RegulatoryOfficial

ANSM authorises Greek-sourced parallel import of Mycohydralin 500 mg vaginal tablets for France

🇫🇷 ANSM · Wed 04 Nov 2026

Spanish company Difarmed has received a five-year parallel import authorisation for Bayer's Mycohydralin, supplied from Greece as Canesten vaginal tablets 0.5 g.

France's medicines agency ANSM has granted a parallel import authorisation for Mycohydralin 500 mg vaginal tablets, in a decision published on 4 November 2026. The holder is Difarmed, SLU, based near Barcelona, Spain, which applied on 18 February 2026.

The product to be imported is authorised by the Greek health authorities as Canesten vaginal tablets 0.5 g per tablet. It will be sold in France in a pack of one vaginal tablet in a blister with an applicator. The reference product is Mycohydralin 500 mg, whose French marketing authorisation holder is Bayer Healthcare SAS in Lille.

The imported medicine remains bound by the French marketing authorisation as regards the summary of product characteristics and its classification under Article R. 5121-36 of the Public Health Code. The decision sets out how labelling and the leaflet will differ from the French version. Both must name the establishment that repackages the product, in addition to the operator and manufacturer. The label must also carry the wording "Médicament autorisé n°", followed by the parallel import authorisation number and the marketing authorisation number in the country of origin, in place of the French number. The leaflet must show its own last-revision date rather than that of the French leaflet.

Difarmed will be responsible for marketing the product in France. The decision notes that it holds a pharmaceutical establishment opening authorisation issued by the Spanish authorities. The authorisation is valid for five years from the date of notification and can be renewed under Article R. 5121-125. It is granted without prejudice to industrial and commercial property rights. The text available to us is truncated at Article 8, so any further provisions, including the authorisation number, are not covered here.

What it means for your team

  • Market-access teams: a Greek-sourced competitor presentation of Mycohydralin 500 mg is now cleared for the French market under Difarmed's authorisation.
  • QA and supply-chain teams: the imported pack carries different label and leaflet mentions, including repackager details and the parallel import and origin-country authorisation numbers, so pack identification and checks should account for these.
  • Regulatory teams: the product follows the French SmPC and classification, with a five-year validity from notification and renewal under Article R. 5121-125.

Official source: ANSM ↗

Article written by VigiEye from the official source (ANSM). AI-assisted; check the source before acting.

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