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11. Will the statutory timeline of 180 days applicable to the placement of a product on the market in the presentation preceding a variation to marketing authorisation apply to the implementation of safety features?

Only in case of the safety feature implementation, the statutory timeline of 180 days for the placement of a product onto the market in a presentation preceding the implementation of the concerned variation to marketing authorisation after the approval of the variation to marketing authorisation (pursuant to Section 35, paragraph 2 of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals) as amended) shall not apply.

All packs of medicinal product batches subjected to the obligation to bear safety features on the packaging, the manufacture of which was completed (i.e. those that have been certified for release by the qualified person - explanation follows below) prior to 9 February 2019, without containing safety features on the packaging, may be placed onto the market of the Member State for which they have been manufactured, and further distributed for their entire shelf-life. Pursuant to Annex 16 to the EU Guidance on Good Manufacturing Practice for medicinal products for human and veterinary use, “Certification by a Qualified Person (QP) and Batch Release”, the process of batch release consists of the following:

  • The checking of the manufacture and testing of the batch in accordance with defined release procedures.
  • The certification of the finished product batch performed by a QP signifying that the batch is in compliance with GMP and the requirements of its marketing authorisation. This represents the quality release of the batch.
  • The transfer to saleable stock, and/or export of the finished batch of product which should take into account the certification performed by the QP. If this transfer is performed at a site other than that where certification takes place, then the arrangement should be documented in a written agreement between the sites.

Nevertheless, where the safety features were implemented within the scope of a single procedure together with another variation to marketing authorisation, this exemption shall apply only to the safety features; other variations shall be governed by the final sale referred to under Section 35, paragraph 2 of the Act on Pharmaceuticals.