Markedsføringstillatelser av legemidler til mennesker: Thalidomide Lipomed - thalidomide
(Utkast) Kommisjonens gjennomføringsbeslutning (EU) .../... om gjennomføring av vilkår eller restriksjoner fastsatt i artikkel 127a i europaparlaments- og rådsdirektiv 2001/83/EF om markedsføringstillatelse for "Thalidomide Lipomed - thalidomide" som et legemiddel til mennesker
(Draft) Commission Implementing Decision (EU) .../... concerning the implementation of conditions or restrictions set out in Article 127a of Directive 2001/83/EC of the European Parliament and of the Council concerning a marketing authorisation for "Thalidomide Lipomed - thalidomide", a medicinal product for human use
Utkast til kommisjonsbeslutning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 21.9.2022
Bakgrunn
BAKGRUNN (fra kommisjonsbeslutningen, engelsk utgave)
(1) The medicinal product "Thalidomide Lipomed - thalidomide" complies with the requirements set out in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use .
(2) It is therefore appropriate to authorise its placing on the market. To this effect, Commission Decision [C(20XX)XXX of (date) to be completed by Secretariat General after adoption] granting marketing authorisation to the medicinal product "Thalidomide Lipomed - thalidomide" is being addressed to Lipomed GmbH.
(3) The marketing authorisation is subject to conditions or restrictions with regard to the safe and effective use of the medicinal product. It is appropriate that implementation of these conditions is ensured by the Member States.
(4) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use,
(1) The medicinal product "Thalidomide Lipomed - thalidomide" complies with the requirements set out in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use .
(2) It is therefore appropriate to authorise its placing on the market. To this effect, Commission Decision [C(20XX)XXX of (date) to be completed by Secretariat General after adoption] granting marketing authorisation to the medicinal product "Thalidomide Lipomed - thalidomide" is being addressed to Lipomed GmbH.
(3) The marketing authorisation is subject to conditions or restrictions with regard to the safe and effective use of the medicinal product. It is appropriate that implementation of these conditions is ensured by the Member States.
(4) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use,