Global Regulatory Standard Compliance

Global Compliance Statement: International Regulatory Conformity for the Distribution of Botulinum Toxin and Dermal Fillers

This compliance statement outlines our company’s commitment to full regulatory conformity for the international distribution, marketing, and professional-use administration of botulinum toxin-based products ("Botox") and dermal fillers. This document affirms our adherence to all applicable legal frameworks, approvals, labeling requirements, distributor responsibilities, and professional use restrictions across all major commercial territories, including the European Union (EU), United Kingdom (UK), United States (USA), Canada, Australia, Asia-Pacific, Middle East and North Africa (MENA), sub-Saharan Africa, and related jurisdictions.


I. European Union (EU)

All products distributed within the EU and EEA (including EFTA countries) comply with Regulation (EU) 2017/745 (MDR) for medical devices and Directive 2001/83/EC for medicinal products.

  • Dermal Fillers are classified as Class III medical devices under MDR Annex VIII and undergo conformity assessment via designated Notified Bodies. CE marking, Declarations of Conformity, and Technical Documentation are provided per MDR Articles.

  • Botulinum Toxin Products are registered under Directive 2001/83/EC and require valid Marketing Authorisations (MAs) issued nationally or via EMA. Pharmacovigilance systems, SmPC documents in local languages, and traceability under the Falsified Medicines Directive are enforced.

  • Labeling includes full translation, CE marking, and EU Authorized Representative details as per MDR Article 11.

  • Marketing and promotional activities follow Directive 2001/83/EC Articles 86-100 and the EFPIA Code, restricting DTC (Direct-to-Consumer) promotion of POMs.


II. United Kingdom (UK)

Post-Brexit, products in the UK are governed by the UK Medical Devices Regulations 2002 and the Human Medicines Regulations 2012.

  • Dermal Fillers must be CE or UKCA marked and registered with the MHRA. A UK Responsible Person (UKRP) is designated.

  • Botulinum Toxin Products require MHRA-issued MAs and must comply with GDP and WDA(H) license regulations.

  • All labeling is in English and includes PILs, batch numbers, and UKRP contact.

  • DTC advertising of POMs is prohibited. Promotions target licensed professionals only. Cosmetic use in minors (<18) is banned under the Botulinum Toxin and Cosmetic Fillers (Children) Act 2021.


III. United States (USA)

All products comply with U.S. FDA requirements:

  • Botulinum Toxin: Classified as biologic drugs, regulated under Biologics License Applications (BLAs) and 21 CFR Part 600. Must be manufactured in cGMP-compliant facilities.

  • Dermal Fillers: Regulated as Class III medical devices via PMA or 510(k) pathway. Packaging and labeling must comply with 21 CFR Parts 801 and 820, including UDI.

  • Prescription products may only be administered by licensed professionals. Advertising must comply with 21 CFR 202.1; off-label promotion is prohibited.

  • Distribution complies with the Drug Supply Chain Security Act (DSCSA).


IV. Canada

  • Botulinum Toxin products must hold a Drug Identification Number (DIN) from Health Canada.

  • Dermal Fillers are Class III devices listed on the MDALL and require a valid MDEL or DEL.

  • Labeling is bilingual (English/French) and meets requirements under the Consumer Packaging and Labelling Act.

  • Public advertising is restricted to name-only or awareness messaging.


V. Australia

  • Regulated by the TGA under the Therapeutic Goods Act 1989.

  • Botulinum Toxin is classified as a Schedule 4 POM.

  • Dermal Fillers are Class III medical devices listed on the ARTG.

  • Packaging must include ARTG number, batch tracking, and comply with TGO 91/92.

  • Only licensed professionals may administer. Advertising of POMs is prohibited.


VI. Asia-Pacific & MENA Regions

  • Countries including China (NMPA), Japan (PMDA), South Korea (MFDS), and India (CDSCO) require local product registration, local-language labeling, and authorized representatives.

  • Middle Eastern countries require bilingual labeling and strict import licensing.

  • Prescription product advertising is restricted or banned.


VII. Africa

  • South Africa (SAHPRA) and Nigeria (NAFDAC) require English labeling, prescription-only classification, and registration with local health authorities.

  • Import/distribution licenses and batch traceability are mandatory.


VIII. Additional Safeguards

  • Cold Chain Logistics: All temperature-sensitive products are shipped using validated cold chain methods (2–8°C), with monitoring devices included. Compliant with WHO GDP guidelines.

  • Traceability & Recall: Full batch-level traceability maintained for 10 years. Recall protocols are annually validated.

  • Adverse Events: Centralized pharmacovigilance system reports to EU (EudraVigilance), USA (MedWatch), Canada (MedEffect), and WHO (VigiBase).

  • Training: Only licensed professionals may purchase and administer products. Certified training is provided and records are maintained.

  • Data Protection: All data handling complies with GDPR, HIPAA, PIPEDA, and similar frameworks.

  • Anti-Counterfeiting: Packaging includes barcodes, holograms, tamper-evident seals, and optional NFC/SMS authentication.

  • Sustainability: Packaging materials are recyclable and comply with EPR schemes. Cold chain packaging is eco-friendly.

  • Employee Training: Annual compliance training covers regional laws, ethical practices, and operational standards.

  • Certifications: Facilities comply with ISO 13485, ISO 9001, and ISO 14001 standards.

  • Anti-Corruption: We comply with FCPA, UK Bribery Act, and equivalent anti-corruption laws globally.


⚠️ Professional Use Only

All botulinum toxin and dermal filler products are strictly for professional use by licensed healthcare providers. Unauthorized use, resale, or redistribution is prohibited. We reserve the right to deny supply to non-compliant entities.