Managing post in lockdown

We asked you to share your strategies for handling post whilst in lockdown by completing a short poll on the PIPA website. We also asked anyone using a different approach to email us, but no other strategies for handling post were shared. Here are the results from the poll:  

SPC updates: best practice

PIPA has the exciting opportunity to work with Datapharm, the BNF and MIMS to develop a standardised process for informing all three organisations of SmPC updates in an efficient and timely manner. We are looking for up to 5 volunteers from the PIPA membership who have responsibility for SmPC update notifications to join our working party for this. If you are interested, please contact PIPA via pipa@pipanonline.org, providing a brief outline of your experience and why you would like to get involved.

MHRA Guidance on Brexit Implementation and ABPI Response

On 6th August, the MHRA published guidance on what the Brexit implementation period means for the life science sector: https://www.gov.uk/guidance/technical-information-on-what-the-implementation-period-means-for-the-life-science-sector The document covers the following areas: • Market access for medicines during the implementation period • Licensing and packaging • Batch release and testing • UK regulatory role • Other points regarding the transition into the implementation period - medicines • Implementation plans for related EU legislation during the implementation period The ABPI have responded to this document, and you can read the statement made by Dr Sheuli Porkess, Deputy Chief Scientific Officer for the ABPI, here: https://www.abpi.org.uk/media-centre/news/2018/august/abpi-response-mhra-guidance-on-brexit-implementation/ We are delighted that Dr Porkess will be joining us again at this year’s PIPA Conference, where she will share any further updates on this subject with the conference delegates.

PMCPA announce launch of consultation period for proposed changes to ABPI Code of Practice

On 29th August, the PMCPA announced the launch of the consultation period for their proposed changes to the ABPI Code of Practice and the PMCPA Constitution and Procedure. The proposed changes are to ensure that the Code reflects UK law and incorporates requirements from the IFPMA and EFPIA Codes. The consultation closes on 10th October, with the new Code to come into operation, with a transition period, on 1st January 2019. Full details, including the approach agreed by the ABPI board, proposed future Code updates and links to the proposal documents, can be accessed via the link below. http://www.pmcpa.org.uk/media/pages/launch-of-consultation-on-proposals-to-change-abpi-code-of-practice-for-the-pharmaceutical-industry-.aspx

MHRA statement on notifying the BNF of updates to SmPCs and PILs

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. Kind Regards Vigilance and Risk Management of Medicines MHRA”