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EMA: Herbal Medicinal Products: Leonurus, Leonuri cardiacae herba, Leonurus cardiaca L

29.12.2010
Community herbal monograph on Leonurus cardiaca L., herba; Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Leonurus cardiaca L., herba ; Overview of ...

EMA: Regulatory and procedural guideline: User guide for micro, small and medium-sized enterprises (SMEs) on the administrative and procedural aspects of the provisions, laid down in Regulation (EC) No 726/2004, that are of particular relevance to SMEs

29.12.2010
This guide has been prepared for micro, small and medium-sized enterprises (SMEs) operating in the pharmaceutical sector. Its aim is to facilitate understanding of the main aspects of medicinal ...

European Commission: Public consultation of the revised chapter 5 of the GMP laying down the detailed guidelines for production

29.12.2010
This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for ...

HMA: Requirements on electronic submissions for Renewals & Variations within MRP, DCP or National procedures

19.12.2010
Most NCAs are now ready to receive electronic-only applications and applicants are therefore strongly encouraged to submit in electronic format (eCTD or NeeS) to these NCAs, even if many still ...

EMA: Scientific guideline: Concept paper on revision of: Note for Guidance on the Clinical investigation of human normal immunoglobulin for subcutaneous and intramuscular use (CPMP/BPWG/283/00), draft

19.12.2010
Subcutaneous and intramuscular immunoglobulin (SCIg/IMIg) products are prepared from pooled human plasma from not fewer than 1000 donations and contain mainly immunoglobulin G (IgG) with a broad ...

EMA: Regulatory and procedural guideline: Annex I variation application(s) content for live attenuated influenza vaccines, draft

19.12.2010
MAHs shall submit a Type II variation application containing the adequate quality documentation in accordance with Article 18 of Commission Regulation (EC) No 1234/2008, by the Agency recommended ...

EMA: Scientific guideline: Concept paper on revision of note for guidance for the determination of withdrawal periods for milk, draft

19.12.2010
In 2000 the note for guidance for the determination of withdrawal periods for milk (EMEA/CVMP/473/98-FINAL) was adopted by the CVMP. Paragraph 2.1.10. thereof addresses dry cow products. Dry cow ...

EMA: Scientific guideline: ICH guideline Q4B annex 7 (R2) on dissolution test – general chapter

19.12.2010
This annex is the result of the Q4B process for Dissolution Test. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). ...

EMA: Biosimilar medicines

19.12.2010
A similar biological or \'biosimilar\' medicine is a biological medicine that is similar to another biological medicine (the ‘biological reference medicine’) that has already been authorised ...

EMA: Scientific guideline: Draft guideline on similar biological medicinal products containing monoclonal antibodies, draft

19.12.2010
This guideline lays down the non-clinical and clinical requirements for monoclonal antibody (mAb) containing medicinal products claiming to be similar to another one already marketed. The ...

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