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EMEA: EMEA PCWP and HCP WG report on information on benefit-risk of medicines: patients' consumers' and healthcare professionals' expectations

27.07.2009
The present document addresses the communication aspect in the light of society’s need for transparent information on the benefits and risks of medicines. It has been prepared in association ...

EMEA: CHMP Recommendations for the Pharmacovigilance Plan as part of the Risk Management Plan to be submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccine (EMEA/359381/2009)

27.07.2009
This document applies to the pharmacovigilance plan as part of the risk management plan introduced with the authorisation application of mock-up pandemic influenza vaccines according to the CHMP ...

EDQM: 134th session of the European Pharmacopoeia Commission

27.07.2009
In its session, the European Pharmacopoeia Commission adopted 91 monographs and 9 general chapters, amongst them a new general chapter on recommendations on dissolution testing (5.17.1) and two ...

European Commission: Variations (codecision part): publication of amendments to Directive 2001/82/EC and Directive 2001/83/EC.

27.07.2009
Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing ...

European Commission: New regulation on Maximum Residue Limits has entered into force

27.07.2009
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: New reclassifications of medicines

27.07.2009
A brief summary of reclassifications that have been approved in the past 12 months. ...

MHRA: Marketing Authorisation applications for medicines using the Decentralised procedure (DCP) with the UK as Reference Member State (RMS): New or earlier slots available in all therapeutic areas

27.07.2009
As a result of cancellations and delays in submissions for booked DCP slots, MHRA has some capacity in all therapeutic areas to offer new or earlier slots to applicants for procedures commencing ...

MHRA: Adverse drug reaction (ADR) reports received by the MHRA from literature articles

27.07.2009
This section provides a list of UK spontaneous adverse drug reaction (ADR) reports based on articles from the scientific literature. The list is updated daily and provides the MHRA ADR reference ...

Polish Ministry of Health: The project of Act of the Pharmaceutical law

23.07.2009
Polish Ministry of Health published the amendment of Act of the Pharmaceutical law. Comments for this act can be apply till 18 of August. ...

EDQM: Actions taken by the EDQM.

22.07.2009
The EDQM announces the suspension of the following CEPs. ...

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