European Commision: Maximum Residue Limits - Key documents

Substances considered as not falling within the scope of Council Regulation (EEC) No 2377/90. Updated version (revision 14 April 2009) from the Committee for Veterinary Medicinal Products. The ...

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

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 ...

EMEA: Regulatory and Procedural Guidance - Article 58 Applications

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)

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

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

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

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

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

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 ...

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