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FDA: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document

28.04.2009
This guidance is intended to clarify for industry where to include the integrated summary of effectiveness (ISE) and integrated summary of safety (ISS) when submitting applications in the common ...

EMEA: Application Procedures - Quality Review of Documents (QRD)

28.04.2009
http://www.emea.europa.eu/htms/human/qrd/docs/listnonstandard.pdf ...

EMEA: Regulatory and Procedural Guidance - Article 58 Applications

28.04.2009
Administrative information application form for a Scientific Opinion according to Article 58 of Regulation (EC) 726/2004 ...

EMEA: Guideline on the Development of Medicinal Products for the Treatment of Post-Traumatic Stress Disorder (PTSD)

28.04.2009
The aim of this guideline is to provide guidance for the planning of clinical studies concerning the treatment of posttraumatic stress disorder (PTSD), the only psychiatric disorder with a causal ...

HMA: Variation Procedure

10.04.2009
HMA: Variation Procedure: BPG CMD(h) recommendations on unforeseen variations; Flow Chart for Recommendations on unforeseen variations - Request to CMD(h); Timetables for resquest ...

HMA: Paediatric Regulation

10.04.2009
HMA: Paediatric Regulation: Paediatric Regulation:Article 29 Recommendations for implementing Commission Decisions following an Art. 29 Application under the Paediatric Regulation ...

HMA: Additional legacy in Product Information

10.04.2009
Additional hypotensive effects following co-administration of non-selective alpha-blockers and phosphodiesterase-5-inhibitors Hydrochlorothiazide and use during pregnancy ...

EDQM: New homoeopathic manufacturing methods for consultation

10.04.2009
The European Pharmacopoeia Commission has undertaken to introduce homoeopathic manufacturing methods into the European Pharmacopoeia. Methods 1 to 4 are already published in monograph 2371 Methods ...

MHRA: New guidance on consumer advertising for registered traditional herbal medicines

10.04.2009
The MHRA has developed advice for companies about the rules governing the advertising of registered traditional herbal medicines to consumers. The MHRA wants to help companies to work within the ...

MHRA: Guidance on changes to labelling and patient information leaflets for self certification: Inclusion of Braille on the labelling

10.04.2009
From 1 April 2009 compliance with article 56(a) of Council Directive 2001/83/EC may be achieved (in certain prescribed conditions) by means of a Better Regulation of Medicines Initiative (BROMI) ...

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