Pharma regulation moves fast.
Vicky keeps you ahead of it.
Vicky tracks EU and national pharmaceutical and environmental law, shows what is about to change, and answers compliance questions with citations to the source text.
Industry leaders choose Vicky
Vicky helps pharma companies with these laws
Rules that already apply, or soon will, to medicine manufacturers and marketing authorisation holders.
- Applies from August 1, 2027
Urban Waste Water Treatment Directive (revised)
Introduces extended producer responsibility for pharmaceutical residues in urban wastewater. Producers of medicines will co-fund the extra treatment.
- Applies since August 12, 2026
Packaging and Packaging Waste Regulation
Sets recyclability, labelling and substance requirements for packaging, including the packaging your medicines are sold in.
- In the pipeline
Critical Medicines Act
Proposed EU rules to secure the supply of critical medicines and strengthen manufacturing in Europe.
- In the pipeline
EU pharma package
The proposed overhaul of the EU's core pharmaceutical directive and regulation, from marketing authorisation to data protection.
- In force
REACH
Registration and authorisation of chemical substances, including the substances of very high concern used in API synthesis.
- In force
CLP Regulation
Hazard classification and labelling of the chemical substances and mixtures you make or import.
- In force
Industrial Emissions Directive (IED 2.0)
Environmental permits and best available techniques for large pharmaceutical manufacturing sites.
- Guidance
EU GMP guidelines (EudraLex Volume 4)
Good manufacturing practice rules for medicines. Vicky follows EudraLex for updates.
Pick a country to see its sources
Every answer traced to its source
Vicky takes official documents, FAQs and related documents straight from these sources: EU and national legal portals and pharma regulators. Every answer cites the source text.
International3 sources
- ICHGuidelines
- PIC/SGuidelines
- WHOGuidelines
European Union4 sources
- EUR-LexLegislation
- EudraLexGuidelines
- EMARegulator
- ECHARegulator
Czechia2 sources
- e-SbírkaLegislation
- SÚKLRegulator
Slovakia2 sources
- Slov-LexLegislation
- ŠÚKLRegulator
Poland1 source
- ELI SejmLegislation
Hungary2 sources
- Nemzeti JogszabálytárLegislation
- OGYÉIRegulator
Germany5 sources
- Rechtsinformationen des BundesLegislation
- VORIS NiedersachsenLegislation
- BfArMRegulator
- Paul-Ehrlich-InstitutRegulator
- G-BARegulator
Austria2 sources
- RISLegislation
- BASGRegulator
France1 source
- LégifranceLegislation
Spain1 source
- BOELegislation
Radar shows what is about to change
See laws that just started applying, the dates coming up next, and EU files still in the pipeline, before they land on your desk.
Regulatory Radar
Dossiers you follow
2001/83/EC
Medicinal Products Directive
- CELEX
- 32001L0083
- Preparation
- Proposal
- Negotiation
- Adopted
- Applicable
- Follow-up acts and transposition
Feed
- CzechiaAuthority measureInformace o výskytu padělků léčivého přípravku EnhertuCounterfeits in the legal supply chain · SÚKL2011/62/EU falsified medicines
- CzechiaAuthority measureInformace o výskytu padělků léčivého přípravku PhesgoCounterfeits in the legal supply chain · SÚKL2011/62/EU falsified medicines
- NewsMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August – 3 September 2026EMA2010/84/EU pharmacovigilance
- CzechiaInterpretation and guidanceSÚKL UST-46 verze 2Reporting supplies of medicinal products to the market · SÚKLCZ 378/2007 Sb.
- Implementing or delegated actDelegated Regulation (EU) 2026/863 corrects the variations rulesIn force 24 Aug 2026 · EUR-Lex2024/1701 variations
28 older items in the dossier
Timeline
- 2026
- Pharmacovigilance activities regulation applies in full2025/1466 pharmacovigilance
- Variations correction (2026/863) enters into force2024/1701 variations
- As of 1 Oct 2026
- Last UK-related derogation authorisations expire2022/642 UK supply derogationsUnchanged
- Not dated yet
- Typically 18–24 months after entry into forceNew pharmaceutical directive transposed into national lawPharma package directive (proposal)Unchanged
Illustrative example, data as of October 1, 2026
Same question, two answers
We asked a general AI assistant and Vicky the same regulatory question. Only one of them worked from the current law.
Pick a question
Question
When does the revised Urban Waste Water Treatment Directive become applicable?
General AI assistant
The revised Urban Waste Water Treatment Directive (Directive (EU) 2024/3019) enters into force 20 days after its publication in the Official Journal of the EU, and it becomes applicable (i.e., must be applied) from 1 January 2026.
Gives 1 January 2026. The revised Directive applies from 1 August 2027.
Vicky
The revised Urban Waste Water Treatment Directive (Directive (EU) 2024/3019) becomes applicable from 1 August 2027 for the provisions explicitly flagged for deferred application — Articles 12 and 13 and Annexes II and IV. source 14
At legislation level, it is recorded as in force and with a general date of application of 1 August 2027. legislation record
If you tell me which obligation you’re tracking (e.g., energy neutrality, quaternary treatment/micropollutants, monitoring/reporting), I can point you to the exact article and the relevant phased deadlines for different plant sizes.
Correct date, taken from the legislation record and the directive text.
Recorded on September 28, 2026. General assistant: GPT-5.2 via API, no tools, web search off. Vicky: Vicky assistant v3. Same prompt to both, first answer, shown in full. Showing 3 of 25 questions we tested.
Why do companies use Vicky?
Working with Sustainova has made a noticeable difference in how our team handles sustainability compliance. Vicky is fantastic—it saves us so much time sifting through complex EU regulations and gives clear, reliable guidance.
Silvie Kovaľ
ESG Manager
Vicky is a unique tool. It marks the end of searching through legislation. And also the end of anxiety that you might have missed some regulation.
Zuzana Hola
Head of Sustainability, Vodafone
I'm getting familiar with Vicky, the AI expert, and my new best friend.
Ines Windisch
Chief Sustainability Officer, Zentiva Group
Set up in minutes
- 1
Tell us your industry and countries
Onboarding starts from pharma, so you do not begin with a blank page.
- 2
Get your list of laws
Vicky matches the regulations that apply to you and what each one requires.
- 3
Stay ahead of changes
Follow updates in Radar and ask Vicky when something is unclear.
Questions from pharma teams
Which regulators does Vicky monitor?
EU sources such as EUR-Lex, EudraLex, EMA, ECHA, ICH and PIC/S, plus national authorities in the Czech Republic, Slovakia, Hungary, Austria and Germany.
Does Vicky replace our regulatory affairs team?
No. Vicky finds the rules, explains them and cites the source text. Your team still makes the decisions.
Can I add our own documents to a conversation?
Yes. You can attach files to a conversation with the Vicky assistant and ask questions about them.
Ready to put compliance on autopilot?
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