One of the most common questions about Poison Centre Notifications (PCN) is whether to submit an EEA-wide PCN (EEA = European Economic Area, which is EU + Iceland, Lichtenstein and Norway) or individual country-specific PCNs. Both approaches have advantages and disadvantages, and choosing the right one depends on your business strategy and distribution model.
What is an EEA-wide PCN?
An EEA-wide PCN is a single notification submitted to the ECHA Submission Portal that covers all European Economic Area (EEA) countries where your product is sold. Instead of submitting multiple notifications, you select all relevant countries in one submission.
Benefits of an EEA-wide PCN:
✅ One submission, multiple markets – Reduces administrative work by covering all selected EEA countries in a single notification.
✅ Cost-effective for broad distribution – Instead of paying for separate submissions, an EU-wide PCN can be more economical if your product is distributed widely.
✅ Consistency across markets – Ensures that the same UFI and safety data apply uniformly across all notified countries.
Challenges of an EEA-wide PCN:
❌ Requires a valid legal entity – Only an EEA-based company (or in Northern Ireland) or representative can submit an EEA-wide PCN.
❌ Not all national requirements are the same – Some countries may have additional local requirements that must be addressed separately.
❌ More complex to update – Any formulation or classification change means updating the notification for all covered countries at once.
What is a country-specific PCN?
A country-specific PCN means submitting separate notifications for each individual EEA country where your product is sold. This approach allows more flexibility but comes with added administrative effort.
Benefits of a country-specific PCN:
✅ If you don’t have an EEA-based entity, your importers or distributors can still submit their own PCNs in each country.
✅ More control over market entry – You can gradually notify countries based on your sales expansion.
✅ Easier updates for specific countries – If you change your formulation, you only need to update the relevant country submissions.
Challenges of a country-specific PCN:
❌ More time-consuming – Requires multiple submissions instead of a single EEA-wide notification.
❌ Higher costs for multiple markets – Each individual notification comes with additional fees, which can add up quickly.
❌ Potential inconsistencies – Differences in notifications between countries could create regulatory confusion.
Which option is right for you?
The choice between an EEA-wide PCN and country-specific PCNs depends on several factors:
- If your company has an EEA-based entity, an EEA-wide PCN may be the most efficient option.
- If you distribute through multiple importers, country-specific PCNs might be necessary since each importer may have different compliance obligations.
- If you are a non-EU manufacturer, your best option is often voluntary PCN combined with country-specific notifications by your importers.
Final thoughts: Making the right compliance decision
Both EEA-wide and country-specific PCNs have their advantages, but the best approach depends on your business structure, distribution model, and regulatory strategy. Understanding these options can help you save time, reduce costs, and maintain compliance across all relevant markets.
In our next post, we’ll tackle a common question: Can a UFI cover all EEA countries? Clearing up the confusion.
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