Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
Marketing Authorisation holders are reminded that the obligation for applications for new indications (including paediatric indications), new pharmaceutical forms and new routes of administration to comply with a Paediatric Investigation Plan (PIP) came into force on 26 January 2009. This requirement arises from Article 8 of the EU Paediatric Regulation.
We published guidance on the MHRA approach to the compliance check when this obligation came into force in July 2008 for new active substances. Our initial approach was to ask the EU Paediatric Committee for its opinion on compliance and we stated that our policy would be reviewed by January 2009 in the light of experience gained. In view of the low numbers of affected submissions, we intend to continue our policy of requesting an opinion from PDCO on PIP compliance for relevant applications under Articles 7 and 8 of the Paediatric Regulation. We will review this policy in mid-2009. Updated guidance reflecting this is also published.
Guidance on the MHRA’s handling of the requirement in the Paediatric Regulation to undertake a ‘compliance check’ during validation 
