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.
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 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.
The European Industrial Pharmacists Group (EIPG) has followed with interest the implementation of a European medicines verification system in line with the provisions of the Falsified Medicines Directive and the Delegated Regulation laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use. EIPG is aware that the implementation of this system by the deadline of February 2019 represents a considerable challenge for all stakeholders, and that all players will need to be involved in the process to ensure its success. With this principle in mind, EIPG dedicated a Working Group at its recent 50th General Assembly in Paris, and approved the following observations and recommendations.
- A new version of Annex 16 (Certification by a Qualified Person and Batch Release) to the Good Manufacturing Practices (GMP) Guidelines came into operation on the 15th April 2016. Although the Annex came into operation after the publication of the Delegated Regulation, it contains little specific guidance in respect of the Delegated Regulation, the Unique Identifier or the Repositories System. EIPG therefore recommends that work should start immediately on a new review of Annex 16 to determine Qualified Persons’ responsibilities and appropriate Qualified Person guidance in respect of the Delegated Regulation.
- The verification and authentication of medicinal products will involve Responsible Persons at wholesale dealer levels. The European Commission’s Good Distribution Practices (GDP) Guidelines include recommendations for qualification and approval of suppliers, as well as provisions for documentation that need to take into account the way the repositories system will maintain records. EIPG recommends that, within the time period required to set up the repositories system, practices falling within the scope of the European Commission GDP Guidelines need to be regularised and harmonised across Member States, and that work should start immediately on a review of the GDP Guidelines to determine Responsible Persons’ responsibilities and appropriate guidance in respect of the Delegated Regulation.
- The Delegated Regulation states that “It should be left to the choice of the wholesaler whether to scan individual unique identifiers or aggregated codes, where available, or the timing of the verification, provided that the wholesaler ensures the verification of all unique identifiers of those products at higher risk of falsification in his physical possession.” The recent Question and Answer document issued by the Commission furthermore indicates that “it is possible to verify the authenticity of or decommission multiple unique identifiers by scanning an aggregated code rather than scanning each individual pack, provided that the requirements of Regulation (EU) No 2016/161 are complied with.” EIPG recommends that more specific guidance be issued with regards to the use of aggregation in the contexts of verification and decommissioning.
- The Delegated Regulation provides for a number of scenarios where requirements are to be established by the Member States, such as the inclusion of a national reimbursement number or other national number identifying the medicinal product in the unique identifier. A timely decision by Member States is required to allow manufacturers and marketing authorisation holders to prepare for the implementation of the Regulation, since such decisions can impact the activities of many marketing authorisation holders. Such timeliness and coordination is even more necessary where packs are shared between Member States. EIPG therefore recommends that Member State decisions required by the Delegated Regulation are taken as soon as possible, and coordinated between Member States in order to allow marketing authorisation holders to make the necessary preparations for the implementation of the Regulation within the established timeframes.
- EIPG has determined that, in the light of the various activities described within the Delegated Regulation, in particular Article 23, which provides that “Member States may require, where necessary to accommodate the particular characteristics of the supply chain on their territory, that a wholesaler verifies the safety features and decommissions the unique identifier of a medicinal product before he supplies that medicinal product to any of the following persons or institutions”, Responsible Persons, or individuals to whom Responsible Persons may have delegated their duties, can, insofar as the activities of verification and decommissioning are concerned, be considered to be assuming responsibilities identical to those of persons entitled to supply medicinal products to the public. EIPG is therefore of the opinion that such individuals, or their representatives, are, as provided in Article 31 of the Delegated Regulation, entitled to be consulted and to participate in the legal entity or entities responsible for setting up and managing the repositories system, on a voluntary basis, at no cost. EIPG therefore recommends that, as a matter of principle:
- Associations of stakeholders at a national or a pan-European level representing users or potential users of the European or National Medicines Verification System (EMVS or NMVS) for verification and/or authentication purposes should be eligible for affiliate membership in the European or National Medicines Verification Organisation (EMVO or NMVO), respectively
- Affiliate members should enjoy the right to be consulted on all activities of the EMVO or NMVO that will affect their members, and not only those activities that may be decided by the voting members of the EMVO or NMVO
- Affiliate members should enjoy the right to be consulted at no cost, and therefore, without obligation to pay any form of membership or participation fee.
EIPG has been invited to join as a partner in an important European educational project addressed to master students willing to achieve a doctorate level degree. This project, called MOGLYNET, involves five European universities (Milan, Antwerp, Leiden, Aberdeen and Barcelona) and the participation of a few industrial partners and professional association partners, who have offered their support in terms of consultancy, training and assistance to the development of the research and educational activities of 12 doctorate candidates. In particular, EIPG will be involved in the recruitment phase of students for this project and in the assistance for setting up appropriate training courses promoting an integrated knowledge between university research and pharmaceutical industrial expectations. Anni Svala, EIPG Vice-President Education and Careers and Finnish delegate, is in charge of representing EIPG in this project.
The European Medicines Agency recently released a concept paper on the development of a guideline on quality and equivalence of topical products for public consultation. EIPG has reviewed the document and, following feedback from its members, has submitted its comments to the EMA.
Read the EIPG Feedback on the Concept paper