Euro Roundup: Pharma groups call for phased rollout of electronic product information

EFPIA and other pharmaceutical trade groups are pushing for the phased rollout of electronic product information (ePI) in the EU.

The branded drug trade group issued the call along with its counterparts in off-patent therapies, Medicines for Europe, and over-the-counter products, AESGP. Together, they have published a series of position papers on topics such as phasing in ePI, alternative ways of providing printed package leaflets, and removing the name of the manufacturer from package leaflets.

A legislative revision proposed by the European Commission has positioned the EU to move from paper to ePI in the future. However, “the proposed gradual implementation of ePI, driven by Member States' readiness, could be challenging to operationalize, particularly if it is not implemented in a harmonized way and the Member State by Member State implementation period extends over a lengthy period,” the trade groups wrote.

The collaborators argued the phasing in of ePI should precede the phasing out of paper package leaflets. In the interim, existing ePI platforms, such as websites run by national regulators and industry, “could be used as solutions” until ePI becomes fully available on the European Medicines Agency (EMA) portal.

“This phasing in of ePI should be supported by an EU-wide education and awareness campaign. ePI should be implemented across the EU in a harmonized way, with all Member States adopting the same standard and utilizing the same EMA/HMA portal as a repository for ePI,” the trade groups wrote.

The industry representatives want the portal to be available one year after the new directive comes into force and fully operational with all key requirements implemented after two years. Within four years, the trade groups want the portal to be fully populated with all ePI.

Phasing out paper package leaflets should start with products administered by healthcare professionals, the trade groups said and begin immediately after new legislation comes into force. The implementation phase for products self-administered by patients “should be kept as short as possible” and happen across the EU, the trade groups said. EFPIA and its peers want the EU to align with industry on the strategy.

“It is crucial to continue providing accessible medicinal information to the small minority without regular internet access or with limited digital skills,” the trade groups said. “Therefore, a solution that strikes a balance between completely removing paper and fully retaining paper, such as printing at the point of dispensation, seems to be one of the best solutions at the moment.”

The groups address additional aspects of packaging via other position papers, making the case for improvements to the layout and readability of leaflets and arguing against changing the rules on including disposal information.

Press Release, Position Papers

Switzerland extends transitional periods for moving to new diagnostic requirements

Amendments to Swiss law on in vitro diagnostics (IVDs) have come into force, extending the transition periods to minimize the risk of supply bottlenecks and keep timelines aligned with the EU deadlines.

Switzerland is outside the EU but has tried to align its IVD requirements with the changes made by its close trading partner. Last year, the EU extended the validity of certificates issued under the outgoing IVD directive, giving companies until 2027, 2028, or 2029, depending on risk class, to comply with the new regulations.

In response, Switzerland’s Ordinance on In Vitro Diagnostic Medical Devices came into effect on 1 January. As well as aligning transition periods with the EU, the updated legislation makes permanent some temporary changes to labeling requirements.

Switzerland initially eased requirements on the labeling of IVDs that are not used by patients to avoid work and costs associated with the regulatory split between the country and the EU in 2022. The success of the simplification of the labeling requirements led Switzerland to make the change permanent in its update to the regulations.

The Swiss Agency for Therapeutic Products (Swissmedic) is developing the swissdamed database to allow companies to register their IVDs and medical devices. Swissdamed is the Swiss equivalent of the EU’s Eudamed database. Voluntary use of swissdamed to register certain products could start this year. The requirement to register devices will take effect on 1 July 2026, six months after the Eudamed deadline.

Swissmedic Notice

MedTech Europe shares wish list for EU’s clean industrial and circular economy acts

MedTech Europe has listed its recommendations for planned EU legislation on clean industry and the circular economy, making the case for the alignment of regulatory requirements to reduce burdens.

EU officials are creating a circular economy action plan and clean industrial deal to try to cut carbon emissions. The industrial deal aims to turn the EU into a world leader in clean technologies and carbon emissions reduction, while the circular economy plan strives to make sustainable products the norm in the EU. Both policies could affect medical devices and diagnostics.

MedTech Europe outlined what the industry wants in a pair of policy documents. Both documents use terms such as “policy synchronization” and “regulatory coherence,” reflecting the trade group’s desire to ensure requirements are aligned with existing regulations. MedTech Europe said aligning requirements across policy domains can cut legal uncertainty, mitigate market fragmentation and minimize burdens.

“Reporting requirements should be streamlined so that they are workable and fit for purpose,” the trade group said. “In particular, ensure that future environmental legislation is consistent with sector-specific regulatory requirements and enhances the sustainability performance of medical technologies both, from a life cycle and care continuum perspective.”

Clean Industrial, Circular Economy

MHRA posts further guidance on Windsor Framework as new Brexit deal takes effect

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance for overseas regulators about the changes to the UK’s relationship to the EU that took effect on 1 January.

UK and EU negotiators formed the Windsor Framework to address some problems the original Brexit deal created in Northern Ireland. The recently implemented rules mean all medicines sold in the UK must be labelled as “UK only” to prevent them from being sold in the EU. MHRA shared guidance to explain the changes to its international counterparts.

“MHRA would like to reassure regulators that the inclusion of ‘UK Only’ on packaging does not mean that goods cannot be exported from the UK to other non-EU countries or territories,” MHRA said. Medicines that carry the “UK only” label can continue to be exported to “any country or territory where the import of those medicines is compliant with local legal requirements or provisions,” the agency said.

The guidance aimed at international regulators was one of a series of updates issued by MHRA as the Windsor Framework took effect. MHRA also updated guidance on renewing marketing authorizations, sourcing medicines for the UK market and other topics to reflect the changes.

MHRA Guidance

Other news:

The first six EU reference laboratories (EURLs) for public health began operations on 1 January. The EURLs, which cover areas such as antimicrobial resistance and vector-borne viral pathogens, will work to align on diagnostics and testing for surveillance, notification and reporting of diseases. Another three EURLs were designated in November. Press Release

Euro Roundup: Pharma groups call for phased rollout of electronic product information

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