Handling of tissues and cells

A quality system must be in place that includes all written procedures and instructions for the activities at the tissue establishment.

If the tissue establishment is to export or import tissues and/or cells to/from a country outside the EEA, an export/import permit is also required. These authorisations must also be applied for through the Swedish Medical Products Agency (Swedish MPA).

Application for authorisation of tissue establishment

Send the application with attachments by mail or email to:

Email: registrator@lakemedelsverket.se

Mail:
Läkemedelsverket
Inspektion av industri och sjukvård 
Box 26
751 03 Uppsala

The application must include details of the person who will act as the responsible person for  the tissue establishment.

There must be a Head of Operations who is responsible for the tissue establishment. If the Head of Operations does not have the required competence and experience to act as the responsible person, a specifically appointed responsible physician or dentist with the required competence must be appointed.

Procedure

Before an authorisation can be issued, an inspection must be carried out. An inspector from the Swedish MPA contacts the responsible person in order to plan and book an inspection.
From the date on which an application is completed, it takes approximately 90 days before an authorisation is issued.

Fees

The Swedish MPA charges an application fee of SEK 2 000, as well as an annual fee of SEK 18 000.
The fee includes, inter alia, inspection of the tissue establishment, issuing/updating of authorisations and the opportunity to receive guidance as well as responses to questions.