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.

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.

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

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]

     Supply Chain Commitment to Tackling Problem of Medicine Shortages

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.

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 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.

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.

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.

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.

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.