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UK: MHRA Updated Administrative Changes, Documentation and Requirements for Variations

Tuesday, February 27, 2018: The Medicines and Healthcare products Regulatory Agency (MHRA) has updated Administrative changes, documentation and requirements for 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)
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