19 July
An updated version of a HMA/CMDv guidance document has been published, including postal correspondence addresses and general email addresses for all the EEA National Competent Authorities. The document is available to download as an Excel spreadsheet via the HMA website (Link).
21 July
An article regarding the transfer of National Authorisations to Mutually Recognised Authorisations via an Article 34 referral procedure, previously published in Regulatory Rapporteur, has been re-published on the CMDv website (Link).
27 July
Best practice guide for Type 1B variations updated (Link) and with a track changes version (Link)
Best practice guide for automatic validation of applications updated (Link) and with a track changes version (Link)
5 August
Updated National Authority Fees Terms of payment and addresses (Link)
Regulatory Outsourcing Options
Cyton’s dedicated regulatory procedures team can support you with:
- Dossier preparation, submission & regulatory procedures
- Regulatory intelligence and strategic planning
- Life cycle management
- Key person cover
- Pharmacovigilance
- Brexit support services