Pharmaceuticals Archives - 2005

21/12/2005

Volume 9a of the Rules Governing Medicinal Products in the European Union: Public consultation on the Guidelines on Pharmacovigilance for Medicinal Products for Human Use
The European Commission today launches a public consultation on Volume 9a, the Guidelines on Pharmacovigilance for Medicinal Products for Human Use. Volume 9a has been updated to take account of Regulation (EC) No 726/2004 and Directive 2004/27/EC, to take account of international harmonisation work carried out in the filed of pharmacovigilance and to take account of scientific and technical progress.
The consultation introduction and orientation can be found herepdf(23 KB) .
The draft of Volume 9a can be found herepdf(806 KB) .
The template for comments can be found heremsw8(36 KB) . Comments and suggestions are invited by 17 March 2006 and should be sent, preferably by email to Dr Peter Arlett (peter.arlett@ec.europa.eu)

21/12/2005

Public consultation on draft Commission guideline on extended marketing protection
The Commission today launches a public consultation on the draft Commission guideline on extended marketing protection entitled:
"Guideline on the elements required to support the significant clinical benefit in comparison to existing therapies of a new therapeutic indication in order to benefit from an extended (11-years) marketing protection."
The draft guideline can be found herepdf(63 KB) .
Comments should be sent by 17 February 2006 to Dr Peter Arlett (peter.arlett@ec.europa.eu). Electronic responses are preferred. Those submitting comments should be aware that their responses may be placed on the Commission web-site.
A template for comments is available heremsw8(37 KB) .
Comments are welcome on any parts of the guideline. However, the Commission would particularly welcome your input on the following points: • the description of "new therapeutic indication" (see sections 2 and 4.1).
The classification of "significant clinical benefit in comparison with existing therapies" (see sections 2 and 4.3).Please note that the final destination of this guideline will be the "Notice to Applicants".

21/12/2005

Public consultation on draft Commission guideline on new therapeutic indication for a well-established substance
The Commission today launches a public consultation on the draft Commission "guideline on new therapeutic indication for a well-established substance". The draft guideline can be found herepdf(20 KB) .
Comments should be sent by 17 February 2006 to Dr Peter Arlett (peter.arlett@ec.europa.eu). Electronic responses are preferred. Those submitting comments should be aware that their responses may be placed on the Commission web-site. A template for comments is available heremsw8(35 KB) .
Comments are welcome on any parts of the guideline. However, the Commission would particularly welcome your input on the following points: • the description of "new therapeutic indication" in section 2 of the draft.
The classification of "significant preclinical or clinical studies" in section 4 of the draft.Please note that the final destination of this guideline will be the "Notice to Applicants".

21/12/2005

Update of the "Guideline on the processing of renewals in the centralised procedure"pdf(66 KB)
DG Enterprise and Industry releases an updated version of the Notice to Applicants Volume 6C "Guideline on the processing of renewals in the centralised procedure". The update reflects the amendments introduced by Directive 2001/82/EC, as amended by Directive 2004/28/EC and Regulation (EC) No 726/2004.

21/12/2005

Guideline concerning the optional scope of the centralised procedure in accordance with Article 3(2)(b) of Regulation (EC) No 726/2004pdf(31 KB)
The Commission services, in cooperation with the EMEA, present a draft of the new guidance concerning the optional scope of the centralised procedure in accordance with Article 3(2)(b) of Regulation (EC) No 726/2004.
This draft guideline applies to human medicinal products and provides guidance on:
- EMEA procedure for confirmation of eligibility to the centralised procedure
- definition of new active substance not authorised in the Community, at the time of
entry into force of the Regulation,
- justification of significant therapeutic, scientific or technical innovation
and
- eligibility based on interests of patients at Community level.

Please send your comments by 31 January 2005 to Birka.Lehmann@ec.europa.eu
This guideline will be included in the Rules of governing Medicinal Products in the European Community Volume 2C: Guidelines

21/12/2005

Consultation on the draft revision of Annex I to Directive 2001/82/EC on "Chemical, pharmaceutical and analytical standards, safety and residue tests, pre-clinical and clinical trials in respect of the testing of veterinary medicinal productspdf(543 KB)
Annex I to Directive 2001/82/EC sets out format and content of application dossiers for marketing authorisations for veterinary medicinal products. As it stands at the moment this Annex lays down scientific requirements which are to be actualised introducing new elements and terminology stemming from Directive 2001/82/EC as amended by Directive 2004/28/EC, to adapt to the human Annex I as amended by Directive 2003/63/ECand to other pharmaceutical Community guidelines published by the Commission in different volumes of "The rules governing medicinal products in the European Community".
The revised Annex I is to be implemented through the adoption of a Commission Directive. Drawing your attention to our Consultation Note, DG Enterprise and Industry invites comments on the draft revision of Annex I to be sent to Dr. Karin Krauss, European Commission, BREY 10/73, 1049 Brussels. E-mail sub-missions are preferred and should be sent to Karin.Krauss@ec.europa.eu until 24.02.2006 at the latest.

20/12/2005

New GMP Annex 19 for Reference and Retention Samplespdf(24 KB)
This new annex to the GMP Guide provides guidance on the taking and holding of reference samples of starting materials, packaging materials and finished products as well as for retention samples of finished products. The annex provides definitions of the terms "reference sample" and "retention sample", which hitherto were often incorrectly considered as synonyms. Updated guidance is also given on the size of reference samples and a consequential change was made to Chapter 6, section 14, of the GMP Guide to maintain consistency (see News on 08/11/2005). Both the revised Chapter 6 and Annex 19 will come into operation on 01 June 2006.

20/12/2005

Revised GMP Part I/ Chapter 8 on Complaints and Product Recallpdf(18 KB)
The revision was made to raise awareness of the possibility that a reported quality defect may be the result of counterfeiting activity and to clarify that the discovery of a counterfeit medicinal product should be reported to the competent authority. These changes are in line with WHO recommendations. The revised Chapter 8 will come into operation on 01 February 2006.

16/12/2005

Authorisation of medicines: Commission makes life easier for SMEs
The Commission Regulation 2049/2005 laying down special financial and administrative provisions for SMEs has been adopted on 15.12.2005 and published on 16.12 in the EU Official Journal L 329

15/12/2005

Authorisation of medicines: Commission makes life easier for SMEs ENpdf(88 KB) Choose translations of the previous link Deutsch (de) français (fr) Deutschfrançais
New and innovative medicines can now be marketed easier to the benefit of patients. To encourage small and medium-sized enterprises (SMEs) to submit applications to the European Medicines Agency (EMEA), the European Commission has today adopted significant fee reductions and deferrals for a number of EMEA services, such as scientific advice.
The Regulation will enter into force in the coming days, following publication in the Official Journal. It will then be posted on this website.
For more information, see the Commission Press Release:
DEpdf(95 KB) Choose translations of the previous link Deutsch (de) français (fr) Deutschfrançais - ENpdf(88 KB) Choose translations of the previous link Deutsch (de) français (fr) Deutschfrançais - FRpdf(88 KB) Choose translations of the previous link Deutsch (de) français (fr) françaisDeutsch

7/12/2005

Updating the Notice to Applicants - Homeopathic Medicinal Products - Volume 2B Presentation and content of the dossier - Part 1: Summary of the dossier - Part 1A Application form
DG Enterprise and Industry releases a addition to the Volume 2B Presentation and content of the dossier for Homeopathic Medicinal Products - Part 1: Summary of the dossier - Part 1A Application form - Administrative data. The update reflects the amendments introduced by Directive 2001/83/EC, as amended by Directive 2004/27/EC.

7/12/2005

Updating the Notice to Applicants Volumes 2C and 6C: Application form for renewal of a marketing authorisation and guidance notes for the completion of the application formmsw8
DG Enterprise and Industry releases an updated version of the Volume 2C and 6C "Application form for renewal of a marketing authorisation and guidance notes for the completion of the application form" for human and veterinary medicinal products. The update reflects the amendments introduced by Directive 2004/27/EC, Directive 2004/24/EC and Directive 2004/28/EC as well as by Regulation (EC) No 726/2004.

25/11/2005

New rules on fees payable to the European Medicines Agency adopted and published New rules on fees for registration of medicines for human and veterinary use at the European Medicines Agency (EMEA) have been adopted by the Council on 14.11.2005, upon a proposal from the European Commission. A number of fees will be reduced, reinforcing the principle of proportionality between the fees levels and the services provided by the Agency. The new regulation puts the fees system in line with the new pharmaceutical legislation in the EU and the new responsibilities conferred to EMEA.
English, French and German versions of the new rules can be found here: ENpdf(68 KB) Choose translations of the previous link Deutsch (de) français (fr) DeutschfrançaisFRpdf(76 KB) Choose translations of the previous link Deutsch (de) français (fr) françaisDeutschDEpdf(72 KB) Choose translations of the previous link Deutsch (de) français (fr) Deutschfrançais
The Commission Press Release on the subject can be found here: ENpdf(75 KB) Choose translations of the previous link Deutsch (de) français (fr) DeutschfrançaisFRpdf(75 KB) Choose translations of the previous link Deutsch (de) français (fr) françaisDeutschDEpdf(81 KB) Choose translations of the previous link Deutsch (de) français (fr) Deutschfrançais
For any questions, please contact Nicolas Rossignol

24/11/2005

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 6 of November 2005pdf(10 KB) )

24/11/2005

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 trialpdf(294 KB)
The second revision of 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' as required by Article 9 (8) of Directive 2001/20/EC is now available.
Information regarding the dossier requirements for all 25 Member States is included. A revised application is attached which will be required once the updated electronic form becomes available in EudraCT version 3.0.0 on the EMEA web site. Please raed the notice for sponsors on the EMEA web site, giving information on the upgrade of Eudra CT to version 3.0.0
Further information is included in section 4.1.5, of the detailed guidance, regarding the Investigator's Brochure and 4.1.6.1
regarding the Investigational Medicinal Products dossier and the possibility in particular
circumstances of using a Summary of Product Characteristics for this purpose
Corrigendum:
Attachment 1 Information required by MS changes introduced in the requirements for Belgium
Attachment 2 - 4 reference to the Common Technical Document updated

18/11/2005

Mutual Recognition Agreements (MRA) - Update of Contact Details for GMP Annexespdf(27 KB) Currently, MRAs are operational with Australia, Canada, New Zealand and Switzerland for the GMP sector with regard to human and veterinary medicinal products and with Japan with regard to GMP for human medicinal products. A MRA with the USA was concluded, but did not enter the operational phase. After enlargement Canada is in the process of evaluating the new Member States for equivalency.
With the accession of 10 new Member States it was deemed necessary to update the contact details as listed in the different GMP Annexes of the MRAs. The attached contact details will be submitted to the Joint Committees under the different MRAs. The list includes the competent authorities for the GMP sector as nominated by the different Member States. It should be noted that some competent authorities further delegate technical and operational aspects to subordinate authorities. Detailed information on this is available through the respective Joint Sectoral Committees of the MRA partners. For the EU it is published on the EMEA website.

17/11/2005

Commission adopts a modified proposal for a regulation on medicines for children
Following the plenary vote of the European Parliament on the Commission's proposal for a regulation on medicinal products for paediatric use, the Commission has carefully assessed the adopted parliamentary amendments and has responded to them in the form of a modified proposal:
The original Commission proposal adopted in September 2004, together with extensive explanatory information are available here.


Discussions in the Council are progressing well and the proposed regulation on medicinal products for paediatric use will be discussed at the Health Council of 9 December 2005.

16/11/2005

EU (European Commission and EMEA) and FDA extend confidentiality arrangements for five more years
The European Commission (EC), the European Medicines Agency (EMEA) and the U.S. Food and Drug Administration (FDA) have extended their confidentiality arrangements related to medicinal products for human and veterinary use for five more years, following the positive experience gained since the initial arrangements were signed in September 2003.
The confidentiality arrangements allow the EC/EMEA and the FDA to exchange information as part of their regulatory processes. The types of information covered by the arrangements include legal and regulatory issues, scientific advice, orphan drug designation, inspection reports, marketing authorisation procedures and post-marketing surveillance. The confidentiality arrangements cover medicinal products that are subject to evaluation or authorised under the centralised procedure as well as medicinal products that are authorised at national level by the EU Member States and that are subject to official European Community arbitrations and referrals.
The September 2003 public statement together with the text of the Exchange of Letters between the European Commission, EMEA and FDA can be found:
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/Doc2003/sept/eu_us_fda_ps.pdf Choose translations of the previous link  (ps)
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/Doc2003/sept/Fdalow.pdfpdf(3 MB) An implementation plan for the confidentiality arrangements as regards medicinal products for human use was agreed and published in 2004 and can be found:
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/Doc2004/oct/ec_emea_fda_conf_impl.pdfpdf(52 KB) A pilot programme allowing companies to obtain parallel scientific advice from the two agencies for the development of medicinal products for human use was part of the first phase of implementation. A general principles document can be found:
http://www.emea.europa.eu/pdfs/general/direct/internationalcoop/EMEA-FDAScientificAdvice.pdfpdf Enquiries regarding the EC/EMEA/FDA confidentiality arrangements should be sent to peter.arlett@ec.europa.eu:

16/11/2005

Commission adopts proposal on tissue engineering and other advanced therapies
On 16 November 2005 the European Commission adopted a proposal for a Regulation of the European Parliament and of the Council on advanced therapy medicinal products. The proposal aims to resolve the current regulatory gap in this emerging field by addressing all advanced therapy products within a single, integrated and tailored framework. This proposal is based on extensive consultation of all stakeholders, and a comprehensive impact assessment. It will now be forwarded to the European Parliament and Council, for co-decision.
More details can be found by clicking here.

15/11/2005

Updating the Notice to Applicants Guidelines - Human Medicinal Products - Volume 2A
Chapter 1 "Marketing Authorisations"pdf(169 KB), Chapter 2 "Mutual Recognition Procedure and Decentralised Procedure"pdf and Chapter 6 "Decision Making Procedure for the Adoption of Commission Decisions"pdf(91 KB)
DG Enterprise and Industry releases updated versions of the Notice to Applicants Volume 2A Chapter 1 "Marketing Authorisations" , Chapter 2 "Mutual Recognition Procedure and Decentralised Procedure" and Chapter 6 "Decision Making Procedure for the Adoption of Commission Decisions". 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.

15/11/2005

Updating the Notice to Applicants Guidelines - Veterinary Medicinal Products - Volume 6A
Chapter 1 "Marketing Authorisations"pdf, Chapter 2 "Mutual Recognition Procedure and Decentralised Procedure"pdf(141 KB) and Chapter 6 "Decision Making Procedure for the Adoption of Commission Decisions"pdf(94 KB)
DG Enterprise and Industry releases updated versions of the Notice to Applicants Volume 6A Chapter 1 "Marketing Authorisations" , Chapter 2 "Mutual Recognition Procedure and Decentralised Procedure" and Chapter 6 "Decision Making Procedure for the Adoption of Commission Decisions". The updates reflect the amendments introduced by Directive 2001/82/EC, as amended by Directive 2004/28/EC and Regulation (EC) No 726/2004.

11/11/2005

Draft Amendment to Annex 1 of the GMP guide for public consultationpdf(37 KB) (corrected version)
Following a revision of Annex 1 on the manufacture of sterile medicinal products, which was launched in May 2003, the need for an ongoing discussion on the table providing environmental cleanliness and a number of other aspects to the annex were identified. The results of this discussion are reflected in the draft amendment of the guide. Public comments are invited on the proposal and should be sent to Sabine.Atzor@ec.europa.eu and David.Cockburn@emea.eu.int before 30 April 2006.

8/11/2005

New GMP Provisions for Product Quality Review and On-going Stability Programme:
Revision of GMP Guidelines, Part I Revision of Chapter 1pdf(23 KB) and Chapter 6pdf(33 KB)
Chapter 1 on Quality Management has been revised to include new requirements on Product Quality Review and is now published in a consolidated version. The revised chapter will come into force in January 2006. Although companies should already have most of the information requested available, it is recognised that some time will be necessary to develop and establish a system and associated procedures to implement this new requirement. Therefore, companies performing their first Product Quality Review in 2006 should cover a period of at least 6 months. Subsequent reports should cover a full 12 months' period.
Chapter 6 on Quality Control includes new provisions for an On-going Stability Programme and an update for reference samples and is also published in a consolidated version. The revised Chapter will come into operation on 01 June 2006.

28/10/2005

NOTICE TO APPLICANTS Volume 2C
The Commission services present an update of the 'Guideline on the Summary of Product Characteristicspdf(117 KB)'.
Directive 2004/27/EC - amending Directive 2001/83/EC - includes changes to the summary of product characteristics.
This guidance interprets the requirements for the summary of product characteristics according to Article 11 of Directive 2001/83/EC as amended and includes changes to sections 4.1 'Therapeutic indications', 4.8 'Undesirable effects' and 5.1 'Pharmacodynamic properties'. In section 4.2 'Posology and method of administration' as well as in section 4.5 'Interaction with other medicinal products and other forms of interactions' requirements for information on use in special populations is requested.
This guideline will be included in The Rules Governing Medicinal Products in the European Union Volume 2C of the Notice to Applicants.

28/10/2005

Updating the Notice to Applicants - Medicinal Products for Human Use - Volume 2B Presentation and content of the dossier-Part 1: Summary of the dossier-Part1A-1998 edition or Common Technical Document-Module 1-Administrative information: application form-2001 editionpdf (Word Versionmsw8)
DG Enterprise and Industry releases an updated version of the Volume 2B Presentation and content of the dossier - Module 1 - Administrative information (Part 1: Summary of the dossier - Part 1A Application form - Administrative data). The update reflects the amendments introduced by Directive 2004/27/EC and by Directive 2004/24/EC and Regulation (EC) No 726/2004.

28/10/2005

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 (Word Versionpdf)
DG Enterprise and Industry releases an updated 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 update reflects the amendments introduced by Directive 2001/82/EC, as amended by Directive 2004/28/EC and Regulation (EC) No 726/2004

26/10/2005

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 trialpdf(294 KB)
The second revision of 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' as required by Article 9 (8) of Directive 2001/20/EC is now available.
Information regarding the dossier requirements for all 25 Member States is included. A revised application form is attached which will be required from 18 November 2005 on. The updated electronic version will be available from 18 November 2005 on from EudraCT version 3.00 on the EMEA web-site. Please read the important notice for sponsors on the upgrade of EudraCT and
interruption of its availability from 7 November 2005 to 18 November 2005.
Further information is included in section 4.1.5 regarding the Investigator's Brochure and 4.1.6.1 regarding the Investigational Medicinal Products dossier and the possibility in particular circumstances of using a Summary of Product Characteristics for this purpose
Corrigendum:
Attachment 1 Information required by MS changes introduced in the requirements for Belgium
Attachment 2 - 4 reference to the Common Technical Document updated

18/10/2005

NOTICE TO APPLICANTS Volume 2C
The Commission services present a draft update of the 'Guideline on changing the classification for the supply of medicinal products'.pdf
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 within the coming year.
In the draft update of the guideline, new parts 3 and 4 are included reflecting the provisions set out by Directive 2001/83/EC as amended by Directive 2004/27/EC. Part 3 explains which data would be eligible for data protection under Article 74a of Directive 2001/83/EC. Part 4 describes the procedure to be followed.
Please send your comments by 13 November 2005 to Birka.Lehmann@ec.europa.eu

18/10/2005

Volume 8 of the Rules governing medicinal products in the European Union. Notice to applicants and guidelines - veterinary medicinal products.pdf(211 KB)
Volume 8 has been updated to take in account of the harmonised data requirements agreed at the International Cooperation on Harmonisation of Technical Requirements for registration of veterinary medicinal products (VICH) and other guidance, and to make it available in one comprehensive document.
It provides information on the operational procedure for applications for the establishment of MRLs and provides guidance on the presentation and content of the application dossier. It also provides information on how the safety and residue data are evaluated and describes the assessment process.

18/10/2005

Consolidated version of the Annexes I to IV of Council Regulation n°2377/90. Updated up to 12.10.2005pdf(151 KB)
An updated consolidated version of Annex I to IV of Council Regulation 2377/90 is now available in English.
This document is not an official version and is only intended for use as a search tool. No liability for its content is assumed. In case of doubt, consult the Official Journal. If mistakes are identified, please give feedback.

10/10/2005

Application of the "sunset clause"pdf(21 KB) in the review of the pharmaceutical legislation to medicinal products authorised before Directives 2004/27/EC and 2004/28/EC and Regulation (EC) No 726/2004 start to apply

10/10/2005

Pharmaceutical Committee - Summary record of the 58th meeting, 1 June 2005pdf(46 KB)

10/10/2005

Restructuring of GMP guide - Revised basic requirements for active substances used as starting materials now public as GMP Part II
The Commission has published the basic requirements for the manufacture of active substances used as starting materials as GMP Part IIpdf(154 KB) replacing the former GMP Annex 18. Compared to Annex 18, the modifications refer to the introduction, indicating that the guide is applicable both for active substances used in the manufacture of human and veterinary medicinal products. The technical requirements remain unchanged compared to the former Annex 18.
A legal provision for the application and publication of GMP Part II is laid down in Article 47 and Article 51 of Directive 2001/83/EC and 2001/82/EC, respectively. Member States shall bring the requirements into force by 30 October 2005 at the latest.
With the implementation of GMP provisions for active substances the GMP Guide was re-structured. The existing basic requirements have now become Part I, the existing annexes remain, except for Annex 18, which has now been withdrawn. For additional information see revisedintroduction to the GMP guidepdf.

10/10/2005

Compilation of Community Procedures on Inspections and Exchange of Information updated to include new EU formats and proceduresmsw8
The updated Compilation includes a revised EU format for the manufacturing authorisation. In addition, the EU inspection report format was updated and the guideline on the preparation of reports under the centralised system revised. A new format for GMP certificates was elaborated. A new procedure on inspection triggers for the conduct of inspections at the premises of manufacturers of active substances used as starting materials was developed jointly with the Member States' authorities. The new September 2004 version of the Compilation was published by the EMEA on behalf of the Commission after the Veterinary Pharmaceutical Committee and the Pharmaceutical Committee had been consulted.
There was a need to update the currently existing manufacturing authorisation and inspection report formats based on practical experiences and the new provisions of Directive 2001/83/EC and of Directive 2001/82/EC, as amended by Directives 2004/28/EC and 2004/27/EC respectively. In addition, the Commission was entitled to publish guidance on the form and content of the GMP Certificate (Articles 47 and 51 respectively).
The new "Guidance on occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers of active substances used as starting materials" was developed in the light of the new obligations of manufactures to ensure the application of GMP for active substances and corresponding inspection provisions for Member States.
The Compilation of Community Procedures is under ongoing development by the EMEA, using Member States' expertise through the Ad Hoc Working Group of GMP inspectors.

14/9/2005

New 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, have adopted their new rules of procedure. Available by clicking the language icons below.

22/8/2005

NOTICE TO APPLICANTS - Volume 2C: Guidance concerning the patients consultation requirements for the package leaflet (Article 59(3) and 61(1) of Directive 2001/83/EC amended by Directive 2001/27/ECpdf(30 KB)

The Commission services present a draft of the new guidance concerning 'consultation with target patient group' for the package leaflet.
Directive 2004/27/EC - amending Directive 2001/83/EC - includes changes to the package leaflet requirements requesting a consultation with target patients groups.
This guidance interprets the requirements for the consultation of target patient groups for the package leaflet to be made available in the marketing authorisation application according to Article 59(3) and 61(3) of Directive 2001/83/EC as amended. The provision of Article 59(3) and 61(1) will apply after the end of the implementation period - 30 October 2005.

Please send your comments by 22 September 2005 to Birka.Lehmann@ec.europa.eu

The guidance will be integrated in the 'Guideline on the readability of the label and package leaflet of medicinal product for human use' in the context of updating this latter guideline.

17/8/2005

Implementation of Article 10 of Regulation (EC) No 726/2004
This document sets out how to apply the timelines in practice.pdf(11 KB)

28/6/2005

Call for proposals - Action n° 16 MedDRA
Objective of the call
The objective of the call is the translation of the Medical Dictionary for Drug Regulatory Activities (MedDRA) developed to harmonise the regulatory communication between competent authorities (EU -United States -Japan) and facilitate exchange of information. The Commission has decided to supply by way of grants the completion of this dictionary. These grants should incite Member States that have not yet conducted the translation work, to start (PT level -Preferred Terms) or to complete (LLT level -Lowest Level Terms) these translations. LLT level represents a specific and more detailed breakdown of the PT terms.
Each new language inserted in the Medical Dictionary for Drug Regulatory Activities will make the EU pharmacovigilance networks more efficient.
The grants shall be available for translation works starting in 2005. The translations performed shall be delivered free of charge to the firm MSSO (Maintenance and Support Services Organisation) responsible for making available, maintaining, and updating the MedDRA database containing the available languages. For further information contact Mr Patrick Accart.

17/06/2005

International Conference on Harmonization: ICH Q9 on Risk Management has reached step 2pdf. After having reached step 2 the document ICH Q9 Quality Risk Management is now available as "Note for Guidance on Quality Risk Management" (EMEA/INS/GMP/157614/2005-ICHpdf - transmission to Interested parties May 2005) for public consultation on the Website of the EMEA.
The document is meant to complement GMP guidelines and to support existing and future guidelines published by CHMP and CVMP concerning the quality of medicinal products.

Although developed within ICH the processes, tools and examples are expected to be equally useful in the context of medicinal products for veterinary use. Public comments on this point would be particularly welcome.

Comments should be sent to Sabine.Atzor@ec.europa.eu and in parallel to David.Cockburn@emea.eu.int by 31 August 2005.

10/05/2005

Tissue engineering and beyond: Consultation on a proposal for a Regulation on advanced therapies
The European Commission has been working on a proposal for a regulatory framework on human tissue engineered products, as well as other cell/tissue based products. In the light of the first round of consultations, which took place earlier in 2002 and 2004, the principles and key elements of this legislative proposal have now been drafted. All interested parties are therefore invited to comment on the attached Consultation paperpdf(70 KB) and draft Regulationpdf(103 KB) .Comments should be sent to Nicolas Rossignol, European Commission, AN88 1/57, 1049 Brussels, Belgium. E-mail submissions are preferred and should be sent to nicolas.rossignol@cec.eu.int.
The consultation will be closed on 20 June 2005.

27/04/2005

Updating the Notice to Applicants - Medicinal Products for Human Use - Volume 2C Regulatory Guidelines

Guideline on the packaging information of medicinal products for human use authorised by the Community (April 2005)
DG Enterprise and Industry publishes an updated version of the "Guideline on the packaging information of human medicinal products authorised by the Community". The requirements of Belgium related to the so called "Blue Box" have been updated.

26/04/2005

Pharmaceutical Committee - Summary record of the 57th meetingpdf(54 KB) , 8-9 November 2004

19/04/2005

Tissue Engineering and Advanced Therapies
From today, informations about the Advanced Therapies : Tissue Engineering, Gene Theraphy, and Cell Therapy are available in a new section "Advanced Therapies" of F2 unit activities.
The new section is available by clicking here.

13/04/2005

Guidance concerning the Braille requirements for labelling and the package leaflet (Article 56a of Directive 2001/83/EC amended by Directive 2001/27EC pdf(17 KB) Directive 2004/27/EC -amending Directive 2001/83/EC - includes changes to the label and package leaflet requirements.
This guidance interprets the requirements for Braille on the packaging, and the requirements for the package leaflet to be made available in formats for the blind and partially sighted according to Article 56a of Directive 2001/83/EC as amended. The provision of Article 56a will apply after the end of the implementation period - 30 October 2005 -to all medicinal product marketing authorization applications approved after this date. It will not apply immediately to products authorized before 30 October 2005.
The guidance will be integrated in the 'Guideline on the readability of the label and package leaflet of medicinal product for human use' after finalisation of the updating of this readability guideline.

12/04/2005

COMMISSION DIRECTIVE 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
The European Commission published in the Official Journal of 9 April 2005 the COMMISSION DIRECTIVE 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 29 January 2006 at the latest.

04/04/2005

Adoption of the Commission proposal on the fees payable to the European Medicines Agency
The Commission proposal for a Council Regulation amending Regulation (EC) 297/95 on the fees payable to the EMEA has been formally adopted and released.
Three major objectives have been pursued by the Commission in its proposal:

To adapt the existing fee scheme to the revised legislation (the 'Pharma Review') and the new responsibilities conferred to the Agency, taking in consideration the experience with the current system;

To ensure proportionality between the amount of the fees and the nature of the service actually provided by the Agency;

To alleviate the financial pressure put on applicants, without undermining the Agency's ability to perform its tasks.

The reference code of the proposal is COM(2005)106.
You can find it on Pre-Lex
English, French and German versions can also be found here : ENpdf(321 KB)FRpdf(325 KB)DEpdf(332 KB)
For any questions, please contact Nicolas Rossignol

11/03/2005

Updating the Notice to Applicants - Veterinary Medicinal Products -Volume 6C
DG Enterprise and Industry publishes an updated version of the "Guideline on the packaging information of veterinary medicinal products authorised by the Communitypdf". Some information required by national authorities of Member States and EFTA States concerning the so called "Blue Boxpdf" has been revised.

11/03/2005

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 an updated version of veterinary Volume 6B Presentation and content of the dossier -Part 1: Summary of the dossier -Part 1A Application form; Administrative data.
PDF Formatpdf - Word Formatmsw8

11/03/2005

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 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.

08/03/2005

Concept Papers available for revision of GMP Guide, Sub-Chapter 3.6 on dedicated facilities and Annex 14, defining requirements for medicinal products derived from human blood or plasma.
For further information see the EMEA website on this subject.
Deadline for comments is 30.05.2005 to david.cockburn@emea.eu.int and sabine.atzor@ec.europa.eu.

08/03/2005

Inspections at Manufacturers of Active Substances - Guidance on Grounds (Triggers) for Inspection - for public consultation
The Commission services present a draft of the new Guidance on the occasions when it is appropriate for Competent Authorities to conduct inspections at the premises of manufacturers of active substances used as starting materialspdf(34 KB) . Article 111 of Directive 2001/83/EC, as amended by Directive 2004/27/EC, and Article 80 of Directive 2001//82/EC, as amended by Directive 2004/28/EC, include new provisions for inspections in this field. The Ad Hoc Working Group of GMP Inspection Services at the EMEA has developed this guidance as a harmonised approach for inspections under the amended EC legislation.Please send your comments by 4 April 2005 to sabine.atzor@ec.europa.eu and gmp@emea.eu.int.
After finalisation the document will be published under the Compilation of Community Procedures.

08/03/2005

Detailed GMP guidelines for active substances used as starting materials -public consultation
The Commission presents a draft of the detailed guidelines on the principles of good manufacturing practice for active substances used as starting materials. The draft revision only affects the introductory text (section1)pdf of the GMP Annex 18pdf, which has been published on the Commission´s website since 2001 implementing the Q7A guideline developed between the ICH partners EC, USA and Japan. No changes to the remaining sections 2-20 of the Annex are currently envisaged. The Commission would like to emphasise that the document will be equally applicable to the veterinary sector. To take the account of the needs of the veterinary sector, ectoparacitides are excluded from the scope. Specific modifications, where identified for active substances to be used in veterinary medicinal products, can be developed in the GMP annexes 4 and 5 as appropriate. Changes refer to:
the structural implementation in the GMP guide as Part II of the "Basic Requirements" instead of Annex 18. The current "Basic Requirements" of the GMP guide will become Part I in the future. The remaining annexes will supplement both Part I and Part II as appropriate and a programme to review the guidance already given on active substances in annexes 2-7 is being undertaken. EMEA will publish a Concept paper on this shortly.

Section I "Introduction" to the existing Annex 18 (the future Part II of the basic requirements).

Specific exclusion of veterinary ectoparaciticides

Please send your comments by 4 April 2005 to sabine.atzor@ec.europa.eu and gmp@emea.eu.int.

The Commission intends to publish the final version before 30 October 2005. Legal provisions for this guideline are vested in Article 47 of Directive 2001/83/EC, as amended by Directive 2004/27/EC, for human medicinal products and Article 51 of Directive 2001/82/EC, as amended by Directive 2004/28/EC, for veterinary medicinal products.

08/03/2005

Authorisations for manufacturing and import & GMP certificates - form and content for public consultation
The Commission publishes a draft format for the authorisations for manufacturing and importpdf(32 KB) for public consultation. The Ad Hoc Working Group of GMP Inspection Services at the EMEA has developed the draft based on a format developed and published previously within the Compilation of Community Procedurespdf The second draft document for public consultation refers to the GMP certificatepdf(28 KB) for manufacturers. Within 90 days of an inspection, the competent authorities shall issue such a certificate, if compliance with GMP requirements can be confirmed. Member States will have to implement these provisions by 30 October 2005. The format is based on that used in connection with the Mutual Recognition Agreements and has been adapted for application in all circumstances in which a GMP certificate is issued.

Please send your comments by 4 April 2005 to sabine.atzor@ec.europa.eu and gmp@emea.eu.int.The Commission intends to publish the final version before 30 October 2005. Legal provisions for the form and content of the authorisation and the certificate of GMP are vested in Article 47 of Directive 2001/83/EC, as amended by Directive 2004/27/EC, for human medicinal products and Article 51 of Directive 2001/82/EC, as amended by Directive 2004/28/EC, for veterinary medicinal products.

07/03/2005

Notice to Applicants Volume 2C and 6C: Application form for renewal of a marketing authorisationpdf
Updating the Notice to Applicants Volume 2C and 6C: Application form for renewal of a marketing authorisation for human and veterinary medicinal products.
The main changes are the inclusion of the new Member States in the tick box area and the reference to the Common Technical Document in the list of documents to be attached for Human Medicinal Products Applications.
PDF Formatpdf - Word Formatmsw8

07/03/2005

Updating the Notice to Applicants- Medicinal Products for Human Use- Volume 2C Regulatory Guidelines Guideline on the Packaging Information of Human Medicinal Products Authorised by the Communitypdf
DG Enterprise and Industry publishes an updated version of the "Guideline on the packaging information of human medicinal products authorised by the Community". The requirements of the Netherlands and Hungary related to the so called "Blue Boxpdf" have been updated.

07/03/2005

Updating the Notice to Applicants - Medicinal Products for Human Use - Volume 2B:

Presentation and content of the dossier-Part 1: Summary of the dossier - Part1A or Common Technical Document-Module 1 - Administrative information: application form .pdf)pdf
(same document in Word Formatmsw8)

User Guide for the Application Formpdf

The application form is updated mainly in sections:
1.1 inclusion of the new Member States in the tick-box area and the request for a renewal date and information of PSUR-cycles.
1.2 with request for additional information regarding orphan medicinal products;
2.5 batch control, 2.5.2 manufacturer and 5.2.3 manufacturer of the active substance
2.5.4 regarding clinical trials
and section 6.9.

07/03/2005

Updating the Notice To Applicants - Volume 2A Chapter 7 "General Information"pdf
DG Enterprise and Industry releases an updated version of Chapter 7 "General Information" of the Notice to Applicants on Medicinal Products on the procedures for marketing authorisation. Clarification is given in respect to the requirements for the Member States: Malta ( section 3.1) and France (section 5.2.1 samples)

03/03/2005

Guideline on the data fields from the European clinical trials database (EudraCT) that may be included in the European database on Medicinal Productspdf(107 KB)
Initiatives to increase transparency in relation to clinical trials through the publication of validated and high quality clinical trial information are important. This information is of potential value to patients, their carers and the medical profession. During the legislative process Article 57 (2) of the Regulation EC No 726/2004 has been introduced calling upon the Commission to issue guidelines on data fields which should be included in the publicly accessible database. We invite comments on the draft proposal to be sent to Birka.Lehmann@ec.europa.eu until 15 April 2005

23/02/2005

European Court of Justice rules on interpretation of Article 6 of Directive 89/105/EEC (Transparency Directive)
In two judgments of 20 January 2004, the European Court of Justice has ruled on the interpretation of Article 6 of Directive 89/105/EEC relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within the scope of national health insurance systems (the so-called Transparency Directive). The Court has ruled that the time-limit to adopt a decision on an application to include a medicinal product in the list of products covered by the health insurance system laid down in Article 6(1) of the Directive is a mandatory time-limit which the national authorities are not entitled to exceed. The Directive does not however impose the automatic entry of a medicinal product on the mentioned list where the time-limit is exceeded; it is for the Member States to determine the effects of exceeding the time-limit, with due respect of the principles of equivalence and effectiveness of Community law. It is also for the Member States to determine whether the fact that the time-limit laid is exceeded precludes the competent authorities from formally adopting a new decision when the previous decision has been annulled in court proceedings. Where Member States allow for the adoption of a new decision in such circumstances, this decision must be adopted within a reasonable time which may not in any event exceed the time-limit laid down in Article 6(1).
C-245-03 (Merck - Transparency)pdf(28 KB)
C-296-03 (GSK - Transparency)pdf(88 KB)

22/02/2005

Consultation on a proposal for a "Guideline on the definition of a Serious Risk to Human or Animal Health or for the Environment"pdf(43 KB)
The McKenna/Anderson report on the "Evaluation of the operation of Community procedures for the authorisation of medicinal products" reflected on the possibilities to improve the Mutual Recognition Procedure by limiting the evocation of reasons of what constitutes a public health risk, sufficient to justify an objection for mutual recognition. During the legislative process Article 33(2) of the veterinary Directive 2001/82/EC, as amended by Directive 2004/28/EC, has been introduced calling upon the Commission to adopt a guideline defining a "potential serious risk to human or animal health or for the environment". We invite comments on the draft proposal to be sent to Karin.Krauss@ec.europa.eu until 31 March 2005.

22/02/2005

Consultation on a proposal for a "Guideline on the definition of a Potential Serious Risk to Public Health"pdf(31 KB)
The McKenna/Anderson report on the "Evaluation of the operation of Community procedures for the authorisation of medicinal products" reflected on the possibilities to improve the Mutual Recognition Procedure by limiting the evocation of reasons of what constitutes a public health risk, sufficient to justify an objection for mutual recognition. During the legislative process Article 29(2) of the human Directive 2001/83/EC, as amended by 2004/27/EC, has been introduced calling upon the Commission to adopt a guideline defining a "potential serious risk to public health'.
We invite comments on the draft proposal to be sent to Birka.Lehmannq@ec.europa.eu until 31 March 2005.

16/02/2005

European Court of Justice judgement on the procedure for generic medicinal productspdf(33 KB)

In a judgment of 20 January 2005, the European Court of Justice has ruled that an application for a marketing authorisation under the abridged procedure of Article 10(1)(a)(iii) of Directive 2001/83/EC may be made for a generic product claiming to be "essentially similar" to a reference product, where that product contains the same therapeutic moiety as the reference product but combined with another salt. According to the Court, such a difference cannot normally prevent two medicinal products from being regarded as essentially similar, unless it appears that the generic product shows significant differences from the original product as regards safety and efficacy.

4/02/2005

Consultation on Commission Regulation on Penaltiespdf(68 KB)

In order to ensure the enforcement of certain obligations connected with marketing authorisations for medicinal products granted in accordance with Regulation (EC) No 726/2004, Article 84(3) of that Regulation empowers the Commission, at the request of the European Medicines Agency, to impose financial penalties on the holders of marketing authorisations. This provision is to be implemented through the adoption of a Commission regulation. DG Enterprise and Industry wishes to receive comments on the draft Commission regulationpdf(68 KB) laying down the procedure to adopt the maximum amounts and the conditions and methods for collection of financial penalties imposed by the Commission under Regulation No (EC) 726/2004. Comments on the draft regulation should be sent to Irene Sacristán Sánchez irene.sacristan-sanchez@ec.europa.eu, European Commission, AN88 1/50, 1049 Brussels.
E-mail submissions are preferred and should be sent to irene.sacristan-sanchez@ec.europa.eu. All submissions received by 8 April 2005 will be taken into consideration.

25/01/2005

DG Enterprise releases the 'Summary of the discussion' of the workshop on 'Borderline Products with Pharmaceuticals' of 28 October 2004 in Brusselspdf(30 KB)

Article 2.2 of Directive 2001/83/EC on the Community code relating to medicinal products for human use, as modified by Directive 2004/27/EC, contains a provision aiming at addressing the issue of the borderline cases between the medicines Community legislation and other Community legislation on products. The new legislation was published by 30 April 2004 in the Official Journal L -311 of 28/11/2004. It will be applicable as from 30 October 2005 when implemented in the national legislation by the Member States.

The aim of the new provision is to clarify, from a legal point of view, the situation of certain borderline products for which there is uncertainty regarding which regulatory system should be applied. The intention of the new legislation is not to extend the definition of medicinal products by covering within the scope of the pharmaceutical legislation products correctly and currently covered by other legislative frameworks.

A workshop was organised by the Commission with representatives of Member States and of different industrial sectors to have their input on the way to consider the application of this provision and on possible concerns.

25/01/2005

DG Enterprise releases new 'Question and Answer' document for clinical trialspdf
In order to give more and detailed information to requirements set in the legislation on clinical trials a document called "QUESTIONS AND ANSWERS" has been prepared. It concerns interpretation of the sponsor and the legal representative in a clinical trial. It also gives advice in relation to EudraCT database and questions in relation to the application.

10/01/2005

Commission awards contract for an assessment of the community system on pharmacovigilance
Following a public call for tender, the European Commission has awarded the contract for an 'Assessment of the European Community system of pharmacovigilance' to a joint bid from "Fraunhofer Institute Systems and Innovation Research" and "Coordination Centre for Clinical Studies at the University of Tubingen" (KKSUKT). Both organisations have experience in systems analyses in the context of therapeutics and regulation. The contractors are independent non-governmental organisations with considerable experience in conducting projects for the European Commission. It is anticipated that the study will report before the end of 2005. The technical specification of the assessment, as published in the call for tender in early 2004, is available by clicking herepdf(29 KB) .

10/01/2005

Results of the Public Consultation on Provisions for Small and Medium-sized Enterprises (SMEs)
In October 2004, the European Commission launched a public consultation on its draft provisions for micro, small and medium-sized enterprises (SMEs), establishing the circumstances in which SMEs may pay reduced fees, defer payment of the fee, or receive administrative assistance. The need for such a proposal comes from the last revision of the pharmaceutical legislation (Regulation (EC) No 726/2004), in particular Article 70(2).
The consultation period ended 26 November 2004. In addition, the Commission held a workshop on 28 October 2004 with key industry associations, in order to get a better understanding of their views and have an in-depth discussion on the main issues.
An overview of the outcome of the public consultation can be found herepdf(21 KB) .
For further information, please contact entr-pharmaceuticals@ec.europa.eu.