S.L. 458.34 · Medicines (Marketing Authorisation) (S.L. 458.34)
S.L. 458.34 Art. 25Applications to be considered in accordance with regulation(EC)No 726/2004.
Applications for marketing authorisations which have been referred to the Committee for Proprietary Medicinal Products before the 1 January, 1995 in accordance with Article 2 of
Directive 87/22/EEC and in respect of which the Committee concerned has not given an opinion by 1 January, 1995, shall be considered in accordance with Regulation (EC) No 726/2004. Regulation 22(1)(f) second paragraph, regulation 23 and Articles 32 to 34 of Directive 2001/83/EC and its subsequent amendments, shall not apply to homeopathic medicinal products referred to in regulation 10(1), (2) and (3).
Verweist auf
- S.L. 458.34 Art. 2
- S.L. 458.34 Art. 32