HMA Substances Validation Group

The HMA Substances Validation Group (SVG) has the following tasks:

1. On behalf of HMA, maintain substances data in the European Substance Registration System (EU-SRS), containing scientific substance information.
   • Analyse the available substances data, available in regulatory documentation as well as in public databases such as G-SRS or Scifinder.
   • Register, validate and approve substances data
   • Update substances data when new information is available
   • Ensure ISO IDMP compliance of data
   • Provide feedback to the EMA SMS team in case of necessary changes on substances data in SMS
2. Maintain and publish substances management guidance documentation
    
3. Maintain training materials for NCA (read-only) users of EU-SRS, and publish in the HMA – SVG site along with the guides
    
4. Support NCA’s and NCA staff with using EU-SRS and extracting data from EU-SRS, either by releasing learning materials or direct support
    
5. Liaise with HMA as well as other expert groups / `regulatory´ groups, associations from interested parties or stakeholders, including but not limited to:
   • EMA SMS team
   • FDA/NCATS team
   • HMA working groups such as CMDh, CMDv, HMPWG
   • EDQM
   • European Commission
   • EMA’s committees and working parties such as CHMP, CVMP, HMPC, BWP, QWP
   • IWP (immunologicals working party)
   • NCA EU-SRS users
   • Kew Gardens
   • WHO
6. Current three SVG groups are implemented as corresponding `sub-working groups´ (covering both Human and Veterinary substances):
   • SVG1, covering Chemicals, Polymers, Mixtures, SSG1
   • SVG2, covering Proteins, ATMPs, Nucleic Acids, Vaccines, Blood Products
   • SVG3, covering Homoeopathics and Herbals

• Substance experts from AT, CZ, DE-PEI, DE-BfArM, DK, ES, FI, FR-ANSES, FR-ASNM, NL, and NO are part of different groups
• Representatives from other agencies new and previous participants,  are welcome to join in the groups.
• The group includes guest membership of WHO-UMC (no access to EU-SRS).
• Chair: Marcel Hoefnagel, CBG-MEB, NL
• Vice-chair: Bjørg Overby, NoMA, NO
• Mentor: Trygve Ottersen, NoMA, NO
• Secretary: Isabel Lazaro, AEMPS, ES
• Meeting cycle: one two-days face-to-face meeting, one two-half day online per year. Regular teleconference meetings, including bi-weekly status meetings technical meetings, and SVG1, SVG2 and SVG3 group meetings.

SVG secretary

E-mail: svgnoSpam@noSpamhmanoSpam.eu

General documents
 

• General EU-SRS user guide, version 2.0
• EU-SRS Read-Only guide, version 1.0
• EU-SRS Chemicals guide, version 1.0
• EU-SRS Polymers guide, version 2.0
• EU-SRS Proteins guide, version 2.0
• EU-SRS Mixtures guide, version 2.0
• EU-SRS Homoeopathics guide, version 1.0
• EU-SRS Human Vaccines guide, version 1.0
• EU-SRS Veterinary Vaccines guide, version 2.0
• EU-SRS Herbal Substances guide 1.0

Newsletter
 

• EU-SRS updates - January 2025

Member of the Veterinary vaccine group 

The Veterinary Vaccines Group is part of SVG2 (covering Proteins, ATMPs, Nucleic Acids, Vaccines, Blood Products). 

The tasks and competencies required are listed below. 

Demands:

• Expert for immunological veterinary substances
• Joy to work in an international group (English as working language) 

Work load:

• Bi-weekly meetings online of 45 minutes
• Two two-day meetings per year (one online, one in presence at EMA - in general reimbursed)
• Around 4 hours per week for the specific work on veterinary vaccines substances 

Topics:

• Validation and cleansing of new (and existing) SMS names
• Discussions around naming of completely new substances and establishing of naming syntax, if necessary
• Building and maintaining of substance data in EU-SRS (European Substance Registration System), containing scientific substance information