Dr Fatima Bicane, German Medicines Manufacturers’ Association (BAH)
Dr Ulrich Kissel, European QP Association
The European Commission on 26 April 2023 published the proposal for the envisaged revision of the EU pharmaceutical legislation. The changes are to be regulated in a directive and a regulation. Specifically, Directive 2001/83 (Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use) and Directive 2009/35/EC are to be replaced. The proposal for a new Regulation 726/2004 (authorisation of medicinal products and establishment of the European Medicines Agency) is intended to replace Regulation 141/2000 for orphan drugs and Regulation 1901/2006 for paediatric medicinal products, but also brings a number of new and adapted regulations.
The reform aims to improve the availability, accessibility and affordability of medicines, while promoting higher environmental standards and increasing the competitiveness and attractiveness of the pharmaceutical industry in the EU. Key elements of the proposal include reducing administrative burdens, promoting innovation and competitiveness, addressing pharmaceutical shortages, ensuring environmental sustainability and tackling antimicrobial resistance..
There are also GMP-relevant changes, which will be discussed in this Live Online Session.
This Live Online Session has been developed for all who are dealing with GMP-relevant aspects in the pharmaceutical industry and would like to get an overview about the envisaged GMP-relevant changes coming with the proposal to revise EU Medicines Legislation.
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical- information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Status and overview of the planned revision of the general pharmaceutical legislation in the EU
- What is currently planned?
- Possible general effects
Possible GMP-relevant Consequences from Directive and Regulation
- What MAHs, CMOs, suppliers and the QP need to know
- Qualification of the Qualified Person (QP)
- Written Confirmation
- Remote inspections
- Security of supply of medicinal products
- Colours and functional excipients
- Traceability of substances
- Decentralised manufacturing sites
- How associations see this
Other possible consequences, QA, QC, Manufacturing and the QP need to know
- New definitions
- Regulatory Data Protection (RDP)
- Paediatric medicines
- Adjustments to risk management plans for the authorisation of generic medicines and Biosimilars
- Electronic product information (ePI) (as opposed to paper leaflets)
- Regulations for products combining a medicinal product and a medical device
- Evaluation of certain excipients (colours as authorised food additives)