Masterarbeit

The Process of Implementation of Safety Changes in the Product Information for Medicinal Products nationally authorised in Germany – Responsibilities and Challenges for a Generic Company ***

Stefanie Scheffel (2015)

Summary
Language: English
Each marketing authorisation holder (MAH) is obliged to keep the product information of its medicinal products on the current state of scientific knowledge. Furthermore the benefit-risk balance of a medicinal product may decrease due to new arising safety information. An important measure in this case is the product information’s revision in order to still ensure safe and effective use and to keep the benefit-risk balance of the medicinal products positive. Safety signals arise continuously. If they trigger a change of a marketing authorisation, a variation has to be planned and submitted to the competent authority. After approval of the variation the change needs to be implemented. This master thesis describes important steps from the time of a new safety signal’s entry until its implementation in the product information of purely nationally authorised medicinal products in Germany at a generic company.
A special focus was set in the application of Commission regulation 1234/2008, the so-called “variation regulation”, which is the new legal basis for purely national marketing authorisations since 4 August 2013. The most relevant safety signals from a generic MAH’s point of view are updates of innovator-texts, updates of BfArM-reference-texts, PSUR assessment reports, PRAC recommendations, company core data sheets, outcomes of referral procedures according Article 30 or 31 or 107i, paediatric assessment reports and graduated plan procedures. These signals are described and analysed regarding classification and requirements for submitting a variation in order to revise the product information. In comparison to the previous variation procedure in Germany valid before 4 August 2013 particularly the variation classification and formal requirements distinguish completely. Several variations, which had not been subject to approval in the past, require now approval according to the variation regulation. This results not only in higher expenses for companies but also in later implementation of safety relevant content. Otherwise the extension of the variation regulation to purely national marketing authorisations (MAs) leads to harmonisation of the variation procedure for all types of MAs within the EU and reduces the administrative burden for the competent authorities. In addition it allows the inclusion of national MAs in the worksharing procedure. Independent of the variation regulation the regulatory requirements throughout the EU are getting harmonised continuously which can be seen e.g. in the newly provision of translations of the PRAC recommendations in all EU languages. Such steps lead to reduced effort and increased convenience for both, pharmaceutical companies and competent authorities.
Pages: 62, Annexes: pages: 4