MANAGEMENT OF PRODUCT INFORMATION – Summary of PIPA Webinar By Charlotte Mason
In March 2021, Harpreet Sandhu, from the PIPA Committee, presented a PIPA MI webinar on the management of product information. Harpreet was joined by Nat Knight and Claire Cox from Datapharm. The session was structured around these topics: - The Ireland/Northern Ireland Protocol - The importance of the NHS Dictionary of Medicines and Devices (dm+d) and keeping it up to date - Best practice on managing digital prescribing information In this article, I have summarised the salient points relating to the Protocol on Ireland/Northern Ireland and the NHS Dictionary of Medicines and Devices. Protocol on Ireland/Northern Ireland Claire and Nat kicked off the webinar with an explanation of the various marketing authorisation (MA) procedures and what has changed with the implementation of the Ireland/Northern Ireland Protocol. Essentially, since the end of the transition period on 31-December-2020, the Ireland/Northern Ireland protocol applies. Medicines that are marketed in Northern Ireland fall under different obligations than the rest of the UK. From 1 January 2021, EU pharmaceutical law applies to the UK in respect of Northern Ireland only. All Pharmaceutical companies had until 31 December 2020 to ensure that their centrally and nationally authorised medicines complied with EU law in order to remain on the EU market.
• Decentralised and Mutual Recognition Procedures • National Procedures • Unfettered Access Procedures Centralised Procedures Products that were approved by the European Medicines Agency (EMA) are centrally approved products (CAPS). All existing CAP MAs automatically converted into UK MAs, effective in GB only. As a result of the Ireland/Northern Ireland Protocol, existing CAPs will remain valid in NI.
According to the Ireland/Northern Ireland protocol, the national MAs for medicinal products issued by the United Kingdom in respect of Northern Ireland, UK(NI), must comply with Article 17 and 18 of Directive 2001/83/EC, i.e. they have to go through the decentralised procedure (DCP) or the mutual recognition procedure (MRP) if the applicant already holds an MA for the same product in an EU/EEA member state (MRP), or applies for MAs for the same product in any EU/EEA member state(s) (DCP).
Under the Ireland/Northern Ireland Protocol, Medicinal Products authorised via the centralised route will be directly authorised for use in Northern Ireland. Any variations to these Marketing Authorisations will be centrally managed by the EMA in accordance with relevant procedures. A separate MA will not need to be issued by the Medicines and Healthcare products
There are several different Marketing Authorisation application procedures: • Centralised Procedures 29
