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Aktualności

MHRA: Periodic (annual) service fees for medicines licences

26.06.2009
Invoices in respect of the 2009/10 Annual Periodic Fees will be sent on 25 June 2009 to all Product Licence Holders and Marketing Authorisation Holders. ...

Polish Ministry of Health: Regulation project on the readability of the package leaflet of medicinal products

23.06.2009
Polish Ministry of Health: Regulation project on the readability of the package leaflet of medicinal products ...

EMEA: Draft documents for Community Herbal Monograph

23.06.2009
Draft documents for Community Herbal Monograph on Thymi aetheroleum Thymus vulgaris L., aetheroleum (Thyme oil) ...

European Commission: 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 declarati

23.06.2009
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 ...

European Commission: 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

23.06.2009
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 only those medicinal products benefiting from a ...

MHRA: Better Regulation of Medicines Initiative (BROMI): Improvements in Detailed Descriptions of Pharmacovigilance System (DDPS) assessments

23.06.2009
A new system for the processing of the Detailed Descriptions of Pharmacovigilance System (DDPS) of Marketing Authorisation Applications (MAAs) has now been introduced. ...

EMEA: Joint scientific report of ECDC, EFSA and EMEA on meticillin resistant Staphylococcus aureus (MRSA) in livestock, companion animals and food

19.06.2009
The information provided represents the overall conclusions and recommendations from the previously mentioned reports The EFSA/BIOHAZ conclusions and recommendations reflect the focus of the ...

European Commission: New regulation on maximum residue limits

19.06.2009
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 ...

MHRA: Medicines for children: Including the product name when submitting information on paediatric studies in accordance with the Paediatric Regulation

19.06.2009
Since the introduction of the European Paediatric Regulation in 2007, Marketing Authorisation (MA) holders are required to submit paediatric studies completed since the date of entry into force ...

EMEA: Draft guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines

15.06.2009
The objective of this guideline is to provide recommendations on the quality, non-clinical and clinical studies that should be performed in order to obtain marketing authorisation of a live ...

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