Changes of marketing authorisations
Changes to medicinal products must be notified or require approval. In the EU the variations regulation defines the requirements for and the testing of changes to the marketing authorisations for
- centrally authorised medicinal products
- nationally authorised medicinal products using:
- decentralised procedure (DCP)
- the mutual recognition procedure (MRP) and
- purely bilateral national marketing authorisations.
All facts relating to changes that require notification or approval are allocated to the default types:
Variation Type IA, IB or type II
including the identification – where possible – of the conditions to be met and the documents from the medicinal product dossier that must be submitted or modified. orangeglobal supports you with regulatory management of your notifications or applications for changes to marketing authorisations for medicinal products nationally, regionally – for example, within the EU – or globally in accordance with the detailed requirements for the data to be submitted as part of your international product marketing.
orangeglobal supports you with the management of your change notifications
- Compilating the documentation for notifications
- Applying for changes
- Submitting the change notifications / change applications
- Monitoring the progress of the procedure including correspondence with the authorities
- Delivering requested documents
- Final tasks after completing of the procedure with submission of documents in the national languages
orangeglobal completes the entire translation management process
Optimal preparation and implementation
for variations in the registration process in all EU languages.
Some documents must be available from the end of a change procedure in the national language, e.g. SmPC, package leaflet, labelling. This includes:
- Integration of changed texts into the documents that must be available in the national language
- Checking of the changes
- Timely submission of the changed documents in the national language for checking by the authorities.
- Advice on establishing an efficient and reliable variation translation process with various, also software supported, labelling quality assurance incl. country reviews
- Various service packages depending on the requirement or process
- Synchronisation/compilation of the documents for different product strengths, dosage forms and types of application
- Translations and reviews of all desired languages by regulatory affairs specialists, medical language experts and native speakers
In order to prepare your documents for this process as best as possible and to avoid annoying delays, we support you with our experienced team of experts “Regulatory Affairs” and “Labelling Translations” with the following options:
- Consistent quality and terminology as well as compliance with regulatory requirements for current and future projects by using Translation Memory™ tools, TermBases and QRD and quality assurance tools.
- Adaptations to current QRD template versions and proofreading of existing translations can be done in preparation before the positive opinion.
To make sure you do not miss the deadline for submitting all documents in the national languages after the Positive Opinion (CP) or after the MRP/DCP approval, we recommend starting the translation process to incorporate changed text components into the national language documents as early as possible, preferably from the day of submission of the variation application or variation notification.
The 5-day deadline post-opinion (CP) or 7-day deadline after DCP/MRP variation approval should be reserved for last-minute changes.