The European Commission has launched a targeted stakeholder consultation on the revised guidelines on excipients in the labelling and package leaflet of medicinal products for human use.
According to Article 63(e) of Directive 2001/83/EC the Commission, in consultation with the Member States and the parties concerned, the Commission shall draw up and publish detailed guidance concerning the list of excipients which must feature on the labelling of medicinal products and the way in which these excipients must be indicated. The original Guidelines on excipients in the labelling and package leaflet of medicinal products for human use were adopted in 2003. These regulatory guidelines are part of Volume 2C of the Notice to Applicants. An amended version of the Guidelines have been prepared in order to reflect the development since publication of the original version. Opinions of the targeted stakeholders on this amended version are being sought. More information is available on the Commission’s website, where the consultation document can also be found.
Comments can be submitted by the 1st May to the contact persons of the EIPG Member Associations.
A Training School on “Medicines Shortages” (COST Action CA15105) addressing Pharmaceutical Supply Chains (SC) is being organized by the Instituto Politécnico de Portalegre (IPP). The programme stakeholder and local organiser is Prof. Joao Luis Miranda. Teachers, researchers, MSc/PhD students and practitioners will meet at Instituto Superior Técnico (IST), Lisboa, Portugal, between the 26th and 28th of April 2017, to discuss topics relevant to the Pharmaceutical Supply Chain within the COST Action “Medicines Shortages” (CA15105), European Medicines Shortages Research Network – addressing supply problems to patients.
The program consists of a seminar that is open to the general public on the first day. The seminar will introduce the Action, its main goals, methodology and workplan; the participants in the seminar will also gain a complete overview of the Training School, since the main topics of the technical sessions in the following days will also be presented.
Attendance of all three days of the school is strongly recommended for those participants interested in Medicines Shortages and in the Pharmaceutical Supply Chain. However, attending either the seminar, the workshop, or only one of the technical sessions is possible upon registration.
A Registration Form is available online. The deadline for registration was originally the 26th February, but has now been extended to Sunday 5th March.
Additional information about the Speakers, Program or other topics of interest is available on the event website or by contacting the Portuguese Coordinator directly.
EPSA and EIPG will be launching their 2017 program for joint webinars with a Webinar on the Falsified Medicines Directive on the 27th February. The speakers will include Sue Kilby, a member of the Industrial Pharmacists Forum of the Royal Pharmaceutical Society, and Prof. Claude Farrugia, President of the European Industrial Pharmacists Group.
The European associations representing manufacturers of medicinal products, parallel distributors, pharmaceutical wholesalers and pharmacists have announced a series of recommendations on the provision of information, designed to help tackle medicines shortages.
Focusing on the transparency and the availability of medicine shortage data, the Associations’ statement is part of their wider commitment to tackling the issue. Evidence suggests it is an increasing problem across the European Union, having a significant impact on patients, on health professionals, on healthcare systems and suppliers.
The recommendations call for greater transparency and availability of medicines shortage data, early detection and assessment of potential shortages, consistency of reporting, increased access to the information available across all parts of the supply chain, improved data infrastructure, and collaborative governance processes.
The recommendations aim to mitigate the impact of shortages on patients, provide patients and health professionals with up-to-date, meaningful information and improve the ability of health systems to diagnose and solve supply issues as they arise.
This statement builds on existing good practices and recommends some specific features of ideal medicines shortages information systems. The European associations representing manufacturers of medicinal products, parallel distributors, pharmaceutical wholesalers and pharmacists hope that, taking into consideration the national specificities of each country, these recommendations can help enhance information systems at a national level, and potentially form the basis of future European level action.
Joint Supply Chain Actors Statement on Information and Medicinal Products Shortages
The European Medicines Agency recently launched a public consultation on a draft Concept paper on Good Manufacturing Practice and Marketing Authorisation Holders. EIPG has reviewed the document and, following feedback from its members, has submitted its comments to the EMA.
Read the EIPG Feedback on the draft Concept Paper.
The December 2016 issue of european Industrial Pharmacy, the journal of EIPG, has been published, and is now available online in the “EIPG Journal” section of the website.
The European Commission recently launched a targeted stakeholder consultation on draft Guidelines on Good Manufacturing Practice for Advanced Therapy Medicinal Products, pursuant to Article 5 of Regulation 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC, that requires the Commission to draw up guidelines on good manufacturing practice specific to advanced therapy medicinal products. EIPG has reviewed the documents and. following feedback from its members, has submitted its comments to the Commission.
Read the EIPG Feedback on the proposed Guidelines.