Pharmaceuticals Archives - 2008

12/12/2008

On 12 December the "Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products", was published in the Official Journal of the European Union (OJ L 334 p. 7). In line with Article 28 "this Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union".
Click here to access the Regulationpdf

10/12/2008

Pharmaceutical package
Safe, innovative and accessible medicines: a renewed vision for the pharmaceutical sector.

Today the European Commission adopted a Communication and three legislative proposals with the overarching objective of ensuring that European citizens can increasingly benefit from a competitive industry that generates safe, innovative and accessible medicines. ... read more

For the full press release including a statement from Vice President Günter Verheugen click herepdf(81 KB) Choose translations of the previous link Deutsch (de) français (fr) .

25/11/2008

Results of public consultation in preparation of the "Communication from the 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 the criteria for assessing significant studies" ("PIP Guideline")

The European Commission is publishing comments received during a public consultation which was conducted in preparation of the "PIP Guideline" and a summary of resultspdf(28 KB) . Interested parties were invited to submit their comments between 31 January 2007 and 30 March 2007. The feedback received from this consultation was used to finalise the guideline, which has been made public on 27 October 2008.

25/11/2008

European Court of Justice judgment on the mutual recognition procedure for generic medicinal productspdf(96 KB)
In its judgment of 16 October 2008 in case C-452/06 (Synthon), the European Court of Justice ruled that an application for mutual recognition must be held to be valid, in accordance with the requirements of Article 28 of Directive 2001/83/EC, where it is accompanied by the information and particulars referred to in Articles 8, 10 and 11 of the directive, the dossier submitted is identical to the dossier accepted by the reference Member State, and any additions or amendments contained in the file have been identified by the applicant.

The Court also held that the existence of a risk to public health constitutes the only ground that a Member State is entitled to rely on to object to the recognition of a marketing authorisation granted by another Member State, and that Article 29 of the directive provides that a Member State wishing to rely on such a ground is required to comply with a specifically prescribed procedure for provision of information, concerted action, and arbitration.

Hence, the Court ruled that the directive confers on the Member State in receipt of an application for mutual recognition only a very limited discretion in relation to the reasons for which that Member State is entitled to refuse to recognise the marketing authorisation in question. In particular, as regards any assessment going beyond the verification of the validity of the application with regard to the conditions laid down in Article 28, the Member State concerned, except where there is a risk to public health, must rely on the assessments and scientific evaluations carried out by the reference Member State .

13/11/2008

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(174 KB)
DG Enterprise and Industry releases a revised version of the veterinary Volume 6B Presentation and content of the dossier - Part 1: Summary of the dossier - Part 1A Application form - Administrative data. The revision contains some corrections and aims at improving the format to facilitate the practicability and usage of this template.

Part 1: Summary of the dossier - Part 1A Application form - Administrative data : PDF Formatpdf(174 KB) - Word Formatmsw8(479 KB)

Eudralex Volume 6 >>>

11/11/2008

Report of Study on Distribution Channels, Part "Policies to Combat Counterfeit Medicines"
In 2006, DG Enterprise and Industry launched a study to assess policies to combat counterfeit medicines. An external contractor, Europe Economics, has now presented results of the study to the European Commission after Member States and stakeholders had the opportunity to provide data and views. The report includes a contribution to an assessment of social, economic and environmental impacts on various policy options to address any possible shortcomings. The reportpdf(438 KB) of the contractor, Europe Economics, and its annexes documents : annex Ipdf(216 KB) , annex IIpdf(340 KB) , annex IIIpdf(2 MB) are now made publicly available.

4/11/2008

The DG Enterprise wishes to consult stakeholders on changes to Eudralex Volume 9A "Pharmacovigilance for Medicinal Products for Human Use".
The Volume 9A Revision 2008 concerns additional guidance in Chapter I.7 on post-authorisation safety studies and clarifications in response to frequently asked questions, mainly regarding electronic reporting, in Chapters I.2, I.4, I.5 and Part III.

The changes to the text are in track changes in the document herepdf

All comments should be sent to Ulla Närhi (ulla.narhi@ec.europa.eu ) by 2 January 2009 and this template (word document)msw8(94 KB) should be used for comments.

27/10/2008

Implementation of the Paediatric Regulation: 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
A Commission guideline implementing certain provisions of Regulation (EC) No 1901/2006 (the paediatric regulation) has been published on 24 September. Pursuant to Article 10 of the Regulation, this guideline provides the detailed arrangements concerning the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers and deferrals. The guideline also lays down the arrangements for the operation of the compliance check referred to in Articles 23 and 28(3) of the Regulation. Finally, pursuant to Article 45(4), the guideline provides the assessment criteria for the significance of studies started before and completed after the entry into force of the paediatric regulation.

All language versions of the guideline are available herepdf(117 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) .

27/10/2008

Variations (codecision part): first reading vote in the European Parliament on the Commission proposal
On 22 October, the European Parliament (EP) has voted in first reading on the Commission proposal for a Directive amending Directive 2001/83/EC and Directive 2001/82/EC as regards variations to the terms of marketing authorisations. The proposal is part of a global revision of the legal framework on variations to make the overall system clearer, simpler and more flexible. This proposal in particular aims at amending the legal basis for the adoption of Community rules on variations in order harmonise those rules for all authorised medicines in the EU.
The final EP opinion has been adopted with a very large majority. The EP has endorsed the objectives and key elements of the Commission proposal and has introduced certain amendments. These include in particular the clarification that the implementing rules by the Commission should ensure simplification and the introduction of a possibility for Member States to continue applying national rules on variations to medicinal products fulfilling certain conditions. The EP's legislative resolution and the Commission proposal, after introduction of the EP amendments, can be found herepdf(73 KB) . This first reading opinion of the European Parliament paves the way for adoption of the text by the Council and the EP without a need for a second reading.

27/10/2008

EudraLex Volume 9A of The Rules Governing Medicinal Products in the European Union
Guidelines on Pharmacovigilance for Medicinal Products for Human Use Version September 2008 is now available, following public consultation on revised text in particular in relation to the Paediatric Regulation, identification of biological products in adverse reaction reports and clarifications for vaccines.

Volume 9A Version September 2008 is available herepdf(2 MB) .
Table of the responses to the public consultation is available herepdf(147 KB)

20/10/2008

Maximum Residue Limits - 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 available. (Revision 13 of October 2008)

13/10/2008

Amended public consultation document an GMP Annex 13 on investigational medicinal products
The public consultation on Annex 13 to the GMP (investigational medicinal products) has been amended by including reconstitution.
The deadline for comments has been extended to 31 January 2009.

13/10/2008

ICH Public Meeting
In May 2007 the ICH Steering Committee agreed to the organisation of focused Public ICH Regional Meetings. The first such European regional public ICH meeting will take place at the Radisson SAS Hotel in Brussels on 14 November 2008. Agenda and Registration form can be accessed on the EFPIA website. This Public ICH Meeting will provide an opportunity to be informed on the recent developments at ICH in the context of globalisation and increasing international cooperation. It will also provide an opportunity to receive the latest news on "hot topics", to make comments to the ICH experts and rapporteurs and to raise questions on quality topics, safety topics, standards development topics and efficacy topics.

7/10/2008

Press release: EC/EMEA/FDA bilateral meeting
The European Commission (EC), the European Medicines Agency (EMEA) and the United States Food and Drug Administration (FDA) met in London on 30 September and 1 October 2008 for the annual review of cooperative activities undertaken under the scope of their confidentiality arrangements. A joint press release can be accessed herepdf(42 KB) .

6/10/2008

Report of Study on Distribution Channels, Part "Safe Medicines through Parallel Trade"
In 2006, DG Enterprise and Industry launched a study to assess aspects of patient safety related to parallel trade with medicines. An external contractor, Europe Economics, has now presented results of the study to the European Commission after Member States and stakeholders had the opportunity to provide data and views. The report includes a contribution to an assessment of social, economic and environmental impacts on various policy options to address any possible shortcomings. The reportpdf(314 KB) of the contractor, Europe Economics, and its annexespdf(689 KB) are now made publicly available.

1/10/2008

Communication from the Commission to the Council and the European Parliament concerning the Report on the experience acquired as a result of the application of the provisions of Chapter 2a of Directive 2001/83/EC, as amended by Directive 2004/24/EC, on specific provisions applicable to traditional herbal medicinal products. The document prepared on the basis of Article 16i of Directive 2001/83/EC, has been adopted and transmitted to the Council and the European Parliament.
All linguistic versions of the Communication COM(2008)584 are available herepdf(49 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) .

19/9/2008

Guideline on aspects of the application of Article 8(1) and (3) of Regulation (EC) No 141/2000: Assessing similarity of medicinal products versus authorised orphan medicinal products benefiting from market exclusivity and applying derogations from that market exclusivitypdf(109 KB)
This guideline concerns the granting of market exclusivity for authorised orphan medicinal products according to Article 8(1) of Regulation (EC) No 141/2000, in particular the assessment of the "similarity" criterion - and the granting of derogations from that market exclusivity under Article 8(3) of that regulation.

17/9/2008

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 productspdf(40 KB)
This guideline concerns the review of market exclusivity for authorised orphan medicinal product according to Article 8(2) of Regulation (EC) No 141/2000. It sets out the general principles and procedures by which the period of market exclusivity of orphan medicinal products is reviewed and may be reduced from ten to six years.

17/9/2008

GMP Annex 7 "Manufacture of Herbal Medicinal Products" of the GMP Guide has been revisedpdf(23 KB)
This revision has been made to specify application of GMP provisions for active substances used as starting materials (Part II) for the manufacture of herbal medicinal products. Additional changes are in particular related to the new Directive 2004/24/EC on traditional herbal medicinal products.
The new Annex will come into operation on 01 September 2009.

EudraLex Volume 4 >>>

17/9/2008

Notice to Applicants: - Volume 2A, Chapter 7 - General Information
An updated version of Chapter 7 - General Information of Volume 2A of the Notice to Applicants is now availablepdf(639 KB) . It reflects the inclusion of updates from Austria, Belgium, Cyprus, Czech Republic, Estonia, Germany, Ireland, Latvia, Luxemburg, Malta, Netherlands, Poland, Romania, Slovak Republic, Sweden, United Kingdom, Iceland and the EMEA
A new Section 3.3 was added, relating to the requirements in terms of electronic copies for new applications for National, Mutual Recognition and Decentralised procedures. In consequence Section 3.1 was deeply revised.

EudraLex Volume 2 >>>

8/9/2008

GMP Annex 3 "Manufacture of Radiopharmaceuticals" of the GMP Guide has been revisedpdf(68 KB)
The annex has been revised in the light of new GMP requirements for actives substances used as starting materials (GMP Part II) and updated for all relevant aspects of GMP for radiopharmaceuticals.
The new annex will come into operation on 01 March 2009.

EudraLex Volume 4 >>>

30/7/2008

Inventory of rewards and incentives to support medicinal products for paediatric usepdf(146 KB)
Pursuant to Article 39 of the paediatric regulation (Regulation EC (No) 1901/2006) the first inventory of Community and Member State rewards and incentives to support research into, and the development and availability of, medicinal products for paediatric use is made public.

Medicines for Children >>>

23/7/2008

Implementation of the Advanced Therapies Regulation: public consultation on the Revised Clinical Trial Application Form as regards advanced therapy investigational medicinal products
Annex 1 to 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' defines the standard template for the Clinical Trial Application (CTA) form
. It is necessary to amend this form in order to incorporate the changes entailed by Regulation (EC) No 1394/2007 on advanced therapy medicinal products. This public consultation document includes the draft amendments. The public consultation paper is available herepdf(61 KB) .

Changes compared to the current version of the CTA form are highlighted.

Comments on this document should be e-mailed before 15 October 2008 to entr-pharmaceuticals@ec.europa.eu.

23/7/2008

Public consultation on the data fields contained in the 'EudraCT' clinical trials database to be included in the 'EudraPharm' database on medicinal products and made public.
On 3 July 2008, the Commission published a guideline on the data fields contained in the clinical trials database (EudraCT) provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products (EudraPharm) provided for in Article 57 of Regulation (EC) No 726/2004.
In this guideline, it was outlined that the Directorate-General for Enterprise and Industry (DG ENTR) should draw up the list of EudraCT data fields and the information on trial results to be included in the EudraPharma database and made publicly available.

DG ENTR now launches a public consultation on this draft list, which is available herepdf(52 KB)  . Comments should be e-mailed by 15 October 2008 to entr-pharmaceuticals@ec.europa.eu.

9/7/2008

Implementation of the Advanced Therapies Regulation: Outcome of the Public Consultation on amendments to Annex I to Directive 2001/83/EC
From 8 May to 10 June 2008, a public consultation was conducted on draft amendments to Annex I to Directive 2001/83/EC as regards advanced therapy medicinal products.
The summary outcome of the public consultation paper is now available herepdf(27 KB) .
Detailed contributions to the public consultation are available here

9/7/2008

Implementation of the Advanced Therapies Regulation: Outcome of the Public Consultation on the Certification Of Quality & Non-Clinical Data For Small And Medium-Sized Enterprises
From 5 May to 4 July 2008, a public consultation was conducted on provisions for certification of quality and non-clinical data for small and medium-sized enterprises (SMEs), pursuant to Article 18 of Regulation (EC) No 1394/2007.
The summary outcome of the public consultation paper is now available herepdf(35 KB).  .
Detailed contributions to the public consultation are available here .

8/7/2008

Publication of the guidelinepdf on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation (EC) No 726/2004

4/7/2008

Implementation of the Advanced Therapies Regulation: public consultation on good clinical practice specific to advanced therapy medicinal products.
Regulation (EC) No 1394/2007 on advanced therapy medicinal products will apply from 30 December 2008. Article 4 of the Regulation requires that detailed guidelines on good clinical practice (GCP) specific to advanced therapy medicinal products be drawn up. This public consultation document presents preliminary proposals to draft such guidance. The public consultation paper is available herepdf

Contributions to this public consultation should be sent by e-mail to entr-pharmaceuticals@ec.europa.eu, before 15 October 2008.

27/6/2008

Public consultation on the data fields of the clinical trials database (EudraCT) and the information on trial results for paediatric clinical trials to be made publicly available.
In February-April 2008, a public consultation was conducted on a draft Guidance on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with article 41 of Regulation No. (EC) 1901/2006

In this draft guidance, it was outlined that the Directorate-General for Enterprise and Industry (DG ENTR) should draw up the list of EudraCT data fields and the information on trial results for paediatric clinical trials to be made publicly available.

DG ENTR now launches a public consultation on this draft list, which is available herepdf(53 KB).

Comments should be e-mailed by 30 September 2008 to entr-pharmaceuticals@ec.europa.eu.

26/6/2008

Revised Annexes 1, 2 and 3 to 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.
In February-April 2008, a public consultation was conducted on a revision of Annexes 1, 2 and 3 on the Clinical Trial Application Form, the Substantial Amendment Form and the Declaration of the end of a Clinical Trial Form to 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'.

The revision was necessary to take into consideration needs stemming from Regulation (EC) No 1901/2006 on medicinal products for paediatric use, from the Guideline on Strategies to Identify and Mitigate Risks for First-in-Human Clinical Trials with Investigational Medicinal Products (Doc. Ref.EMEA/CHMP/SWP/28367/07, of 19 July 2007) and to clarify the submission of information on the results of clinical trials in view of its publication.

After analysis of the comments received within that public consultation, the revised Annexes have been finalised. The revised Annexes are now available [here]

For any questions, please contact entr-pharmaceuticals@ec.europa.eu .

25/6/2008

Update MRL Regulation
Commission Regulation (EC) No 542/2008 of 16 June 2008 amending Annexes I and II to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, as regards cyfluthrin and lectin extracted from red kidney beans (Phaseolus vulgaris) (Official Journal L 157, 17/6/2008 p.43)

24/6/2008

EudraLex - Volume 1 Directive 2008/29/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission (Official Journal L 81, 20/3/2008, p. 51 - 52 ).

20/6/2008

Summary of responses to the public consultation document on a legislative proposal to combat counterfeit medicines for human use

17/6/2008

Medicines Regulation: Transatlantic Administrative Simplification Action Plan
Under the auspices of the Transatlantic Economic Council, on 28 November 2007 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).
As a follow up to the workshop the European Commission DG Enterprise and Industry and the U.S. FDA (in collaboration with EMEA and national medicines agencies) have agreed the action plan which can be accessed herepdf(42 KB) .

17/6/2008

Pharmaceutical Committee - Summary record of the 63nd meeting, 10 December 2007pdf(60 KB)17/6/2008

Update of the Guideline on the Processing of Renewals in the Mutual Recognition and Decentralised Procedures included in Volume 2C - Regulatory Guidelines
An updated version of the Guideline on the Processing of Renewals in the Mutual Recognition and Decentralised Procedures included in Volume 2C - Regulatory Guidelines, prepared by the Coordination Group for Mutual Recognition and Decentralised Procedures -Human, is now available. The update concerns the referral procedure in case of disagreement between Member States in relation to a renewal application.

10/6/2008

Better Regulation of pharmaceuticals: Revision of the Variations Regulations: Commission delivers on cutting red tape On 10 June 2008, the Member States have approved the new Commission Regulation on variations which will replace the existing Regulations (EC) No 1084/2003 and 1085/2003. The draft Regulation was put to vote at a joint meeting of the Standing Committee on Medicinal Products for Human Use and the Standing Committee for Veterinary Medicinal Products. Both Committees issued a favourable opinion by a very large majority.

The agreed text now enters a 3-months period of scrutiny by the European Parliament and Council (until 13 September 2008), before it can be formally adopted by the Commission and enters into force. For economic operators, the new rules will apply one year after entry into force, i.e. most likely around Q4 2009.

The text of the Regulation which was approved on 10 June 2008 is available herepdf .

Please note that some of these linguistic versions may still be subject to minor linguistic editorial amendments.

For any questions, please contact Nicolas.rossignol@ec.europa.eu .

6/6/2008

Counterfeit medicines - Responses to public consultation
In the course of the public consultation, the Commission has received 100 stakeholder responses from industry (pharmaceutical industry, wholesalers, pharmacies, companies producing authenticity features, etc.), 12 from civil society (patient groups, consumer associations, citizens) and 3 from Health Insurances and Health Care Centres. These responses are now available.

3/6/2008

Publication of GCP inspection guidance
In accordance with Article 29 of Commission Directive 2005/28/EC, in order to harmonise the conduct of Good Clinical Practice (GCP) inspections by the competent authorities of the Member States, guidance documents containing the common provisions on the conduct of those inspections shall be published by the Commission after consultation with the Member States.
In accordance with this procedure, on the basis of input from the GCP Inspectors Working Group and after consultation of the Member States, GCP guidance is now published in Chapter IV of the Eudralex Volume 10. Guidance documents can be found [here]. For any questions please contact: Nicolas.rossignol@ec.europa.eu2/6/2008

Updating the Notice to Applicants -Veterinary Medicinal Products - Volume 6A Chapter 7 "General Information" DG Enterprise and Industry releases an updated version of Chapter 7 "General Information" of the veterinary Notice to Applicants Volume 6A. The revised version provides updates required by Belgium, Cyprus, Czech Republic, Greece, Iceland, Ireland, Portugal, Romania and Spain.

26/5/2008

Outcome of the public consultation on the key elements of a legal proposal on information to patients DG Enterprise and Industry conducted a public consultation between 5 February and 7 April 2008 on the key ideas of a legal proposal aiming at ensuring that all EU citizens have access to good-quality, objective, reliable and non-promotional information on prescription-only medicinal products.

A summary of the outcome of this consultation is available here.pdf(37 KB) Responses to the public consultation are available here.

23/5/2008

Transatlantic Economic Council notes strengthened collaboration on medicines regulation At the May 13th Transatlantic Economic Council (TEC) the work of the European Commission, the European Medicines Agency and the U.S. Food and Drug Administration on medicines regulation was noted as an example of close and productive collaboration to the benefit of citizens.
The TEC noted especially the further strengthening of transatlantic cooperation on medicines regulation. Highlighting this further strengthening of regulatory cooperation was the announcement that a first set of projects on medicinal products have been agreed following the administrative simplification workshop held in Brussels in November 2007pdf(34 KB) .

More specifically the following specific priority projects have been agreed:

The Commission/EMEA and the FDA will pilot joint inspections of companies manufacturing pharmaceuticals in the U.S. and in the EU and of companies manufacturing active pharmaceutical ingredients in third countries.

The Commission/EMEA and the FDA will pilot the exchange of inspection schedules, results, and information on inspected manufacturing sites in order to attain more GMP inspection coverage collectively and to better identify manufacturing sites producing active pharmaceutical ingredients in third countries.

The Commission/EMEA and the FDA will step up collaboration to determine to what extent dedicated production facilities are necessary for certain pharmaceuticals taking into account a risk based approach. Subsequently, it is expected that a revised EU guideline will be published for public consultation in the first quarter of 2009. FDA is also in the process of clarifying this issue through proposing amendments to existing regulations and draft guidances that are in the process for issuance.

The EMEA and the FDA have recently announced successes in their transatlantic work on biomarker development and validation for various product development purposes. Both parties will continue to work on this initiative with further biomarker development and validation.

These results will provide important benefits for industry and patients. It is of particular note that the collaboration on inspections should result in more effective use of resources and a higher safety level of products from third countries.

Work is continuing to identify other items of intensified regulatory collaboration for mutual benefit and this will include further action points from the administrative simplification workshop held in Brussels in November 2007.

Finally, the EMEA and the FDA have agreed recently on an implementation work plan for veterinary medicinal products regulation and have agreed on a process for offering parallel scientific advice to veterinary medicinal products manufacturers that wish to receive such advice simultaneously from the FDA and.

22/5/2008

Notice to Applicants: Volume 2B - Presentation and content of the dossier, incorporating the Common Technical Document (CTD), Module 1
An updated version of Module 1 - Administrative Information and Prescribing Information of Volume 2B - Presentation and content of the dossier, incorporating the Common Technical Document (CTD) is now available. This updated version contains a new section 1.10 for information relating to paediatrics and incorporates a number of minor corrections or updates (e.g. references to new guidance documents).

EudraLex Notice to Applicants: Volume 2B >>>22/5/2008

Notice to Applicants: Volume 2C - Regulatory Guidelines, Application form for variation to a marketing authorisation for medicinal products (human and vet) to be used in the mutual recognition/decentralised and centralised procedure An updated version of the application form for variation included in Volume 2C - Regulatory Guidelines is now available. The update consisted mainly in creating a new section for requirements according to Regulation (EC) No 1901/2006 ("Paediatric Regulation").

Application Form : PDF formatpdf(88 KB) - Word formatmsw8(493 KB)

EudraLex Notice to Applicants: Volume 2C >>>

7/05/2008

Implementation of the Advanced Therapies Regulation: public consultation on the certification of quality & non-clinical data for small and medium-sized enterprises.

Regulation (EC) No 1394/2007 on advanced therapy medicinal products will apply from 30 December 2008.
Article 18 of the Regulation provides that small and medium-sized enterprises (SMEs) developing advanced therapy products may submit to the European Medicines Agency quality and, where available, non-clinical data, for scientific evaluation and certification. Provisions for the evaluation and certification of such data must be laid down by the Commission.
This public consultation document presents preliminary proposals to establish such provisions. The public consultation paper is available herepdf(28 KB)
pdf
Contributions to this public consultation should be sent by e-mail to entr-pharmaceuticals@ec.europa.eu, before 4 July 2008.

17/04/2008

Commission Pharmacovigilance Strategy: results of public consultation on draft legislative proposals

Between 5 December 2007 and 1 February 2008 the European Commission services consulted stakeholders on legislative proposals to strengthen and rationalise the EU system of pharmacovigilance.

- An analysis of the consultation results can be found herepdf(134 KB) - The individual consultation responses can be found here16/04/2008

Public consultation on revisions of GMP Part II on Basic Requirements for Active Substances used as Starting Materialspdf(378 KB)
An amendment is proposed to Part II of the GMP Guide to incorporate principles of Quality Risk Management as laid down in the ICH guideline Q9, which also correspond to similar changes made to Part I Chapter 1 of the Guide and published in February 2008.
Comments should be sent to entr-gmp@ec.europa.eu and GMP@emea.europa.eu by 31 October 2008. It should be noted that changes besides the implementation of ICH Q9 are currently not foreseen and would need proper discussion at the ICH level.

16/04/2008

Public consultation on revisions of GMP Annex 13 on Investigational Medicinal Productspdf(80 KB)
Based on practical experiences a revision of the Annex was deemed necessary to clarify certain points related to reference and retention samples, the two-step release procedure for investigational medicinal products and to the principle of independence between production and quality control functions.
Comments should be sent to entr-gmp@ec.europa.eu and GMP@emea.europa.eu by 31 October 2008.

11/04/2008

Public consultation on revisions of GMP Annex 11 on Computerized Systemspdf(73 KB) and related changes in GMP Part I/ Chapter 4 on Documentationpdf(72 KB)
The Annex has been updated in response to the increased use of computerised systems and the increased complexity of these systems. Consequential amendments are also proposed for Chapter 4 of the GMP Guide (Documentation).

Comments should be sent to entr-gmp@ec.europa.eu and GMP@emea.europa.eu by 31 October 2008.

10/04/2008

Implementation of the Advanced Therapies Regulation: public consultation on the revision of Annex I to Directive 2001/83/EC.
Regulation (EC) No 1394/2007 on advanced therapy medicinal products will apply from 30 December 2008. The European Commission services have published on 13 December 2007 an implementation plan, outlining their priorities for the implementation of the Regulation. As part of this plan, the Commission intends to revise Part IV of Annex I to Directive 2001/83/EC in order to adapt it to the specificities of advanced therapy medicinal products. This public consultation document presents preliminary proposals to replace the existing Part IV of this Annex I. The public consultation paper is available
Contributions to this public consultation should be sent by e-mail to entr-pharmaceuticals@ec.europa.eu, before 10 June 2008.

8/04/2008

Commission Regulation (EC) No 312/2008pdf of 3 April 2008 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate

12/03/2008

Public consultation on changes to Eudralex Volume 9A "Pharmacovigilance for Medicinal Products for Human Use"
The Commission services wish to consult stakeholders on changes to Eudralex Volume 9A "Pharmacovigilance for Medicinal Products for Human Use"

The Commission services wish to consult stakeholders on changes to Eudralex Volume 9A "Pharmacovigilance for Medicinal Products for Human Use". The changes relate to the following:

Chapter I.3 "Requirements for Risk Management Systems" to introduce modifications pursuant to Regulation EC (No) 1901/2006 (the paediatric regulation);

Chapter I.4 "Requirements for Expedited Reporting of Individual Case Safety Reports" to introduce modifications regarding the identification of biological medicinal products;

Chapter I.5 "Requirements for Reporting in Special Situations" to introduce modifications regarding reporting of cases of lack of efficacy and of suspected transmission of an infectious agents in the context of vaccines, and to introduce cross references to new documents on pandemic influenza;

Chapter II.1 "Undertaking of Pharmacovigilance Activities by Competent Authorities in the Member States" to introduce modifications regarding the identification of biological medicinal products;

The changes to the text are underlined in the document here.pdf(343 KB) All comments should be sent to Peter Arlett (peter.arlett@ec.europa.eu) by 2 May 2008 and this template (word document)msw8(117 KB) should be used for comments.

12/03/2008

Outcome of the public consultation on a draft report on traditional herbal medicinal products
Outcome of the 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.

A summary of the public consultation responses is available herepdf(33 KB)

11/03/2008

Public consultation in preparation of a legal proposal to combat counterfeit medicines for human use - key ideas for better protection of patients against the risk of counterfeit medicinespdf(62 KB)
Counterfeiting of medicinal products has become an increasing threat for patients, healthcare professionals and industry and a concern for EU and national policy-makers. The Directorate-General Enterprise and Industry is consulting all stakeholders and interested parties on key ideas for amending the regulatory framework for medicinal products in an effort to combat the counterfeiting of medicinal products.
For the purpose of this public consultation, which concentrates on sectoral pharmaceutical EU-legislation, the Commission has identified three areas of regulation of medicinal products where improvements to the regulatory framework could make a real contribution to protecting against counterfeit medicinal products.

These measures relate to:
- Manufacture, placing on the market of medicinal products and related inspections
- Import, export, transit (transhipment) of medicinal products
- Manufacture, placing on the market of active substances and related inspections

Contributions should be sent by e-mail to entr-pharmaceuticals-counterfeit@ec.europa.eu by 9 May 2008.

4/03/2008

Adoption of the Commission proposal on variations (co-decision part)
On 4 March 2008, the Commission has adopted its proposal for a Directive of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products. The proposal is available herepdf in all EU official languages.

The proposal is accompanied by an [Impact Assessmentpdf(493 KB) ].

Both the proposal and the impact assessment will now be discussed in the European Parliament and in the Council

Review of the Variations Regulations >>>

3/03/2008

Notice to Applicants: - Volume 2B - Presentation and content of the dossier, CTD Questions & Answers
An updated version of Questions & Answers of Volume 2B of the Notice to Applicants is now availablepdf(51 KB) . Some of the previously existing Q&As were deleted since no longer of utility (either because they dealt with the transitional period which is currently over or because they are now covered by the Guideline on processing of Renewals in the Centralised and Mutual Recognition Procedure). The remaining Q&As were reviewed and corrected as necessary.

EudraLex Volume 2B >>>

26/02/2008

Consultation on the Revised Annexes 1,2 and 3 on the Clinical Trial Application Form, the Substantial Amendment Form and the Declaration of the end of a Clinical Trial Form to 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'
Annexes 1, 2 and 3 on the Clinical Trial Application Form, the Substantial Amendment Form and the Declaration of the end of a Clinical Trial Form to 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' have been revised in order to take into consideration needs stemming from Regulation (EC) No 1901/2006, of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use, from the Guideline on Strategies to Identify and Mitigate Risks for First-in-Human Clinical Trials with Investigational Medicinal Products (Doc. Ref.EMEA/CHMP/SWP/28367/07, of 19 July 2007) and to clarify the submission of information on the results of clinical trials in view of its publication. These revised annexes will be required once the changes have been implemented in EudraCT version 7.0 on the EMEA website. It is anticipated that version 7.0 will be available towards the end of 2008. Comments on the changes introduced into the revised annexes should be e-mailed by 18 April 2008 to entr-pharmaceuticals@ec.europa.eu.

Click here for the documents (pdf format)pdf(106 KB) - (word format)msw8(410 KB)

26/02/2008

Consultation on a "Draft Guidance on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with article 41 of Regulation No. (EC) 1901/2006"
Regulation (EC) No 1901/2006, of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use, requires the Commission to draw up guidance on the nature of the information on paediatric clinical trials to be entered into the database of clinical trials (EudraCT), created by Directive 2001/20/EC, on which information shall be made available to the public, on how clinical trials results shall be submitted and be made public and on the European Medicines Agency (EMEA)'s responsibilities and tasks in this regard. DG ENTR launches a public consultation on the above draft guidance. Comments are invited and should be e-mailed by 18 April 2008 to entr-pharmaceuticals@ec.europa.eu.

Click here for the draft guideline.pdf

15/02/2008

Good Manufacturing Practice (GMP) - Volume 4 - Revision of GMP Guidelines to implement concept of Quality Risk Management

As an implementation measure related to the ICH Q9 guideline on quality risk managementpdf , the European Commission has reviewed the existing GMP provisions. With the revision of GMP Part I, Chapter 1 on Quality Managementpdf(29 KB) quality risk management becomes an integral part of a manufacturer's quality system. This concept will also be considered in a future revision of GMP Part II. The ICH Q9 guideline as such has been implemented with the new Annex 20pdf(99 KB) . It should be noted that the new Annex is not intended, however, to create any new regulatory expectations; but rather provides an inventory of internationally acknowledged risk management methods and tools together with a list of potential applications at the discretion of manufacturers. For background on the implementation of these revisions please see the revised Introductionpdf(20 KB) .

EudraLex Volume 4 >>>

15/02/2008

Good Manufacturing Practice (GMP) - Volume 4 - Annex 1 "Manufacture of Sterile Medicinal Products" : Revised version now public

GMP Annex 1 of the GMP Guide has been revised. The revision of the Annex was necessary in particular to align the classification table for environmental cleanliness of clean rooms with ISO standards. Two public consultations took place in preparation of this new revision. The revised Annex 1 provides supplementary guidance on the application of the principles and guidelines of GMP to sterile medicinal products. The guidance has been updated in four main areas:

- Classification table for environmental cleanliness of clean rooms, and associated text
- Guidance on media simulations
- Guidance on bioburden monitoring
- Guidance on capping of vials

The new annex should be implemented by 01 March 2009 except for the provisions on capping of freeze-dried vials, which should be implemented by 01March 2010.

EudraLex Volume 4 >>>

14/02/2008

Notice to Applicants: - Volume 2C - Regulatory Guidelines, Guideline on the packaging information of medicinal products for human use authorised by the Community
An updated version of the Annex of the Guideline on the packaging information of medicinal products for human use authorised by the Community is now available. The update relates solely to the requirements from Bulgaria and Romania which had to be urgently included in the Annex. The text of the Guideline will be subject to a revision in the coming months, in orded to update legislative references and provisions on substance.
EudraLex Volume 2C >>>

11/02/2008

Results of Public Consultation on Pharmaceutical Excipients

According to Directive 2001/83/EC, as amended by Directive 2004/27/EC, the European Commission should adopt, via comitology procedure, a Directive on the list of certain excipients to which specific conditions of Good Manufacturing Practice (GMP) should be applied (Article 46 f).
In preparation of such a Directive, the Commission has broadly consulted manufacturers and users of certain categories of excipients on various policy options. In total, 285 validated responses were assessed and summarised by an external contractor, Europe Economics. Results of this consultation are included in this Impact Assessment Reportpdf(135 KB) and its Appendicespdf(794 KB) .
The report concludes that compared to current policies a Commission Directive on GMP for excipients, as currently foreseen in legislation, is not expected to lead to benefits to patients but to increases costs.

7/02/2008

WHO' s presents first results of Anti-Counterfeiting Strategy
Recently WHO has published its "Principles and Elements for National Legislation to Combat Counterfeit Medical Products"pdf .
The document was endorsed by the General Meeting of the International Medical Products Anti Counterfeiting Task Force IMPACT on 12 December 2007.
IMPACT in this project also defined specific obligations and responsibilities to address the so-called problem of "double standards" for medicines for the local market and for export. The document is meant to give guidance to governments and parliaments for the establishment of national legislation. The European Commission had funded this specific project under the Competitiveness and Innovation Framework Programme (http://ec.europa.eu/cip/docs/eip_wp2007.pdfpdf ; http://ec.europa.eu/cip/docs/eip_wp2007_measures.pdfpdf ). DG Enterprise and Industry will take account of the results of IMPACT in its strategy on counterfeit medical products.

5/02/2008

Commission launches a Public consultation on the key ideas of a legal proposal on information to patients
The 'Report on current practices with regard to the provision of information to patients on medicinal products', published on our website for public consultation in 2007, revealed the need to harmonise the way in which information on medicinal products is made available in the EU in order to ensure that all patients have equal access to information on medicinal products.
With this in mind, DG Enterprise and Industry invites you to give your opinion on the key ideas of a legal proposal aiming at ensuring that all EU citizens have access to good-quality, objective, reliable and non promotional information on prescription-only medicinal products.

Please click here to access the Consultation paperpdf(79 KB) Choose translations of the previous link français (fr) .
All responses to the public consultation should be sent by e-mail to ulla.narhi@ec.europa.eu by 7 April 2008.

30/01/2008

Ethical considerations for clinical trials in children
The ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use, chaired by the Commission services, has adopted recommendations on various ethical aspects of clinical trials performed in children. These recommendations will contribute to the protection of children who are the subject of clinical trials. Furthermore, the recommendations are intended to facilitate a harmonised application of rules on clinical trials across the EU and thereby facilitate the conduct of clinical trials in the EU.

These recommendations are published in Eudralex Vol 10 Clinical trials (Chapter V: Additional Information)herepdf(233 KB) .

A summary of the consultation response can be found herepdf(187 KB) .

EudraLex volume 10 >>>

30/01/2008

Commission at present not in a position to select a symbol for medicines authorised for a paediatric indication
Article 32 of the Paediatric Regulation (Regulation (EC) No 1901/2006) foresees that medicinal products granted a marketing authorisation for a paediatric indication shall display a symbol for their identification. Following this Regulation, the selection of the symbol by the European Commission is to be based on a recommendation of the European Medicines Agency Paediatric Committee. The Regulation provides for the Commission to select the symbol by 26 January 2008 and make the symbol public. On the 20th of December 2007 the Paediatric Committee adopted its recommendation regarding the symbol by a majority vote of eighteen against four. The adopted recommendation is that "As a consequence of its analysis balance of benefits and risks of the symbol, the Paediatric Committee was unable to recommend to the European Commission any symbol for which the benefits would outweigh the risks identified and dominated by potentially fatal medication errors".
Publication of this announcement serves to inform stakeholders that on the basis of this recommendation, the European Commission is at present not in a position to select a symbol and the provisions of Article 32 of the Paediatric Regulation cannot therefore be implemented. The full recommendation of the Paediatric Committee to the European Commission regarding the symbol can be found here.pdf(157 KB)

25/01/2008

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 updates required by Bulgaria, Czech Republic, Germany, Portugal and the United Kingdom.
EudraLex Volume 6 >>>

25/01/2008

Updating the Notice to Applicants - Veterinary Medicinal Products - Volume 6C "pdf(194 KB) Guideline on the packaging information of veterinary medicinal products authorised by the Community"pdf(194 KB)
DG Enterprise and Industry releases an updated version of "Guideline on the packaging information of veterinary medicinal products authorised by the Community" of the veterinary Notice to Applicants Volume 6C. The annex to the guideline provides updates required by Bulgaria, Portugal, Romania and the United Kingdom.
EudraLex Volume 6 >>>

15/01/2008

Outcome of the Public Consultation (comitology part)
A public consultation was conducted in October 2007-January 2008 on the 'comitology' aspects of the review of the Variations Regulations.

Comments from stakeholders are available [here].

A summary of the outcome of this consultation will be published soon.

For any questions, please contact nicolas.rossignol@ec.europa.eu

11/01/2008

Confidentiality arrangements finalised with Canada
The European Commission's Directorate-General Enterprise and Industry, the European Medicines Agency (EMEA), and the Health Products and Food Branch of Health Canada have concluded confidentiality arrangements in the area of medicines during their recent bilateral meeting in Brussels.
The joint announcement can be found here :pdf(36 KB)

10/01/2008

Update 9/1/2008: Implementation of the Regulation on Advanced Therapies: Public call for expressions of interest as Commission appointees to the European Medicines Agency Committee for Advanced Therapies
The Commission publishes today a public call for expressions of interest relates to the appointment by the European Commission of members and alternates representing clinicians and patients' associations at the Committee for Advanced Therapies of the European Medicines Agency (EMEA). The public call is available in all EU official languagespdf(234 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) :