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Ferring Pharmaceuticals Ltd

Ferring

Ferring is a family-owned, research-driven specialty biopharmaceutical group committed to helping people build healthy families and live better lives.

Lobbying Activity

Meeting with Sirpa Pietikäinen (Member of the European Parliament)

26 Mar 2025 · Fertility, SRHR and health innovations

Meeting with Irène Tolleret (Member of the European Parliament)

17 Nov 2022 · Par mon équipe - Droits des femmes

Meeting with Karen Melchior (Member of the European Parliament)

8 Nov 2022 · EU Health related to Fertility

Response to Labelling requirements for unauthorised medicinal products used in Clinical Trials

29 Jun 2022

Ferring Pharmaceuticals A/S is pleased with the opportunity to provide feedback to Annex to the amending Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards labelling requirements for unauthorised investigational and unauthorised auxiliary medicinal products for human use. Ferring Pharmaceuticals A/S finds it positive that Annex VI will be amended to include the option of omitting the period of use on the immediate packaging in the case where the immediate and outer packaging are intended to remain together and if the immediate packaging takes the form of blister packs and small unites such as ampoules. This will omit re-labelling of the immediate packaging related to period of use, e.g. extension of shelf-life and the associated risk of the quality of the clinical trial supply like temperature variations, re-opening of secondary packaging material multiple times related to the re-labelling process. This at the same time decreases the risk of disruptions and delays in the clinical trials related to re-labelling of the Clinical Trial Supply. Ferring Pharmaceuticals A/S would like to suggest that for Unauthorized Auxiliary Medicinal Products described in section B in Annex VI, that 6. (h) “the storage conditions; and” can be omitted on the immediate packaging in the case where the immediate and outer packaging are intended to remain together and if the immediate packaging takes the form of blister packs and small unites such as ampoules. The reason for this, is that storage condition will increase the complexity of the packaging of the supply, as this could mean the need of a larger label and as a result in need of lager secondary packaging material, hence the product can not be packed in the original secondary packaging material. This would mean that Annex VI to Regulation (EU) No 536/2014 is amended as follows for the storage conditions: (2) Section B is amended as follows: (a) the number of point “6.” is replaced by “6.1.”; (b) the following paragraphs B.6.2 and B.6.3 are added: “6.2. In the case where the immediate and outer packaging are intended to remain together, the outer package shall carry the particulars listed in section B.6.1. The immediate packaging shall carry the particulars listed in section B.6.1 with the exception of storage condition and the period of use (expiry date or re-test date as applicable) that can be omitted.” “6.3. If the immediate packaging takes the form of blister packs or small units such as ampoules, on which the particulars listed in section B.6.1 cannot be displayed, an outer packaging shall be provided bearing a label with those particulars. The immediate packaging shall contain the particulars listed in section B.6.1 with the exception of storage condition and the period of use (expiry date or re-test date as applicable) that can be omitted.”; (3) Section D is amended as follows: (a) in section D.9 points (b), (c) and (d) are replaced by the following: “(b) paragraph 4, points (b), (c) and (e); (c) paragraph 5, points (b), (c) and (e); (d) paragraph 6.1, points (b), (d), and (e) “ (b) in section D.9 the following point (e) is added: “(e) paragraph 6-1, point (h) and (i), with the exception of cases in which storage condition and the period of use (expiry date or re-test date as applicable) that can be omitted from the inner packaging in accordance with sections B.6.2 and B.6.3.“
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Response to Recommendation for strengthened actions against antimicrobial resistance

21 Mar 2022

AMR is one of the gravest threats facing our healthcare systems today. Supporting the development of new antimicrobials whilst encouraging conservative use of existing therapies is necessary, but this can only be one limited part of the solution. As the Commission’s 2017 “One Health Action Plan against AMR” noted in section 3.2, the development of new, non-antibiotic-based therapies is equally important, if not more so, to ensure the availability of sufficient effective therapeutic options for patients to fight serious bacterial infections. This is an area of medical research to which we at Ferring are fully committed and with promising results. Specifically, our company is actively involved in researching how to leverage new live microbiota-based biotherapeutics to address conditions like Clostridioides difficile (C.diff) infection and recurrent bacterial vaginosis (rBV). While both conditions are usually treated with antibiotics, unfortunately they are characterised by high levels of recurrence which leaves patients with little other choice than to undergo new courses of antibiotic treatment. The result is an increased utilisation of antibiotics without a guarantee of a strongly improved outcome for the patient. Moreover, according to the ECDC, C. Diff. infections represent nearly 124,000 cases of admissions in acute care hospitals every year in the EU/EEA, as well as an estimated 3,700 directly attributable deaths every year (using a conservative ratio of 3% attributable mortality). Those patients with recurring infections have limited treatment options and as such, we hope to offer them new solutions that will break the cycle of recurring infections – and could also potentially relieve health systems from the associated medical and economic burden (previously referenced). Medical research on microbiota-based biotherapeutics has the potential to deliver much needed therapeutic innovations. While there is growing knowledge and activity in this field, it is important to support the intensification of research programmes and provide developers with the best chance of delivering novel medicines for patients. Moreover, combining new incentives with a clearer regulatory framework could stimulate important research in this area. Some of the ideas voiced by the European Commission in its 2021 consultation on the revision of the general pharmaceutical legislation were and remain excellent proposals which deserve further attention and accelerated action – for instance: - Priority review vouchers; - Leveraging existing regulatory pathways for breakthrough innovations like microbiota-based therapeutics; - The establishment of an EU fund to support innovators by sharing R&D risks; - The creation of new “regulatory sandboxes” (beyond what exists today, e.g. scientific advice, protocol assistance) for policy experimentation to apply to technologies falling outside the scope of or not appropriately covered by existing legislation. While medicine regulations are harmonised across the EU, some of these other regulatory frameworks are not, and even happen to diverge widely between Member States (e.g. on aspects such as donor qualification, screening requirements, etc.). Leveraging a single application or approval pathway and a common harmonised HTA rulebook for these new medicines would be beneficial in accelerating access to these innovations. Furthermore, this clarity and framework support could better enable delivery of these innovations to EU patients as early as possible following EMA authorisation. References - weforum.org/agenda/2022/01/antimicrobial-resistanc-deaths-study/ - eurosurveillance.org/upload/site-assets/imgs/Special_Issue_Clostridium%20difficile.pdf - cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf - pwc.com/gx/en/governance-risk-compliance-consulting-services/resilience/publications/pdfs/case-response.pdf - thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext
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