Pharmaceuticals Archives - 2009

  • 22/12/2009
    Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products.
    The Commission “Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products” Following Article 4(1)(a) of Commission Regulation (EC) No 1234/2008 of 24 of November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products was adopted by the Commission on 21 December 2009 and shall be published in the Official Journal before the end of the year. The guideline applies from 1 January 2010.

  • 22/12/2009
    Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008
    Implementation of the Variations Regulation : Communication from the Commission -Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products.
  • 16/12/2009
    The DG Enterprise and Industry has launched a public consultation on part I chapter 1 of the good manufacturing practices laying down the guidelines on Quality Management System.
    Closing Date: 31 May 2010
    Comments and suggestions are invited by 31 May 2010 and should be sent by email to: adm-gmdp@ema.europa.eu and ENTR-GMP@ec.europa.eu
    Downloads : Chapter 1 of the GMP laying down the guidelines for Quality Management Systempdf - word document
    msw8

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  • 16/12/2009
    The DG Enterprise and Industry has launched a public consultation on part I chapter 2 of the good manufacturing practices laying down the guidelines on Personnel. Chapter 2 is proposed to be updated to take into account the principles of “Pharmaceutical Quality System” as described in the ICH Q10 guideline.
    Closing Date: 31 May 2010
    Comments and suggestions are invited by 31 May 2010 and should be sent by email to:adm-gmdp@ema.europa.eu and ENTR-GMP@ec.europa.eu .
    Downloads : Chapter 2 of the GMP laying down the guidelines for Personnelpdf - word documentmsw8
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    27/10/2009

    Transatlantic Administrative Simplification Action Plan – 2009 implementation reportpdf(52 KB)

    During the recent annual EU-EMEA/FDA bilateral meeting the parties took stock of the progress achieved regarding the implementation of the Transatlantic Administrative Simplification Action Plan, agreed in June 2008.

    12/10/2009

    "Droit de regard": Important notice to stakeholders - follow-up to the notice of 29/07/09:

    Following an agreement with the responsible Committee in the European Parliament and in accordance with the interinstitutional agreement of 3 June 2008, the period of the "droit de regard" for the Commission Decisions taken as part of the "Decision making process" is shortened on a permanent basis to 7 days. This applies also in the recess periods of European Parliament.

    The shortened period of the "droit de regard" does, however, not apply in the following cases:

    • the draft Commission Decision is not in accordance with the scientific opinion of the EMEA;
    • Member States, during the vote, request that the draft Decision is discussed in a plenary meeting of the Standing Committee; or
    • the opinion of the Standing Committee is unfavourable.

    The "Notice to applicants", Chapter VI, is going to be updated to this effect.

    This arrangement applies with immediate effect, i.e.:

    • Procedures in the Comitology phase which have been in the "droit de regard" stage for more than 7 days are going to be moved into the adoption phase (15 calendar days);
    • Procedures in the Comitology phase which are still in the voting phase of Member States will be subject to a shortened period of "droit de regard" of 7 days.

    In practice, the additional 7 days of the "droit de regard" following the vote by Member States will be used to prepare the final Decision for adoption once the 7 days have expired. Therefore, in practice, the timelines will not be much affected by the "droit de regard".

    Companies are kindly requested to refrain from ringing up the Commission staff to 'urge' a faster processing of the draft Decision of "their" products.

    29/09/2009

    Commission paves the way for vaccinations for influenza pandemic (H1N1) 2009

    29/09/2009

    Substances considered as not falling within the scope of Council Regulation (EC) No. 470/2009 (Revision 17 - September 2009)pdf(15 KB)

    23/09/2009

    Implementation of the Advanced Therapies Regulation
    Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products
    Commission Directive 2009/120/EC of 14 September 2009 amend the Annex to Directive 2001/83/EC by updating the definitions and detailed scientific and technical requirements for gene therapy medicinal products and somatic cell therapy medicinal products and establishing technical requirements for tissue engineered products, as well as for advanced therapy medicinal product containing devices and combined advanced therapy medicinal products. It has been published in the Official Journal on 15 September 2009 and shall enter into force on the twentieth day after publication. The text of the Regulation is available here.
    Eudralex Volume 1 >>>

    21/09/2009

    Notice to Applicants, Volume 2C Guidance on Summary of Product Characteristics (SmPC)
    Notice to Applicants, Volume 2C, the guidance document on Summary of Product Characteristics (SmPC) has been updated. It will apply as from 1 May 2010 but submissions in accordance with the updated guidance will also be possible prior to that date.

    The guidance document shall be included in the Notice to Applications, Vol. 2C. It can be found here.

    18/09/2009

    Notice to Applicants, Volume 2B -Electronic Common Technical Document (eCTD)
    This concerns an update in EudraLex. The old XML files (dated March 2007) of the electronic application form in EudraLex (form-new, form-variation, form-renewal) should be replaced by the new XML files developed by the EMEA (at the request of MS).
    EudraLex Volume 2 >>>

    18/09/2009

    Notice to Applicants - Veterinary Medicinal Products - Volume 6B
    Presentation and content of the dossier - Part 1: Summary of the dossier Part 1A Electronic Application form (XML file)
    In addition to the word version DG Enterprise and Industry releases the electronic version (XML file) of the veterinary Volume 6B Presentation and content of the dossier - Part 1: Summary of the dossier - Part 1A Application form - Administrative data.
    EudraLex Volume 6 >>>

    18/09/2009

    Notice to Applicants - Veterinary Medicinal Products - Volume 6C
    Electronic application form (XML file) for the renewal of a centrally marketing authorisation
    Electronic Application form (XML file) for the variation of a centrally marketing authorisation
    In addition to the word versions DG Enterprise and Industry releases the electronic versions (XML files) of the veterinary Volume 6C application forms for renewals and variations of centrally authorised veterinary medicinal products.

    EudraLex Volume 6 >>>

    04/09/2009

    Requests for withdrawal of Community authorisations:
    Holders of Community authorisations for the placing on the market of a medicinal product intending to request a withdrawal of their authorization with effect of the end of this year are asked to inform the Commission to this effect in writing before Friday, 30 October 2009, close of business, to allow for the timely completion of the decision-making procedure necessary for the withdrawal of the authorisation (contact address).

    04/09/2009

    Substances considered as not falling within the scope of Council Regulation (EC) No. 470/2009 (Revision 16 - September 2009)

    01/09/2009

    Summary record of the 65th Pharmaceutical Committeepdf
    The 65th meeting of the Pharmaceutical Committee took place on 16 March 2009 in Brussels.

    01/09/2009

    Implementation of the Advanced Therapies Regulation
    Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises was published in the Official Journal on 25 July 2009 and has entered into force. The text of the Regulation is available here.

    03/08/2009

    Volume 9B of the Rules Governing Medicinal Products in the European Union: Public consultation on the Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use
    The European Commission today launches a public consultation on Volume 9B, the Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use. Volume 9B has been updated to take account of Regulation (EC) No 726/2004 and Directive 2004/28/EC as well as to take account of scientific and technical progress. Before the decision was taken to split the guideline into Volume 9A and 9B respectively, the old Volume 9 covered medicinal products both for human and veterinary use. The new Volume 9A on medicinal products for human use has already been published. This public consultation relates to Volume 9B i.e. medicinal products for veterinary use only. The document has been elaborated by the Pharmacovigilance Working Party of the EMEA's Committee for Veterinary Medicinal Products and was agreed by this Committee. DG Enterprise will review the document after the public consultation taking into account the comments received.

    The text which forms the basis of the current consultation is presented as a complete draft Volume 9B, following the structure of Volume 9A to its large parts as follows:

    • Introduction
    • Part I: Guidelines for Marketing Authorisation Holders,
    • Part II: Guidelines for Competent Authorities and the Agency,
    • Part III: Guidelines for Marketing Authorisation Holders, Competent Authorities and the Agency on Electronic Exchange of Pharmacovigilance Information in the EU,
    • Part IV: Guideline on Public Communication on Medicinal Products for Veterinary Use.

    The draft of Volume 9B can be found here.pdf(2 MB)
    The template for comments can be found here.msw8(35 KB)

    Comments and suggestions are invited by 6 October 2009 and should be sent, preferably by email to Fia.Westerholm@emea.europa.eu (or by fax to +44 20 7418 8447) and Karin.Krauss@ec.europa.eu (or by fax to +32 2 299 8046)

    29/07/2009

    Important notice to stakeholders - applies to all Commission Decisions on medicinal products the Comitology procedure of which has been launched since 10 July 2009:
    The adoption of Commission Decisions in the area of medicinal products involves in some cases a Comitology procedure in accordance with Articles 4, 7, 8 of Council Decision 1999/468/EC. In the Comitology procedure Member States have to vote on a draft prior to its adoption by the Commission.

    As part of the Comitology procedure, the European Parliament (EP) has a "droit de regard" (Article 7, 8 of the Council Decision 1999/468/EC). The "droit de regard" shall allow the EP to examine whether the Commission exceeds its implementing powers. The modalities of the "droit de regard" are further set out in an interinstitutional agreement of 3 June 2008pdf . According to this agreement, the EP has a "droit de regard" of one month after Member States have voted. Only after this period has elapsed can the Commission adopt a Decision.

    In order to fully respect the institutional commitments vis-à-vis the newly-constituted EP, the Secretary-General of the Commission has instructed the Directorate-General for Enterprise and Industry to submit all applicable draft decisions in accordance with the inter-institutional agreement.

    Therefore, pending a specific arrangement with the newly-elected EP, all Decisions involving Comitology procedure will only be adopted by the Commission after one month has elapsed following the vote of the Standing Committee.

    It should be stressed that the "droit de regard" has been established by the Community legislator. Its working arrangements have been agreed by the Presidents of the European Commission and the European Parliament. The President of the Commission has instructed that the applicable rules are strictly respected.

    28/07/2009

    Contribution submitted in response to the Public Consultation Paper on a Contribution for a future Commission regulation on the format and content for applications and requests for an opinion on a maximum residue limit for a pharmacologically active substance
    From 11 May 2009 till 6 July 2009 the Directorate General for Enterprise and Industry invited stakeholders to comment on a contribution to the preparation of a future Commission regulation on the format and content for applications and requests for an opinion on a maximum residue limit for a pharmacologically active substance prepared by the European Medicines Agency and its Committee for Veterinary Medicinal Products ('CVMP').
    In response to this consultation, IFAH-Europe sent in comments on the contribution. These comments can be found herepdf(28 KB) .
    Maximum Residue Limits - Key documents >>>

    28/07/2009

    EudraLex Volume 10 - Clinical trials guidelines
    The "Questions and Answers document" in the EudraLex volume 10 on clinical trials has been revised. The revised version 4.0 of this document is available herepdf.
    EudraLex Volume 10 >>>

    28/07/2009

    Publication of summaries of Community Decisions on marketing authorisations:
    The Commission publishes, in the Official Journal of the European Union, summaries of Community Decisions on marketing authorisations.
    These summaries are usually published on the last Friday of every month and they cover the Community Decisions adopted during the preceding month.
    Readers are informed that, for the Community Decisions adopted in the month of July 2009, the summary is going to be published in the second half of September 2009.

    14/07/2009

    Variations (codecision part): publication of amendments to Directive 2001/82/EC and Directive 2001/83/EC.
    Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products, has been published in the Official Journal on 30 June 2009. This Directive is part of a global revision of the legal framework on variations to make the overall system clearer, simpler and more flexible and it amends the legal basis for the adoption of Community rules on variations in order to harmonise those rules for all authorised medicines in the EU.
    EudraLex Vol 1 >>
    EudraLex Vol 5 >>

    08/07/2009

    New regulation on Maximum Residue Limits has entered into force
    The new Regulation laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council has entered into force on 6th July 2009.
    EudraLex Vol 5 >>

    03/07/2009

    Implementation of the Variations Regulation
    Summary and contributions from stakeholders to the public consultation paper for the preparation of guidelines on the details of the various categories of variations.
    Directorate General for Enterprise and Industry consulted stakeholders on a contribution to the preparation of the guidelines on the details of the various categories of variations following Article 4(1)(a) of Commission Regulation (EC) No 1234/2008 of 24 of November 2008 concerning the examination of variations to the terms of marketing authorisations for medical products for human use and veterinary medicinal products. A summary and all contributions received from stakeholders regarding the above mentioned public consultation can be found here.

    03/07/2009

    Implementation of the Variations Regulation
    Summary and contributions from stakeholders to the public consultation paper for the preparation of guidelines on the operation of the variation procedures.
    Directorate General for Enterprise and Industry consulted stakeholders on a contribution to the preparation of the guidelines on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 of 24 of November 2008 concerning the examination of variations to the terms of marketing authorisations for medical products for human use and veterinary medicinal products, following Article 4(1)(b) of the Regulation. A summary and all contributions received from stakeholders regarding the above mentioned public consultation can be found here. 03/07/2009 Updating the Notice to Applicants - Veterinary Medicinal Products - Volume 6A Chapter 7 "General Informationpdf"
    DG Enterprise and Industry releases an updated version of Chapter 7 "General Informationpdf" of the veterinary Notice to Applicants Volume 6A. The revised version provides updates required by Belgium, Cyprus, Czech Republic, Germany, Portugal, Slovak Republic, Spain and United Kingdom.

    29/06/2009

    Notice to Applicants, Volume 6C Guidance on the Assessment of environmental risks of veterinary medicinal products
    Notice to Applicants, Volume 6C, new guidance document as regards the assessment of environmental risks of veterinary medicinal products resulting from amending Directive 2004/28/EC to Directive 2001/82/EC.
    Amending Directive 2004/28/EC to Directive 2001/82/EC included new provisions regarding the consideration of effects on the environment in the risk/benefit assessment of veterinary medicinal products and on the data requirements regarding such effects.
    Based on considerations of the Committee for Veterinary Medicinal Products ('CVMP') and its Environmental Risk Assessment Working Party a guidance document has been developed as regards the assessment of environmental risks of veterinary medicinal products.

    The guidance document shall be included in the Notice to Applications, Vol. 6C. It can be found herepdf.

    22/06/2009

    European Court of Justice judgment on the definition of a medicinal product to be considered as a reference medicinal product in the meaning of Article 10 of the Directive 2001/83/CE
    In its judgment of 18 June 2009 in case C-527/07pdf(90 KB), the European Court of Justice ruled that Directive 2001/83/EC is to be interpreted as meaning that a medicinal product which falls outside the scope of Regulation No 726/2004, and the placing of which on the market in a Member State was not authorised in accordance with the applicable Community law, cannot be considered to be a reference medicinal product within the meaning of Article 10(2)(a) of Directive 2001/83.
    In that regard, the Court stated that to allow a medicinal product benefiting from an authorisation issued on the basis of national provisions alone to be considered to be a reference medicinal product would amount, in fact, to authorising an exception to the rule, laid down in particular in Article 6(1) of Directive 2001/83 that a medicinal product which has not been authorised in accordance with Community law may not be placed on the market of a Member State. Moreover, there is no provision of Directive 2001/83 which supports the finding that the mere placing on the market, even for a number of years, of a medicinal product which has not been the subject of a marketing authorisation issued in accordance with Community law, can replace such authorisation.

    22/06/2009

    Public consultation on draft revision 3 of 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 Clinical Trials Directive provides a regime of authorisation of the NCA, notification of substantial amendments, and declaration of the end of the trial, and exhaustively harmonises these aspects. The Commission is under an obligation to draw up detailed guidance to ensure that the format and content of the request for authorisation of a clinical trial are harmonised. A draft revision of the existing detailed guidance is being submitted for public consultation. Contributions should be sent by e-mail to entr-pharmaceuticals@ec.europa.eu. The document is accessible herepdf(135 KB) .

    Deadline for public consultation: 8 September 2009

    16/06/2009

    New regulation on maximum residue limits published today in the Official Journal
    The new Regulation laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council was published in the Official Journal of 16 June 2009. The new regulation will enter into force on the twentieth day following its publication in the Official Journal.
    EudraLex Vol 5 >>

    16/06/2009

    Meeting of the Standing Committee on Medicinal Products for Veterinary Use - Summary Report
    A meeting of the Standing Committee on Medicinal Products for Veterinary Use dedicated primarily to the implementation of the new regulation on maximum residue limits took place on 29 May 2009 in Brussels. A summary report of the meeting can be found herepdf(13 KB) .

    08/06/2009

    Guidance for coordination of GCP inspections and co-operation between GCP inspectors, the reference and concerned Member States and CMD(h) , in the context of the evaluation of the GCP compliance of marketing authorization applications for mutual recognition and decentralized procedures has been published today in EudraLex. The text is accessible here.

    03/06/2009

    DG ENTR Conclusions on Study on Pharmaceutical Excipients
    Following the publication of the report on an impact assessment study by an external contractor DG Enterprise and Industry has taken the decision not to continue with the preparation of a Commission Directive on GMP for certain excipients as originally foreseen in Article 46(f) of Directive 2001/83/EC.
    The results of a public consultation conducted by DG ENTR have confirmed concerns previously raised by stakeholders and experts from Member States regarding the lack of flexibility of the current legal basis, which stipulates for a list of certain excipients for which conditions of GMP should be applied and which should be established in implementing legislation.
    The results of the consultation suggest a balanced approach for requiring GMP for excipients within the concert of legal requirements on manufacturing and quality control in the legal pharmaceutical framework. The requirement for selected GMP conditions to be applied for excipients seems to be justified both from a public health and a business perspective if linked to a formalised decision-making process by the manufacturer of the medicinal product. Such a decision making process should be based on the application of internationally agreed concepts and criteria for quality risk management (ICH Q9/ GMP Annex 20). An adjustment of the legal basis in Directive 2001/83/EC will be necessary for such a concept to be pursued further.

    27/05/2009

    Pharmaceutical legislation aligned with the new regulatory procedure with scrutiny
    Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny - Part Two (Official Journal L 87, 231/3/2009, p. 109 - 154, especially p. 116 - 118, Annex 2.9, where Regulation (EC) No 726/2004 is adapted).

    13/05/2009

    Issues arising in the context of authorising non-prescription medicinal products through the centralised procedurepdf(381 KB)
    The attached notepdf(381 KB) summarizes and puts into context Community legislation and DG Enterprise and Industry's interpretation thereof with regard to a number of issues linked to prescription and non-prescription medicinal products, raised in the context of the first authorisations of non-prescription products through the centralised procedure.
    The notepdf(381 KB) was presented to Member States during the 65th Pharmaceutical Committee on 16 March 2009 and Member States overall welcomed the clarification of DG Enterprise's interpretation. In addition, DG Enterprise took note of an issue not addressed in the note: in certain Member States, non-prescription status is granted for small pack sizes for products otherwise classified as prescription-only; furthermore certain Member States may determine classification of prescription depending on age groups. In addition, the consequences of a negative CHMP-opinion, concerning an application for a switch of prescription status, for subsequent applications to national competent authorities were also discussed. (Further details on the discussion in the Pharmaceutical Committee will be included in the minutes of the Pharmaceutical Committee, which will be published in due course on this website.)

    11/05/2009

    Implementation of the new Regulation on maximum residue limits for pharmacologically active substances
    Public Consultation Paper on a Contribution for a future Commission regulation on the format and the content for applications and requests submitted for an opinion on a maximum residue limit for a pharmacologically active substance
    The new regulation on maximum residue limits scheduled for entry into force in the end of May/beginning of June foresees that the Commission shall, in consultation with the Agency, adopt measures regarding the form and the content of the applications and requests referred to in Articles 3 and 9 of the new regulation.

    With this public consultation, the Directorate General for Enterprise and Industry intends to consult all stakeholders on a contribution to the preparation of a future Commission regulation. This contribution is an input from the European Medicines Agency and the Committee for Veterinary Medicinal Products ('CVMP'). It can be found herepdf(424 KB)

    Deadline for Public Consultation: 06 July 2009

    04/05/2009

    European Court of Justice judgment on the definition of advertising in Directive 2001/83/EC
    In its judgment of 2 April 2009 in case C-421/07, the European Court of Justice ruled that Directive 2001/83/EC is to be interpreted as meaning that dissemination by a third party of information about a medicinal product may be regarded as advertising within the meaning of that directive, even though the third party in question is acting on his own initiative and completely independently, de jure and de facto, of the manufacturer and the seller of such a medicinal product.
    In that regard, the Court stated that even where the activity is carried out by an independent third party outside any commercial or industrial activity, advertising of medicinal products is liable to harm public health, the safeguarding of which is the essential aim of Directive 2001/83/EC.

    The judgment is available herepdf(84 KB)

    16/04/2009

    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 14 of April 2009)

    08/04/2009

    European Commission, European Medicines Agency and Health Canada implementation plan for confidentiality arrangement.
    The European Commission, together with the European Medicines Agency and Health Canada, the Canadian regulatory authority for medicines, have agreed on an implementation plan for their confidentiality arrangement, signed in December 2007.
    The implementation plan details the process for both regular and ad-hoc exchanges of information and describes the process for monitoring the progress of the implementation plan.
    The implementation plan can be found herepdf(88 KB) Choose translations of the previous link français (fr) .

    02/04/2009

    Commission Directive regarding advanced therapy medicinal products approved by Standing Committee
    On 2 March 2009, the Member States have approved the new Commission Directive amending, as regards advanced therapy medicinal products, Annex I to Directive 2001/83/EC. The draft Directive was put to vote at a meeting of the Standing Committee on Medicinal Products for Human Use.
    The text now enters a 3-months period of scrutiny by the European Parliament and Council, before it can be formally adopted by the Commission and enters into force.

    The text of the draft Directive which was voted on 2 March 2009 is available herepdf(58 KB).

    02/04/2009

    Draft Commission Regulation laying down provisions for the certification of quality and non clinical data for small and medium-sized companies approved by Standing Committee
    On 2 March 2009, the Member States have approved the new Commission Regulation laying down provisions for the certification of quality and non clinical data for small and medium-sized companies. The draft Regulation was put to vote at a meeting of the Standing Committee on Medicinal Products for Human Use.
    The text now enters a 1-month period of consideration by the European Parliament, before it can be formally adopted by the Commission and enters into force.

    The text of the draft Regulation which was voted on 2 March 2009 is available herepdf(29 KB).

    30/03/2009

    65th Pharmaceutical Committee - Meeting Reportpdf
    The 65th meeting of the Pharmaceutical Committee took place on 16 March 2009 in Brussels.

    20/03/2009

    Implementation of the Variations Regulation
    Public Consultation Paper for the preparation of guidelines on the operation of the variation procedures herepdf(948 KB)
    Article 4(1)(b) of Commission Regulation (EC) No 1234/2008 of 24 of November 2008 concerning the examination of variations to the terms of marketing authorisations for medical products for human use and veterinary medicinal products establishes that the Commission shall, after consulting the Member States, the Agency and interested parties, draw up guidelines on the operation of the procedures laid down in Chapters II, III and IV of the Regulation.
    With this public consultation, Directorate General for Enterprise and Industry intends to consult all stakeholders on a contribution to the preparation of the above mentioned guidelines. This contribution is an input from the EU Variation Task Force coordinated by EMEA and it will form the basis for the preparation of the Commission guidelines. It can be found herepdf(948 KB) .

    20/03/2009

    Implementation of the Variations Regulation
    Public Consultation Paper for the preparation of guidelines on the details of the various categories of variations here.pdf(3 MB)
    Article 4(1)(a) of Commission Regulation (EC) No 1234/2008 of 24 of November 2008 concerning the examination of variations to the terms of marketing authorisations for medical products for human use and veterinary medicinal products establishes that the Commission shall, after consulting the Member States, the Agency and interested parties, draw up guidelines on the details of the various categories of variations.
    With this public consultation, Directorate General for Enterprise and Industry intends to consult all stakeholders on a contribution to the preparation of the above mentioned guidelines. This contribution is an input from the EU Variation Task Force coordinated by EMEA and it will form the basis for the preparation of the Commission guidelines. It can be found here.pdf(3 MB)

    27/02/2009

    Draft revision of " Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Productspdf(130 KB)" for public consultation

    The European Commission is consulting on the draft revision of the Note for Guidance 2004/C 24/03. This technical revision has been undertaken to take into account advancement of science in the area of transmissible encephalopathies, as well as the evolving situation regarding Bovine Spongiform Encepalopathy (BSE) across the world. For the classification of countries or regions according to their BSE risk, the revised Note for Guidance will make reference to the rules laid down by the World Organisation for Animal Health (OIE), replacing the previous GBR classification. New criteria for the sourcing and processing of gelatine and bovine blood derivatives used in the manufacture of medicinal products for human or veterinary use have been introduced, as well as a new subsection on Peptones. Comments should be sent to entr-gmp@ec.europa.eu and tse.guideline.bwp@emea.europa.eu by 30 June 2009.

    05/02/2009

    The Commission services wish to consult stakeholders on the Recommendation on "Pharmacovigilance Urgent Measures" procedure under Article 107 of Directive 2001/83/EC, with a view to the incorporation of the guidance in Volume 9A in Eudralex.
    The public consultation document is herepdf(42 KB) .

    Contributions should be sent by e-mail to entr-pharmaceuticals@ec.europa.eu by 3 April 2009.

    04/02/2009

    Guidelines concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT), and on EudraCT information to be made public by the European Medicines Agency have been published today in EudraLex. The guidelines are accessible here.

    21/01/2009

    Public consultation on revisions of GMP Annex 14 on "Manufacture of medicinal products derived from human blood or plasma"pdf(48 KB)
    The annex has been revised in the light of Directive 2002/98/EC and relevant implementing directives setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components. These directives apply to the collection and testing of blood for all uses, including the manufacture of medicinal products.
    Comments should be sent to entr-gmp@ec.europa.eu and GMP@emea.europa.eu by 31 July 2009.

    21/01/2009

    Implementation of the Regulation of Orphan Medicinal Products: Public call for expressions of interest for Commission appointees to the Committee for Orphan Medicinal Products of the European Medicines Agency.
    The Commission publishes today a public call for expressions of interest related to the appointment by the European Commission of members representing patients' organisations at the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA). The public call is available herepdf .

    Expressions of interest should be notified to the European Commission by e-mail to : entr-pharmaceuticals@ec.europa.eu .

    The deadline for receipt of the notifications is Friday 13 March 2009

    12/01/2009

    Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for human use, revision 1, 12 January 2009
    A revised version of the "Readability guideline" has been published in EudraLex. The document is available here