Recommendation on HMA Article 5 on unforeseen variations

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Recommendation on HMA Article 5 on unforeseen variations

Art.5 on Unforeseen Variations

From http://www.hma.eu/293.html

See guidance on when to follow an Article 5 procedure:

• All Article 5 recommendation are published under http://www.hma.eu/293.html

• The CMD(h) would remind applicants that the default position is a Type IB variation

• If the specific change is not listed. Is change covered by any of the high-level scopes?
  

  • YES: Type IB by default, use an additional box using the sub-indent ‚z‘

  • NO: Would you recommend to classify as a Type IA?

    • NO: Submit as a Type IB by default or as a Type II (safeguard clause)

    • YES: Follow Article 5 recommendations

As a summary, Article 5 is to be followed only if change is not listed and a Type 1A would be recommended