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Dear Health and Food Safety,

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting information.

The French regulator l'Agence nationale de sécurité du médicament et des produits de santé (ANSM) made on 12 september 2018 the decision to suspend all medical devices for plasma apharesis, referred to as 782HS-P-SL, manufactured and put on the market by the American company Haemonetics.See https://www.ansm.sante.fr/S-informer/Poi...).
The usage of the machines MCS+ and PCS2 with these devices was also suspended because of the health risks for donors.

In that respect I am requesting documents which contain the following information:

- the information that has been shared by the French authorities with the EU and/or the member states with regard to this issue;
- the communication between member states in the aftermath of this issue;
- the decision within the EU not to suspend these devices in other parts of Europe;

Yours faithfully,

Jeroen Wester
Investigative report NRC Handelsblad
The Netherlands

Health and Food Safety

1 Attachment

Dear Mr Wester,

 

Thank you for your request for access to documents.

Unfortunately you have not indicated your postal address that is required
for registering and handling your request in line with the procedural
requirements. Please send us your full postal address at your earliest
convenience. Pending your reply, we reserve the right to refuse the
registration of your request.

You may, of course, use directly the electronic form for entering your
request:

[1]http://ec.europa.eu/transparency/regdoc/...

 

Best regards,

 

SANTE ACCESS TO DOCUMENTS

[2]cid:image001.gif@01D3FF48.374A49E0
European Commission
Health and Food Safety

 

 

 

show quoted sections

Dear Health and Food Safety,

How can I share my postal address with you?

Yours faithfully,

Jeroen Wester

Health and Food Safety

1 Attachment

Dear Mr Wester,

 

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Yours faithfully,

 

SANTE ACCESS TO DOCUMENTS

[2]cid:image001.gif@01D3FF48.374A49E0
European Commission
Health and Food Safety

References

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We don't know whether the most recent response to this request contains information or not – if you are Jeroen Wester please sign in and let everyone know.