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Parliamentary questions
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28 August 2017
E-004885/2017(ASW)
Answer given by Mr Andriukaitis on behalf of the Commission
Question reference: E-004885/2017

The EU pharmaceutical legislation includes derogatory provisions when it comes to contraceptives and abortifacients, namely Article 4(4) of Directive 2001/83/EC(1). Under those derogations, Member States may prohibit or restrict the use of such products in their territory. In accordance with Article 13(1) of Regulation (EC) 726/2004(2) this derogation can also be invoked for products, which have been authorised by the Commission on the basis of a scientific opinion of the European Medicines Agency.

Poland recently notified the Commission of its intention to make use of the derogation in accordance with Article 4(4) of Directive 2001/83/EC.

(1)http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:en:PDF
(2)http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:en:PDF

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