Transfer of Marketing Authorisation: What you should know for Bulgaria?
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21 Feb Transfer of Marketing Authorisation: What you should know for Bulgaria?

Posted at 12:34h in Problem-Solution, Regulatory Affairs by

A Transfer of Marketing Authorisation (MA) is the formal process for medicinal products through which the MA shifts from the current approved Marketing Authorisation Holder (MAH) to a new MAH, which is a distinct legal entity. This transfer may be prompted by a strategic decision to divest the MA or may be deemed necessary in anticipation of alterations in the MAH structure or regulatory considerations.

With the exception of centrally authorized products, national competent authorities govern the procedures for MA transfers. In Bulgaria, it is obligatory for every MAH to enlist a local representative whose professional involvement in the transfer procedure with the Bulgarian Drug Agency (BDA) yields significant advantages, including:

  • Strategically planning the timing for the submission and approval of the MA transfer procedure, taking into account the targeted implementation date and planned variations by the MAH.
  • Offering guidance on market-specific nuances and recommending measures to prevent potential shortages of the transferred products.
  • Coordinating the strategy and submissions to other national administrative bodies subsequent to the BDA’s approval of the MA transfer.

 

MA Transfers in Bulgaria have played a role in recent years, as evident in the two well-structured peaks illustrated in the graph below. According to Petko Konakchiev, our Head Legal & Regulatory Affairs, key influencing factors during these periods included:

  • The impact of Brexit on UK-based holders.
  • The introduction of safety features as part of the European medicines verification system, mandated by Directive 2011/62/EU and further detailed in Delegated Regulation (EU) 2016/161. This implementation incurred additional costs for the industry and compelled MAHs with a small number of national MAs to optimize their MA holding structures.
  • Closure of local offices of several pharmaceutical companies and divestment of products.

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