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Anfang 2023 wurde unter dem Dach der Fachgruppe „Pharmazeutische Biologie“ der DPhG die Expertengruppe „Medizinischer Cannabis“ gegründet. Ziel der interdisziplinären Arbeitsgruppe ist die wissenschaftliche und regulatorische Auseinandersetzung mit aktuellen Fragestellungen rund um Medizinalcannabis. Der Schwerpunkt liegt dabei auf Qualität und Qualitätssicherung, von Anbau und Verarbeitung bis hin zu Cannabis-basierten Rezeptur- und Defekturarzneimitteln. Berücksichtigt werden insbesondere die Anforderungen der Guten Anbau- und Sammelpraxis (GACP), der Guten Herstellungspraxis (GMP) sowie der Guten Vertriebspraxis (GDP). Das Mandat der Expertengruppe umfasst unter anderem die Erarbeitung von Positionspapieren zu Qualitätsaspekten von Medizinalcannabis, Stellungnahmen zu Monografien des Europäischen Arzneibuchs (Ph. Eur.) und anderen relevanten Regelwerken sowie die Bewertung europäischer Leitlinien zur Herstellung, Kontrollstrategie und Prüfung pflanzlicher Arzneimittel unter Berücksichtigung der Besonderheiten von Cannabis-basierten Ausgangsmaterialien und Zubereitungen. Die Expertengruppe „Medizinischer Cannabis“ tagte nun am 6. August 2026 unter dem Vorsitz von Dr. Markus Veit in der Geschäftsstelle Bonn von Pharma Deutschland. Themen waren u.a. Neue Regelungen durch das GKV- Beitragsstabilisierungsgesetz (BStabG) Verabschiedung eines Positionspapiers zur QP-Freigabe von Cannabisblüten Best-Practice-Guide zur Probenvorbereitung für mikrobiologische Bestimmungen White Paper zur Taxation von hochkonzentrierten Cannabisextrakten Regulatorische Bewertung der Zertifizierung von medizinischen Verdampfern Überarbeitung der Ph. Eur. Monografie „Cannabis flos“ durch das EDQM GMP-Washing über Hubs in EU-Mitgliedstaaten außerhalb Deutschlands und mögliche Auswirkungen auf die Qualität von Cannabisblüten Aktivitäten des Technischen Komitees D37 „Cannabis“ des ASTM Die Diskussionen lieferten zahlreiche neue Impulse für zukünftige Aktivitäten der Expertenfachgruppe mit dem Ziel, die Qualität, Versorgung und Therapie mit cannabisbasierten Arzneimitteln weiter zu verbessern.

Die Europäische Arzneimittel-Agentur (EMA) hat eine Guidance für die Industrie zur Umsetzung von Shortage Prevention Plans (SPP) veröffentlicht. Die Pläne sollen Zulassungsinhaber dabei unterstützen, potenzielle Risiken für die kontinuierliche Versorgung mit Arzneimitteln systematisch zu identifizieren, zu bewerten und geeignete Maßnahmen zur Risikominimierung vorzusehen. Hintergrund sind die erweiterten Anforderungen an die Überwachung und Bewältigung von Arzneimittelengpässen auf europäischer Ebene, insbesondere aus der Verordnung (EU) 2022/123 und der geplanten neuen EU-Pharmagesetzgebung (Artikel 117 der neuen Verordnung). Die Guidance beschreibt insbesondere, welche Informationen in einem SPP enthalten sein sollten – etwa Angaben zu Produktdetails, Herstellungs- und Lieferketten, Produktionskapazitäten, alternativen Herstellungsstätten, Mindestbeständen sowie bisherigen Engpässen und deren Ursachen. Der Ansatz ist risikobasiert ausgestaltet: Umfang und Detailtiefe der Dokumentation sollen sich nach dem jeweiligen Versorgungsrisiko des Arzneimittels richten. Die SPP müssen grundsätzlich aktuell gehalten und auf Anforderung der zuständigen Behörden, der EMA oder der Europäischen Kommission kurzfristig vorgelegt werden können. Weitere Informationen zu sind auf der Webseite der EMA verfügbar, u.a. auch die entsprechende Guidance der EMA für Shortage Mitigation Plans - SMP (Stand 4. Dezember 2025) sowie die ebenfalls aktualisierten Templates für SPP und SMP. In diesem Zusammenhang möchte Pharma Deutschland auch noch einmal auf die folgende Online-Informationsveranstaltung am 21. September 2026, von 9.00 Uhr bis 13.00 Uhr aufmerksam machen. Neue Regularien zur Versorgungssicherheit: EU-Pharmapaket, Critical Medicines Act – Was kommt auf die Pharma-Branche zu? Aktuelle EU-Regulierungen zur Versorgungssicherheit von der EU-Pharmareform und dem Critical Medicines Act bis hin zu neuen Anforderungen an das Lieferengpassmanagement. Details & Anmeldung

EN EN EUROPEAN COMMISSION Brussels, XXX […](2026) XXX draft ANNEXES 1 to 2 ANNEXES to the Commission Implementing Regulation (EU) 2026/XX as regards the format for registration in and reporting to the register of producers and the information to be provided in the context Ref. Ares(2026)7688068 - 06/08/2026 EN 1 EN ANNEX I Format for registration in the register of producers Mandatory information is marked with ‘M’. Filter-dependent information is marked with ‘F’ and is part of the mandatory information but only applies when a specific response under the previous point is selected. Optional information for Member States to include is marked with ‘O’. If the ‘M’ or ‘F’ is marked by an asterisk (*), the information shall be part of a list of registered producers that Member States is to make easily accessible and publicly available free of charge, as specified in Article 44(13) of Regulation (EU) 2025/40. Part A Information to be submitted for the producer Information element Description Type of information Name of producer: Official name of the producer linked to the national tax number or to the identification code/number provided when registering in the business register in the Member State. M* Is the producer a legal or natural person? Information to be provided below depends on the reply. F If the producer is a legal person: __Name of company F If the producer is a natural person: __First name __Last name F E-mail address M Phone number (if available) M Web address (if available) M Brand name(s) (if available) Name(s) under which the producer makes its packaging or packaged products, available on M* EN 2 EN the territory of the Member State, excluding brands that the producer will not place on the market in the calendar year. The physical space in both the format and the public register should be large enough to take into account all the brands for large producers. Legal address: __ Street name M __Street number M __Postal code M __ City M __ Province (if available) M __ Country M European or national tax identification number Applies to producers who are established in the Union. TIN or VAT number of the producer in the Member State F* National identification code Applies to producers who are legal persons. The identification number provided when registering in the business register in the Member State or equivalent official registration number. F* Other identification information Applies to producers established in third countries, who do not have a TIN or VAT number. F Contact person Applies only if the producer is a legal person or if the producer is a natural person but that person is not the contact person. F __ First name F __ Last name F __ Phone number (if available) Business phone. M __ E-mail address Business e-mail address F Address (if different from the address of the producer) Applies only if the address of the contact person is different from the address of the legal or natural person. F — Street name F EN 3 EN — Street number F — Postal code F — City F — Country F Registration number of authorised representative Applies only if an authorised representative is appointed. F Part B Declaration on how the producer meets its responsibilities under Article 45 of Regulation (EU) 2025/40 Type of information Description Type of information Registration number in the register of producers M System for management of packaging waste (if applicable) Identification of each separate system for management of packaging waste in the Member State. If only one system is in place, this row may be removed. O Responsible operator for carrying out the extended producer responsibility obligations. Identification of whether the extended producer responsibility obligations are carried out individually or collectively. M If an individual producer: __Name of producer __Authorisation date __Proof of authorisation If a Member States does not allow producers to carry out their extended producer responsibility obligations individually, for some or all packaging categories by use, this column maybe removed or only shown when allowed. Authorisation date is when the producer received the authorisation as specified in Article 47of Regulation (EU) 2025/40. Proof of authorisation may be an authorisation number or similar information that can identify the authorisation. F EN 4 EN If a producer responsibility organisation: __Name of the entrusted producer responsibility organisation F Contact details of the producer responsibility organisation The contact details of the producer responsibility organisation, as specified in Part A, point 2, of Annex IX to Regulation (EU) 2025/40, shall be autogenerated in the register when providing the name of the producer responsibility organisation. F Phone number F E-mail address F Web address F Address: F __Street name F __Street number F __Postal code F __City F __Country F Phone number F E-mail address F National identification code F Trade register number or equivalent official registration number F European or national tax identification number F Declaration ‘I declare that the provided information is true and accurate. The declaration shall be filled out by the responsible operator by marking a check box. M EN 5 EN Part C Certificate issued by the producer responsibility organisation where Article 46(1) of Regulation (EU) 2025/40 applies Information element Description Type of information Member State concerned M Registration number in the register of producers M System for management of packaging waste (if applicable) Identification of each separate system for management of packaging waste in the Member State. If only one system is in place, this row may be removed. O Name of the producer responsibility organisation M Contract period M Part D Registration of the authorised representative Information element Description Type of information Name of authorised representative: Official name of the authorised representative linked to the national tax number or to the identification code/number provided when registering in the business register in the Member State M __ If the authorised representative is a legal person F If the authorised representative is a natural person: — First name — Last name F Phone number (if available) M E-mail address M EN 6 EN Address: Legal address of the authorised representative. The representative shall be established in the Member States where the packaging is made available on the territory for the first time. M Street name M — Street number M — Postal code M — City M National identification code/business registration code For authorised representatives that are legal persons, the identification code/number provided when registering in the business register in the Member State F National tax number M Name of the represented producer M Registration number of the represented producer M Contact person (if not the same as the designated person): F __ First name F __ Last name F __ Phone number (if available) Business phone F __ E-mail address Business e-mail address F __ Address Business address of the contact person F — Street name F — Street number F — Postal code F — City F EN 7 EN ANNEX II Information to be submitted for reporting Mandatory information is market with ‘M’. Filter-dependent information is market with ‘F’ and is part of the mandatory information but only applies when a specific response under the previous point is selected. Optional information for Member States to include is marked with ‘O’. Information to be submitted by the economic operator who is responsible for reporting on waste Information element Description Type of information Registration number in the register of producers The number provided when registering in the register of producers in the Member State. M System for management of packaging waste (if applicable) Identification of each separate system for management of packaging waste in the Member State. If only one system is in place, this row may be removed. O Reporting Period M EN 8 EN Part A Quantities of packaging made available by producers making 10 tonnes or more available on the territory of a Member State in a year (tonnes) Cate gory No Predomin ant material Packaging type Glass Paper and cardboa rd Ferrous metal Alumini um Plastic Wood Other Infor- mation type 1.0 Glass Glass and composite packaging of which the majority is glass. M 2.0- 3.0 Paper/ cardboard Paper/cardboard packaging and composite packaging of which the majority is paper/ cardboard. M 4.0 Metal Ferrous metal and composite packaging of which the majority is ferrous metal (unless 4.1) M 4.1 Metal Single-use beverage containers of ferrous metal with a capacity of up to 3 l. F 5.0 Metal Aluminium and composite packaging of M EN 9 EN which the majority is aluminium – rigid (unless 5.1) 5.1 Metal Single-use beverage containers of aluminium with a capacity of up to 3 l - rigid F 6 Metal Aluminium and composite packaging of which the majority is aluminium – semi-rigid and flexible M 7.0 Plastic Single-use plastic beverage bottles with a capacity of up to 3 L. PET – rigid M 8.0 Plastic PET and composite packaging of which the majority is PET – rigid M 9.0 Plastic PET and composite packaging of which the majority is PET – flexible M 10.0 Plastic PE and composite packaging of which the majority is PE – rigid M EN 10 EN (unless 10.1) 10.1 Plastic Single-use beverage bottles of PE with a capacity of up to 3 L. F 11.0 Plastic PE and composite packaging of which the majority is PE – flexible M 12.0 Plastic PP and composite packaging of which the majority is PP – rigid (unless 12.1) M 12.1 Plastic Single-use plastic beverage bottles with a capacity of up to 3 L. F 13.0 Plastic PP and composite packaging of which the majority is PP – flexible M 14.0 Plastic HDPE or PP and composite packaging of which the majority is HDPE or PP – rigid (unless 14.1) M EN 11 EN 14.1 Plastic Single-use plastic beverage bottles with a capacity of up to 3 L. F 15.0 Plastic PS and XPS and composite packaging of which the majority is PS or XPS – rigid (unless 15.1) M 15.1 Plastic Single-use plastic beverage bottles with a capacity of up to 3 L. F 16.0 Plastic EPS and composite packaging of which the majority is EPS – rigid M 17.0 Plastic Other rigid plastics incl. composite packaging - rigid M 18.0 Plastic Other flexible plastics incl. composite packaging – flexible M 19.0 Plastic Biodegradable plastics – rigid (PLA, PHB) and flexible (PLA) M EN 12 EN 20.0 Wood, cork Wood, cork and composite packaging of which the majority is Wood or cork. M 21.0 Textile Natural and synthetic textile fibres, and composite packaging of which the majority is natural and synthetic textile fibres. M 22.0 Ceramic, porcelain stoneware Clay, stone and composite packaging of which the majority is clay or stone. M 23.0 Other Any other material not listed. M EN 13 EN PART B Quantities of packaging made available by producers, that make less than 10 tonnes of packaging available in a year, on the territory of a Member State (tonnes) Cate gory No Predomin ant material Packaging type Glass Paper and cardboa rd Ferrous metal Alumini um Plastic Wood Other Infor- mation type 1.0 Glass Glass and composite packaging of which the majority is glass. M 2.0- 3.0 Paper/ cardboard Paper/cardboard packaging and composite packaging of which the majority is paper/cardboard M 4.0 Metal Ferrous metal and composite packaging of which the majority is ferrous metal (unless single use beverage packaging) M 5.0- 6.0 Metal Aluminium and composite packaging of which the majority is aluminium (unless single use beverage packaging) M EN 14 EN 4.1, 5.1, Metal Single-use beverage containers of metal with a capacity of up to 3 l. F 8-19 Plastic Plastic and composite packaging M 7.0, 10., 12.1, 14.1, 15.1 Plastic Single-use plastic beverage bottles with a capacity of up to 3 l. F 20.0 Wood, cork Wood, cork and composite packaging of which the majority is Wood or cork. M 21.0 Textile Natural and synthetic textile fibres, and composite packaging of which the majority is natural and synthetic textile fibres M 22.0 Ceramic, porcelain stoneware Clay, stone and composite packaging of which the majority is clay or stone M EN 15 EN 23.0 Other Other materials M EN 16 EN PART C Quantities of single-use beverage plastic bottles and beverage metal containers separately collected on the territory of the Member State in accordance with Article 50(1) of Regulation (EU) 2025/40 in a year (tonnes) Packaging type and format Total weight of single use beverage packaging separately collected and not in a deposit and return system Total weight of single use beverage separately collected in a deposit and return system Single use plastic beverage bottles Single-use metal beverage containers PART D Quantities of packaging waste collected on the territory of the Member State in a year (tonnes) Category Materials Weight of the packaging collected Information type 1 Glass M 2-3 Paper/ cardboard M 4-6 Metal M 8-19 Plastic M 20 Wood, cork M 21-23 Other materials M Total PART E Quantities of packaging waste disposed of, recovered and recycled within the Union in a year (tonnes) Category Material Total packaging waste disposed of Weight of the total packaging waste recovered Total packaging waste recycled Informati on type EN 17 EN 1 Glass M 2-3 Paper/ cardboard M 4 Ferrous metal M 5-6 Aluminium M 7-8 Plastic: PET rigid M 10, 12, 14 Plastic: PE, PP, HDPE, PP - rigid M 9, 11, 13, 18 Plastic: Films / Flexibles M 15,16 Plastic: PS, XPS, EPS M 17 Plastic: Other rigid plastics M 19 Plastic: Biodegra- dable - flexible and rigid M 20 Wood and cork M 21-23 Other materials M Total PART F Quantities of packaging waste disposed of, recovered and recycled outside the Union in a year (tonnes) Category Material Weight of total packaging waste disposed of Weight of total packaging waste recovered Weight of total packaging waste recycled Information type 1 Glass M EN 18 EN 2-3 Paper/cardb oard M 4 Ferrous metal M 5-6 Aluminium M 7-8 Plastic: PET rigid M 10, 12, 14 Plastic: PE, PP, HDPE, PP - rigid M 9, 11, 13, 18 Plastic: Films / Flexibles M 15-16 Plastic: PS, XPS, EPS M 17 Plastic: Other rigid plastics M 19 Plastic: Biodegrada ble - flexible and rigid M 20 Wood and cork M 21-23 Other materials M Total

EN EN EUROPEAN COMMISSION Brussels, XXX […](2026) XXX draft COMMISSION IMPLEMENTING REGULATION (EU) …/... of XXX laying down rules for the application of Regulation (EU) 2025/40 of the European Parliament and of the Council as regards the format for registration in and reporting to the register of producers and the information to be provided in that context (Text with EEA relevance) This draft has not been adopted or endorsed by the European Commission. Any views expressed are the preliminary views of the Commission services and may not in any circumstances be regarded as stating an official position of the Commission. Ref. Ares(2026)7688068 - 06/08/2026 EN 1 EN COMMISSION IMPLEMENTING REGULATION (EU) …/... of XXX laying down rules for the application of Regulation (EU) 2025/40 of the European Parliament and of the Council as regards the format for registration in and reporting to the register of producers and the information to be provided in that context (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC1, and in particular Article 44(14) thereof, Whereas: (1) Article 44(1) of Regulation (EU) 2025/40 lays down obligations for Member States to establish a national register to monitor producers’ compliance with the requirements laid down in Chapter VIII of that Regulation and for producers to register in and report to the register. The Commission is to establish a format for the registration and reporting in the register and to specify the data to be provided to it. Such a format should allow producers to submit data in a single, consistent way across Member States, thereby reducing the administrative burden associated with registration and reporting by preventing the proliferation of divergent formats and information to be provided. (2) The format should specify the information to be provided for the registration of producers pursuant to Article 44(5) of Regulation (EU) 2025/40 by producers or, where applicable, by producer responsibility organisations or authorised representatives. (3) The format should also specify the information to be provided for reporting pursuant to Article 44(7), (8) and (10) of Regulation (EU) 2025/40 by producers or, where applicable, producer responsibility organisations, including waste management operators acting on their behalf, authorised representatives or re-use system operators or, where permitted under national law, by public authorities. (4) Where separate systems for management of packaging waste are established in a Member State, such as for household, commercial and industrial waste, the format should allow for the identification of each system to ensure compliance with extended producer responsibility and fair allocation of waste management costs. (5) Directive (EU) 2019/904 of the European Parliament and of the Council2 establishes extended producer responsibility for certain single-use plastic products, including 1 OJ L, 2025/40, 22.1.2025, ELI: http://data.europa.eu/eli/reg/2025/40/oj. 2 Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the reduction of the impact of certain plastic products on the environment (OJ L 155, 12.6.2019). http://data.europa.eu/eli/reg/2025/40/oj EN 2 EN packaging, in accordance with Articles 8 and 8a of Directive 2008/98/EC of the European Parliament and of the Council3. In order to minimise any unnecessary administrative burden for producers of these items, the format for the register of producers should allow for integration of the additional reporting necessary to show compliance with Article 8(2), points (a), (b) and (c), of Directive (EU) 2019/904. (6) In certain areas and under the conditions set out in Regulation (EU) 2025/40, Member States may adopt national measures that go beyond the harmonised provisions laid down in that Regulation, including by setting additional national recycling targets. The format for the register of producers should allow for the integration of the additional reporting related to such measures in order to provide a single entry point for data submission. (7) To ensure that Member States can comply with their reporting obligations pursuant to Article 56(1) and (2) of Regulation (EU) 2025/40, the format should allow Member States to include the data necessary to calculate annual consumption of plastic carrier bags in accordance with Article 56(1), point (b), of Regulation (EU) 2025/40 and Table 4 of Annex XII to that Regulation. (8) For the purpose of compliance with the recycling targets set out in Article 52 of Regulation (EU) 2025/40, composite packaging and other multi-material packaging are to be calculated and reported by material. The format should therefore include information on the weight of each material contained in the packaging. Certain components may be separable from the main body of the packaging, may enter different material streams after use and may have different recyclability characteristics depending on their design and material composition. Those components should therefore be reported separately. (9) Article 39 of Regulation (EU) 2025/40 and Annex VII to that Regulation require manufacturers to draw up a written EU declaration of conformity, supported by technical documentation, demonstrating compliance with the applicable sustainability and labelling requirements. That technical documentation includes information on the composition of the packaging, including the weight of each material, and can therefore be used for the purposes of registration in and reporting to the register of producers, in order to ensure high-quality data, a uniform application of Regulation (EU) 2025/40, and easier verification by the competent national authorities. (10) To minimise the administrative burdens when registering and reporting to the register of producers, the format should ensure that the information can be submitted via a data processing system that can be fully automated. Where a packaged product is subject to Regulation (EU) 2024/1781 of the European Parliament and of the Council4 or other Union legislation requiring a digital product passport, the format should allow that the digital product passport can be used to provide the necessary information to the register of producers. 3 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008). 4 Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/EC (OJ L, 28.6.2024). EN 3 EN (11) To contribute to the effective enforcement of producers’ extended producer responsibility obligations, the format should allow that the information submitted pursuant to Article 45(4) and (7) of Regulation (EU) 2025/40 to providers of online platforms and fulfilment service providers can be verified in bulk. (12) The measures provided for in this Regulation are in accordance with the opinion of the committee established by Article 65(1) of Regulation (EU) 2025/40, HAS ADOPTED THIS REGULATION: Article 1 Format and data for registration 1. The formats for registration in the register of preducers shall be as set out in Annex I and shall be used as follows: (a) Part A for registering a producer; (b) Part B for declaring how a producer meets its extended producer responsibility obligations: (c) Part C for proving a certificate issued by the producer responsibility organisation; (d) Part D for registering an authorised representative. 2. Member States that have established separate systems for the management of packaging waste shall ensure that the format set out in Annex I enables each separate system to be identified. Producers, that make packaging available on the territory of the Member State and that participates in more than one system, must register separately in Parts B and C, the packaging covered by each system. 3. Information shall be submitted electronically via a data processing system that allows for a fully automated process and that supports bulk verification of producers’ registration numbers and digital certificates referred to in Part C of Annex I certifying compliance with extended producer responsibility obligations. Article 2 Format and data for reporting 1. The formats for reporting to the register of producers shall be as set out in Annex II and shall be used as follows: (a) Part A for producers who has made available 10 tonnes or more packaging available per calendar year on the territory of a Member State; (b) Part B for producers who has made available less than 10 tonnes of packaging per calendar year on the territory of a Member State. (c) Part C for quantities of separately collected single-use plastic beverage bottles and metal beverage containers with a capacity of up to three litres; (d) Part D for quantities of packaging waste collected that do not fall under point (c); (e) Part E for quantities of packaging waste disposed of, recovered or recycled within the Union; EN 4 EN (f) Part F for quantities of packaging waste disposed of, recovered or recycled outside the Union. 2. Member States that have established separate systems for the management of packaging waste shall ensure that the format set out in Annex II enables each separate system to be identified. 3. Packaging that is made available for the first time on the territory of the Member State and that is reported under Parts A and B of Annex II shall be reported on the basis of the predominant material, which is the material which accounts for the highest proportion by weight of the packaging, and of each separate component of a packaging unit. Where packaging contains multiple materials, including composite packaging, the weight of all constituent materials shall be reported in the respective columns. 4. The information reported under Parts A and B of Annex II to this Regulation shall be based on the technical documentation established in accordance with Annex VII to Regulation (EU) 2025/40 or an equivalent complete description of the packaging unit, including all integrated and separate components. Article 3 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, On behalf of the President

Die EU-Kommission hat am 6. August 2026 eine öffentliche Konsultation zu einer Durchführungsverordnung im Rahmen der EU-Verpackungsverordnung (PPWR) gestartet. Gegenstand sind harmonisierte Anforderungen an die Herstellerregistrierung sowie die Melde- und Berichtspflichten für Hersteller und Systeme der erweiterten Herstellerverantwortung (EPR/PRO). Die Konsultation läuft bis zum 10. September 2026. Der Entwurf sieht EU-weit einheitliche Registrierungs- und Meldeformate vor und enthält insbesondere erweiterte Berichtspflichten zu Verpackungsmaterialien und Kunststoffverpackungen. Ziel ist die Harmonisierung der nationalen Systeme und die Reduzierung des Verwaltungsaufwands. Wesentliche Inhalte: Einheitliche Registrierungsformate für Hersteller und Bevollmächtigte. Harmonisierte Meldeformulare für Verpackungen und Verpackungsabfälle. Detailliertere Berichterstattung zu Materialzusammensetzung und Verpackungskomponenten. Unterschiedliche Anforderungen für Hersteller über bzw. unter 10 Tonnen Verpackungsmenge pro Jahr. Vorgaben für die elektronische Berichterstattung und mögliche Anbindung an den Digitalen Produktpass. Zusätzliche Berichtspflichten für bestimmte Einweg-Kunststoffverpackungen. Mitgliedsunternehmen, die eine Stellungnahme über Pharma Deutschland einreichen möchten, werden gebeten, ihre Rückmeldung bis spätestens 8. September 2026 an Dr. Dennis Stern ( stern@pharmadeutschland.de ) zu senden.

ECDD Member State Questionnaire: General Information This questionnaire consists of three sections. First, you will complete the General Information section. Next, you will be presented with the Statement of Policy on Data Sharing. If you agree to the statement, you will proceed to the substance-specific questionnaire. This questionnaire collects information to support the World Health Organization (WHO) Expert Committee on Drug Dependence (ECDD) in its evaluation of substances under review. Responses are saved each time you click Previous or Next. This means that you can close the questionnaire at any time by exiting your browser (after clicking Previous or Next) and continue working on it later. You do not need to go to the last page of the survey before exiting. The information entered here allows WHO to gather information on the legitimate use, harmful use, status of national control, and potential impact of international control for the substances under evaluation by the ECDD. If you have any questions about this questionnaire, please email ecddsecretariat@who.int with the subject line “ECDD Member State Questionnaire”. The questionnaire will take approximately 15–25 minutes to complete. You may return to the questionnaire and amend your responses at any time until the questionnaire closes. Responses will be compiled into a report that will be made publicly available on the WHO ECDD website. All data will be presented at the WHO regional level and will not be attributed to any individual country. If you wish to submit additional information for consideration by the ECDD Secretariat, you will have an opportunity to upload supporting documents at the end of the questionnaire. Any sensitive, confidential, or unpublished documents should be emailed to ecddsecretariat@who.int. We thank you in advance for taking the time to complete this questionnaire. Country Name: Focal Point: Please confirm whether you agree to the information provided in this questionnaire being published, (Please select only one). ☐ I agree for the information provided in this questionnaire to be published. I understand that all data will be presented at the WHO regional level and will not be attributed to any specific country. ☐ I do not agree for the information provided in this questionnaire to be published. (Selecting this option will end the survey.) ECDD Member State Questionnaire: Statement of Policy on Data Sharing WHO Member State Questionnaire Expert Committee on Drug Dependence Statement of policy on data sharing Data are the basis for all sound public health actions and the benefits of data sharing are widely recognized, including scientific and public health benefits. Whenever possible, WHO wishes to promote the sharing of health data, including but not restricted to surveillance and epidemiological data. In this connection, and without prejudice to information sharing and publication pursuant to legally binding instruments, by providing data to WHO, the focal point of (Country Name). Confirms that all data to be supplied to WHO (including but not limited to the types listed in Annex 31) hereunder have been collected in accordance with applicable national laws, including data protection laws aimed at protecting the confidentiality of identifiable persons; Agrees that WHO shall be entitled, subject always to measures to ensure the ethical and secure use of the data, and subject always to an appropriate acknowledgement of (Country Name) to publish the data, stripped of any personal identifiers (such data without personal identifiers being hereinafter referred to as "the Data") and make the Data available to any interested party on request (to the extent they have not, or not yet, been published by WHO) on terms that allow noncommercial, not-for-profit use of the Data for public health purposes (provided always that publication of the Data shall remain under the control of WHO); to use, compile, aggregate, evaluate and analyse the Data and publish and disseminate the results thereof in conjunction with WHO's work and in accordance with the Organization's policies and practices. Except where data sharing and publication is required under legally binding instruments (IHR, WHO Nomenclature Regulations 1967, etc.), the focal point of (Country Name) may in respect of certain data opt out of (any part of) the above, by notifying WHO thereof in writing at the following email address, provided that any such notification shall clearly identify the data in question and clearly indicate the scope of the opt-out (in reference to the above), and provided that specific reasons shall be given for the opt out. ecddsecretariat@who.int Email Address Substances under review for the 49th ECDD: · Cychlorphine (N‑propionitrile chlorphine) · Etomethazene (5‑methyl etodesnitazene) · Spirochlorphine (R-6890) · Desalkylgidazepam · Ethylbromazolam · Etomidate · Medetomidine Section 0. INFORMATION ON: [Substance name: ......................................) 1. Do you have any information on the use of [Substance name: ......................................) in your country? (please select only one). ☐ Yes ☐ No The substance may be used for medical, scientific, industrial or other professional purposes, non-medical consumption or recreational purposes, or any other purpose. Section 1. APPROVED MEDICAL OR SCIENTIFIC USE 2. Do you know if approved medical products containing [Substance name: ......................................) are available in your country for human or veterinary indications? (Please select all that apply.) ☐ Human medical product ☐ Veterinary medical product ☐ Not available in human or veterinary medical products ☐ Do not know 3. What are the therapeutic indications approved for [Substance name: ......................................) in your country? [bookmark: _Hlk236998943] 4. Is [Substance name: ......................................) currently used in medical or scientific research (excluding use as an analytical reference standard) in your country? E.g. is it in clinical trials for any human or veterinary indication? (please select only one). ☐ Yes ☐ No ☐ Do not know If yes, please specify: Section 2. INDUSTRIAL USE 5. Is [Substance name: ......................................) used for legitimate (legal) industrial purposes in your country? (please select only one). ☐ Yes ☐ No ☐ Do not know If yes, please specify: Section 3. EPIDEMIOLOGY OF NON-MEDICAL USE 6. Is there any evidence of non-medical use (use outside of the medical, industrial or scientific context) of [Substance name: ......................................) in your country? (please select only one). ☒ Yes ☐ No ☐ Do not know 6A. If there is evidence of non-medical use (use outside of the medical, industrial or scientific context) of [Substance name: ......................................) in your country, where does this evidence come from? ☐ Seizures from law enforcement ☐ Seizures from customs (suggesting detection at international border points) ☐ Toxicology reports from deaths ☐ Toxicology reports from emergency departments ☐ Poisons information calls ☐ Other ☐ N/A If other, please specify 7. By what route(s) of administration are [Substance name: ......................................) used for non-medical/non-scientific purposes in your country? (Please select all that apply) ☐ Oral ☐ Injection ☐ Inhalation ☐ Sniffing ☐ Smoking ☐ Do not know ☐ Other If other, please specify 8. In which formulations is [Substance name: ......................................) used for non-medical/non-scientific purposes in your country? (Please select all that apply) ☐ Powder ☐ Tablets ☐ Liquid or solution for oral administration/use ☐ Solution for injection ☐ Other ☐ Do not know If other, please specify 9. As an expert, what negative health impact do you believe the non-medical consumption of [Substance name: ......................................) has in your country? · Negligible · Substantial · Especially serious · Do not know Emergency department / rooms 10. Are you aware of any emergency room/department visits related to the use of [Substance name: ......................................) in your country? (please select only one). ☒ Yes ☐ No 11. Please specify the number of patients who presented at emergency rooms/departments (non-fatal intoxications, etc.) in your country after use of [Substance name: ......................................). Provide data for the last year of reporting and indicate which year is the last year of reporting. Type of presentation 2026 2025 2024 Other year(s) [Substance name: ......................................) was the only substance involved [Substance name: ......................................) was involved together with other substances Unknown whether other substances were involved Total number of presentations *Count each presentation once only. Example: If the total number of presentations involving [Substance name: ......................................) in 2026 was 10, of which 6 involved only [Substance name: ......................................) together with other substances, and for 1 it was unknown if other substances were involved, enter 6, 3, 1, and 10. 12. Please list the adverse effects (non-fatal intoxications, etc.) patients have presented with at emergency rooms/departments in your country after use of [Substance name: ......................................). ☐ Headache ☐ Dizziness ☐ Confusion ☐ Hypertension ☐ Hypotension ☐ Agitation ☐ Tachycardia ☐ Bradycardia ☐ Hallucinations ☐ Psychosis ☐ Anxiety ☐ Depression ☐ Nausea ☐ Vomiting ☐ Unconsciousness ☐ Seizures ☐ Respiratory depression ☐ Chest pain ☐ Sweating ☐ Memory loss ☐ Seizures / convulsions ☐ Other (please specify below) If other, please specify Deaths 13. If available, please provide the number of deaths where [Substance name: ......................................) was involved. Please ensure to only report each death once. Provide data for the most recent completed year available*. Number of deaths 2026 2025 2024 Other year(s) [Substance name: ......................................) was the only substance involved [Substance name: ......................................) was involved together with other substances Unknown whether other substances were involved Total number of deaths *Count each death once only. Example: If the total number of deaths involving cychlorphine (N- propionitrile chlorphine) in 2026 was 10, of which 6 involved only [Substance name: ......................................), 3 involved [Substance name: ......................................) together with other substances, and for 1 it was unknown if other substances were involved, enter 6, 3, 1, and 10. Drug dependence and other harms 14. Are you aware of people presenting for drug dependence treatment due to the use of [Substance name: ......................................) in your country? (please select only one). ☐ Yes ☐ No ☐ Do not know If yes, please specify 15. Please provide any other information on the extent and magnitude of public health problems or social harm caused by the use of [Substance name: ......................................) in your country e.g. use in certain settings or populations (Please specify your sources/type of evidence): Section 4. CURRENT CONTROL 16. Is [Substance name: ......................................) currently controlled under national legislation in your country in order to regulate its availability in your country? (please select only one). ☐ Controlled under substance specific legislation ☐ Controlled under analogue or generic legislation ☐ No ☐ Do not know Illicit manufacture and trafficking-related information 17. Are there activities involving [Substance name: ......................................) for purposes other than medical, scientific or industrial use? ☐ Smuggling (from other countries) ☐ Manufacture of the substance by chemical synthesis ☐ Manufacture of the substance by extraction from other products ☐ Production of consumer products containing the substance ☐ Trafficking ☐ Diversion (from legal supply chain) ☐ Internet sales (seller or website located in your country) ☐ Internet sales (from abroad to buyers in your country) ☐ Internet sales (other or location of sellers and website unknown) ☐ Direct sales ☐ Do not know ☐ Other If other, please specify 18. Are you aware of [Substance name: ......................................) detected in any falsified (counterfeit) medicines or other products? (please select only one). ☐ Yes ☐ No ☐ Do not know ☐ Other If yes, please specify including what they are falsely sold as If other, please specify 19. Seizures of [Substance name: ......................................) in your country in the past 3 years: Please write in the answers using numerals and indicate which year is the last year of reporting. Year Number of seizures Amount seized Unit of measurement (e.g. grams) No data available 2026 2025 2024 20. If [Substance name: ......................................) were to be placed under international control, does your country have the forensic laboratory capacity to analyse the substance (identification, purity)? (please select only one). ☐ Yes ☐ No ☐ Do not know 21. Please provide any additional information

Das Bundesministerium für Gesundheit hat Pharma Deutschland um fachliche Unterstützung im Zusammenhang mit der 49. Sitzung des WHO Expert Committee on Drug Dependence (ECDD) gebeten. Ziel des Bewertungsverfahrens ist es, die Notwendigkeit und gegebenenfalls den Umfang einer künftigen internationalen Kontrolle einzelner Stoffe im Rahmen der UN-Drogenübereinkommen zu bewerten. Die Ergebnisse der WHO-Bewertung werden der Commission on Narcotic Drugs (CND) im März 2027 vorgelegt. Folgende Stoffe stehen auf der Tagesordnung: Critical Review Cychlorphine / N-propionitrile chlorphine Desalkylgidazepam Ethylbromazolam Etomethazene (5-methyl etodesnitazene) Spirochlorphine Pre-Review Etomidate Medetomidine Die WHO bittet die Mitgliedstaaten um Informationen unter anderem zu: zugelassenen Human- oder Tierarzneimitteln, medizinischer, veterinärmedizinischer oder wissenschaftlicher Verwendung, laufenden Forschungs- und Entwicklungsaktivitäten, industrieller Nutzung, Erfahrungen im Zusammenhang mit Missbrauch oder Intoxikationen, bestehender nationaler Kontrolle sowie möglichen Auswirkungen einer internationalen Kontrolle auf Herstellung, Forschung, Versorgung und Verfügbarkeit. Das BMG bittet darum, für jeden der sieben Stoffe eine separate Rückmeldung auf Grundlage des bereitgestellten WHO-Fragebogens zu erstellen. Gefragt sind Informationen zur medizinischen, wissenschaftlichen oder industriellen Verwendung der Stoffe sowie zu möglichen Auswirkungen einer internationalen Kontrolle. Sofern Ihrem Unternehmen hierzu Informationen vorliegen, bitten wir um direkte Übermittlung Ihrer Rückmeldung bis zum 25. August 2026 an das Referat 122 des Bundesministeriums für Gesundheit unter 122@bmg.bund.de . Das BMG bittet darum, die Angaben für jeden Stoff in einem separaten Dokument einzureichen.

Im Rahmen unserer Pharma Deutschland Jahrestagung am 10. und 11. November 2026 in Berlin möchten wir zu Beginn der Veranstaltung zwei kurze Videos zeigen, die die Perspektiven und Stimmen unserer Mitgliedsunternehmen sichtbar machen. Dabei möchten wir vor allem eines: unsere Mitglieder selbst zu Wort kommen lassen – persönlich, authentisch und auf den Punkt. Für die beiden Videos suchen wir daher Mitglieder, die bereit sind, vorab ein kurzes Statement aufzunehmen. Die Videos werden anschließend bei der Jahrestagung bzw. im Rahmen der Mitgliederversammlung gezeigt. Wir würden uns sehr freuen, wenn Sie dabei sind und Ihre persönliche Perspektive einbringen. Die Aufnahme ist unkompliziert und dauert nur wenige Minuten. Die konkreten Fragen sowie alle Informationen zur Aufnahme erhalten Sie selbstverständlich vorab. Sie möchten mitmachen? Dann melden Sie sich gerne bis 30. September 2026 bei Thi Hanh Nhi Nguyen ( nguyen@pharmadeutschland.de ). Wir stimmen anschließend alles Weitere direkt mit Ihnen ab. Wir freuen uns auf Ihre Stimme und darauf, gemeinsam die Vielfalt unserer Mitgliedschaft sichtbar zu machen!

Weitere Informationen zu der Veranstaltung finden Sie auf der Veranstaltungsseite über Ihren Anmeldelink.

Die Europäische Arzneimittel-Agentur (EMA) hat ihre Website Fees payable to the European Medicines Agency: Guidance for all applicants aktualisiert. Im Rahmen der Überarbeitung wurden mehrere Fragen und Antworten angepasst. Die Änderungen betreffen insbesondere die Regelungen zu Anreizen für kleine und mittlere Unternehmen (SME incentives), die Möglichkeit einer Stundung von Gebühren (fee deferrals) sowie bedingte Gebührenbefreiungen für das Produkt (conditional fee exemptions for the product). Die aktualisierten Fragen und Antworten sollen die Anwendung der Gebührenregelungen präzisieren und Antragstellern zusätzliche Orientierung bieten.