MHRA: Medicines for children: Including the product name when submitting information on paediatric studies in accordance with the Paediatric Regulation

Since the introduction of the European Paediatric Regulation in 2007, Marketing Authorisation (MA) holders are required to submit paediatric studies completed since the date of entry into force (26 January 2007) to the competent authority within six months (Article 46). Member States, through CMD(h) have agreed a procedure whereby MA holders initially notify competent authorities of the study via e-mail.