Variations to Marketing Authorisations in Europe

Online Course • grapl

About the CPD course

Changes to the terms of marketing authorisations for medicinal products; called variations in Europe; must be notified to or approved by the relevant regulatory authorities. Variations include changes to the composition of products; their manufacturing processes; the way they are used; or the indications for which they are authorised. Common approaches are adopted within the European Economic Area to variations to marketing authorisations approved through the Centralised; Decentralised or Mutual Recognition Procedures. This module covers the classification of variations into their several types and the regulatory requirements; guidance and procedures to be followed for each type.

CPD Provider

grapl

View Profile

Send an enquiry

Full Name*

Email Address*

Contact Number*

Industry*

Your Enquiry*

By submitting this form, you consent to CPD sending you email regarding your application.

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

grapl

grapl is a UK based digital learning and development specialist, authoring and designing Zenosis® courses to provide an extensive eLearning library for the pharmaceutical, biotech and medicinal products sector. This learning can be delivered via the customers LMS, the grapl LMS or its social, knowledge and collaborative CloudRooms platform. Continuously updated to reflect regulatory changes, Zenosis® courses are trusted to educate their people by some of the worlds leading companies.