In this seminar, we will look into all elements of the MAA dossier, in particular module 1, and within this module the Product Information. In addition, the various meetings with the Health Authorities in the centralized procedure will be discussed.
Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices. It is also important that patients and caregivers, as appropriate, are made aware of the information contained in the Package Leaflet (PL) and should be encouraged to read it prior to and during their treatment.
The PL reflects the more comprehensive information described in the SmPC, but is required to be presented in an abbreviated and easy-to-read format for patients.
The SmPC provides the basis of information for healthcare professionals to use a medicine safely, effectively and in the most appropriate manner. It is also a legal document, agreed between the Authorities and the relevant pharmaceutical company.
The format and content of the SmPC is laid down in EU/national legislation and regulatory guidance documents. Use of a medicine outside the conditions/ recommendations described in the SmPC falls under the responsibility of the healthcare professional.
It is important to note that the SmPC is not intended to provide general advice on the treatment of particular medical conditions. On the other hand, specific aspects of the treatment related to use of the medicine, or its effects may be mentioned. Similarly, general advice on administration procedures is not included, but any advice specific to the medicine concerned will be included, if appropriate.
The PL is drawn up in accordance with the SmPC and is subject to user-testing to ensure its ease of readability by patients/consumers. It plays an essential part in supporting the safe and effective use of a medicine by a patient. Consequently, it is important that a PL is provided each time a product is dispensed. Patients and care-givers should be encouraged to read the current version of the PL that accompanies their medicine(s) and to discuss any relevant concerns with a healthcare professional involved in their care.
Pre-submission meetings with the EMA and Rapporteurs are a vital element in the preparation of the MAA filing, and knowledge of the how to conduct these is vital for a successful outcome
Why Should You Attend?
This seminar is specifically designed for personnel that will have to prepare a Marketing Authorisation Application in the EU. It is important to do this correctly, as otherwise the application may be rejected at validation (at the time of submission) or there may be delays later in the process.
Product Information is a key part of the marketing authorisation of all medicines authorised in the European Union.
The product information is comprised of the Summary of Product Characteristics (SmPC) and the PL. These documents are issued when a medicine is first licensed for use and are reviewed and updated as necessary throughout the lifetime of a medicine, to reflect the current state of knowledge of the medicine and the risks associated with its use. The SmPC is mainly intended for use by healthcare professionals.
SmPCs are also the basis for the preparation of package leaflets, so are important documents in enabling information on medicines to reach patients.
The labelling and package leaflet are important tools to achieve correct use of the medicinal product. Marketing Authorisation Holders (MAHs) are required to ensure that current versions of the labelling and package leaflet are used when medicines are supplied to pharmacies.
Areas Covered in the Session:
- Package Leaflet
- Readability testing
- How to conduct presubmission meetings with the EMA and Rapporteurs
Day 1 Schedule
Lecture 1: Introductions
1.0 Cover Letter
1.1 Comprehensive Table of Contents
1.2 Application Form
1.3 Product Information
1.4 Information about the Experts
1.5 Specific Requirements for Different Types of Applications
1.6 Environmental Risk Assessment
1.7 Orphan Market Exclusivity
1.8.1 Pharmacovigilance system, where appropriate
1.8.2 Risk-Management System
1.9 Information relating to clinical trials
1.10 Information relating to Paediatrics
Lecture 2: In-dept review of requirement for product information
Day 2 Schedule
Lecture 1: In dept review of requirement for product information (continued)
Lecture 2: Pre-submission meetings with EMA and Rapporteurs
Regulatory Affairs Consultant ,
CATS Consultants GmbH
Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands.
He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004 he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003 he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked during four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom.
He joined the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was Regulatory Affairs Project Manager in the Oncology group in 1996 and 1997.
Before 1996 he was Head of Drug Regulatory Affairs for six years at Ciba-Geigy in the Netherlands, and has worked as Manager Regulatory Affairs at Glaxo, also in the Netherlands.
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