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Polish Ministry of Health: The project of the Act related to the change of the Pharmaceutical Law

02.09.2010
The project of the Act related to the change of the Pharmaceutical Law including changes in Art. 15 and Art. 16. ...

EMA: Herbal Medicinal Products: Valeriana/Humulus, Valerianae radix/Lupuli flos, Valeriana officinalis L. / Humulus lupulus L.

02.09.2010
Final community herbal monograph, opinion, assessment report, list of references, overview of comments on Valeriana officinalis L., radix and Humulus lupulus L., flos ...

MHRA: First draft of the consolidated medicines regulations

02.09.2010
The MHRA is undertaking a consolidation and review of medicines legislation. The aim of the project is to ensure that the legislative framework for medicines is comprehensive, comprehensible and ...

MHRA: Variations legislation 2010 - details of our experience to date, submissions audit and update to FAQs

02.09.2010
The new Variations Regulation (EC/1234/2008) took effect on 1 January 2010. This immediately applied to variations to marketing authorisations covered by European procedures. However, the MHRA has ...

FDA: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 12 Analytical Sieving General Chapter

02.09.2010
This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their ...

Polish Office of Registration: Statement concerning the terms for batch number and expiry date to be used on inner labelling.

26.08.2010
Statement of the President of the Registration Office concerning the terms for batch number and expiry date to be used on inner labelling. ...

HMA: Additional Data requested for New Applications in the Mutual Recognition and Decentralised Procedures

26.08.2010
Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B. Presentation and format of the dossier Common Technical Document(CTD) ...

EMA: Scientific guideline: Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders

26.08.2010
The scope of this document is restricted to treatment of seizures in epileptic disorder although there are some remarks concerning non-seizure features of epilepsy syndromes. The guideline is ...

MHRA: Variations legislation 2010 - details of our experience to date, submissions audit and update to FAQs

26.08.2010
The new Variations Regulation (EC/1234/2008) took effect on 1 January 2010. This immediately applied to variations to marketing authorisations covered by European procedures. However, the MHRA has ...

FDA: Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment

26.08.2010
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of acute bacterial skin and skin structure infections (ABSSSI), impetigo, and minor ...

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