Medical devices Free Sales Certificate

For the export of medical devices to non-European countries it may be necessary to apply for a Free Sales Certificate. This certificate states that the products referred to can be freely marketed within Europe.

You can apply for a Free Sales Certificate via Farmatec

You have to apply for a Free Sales Certificate online. You will also have to submit certain documents. To log in you need level 2+ eHerkenning.
Standard procedure is only to state the group and brand name on the Free Sales Certificate. If you want to add more details to the Free Sales Certificate you can submit a separate request along with the online application (see Product list and/or production location annex).

Applying for the eHerkenning login

You can obtain an eHerkenning login from one of the 6 certified suppliers. On the eHerkenning website you can find a step-by-step plan that will help you apply for a login.
If you already have an eHerkenning login you should proceed immediately to Log in.

Legislation and regulations

European: Directives 93/42/EEC, Directive 98/79/EC and Directive 90/385/EEC.

Documents

In order to apply for a Free Sales Certificate you must upload a number of documents along with the online application. Without these documents we will not be able to process your application.

Find out here which documents you have to add to your application.


Costs

Farmatec charges an amount of € 62 per Free Sales Certificate. For each invoice Farmatec charges € 62 in administrative costs. The invoices are sent out the following quarter.

Processing period

If the details and documents required for your application are complete, you will receive the Free Sales Certificate within 4 weeks.

Changes

Confirmed product notifications can be changed online (product mutations). To do so you will once again have to log in with eHerkenning. A change can consist of a change (WIJZ), deregistration (AFM), or reregistration (OPN) if the product has previously been deregistered.
No costs are charged for deregistering products or giving notice of changes.
A deregistration or change will be processed within no more than 3 months.