Webinar on EU Variations Regulation – national/DCP/MRP variations to marketing authorisations for human medicines

The HPRA will deliver a webinar providing information about the revised EU Variations Regulation and updated guidelines. The webinar will outline what these changes mean for licences authorised via national and DCP/MRP procedures.

The webinar will be held in conjunction with BioPharmaChem Ireland and BioPharmaChem Skillnet. 

Purpose of the webinar

Following the amendment of the EU Variation Regulation, applicable since 1 January 2025, the European Commission has adopted and published an updated version of its variations guidelines; the guidelines have applied since 15 January 2026.

To support stakeholders with national licences authorised via a national, a mutual recognition or decentralised procedure, the HPRA will host a webinar discussing implementation of the revised guidelines. In addition, the HPRA will present on other topics relevant to variations, such as commonly seen issues associated with applications during both the submission and assessment phases.

The session will cover: 

• A clear understanding of the revised EU Variations Regulation and updated guidelines
• Practical interpretation of implications for national and DCP/MRP licences
• Insight into new variation categories, terminology and procedural updates
• HPRA expectations during submission and assessment
• Common deficiencies observed (clinical, quality and product information)
• Guidance on avoiding frequent submission errors and delays
• Greater confidence in managing variation lifecycle compliance

Date and time

• Date: Tuesday, 24 March 2026
• Time: 10am-1pm
• Venue: Online webinar

Agenda and registration

To view the full agenda and to register to attend, visit the BioPharmaChem Skillnet website. 

There is no fee to attend, but advance registration is essential.