The ISO MPID Standard (11615) and the EU Implementation of. medicinal product information

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1 The ISO MPID Standard (11615) and the EU Implementation of the electronic submission of medicinal product information Ilaria Del Seppia, EMA, EU Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual id presenter and should not be attributed t to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. i All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. Drug Information Association 2 1

2 Outline 1. Objectives of the MPID standard 2. Concepts required for the unique identification of medicinal products 3. Implementation of electronic submission of medicinal Drug Information Association 3 Outline 1. Objectives of the MPID standard 2. Concepts required for the unique identification of medicinal products 3. Implementation of electronic submission of medicinal Drug Information Association 4 2

3 OBJECTIVES OF THE MPID STANDARDS The MPID standard (PrEN ISO 11615) is aimed: To define, characterise and uniquely identify regulated medicinal products during their entire life-cycle Authorised Medicinal Products Investigational Medicinal Products To establish definitions and concepts To describe data elements and their structural relationships to uniquely identify and describe medicinal i products Drug Information Association 5 OBJECTIVES OF THE MPID STANDARDS To support the exchange of medicinal product information Use of other normative IDMP messaging standards e.g. HL7 Version 3 Standard, Common Product Model CMETs, DSTU Update Release 11 (currently under review) Drug Information Association 6 3

4 Outline 1. Objectives of the MPID standard 2. Concepts required for the unique identification of medicinal products 3. Implementation of electronic submission of medicinal Drug Information Association 7 Concepts required for the unique identification of medicinal products Unique identification of medicinal products at international level, wherever required Pharmacovigilance, ICSR, PSUR, Risk Management Jurisdictions already have systems for issuing identifiers Marketing authorisation numbers, package identifiers, batch numbers, bar codes Additional identifiers defined by IDMP provide a harmonised indexing mechanism Supplementary to the existing systems NOT a replacement Drug Information Association 8 4

5 Concepts required for the unique identification of medicinal products Unique Medicinal Product Identifier (MPID) to reliably recognise, monitor and trace the use of medicinal products Unique Medicinal i Product Package Identifier (PCID) to reliably recognise and trace medicinal products as packaged for sale or supply Unique Medicinal Product Batch Identifier (BAID_1) to reliably recognise and trace a manufacturer s batch number, which appears on the outer packaging of the medicinal product Unique Medicinal Product Batch Identifier (BAID_2) to reliably recognise and trace a batch number on the immediate packaging Drug Information Association 9 Unique identification of medicinal products The unique identification of medicinal products is defined by: Name of the medicinal product Legal status of supply Terms of the marketing authorisation Marketing authorisation (license) holder Manufacturer(s) Authorising Medicines Regulatory Agency Qualitative and quantitative composition Ingredients, strength, pharmaceutical form, route of administration Device(s) as part of a medicinal product Clinical particulars Product classification(s) Package description (e.g. container, administration device(s) and package quantity) Regulated product information and documentation Drug Information Association

6 Full Model class Full Model Authorised Medicinal Products Conceptual Level Regulated Document Country / Language Medicinal Product Classification Manufacturing Operation Medicines Regulatory Agency (Organisation) Marketing Authorisation Holder (Organisation) Marketing Authorisation Interactant Version Medicinal Product Name Manufacturer Application /Establishment (Organisation) Marketing Authorisation Procedure Interactions Undesirable Effects Marketing Authorisation Periodic Safety Update Report Submission Medicinal Product Marketing Status Population Contra-indications Clinical Particulars Specifics Dev ice Batch Identification Packaged Medicinal Product Batch Identifier Shelf Life / Storage Other Therapy Specifics Therapeutic Indication Pharmaceutical Product Dev ice Data Carrier Dev ice Nomenclature Identifier Route of Administration Pharmaceutical Product Characteristics PhPID Set Other Characteristics Package Item (Container) Package (Component) Manufactured Item Specified Substance Ingredients Physical Characteristics Reference Strength Strength Substance ISO/FDIS 11615: 2011 Drug Information Association 11 Outline 1. Objectives of the MPID standard 2. Concepts required for the unique identification of medicinal products 3. Implementation of electronic submission of medicinal Drug Information Association

7 Implementation of electronic submission of medicinal Implementation of the electronic submission of information on medicines is the first deliverable of the new EU Pharmacovigilance Legislation published by the EU Council and Parliament on 31 st December 2010 Article 57(2), second subparagraph of Regulation (EC) No. 726/2004 requires: The Agency to publish the format for the electronic submission of information on medicinal products for human use by 2 July 2011 The marketing-authorisation authorisation holders to submit information to the Agency electronically on all medicinal products for human use authorised or registered in the European Union by 2 July 2012, using this format The marketing-authorisation holders to inform the Agency of any new or varied marketing authorisations granted in the EU as of 2 July 2012, using this format Drug Information Association 13 Phased Implementation Implementation plan agreed by the EMA Management Board in March 2011 The Agency adopted a phased approach: Phase one: Phase two: Phase three: Phase four: Notification of the electronic submission format Electronic submission by marketing authorisation holders Processing and validation of the submitted information Update of the format in compliance with the ISO IDMP standards Drug Information Association

8 Implementation of electronic submission of medicinal Phase one: Notification of the electronic submission format Agency published on 1 July / 1 September 2011 the format for the electronic submission of medicines in the EU in accordance with the provisions set out in Article 57(2), 2 nd subparagraph of Regulation (EC) No 726/2004 i.e. the Extended EudraVigilance Product Report Message (XEVPRM) Point to note on the XEVPRM format The format and detailed guidance has taken into account the work on international harmonisation carried out in the area of pharmacovigilance and the discussion happened at international level with FDA Drug Information Association 15 Implementation of electronic submission of medicinal Phase two: Electronic submission by marketing authorisation holders By 2 July 2012 at the latest, marketing authorisation holders shall electronically submit to the Agency information on all medicinal products for human use authorised or registered based on XEVPRM format Phase four: Update of the format in compliance with the ISO IDMP standards Plan foresees full implementation of the ISO IDMP standards, resulting terminology and related HL7 messages by end of 2014 Same timelines as for implementation of the new ISO ICSR standards Implementation will take into account migration of current Extended EudraVigilance Product Report Message (XEVPRM) Drug Information Association

9 Implementation of electronic submission of medicinal Phase four: Update of the format in compliance with the ISO IDMP standards Legal Notice Regulation (EC) No 726/2004, Article 57(2), 2 nd subparagraph, provides basis for implementation ti strategy t By 31 December 2015 at the latest, medicinal product information submitted previously to the Agency using the XEVPRM format shall be updated by marketing authorisation holders by applying the ISO IDMP standards and resulting terminology After 31 December 2015 medicinal product information for new or varied, suspended or revoked marketing authorisations, shall be submitted electronically by marketing authorisation holders to the Agency using the format referred to in point 1(d) immediately and no later than 15 calendar days from the date of authorisation, variation, suspension or revocation. This shall also include information where the marketing authorisation has been withdrawn. Drug Information Association 17 Implementation of electronic submission of medicinal The Agency is making all efforts to make sure that the information on medicines submitted by 1 July 2012 can be migrated in compliance with the future ISO IDMP standards Most data elements and detailed descriptions of substances in the format published in July 2011 are aligned with the future ISO IDMP standards and has been developed in collaboration with FDA Therefore, marketing authorisation holders should not need to resubmit data previously provided However, the Agency will ask marketing authorisation holders to provide updates based on additional ISO data elements not included in the July 2011 format Drug Information Association

10 Implementation of electronic submission of medicinal product information - BENFITS The implementation of electronic submission of medicinal product information will help the Agency to: Create a list of all medicines authorised and registered in the EU, including medicines authorised centrally via the Agency and medicines authorised by regulatory authorities in EU Member States Coordinate the regulation and safety-monitoring of medicines across the EU and in collaboration with FDA This information will help the Agency and stakeholders including other regulators to: Identify medicines (including biologics/biosimilars) accurately, especially medicines included in reports of suspected adverse reactions Facilitate the international harmonisation activities (ICH E2B and M5) Drug Information Association 19 Thank you Any questions? Drug Information Association

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