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Home / Activities / Registration / Post Authorisation Procedures / Withdrawals of product licences and authorisations

Withdrawals of product licences and authorisations

Introduction

A Marketing Authorisation (MA), an Authorisation in accordance with article 126(a) of Directive 2001/83/EC, as amended and a Parallel Import (PI) licence may be withdrawn at the request of a Marketing Authorisation/Licence Holder, should they no longer be interested in placing a product on the market.

Requesting a Withdrawal

When a Marketing Authorisation or Licence Holder decides to have the product licence withdrawn, the holder has to request the withdrawal of the Authorisation or Licence using the appropriate withdrawal form.

Only the Marketing Authorisation/Licence Holder or a person specifically authorised on his behalf can apply for a withdrawal and all the information required in the form and in the annexes must be submitted correctly and in full. Most importantly, the MAH has to state the reasons behind the request for withdrawal of the Authorisation or Licence.

A proposed withdrawal date must be indicated in the form. The proposed date must not be retroactive, that is, before the date the application form is submitted. The earliest date of withdrawal is the date of the submission of the withdrawal application.

You will be informed that the withdrawal is acceptable in writing by the Medicines Authority.

After the withdrawal date, the product can no longer be brought into Malta or distributed and Marketing Authorisation Holders will remain responsible for post-marketing and pharmacovigilance duties until all stocks available are exhausted.

When not all strengths and forms of a product having a combined Summary of Product Characteristics (SmPC) are withdrawn, updated product information should be submitted with the withdrawal form.

Applying for a product authorisation/licence withdrawal

 When applying for a product authorisation/licence withdrawal, Marketing Authorisation/Licence Holders are informed that: 

  • The original Authorisation or Licence issued by the Medicines Authority must be returned.
  • Once a withdrawal becomes effective, the authorisation or licence cannot be re-instated and an authorisation for the same product can only be requested by the Marketing Authorisation/Licence Holder using procedures as stipulated in regulation 4(1) of the Medicines (Marketing Authorisation) Regulations (Subsidiary Legislation 458.34) (Mutual Recognition Procedure).
  • The procedure used at accession (PMA-MA process) to register products that had been previously on the market is no longer viable, not even for products initially registered through this procedure.
  • The product can no longer be brought into Malta or distributed.
  • The authorisation holder remains responsible for any stock available in pharmacies until it is exhausted or expired, whichever is the latest.
  • The annual fees due for this product will be paid until the end of the current financial year.