Representante Autorizado (EC REP, European Authorized Representative)

La Directiva 93/42/CEE de productos sanitarios establece para todos los fabricantes de productos sanitarios  (activos e in vitro incluidos) establecidos fuera de la UE la obligatoriedad de contar con un Representante Autorizado, con las siguientes funciones: 

Risk minimisation strategy for high strength and fixed combination insulin products, addendum to the good practice guide on risk minimisation and prevention of medication errors

The guidance provides a strategy to minimise the potential risk of medication errors associated with the introduction of high strength insulins (i.e. higher than the EU-wide standard of 100 units/ml concentration) and fixed combinations of insulin with another non-insulin injectable blood glucose lowering agent.

Consultation start date: 14/04/2015

Consultation end date: 14/06/2015

Posted on the EMA website on 14 April 2015

Revipharm: Preventing medication errors in the European Union

Revipharm: Preventing medication errors in the European Union

Related documents:

• Good practice guide on risk minimisation and prevention of medication errors
• Good practice guide on recording, coding, reporting and assessment of medication errors

Preventing medication errors in the European Union

EMA invites comments on draft good practice guides

Posted on the EMA website on 14April 2015

The European Medicines Agency (EMA), on behalf of the European Union (EU) Regulatory Network, has released two draft good practice guides that aim to improve the reporting, evaluation and prevention of medication errors by regulatory authorities and pharmaceutical industry throughout the EU. The deadline for stakeholders to send their comments to EMA is 14 June 2015.

Medication errors are unintended mistakes in the prescribing, dispensing and administration of a medicine that could cause harm to a patient. They are the most common preventable cause of undesired harmful effects (adverse events) in medication practice and present a major public health burden.

With the entry into force of the EU pharmacovigilance legislation in 2012, reporting of all suspected adverse reactions resulting from medication errors became mandatory. Pharmaceutical companies and national regulatory agencies in the EU Members States are obliged to enter these adverse events in EudraVigilance, the EU adverse reaction collection and management system. The primary purpose of the two guides released today is to support industry and regulators in the implementation of these legal requirements.

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2015

PRAC recommends updating advice on use of high‑dose ibuprofen

The PRAC has completed a review confirming a small increase in the risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen (at or above 2,400 mg per day). No increase in cardiovascular risk is seen with ibuprofen at doses up to 1,200 mg per day, which is the highest dose generally used for over-the-counter (OTC) preparations taken by mouth in the European Union (EU).

The PRAC recommended updating the advice in the product information of ibuprofen medicines. The recommendations for ibuprofen also apply to dexibuprofen, a medicine similar to ibuprofen. A high dose of dexibuprofen is a dose at or above 1,200 mg per day.

PRAC recommends further measures to minimise known risk of osteonecrosis of the jaw associated with zoledronic acid-containing medicines and denosumab

The PRAC has conducted three periodic reviews of denosumab (Prolia, Xgeva) and the bisphosphonate medicine zoledronic acid (Zometa, Zoledronic acid medac, and other nationally authorised medicines). Osteonecrosis of the jaw is a known risk for these medicines. The PRAC recommended measures, including updates to the product information and the introduction of patient reminder cards, to further minimise the known risks.

These reviews, known as a periodic safety update single assessment (PSUSA), are part of the regular safety monitoring of medicines. These recommendations follow a similar recommendation for another bisphosphonate medicine containing zoledronic acid(Aclasta) in March 2015.  The PRAC will also consider similar measures for other intravenous bisphosphonates used for osteoporosis or for preventing bone complications of cancers. The measures will be considered during the upcoming and ongoing periodic reviews for these medicines, which are planned to take place over the course of 2015/2016.

Posted on the EMA website on 13 April 2015