Global Compliance Statement
Comprehensive Regulatory Conformity for International Distribution of Botulinum Toxin and Dermal Fillers
Issued by: Opal Nirvana UAB
Company Number: 306805967
Registered Address: Girulių g. 5, LT-12124, Vilnius, Lithuania
This document serves as a comprehensive and definitive compliance statement intended for legal, regulatory, and operational assurance regarding the international distribution, marketing, importation, and professional-use-only administration of botulinum toxin-based products (“Botox”) and dermal fillers.
It outlines Opal Nirvana UAB’s adherence to local and supranational legal frameworks, regulatory approvals, labeling mandates, distributor obligations, and practitioner limitations across all major commercial territories — including, but not limited to, the European Union, United Kingdom, United States, Canada, Australia, Asia-Pacific, MENA, sub-Saharan Africa, and associated offshore jurisdictions.
I. European Union (EU)
All products distributed within the European Economic Area (EEA) 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 by a Notified Body, bearing a valid CE marking and Declaration of Conformity.
Botulinum toxin products are registered under the medicinal product framework and possess Marketing Authorization (MA) via either the EMA’s centralized procedure or national approval in compliance with Article 6 of Directive 2001/83/EC.
Labeling, SmPCs, and patient information leaflets are fully localized per MDR Annex I and the Falsified Medicines Directive (2011/62/EU).
All EU-distributed products list an EU Authorized Representative on the label as required under MDR Article 11.
Opal Nirvana UAB ensures that promotional activity strictly targets licensed healthcare professionals, in accordance with Directive 2001/83/EC (Articles 86–100) and the EFPIA Code of Practice.
II. United Kingdom (UK)
Following Brexit, all Botox and filler products distributed within the UK are governed by the UK Medical Devices Regulations 2002 (UK MDR 2002) and the Human Medicines Regulations 2012.
Products bear CE or UKCA marking and are registered with the MHRA under a designated UK Responsible Person (UKRP).
Prescription-only medicines (POMs) hold valid MHRA-issued Marketing Authorisations, and all distribution adheres to Good Distribution Practice (GDP).
Consumer advertising of prescription medicines remains prohibited. Promotions are strictly professional-facing in accordance with CAP and ASA rules. The Botulinum Toxin and Cosmetic Fillers (Children) Act 2021 is observed in full.
III. United States of America (USA)
Botulinum toxin is regulated by the U.S. FDA as a prescription biological product under 21 CFR Part 600. Dermal fillers are classified as Class III medical devices under 21 CFR Parts 801–820, requiring PMA or 510(k) clearance.
All manufacturing facilities comply with cGMP, and distribution follows the Drug Supply Chain Security Act (DSCSA).
Marketing to consumers is restricted under 21 CFR 202.1; advertising must be fair, balanced, and risk-inclusive. Only licensed practitioners may prescribe or administer these products.
IV. Canada
Under Health Canada regulation, Botox products possess a valid Drug Identification Number (DIN), while dermal fillers are Class III medical devices listed on MDALL.
Labeling complies with bilingual (English/French) standards per the Consumer Packaging and Labelling Act.
Advertising of prescription drugs to the public is restricted to reminder or disease-awareness formats.
All importers hold appropriate MDEL or DEL licenses.
V. Australia
Governed by the Therapeutic Goods Administration (TGA), Botox is classified as a Schedule 4 prescription medicine, and dermal fillers as Class III medical devices.
Products appear on the ARTG, with batch tracking, temperature monitoring, and TGO 91/92 compliance.
Direct consumer advertising is prohibited, and administration is limited to licensed professionals.
VI. Asia-Pacific and MENA
All products distributed in China (NMPA), Japan (PMDA), South Korea (MFDS), India (CDSCO), and Middle Eastern markets such as the UAE (MOHAP) and Saudi Arabia (SFDA) are registered under local laws with corresponding bilingual labeling, import licensing, and authorized representatives.
Promotional activity complies with prescription-only restrictions and national advertising bans.
VII. Africa
Distribution in South Africa (SAHPRA), Nigeria (NAFDAC), and other regional jurisdictions requires full local registration, licensed importers, and English labeling.
Schedule 4 and prescription-only controls are observed, and pharmacovigilance procedures are integrated into Opal Nirvana UAB’s centralized compliance system.
VIII. Additional Provisions and Regulatory Safeguards
Product Storage & Transport
All Botox and filler products are shipped under validated cold chain conditions (2–8 °C), with temperature tracking per WHO GDP guidelines.
Batch Record & Recall
Records, Certificates of Analysis, and traceability data are maintained for 10 years, with a tested Recall Protocol in place.
Adverse Event Reporting
Pharmacovigilance operates under systems including EudraVigilance (EU), MedWatch (USA), MedEffect (Canada), and VigiBase (WHO), following ISO 13485:2016 standards.
Clinical Training
Opal Nirvana UAB provides certified professional training for practitioners, including safety, anatomy, and adverse event management modules.
Data Privacy & Cybersecurity
All records comply with GDPR, HIPAA, PIPEDA, and relevant data protection laws. Systems are secured under ISO/IEC 27001 standards.
Anti-Counterfeiting & Packaging Integrity
Packaging incorporates serialized barcodes, tamper seals, and authentication holograms, ensuring full traceability and product authenticity.
Environmental Responsibility
Packaging and logistics follow EPR and sustainability principles, using recyclable and eco-friendly materials.
Ethics & Anti-Corruption
Opal Nirvana UAB enforces a zero-tolerance policy toward bribery and corruption, complying with the FCPA, UK Bribery Act 2010, and equivalent global standards.
⚠️ Professional Use Disclaimer
All botulinum toxin and dermal filler products supplied by Opal Nirvana UAB are strictly for professional use by licensed healthcare practitioners.
These products are not available for direct consumer sale and must be prescribed, handled, and administered only by qualified medical professionals.
Any misuse, off-label administration, resale, or unauthorized distribution is strictly prohibited.
Opal Nirvana UAB reserves the right to refuse supply to any entity failing to demonstrate appropriate credentials or regulatory compliance.
Issued by:
Opal Nirvana UAB
Company Number: 306805967
Registered Address: Girulių g. 5, LT-12124, Vilnius, Lithuania
Effective Date: 12 January 2025
