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Administrative changes, documentation and requirements

Posted by: , Posted on: - Categories: Uncategorized, Variations

Administrative changes can be either Type 1A or Type 1B and are considered minor variations. These include company name, postcode and/or address changes, the removal of redundant sites, and drug substance name changes.  Additionally, changes can include ‘Quality Review of Documents’ (QRD) updates (when not submitted as part of Type IB or Type II) and corrections to minor spelling mistakes. National and Mutual Recognition (MR) (excluding worksharing) variations must be submitted separately and these variations are processed with the relevant CMDh variation procedure guidance.

Where a change is proposed to the name and/or address of the ‘Marketing Authorisation Holder’ (MAH) and/or a change to the ‘Trading style’, these fall under the category A.1, but if the change concerns trading style it must not include the term 'Limited' in the chosen title as that is a change to the legal entity.

Under some category change codes, some documentation requirements state “formal documentation from a relevant official body” (for example change codes A.1, A.4 and A.5). The following accepted documents for these change codes are listed below:

  • A Companies House Certificate (or its equivalent in other Member States) or other government organisations (e.g. Customs and Excise) which state the new address (A.1)
  • Where a new trading style is being introduced with the company name remaining the same, a letter from the company secretary or a company director confirming the trading style is acceptable (A.1)
  • Current Good Manufacturing Practice (GMP) certificate (A.4)
  • An updated manufacturing authorisation confirming the new name and/or address (A.5)


Note: English translations are required where necessary

In some cases, administrative changes can impact the label or Carton (livery) and where this applies, full colour mock-ups (text versions, if not marketed) must be provided for all affected licences.  Revised livery must then be submitted for all registered product names and Own Label Suppliers (OLS).

When there is a change in name and address to the existing manufacturer of an active ingredient and no EP Certificate of Suitability (CEP) is available, a change code A.4 will apply, if there is not a physical change to the site.

If the active manufacturer holds a CEP then this will have been updated by the ‘European Directorate for the Quality of Medicines & Healthcare’ (EDQM) and a revised CEP will be issued.  In this case, notification is to be presented as a change code (B.III.1) and to include the most recent revised CEP.

Several manufacturing sites may be deleted at the same time under a single change code A.7 group variation, however, at least one registered manufacturing site must remain on the licence.

When submitted independently from a Summary of Product Characteristics (SmPC) change, updates in line with the QRD template may be submitted as a ‘C.1.z’ Type IB procedure.

Within context of the administrative section of the scope of changes, an A.z is used where a change is proposed but does not fit into any specific administrative sub-category.  A default Type 1B will apply unless there is an Article 5 recommendation.

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