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Do you have a side-effect

You can define a side-effect as any unwanted or harmful reaction/effect that arise while or as a reaction to a pharmaceutical product.

Any questions related to side-effects should be sent to kvalitet@2care4.dk, if you prefer a phone call please call 0045 75 15 29 00. Side-effects can be reported to us and also to your local authorities, remember side-effects should be reported to the authorities, in the country in which the side-effect occur, and not to the authorities in your country of origin:

In order to have a valid side-effect we need the following information

  • Your name
  • Your age or birthday
  • Your sex
  • A description of the event or side-effect
  • The name, batch number and item number (V.nr) for the suspected pharmaceutical product
  • In order to give the fullest account to the authorities, we would also like a list of other pharmaceuticals and supplements that you might use.

You can read more about side effects in GVP module VI and GVP Annex 1.

How do we process your information

When we, at 2care4, receive information about a side effect, the first thing we do is to make sure that we have all the needed information.

The information is then encrypted and forwarded to Pharmalex, who then reports the information to eudravigilance. Pharmalex might sometime require that 2care4 gather additional information relating to the side-effect, which is why we might need to contact you again.

The mandate of Eudravigilance is to monitor the safety profile of all pharmaceuticals in Europe, so by sending information relating to a side-effect, you might help ensuring that the pharmaceuticals are safe for your fellow Europeans.

 Archive

2care4 can in accordance with REGULATION (EU) 2016/679 article 9 section 2.i store information, that has to do with the safety of our pharmaceutical products. We will keep your data in minimum 10 years.2care4 is according to GVP module VI.B.5 and I.B.10 required to store all the information regarding side-effects. At 2care4 we care about protecting your personal information, which is why all information regarding side-effects, stored in a locked locker, to which only key necessary employees have access.

Your rights

The GDPR (Regulation (EU) 2016/679) ensures that you have the following rights in regard to our processing of your personal information:

  1. We are obligated to, upon your request, show you any and all data, we might have about you, with minor exceptions.
  2. You have a right to get any personal information corrected in case they are wrong/misunderstood.
  3. Deletion rights: Our general dates of deletions are described in “ archive”. You may in some cases have a right to have some of your personal information deleted prematurely and we will of course tell you of any such rights if needed.
  4. We may in some cases limit the processing of you information, upon your request.
  5. You may in some cases have a right to objection to our processing of your information.
  6. We can in some circumstances supply you with a well structured overview of your information. The information will be in an ordinary machine format, and have us forward it to an additional data provider.

In case you want to inforce any of these rights (a-f), please contact 2care4 at kvalitet@2care4.dk.

Complaints

If you wish to complaint about our handling of your personal information, please contact us. You can also complaint to the Danish authorities at  Datatilsynet, Borgergade 28, 5., 1300 København K.