ensure the enforcement of certain obligations connected with the marketing authorisations. The Commission is to adopt implementing provisions (a Commission Regulation) following a regulatory committee procedure. In accordance with this procedure, a draft Regulation was submitted to the Standing Committee on Medicinal Products for Human Use and to the Standing Committee on Veterinary Medicinal Products in a joint meeting held on 11 January, 2007. Both committees delivered a positive opinion on the draft Regulation, which can be found herepdf(255 KB) .

The final text will be published on this website once the adoption procedure has been completed and the Regulation has been published in the Official Journal.

25/01/2007

Volume 9A of the Rules Governing Medicinal Products in the European Union: Pharmacovigilance for medicinal products for human use

Following the adoption and entry into force of Regulation (EC) No 726/2004 and Directive 2004/27/EC, Volume 9 of the Rules Governing Medicinal Products in the European Union has been extensively revised and updated. The guideline has been split into Volume 9A relating to medicinal products for human use and Volume 9B on medicinal products for veterinary use. Volume 9A underwent public consultations during 2005 and 2006, and based on the comments received the final Volume 9A is now made public and takes effect immediately. Volume 9A can be found by clicking here.

It should be noted that Volume 9B is not yet available and therefore the version of Volume 9 that was made public in June 2004 remains valid for medicinal products for veterinary use: this can be found by clicking here.

Feedback from the Volume 9A public consultations of 2005 and 2006

Feedback: General Commentspdf(279 KB)

Feedback: Introductionpdf(47 KB)

Feedback: I.1pdf(274 KB) , I.2pdf(285 KB), I.4, , I.6pdf(540 KB), I.7pdf(265 KB),

Feedback: II.1pdf(148 KB) , II.3pdf(70 KB) , II.4pdf(33 KB) , II.6pdf(33 KB)

Feedback: IIIpdf(691 KB)

Feedback: IVpdf(195 KB)

Feedback: Glossarypdf(66 KB)

Note: those feedback documents that are not yet available (in black and strikethrough) are anticipated to be added to this section soon.

17/01/2007

Commission adopts proposal to adapt Directive 2001/83/EC to the new "comitology" rules
Directive 2001/83/EC, on the Community code relating to medicinal products for human use, contains several provisions giving the Commission responsibility for implementing Community legislation, and making the exercise of such implementing powers subject to the so-called "comitology" procedures of Council Decision 1999/468/EC of 28 June 1999. This Council Decision has been recently amended by Council Decision 2006/512/EC of 17 July 2006, which has introduced a new type of procedure for the exercise of implementing powers by the Commission, the 'regulatory procedure with scrutiny'.

On 22 December 2006, the Commission has adopted a legislative proposal to amend Directive 2001/83/EC in order to bring it in line with this new 'regulatory procedure with scrutiny'. The proposed amending directive affects various implementing measures provided for in Directive 2001/83/EC, in the areas of homeopathic medicinal products, variations, good manufacturing practice, pharmacovigilance and the Annex to the Directive.

The different language versions of the legislative proposal can be found below :

12/01/2007

Commission Directive 2006/130/EC of 11 December 2006 implementing Directive 2001/82/EC of the European Parliament and of the Council as regards the establishment of criteria for exempting certain veterinary medicinal products for food-producing animals from the requirement of a veterinary prescription was published in the Official Journal on 12 December 2006. The different language versions can be found here.

Commission Regulation (EC) No 1950/2006 of 13 December 2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae was published in the Official Journal on 22 December 2006. The different language versions can be found here.

9/01/2007

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use was published in the Official Journal on 27 December 2006 and will enter into force on 26 January 2007. The different language versions can be found here.

New rules on the adoption of implementing texts by the European Commission (so called 'comitology' rules) were adopted after the 'second reading agreement' between the European Parliament, the Council and the Commission on the paediatric regulation. Therefore a regulation has also been adopted and published to bring the paediatric regulation in line with these new 'comitology rules' (Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation). The different language versions can be found here.