All registration procedures: NP, CP, DCP and MRP National procedure, centralised and decentralised procedures, mutual recognition procedure
LABELLING TRANSLATIONS FOR THE LIFE CYCLE MANAGEMENT OF MEDICINAL PRODUCTS
Summary of product characteristics (SmPC), package leaflet (PL), labels
Regulatory procedures for the life cycle management of medicinal products include variations, renewals, annual re-assessments, PSUR assessments and PSUSA.
Within the procedures indicated, documents may need to be altered to a greater or lesser extent and these documents have to be submitted for the
- Centralised procedure (CP) in all official languages EU - Decentralised procedure (DCP) - Mutual recognition procedure (MRP) in all official languages of the Member States involved.
This basically affects the documents for product information, that is, the SmPC, package leaflet and labels.
VARIATIONS AND TRANSLATIONS
Die The variations regulation specifies the review of changes made to marketing authorisations for centralised (CP) or decentralised (DCP) procedures or mutual recognition procedures (MRP) as well as strictly national marketing authorisations
In addition, depending on their scope, various other change elements are assigned to predefined categories as a type IA, IB or type II variation, including specification – where possible – of the conditions to be satisfied and the documentation to be submitted.
Triggers for changes that affect the product information documents (SmPC, PL, labelling) may include:
a) Minor changes such as a change to the name and/or address of the marketing authorisation holder or manufacturer, contact addresses for reporting adverse events
b) Adaptation to an updated company core data sheet
c) Change, addition or removal of essential statements about the indications, dosage, safety, pharmacology/toxicology or pharmaceutical information (excipients, incompatibilities, shelf life, container)
d) Changes that are based on the outcomes of the scientific assessment of a PSUR or PSUSA.
In light of the extremely tight deadline for submitting the documents in the national languages – 5 calendar days after completion of the review of the documentation with a Positive Opinion, MRP/DCP approval, etc. – it is essential to incorporate the majority of the text changes into the national language documents as early as possible.
mpü processes assure far-sighted planning of the translation process and timely delivery of correct and reviewed documents in the national languages.