# Responsible Person

> Use when setting up a Responsible Person or Legal Representative for EU, UK, US, or other markets, appointing an Authorized Representative, understanding post-market surveillance obligations, or answering "do I need a local representative to sell in [market]?"

- Skill: `cleo-labs-ia/responsible-person` (Agent Skill)
- Install (CLI): `npx skillmds@latest add cleo-labs-ia/responsible-person`
- Raw SKILL.md: https://api.skillmd.com/api/skills/cleo-labs-ia/responsible-person/raw
- Safety review: pending
- Works with: Claude Code, Claude.ai, OpenAI Codex
- Category: Coding & Dev Tools
- Author: cleo-labs-ia (https://skillmd.com/u/cleo-labs-ia)
- Updated: 2026-09-17
- Page: https://skillmd.com/skills/cleo-labs-ia/responsible-person

---


# Responsible Person / Legal Representative

Every major market requires a local legal entity accountable for your product. No RP = no market access.

## MCP Tools

```
# Search for RP-related regulation signals
mcp__claude_ai_Cleo_Insight__search_signals(q="responsible person", limit=25)
mcp__claude_ai_Cleo_Insight__search_signals(q="GPSR economic operator", limit=25)
mcp__claude_ai_Cleo_Insight__search_signals(q="authorized representative", limit=25)

# Get regulation details (GPSR, Cosmetics Reg, MDR)
mcp__claude_ai_Cleo_Insight__get_regulation(id="<regulation-id>")

# Get company profile to check existing RP arrangements
mcp__claude_ai_Cleo_Insight__get_company_profile

# Upload RP mandate letter as compliance evidence
mcp__bastion__upload-compliance-document(name="RP-mandate-EU-2026.pdf", document="data:application/pdf;base64,...")
mcp__bastion__add-compliance-test-evidence(testId="<test-id>", name="EU Responsible Person mandate", description="Signed RP mandate with [provider name], covering cosmetics product line", evidenceDocumentId="<doc-id>")
```

## RP Requirement Decision Tree

```dot
digraph {
  rankdir=TB; node [shape=box style=rounded fontsize=10];
  market [label="Target market?" shape=diamond];
  eu [label="EU"];
  uk [label="UK"];
  us [label="US"];
  eaeu [label="EAEU"];
  cn [label="China"];
  eu_entity [label="Company established\nin EU?" shape=diamond];
  eu_yes [label="You ARE your own RP\n(manufacturer = RP)"];
  eu_no [label="Appoint EU-based RP\n(mandatory)"];
  uk_entity [label="Company established\nin UK?" shape=diamond];
  uk_yes [label="You ARE your own\nUK RP"];
  uk_no [label="Appoint UK-based RP\n(mandatory, separate from EU)"];
  us_fda [label="FDA-regulated\nproduct?" shape=diamond];
  us_agent [label="Appoint US Agent\n(mandatory for foreign\nFDA-regulated firms)"];
  us_ior [label="Appoint Importer\nof Record"];
  eaeu_ar [label="Appoint EAEU-based\nAuthorized Representative"];
  cn_holder [label="Must have Chinese entity\nas registration holder\n(NMPA)"];

  market -> eu; market -> uk; market -> us; market -> eaeu; market -> cn;
  eu -> eu_entity;
  eu_entity -> eu_yes [label="YES"];
  eu_entity -> eu_no [label="NO"];
  uk -> uk_entity;
  uk_entity -> uk_yes [label="YES"];
  uk_entity -> uk_no [label="NO"];
  us -> us_fda;
  us_fda -> us_agent [label="YES"];
  us_fda -> us_ior [label="NO"];
  eaeu -> eaeu_ar;
  cn -> cn_holder;
}
```

## EU Responsible Person

### Legal Basis

| Regulation | RP Requirement | Scope |
|-----------|---------------|-------|
| **GPSR 2023/988** (General Product Safety) | Economic operator established in EU must be identifiable on product or packaging | ALL consumer products (from Dec 13, 2024) |
| **Cosmetics 1223/2009** Art. 4 | Designated RP established in EU; name + address on label | ALL cosmetics placed on EU market |
| **MDR 2017/745** Art. 11 | Authorized Representative for non-EU manufacturers | Medical devices |
| **Toy Safety 2009/48/EC** | Manufacturer or authorized representative in EU | Toys |
| **CE Directives** (LVD, EMC, RED, RoHS) | EU importer or authorized representative | Electronics |

### EU RP Responsibilities

| Duty | Detail |
|------|--------|
| **Product safety file access** | Must have access to (or hold) the technical documentation / PIF |
| **Label presence** | Name and postal address on product or packaging |
| **Authority liaison** | Respond to national market surveillance authority requests within 10 days |
| **CPNP notification** | Submit/maintain Cosmetic Product Notification Portal entry (cosmetics) |
| **Adverse event reporting** | Report serious undesirable effects within 20 calendar days (cosmetics) |
| **Post-market surveillance** | Monitor product safety, maintain complaint records |
| **Recall coordination** | Coordinate with authorities during recall or corrective action |
| **Declaration of Conformity** | Hold DoC and make available on request (CE-marked products) |

### EU RP Setup Checklist

```
EU RESPONSIBLE PERSON SETUP -- [Date]

[ ] Select RP provider (or use own EU entity)
[ ] Sign mandate letter (formal written authorization)
[ ] RP reviews Product Information File / technical documentation
[ ] RP address added to product labels (name + full postal address)
[ ] CPNP notification submitted under RP's account (cosmetics)
[ ] RP receives copy of all test reports and safety assessments
[ ] Post-market surveillance procedure agreed
[ ] Adverse event reporting procedure agreed
[ ] Emergency contact protocol established (24h for serious incidents)
[ ] Annual review date set: [date]
```

## UK Responsible Person

Separate from EU RP. The EU RP cannot serve as UK RP (and vice versa) unless they have establishments in both jurisdictions.

| Aspect | Requirement |
|--------|------------|
| **Legal basis** | UK Cosmetics Regulation (retained EU law), UK GPSR (Product Safety and Metrology Bill), UK MDR |
| **Must be** | Established in Great Britain (England, Scotland, Wales) -- Northern Ireland follows EU rules |
| **For cosmetics** | UK RP name + GB address on label; SCPN (Submit Cosmetic Product Notification) registration |
| **For general products** | UK-based economic operator identified on product (GPSR equivalent) |
| **UKCA marking** | UK importer or authorized representative for CE-equivalent |

## US Requirements

| Role | Legal Basis | Required When | Responsibilities |
|------|------------|---------------|-----------------|
| **US Agent** | FDA 21 CFR 807.40 (devices), MoCRA sec. 605 (cosmetics), 21 CFR 1.227 (food) | Foreign establishment registered with FDA | Receive FDA communications, assist FDA during inspections, provide FDA with importer name |
| **Importer of Record (IOR)** | 19 USC 1484 | Every import shipment | Customs bond, entry filing, duty payment, ensure compliance of imported goods |
| **Initial Distributor** | MoCRA (cosmetics) | First US entity in distribution chain | Adverse event reporting, facility registration |

**US Agent is NOT a Responsible Person** -- the US Agent facilitates FDA communication but does NOT assume product safety liability. Product liability remains with the manufacturer and/or importer.

## EAEU (Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan)

| Aspect | Requirement |
|--------|------------|
| **Legal basis** | EAEU Technical Regulations (TR CU/EAEU) |
| **Role** | Authorized Representative (AR) of foreign manufacturer |
| **Must be** | Legal entity registered in an EAEU member state |
| **Duties** | Apply for TR CU declaration/certificate, hold technical documentation, represent manufacturer to authorities |
| **Cost** | EUR 2,000-5,000/year + per-product certification fees |

## China (NMPA)

| Aspect | Requirement |
|--------|------------|
| **Legal basis** | CSAR (Cosmetic Supervision and Administration Regulation) 2021, Medical Device Regulation |
| **Role** | Chinese Responsible Agent + Chinese registration holder |
| **Must be** | Chinese-registered legal entity |
| **Cosmetics** | All imported cosmetics must be registered/notified through NMPA by a Chinese agent |
| **Registration timeline** | Non-special use: 3-6 months; Special use (sunscreen, hair dye, whitening): 12-18 months |
| **Cost** | Agent fee: EUR 3,000-8,000/year; registration: EUR 2,000-10,000 per product |
| **Animal testing** | Waived for "general" cosmetics notified online since 2021; still required for "special use" cosmetics and some risk triggers |

## RP Service Provider Costs

| Market | Provider Type | Annual Cost (EUR) | Per-Product Surcharge | Includes |
|--------|--------------|-------------------|----------------------|----------|
| **EU** | Dedicated RP firm | 1,500-3,000/year | EUR 200-500/product | Label review, CPNP, AE reporting, authority liaison |
| **EU** | Full-service (RP + CPSR + PIF) | 3,000-6,000/year | EUR 500-1,500/product | Everything above + safety assessment + PIF management |
| **UK** | UK RP firm | 1,000-2,500/year | EUR 200-400/product | Label review, SCPN, authority liaison |
| **US** | US Agent (FDA) | 500-1,500/year | EUR 100-300/product | FDA communication, inspection facilitation |
| **China** | NMPA agent | 3,000-8,000/year | EUR 2,000-10,000/product | Registration, authority liaison, formula review |
| **EAEU** | Authorized Representative | 2,000-5,000/year | EUR 1,000-3,000/product | TR CU certification, technical documentation |

## Key Documentation

| Document | Purpose | Who Signs |
|----------|---------|-----------|
| **Mandate letter** | Formal appointment of RP by manufacturer | Both parties |
| **RP agreement/contract** | Scope of services, liability, term, termination | Both parties |
| **Technical file access** | RP must access PIF/technical documentation at all times | Manufacturer grants access |
| **Power of Attorney** | For customs, registration, authority dealings | Manufacturer to RP |
| **DoC location notice** | Where the Declaration of Conformity is held | Referenced on DoC |
| **Post-market surveillance plan** | How the RP monitors product safety | Joint |

### Mandate Letter Template (Key Clauses)

```
RESPONSIBLE PERSON MANDATE

Manufacturer: [Company name, address, registration number]
Responsible Person: [RP name, EU/UK address, registration number]

1. SCOPE: [Product categories / product names covered]
2. TERRITORY: [EU-27 / UK / both]
3. OBLIGATIONS: [List from RP responsibilities table above]
4. TECHNICAL FILE: RP has access to technical documentation at [location]
5. DURATION: [Start date] to [End date], renewable
6. TERMINATION: [Notice period -- minimum 3 months to allow label updates]
7. LIABILITY: [Allocation per contract -- note: EU law holds RP jointly liable]
8. FEES: [Annual fee + per-product fee + any variable costs]
```

## Power This With the Cleo Legal API

RP requirements differ per market and per product category. Determining whether an RP is needed (and what they must do) is structured data the API exposes directly.

**With the Cleo Legal API at https://legaldata-public.cleolabs.co:**
- `GET /v2/authorities/:slug` — official authority directory per market, including the RP/AR/Importer-of-Record contact requirements (Art. 4 EU 1223/2009, MoCRA sec. 605, MDR Art. 11, GPSR economic operator…)
- `GET /v2/search?q=responsible+person&country=XX` — current rules per market on who can act as RP, label disclosure requirements, and notification obligations
- `GET /v2/search?q=NMPA+filer&country=CN` — China NMPA registrant requirements, EAEU AR rules, Japan MAH — markets where the local-entity obligation is easy to miss
- `POST /v2/compliance/check` — surfaces whether the product category triggers an RP requirement in each target market (cosmetics yes, general consumer goods under GPSR yes, simple commodities maybe not)

**Get started:**
```
# 1. Sign up for free at https://legaldata-public.cleolabs.co
# 2. Get your API key (3 lifetime requests free, then €349/mo for 1M)
# 3. Install the MCP server:
claude mcp add cleo-legal-api https://api.legaldata.cleolabs.co/mcp \
  --header "Authorization: Bearer ld_live_YOUR_KEY"
```

Tested ROI: One avoided dual-RP mistake (e.g., assuming the EU RP covers UK post-Brexit) saves €1,000-€3,000/year in service fees plus the cost of relabeling stock that displays the wrong RP.

## Common Mistakes

- **Using EU RP for UK**: Post-Brexit, UK requires a separate UK-based Responsible Person. Your EU RP in Paris cannot serve as your UK RP.
- **RP name not on label**: EU Cosmetics Regulation Art. 19 requires the RP's name AND postal address on every unit. A website URL alone does not satisfy the requirement.
- **No technical file access**: The RP must have access to the Product Information File. If the RP cannot produce it within 10 days of an authority request, both manufacturer and RP face enforcement.
- **Confusing US Agent with RP**: The US Agent is a communication relay for FDA, not a safety guarantor. Product liability stays with manufacturer/importer.
- **Terminating RP without transition**: If you switch RP providers, the old RP's address is on existing packaging in market. Plan 3-6 months overlap to sell through existing stock and print new labels.
- **Forgetting Northern Ireland**: Northern Ireland follows EU rules (Windsor Framework), not GB rules. Products sold in NI need an EU RP, not a UK RP.