State Institute for Drug Control

32. Will a maintenance fee accrue for medicinal products whose marketing authorisation expired due to sunset clause?

Whole Article Monday, 13. May 2013 | Author

Zanikne-li rozhodnutí o registraci v důsledku sunset clause, zanikne důvod pro placení udržovacího poplatku.

31. What will be the procedure in case the marketing authorisation of MP ceases to be valid pursuant to Section 34a of the Act on Pharmaceuticals?

Whole Article Monday, 13. May 2013 | Author

A medicinal product whose marketing authorisation expired due to the application of the sunset cause shall be considered a non-authorized medicinal product with all the consequences ensuing from this fact.

30. For how long is the exemption from the application of provision in Section 34a (3) of the Act on Pharmaceuticals granted?

Whole Article Monday, 13. May 2013 | Author

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”.

29. Is there a notification form on your website for launch or resumption of MP supplies to the market after submission of application for granting of exemption pursuant to Section 34a (4) of the Act on Pharmaceuticals? To whom and how should this notifi

Whole Article Monday, 13. May 2013 | Author

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).

28. Will SUKL publish a list of grounds based on which it will grant an exemption from the sunset clause ex officio?

Whole Article Monday, 13. May 2013 | Author

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.

27. Which marketing authorisation holder does apply for an exemption if there was a transfer of marketing authorisation holder – the old or the new one?

Whole Article Monday, 13. May 2013 | Author

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.

26. Who is authorized to represent the marketing authorisation holder in an administrative procedure for granting of exemption from application of the sunset clause?

Whole Article Monday, 13. May 2013 | Author

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.

25. What would you advise us if the CR is a RMS, the medicinal product does not have any consumption in the Czech market and the only CMS to which we could transfer the respective marketing authorisation does not respond to our e-mails?

Whole Article Monday, 13. May 2013 | Author

In case no CMS wishes to assume the RMS position, contact the CMDh Secretariat. The situation which arose will be solved in one of the regular CMDh meetings.

24. Can patent protection be considered a relevant reason for granting of an exemption?

Whole Article Monday, 13. May 2013 | Author

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.

23. Can an exemption be granted on marketing grounds?

Whole Article Monday, 13. May 2013 | Author

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.

22. Can an exemption be granted due to the fact that the medicinal product is in another administrative procedure (price setting)?

Whole Article Monday, 13. May 2013 | Author

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.

21. Is there an application for granting of exemption available on your website?

Whole Article Monday, 13. May 2013 | Author

19. Do I understand it well that the sunset clause shall either apply upon statutory requirements or upon request?

Whole Article Monday, 13. May 2013 | Author

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).

18. If it for instance occurs that the 3 year period is about to expire shortly, while the medicinal product was not introduced to the Czech market, but there are valid grounds why this did not happen, may an exemption for the MP be applied for?

Whole Article Monday, 13. May 2013 | Author

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.

17. Does this mean that SUKL will monitor which medicinal products are jeopardized by the sunset clause and will inform companies?

Whole Article Monday, 13. May 2013 | Author

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.

16. Will there be a list of pharmaceuticals to which sunset clause could be applied? What information will it contain?

Whole Article Monday, 13. May 2013 | Author

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.

15. What will be the procedure when sunset clause is applied to transfer of marketing authorisation?

Whole Article Monday, 13. May 2013 | Author

The transfer of marketing authorisation has no impact on the application of sunset clause. The new holder assumes all rights and obligations of the original holder.

14. The name of medicinal product has changed. Do periods pursuant to Section 34 (1) and (2) of the Act on Pharmaceuticals commence only after the change?

Whole Article Monday, 13. May 2013 | Author

No. Changes of marketing authorisation do not impact on the application of sunset clause, because this is linked to the marketing authorisation, not to the decision on change to marketing authorisation.

13. If we have a medicinal product whose marketing authorisation number was differentiated or is about to be differentiated, how will the sunset clause be applied to individual differentiated marketing authorisation numbers?

Whole Article Monday, 13. May 2013 | Author

The sunset clause is linked to the marketing authorisation and thus to the marketing authorisation number which is linked to this decision. The period of 3 years when the marketing authorisation holder must introduce the medicinal product to the market shall commence on 1 January of the following year after the date on which the marketing authorisation of medicinal product has become binding, not from the date of differentiation. For medicinal products whose marketing authorisation became binding before 31 December 2007 (see Question 5) Example: MP was authorized in strengths 5, 10 and 20 mg with marketing authorisation number 01/111/11-C. Subsequently, marketing authorisation numbers were differentiated as follows: 5 mg – 01/111/11-A/C 10 mg – 01/111/11-B/C 20 mg – 01/111/11-C/C Only one pack of 5 mg (01/111/11-A/C) was introduced to the market, the period of three years of market availability shall be calculated for all three strengths (5 mg; 10 mg; 20 mg) from 1 January of the following year. In this case, one strength (5 mg) “saves” the remaining two strengths (10 mg; 20 mg).

10. Will a sample be considered for market availability as well?

Whole Article Monday, 13. May 2013 | Author

No. Pursuant to Section 5b (7) of the Act No. 40/1995 Coll., on Advertising Regulation, as amended, samples of medicinal products may only be provided exceptionally to individuals authorized to prescribe them in a limited number for one calendar year at most. Every sample must correspond to the smallest pack of a humane medicinal product introduced to the market and must be labelled “Unsalable sample” or “Free sample”. Samples may not be used for a continuous treatment of patients, and patients themselves do not have any access to samples. In case of new pharmaceuticals in the market, samples of medicinal products are provided in order to test the new drug in practice.

9. What does a medicinal product available in the market for the purposes of application of the sunset clause mean?

Whole Article Monday, 13. May 2013 | Author

A medicinal product available in the market means a product notified pursuant to DIS-13.

8. When does the period of 3 years for market introduction of MP commence pursuant to Section 34a (1) of the Act on Pharmaceuticals for generic medicinal products?

Whole Article Monday, 13. May 2013 | Author

The provision in Section 34a (1) of the Act on Pharmaceuticals stipulates that the period for a generic medicinal product shall commence only on the day on which the period in which it may not be introduced to the market pursuant to Section 27 (1) of the Act on Pharmaceuticals terminates. We kindly ask the marketing authorisation holder to contact SUKL staff by e-mail should they establishes any discrepancies.

7. If we notify an interruption of MP supplies, will the period of 3 years in which a sufficient amount of MP must be available in the market be interrupted as well?

Whole Article Monday, 13. May 2013 | Author

No. Section 34 a (2) of the Act on Pharmaceuticals stipulates that if the medicinal product launched fails to be available in the market in the course of 3 consecutive years, the marketing authorisation shall cease to be valid, and this period shall commence on 1 January of the following year. Obviously, an uninterrupted period of 3 years is meant. Neither the respective clause of Directive 2001/83/EC in Article 24 nor the respective provision of the Act on Pharmaceuticals stipulate that interruption of medicinal product supplies have an impact on the above mentioned. The application of sunset clause thus does not take the interruption of supplies into account.

6. We notified market introduction of the medicinal product before the Act on Pharmaceuticals became effective (31 December 2007). Are we obliged to notify this again?

Whole Article Monday, 13. May 2013 | Author

Should a medicinal product be jeopardized by the sunset clause, it is in the best interest of the marketing authorisation holder to notify of the date of the first market introduction after 31 December 2007. The period of 3 years in which the medicinal product must be available in the market in a sufficient amount, shall commence on the first day of the year following the year in which this medicinal product was introduced to the market in the Czech Republic . If SUKL does not have the date of market introduction after 31 December 2007 and if consumption of this medicinal product is notified in 2008, SUKL will consider the date of 1 January 2008 to be the date of market introduction after the Act on Pharmaceuticals has become effective.

5. When does the period of 3 years for market introduction of medicinal product commence for medicinal products authorized before 31 December 2007?

Whole Article Monday, 13. May 2013 | Author

According to the provision in Section 113 (5) of the Act on Pharmaceuticals, the period of 3 years in which the marketing authorisation holder must launch the medicinal product authorized before 31 December 2007 shall commence on 31 December 2007, i.e. when the Act became effective. The period of 3 years in which the marketing authorisation holder must launch the medicinal product authorized after 31 December 2007 shall commence on 1 January of the following year after the marketing authorisation has become binding.

4. What does a launched medicinal product mean?

Whole Article Monday, 13. May 2013 | Author

For the purposes of Section 34a (1) of the Act on Pharmaceuticals, a market launch shall be the first market introduction of a medicinal product after termination of production, pursuant to Section 3a (10) thereof, i.e. introduction to the distribution chain. In simple words, it is the point when the producer finishes production and gives the medicinal product to the distributor. The marketing authorisation holder shall be obliged to notify SUKL (pursuant to Section 33 (2) of the Act on Pharmaceuticals) of market introduction of the medicinal product by means of an electronic form which is available on the SUKL website, see http://www.sukl.cz/hlaseni-uvedeni-preruseni-nebo-ukonceni-uvadeni-na-trh , within two months after the actual market introduction at the latest. For the purposes of Section 34a (2) of the Act on Pharmaceuticals, market introduction shall be every following market launch of medicinal product pursuant to Section 3a (10) thereof.

3. How shall be the period of 3 years calculated pursuant to Section 34a (1) and (2) of the Act on Pharmaceuticals?

Whole Article Monday, 13. May 2013 | Author

The provision in Section 34 a of the Act on Pharmaceuticals differentiates between two periods of 3 years which are linked to expiration of marketing authorisation. The first period of 3 years pursuant to Section 34 a (1) of the Act on Pharmaceuticals shall commence on 1 January of the following year after the marketing authorisation has become binding – the marketing authorisation holder shall launch the medicinal product, i.e. introduce it to the distribution chain, pursuant to Section 3a (10) of the Act on Pharmaceuticals in the course of these three years. The other period of 3 years pursuant to Section 34 a (2) of the Act on Pharmaceuticals shall commence on 1 January of the following year after the date of market launch of the medicinal product – at least one pack must be in the market in the course of 3 consecutive years from this date.

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