Exemptions from the application of the sunset clause

In the context of the “sunset clause” provision, on the basis of the first and second paragraphs of Article 61 of the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/14 and No. 66/19; hereinafter: ZZdr-2), the marketing authorisation (hereinafter: MA) of medicinal product shall be revoked if the medicinal product has not been placed on the market within three years of issuing the MA or was previously placed on the market but ceased to be available on the market for three consecutive years.

The MA will remain valid if at least one presentation (dosage form, strength) of the MA is placed on the market.

On the basis of the third paragraph of Article 61 of the ZZdr-2, Agency for Medicinal Products and Medicinal Devices of the Republic of Slovenia (hereinafter: JAZMP) may grant an exemption from the sunset clause provision on public health grounds and in exceptional circumstances if duly justified.

In order to grant exemption from the sunset clause provision, marketing authorisation holder (hereinafter: MAH) may submit to JAZMP a request for such an exemption with proper justification.

In exceptional well-justified cases in order to ensure undisrupted supply of the medicinal product or to protect public health JAZMP may extend the period of validity of a MA for up to 3 years.

We would like to stress that the MAH is obliged to inform JAZMP of the date of the actual marketing of the medicinal product in Slovenia.

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