Hospital Pharmacy Europe - Legislation and regulation,

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Pharmacy Zone: Legislation and regulation

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Wed 8 May

EU proposals on medical device regulation do not go far enough
As the EU debates new legislation to regulate medical devices, experts in this week's BMJ argue that the proposals do not go far...

Mon 8 Apr

SMC accepts Eylea® for wAMD
The Scottish Medicines Consortium (SMC) has announced that Eylea® (aflibercept solution for injection, known in the...

Mon 8 Apr

SMC recommends abatacept
The Scottish Medicines Consortium (SMC) has announced today that abatacept (Orencia®) has been accepted for use within NHS...

Mon 8 Apr

NDA for Injectafer® accepted for review
Vifor Pharma has announced that its US partner, Luitpold Pharmaceuticals, Inc., has received confirmation from the US Food and...

Wed 3 Apr

Humira approved for JIA
AbbVie (NYSE: ABBV) has announced that the European Commission (EC) has approved an extension of the EC marketing authorisation...

Tue 2 Apr

2D barcoding in the safe labelling of pharmaceuticals
Efforts taken by Europe’s key pharmaceutical supply chain players to secure the legal supply chain and protect patient...

Tue 2 Apr

Supreme Court denial of Glivec patent
A decision issued on April 1st by the Indian Supreme Court regarding the Novartis breakthrough medicine Glivec® (imatinib...

Tue 12 Mar

Ruconest: drug evaluation
Recombinant human C1-inhibitor (Ruconest®) has been granted market authorisation in Europe for the treatment of acute...

Tue 29 Jan

Healthcare coalition on data protection
The Healthcare Coalition on Data Protection has published a joint statement highlighting the role of personal data in delivering...

Fri 23 Nov
2012

Legislation on falsified medicines applicable 2 January 2013
An excerpt from Council Directive 2011/62/EU

Fri 23 Nov
2012

Council Directive 2010/32/EU: impact on pharmacy team
Member States of the European Union (EU) have until 11 May 2013 to implement Council Directive 2010/32/EU. This article examines...

Fri 23 Nov
2012

Council Directive 2010/32/EU and needlestick injuries
Under-reporting of needlestick injuries will, if left untreated, seriously compromise implementation of Council Directive...

Fri 23 Nov
2012

ECJ rules on products covered by MDD
Case C-219/11 - Brain Products GmbH versus BioSemi VOF and others

Mon 15 Oct
2012

An excerpt from Council Directive 2010/32/EU
All hospitals have policies for avoiding, managing and reporting needlestick injuries but audits repeatedly show that there is...

Mon 30 Jul
2012

EMA releases further pharmacovigilance modules
Two modules of guideline on good pharmacovigilance practices are open to consultation until 21 September

Tue 24 Jul
2012

Global pharma unveils new strategy to tackle fake drugs
The group has launched the Center for Safe Internet Pharmacies initiative to target illegal pharmacies

Thu 12 Jul
2012

Pharma supply chain in Europe evolves
Pharma companies are joining third party logistics providers, such as direct to pharmacy

Thu 12 Jul
2012

EAHP calls for action on medicine shortages
President Roberto Frontini voiced his 'great fears for patient safety' if the problem worsens

Mon 9 Jul
2012

EMA updates drug interactions guideline
The Agency has made a major revision to its guideline on investigation of drug interactions

Thu 5 Jul
2012

Access to Regulatory Focus news and features 'free for July'
Open access RAPS materials extends to Focus mobile apps for the iPhone and iPad

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