We would like to inform you about the latest updates of the Notice to
Applicants. Please find a summarisation of these latest updates with
hyperlinks to the revised documents - listed in the order of the Volumes
– mentioned below:
Notice to Applicants – Volume 2A Chapter 7: General
Information (March 2005)
Link
Main changes:
- Clarification is given in respect to the requirements for the Member
States Malta (section 3.1) and France (section 5.2.1 samples)
Notice to Applicants Volume 2B:
Presentation and content of the dossier Part 1: Summary of the dossier
– Part 1A
or
Common Technical Document – Module 1 – Administrative information:
Application form (March 2005)
Link
User Guide for the Application Form (March 2005)
Link
Main changes:
- Section 1.1: Inclusion of the new Member States in the tick-box area
and the request for a renewal date and information of PSUR-cycles
- Section 1.2: Request for additional information regarding orphan
medicinal products
- Section 2.5: Manufacturers
- 2.5.2 Manufacturer(s) of the medicinal product and site(s) of
manufacture
- 2.5.3 Manufacturer of the active substance
- 2.5.4 Contract companies used for bioavailability or bioequivalence
trials or used for the
validation of blood product manufacturing processes
- Section 6.9 (Annexed documents)
Summarisation of latest updates of some Notice to Applicants (listed in
the order of the Volumes) – cont'd:
Notice to Applicants Volume 2C and 6C : Application Form
for renewal of a marketing authorisation (March 2005)
Link
Main changes:
- inclusion of the new Member States in the tick box area
- Reference to the Common Technical Document in the list of documents
to be attached for Human Medicinal Products Aplications
Notice to Applicants Volume 2C: Guideline on the Packaging
Information of Human Medicinal Products authorised by the Community (March
2005)
Link
Main changes:
- The requirements of the Netherlands and Hungary
related to the 'Blue Box' have been updated
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