Summary of Changes in the Notice to Applicants

GMP News No. 549

Regulatory Affairs News
25 April 2005

 Summary of Changes in the Notice to Applicants

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)

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
Common Technical Document – Module 1 – Administrative information: Application form (March 2005)

User Guide for the Application Form (March 2005)

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)

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)

Main changes:

  • The requirements of the Netherlands and Hungary related to the 'Blue Box' have been updated

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