Here you will find interesting news and links to current RMS-relevant topics.

• RECENT COMMITTEE NEWS

Deletion of the requirement to submit cover letters for Type IA variations. As of 1 July 2026, the requirement to submit a cover letter for Type IA variations will be removed. The following guidance documents have been updated accordingly and will be published on the CMDh website:

• Requirements on submissions for variations and renewals within MRP and national procedures
• BPG on the use of eCTD in the MRP/DCP
• Cover letter for variation applications in MRP
• Questions and answers on variations
• BPG for the allocation of the MRP variation number for Type I notifications, Type II variations, grouping and worksharing (Chapter 1)
• BPG for the processing of Type IA minor variations (notifications) in MRP (Chapter 3)
• BPG for the processing of grouped applications in MRP (Chapter 6)

Updated version of the electronic Application Form (eAF). The updated version 1.28.0.0 of the MAA eAF is now available on the eAF website to allow applicants and marketing authorisation holders (MAHs) to familiarise themselves with the changes. The main reason for the changes to the form is the alignment of product data with the ISO IDMP model.

The form can be used as of 1 September 2026 for new MAA submissions to the National Competent Authorities (NCAs) within national, MR and DC procedures. From 1 January 2027, the use of the updated form will be mandatory for all new MAA submissions to the NCAs.

Applicants are reminded that the version of the eAF should not be changed during an ongoing procedure.

Update of Questions & Answers on Brexit. The CMDh has agreed on an update of its Post-Brexit Questions & Answers. The information on reference medicinal products authorised in the United Kingdom has been further clarified in the document.

The updated document will be published here on the CMDh website.

Meeting with Interested Parties. In June 2026, the CMDh held a meeting with representatives of Interested Parties and exchanged views on the following topics: the new pharmaceutical legislation (NPL), the CMDh Multi-Annual Workplan, variations, safety label variations, multilingual packs, as well as challenges related to trade names.

All presentations as well as the minutes will be published here on the CMDh website.

A strong signal of trust and expertise: Austria acts as Reference Authority in a worksharing procedure for the 500th time! In early January 2026, the moment had arrived. For the 500th time, Austria was able to accept a worksharing request as Reference Authority. This milestone underscores Austria’s important role in European cooperation and the trust placed in its regulatory and expert assessment expertise. Furthermore, the Austrian authority’s strong 6th place in the CMDh statistics for 2025 is also worth noting, both in terms of variation worksharing procedures initiated and those completed.

Marketing authorisation holders can find all essential information on variation worksharing in Chapter 7 of the current CMDh Best Practice Guide.

In the CMDh’s Q&A document on variations, question 4.7 clarifies how the Reference Authority for a worksharing procedure should ideally be selected – this requires, in any case, the consent of the requested authority.

• RECENT COMMITTEE NEWS

CMDh Multi-Annual Work Plan. The CMDh has published a summary of its Multi-Annual Work Plan up to 2025. This outlines the measures that the CMDh, or the CMDh in collaboration with other stakeholders, has implemented in recent years in the following priority areas:

• Availability of critical medicines and coordination in times of crisis
• Optimisation of procedures
• Innovative projects
• Preparation for legislative changes
• Optimisation of communication with interested parties and stakeholders.

The CMDh is currently working on its Multi-Annual Workplan up to 2028 – this is also due to be published shortly.

MRP/DCP statistics for 2025. The CMDh has presented its annual statistics on DC/MR procedures for 2025, based on the CTS database. In 2025, Austria ranked 10th among Reference Member States (RMS) for finalised marketing authorisation procedures for human medicinal products, and 9th for procedures started! Thank you very much for your trust – we are delighted to continue to be your expert and reliable partner in authorisation procedures at European level!

Slot matrix for procedures with AT as RMS. To present the availability of slots for new applications with Austria as RMS even more transparently, the slots for chemical medicinal products will now be broken down by application type. Applications under Article 10(1), 10(3) or Article 10c of Directive 2001/83/EC are listed under the category “CHEM A”; applications under Article 10a, 10b or Article 8(3) of Directive 2001/83/EC are listed under “CHEM B”. This change is intended to help applicants plan their slot requests more accurately and efficiently in the future.

• RECENT COMMITTEE NEWS

CMDh Guidance on the application of the new Variation Regulation. The CMDh has adopted updates to several guidance documents and templates in relation to variation procedures, to align them with the new EC guidelines on the details of the different variation categories and the conduct of the procedures.

The new European Commission guidelines and the correspondingly updated CMDh guidance documents have been applicable since 15 January 2026.

Recommendation to applicants to use the RMS validation checklist before submitting a DCP. To support applicants in preparing and submitting compliant new marketing authorisation applications in a DCP, and to reduce validation issues due to missing documentation, it is strongly recommended to use the RMS Validation Checklist for self‑assessment prior to dossier submission.

The CMDh Best Practice Guide on the compilation of the dossier for new applications submitted in Mutual Recognition & Decentralised procedures has been updated accordingly and now also includes information on the requirement to provide bridging data in Article 10a applications.

Update of Public Assessment Report templates. Following the publication of the updated template for the DCP D70 Assessment Reports, it is now possible for the RMS to prepare the PAR based on the final Assessment Report. The updated template is available on the CMDh website.

• RECENT COMMITTEE NEWS

Guidance on the application of the new Variation Regulation. Following the revision of the new Variation Regulation, which has been in force since 1 January 2025, the European Commission (EC) has now published the final version of the EC guidelines on the details of the classification of variations and on the implementation of the procedures. The guidelines will apply from 15 January 2026.

To facilitate the transition for Type IA variations, all Type IA changes implemented in 2025 should be submitted in an annual update in December 2025 or before 15 January 2026. Only in cases where individual Type IA variations are implemented after the annual update has been submitted, will they be accepted as individual notifications.

Within the next months, the CMDh will publish updates to several guidance documents and templates related to variations to bring them into line with the new European Commission guidelines. Further information on the application of the revised Variation Framework can be found on the CMDh website.

The BASG will also address the topic of ‘New Variation Regulation and Classification Guideline 2025’ during a so-called BASG discussion on 16 October 2025. Further information and registration details can be found in the AGES event calendar at this link.

Template for request for RMS in DCP updated. The CMDh has added a footnote clarifying that, in case of bioequivalence studies, the applicant should check whether the relevant site is already included in the OMS database or should apply for its inclusion as early as possible before submitting the application.

The updated template can be found on the CMDh website and the BASG website.

• RECENT COMMITTEE NEWS

Public consultation on QRD template version 11. Public consultation on version 11 of the QRD template and the possible inclusion of a ‘key information section’ in the package leaflet of centrally authorised medicinal products is currently open. The CMDh would like to encourage stakeholders to submit comments as the QRD template for MR/DC procedures is based on the QRD template for centrally authorised medicinal products. The public consultation documents and the instructions for submitting comments are available on the EMA website.

Removal of the rabbit pyrogen test. In the context of Directive 2010/63/EU, the EMA has published a guidance document on the phasing out of the rabbit pyrogen test. This follows the revision of the European Pharmacopoeia, which includes the introduction of a new general chapter 5.1.13 Pyrogenicity and the deletion of references to the rabbit pyrogen test from 57 existing monographs. The new and revised texts will be published in Supplement 11.8 of the Pharmacopoeia and will apply from July 1, 2025. As a result, the use of the rabbit pyrogen test will no longer be required in any text of the European Pharmacopoeia and it will be the responsibility of the manufacturers of medicinal products to select an appropriate in vitro test to control the pyrogenicity of their product.

Applicants/Marketing Authorisation Holders are therefore advised to remove the rabbit pyrogen test from their dossiers and to assess the need for a suitable replacement method (see Q&A European Pharmacopeia (Ph. Eur.) - Phasing out Rabbit Pyrogen Test); this applies to both centrally and nationally authorised medicinal products for human use.

Guidance on the application of the new Variation Regulation. Following the revision of the Variation Regulation, which has been in force since 1 January 2025, the European Commission has now published a draft guidance on the details of the different categories of variations and how the procedures work and is expected to be applicable from 15 January 2026.

Stakeholders are invited to follow the updated EMA and CMDh websites in this regard and take the necessary steps to prepare their systems, processes, procedures and documentation to comply with the revised variation framework.

Recommendation of the MWP on the requirements for well-established use applications. The CMDh has agreed to the CHMP Methodology Working Party (MWP) recommendation on bridging requirements for applications under Article 10a of Directive 2001/83/EC (‘well-established use’/WEU). The MWP recommendation includes a Q&A document that further clarifies the requirements for bridging data in the context of WEU applications, i.e. when an active substance of a medicinal product has been used in the Union for at least ten years with recognised efficacy and an acceptable level of safety. The Q&A document will be published on the EMA website and on the CMDh website under ‘Procedural Guidance > Application for MA’.

• RECENT COMMITTEE NEWS

Update Procedural Advice on Repeat-Use. The CMDh approved an update of the guidance document “Procedural Advice on Repeat-Use”. The most important change is the alignment with the updated guidance on renewal procedures. The updated document can be found on the CMDh website.

Update Q&A on the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746). The CMDh, together with the EMA, has agreed an update to the common questions and answers on the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations. It has been updated that - if a declaration of conformity is not available from the manufacturer of the medical device - in certain cases (for class I medical devices - except Is and Im) the marketing authorisation holder's declaration of compliance with the relevant general safety and performance requirements (GSPRs) of MDR Annex I, can be accepted. The updated document has been published on the EMA website.

Update CMDh SOP on decision-making process for new active substance status or extension of marketing protection/data exclusivity. The CMDh has updated the “CMDh SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity” and it has been included in the document that decisions on an additional year of market protection/data exclusivity for new therapeutic indications will be published in a separate document (in addition to the CMDh Minutes). It has also been added how the start of the non-cumulative period of one year of data exclusivity for a new therapeutic indication should be calculated. The updated document can be found on the CMDh website.

Update Assessment Report Templates. The CMDh agreed to update all assessment report templates published on the CMDh website and remove the “Names of the assessors” section; this is also in line with the centralised procedure. The name/contact details of the RMS contact person remain included.

MRP/DCP statistics for 2024. The CMDh has presented its annual statistics on DC/MR procedures for 2024 according to the CTS database. In 2024, Austria as RMS was again in 7^th place for finalised marketing authorisation procedures for human medicinal products and 9^th place for started marketing authorisation procedures! Thank you very much for your trust - we look forward to continuing to be your competent and reliable partner in marketing authorisation procedures at European level!

• IMPORTANT LINKS

CMDh (Press releases)

CHMP (Committee meeting highlights)

PRAC (Meeting highlights)

List of committees and working parties

RMS flyer

Assignment scheme

Current Slotmatrix

**REMINDER**

Registration in IRIS platform. Since January 2025, registration in IRIS has been mandatory for all lifecycle procedures managed by EMA. It is important to note that nationally or decentrally authorised products may also be affected, e.g. for worksharings with NAPs/MRPs/DCPs and CAPs, single assessments of PSURs, referrals and post-authorisation safety studies. Therefore, please make sure that your company also applies for access to IRIS, even if you do not have any centrally authorised products. You can also find helpful information in this EMA document.

• RECENT COMMITTEE NEWS

Edit function of PMS data for Marketing Authorisation Holders. From the first quarter of 2025, the EMA will introduce write access for Marketing Authorisation Holders in the Product Management Service (PMS), initially via the Product User Interface (PUI) and later via Application Programming Interfaces (API). This functionality is crucial for the monitoring of shortages of medicinal products via the European Shortages Monitoring Platform (ESMP). Further information on the possible data input and the specified timelines can be found in the press release of the CMDh meeting of October 2024.

Amended Variation Regulation. Marketing Authorisation Holders are reminded that the Variation Regulation 1234/2008/EC, as amended, and the corresponding updated guidance documents of the CMDh are applicable as of 1 January 2025 and will apply to all variation applications submitted after this date and to Type IA/IAIN notifications implemented by the MAHs in their internal databases as of this date. Type IA/IAIN variations already implemented in 2024 can still be submitted during 2025 according to the old rules. The corresponding updated documents can be found on the CMDh website.

• IMPORTANT LINKS

CMDh (Press releases)

CHMP (Committee meeting highlights)

PRAC (Meeting highlights)

List of committees and working parties

RMS flyer

Assignment scheme

Current Slotmatrix

• RECENT COMMITTEE NEWS

New labelling requirements for metered dose inhalers (MDIs) containing fluorinated greenhouse gases (centrally, decentrally and nationally authorised products). Due to the entry into force of Regulation (EU) 2024/573, new labelling requirements for MDIs that use fluorinated greenhouse gases (F-gases) as propellants will apply from 1 January 2025. 

The European Medicines Agency (EMA) published two guidance documents (Q&As and QRD statements for the labelling and the package leaflet) on 19.09.2024: 

The ‘Questions and answers on labelling requirements for centrally authorised metered dose inhalers containing fluorinated greenhouse gases’ explain

• how the regulation impacts MDIs containing F-gases
• how these products are to be labelled
• which regulatory procedures should be taken to fulfil the new requirements.

The supplementary document ‘QRD statements for metered dose inhalers containing fluorinated greenhouse gases’ contains translations of the standard statements into all official EU/EEA languages.

Active Substance Master File worksharing. After completing the revision of the document ‘The worksharing procedure for the assessment of Active Substance Master File (ASMF)’, the CMDh has also updated the corresponding ‘EU ASMF number request form’. The most important change is the request for additional information in order to assess the admissibility of including already approved ASMFs (with an assessment history of at least 2 years) in the ASMF worksharing procedure.

The updated template is published on the CMDh website under ‘CMD Working Parties/Working Groups > Working Group on Active Substance Master File Procedures’.

Environmental Risk Assessment (ERA) in MRPs/RUPs. The CMDh agreed to update the request form for MRPs and RUPs. In order to facilitate the implementation of the updated ERA guideline (legal effective date: 01.09.2024), applicants are requested to confirm that the ERA present in Module 1.6 complies with the current version of the guideline before starting an MRP/RUP. For MRP/RUP applications submitted by 31.03.2025, it is possible to commit to submitting a variation within 3 months of the end of the MRP/RUP if the ERA included in Module 1.6 does not comply with the current version of the guidance document.

The updated template is published on the CMDh website under ‘Templates > MRP/RUP’ and BASG website.

Registration in IRIS platform. From January 2025, registration in IRIS will be mandatory for all lifecycle procedures managed by the EMA. It is important to note that nationally or decentrally authorised products may also be affected, e.g. for worksharings with NAPs/MRPs/DCPs and CAPs, single assessments of PSURs, referrals and post-authorisation safety studies. Therefore, please make sure that your company also applies for access to IRIS in good time, even if you do not have any centralised authorisations.

• IMPORTANT LINKS

CMDh (Press releases)

CHMP (Committee meeting highlights)

PRAC (Meeting highlights)

List of committees and working parties

RMS flyer

Assignment scheme

Current Slotmatrix