Disposable bags, tubes and accessories for health care

Below you will find all the necessary documents and background information to apply for the Nordic Swan Ecolabel.

Fees valid from 1st January 2018

Disposable bags, tubes, and instruments for medical use, including dialysis, drip, ostomy and urine bags.

Type of fee	Amount
Application fee*	EUR 3,000 + VAT
Renewal fee*	EUR 1,500 + VAT
More than one inspection visit within the Nordic region**	EUR 500 + VAT per visit
Inspection visits in Europe**	EUR 1,500 + VAT per visit
Inspection visits outside Europe**	EUR 2,500 + VAT per visit
Extension of existing licence***	Extension of existing or changes in licence < 4 hours: EUR 375 + VAT < 8 hours: EUR 750 + VAT ≥ 8 hours: EUR 1,500 + VAT
Annual licence fee for Nordic region	0,3% of turnover + VAT per year
Minimum fee for Nordic region	EUR 2,000 + VAT per year
Maximum fee for Nordic region	EUR 100,000 + VAT per year
Fees for sale outside the Nordic region (Only if revenue > EUR 300,000 per year)	EUR 2,000 + VAT per year

* When both the applicant and the manufacturer are micro-enterprises, the fee is reduced by 50%. A micro-enterprise is in this context defined as an enterprise with less than 10 employees and an annual turnover (of both ecolabelled and not ecolabelled products) below EUR 2 million.

** Where audits requires more than one day away from the office including travelling, Nordic Ecolabelling can invoice an additional fee of 1,000€ per extra day. Other extraordinary costs induced by the audit can also be invoiced the applicant.

*** As for an extension of or amendments to a licence, time consumed in connection with the review process will be invoiced according to the extent of the required task. We make a distinction between entirely administrative tasks that last less than 1 hour, and all other tasks that last between 1 and 4 hours, between 4 and 8 hours and more than 8 hours.

The recipient is liable for the VAT according to article 56 of the Council Directive 2006/112/EC.
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