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Parliamentary questions
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23 February 2010
by Elena Oana Antonescu (PPE)
to the Commission

 Subject: Access for suppliers of medicines in one Member State to medicinal products authorised in another Member State or not authorised at European level
 Answer in writing 

A recent case in which someone used a medicine not authorised in Romania, resulting in their death, raises the issue of access for suppliers of medicines to medicinal products which are not authorised at European level or are only authorised in another Member State.

Can the Commission state:

1. What the situation is with regard to the authorisation and use of the product Cytotec (active ingredient misoprostol) across the Member States;
2. Whether procedures exist — in the event of that medicinal product having been authorised at national level within one Member State, but not at European level — for the monitoring of access to a medicinal product, in the Member State where it is authorised, for suppliers of medicines or medical services from another Member State in which that medicinal product has not been authorised?

Original language of question: ROOJ C 138 E, 07/05/2011
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