The Member States may continue to apply national transposition measures adopted under Commission Directive 2003/94/EC(1) to the manufacture of investigational medicinal products used in clinical trials governed by Directive 2001/20/EC of the European Parliament and of the Council(2) in accordance with the transitional provisions laid down in Article 98 of Regulation (EU) No 536/2014.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from six months after the date of publication in the Official Journal of the European Union of the notice referred to in Article 82(3) of Regulation (EU) No 536/2014 or 1 April 2018, whichever is the later.
Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22).
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).