In response to an enquiry from a PIPA member, PIPA contacted the MHRA to provide clarification of whether it is a requirement for Marketing Authorisation Holders to notify the BNF of SmPC and PIL updates.
We have received the following response from the MHRA and we will update the PIPA medical information guidance document in line with this.
“The MHRA’s expectation is that marketing authorisation holders (MAH) keep UK authorised product information up to date and ensure that patients and healthcare professionals have access to the most up to date information in relation to the medicines that they use. The associated legal requirement is outlined in Directive 2001/83/EC as amended, Article 23(3) “The marketing authorisation holder shall ensure that the product information is kept up to date with the current scientific knowledge, including the conclusions of the assessment and recommendations made public by means of the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004.” In addition, paragraph 40 of the same directive states “The provisions governing the information supplied to users should provide a high degree of consumer protection, in order that medicinal products may be used correctly on the basis of full and comprehensible information.”
Specifically in relation to product information published on the internet, it is expected that websites or digital media under the MAH’s management or responsibility are kept up to date with the current version of the product information; this would include websites managed by commercial partners on behalf of the MAH or national medicines compendia that publish product information that is provided directly by pharmaceutical companies. As BNF publications are not under the MAH’s management or responsibility and are published jointly by the British Medical Association and the Royal Pharmaceutical Society, it is not expected that pharmaceutical companies notify the BNF publishers of updates to SmPCs and PILs.
Vigilance and Risk Management of Medicines