.From the Bureau

The Practical Implementation of EU Regulations for Medical Devices and in vitro Diagnostic Medical Devices (Webinar)

In EIPG’s and PIER’s next webinar, John Deavin will review current Medical Device Directives and the timetable for transition to the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), the proposed UK system.

This is an event for members of EIPG member organisations, Contact your national association EIPG representative for further information.

Annex 1 – a focus on its main issues (Webinar)

EIPG and Tecniche Nuove’s next webinar, presented by Dr Francesco Bosci, summarizes the most relevant comments to the V12 draft document of Annex 1 (appendix of Eudralex Vol. 4 EU GMP) as developed by the EIPG national working groups and delivered to EC for consideration for the preparation of the final Annex to be published. Comments are mainly focused on the key issues about the aseptic process, such as premises, personnel, production technologies and process monitoring.

This is an event for members of EIPG member organisations, Contact your national association EIPG representative for further information.

How a pandemic has affected the pharma industry (Webinar)

In EIPG’s and PIER’s next webinar, Dr Sheuli Porkess will review the changes in the way research is being undertaken as a result of COVID with the current extraordinary collaboration between industry, academia, charities, foundations and public-private partnerships, and contemplate whether these changes are likely to continue in a highly competitive industry. She will discuss how to achieve robust research “at a pace” especially when vaccines for the elderly do not usually produce extensive immune response. She will explain the positive aspects of the management of clinical trials during COVID and whether there are likely to be permanent changes resulting from the experience with COVID. She will reflect on what we have learnt about the sudden switching to manufacture of medicinal products needed in Intensive Care Units and other supportive medicines for COVID patients. She will consider whether the established management systems set up to prevent shortages of medicines are working post-COVID or whether COVID-related medicines are causing shortages of other medicinal products.

This is an event for members of EIPG member organisations, Contact your national association EIPG representative for further information.

EIPG publishes updated version of Code of Practice for Qualified Persons

The EIPG Code of Practice for Qualified Persons has been conceived with the aim of offering an updated view of the legal and technical requirements pertaining to the position of the Qualified Person (QP) in Europe. The added value of this document is represented by the comments and recommendations which have been added to each requirement, taking into account the practical experience of many European industrial pharmacists in their role of QPs.

Authored by EIPG Vice-President Technical and Professional Development Piero Iamartino and EIPG Vice-President European Affairs Maurizio Battistini, with contributions by Luciano Gambini (Italy), and contributions from Italy, Belgium, Spain, UK and Czech Republic, the scope of this document to provide a living Code of Practice by ensuring a constant updating as a consequence of the introduction of new European requirements pertaining to the QP and considering the possible integration of new comments based on the contributions of EIPG members.

The EIPG Code of Practice for Qualified Persons 2020 is available on the EIPG Website in the EIPG Guides and Codes section.

Consultation on Annex 21: Importation of medicinal products, of the EudraLex Volume 4 (Webinar)

EIPG’s and PIER’s next webinar, presented by Stan O’Neill, will address the European Commission’s has targeted stakeholders’ consultation on the draft Annex 21: Importation of medicinal products, of the EudraLex Volume 4. This new Annex, in which the Qualified Person (QP) has a key role, and which has been under discussion for a long time, provides guidance for the interpretation of the principles and guidelines of GMP for both human and veterinary medicinal products. The document intends to bring clarity to areas which have been unclear for some time, and the speaker will discuss the background to the Annex, the challenges which have existed within the EU Regulatory Framework, and how the proposed Annex may or may not address these challenges. The speaker will suggest potential areas of concern, and how delegates may wish to communicate these to the European Commission both via the European Commission’s own communication process, and through the participation of their member organisations in the consultation process within the European Industrial Pharmacists Group.

This is an event for members of EIPG member organisations, Contact your national association EIPG representative for further information.

The role of the body clock in drug development, efficacy and toxicity (Webinar)

EIPG’s and PIER’s next webinar, presented by Dr Annie Curtis, will cover the role of the body clock in drug development, efficacy and toxicity. For centuries we have known that rhythms in our physiology exist so that our bodies stay in tune with the daily cycle, imposed by the rotation of the Earth. Twenty years ago scientists began to genetically pick apart the molecular make-up of these rhythms, and discovered that each of our cells has the capacity to tell the time of day. This has opened up a new field in biology, called chronobiology, which is the study of our body clocks in health and disease. Today, this field has begun to unpick the implications of our body clocks in terms of drug development, efficacy and toxicity. This has major implications as up to half of the 100 top selling medicines are against a target that is controlled by our molecular clock, leading to daily changes in the expression of this target. Chronotherapy has the aim of harnessing our body clocks and these subsequent rhythms to improve the efficacy and safety of drugs.

This is an event for members of EIPG member organisations, Contact your national association EIPG representative for further information.

Medicines shortages: root causes and potential solutions

Medicines shortages are a significant cause of concern for patients, clinicians and our public health. They impact on patients’ health outcomes by causing delays in treatment or forcing changes in treatment regimes as well as inducing a great deal of stress and worry to patients and their families.

The European associations representing manufacturers of vaccines and medicines, parallel distributors, pharmaceutical full-line wholesalers and industrial pharmacists are committed to working with the EU and member states to progress short term and longer term solutions addressing the root causes of medicines shortages that occur across Europe.

The root causes of medicines shortages include manufacturing, quality, economic, and supply chain issues. Our associations are committed to stepping up efforts to prevent and to mitigate medicines shortages. As a group, we believe that the root causes of shortages can be addressed by a set of short term and longer term solutions including harmonising data and monitoring medicines shortages at EU level, creating regulatory incentives for essential low-priced medicines, allowing regulatory flexibility and improved regulatory efficiency to mitigate shortages, and ensuring market stability and sustainability.

We call for a dialogue with EU and national competent authorities in order to implement solutions effectively addressing the root causes of shortages in the short, medium and long term perspectives rather than placing short term disproportionate requirements on manufacturers and supply chain stakeholders that could have opposite effects to the ones intended.

ENDS

Notes to Editors

1. The joint paper on addressing the root causes of medicines shortages in full can be accessed here.

2. The joint paper has been developed and agreed by the following organisations:

• The Association of the European Self-Medication Industry (AESGP) is the official representation of manufacturers of non-prescription medicines, food supplements and self-care medical devices in Europe. AESGP was founded in 1964 to contribute to the improvement of responsible self-medication at the European level and to ensure that the value of responsible self-care is recognised in pharmaceutical, food and health matters.

• The European Association of Euro-Pharmaceutical Companies (EAEPC) represents Europe’s licensed parallel distribution industry, an integral part of the European pharmaceutical market that adds value to society by introducing price competition and a supplementary layer of safety for medicines. We represent 125 companies in 23 EU/EEA Member States. These members account for approximately 85% of the total parallel import market volume in the EU/EEA.

• The European Industrial Pharmacists Group (EIPG) is a European association representing the national, professional organizations of pharmacists employed in the pharmaceutical or allied industries of the Member States of the European Union, the European Economic Area, or European countries having a mutual recognition agreement with the European Union on compliance control of regulated medicines.

• The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through its direct membership of 36 national associations and 39 leading pharmaceutical companies, EFPIA’s mission is to create a collaborative environment that enables our members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy. Our vision is for a healthier future for Europe. A future based on prevention, innovation, access to new treatments and better outcomes for patients.

• The European Healthcare Distribution Association (GIRP) is the umbrella organisation for pharmaceutical full-line wholesalers and distributors of healthcare products and services in Europe. It represents the national associations of over 750 pharmaceutical wholesalers serving 34 European countries, as well as major international and pan-European healthcare distribution companies. GIRP members employ over 140,000 people and distribute around 15 billion packs of medicines as well as a wide range of healthcare products per year. As the vital link in healthcare, they are committed to developing and providing innovative and efficient healthcare products and services to improve health and wellbeing of patients across Europe.

• Medicines for Europe (formerly EGA) represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members employ 160,000 people at over 350 manufacturing and R&D sites in Europe, and invest up to 17% of their turnover in medical innovation.

• Vaccines Europe (VE), is a specialised vaccines group within the European Federation of Pharmaceutical Industries and Associations. Formed in 1991, Vaccines Europe represents major innovative research-based vaccine companies as well as small and medium sized enterprises operating in Europe which account for a large share of human vaccines used worldwide. Companies represented within Vaccines Europe are involved in research and development (R&D), clinical trials, production and marketing of vaccines and are dedicated to improving public health through immunisation.

GMP documentation management: requirements and best practices (Webinar)

EIPG’s and PIER’s next webinar, presented by Alessandro Regola, will cover the GMP requirements and the practical implementation of a management system for quality related documentation. After an introduction referencing the relevant GMP norms and guidances, the different types of documents will be described with their function in the Quality System and their requirements. Paper and electronic based systems will be described with their peculiarities. The presentation will continue with a description of the most frequent deficiencies in documentation management, including some examples of Authorities’ observations during inspections (observations from FDA, EMA and MHRA inspections will be presented). Finally, some best practices will be presented, combining GMP compliance and efficiency in documentation management and recommended by the speaker based on his experience.

This is an event for members of EIPG member organisations, Contact your national association EIPG representative for further information.

EIPG notes risk of shortages of medicines in Europe arising from the Falsified Medicines Directive and Brexit

During the EIPG General Assembly held in Casablanca on 5 and 6th May, two Working Groups reviewed the implications for Qualified Persons of the Falsified Medicines Directive and the impact of Brexit on European industrial pharmacists in their roles to ensure availability and accessibility of quality, safe and efficacious medicinal products for patients.

The first Group considered the responsibilities of Qualified Persons involved in serialisation. The structure of a guidance document was discussed and it was recommended to issue the publication as soon as possible after this General Assembly, due to the impending deadlines and increased serialisation activities.

The second Group recommended that clarity is required for the Qualified Persons of pharmaceutical importers in terms of their roles and responsibilities in view of the technological challenges arising from serialisation which they will have to face. The Group noted that all actors in the pharmaceutical supply chain must adapt their quality systems in considerably short time frames and this relies heavily on key individuals, in particular Qualified Persons and Responsible Persons.

Commenting on the outcomes of the Working Groups, EIPG President Claude Farrugia noted that since the Falsified Medicines Directive deadline coincides with Brexit, this exacerbates the potential risk to the availability of medicines.

EIPG Feedback on Revised Annex 1

The European Commission recently launched a targeted stakeholders consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of the Eudralex Volume 4. EIPG has reviewed the document and, following feedback from its members, has submitted its comments to the EMA.

Read the EIPG Comments on the revised Annex 1.

Supply chain commitment to tackling problem of medicine shortages

The European associations representing manufacturers of medicinal products, parallel distributors, healthcare distributors and pharmacists welcome pan-European efforts by the Heads of Medicine Agencies [1], the European Medicines Agency, the Council [2] and the European Commission [3] to address medicine shortages. Supply chain stakeholders believe that the long-term resolution of medicines shortages is dependent upon collaborative and unified actions. We therefore call for the inclusion of the supply chain actors in the above-mentioned initiatives organized by Governments and the regulatory community.

Ahead of the Bulgarian Presidency event ‘Health as the Real Winner: Presidency conference on options to provide better medicines for all’ on 6 March in Sofia, supply chain stakeholders call for their greater involvement in discussions about medicines shortages. Specifically, supply chain stakeholders wish to make the Health Ministers aware of an existing collaboration on this crucial issue, created with the objective of helping to mitigate the impact of shortages. Furthermore, supply chain stakeholders strongly believe that the input, perspectives and experience of the variety of stakeholders affected by the issue of shortages needs to be sought and taken on board to reach best-informed conclusions.

The supply chain partners have set up an informal working group in 2015 and published a set of recommendations in early 2017 [4] calling 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 stakeholder governance processes. The Associations’ statement4 is part of their wider commitment to tackling the increasing problem of shortages across the European Union, having a significant impact on patients, health professionals, healthcare systems and manufacturers and distributors.

1. HMA/EMA Task Force on Availability of authorised medicines for human and veterinary use (TF AAM)
2. Health as the Real Winner: Presidency conference on options to provide better medicines for all
3. Commission Expert Group on Safe and Timely Access to Medicines for Patients (“STAMP”)
4. Joint Supply Chain Actors Statement on Information and Medicinal Products Shortages

Notes to Editors

1. The recommendations in full can be accessed here.
2. The recommendations have been developed and agreed by the following organisations
   • The Association of the European Self-Medication Industry (AESGP) is the official representation of manufacturers of non-prescription medicines, food supplements and self-care medical devices in Europe. AESGP was founded in 1964 to contribute to the improvement of responsible self-medication at the European level and to ensure that the value of responsible self-care is recognised in pharmaceutical, food and health matters. http://www.aesgp.eu/
   • The European Association of Euro-Pharmaceutical Companies (EAEPC) is the representative voice of pharmaceutical parallel distribution in Europe. Through national association or individual company membership it encompasses more than 100 companies from 23 countries in the European Economic Area (EEA). The EAEPC’s primary aims are to safeguard the free movement of medicines, as laid down in the EU treaty, and to counteract any attempts to restrict the freedom of choice for the consumer through trading patterns in breach of European competition law. The Association believes that free trade will lead to improvements in health standards through the provision of innovative medicines at lower cost, benefiting statutory healthcare systems, other third-party payers, and the public as both patients and taxpayers, as well as assisting the EU to achieve its objective of a single, internal market. More information www.eaepc.org
   • The European Association of Hospital Pharmacists (EAHP) represents c. 21,000 hospital pharmacists across 35 European countries. More information about its activities in respect to medicines shortages is available at http://www.eahp.eu/practice-and-policy/medicines-shortages
   • The European Industrial Pharmacists Group (EIPG) is a European association representing the national, professional organizations of pharmacists employed in the pharmaceutical or allied industries of the Member States of the European Union, the European Economic Area, or European countries having a mutual recognition agreement with the European Union on compliance control of regulated medicines. https://eipg.eu/
   • The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients’ new medicines that will improve health and the quality of life around the world. https://www.efpia.eu/
   • The European Healthcare Distribution Association (GIRP) is the umbrella organisation for pharmaceutical full-line wholesalers and distributors of healthcare products and services in Europe. It represents the national associations of over 750 pharmaceutical wholesalers serving 32 European countries, as well as major international and pan-European healthcare distribution companies. GIRP members employ over 140,000 people and distribute around 15 billion packs of medicines as well as a wide range of healthcare products per year. As the vital link in healthcare, they are committed to developing and providing innovative and efficient healthcare products and services to improve health and wellbeing of patients across Europe. http://www.girp.eu/
   • Medicines for Europe represents the generic, biosimilar and value-added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members employ 160,000 people at over 350 manufacturing and R&D sites in Europe and invest up to 17% of their turnover in medical innovation. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.
   • The Pharmaceutical Group of the European Union (PGEU) is the association representing community pharmacists in 32 European countries. In Europe over 400.000 community pharmacists provide services through a network of more than 160.000 pharmacies, to an estimated 46 million European citizens daily. PGEU’s objective is to promote the role of pharmacists as key players in healthcare systems throughout Europe and to ensure that the views of the pharmacy profession are taken into account in the EU decision-making process. For more information please visit the PGEU website www.pharmacy.eu
3. For more information please contact: [email protected]

european Industrial Pharmacy Issue 35 published

The December 2017 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.

EIPG Bureau meets Ordre des Pharmaciens industrial pharmacist representatives

The EIPG Bureau met industrial pharmacist representatives of the French Ordre des Pharmaciens at a meeting held at the premises of the Ordre in Paris. EIPG President Claude Farrugia updated the Ordre with the latest activities of EIPG, whilst Section B President Frédéric Bassi outlined the roles and responsibilities of French industrial pharmacists. Both parties expressed their satisfaction at the opportunity to update each other on their respective activities, and on the outcome of the meeting. Commenting on EIPG’s social media, EIPG President Claude Farrugia said, “This was a very productive meeting between EIPG and industrial pharmacists of the Ordre des Pharmaciens. We are eager to work together, so that EIPG can support French industrial pharmacists, and so that French industrial pharmacists can contribute to the European industrial pharmacist family.”

EPSA and EIPG resume 2017 Webinars

EPSA and EIPG are resuming their 2017 program for joint webinars with a Webinar entitled “Insight to a New Medical Device EU legislation – new challenges ahead”, delivered by Petra Lehtinen, Senior Regulatory Affairs and Quality Management Specialist at PHAME, Biocodex Oy.

european Industrial Pharmacy Issue 34 published

The September 2017 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.

EIPG feedback on draft guideline for notification of serious breaches in clinical trials

The European Medicines Agency recently launched a public consultation on a draft guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol. 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 guideline.

EIPG Comments on Two EMA Papers for Consultation

The European Industrial Pharmacists Group is preparing comments on two more documents submitted for consultation by the European Medicines Agency.

The first document is “Scientific guideline: Concept paper on an addendum on terms and concepts of pharmacogenomic features related to metabolism to the Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products (EMA/CHMP/37646/2009), draft: consultation open“. This addendum to the guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products (EMA/CHMP/37646/2009) intends to provide clear definitions of terms used for metabolic phenotyping, as well to propose concepts regarding the translation of genotypes into the predicted metabolic phenotype, of significant importance for the correct treatment of patients. The EMA consultation deadline is the 10th October, 2017. Comments can be submitted before the 5th October to the contact persons of the EIPG Member Associations, or directly to the EIPG Vice-President Technical and Professional Development, Piero Iamartino.

The second document is “Scientific guideline: Draft reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development, draft: consultation open“. The reflection paper provides current regulatory considerations regarding statistical aspects for the comparative assessment of quality attributes in the settings of pre- and post-manufacturing change, biosimilar development as well as generics development. It raises open issues from a methodological perspective addressing questions related to comparison objectives, sampling strategies, sources of variability, acceptance ranges and statistical analysis approaches to conclude on the similarity of two drug products based on quality attribute data. A main objective of the reflection paper is to establish a framework and a common language to facilitate future discussion among stakeholders and to invite comments in relation to the issues raised. The EMA consultation deadline is the 31st March, 2018. Comments can be submitted before the 1st December to the contact persons of the EIPG Member Associations, or directly to the EIPG Vice-President Technical and Professional Development, Piero Iamartino.

EIPG Request for Comments on EMA Draft Guideline

The European Medicines Agency have published: Scientific guideline: Draft guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol, draft: consultation open.

This guideline outlines the practical arrangements for notification of serious breaches of clinical trials authorised in the Europe Union / European Economic Area. It aims to provide advice on what should and what should not be classified as a serious breach and what must be reported. It does not include guidance related to urgent safety measures or other reporting obligations related to subject safety. More information is available on the EMA’s website.

The EMA consultation deadline is the 22nd August, 2017. Comments can be submitted before the 18th August to the contact persons of the EIPG Member Associations, or directly to the EIPG Vice-President Technical and Professional Development, Piero Iamartino.

EIPG comments on latest Eurostat statistics on international trade in medicinal and pharmaceutical products

The European Industrial Pharmacists Group (EIPG) notes with satisfaction the latest figures issued by Eurostat in regards of international trade by Member States of the European Union in medicinal and pharmaceutical products. The figures point to the pharmaceutical industry, in the area of export of medicinal products, as a key contributor to the economy of the European Union, leading other global areas in the sector. This success is due, in no small manner, to the role of professionals operating within the sector, in particular the industrial pharmacist. EIPG therefore takes this opportunity to highlight the importance of the industrial pharmacist as a key professional within the European pharmaceutical industry, and to solicit the importance of ensuring that industrial pharmacy remains a key component of pharmacy curricula throughout Europe, as well as to ensure that suitable opportunities continue to be made available for pharmacy students and graduates choosing this career path.

EIPG also notes that that the importation activity of medicinal and pharmaceutical products within the European Union is second only to that of the United States. This highlights the importance of the various measures within the Falsified Medicines Directive that have the objective of preventing falsified medicinal products from reaching patients in Europe. Here, again, industrial pharmacists are individuals whose role in the setting up of a European medicines verification system throughout the pharmaceutical supply chain must not be underestimated. EIPG, therefore, reiterates its opinion that the presence of professional associations representing industrial pharmacists within organisations responsible for the implementation of the system is important to ensure its success.

The European Industrial Pharmacists Group (EIPG) is a European association representing the national, professional organizations of pharmacists employed in the pharmaceutical or allied industries of the Member States of the European Union, the European Economic Area, or European countries having a mutual recognition agreement with the European Union on compliance control of regulated medicines.

Second COST Action CA15105 (Medicines Shortages) Training School

A second summer Training School on “Medicines Shortages” (COST Action CA15105 – European Medicines Shortages Research Network – addressing supply problems to patients) addressing Pharmaceutical Supply Chains II is being organized by the Instituto Politécnico de Portalegre (IPP) and Centro de Recursos Naturais e Ambiente (CERENA/IST), with the support of IBM Portugal and TAP Portugal. The programme stakeholder and local organiser is Prof. Joao Luis Miranda. Teachers, researchers, MSc/PhD students, post-docs, and practitioners will meet at the College of Technology and Management (ESTG/IPP), Portalegre, Portugal, 03-07 of July-2017, to discuss “Medicines Shortages” topics.

The program consists of a seminar that is open to the general public on the first day (3rd July). The seminar will present other relevant challenges to the Action, and the participants in the seminar will also gaining a complete overview of the Training School, since the main topics of the technical sessions in the following days will also be introduced.

Attendance at all five 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 workshops, or only one of the technical sessions is possible upon registration.

Beyond the active participation in the technical sessions, young researchers are also invited to present their works related to the Action subjects and to Pharmaceutical Supply Chain, either by Poster or in a special session for oral presentations.

A Registration Form is available online.

Additional information about the Speakers, Program or other topics of interest is available on the event website or by contacting the Portuguese Coordinator directly.

EIPG Comments on European Commission Public Consultation on Excipients Guidelines

The European Commission recently launched a targeted stakeholder consultation on the revised guidelines on excipients in the labelling and package leaflet of medicinal products for human use. EIPG has reviewed the document and, following feedback from its members, has submitted its comments to the European Commission.

Read the EIPG Feedback on the targeted stakeholder consultation.

EIPG Feedback on draft Questions and Answers on Exposure Limits in Shared Facilities

The European Medicines Agency recently launched a public consultation on draft Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/SWP/169430/2012). 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 questions and answers.

EIPG Request for Comments on Excipients in Labelling and PIL

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.

COST Action CA15105 (Medicines Shortages) Lisbon Training School

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.

Joint Statement on Shortages

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.

EIPG Feedback on Concept paper on Good Manufacturing Practice and Marketing Authorisation Holders

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.

EIPG Feedback on draft Questions and Answers on production of Water for Injections

The European Medicines Agency recently launched a public consultation on draft questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies. 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 questions and answers.

EIPG Feedback on draft Guidelines on GMP for Advanced Therapy Medicinal Products

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.

EIPG Statement on Delegated Regulation for Safety Features

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.

1. 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.
2. 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.
3. 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.
4. 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.
5. 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 Feedback on proposed GMP Guidelines

The European Commission recently launched a public consultation on a Commission Delegated Act on principles and guidelines on good manufacturing practice for investigational medicinal products and on inspection procedures, pursuant to the first subparagraph of Article 63(1) of Regulation (EU) No 536/2014 and Detailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014. EIPG has reviewed the documents and. following feedback from its members, has submitted its comments on the Commission.

Read the EIPG Feedback on the proposed Commission Delegated Act and GMP Guidelines.

EIPG joins as partner in MOGLYNET project

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.

EIPG Feedback on Concept Paper on Topical Products

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