The following legal obligations apply to marketing authorisation holders (MAs) in the United Kingdom. This includes those covering the whole of the United Kingdom or specific to Northern Ireland or Great Britain (England, Wales and Scotland), including UK administrative authorities, which are allowed to allow unhindered access from Northern Ireland. For UK-wide or Northern Ireland-specific administrative authorisations, the legal requirements for the qualifications and responsibilities of the QPPV set out in Article 10 of Commission Implementing Regulation (EU) No 520/2012 (CIR) remain unchanged. As the legal format and content requirements of the PSMF are the same for marketing authorisations covering the whole of the United Kingdom and Northern Ireland and for Great Britain, which apply specifically to Great Britain, a single PSMF for the United Kingdom may be used for all products authorised in the United Kingdom. This assumes that the pharmacovigilance system applied to all products is the same. In order to support the voluntary submission of information on medicinal products supplied in the European Union (EU) or the European Economic Area (EEA) and not covered by the requirements of Article 57 (e.g. parallel import, emergency use, compassionate use), new values for the legal basis are made available in the Article 57 database. According to the Agency, the addition of the new legal basis will allow companies supplying products without a marketing authorisation in the EU/EEA, provided under emergency response, compassionate use or other national systems, to correctly register and identify those products in the Article 57 database on a voluntary basis. However, companies are not required to carry out a dedicated and immediate update of their product units in the Article 57 database to refer to the new legal basis values, as this can be done as part of regular maintenance. On this page you will find data submission documents for authorised medicines, including legal advice, detailed guidance documents and controlled vocabularies for the Extended Eudravigilance Product Report Message (XEVPRM) system. For UK-specific MAs, the legal requirements for the qualifications and responsibilities of the QPPV are described in paragraph 10 of Annex 12A of the HMR (inserted by the EU Exit Regulation 2019), which reflects Article 10 of the CIR.

All API update requests must be submitted as an IAIN — C.I.8 variant through the MHRA submission portal. You must use the Agency Activity Reference ID: G0098 – IA Change Type – UK QPPV-PSMF Configuration and Sub-Activity Text: H002 – «Original Submission». For UK licences granted through mutual recognition or decentralised procedures, an amendment updating the UK single payment scheme should be submitted as a national procedure for the UK only and the SPS should be included in module 1.8.1 as a stand-alone file or, alternatively, in a sub-folder of the United Kingdom. For more information, see the SPS update management overview (PDF, 95.8 KB, 1 page) for licences issued in the UK through mutual recognition or decentralised procedures. In the case of licence applications submitted by the United Kingdom under mutual recognition or decentralised procedures, the United Kingdom`s SPS system should be included in module 1.8.1 as a stand-alone file or, alternatively, in a sub-folder of the United Kingdom. You must submit the following documents in a C.I.8 submission (introduction or amendments to a summary of the pharmacovigilance system for medicinal products for human use): Within two weeks of a change in the identity, location or contact details of the QPPV responsible for authorised products in the UK, you must submit a single IAIN — C.I.8 variation. This should cover all UK PLs subject to a single pharmacovigilance system (in collections not exceeding PL 25). This is provided for in Regulation 182 of the Human Drugs for Human Use Regulations (as amended) (HMR), 2012. When filing the baseline that initiates the eCTD sequence, you must follow the instructions below: You must inform the MHRA of the details in the SPS as a result of the changes to the QPPV, which is responsible for products approved in the UK based on the basic information of the MHRA. The basic information is the QPPV details recorded in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) at the end of December 13, 2020. For all VAQP updates submitted before December 13, 2020, you should have received a confirmation message (coded «01») indicating that the information contained in the XEVPRM has been successfully processed. Indeed, the MHRA compiled QPPV details for UK approved products that were in XEVMPD on 14 December 2020.

Changes made after December 13, 2020 will not be included in the reference file. Once the national pharmacovigilance contact person has been designated, their data must be submitted to the MHRA via the MHRA submission portal. You must follow the instructions to submit this information. You should receive a confirmation email immediately after completing the form. From 1 January 2021, for products related to Northern Ireland (UK and Northern Ireland-wide authorisation authorisations only), in addition to notifying details of the QPPV and PSMF to the MHRA, you will need to submit information on the UK QPPV and the location in the EU of the UK PSMF in accordance with Article 57, paragraph 2 of the database referred to in Article 57(2) of Regulation (EC) No 726/2004. The UK PSMF should describe the global pharmacovigilance system and reflect the global availability of safety information for products authorised in the UK. For general questions about QPPV, PSMF and the establishment of pharmacovigilance systems for products authorised in the UK, please contact gpvpinspectors@mhra.gov.uk You must submit IAIN-type variations related to SPS to the MHRA and these submissions must cover all UK marketing licences (PLs) under a single pharmacovigilance system. All UK PSMFs must be accessed electronically at the same location in the UK from which reports of suspected adverse reactions under HMR Rule 187 are accessible. This requirement shall apply from 1 January 2021.

Failure to provide all required documents and information may result in the rejection of the application, requiring a resubmission that takes into account any discrepancies. Once a UK PSMF number has been assigned to a pharmacovigilance system, it must remain unchanged, regardless of how the system may change and evolve over time. You should not apply for a new UK PSMF number if there are changes to the pharmacovigilance system, including a change to the UK QPPV. Compassionate use refers to the use of unauthorised medicinal products for patients in particularly severe cases of illness who cannot be satisfactorily treated with currently authorised medicinal products. If the identity, location and contact details of the QPPV responsible for approved products in the UK are the same as those of the EU/EEA-QPPV at the end of 13 December 2020 (as entered in XEVMPD), no immediate action is required to notify the MHRA. The transmission of PLC information for authorisations approved under the EU centralised procedure should be treated differently from that for UK national authorisations. Please refer to the Submission Deadline Overview (PDF, 12.3 KB, 1 page), which provides an overview of the deadlines for submitting SPS details to the MHRA.