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Latest news on Pharmaceuticals from the European Commission - Enterprise and Industry Directorate General - Pharmaceuticals regulatory framework and marketing authorisations unit.
URL: http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm
Updated: 12 hours 44 min ago

2009, ΟΚΤΩΒΡΙΟΣ 27 - 13:06 - Transatlantic Administrative Simplification Action Plan – 2009 implementation report

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.

2009, ΟΚΤΩΒΡΙΟΣ 12 - 09:42 - Assessment of the functioning of the "Clinical Trials Directive” 2001/20/EC - Public consultation paper

In its Communication of 10 December 2008 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on “Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector”1, the Commission announced that an assessment would be made of the application of Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use2 (“Clinical Trials Directive”). This assessment would consider, in particular, various options for further improving the functioning of the Clinical Trials Directive with a view to remedy shortcomings and unintended negative consequences while taking the global dimension of clinical trials into account.

2009, ΟΚΤΩΒΡΙΟΣ 12 - 09:35 - "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 VII, 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.

2009, ΣΕΠΤΕΜΒΡΙΟΣ 29 - 16:25 - Commission paves the way for vaccinations for influenza pandemic (H1N1) 2009

Following the positive scientific opinion issued by the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMEA) on 24 September, today the European Commission granted variations to two existing authorisations for vaccines for influenza pandemic (H1N1) 2009. The products concerned are Focetria® (Novartis), and Pandemrix® (GlaxoSmithKline). The vaccines will be authorised for use in all Member States of the EU and the EEA (Iceland, Liechtenstein and Norway). That should ensure that sufficient vaccines will be available before the start of the flu season and will reduce the risks for illnesses and deaths for European Citizens.

2009, ΣΕΠΤΕΜΒΡΙΟΣ 29 - 10:05 - MRL - Substances considered as not falling within the scope of Council Regulation (EC) No. 470/2009 (Revision 17)

Rivision 17 of the document Substances considered as not falling within the scope of Council Regulation (EC) No. 470/2009 (September 2009) is now available.

2009, ΣΕΠΤΕΜΒΡΙΟΣ 18 - 14:27 - 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).

2009, ΣΕΠΤΕΜΒΡΙΟΣ 18 - 11:46 - 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.

2009, ΣΕΠΤΕΜΒΡΙΟΣ 18 - 11:42 - 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.

2009, ΣΕΠΤΕΜΒΡΙΟΣ 4 - 11:59 - Update list of Substances considered as not falling within the scope of the MRL Regulation

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

2009, ΣΕΠΤΕΜΒΡΙΟΣ 3 - 16:40 - Summary record of the 65th Pharmaceutical Committee

The Summary record of the 65th meeting of the Pharmaceutical Committee that took place on 16 March 2009 in Brussels is now available.

2009, ΣΕΠΤΕΜΒΡΙΟΣ 2 - 14:31 - 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.

2009, ΑΥΓΟΥΣΤΟΣ 3 - 11:59 - 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.

2009, ΙΟΥΛΙΟΣ 29 - 10:34 - 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 2008. 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.

2009, ΙΟΥΛΙΟΣ 28 - 13:07 - 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 subst

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 are now available.

2009, ΙΟΥΛΙΟΣ 28 - 13:06 - 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 now available

2009, ΙΟΥΛΙΟΣ 28 - 10:06 - 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.

2009, ΙΟΥΛΙΟΣ 14 - 14:26 - 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.

2009, ΙΟΥΛΙΟΣ 14 - 11:24 - 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.

2009, ΙΟΥΛΙΟΣ 14 - 10:36 - 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 is now available.

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