Last updated: 7 September 2026

This page explains the regulatory principles relevant to the Products offered through brunodermalfiller.com, the responsibilities associated with international purchases, and our approach to Product information, eligibility and safety concerns.

The title of this page describes its subject. It is not a certification, regulatory endorsement or declaration that every Product is authorised in every country.

Regulatory requirements depend on the specific Product, destination, intended activity and supply arrangement. This page does not replace Product-specific documentation, official regulatory information or legal requirements.

1. Website Operator and Scope

Brunodermalfiller.com is operated by STBRUNO GLOBAL TRADING – FZCO, registered in the United Arab Emirates.

In this statement, “we”, “us” and “our” refer to STBRUNO GLOBAL TRADING – FZCO.

Our catalogue includes medical aesthetic, beauty, skincare and related Products. Different regulatory frameworks may apply to different Products, including those sold through the same website.

Our company registration, website operation or use of fulfilment partners does not, by itself, establish authorisation to supply a particular Product in a particular jurisdiction.

The respective obligations of the Seller, manufacturer, importer, distributor, authorised representative and Buyer depend on their actual activities and applicable law.

2. Product Categories

Product classification must be assessed according to the relevant jurisdiction. Marketing descriptions and website categories do not determine legal classification.

Product category	Regulatory considerations
Botulinum toxin products	Generally regulated as prescription medicines or biological medicinal products, with Product-specific authorisation and lawful supply requirements
Dermal fillers and certain aesthetic implants	May fall under medical-device or other applicable aesthetic-product frameworks, depending on their characteristics, intended purpose and destination
Skin boosters and other injectable Products	Classification depends on composition, mode of action, intended purpose, claims and local law; they must not automatically be treated as ordinary cosmetics
General cosmetics and non-injectable skincare	May be subject to cosmetic safety, ingredient, labelling, responsible-person and notification requirements
Accessories, consumables and equipment	Requirements depend on the individual Product, its intended use and the relevant market

The term “botulinum toxin products” is used for the Product category. Individual brand names identify particular Products and are not interchangeable generic descriptions.

3. Regulatory Status Is Product- and Market-Specific

Availability on our website does not mean that a Product is authorised for purchase, importation, distribution or use in every destination.

Assessment may require consideration of:

• The exact Product name, model or market version.
• The manufacturer and relevant manufacturing location.
• Composition, strength, presentation and pack size.
• Intended purpose and approved indications, where applicable.
• Product registration, marketing authorisation or conformity documentation.
• Required labelling and accompanying information.
• Applicable supply-chain licences and local representation.
• The Buyer’s eligibility and intended activity.

Authorisation of another Product from the same manufacturer, or another version sold under a similar brand name, does not establish authorisation of the item being purchased.

A Product’s authenticity, regulatory status and suitability for a particular use are separate matters.

4. Buyer Eligibility and Responsibilities Before Ordering

Our restricted professional-use Products are intended only for Buyers legally entitled to purchase and receive them.

General cosmetics and skincare may be purchased without professional credentials where the Product and applicable law permit.

Before ordering, you must establish the requirements that apply to the specific Products and your intended activities in the destination country.

You must:

• Confirm that you may lawfully purchase, import and possess the Products.
• Hold any professional qualifications required for your intended activities.
• Obtain prescriptions, import permissions or other authorisations legally required from you.
• Confirm any requirements applicable to resale or distribution.
• Provide accurate business, recipient and delivery information.
• Supply relevant documents reasonably required for lawful fulfilment.
• Inform us of restrictions that could affect your Order.

A training certificate alone does not necessarily establish legal authority to purchase, prescribe or administer a regulated Product.

If you are uncertain, obtain confirmation from the relevant competent authority or an appropriately qualified adviser before ordering.

Your responsibilities do not replace obligations legally imposed on us or other parties in the supply chain.

5. Verification and Order Restrictions

We may request information relevant to the proposed transaction, including:

• Professional registration or licence details.
• Business information.
• Identification or authority to act for an organisation.
• Product-specific permissions.
• Import or recipient documentation.

Where verification or a prescription is legally required for us to supply a Product, the Order must not proceed without the required checks.

We may restrict, suspend, decline or cancel an Order where eligibility or lawful supply cannot be established.

Payment, checkout availability or acceptance of website terms does not replace a required permission or make an otherwise unlawful transaction lawful.

Cancellation and refund arrangements are governed by the applicable policies and mandatory law.

6. Regional Regulatory Frameworks

The following overview identifies matters that may require verification. It is not an exhaustive legal guide, a list of available shipping destinations or confirmation that any particular Product is authorised in the markets mentioned.

Market	Matters requiring Product-specific assessment
European Union and European Economic Area	Applicable medicinal-product, medical-device or cosmetic requirements; relevant MDR Annex XVI requirements for certain Products without an intended medical purpose; local supply, labelling and professional rules
Great Britain	Applicable MHRA requirements, lawful medicine supply, medical-device registration and the conformity route recognised at the time of supply
Northern Ireland	The requirements applicable to the specific Product and transaction, including relevant arrangements that differ from Great Britain
Switzerland	Swiss requirements, including applicable registration, representation, import and supply obligations; EU compliance alone should not be assumed sufficient
United States	Product-specific FDA authorisation where required, applicable federal and state supply requirements, and the permissions associated with the parties’ activities
Canada	Applicable Health Canada Product authorisations, device classifications, establishment requirements and provincial professional rules
Australia	Applicable TGA requirements, Australian Register of Therapeutic Goods status where required, sponsor arrangements and prescribing, supply and advertising restrictions
Other destinations	Requirements of the relevant national and local authorities, including Product classification, authorisation, importation, labelling and professional eligibility

References to a regulator or regulatory framework do not imply endorsement of our business or approval of our full catalogue.

Requirements and transitional arrangements can change. Current official information must be checked for the relevant transaction.

7. Understanding Approvals, Registrations and Certifications

Different regulatory terms have different meanings.

Term or evidence	What it does—and does not—establish
Product authorisation or registration	Relates to the specific Product and scope recorded by the relevant authority; it does not automatically apply worldwide
CE marking	Indicates conformity with applicable EU requirements within its scope; it is not a universal import permission or an endorsement of the Seller
FDA registration or listing	Does not, by itself, establish FDA approval or clearance of a Product
Cosmetic notification	Records a notification required under a particular framework; it must not be presented as a general certification or approval of safety
ISO certification	Applies to the named organisation, site and certified scope; it does not automatically certify another business or authorise every Product
Company or trade registration	Identifies or licenses a business within its applicable scope; it does not replace Product-specific permissions
Customs release	Records a clearance outcome; it does not independently establish every requirement for marketing, distribution or use
Authenticity evidence	Supports the identity or provenance of a Product; it does not automatically establish destination-market authorisation

A manufacturer’s or supplier’s certification must not be represented as certification of STBRUNO GLOBAL TRADING – FZCO unless the certificate expressly covers our entity and activities.

8. Product Information and Documentation

Regulatory information should relate to the exact Product and market concerned.

Relevant documentation may include, where applicable:

• Product labelling and official instructions.
• Marketing authorisation or registration information.
• Declarations of conformity and relevant certificates.
• Manufacturer or representative details.
• Batch, lot or serial identifiers.
• Required supply-chain and import documentation.

The documents legally required, the party responsible for holding them and the persons entitled to receive them vary.

A complete manufacturer technical file, batch testing report or confidential commercial record is not automatically supplied with every Order. Equally, confidentiality must not be used to withhold information that we are legally required to provide.

For a documentation enquiry, identify:

• The exact Product and version.
• The intended destination.
• Your proposed activity.
• The specific information required.

We will assess the request and explain what information can appropriately be provided or obtained. A response to an enquiry does not replace approval from a competent authority where required.

9. Authenticity, Packaging and Traceability

Product identity and provenance should be assessed using evidence appropriate to the Product.

Packaging features vary between manufacturers and markets. Not every Product uses a hologram, QR verification system, serialised code or identical security seal.

A packaging variation does not, by itself, establish that a Product is counterfeit. Conversely, a barcode, hologram or QR code alone does not prove authenticity.

Where a concern arises, relevant information may include:

• Product name and market version.
• Manufacturer details.
• Batch, lot or serial number.
• Expiry information.
• Packaging and label photographs.
• Relevant supply and Order records.

Traceability records must be maintained where required by the applicable Product framework and the party’s role. Retention periods must reflect the applicable requirements rather than one universal period for every Product.

Report suspected authenticity or traceability concerns through the contact details below.

10. Storage and Transportation

Storage and transport arrangements must reflect the specific Product’s documented requirements.

There is no single temperature or packaging requirement applicable to the entire catalogue.

Depending on the Product and shipment, appropriate arrangements may include insulation, cooling materials or other protective measures. The use of temperature-monitoring equipment must be described accurately for the service concerned.

Insulated packaging or a frozen ice pack alone does not prove compliance with Product requirements. Melted ice alone does not prove damage.

Potential transport concerns must be assessed using relevant Product requirements and available shipment evidence.

Customers must promptly follow labelled storage requirements after receipt and report suspected compromise without using or distributing the affected Products.

Detailed delivery and claim procedures are provided in the Shipping and Refund Policies.

11. Customs Clearance and International Supply

Customs clearance, Product authorisation and professional eligibility are separate requirements.

An Order must not be treated as lawful solely because:

• A shipping option is available.
• Duties or taxes have been paid.
• The parcel has cleared customs.
• A similar shipment was delivered previously.
• The Buyer has accepted a disclaimer.

Customs descriptions and supporting documents must accurately reflect the shipment.

Special Logistics may include clearance services, duties and taxes as described in our Shipping Policy. Those commercial arrangements do not replace Product-specific approvals or permissions.

Any importer-of-record arrangement must reflect the actual transaction and applicable law.

12. Product Complaints, Safety Concerns and Recalls

Contact us promptly if you suspect:

• A Product defect or lack of conformity.
• Compromised packaging or possible contamination.
• Incorrect labelling or expiry information.
• An authenticity concern.
• A safety issue or adverse incident involving a supplied Product.

Provide relevant Order and Product details, including batch information where available.

If a Product may be unsafe:

• Stop using or distributing the affected Product.
• Keep it separate from usable stock.
• Follow its labelled storage requirements.
• Preserve relevant evidence where safe and practicable.
• Follow urgent instructions from competent authorities or treating professionals.

Do not delay necessary medical attention while waiting for a commercial investigation.

We will assess reports and cooperate with relevant manufacturers, suppliers and authorities where required. Regulatory reporting responsibilities depend on the Product, incident and legal role of each party.

Submitting a report to us does not replace any reporting obligation that applies directly to a practitioner, importer or other party.

Where a recall or corrective action applies, affected parties must follow the relevant instructions. Refund and replacement rights remain governed by the applicable policies and law.

This statement does not claim certification of a pharmacovigilance system or formal participation in every national or international reporting database.

13. Professional Use and Clinical Responsibility

Restricted Products must not be purchased for unauthorised self-administration or supplied to persons who are not legally entitled to receive them.

The treating professional is responsible for matters within their professional role, including patient assessment, informed consent, lawful treatment and follow-up.

We do not provide:

• Prescribing services.
• Clinical treatment.
• Certified clinical training.
• Patient-specific administration advice.

Website content and support communications do not replace official Product information or professional judgement.

Questions about clinical use must be addressed through appropriately qualified professionals and the applicable professional framework.

14. Resale and Distribution

Lawful business purchases for resale or distribution are subject to the permissions and obligations applicable to the Buyer’s activities.

Business Buyers must establish any requirements relating to:

• Wholesale or distribution authorisation.
• Importation and local representation.
• Eligible downstream customers.
• Storage and transportation.
• Traceability and recordkeeping.
• Product information and advertising.
• Safety reporting and recalls.

Purchasing through our website does not grant a distribution licence, trademark licence or appointment as an authorised representative.

Unauthorised or unlawful resale, redistribution, relabelling or supply is not permitted.

15. Advertising, Product Claims and Third-Party Brands

Advertising rules depend on the Product, audience, communication channel and jurisdiction.

Prescription-product restrictions may apply to public webpages, promotions, emails, social media and other communications. A professional-use disclaimer does not, by itself, make an advertisement lawful.

Product claims must not:

• Imply authorisation beyond the relevant market or scope.
• Present registration as approval where that is inaccurate.
• Promise guaranteed treatment outcomes.
• Misrepresent certification, endorsement or distributor status.
• Omit information required by applicable advertising rules.

We do not claim ownership of third-party brand names, trademarks or logos displayed on our website. Their use identifies the relevant Products and does not, by itself, imply endorsement, affiliation or an authorised-distributor relationship.

Further information is provided in our Legal Notice.

16. Personal Information and Complaint Evidence

Personal information is handled according to our Privacy Policy and applicable law.

Professional verification and complaint investigations should use only information reasonably necessary for their purpose.

Do not send identifiable patient records or unnecessary medical information through ordinary email or messaging. Contact us first to establish what is needed and an appropriate method of providing it.

Sensitive information requires the legal basis, safeguards and access restrictions appropriate to the circumstances.

A general reference to privacy legislation or a security standard does not establish certification or universal compliance with every jurisdiction’s requirements.

17. Environmental and Business Conduct

Packaging and Product disposal must follow applicable local requirements.

Used medical items, residual medicinal Products and contaminated materials should not be treated as ordinary recyclable packaging. Follow relevant Product information and local disposal rules.

Any recyclability, environmental certification or sustainability claim must be specific and supported. The availability of recycling arrangements varies by location and material.

Bribery, falsified documents, misleading declarations and attempts to evade applicable requirements are not acceptable means of obtaining authorisation or completing a shipment.

Suspected misconduct connected with our business may be reported through the contact details below.

18. Relationship with Our Other Policies

This page provides regulatory information and explains responsibilities. It does not replace the contractual terms or introduce a separate liability regime.

Document	Matters covered
Terms and Conditions	Purchases, eligibility, contract formation and the parties’ responsibilities
Shipping Policy	Processing, delivery, customs charges and express shipping guarantees
Refund, Return, Replacement and Cancellation Policy	Claims, cancellations, returns and available remedies
Privacy Policy	Personal information, privacy choices and applicable rights
Legal Notice	Website operator information, legal contact details and third-party intellectual property

Nothing on this page removes mandatory rights, transfers our legal obligations to the Buyer or overrides an express commitment made for an accepted Order.

19. Updates and Accuracy

Regulatory requirements, Product classifications and recognised conformity routes may change.

We may revise this page to reflect relevant developments or corrections. The current version will display its update date.

The page is not an exhaustive register of Product approvals or a substitute for checking current official information.

Please report a statement you believe is inaccurate or outdated, identifying the relevant wording and supporting information where available.

Changes to this page do not retrospectively remove rights associated with an accepted Order.

20. Contact Us

For regulatory information, Product documentation enquiries, safety concerns or corrections to this page, contact:

STBRUNO GLOBAL TRADING – FZCO
Email: info@brunodermalfiller.com
Phone / WhatsApp: +370 629 93 526

Where relevant, include:

• The exact Product name and version.
• The destination country.
• Your order number.
• Batch or lot information.
• A clear description of the enquiry.

Please avoid including unnecessary personal or patient information.