Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Decentralised Procedure, Mutual Recognition Procedure and Readability of SPC, PL, Labelling

Dr. Rudolf Gmeinbauer (Abschlußjahr: 2005)

Language: English
 
The focus of this paper is to work out the differences between the new Decentralised Procedure (DCP) and the Mutual Recognition Procedure (MRP), as well as to depict the new elements in these procedures and the effects on the readability of the approved texts (Summary of Product Characteristics (SPC), Package Leaflet (PL) and labelling). This new European legislative will come into effect in November 2005.

The principles of the MRP remain unchanged. The new DCP will be applicable in cases where a Marketing Authorisation (MA) does not yet exist in all Member States (MSs).
First National Assessment Process: In the DCP, identical dossiers will be submitted to all MSs which are included in the procedure. In contrast to the MRP, where in the first National Assessment Process a national MA will be granted, an MA is not the result of this first step in the DCP. The new key element is that in the DCP a consultation between the MSs prior the first MA will take place. The Reference Member State (RMS), which is chosen by the applicant, has to prepare a draft Assessment Report (AR) within 120 days, which is the basic document for the next step.
European Assessment Process: There is still the 90 day European Assessment Process in the MRP and also in the new DCP. The result of this procedure is the final agreed SPC, the PL and labelling. A withdrawal of an objecting CMS during the European Assessment Procedure is still possible, but will lead to forced arbitration. If there is disagreement between a concerned MS and the RMS, a 60 day negotiation phase with the Co-ordination Group (CMD) will follow. If the disagreement cannot be solved, this will result in the forced arbitration procedure. A risk to public health guideline was developed, which should help to reduce redundant and politically driven objections by MSs.
Second National Assessment Process: After finalising the European Assessment Process, the competent authority has to grant an MA within 30 days.

The “end products” of the submitted dossier are the SPC, the PL and the labelling. Improvement of readability of these documents is a further step to make medicinal products more safe for healthcare personnel as well as for the patients. Topics which will support this goal are:

• Harmonisation of the PL and labelling: For national requirements, the “Blue Box” concept of the Centralised Procedure should be used.
• User consultation of PL: The understand ability of the content of PL should be tested with relevant patient target groups.
• Braille: The use of Braille for the name of the medicinal product on the outer package.
• Standardisation: The use of standard templates developed by the QRD group and standardised medical terms of MedDRA.

New guidelines are being developed and some of them are already underway. They should help the authorities, the industry and other relevant stakeholders to use and interpret the new European pharmaceutical legislation. However, there will be many national transitional periods how to move from the old legislation status to the new one. Considering the complexity of the new legislation, and because since May 2004 also 10 new MSs with nine new languages are involved, the complexity from a regulatory point of view will increase for all parties.

Pages: 56