SUKL prepares a list of medicinal products jeopardized by the sunset clause. The list includes medicinal products jeopardized by the sunset clause due to failure to comply with the period pursuant to Section 34 a (1) of the Act on Pharmaceuticals as well as medicinal products jeopardized by the sunset clause due to failure to comply with the period pursuant to Section 34 a (2) of the Act on Pharmaceuticals.
The list is available on the SUKL website http://www.sukl.cz/leciva/sunset-clause. The list contains basic information on medicinal products – marketing authorisation number, SUKL code, product name, pharmaceutical form, ATC code, and the marketing authorisation holder.
We would like to stress that the list serves informative purposes only . We kindly ask the marketing authorisation holder to contact SUKL staff by e-mail should they establishes any discrepancies. Evidence must always be provided for any statements made.
SUKL does not decide upon expiration of marketing authorisation. The marketing authorisation ceases to be valid directly by law.
It is not SUKL which handles marketing authorisations of medicinal products, but the marketing authorisation holder. Monitoring of validity of marketing authorisation of individual medicinal products is primarily up to the marketing authorisation holder and it is also in their interest. SUKL has taken steps to ensure that holders are informed. However, the actual steps to maintain validity of marketing authorisation are up to holders.
Pursuant to Section 34 a (3) of the Act on Pharmaceuticals, SUKL may under exceptional circumstances and in view of public health protection or due to rights of third parties decide that the marketing authorisation of medicinal product shall not cease to be valid. Such decision shall be made in an administrative procedure which may be started upon its own initiative or based on a justified request of a marketing authorisation holder. The Act on Pharmaceuticals stipulates that the request be submitted 6 months prior to the day on which the 3 year period expires at the earliest and 3 moths at the latest.
This means in practice that an exemption may thus be submitted to SUKL always from 1 July to 1 October of the particular year.
If the marketing authorisation holder claims that there are grounds which comply with requirements set out by the Act on Pharmaceuticals, these grounds shall be listed and documented in the request. SUKL will issue a decision in a subsequent administrative procedure pursuant to the valid Administrative Code, e.g. before expiration of the statutory 3 year period. As soon as this decision becomes effective, SUKL will publish the information on whether the marketing authorisation ceased to be valid or not together with a rationale on its website.
No. The sunset clause shall always be applied only by law (see Question 19). SUKL may only lift these effects of the law, e.g. it may decide upon fulfilment of statutory requirements (e.g. there must be exceptional circumstances and public health protection must always be taken into account or rights of third parties must be at stake) that the sunset clause shall not apply. However, this may only be decided within an administrative procedure pursuant to the Administrative Code. This administrative procedure may either be initiated by an application filed by the marketing authorisation holder or on its own initiative. SUKL may decide upon non-application of the sunset clause only in cases stipulated by law (public health protection, e.g. if an irreplaceable medication is concerned; rights of third parties – e.g. granting of sufficient protection period for the originator).
An administrative fee for the application pursuant to provision in Section 34 a (3) of the Act on Pharmaceuticals will not be charged. Reimbursement of costs related to the application pursuant to the above mentioned provision is applicable, and according to the Annex 1 of the Decree no. 427/2008 Coll., item R-053, the reimbursement is 5 400,- CZK per application (i.e. for each MA number).
Grounds based on which SUKL may decide that marketing authorisation shall not cease to be valid are set out by the Act on Pharmaceuticals and are mentioned above (see Question 20). In every administrative procedure, statutory grounds will also be assessed depending on specific circumstances of the respective case.
Marketing grounds as such are not listed in the Act on Pharmaceuticals as a reason for granting an exemption. Again, it must be stated that SUKL will always evaluate the matter ad hoc, e.g. in view of specific circumstances of every particular administrative procedure. If SUKL comes to the conclusion that there are grounds set out in the Act on Pharmaceuticals, it shall decide that the sunset clause shall not apply, i.e. the marketing authorisation shall not cease to be valid.
Yes. The provision in Section 34 a (3) of the Act on Pharmaceuticals stipulates that SUKL may decide under exceptional circumstances and in view of public health protection or due to rights of third parties based on a justified application of marketing authorisation holder submitted 6 months prior to the expiration date of the period at the earliest or 3 months at the latest pursuant to Subsections 1 or 2 or ex officio that an exemption be granted so that this provision does not apply to the respective marketing authorisation.
An individual having the power of attorney is authorized hereto. This power of attorney was granted them either expressly for representation in the administrative procedure for granting of exemption from the application of the sunset clause or for representation of marketing authorisation holder in marketing authorisation matters (a simple authorisation to represent in matters of pricing and reimbursements does not suffice). In addition, principles set out in provisions in Section 33 and 34 of the Act No. 500/2004 Coll., Administrative Code, generally apply to powers of attorney.
The application for exemption from the sunset clause after a lawful transfer of marketing authorisation shall be filed by the new (current) holder who assumes all rights and obligations of the original holder (Section 36 (4) of the Act on Pharmaceuticals) upon transfer of marketing authorisation. If transfer is not completed at the time of application submission, the application for exemption shall be submitted by the current marketing authorisation holder.
SUKL will only grant an exemption from the sunset clause under exceptional circumstances and in view of public health protection or due to rights of third parties as is set out in Section 34 a (3) of the Act on Pharmaceuticals.
The Act on Pharmaceuticals does not set out any special form of this notification. Notifications submitted pursuant to Section 34 a (4) of the Act on Pharmaceuticals shall contain the name of medicinal product, its code, batch, distributor, date of launch or resumption of market supplies of MP, and the number of packs.
This notification shall be sent to SUKL by mail or electronically to contact persons listed on the website http://www.sukl.cz/leciva/kontakty . The notification shall be submitted pursuant to the Act No. 500/2004 Coll., Administrative Code.
In parallel, the launch or resumption of MP supplies must be notified in a standard manner pursuant to Section 33 (2) of the Act on Pharmaceuticals (see Question 4).
The provision in Section 34a of the Act on Pharmaceuticals does not in any way specify the validity of the exemption. However, Section 34a (6) of the Act on Pharmaceuticals stipulates that “if a medicinal product has not been introduced to the market or has not been available in the market within 6 months after cessation of grounds for granting of an exemption, the respective institute may ex officio decide upon annulment of the decision on granting of exemption”.