EU Compliance & Legal Framework

THEDERMALFILLER® operates exclusively as an independent European Union commercial intermediary and procurement coordination interface.

The platform functions within a structured professional environment linking licensed healthcare professionals with authorised EU manufacturers, marketing authorisation holders and licensed pharmaceutical wholesalers.

THEDERMALFILLER® does not act as:

– manufacturer;
– importer of record;
– distributor;
– wholesaler;
– pharmacy;
– marketing authorisation holder;
– economic operator under Regulation (EU) 2017/745 or Regulation (EU) 2017/746.

All statutory regulatory responsibilities remain exclusively with the legally designated economic operators under applicable Union and national law.

All referenced products are governed, where applicable, by:

– Regulation (EU) 2017/745 on medical devices (MDR);
– Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR);
– Directive 2001/83/EC relating to medicinal products for human use;
– EU Good Distribution Practice (GDP) Guidelines;
– Applicable national transposition and enforcement legislation of the relevant Member State.

THEDERMALFILLER® does not replace, duplicate or absorb regulatory obligations assigned by these instruments.

Procurement facilitation is conducted without:

– ownership or custody of goods;
– stock holding or warehousing;
– repackaging, relabelling or modification;
– cold-chain handling;
– physical transport control;
– assumption of product liability.

All invoicing and delivery are executed by authorised EU supply partners operating under their own regulatory licences.
Commercial structuring, sourcing coordination and transaction execution are managed by THEDERMALFILLER® as an independent EU intermediary.

Supply chain integrity, pharmacovigilance, post-market surveillance and batch traceability remain under the responsibility of the authorised economic operator.

This platform is intended exclusively for licensed healthcare professionals operating in a regulated professional capacity within the European Union.

By accessing this website, users confirm that:

– they are legally authorised to practise in their jurisdiction;
– they act within the scope of their professional licence;
– they are responsible for compliance with local regulatory requirements.

Access by private individuals, patients or non-licensed intermediaries is not permitted.

All content published on this platform is informational and declarative in character.

It does not constitute:

– a public commercial offer;
– an online retail shop;
– consumer marketing;
– advertising directed to the general public;
– medical advice, dosage guidance or clinical protocol.

Healthcare professionals remain solely responsible for clinical judgement, lawful product use and regulatory compliance in their jurisdiction.

All regulatory references and operational descriptions relate exclusively to the European Union legal framework.

No representation is made regarding legality, availability or regulatory status outside the European Union.

Users accessing this website from outside the EU do so at their own initiative and assume full responsibility for compliance with applicable local laws.

Reference to third-party trademarks, product names or manufacturers does not imply endorsement, partnership or representation.

All trademarks remain the property of their respective owners.

To the maximum extent permitted by applicable law, THEDERMALFILLER® shall not be liable for:

– regulatory non-compliance by independent supply partners;
– inaccuracies originating from third-party documentation;
– clinical outcomes or off-label use;
– supplier-side delays or operational interruptions;
– misuse of products by third parties.

Nothing in this section excludes liability where such exclusion is prohibited by applicable law.

This EU Compliance Framework may be modified at any time to reflect regulatory or operational developments.

Continued use of this website constitutes acceptance of the current version.

This platform is structured for regulatory clarity, professional access control and strict functional separation within the European Union legal order.