GDP Update for 2024/2025
Good Distribution Practice (GDP) is a key element in ensuring the safety of pharmaceuticals. It ensures that the quality, efficacy, and integrity of medicinal products and active pharmaceutical ingredients (APIs) are preserved throughout storage and transportation. The primary objective of GDP is to safeguard product integrity along the entire supply chain - from the manufacturer to the end user. In many countries, adherence to GDP requirements is a legal obligation and is subject to regular inspections by regulatory authorities. Importantly, the responsibility for compliance extends beyond manufacturers: wholesalers, logistics providers, as well as storage and transport service companies must also implement and maintain GDP-compliant processes.
In recent months, there have once again been numerous regulatory developments and initiatives by authorities. Building on the article "GDP Update 2023/2024" published in Issue 40 of last year's ECA GMP Journal1 , this contribution provides an overview of the most important updates from 2024 and the first quarter of 2025.
Regulatory Developments in the EU
Extension of GDP Certificates
The GDP Update 2023/2024 already addressed special provisions introduced during the pandemic concerning the validity and extension of GDP certificates. Originally, an automatic extension was granted until the end of 2021; however, this timeframe was adjusted several times.2 In December 2023, it was finally decided that GMP and GDP certificates expiring at the end of 2023 would remain valid either until the end of 2024 or until the next on-site inspection - whichever comes first.3
In a further update dated 24 February 2025, the European Medicines Agency (EMA) clarified that a blanket extension of GDP certificates will no longer be granted in 2025. This decision is based on the fact that national authorities have resumed regular on-site inspections and that alternative approaches, such as remote assessments, are now available. However, in individual cases, national authorities may still grant extensions.4
Recommendation
10/11 September 2025
Stability Studies to Support Shipping/Distribution of Pharmaceuticals and Biopharmaceuticals - Live Online Training
EMA Q&A Document on Remote Activities of the Responsible Person
On 18 April 2024, the European Medicines Agency (EMA) published a new document addressing remote activities of the Responsible Person (RP), made available as part of the frequently asked questions on GDP on its website.5 The background to this publication lies in repeated inspection findings indicating that the designated RP was operating from outside the EU/EEA. The new document states that remote activities could be allowed if accepted by the national competent authority where the authorised site is located. As a general rule, RP activities should be carried out within the EU/ EEA (or Northern Ireland). Wholesalers are advised to consult the applicable national requirements.
ZLG Documents on GDP for Active Substances
The German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG) has updated several documents related to GDP for active substances as part of its Quality Manual (Qualitätssicherungshandbuch, QSH).6
In Chapter 7, the procedural instruction VAW 07114403 on the preparation, execution, and follow-up of inspections of active substance distributors7 as well as the two associated forms, 071144_ F02_018 and 071144_F01_029 , were updated. The amendment is attributed to the routine revision cycle and the need to align with current national and European veterinary medicinal product legislation.
Chapter 15 (Authorization Granting) has also been revised: The procedural instruction VAW 15111903 for the registration of manufacturers, importers, and distributors of pharmaceutical active substances,10 as well as the associated forms 151119_F01_0211 and 151119_F02_0212, have been updated. Key changes include clarifications regarding the registration of full-line wholesalers, increased use of the EudraGMDP database, and the inclusion of active substances intended for use in clinical trial investigational medicinal products. In this context as well, the applicable veterinary medicinal product legislation has been taken into account.
Regulatory Developments in the United States
USP Chapter on Mean Kinetic Temperature (MKT)
Mean Kinetic Temperature (MKT) is a calculated value that weights temperature fluctuations based on their impact on the stability of a product. It serves as a potential tool for evaluating storage and transportation conditions.
In December 2024, the United States Pharmacopeia (USP) published a so-called Pre-posting Notice13 announcing the planned publication of new chapter <1079.2> in USP-NF 2025, Issue 2.
Chapter <1079.2> is part of a series addressing the storage and distribution of medicinal products. In the U.S., chapters numbered below 1000 are considered enforceable when referenced in a monograph or another applicable chapter. Chapters above 1000 - such as the <1079> series - are informational and intended to provide guidance and clarification.
Chapter <1079.2> outlines the use of Mean Kinetic Temperature (MKT) in the context of short-term temperature excursions, with specific consideration given to climatic zone IVb - a region of significant regulatory interest. A companion Stimuli article provides the scientific rationale behind the chapter.14
In February 2025, USP responded to public comments received on <1079.2> with a detailed statement.15 A total of 15 submissions were reviewed, focusing on the practicality and regulatory relevance of the MKT concept. Many suggestions were not incorporated, including the proposal to use only selected temperature data for MKT calculations. USP emphasized that all available temperature data must be included. The suggestion to define specific thresholds for repeated temperature fluctuations was also rejected, as such limits are to be determined by the manufacturer and should reflect a functioning quality system. Another key topic was the scope of the chapter: USP clarified that <1079.2> is intended as a global document and is therefore not limited to North America.
Implementation of the Drug Supply Chain Security Act (DSCSA)
The U.S. Food and Drug Administration (FDA) continued its efforts to implement the Drug Supply Chain Security Act (DSCSA) throughout 2024 and into the first quarter of 2025. Enacted in 2013, the DSCSA mandates, among other requirements, electronic traceability of prescription drugs at the package level and sets national licensing standards for wholesalers and third-party logistics providers (3PLs).16
In 2024, the FDA introduced transition policies for trading partners that have made significant progress in developing electronic systems but are still facing technical challenges. The extended compliance deadlines are as follows:
- Manufacturers and Repackagers: until 27 May 2025
- Wholesale Distributors: until 27 August 2025
- Dispensers with 26 or more full-time employees: until 27 November 2025
- Small dispensers (≤25 full-time pharmacy staff): until 27 November 2026
Trading partners not covered by these transition policies may submit individual requests for exemptions or waivers. However, submitting such a request does not suspend the obligation to continue implementing DSCSA requirements.17
On 26 March 2025, the FDA and the Partnership for DSCSA Governance (PDG) held a joint virtual town hall meeting focused on the upcoming end of the transition period for manufacturers. Two additional sessions - one for wholesalers18 and one fordispensers19 - are planned and will take place approximately two months before each respective compliance deadline.
Recommendation
Thursday, 2 October 2025 9 .30 - 16.45 h
Pharma Supply Chain - GDP Requirements and Certification for Logistics Vendors - Live Online Training
Other Regulatory Guides, Guidelines and Regulations
MHRA Guidance for Manufacturers and Wholesaler
As part of the Windsor Framework, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance titled "Wholesalers' and manufacturers' guidance following agreement of the Windsor Framework." This guidance came into effect on 1 January 2025 and is intended for manufacturers and wholesalers in the United Kingdom.20
In particular, Chapter 4 sets out specific requirements for the "Responsible Person for Import" (RPi). Medicinal products from countries listed as an "Approved Country for Import" may only be imported by an RPi under certain conditions. In contrast, products from Northern Ireland do not require additional checks. Wholesalers must ensure that, as of 1 January 2025, imported medicines are properly labelled ("UK Only") and handled separately according to their target market to prevent erroneous shipments to Northern Ireland.
In addition, the guidance document "Sourcing Medicines for the UK Market" has also been updated. It describes the procurement process for holders of a UK wholesale dealer licence and has been adapted to reflect the national marketing authorisation regulations in effect since 2025.21
Swissmedic: Technical Interpretation on the Responsible Person
On 26 August 2024, Swissmedic published a new version of its technical interpretation "Responsible Person: requirements" (Document number: I-SMI.TI.17e, Version 7.0).22 This replaces the previous version from 7 August 2023 and includes numerous clarifications regarding the qualifications and responsibilities of the Responsible Person (FvP - fachtechnisch verantwortliche Person).
A particular focus is placed on language proficiency: Chapter 5.5 requires a good knowledge of the local language for the responsible person. Companies whose currently appointed FvP does not yet meet this requirement have 12 months (until August 2025) to either appoint a new responsible person with the required language skills or to ensure that the responsible person acquires the required language skills within this period.23
Other Publications
IPEC GDP Guide for Pharmaceutical Excipients
In 2024, the International Pharmaceutical Excipients Council Europe (IPEC Europe) published Version 3 of its "Good Distribution Practices Guide for Pharmaceutical Excipients."24 The updated guide is aligned with the WHO guideline on Good Trade and Distribution Practices (GTDP) and addresses the safe handling of pharmaceutical excipients throughout the entire supply chain.
New aspects include, in particular, a stronger alignment with international standards such as EXCiPACT, IPEC-PQG GMP, and NSF/ IPEC/ANSI 363, as well as an expanded focus on data integrity, risk management, traceability, and complaints management. A matrix outlines which GDP requirements apply to specific activities (e.g. storage, transport, repackaging), and a table links the WHO guidelines to the corresponding IPEC recommendations.
APIC Guide on Supplier Management
In March 2024, the APIC (Active Pharmaceutical Ingredients Committee) Supplier Management Task Force published the revised guide "Best practices guide for managing suppliers of API manufacturers." It replaces the previous Supplier Qualification and Management Guideline from 2009.25
The main objective of the new document is to support API manufacturers in the risk-based selection, qualification, and monitoring of suppliers and service providers - including those involved in GDP-relevant activities. Services such as the transport and storage of active pharmaceutical ingredients are generally considered highly critical. This results in requirements such as audits, quality agreements, documented fitness-for-purpose, and regular reevaluations.
For less critical activities, such as the transport of excipients, a simplified assessment may be sufficient. However, for critical services, contractually defined quality agreements are mandatory. If such an agreement is refused, the remaining risk must be reassessed and, if necessary, mitigated through measures such as more frequent audits or additional documentation. The new Annex 2 includes a template for a so-called Commitment Declaration.
PDA Technical Report on Last Mile Distribution
The Parenteral Drug Association (PDA) has completely revised its 2009 Technical Report No. 46 and republished it in August 2024 as "PDA Technical Report No. 46 (Revised 2024): Last Mile."26
The updated version addresses current regulatory requirements, technological developments, and challenges in increasingly complex supply chains. Key focus areas include temperature control, monitoring, supply chain management, and data security - with particular attention to challenges on the "last mile." Regional specifics in Europe, Africa, Brazil, North America, and China are explicitly taken into account.
BioPhorum Position Paper on Restarting the Supply Chain
In October 2024, BioPhorum published the position paper "Restarting the inbound supply chain,"27 which addresses the challenges of restarting disrupted supply chains in the aftermath of the COVID-19 pandemic. The paper was developed by the Supply Partnering and Relationship Management working group.
Recommendations include flexible ordering strategies, transparent communication between suppliers and customers, the use of early warning indicators (e.g. capacity expansion, staff turnover), and pragmatic approaches to specification design. BioPhorum also emphasizes the importance of long lead times and the timely reactivation of dormant capacities. The paper is particularly relevant for companies facing variable raw material quality, global shortages, and extended delivery times.
GDP Inspections and Audits
PIC/S Documents on Remote Assessments
In 2024, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) published two documents on the conduct of remote assessments: "PIC/S Guidance on Remote Assessments" (PI 056-1)28 and "PIC/S Aide Memoire on Remote Assessment" (PI 057-1).29
Although these documents are primarily intended for GMP inspectors, they can also be applied, appropriately adapted, for GDP-related remote audits. The guidance documents provide orientation on technical implementation, procedures, communication, and evaluation of remote inspections, and aim to support harmonization of assessment approaches.
SwissGMDP Database
After an extended preparation phase, Swissmedic officially launched the SwissGMDP database30 in September 2024 - similar to the EMA's well-known EudraGMDP database.
The SwissGMDP database contains entries for all Swiss-based licence holders,31 including their operational sites and the activities authorized at each site. GMP and GDP certificates can also be accessed through the database. Similar to the data available in EudraGMDP, the compliance status of licence holders' sites can be verified. Swissmedic has summarized instructions for using the SwissGMDP database in a dedicated guidance document.32
Swissmedic Guideline on the Conduct of Inspections
In autumn 2024, Swissmedic also updated its GMP/GDP-related documents33 published on the Inspectorate website, including the guideline I-SMI.RL.01 "Conduct of inspections of establishments manufacturing or distributing medicinal products or collecting blood."34 The new Version 4.0 came into effect on 21 October 2024, replacing the previous version from 2020.
The changes primarily affect Chapter 5.6 (Handling of urgent actions during closing meeting and its description in the inspection report) and Chapter 5.9 (Clarification on expectations regarding critical and major deviations).
GDP Non-Compliance Reports
Entries in EudraGMDP
Wholesalers and manufacturers are regularly inspected by the competent supervisory authorities. If deficiencies are identified, GDP or GMP compliance may not be confirmed - in such cases, a notice is entered into the publicly accessible EudraGMDP database maintained by the EMA.35
As of 31 March 2025, a total of 49 GDP non-compliance reports from the years 2014 to 2025 were publicly available. However, the actual number is higher, as some older entries have since been withdrawn and removed from public access.
Key Deficiencies in 2024
In 2024, five new GDP non-compliance reports were entered into the EudraGMDP database - one each from Germany and the Czech Republic, and three from Romania. As in previous years, many of the deficiencies related to the Responsible Person (see Chapter 2 of the EU GDP Guidelines36): in some cases, continuous availability was not ensured; in others, the duties were not fulfilled to the required extent.
Other documented deficiencies included:
- Inadequate qualification processes for customers and suppliers
- Incomplete documentation
- Outsourced activities not properly monitored
- Weaknesses in the quality management system
- Violations of legal reporting obligations
- Deficient IT systems
Non-Compliance Reports in the First Quarter of 2025
The first report in 2025 concerns an inspection of a wholesaler in Budapest. The report dated 21 January 2025 focuses on IT security. Among the findings was insufficient protection of user accounts against unauthorized access. Login credentials of the Responsible Person had been shared, and critical quality-related decisions were made by unauthorized personnel. Remote access was also not adequately controlled.
A second report, dated 20 March 2025 and issued by the competent authority in Cyprus, involves a wholesaler whose wholesale distribution authorization was revoked due to the supply of medicinal products to unauthorized recipients.
The third report published in the first quarter of 2025, dated 26 March 2025, refers to an Austrian wholesaler. In this case, the authority cited general violations of GDP requirements without providing further details.
Falsified Medicines
Falsified medicines pose a serious health risk: they do not meet the required standards of quality, safety, and efficacy and can have severe health consequences. The GDP Update 2023/2024 already highlighted falsified batches of Ozempic® found within legal supply chains - an example that underscores the urgent need for robust control systems.
European Commission Report
The European Commission has published a report on current trends in medicinal product falsification, as foreseen in Directive 2011/62/EU (the "Falsified Medicines Directive").37 A comprehensive evaluation of the Directive is currently not possible, as implementation remains incomplete in some Member States and there is no centralised EU-wide system for recording falsification cases.
The report highlights the following points:
- High-priced prescription medicines and lifestyle products such as Ozempic® are particularly affected.
- Online sales remain the biggest vulnerability.
- The legal supply chain is more difficult to infiltrate today, thanks in part to Track & Trace systems and the European Medicines Verification System (EMVS).
Nevertheless, significant implementation deficits remain - for example, pharmacies not connected to the system, inefficient IT infrastructures, or a lack of standard procedures for reporting and evaluating falsification cases. The Commission calls on Member States to take responsibility and increase the number of connected stakeholders.
Control Measures by Swissmedic
In Switzerland, Swissmedic, the Federal Office for Customs and Border Security (FOCBS), and Swiss Sport Integrity (SSI) are jointly combating the illegal importation of medicinal products - particularly via online channels. As part of an operation coordinated by Europol, more than 1,000 suspicious postal consignments were inspected. Around a quarter of them contained illegal medicines or doping substances. A total of 246 packages were seized, including products such as erectile stimulants, narcotics, and other prescription-only medicines.38
The overall figures for 2024 show that 5,668 illegal medicinal product imports were confiscated - a 15% decrease compared to the previous year. The most frequently seized product categories were erectile stimulants (57%), followed by psychotropic drugs and sedatives (10%). The products mainly originated from Western Europe, India, and Eastern Europe - often routed through detours designed to bypass customs and safety controls.39
EMA Guidance on Suspicious Offers
The European Medicines Agency (EMA) has published two new Q&As in the section "Guidance on good manufacturing practice and good distribution practice: Questions and answers" on its website.40
These updates are aimed in particular at wholesalers and brokers, and include the following recommendations:
- Thorough due diligence checks when dealing with new suppliers
- Use of the EudraGMDP database for verification
- Increased awareness of offers with unusually low prices or lack of traceability
In cases of suspicion, there is an obligation to report to the relevant national authority and the marketing authorisation holder - even if the offer was not addressed directly to one's own company.
Loss and Theft of Medicines
Repeated cases of missing or tampered medicines within the legalsupply chain have raised growing concerns at the European level. In many instances, thefts are reported only to local law enforcement authorities and not to medicines agencies - a deficient practice that hampers effective oversight.41
In response, the Council of Europe adopted Recommendation CM/ Rec(2024)3 on 10 April 2024.42 The recommendation calls for the establishment of national systems for the recording, reporting, and forwarding of incidents involving the loss of human and veterinary medicinal products - ideally under the coordination of national medicines authorities. In addition, the recommendation urges stronger collaboration between authorities, industry, and law enforcement.
Securing the Supply of Medicines
The COVID-19 pandemic, geopolitical crises, production disruptions, and quality issues have exposed the vulnerability of global pharmaceutical supply chains in recent years. As a result, numerous shortages - particularly of essential medicines - occurred across Europe. These shortages not only impacted patient care, but also undermined public trust in the healthcare system. In response, various initiatives to strengthen supply security were launched at both national and European levels in 2024 and 2025.
Union List of Critical Medicines
On 16 December 2024, the European Commission, the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) published an updated version of the Union List of Critical Medicines - a key instrument to ensure the supply of essential medicines. The list is based on an analysis of approximately 2,200 active substance groups and is regularly reviewed to identify potential vulnerabilities at an early stage.43 The first version of the list was published at the end of 2023.
An accompanying Q&A document explains the selection criteria and regulatory implications.45
EDSForm Project
A key tool for addressing medicine shortages is the European Drug Shortages Formulary (EDSForm)46 The project aims to provide technical and regulatory support to community and hospital pharmacies for the preparation of unauthorised medicines - particularly in situations where authorised alternatives are unavailable.
In 2024, the first framework and procedural documents were approved by the CD-P-PH (European Committee on Pharmaceuticals and Pharmaceutical Care) and the European Pharmacopoeia Commission. Based on these, the first seven EDSForm monographs were published - including formulations for paracetamol, furosemide, and methotrexate.
Critical Medicines Act
On 28 February 2025, the Critical Medicines Alliance published a comprehensive strategic report aimed at strengthening the supply of medicines in Europe.47 The report analyses key dependencies and proposes a range of measures, including:
- Expansion of European manufacturing capacities
- Diversification of supply chains
- Improving competitiveness
On 11 March 2025, the European Commission followed with a proposal for the so-called Critical Medicines Act.48 The aim is to establish a binding European legal framework to ensure the long-term supply of critical medicines and to reduce dependencies on third countries.
EMA Recommendations on Strengthening Supply Chains
On 23 April 2024, the European Medicines Agency (EMA) published additional recommendations aimed at strengthening the supply chains for medicines included on the Union List of Critical Medicines.49 The proposals, developed by the Medicinal Shortages Steering Group (MSSG), include:
- Promoting the expansion of manufacturing capacities
- Identifying alternative suppliers
- Applying regulatory flexibilities
- Providing financial incentives for critical products
Implementation is carried out on a case-by-case basis, in close coordination with the Critical Medicines Alliance, which is responsible for developing broader industrial policy solutions.
Shortage Prevention and Mitigation Plans (SPP/SMP)
On 18 June 2024, the European Medicines Agency (EMA) published standardised templates for:
- Shortage Prevention Plans (SPP): Risk assessment and preparedness along the supply chain for each marketed medicinal product. Mandatory for medicines listed on the Union List of Critical Medicines.
- Shortage Mitigation Plans (SMP): A catalogue of measures to address actual or anticipated shortages, including escalation pathways and communication strategies.
Both types of plans must be reviewed regularly and made available upon request. They should incorporate elements of ICH Q9 and include a central risk register.50 In crisis situations, SPPs are mandatory for listed medicines in accordance with Regulation (EU) 2022/123.51
Measures in Switzerland
In 2024, Switzerland also adopted measures to strengthen the supply of medicines. On 21 August 2024, the Federal Council approved a corresponding action plan,52 which includes:
- Expansion of mandatory stockpiles
- Simplified import regulations in the event of shortages
- Incentives for the production of essential medicines
- Regulatory simplifications for the approval of unregistered products
In addition, the Federal Office of Public Health (FOPH) was assigned overall responsibility for pandemic preparedness, including the procurement and distribution of medical goods in crisis situations. An expert group appointed by the Federal Council is expected to propose further measures to ensure long-term supply security by the end of 2025.
European GDP Association
The European GDP Association (GDPA)53, an international network of professionals in the field of Good Distribution Practice (GDP) - continued to grow in 2024. The organisation now counts more than 5,000 members worldwide.54
The revamped website, launched in 2024, serves as a central information platform and offers:
- Up-to-date news
- A variety of publications (e.g. Q&A documents, practical guides)
- A discussion forum for members
Membership is free of charge and can be easily requested via an online application form55 on the website.
About the Author
Dr Markus Funk joined CONCEPT HEIDELBERG in October 2019 as operational director and is in charge of the topics GDP and analytics.
Notes:
1 GMP Journal, GDP Update 2023/2024, https://www.gmp-journal.com/current-articles/details/gdp-update-for-2023-2024.html
2 EMA, Questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic, https://health.ec.europa.eu/document/download/dde482a9-c418-4929-821d-57254f7dd45e_en?filename=guidance_regulatory_covid19_en_0.pdf
3 EMA, Phasing out of extraordinary COVID-19 regulatory flexibilities, https://www.ema.europa.eu/en/news/phasing-out-extraordinary-covid-19-regulatory-flexibilities
4 EMA, Regulatory expectations and certificates following COVID-19 public health emergency, https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice#regulatory-expectations-and-certificates-following-covid-19-public-health-emergency-10391
5 EMA, Remote RP activities, https://www.ema.europa.eu/en/documents/other/remote-rp-activities_en.pdf
6 Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG), Qualitätssicherungshandbuch (QSH), https://www.zlg.de/arzneimittel/deutschland/qualitaetssystem
7 ZLG, VAW Vorbereitung, Durchführung und Nachbereitung von Inspektionen von Wirkstoffhandelsbetrieben, https://www.zlg.de/index.php?eID=dumpFile&t=f&f=5745&token=af5e4ff19588b84d5cc16f288231c3f7fc6b513a
8 ZLG, Formular: Niederschrift über die Besichtigung eines Handelsbetriebes für Wirkstoffe, die als Ausgangsstoffe für Tierarzneimittel verwendet werden https://www.zlg.de/index.php?eID=dumpFile&t=f&f=9712&token=e75ce072945fda167b2a7272d8237e489923a274
9 ZLG, Formular: Niederschrift über die Besichtigung eines Handelsbetriebes für Wirkstoffe, die als Ausgangsstoffe für Arzneimittel zur Anwendung am Menschen verwendet werden, https://www.zlg.de/index.php?eID=dumpFile&t=f&f=2468&token=341ba593af3fb25f9798034eb704b2f2c37283b4
10 ZLG, VAW Registrierung von Herstellern, Importeuren oder Händlern von pharmazeutischen Wirkstoffen, https://www.zlg.de/index.php?eID=dumpFile&t=f&f=2637&token=eabbc7760fddfcfb13da1963c8815767b92f0df5
11 ZLG, Formular: Format für die Anzeige von Herstellern, Importeuren oder Händlern von Wirkstoffen (DE), https://www.zlg.de/index.php?eID=dumpFile&t=f&f=2526&token=a69e63ddd8dc46dfd e7459523f200b168fdcc22f
12 ZLG, Formular: Registration of manufacturer, importer or distributor of active substances (EN), https://www.zlg.de/index.php?eID=dumpFile&t=f&f=2527&token=21d16f9a4614e2c3cc1468b5ed3aa5451d93d48e
13 USP, <1079.2> Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products, https://www.uspnf.com/notice/1079.2-preposting-20241202
14 USP-NF, The Use of Mean Kinetic Temperature and the Need for Allowable Excursion Limits for Climatic Zone IVb, https://online.uspnf.com/uspnf/document/2_GUID-1B0F4294-DED1-4F7AA88D-9B101302D1EF_10101_en-US
15 USP, Commentary, USP-NF 2025 Issue 2, https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/usp-nf-commentary/usp-nf-2025-issue-2-commentary-20250203.pdf
16 Public Law 113-54, https://www.govinfo.gov/content/pkg/PLAW-113publ54/pdf/PLAW-113publ54.pdf
17 FDA, Waivers and Exemptions Beyond the Stabilization Period, https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/waivers-and-exemptions-beyond-stabilization-period?utm_medium=email&utm_source=govdelivery
18 FDA, 2025 PDG-FDA Town Hall- Wholesale Distributor Exemption, https://hma.connect.space/2025-pdg-fda-town-hall-06-25-25/details
19 FDA, 2025 PDG-FDA Town Hall- Dispenser Exemption, https://hma.connect.space/2025-pdg-fda-town-hall-09-24-25/details
20 MHRA, Wholesalers' and manufacturers' guidance following agreement of the Windsor Framework, https://www.gov.uk/government/publications/wholesalers-manufacturers-guidance-following-agreement-of-the-windsor-framework/wholesalers-manufacturers-guidance-following-agreement-of-the-windsor-framework
21 MHRA, Sourcing medicines for the UK market, https://www.gov.uk/guidance/sourcing-medicines-for-the-great-britain-market-from-an-approved-country-for-import-or-northern-ireland
22 Swissmedic, Responsible Person: requirements (I-SMI.TI.17e), https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/responsible-person-requirements.html
23 Swissmedic, General communication of 26 August 2024, Responsible Person: requirements (I-SMI.TI.17e), https://www.swissmedic.ch/swissmedic/de/home/news/mitteilungen/responsible-person-requirements.html
24 IPEC, Guidelines, The IPEC Good Distribution Practices Guide (GDP) for Pharmaceutical Excipients https://www.ipec-europe.org/guidelines.html
25 APIC, Best practices guide for managing suppliers of API manufacturers, https://apic.cefic.org/publication/best-practices-guide-for-managing-suppliers-of-api-manufacturers/
26 PDA, Technical Report No. 46 (Revised 2024) Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users, https://www.pda.org/bookstore/product-detail/7955-technical-report-no-46-revised-2024
27 BioPhorum, How to ensure the resilience of your supply chain, https://www.biophorum.com/news/how-to-ensure-the-resilience-of-your-supply-chain/
28 PIC/S Guidance on Remote Assessments (PI 056-1), https://picscheme.org/docview/9256
29 PIC/S Aide Memoire on Remote Assessment, https://picscheme.org/docview/9257
30 Swissmedic, Go-live der SwissGMDP Datenbank, https://www.swissmedic.ch/swissmedic/de/home/humanarzneimittel/bewilligungen_zertifikate/betriebsbewilligungen/swissgmdp.html
31 Swissmedic, Welcome to the SwissGMDP database, https://swissgmdp.ch
32 Swissmedic, Guidance document SwissGMDP Database, https://www.swissmedic.ch/dam/swissmedic/de/dokumente/bewilligungen/i-303/i-303_aa_04-a08d_wl_swissgmdp.pdf.download.pdf/I-303.AA.04-A08d_Wegleitung_SwissGMDP%20Datenbank.pdf
33 Swissmedic, Inspectorates, https://www.swissmedic.ch/swissmedic/de/home/humanarzneimittel/bewilligungen_zertifikate/betriebsbewilligungen/inspektorate.html
34 Swissmedic, Conduct of inspections of establishments manufacturing or distributing medicinal products or collecting blood, https://www.swissmedic.ch/dam/swissmedic/de/dokumente/bewilligungen/inspektorat/i-smi_rl_01d_durchfuehrungvoninspektioneninbetriebendiearzneimit.pdf.download.pdf/i-smi_rl_01d_durchfuehrungvoninspektioneninbetriebendiearzneimit.pdf
35 EudraGMDP, GDP Non-Compliance Reports, https://eudragmdp.ema.europa.eu/inspections/view/gdp/searchGDPNcr.xhtml?search=nonCompliance
36 Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01, https://eur-lex.europa.eu/legal-content/DE/TXT/HTML/?uri=CELEX:52013XC1123(01)
37 Report from the commission to the European Parliament and the Council on trends in the falsification of medicinal products and measures provided according to Directive 2011/62/EU as required in Article 3 thereof, https://eur-lex.europa.eu/legal-content/DE/TXT/PDF/?uri=CELEX:52024DC0274
38 Swissmedic, Successful operation in control campaign against illegal trading in medicinal products, https://www.swissmedic.ch/swissmedic/de/home/humanarzneimittel/marktueberwachung/arzneimittel-aus-dem-internet/statistik/einsatz-bei-kontrollaktion-gegen-illegale-am.html
39 Swissmedic, Illegal imports of medicinal products in 2024: continuing trend in high-dose erectile dysfunction products, https://www.swissmedic.ch/swissmedic/de/home/humanarzneimittel/marktueberwachung/arzneimittel-aus-dem-internet/statistik/illegale-arzneimittelimporte-2024.html
40 EMA, Guidance on good manufacturing practice and good distribution practice: Questions and answers - Considerations for wholesale distributors/brokers on suspicious offers (New Dec 2024),
https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers
41 EDQM, Council of Europe adopts recommendation on reporting of disappearances of medicines https://www.edqm.eu/en/-/council-of-europe-adopts-recommendation-on-reporting-of-disap-pearances-of-medicines
42 Recommendation CM/Rec(2024)3 of the Committee of Ministers to member States on reporting of disappearances of medicinal products for human and veterinary use from the legal supply chain,
https://search.coe.int/cm#{%22CoEIdentifier%22:[%220900001680af31ee%22],%22sort%22:[%22CoEValidationDate%20Descending%22]}
43 EMA, Union list of critical medicines, https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/availability-medicines-during-crises/union-list-critical-medicines
44 EMA, First version of the Union list of critical medicines agreed to help avoid potential shortages in the EU, https://www.ema.europa.eu/en/news/first-version-union-list-critical-medicines-agreed-help-avoid-potential-shortages-eu
45 EMA, Questions and answers on the Union list of critical medicines, https://www.ema.europa.eu/en/documents/other/questions-and-answers-union-list-critical-medicines_en.pdf
46 EDQM, EDQM initiatives on medicine shortages, https://www.edqm.eu/en/edqm-initiatives-on-medicine-shortages
47 Critical Medicines Alliance, Strategic Report of the Critical Medicines Alliance, https://health.ec.europa.eu/document/download/3da9dfc0-c5e0-4583-a0f1-1652c7c18c3c_en?filename=hera_cma_strat-report_en.pdf
48 Europäische Kommission, Commission proposes Critical Medicines Act to bolster the supply of critical medicines in the EU, https://ec.europa.eu/commission/presscorner/detail/en/ip_25_733
49 EMA, MSSG recommendations to strengthen supply chains of critical medicinal products, https://www.ema.europa.eu/en/documents/other/mssg-recommendations-strengthen-supply-chains-critical-medicinal-products_en.pdf
50 EMA, Medicine shortages and availability issues: guidance for companies, https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/medicine-shortages-availability-issues-guidance-companies
51 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (Text with EEA relevance), https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R0123
52 BAG, Bundesrat verstärkt Massnahmen gegen Engpässe bei den Arzneimitteln, https://www.bag.admin.ch/bag/de/home/das-bag/aktuell/medienmitteilungen.msg-id-102159.html
53 European GDP Association, https://gdp.gmp-compliance.org/
54 ECA Foundation, Annual Reports, https://www.eca-foundation.org/annual-reports.html
55 European GDP Association, Register for Membership, https://gdp.gmp-compliance.org/membership/registration.html
