Industry Guide
Compliance for Pharmaceutical
Pharmaceutical companies operate under dense chemical, environmental, and product authorisation regulation – covering substance registration, wastewater obligations, manufacturing emissions, and the full lifecycle of medicinal products.
Key Regulations
REACH
Requires pharmaceutical manufacturers to register chemical substances produced or imported above 1 tonne per year, evaluate their hazards, obtain authorisation for substances of very high concern (SVHCs) – including CMRs and endocrine disruptors used in API synthesis – and communicate applicable restrictions to downstream users.
→ Learn moreCLP – Classification, Labelling and Packaging Regulation
Requires manufacturers and importers of chemical substances and mixtures to classify hazards according to the UN GHS criteria, label products with standardised hazard and precautionary pictograms, and notify classifications to the ECHA C&L Inventory – with direct implications for pharmaceutical raw material handling, storage, and packaging.
→ Learn moreUWWTD – Urban Waste Water Treatment Directive (Revised)
The 2024 revised directive introduces a first-of-its-kind extended producer responsibility obligation for pharmaceutical companies, requiring producers and importers of medicines to contribute financially to the costs of removing pharmaceutical residues from urban wastewater treatment systems.
→ Learn moreMedicinal Products Directive
Sets the foundational rules for the authorisation, manufacture, labelling, classification, supply, and pharmacovigilance of medicinal products for human use in the EU, requiring marketing authorisation from EMA or national competent authorities before any medicine can be placed on the market.
→ Learn moreWhat Also Applies to Your Business
Sector-specific obligations that are often overlooked
Drinking Water Directive
Introduces a risk-based approach to drinking water safety and new quality parameters for emerging contaminants including pharmaceutical residues and PFAS. Pharmaceutical manufacturers operating near drinking water catchments face increased regulatory scrutiny regarding API and metabolite discharge to water sources.
→ Learn moreRoHS – Restriction of Hazardous Substances Directive
Restricts the use of lead, mercury, cadmium, hexavalent chromium, and certain flame retardants in electrical and electronic equipment. Pharmaceutical companies manufacturing or distributing electronic medical devices, diagnostic instruments, or patient monitoring systems must ensure RoHS compliance across these product categories.
→ Learn moreChemical Agents Directive
Requires employers to assess and control worker exposure to hazardous chemical agents in the workplace, implement engineering controls and personal protective equipment, establish occupational exposure limits, and provide health surveillance for workers handling CMR substances – critical for pharmaceutical API manufacturing and formulation environments.
→ Learn moreIndustrial Emissions Directive (IED II)
Requires large pharmaceutical manufacturing installations to hold an integrated environmental permit, apply Best Available Techniques (BAT) for controlling emissions to air, water, and land, and report to national authorities. Specific BAT conclusions apply to the chemical and pharmaceutical industry, covering solvent emissions and wastewater treatment.
→ Learn moreWe track 135+ laws relevant to Pharmaceutical – across EU-wide directives and national legislation. Explore the full registry →
How Sustainova Helps
Vicky AI
Get answers now
Ask Vicky anything about Pharmaceutical compliance. Instant, sourced answers – no setup required.
Example questions
Which substances in our manufacturing process are classified as SVHCs under REACH, what authorisation is required, and what are the applicable sunset dates?
What hazard classification and CLP labelling requirements apply when we import a new chemical raw material for use in API synthesis or formulation?
What are our obligations as a pharmaceutical manufacturer under the revised UWWTD's EPR scheme for pharmaceutical residue removal from wastewater?
ComplyOne
Manage it ongoing
Track obligations, assign tasks, maintain audit trail – built for Pharmaceutical specifics.
Example workflows
Maps REACH, CLP, UWWTD, and Medicinal Products Directive obligations to your substance portfolio and product authorisations – with SVHC sunset dates and penalty exposure
Assigns SVHC authorisation, CLP label updates, and UWWTD EPR tasks to regulatory affairs and EHS teams with tracked deadlines
Flags SVHC candidate list additions, REACH restriction proposals, and UWWTD national transposition changes automatically
See how it works for Pharmaceutical
We'll walk you through exactly how Vicky and ComplyOne apply to your regulatory landscape.