Variation Application Form: Revision of the "Explanatory Notes"

The updated version of the "EMA/CMDh explanatory notes on variation application form (Human medicinal products only)" was prepared in December 2021 and has now been published on the HMA (Heads of Medicines Agencies) website. This document is intended to serve as a supportive guide for the submission of the variations application form (specifically for human medicinal products).

In addition to formal adjustments and revisions, a new classification of the application form statements into four "Sections" has been established. These include the following parts:

• Section 1 Application for variation to a marketing authorization
• Section 2 Products concerned by this application
• Section 3 Types of change(s)
• Section 4 (a-d)
  - Section 4a Orphan medicinal product information
  - Section 4b Paediatric requirements
  - Section 4c Extended data exclusivity / market protection
  - Section 4d Change to the design or intended purpose of the medicinal device component, or introduction of a new device/device constituent part

Section 1 Application for variation to a marketing authorization

The first part explains the topics of pages 1 and 2 of the application form.
The subsection "Type of Authorization", which introduces Section 1, has been newly included in the explanations. Moreover, minor and major changes have been made to the subsections "Variation procedure number(s)", "Concerned Member States", "Type of application", "Change(s) concern(s)", "Name and address of the MA holder" and "Name and address of contact person". This includes, for example, the information on the handling of variations relating to changes concerning the API of Corona vaccines.

Section 2 Products concerned by this application

The second part refers to the items on pages 3 and 4 of the application form.
Here, the example tables for "Worksharing Procedures" and "Grouped Variations" have been deleted and explanations have been added to the introduction text.

Section 3 Types of change(s)

The third part deals with pages 5 to 8 of the application form.
The introductory note again clarifies that the first section of the application form must always be completed in order to make entries in Section 3. Three examples (Type IA B.I.a.2.a notification, Type IB C.I.z. variation and two Type II C.I.4 variations) are used to describe the procedure and provide guidance.

Section 4 (a-d)

The fourth part deals with pages 9 and 10 of the application form.
As in Section 3, it is again pointed out that in order to make entries in Section 4, the previous sections must first be completed. Here, four examples are used to clarify the procedure and provide guidance. In addition, in the subsection "Declaration of the Applicant / Signature", additions have been made to worksharing/grouping and harmonization procedures.

Here you can find the new version of the "EMA/CMDh explanatory notes on variation application form (Human medicinal products only)" and the recently published documents on the HMA website.