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EC Pharmaceuticals
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Latest news on Pharmaceuticals from the European Commission - Enterprise and Industry Directorate General - Pharmaceuticals regulatory framework and marketing authorisations unit.
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New MRL for tiludronic acid and iron fumarate
Commission Regulation (EC) No 485/2009 of 9 June 2009 amending Annex 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 tiludronic acid and iron fumarate (Official Journal L 145, 10/6/2009 p.31-33)
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New MRL for monepantel
Commission Regulation (EC) No 478/2009 of 8 June 2009 amending Annexes I and III 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 monepantel (Official Journal L 144, 9/6/2009 p.17-19)
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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.
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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-527/07, 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.
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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. Deadline for public consultation: 8 September 2009.
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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.
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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 is now available.
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Guidance for coordination of GCP inspections and co-operation between GCP inspectors published
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.
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Clinical trials
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.
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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.
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