Sweden requires new notification

5 May 2020

Companies are required to take urgent action if they wish to keep their products on sale in Sweden.

Until recently, to have products on sale in Sweden only required standard EU-CEG notification. On 31 March 2020 this changed. Sweden now require companies to notify The Public Heath Agency of Sweden (https://www.folkhalsomyndigheten.se/the-public-health-agency-of-sweden/) via the EU-CEG system in addition to the rest of Europe.

The information required includes:

  • Comprehensive data on sales volumes by brand name and type of the product.
  • Information on consumer preferences, including; young people (29 years and younger), non-smokers, and the main types of current users.
  • The mode of sale of the products – typically online or retail.
    Executive summaries of any market surveys carried out.
    The information above must be submitted annually and no later than the 31 March for the previous year.

Companies that fail to complete this reporting obligation, will not be to sell their products in Sweden. The Agency has said that they plan to carry out controls of the annual reporting obligation during 2020 and will take appropriate action for failure to comply with the new rules.

ADACT’s Chief Regulatory Officer, Damien Bové, commented, ‘It is essential companies comply with the new regulations as soon as possible as random checks are already taking place. You have probably already trusted ADACT to deal with your European notifications, so we are ideally placed to complete the new Swedish notifications too. We would also take this opportunity to remind you to keep your contact details for the European Union updated in EU-CEG.’

Please contact us today by calling +44 (0)1302 986 088 or emailing sales@adactmedical.com. We are operating largely as normal during the pandemic and look forward to hearing from you soon.

Get in touch with ADACT

Call or email ADACT using the buttons below