State Institute for Drug Control

It pertains to all medicinal products authorised via both national or MRP or DCP procedures. It is not applicable to centrally authorised medicinal products (centralised medicinal products are handled by the European Medicines Agency). 

SÚKL shall proceed in compliance with Section 19, paragraph 1 of Decree No 228/2008 Coll., on marketing authorisation of medicinal products, as amended, i.e. compliance with the requirements for the quantity of the product adequate to the minimum of 10.000 DDDs (daily defined doses).
This requirement shall be applicable only to products for which the DDD has been determined by the World Health Organisation (WHO).

Where no DDD has been determined for the active substance and it is not possible to determine it according to the current WHO methodology, SÚKL will proceed in compliance with the recommendation of the European Medicines Agency and the EC (Enterprise Directorate-General) which stipulates:

Marketing authorisation of a medicinal product shall remain valid, if:

• at least one presentation of the marketing authorisation (the form of packaging which has been allocated a SÚKL code) has been placed on the market; and
• at least one pack-size of all authorised pack-sizes is marketed. 

SÚKL has prepared an overview of medicinal products which to date have no reported consumption or which do not comply with the requirements of the Decree, i.e. not more than 10,000 DDDs nor at least one package have been distributed during the concerned period. This overview is available from SÚKL's website at http://www.sukl.cz/sunset-clause-a-list-of-medicinal-products. The overview contains basic information about the product – name of the product, pharmaceutical form, MA number, ATC code and the marketing authorisation holder.
SÚKL emphasises that the overviews are of informative nature only. Should the marketing authorisation holder identify any discrepancies, SÚKL kindly requests the holder to contact SÚKL, ideally by email. Any statement must be always supported with evidence.

Section 34 of Act No 378/2007 Coll., on Pharmaceuticals, as amended (hereinafter referred to as the “Act on Pharmaceuticals”) specifies that a marketing authorisation of a medicinal product shall cease to be valid if within the period of 3 consecutive years since the marketing authorisation came legally into force the medicinal product has not been placed on the market in the Czech Republic. SÚKL does not decide on the cessation of the marketing authorisation. The marketing authorisation shall cease to be valid on the basis of the provisions of the Act.

Marketing authorisations of individual medicinal products validity pursuing is in the interest of every marketing authorisation holder. SÚKL has adopted steps to provide the information to the MA holders, but the respective measures resulting in maintaining the validity of the marketing authorisation are to be taken by the MA holders themselves.  

Section 34 of the Act on Pharmaceuticals distinguishes between two 3-year periods which are associated with the  invalidation of the marketing authorisation.
The first 3-year period is calculated from the coming of the marketing authorization legally into force – in the course of these three years the marketing authorisation holder must place the medicinal product onto the market, i.e. hand it over to the distribution chain.
The other 3-year period is calculated from the date of placing the medicinal product onto the market – in the course of these 3 years, 10,000 daily defined doses of the medicinal product (in compliance with the definition set forth in Section 19 of Decree No 228/2008 Coll.) must be present on the market, if a DDD for the product has been determined by the World Health Organisation. Where no DDD has been determined for the medicinal product, at least one packaging of this medicinal product must be present on the market in the course of these 3 consecutive years (please refer also to Questions nos. 2 and 3).
After the expiry of the period of three years following the placement of the medicinal product onto the market, SÚKL may, at any time,  check whether the medicinal product has been present on the market for the past 3 years in sufficient amount, i.e. either 10,000 DDDs or one package thereof (see above).

Pursuant to the provisions of Section 113, paragraph 5 of the Act on Pharmaceuticals, the period of 3 years during which the marketing authorisation holder is obliged to place the medicinal product onto the market, shall, in the case of products authorised prior to December 31 2007, commence upon the coming of the Act into force, i.e. on December 31 2007.  
For products authorised after December 31 2007, the 3-year period during which the marketing authorisation holder is obliged to place the medicinal product onto the market shall commence on the date of the coming of the marketing authorization legally into force .

It means the first entry of the medicinal product onto the market following the completion of manufacture, i.e. entry into the distribution chain beyond the control of the MA holder. In lay terms, it is the moment as of which the manufacturer completes manufacture and hands the medicinal product over to the distributor.

The marketing authorisation holder is obliged to notify SÚKL of the placement of a medicinal product onto the market (as set forth in Section 33, paragraph 2 of the Act on Pharmaceuticals), using an electronic form which is available from SÚKL's website – see http://www.sukl.cz/modules/marketreport/edit.php?lang=2.

The definition of “presence of a medicinal product on the market” is provided in the provisions of Section 19, paragraph 1 of Decree No 228/2008 Coll.

Information of this sort is truly essential for the possible application of the sunset clause, and for this reason it should be communicated to SÚKL.  

No, they will not. Samples of medicinal products may be, pursuant to Section 5b, paragraph 7 of Act No 40/1995 Coll., on Advertising Regulation, as amended, provided only exceptionally to persons authorised to prescribe the medicinal products, in limited amounts for the maximum period of one year. Each sample must conform to the smallest pack-size of a human medicinal product placed on the market and must be labelled as a “Sample not intended for sale” or as a “Free sample”.
Samples cannot be used for systematic patient treatment and the patient himself/herself has no access to the samples. The purpose of medicinal product sample provision is to provide the opportunity to try out a new medicine on the market in practice.   

Pursuant to Section 34 of the Act on Pharmaceuticals, SÚKL may, under exceptional circumstances and with regard to public health protection, decide that the marketing authorisation of the medicinal product shall not cease to be valid. This decision shall be passed within the scope of an administrative procedure which may be initiated by virtue of SÚKL ("ex officio") or on the basis of a justified application of the marketing authorisation holder. The Act on Pharmaceuticals stipulates that the application must be submitted no later than within 3 months prior to the expiry date of the three-year period.

Thus, if there are indeed reasons which satisfy the conditions laid down by the Act on Pharmaceuticals, these reasons have to be specified and, naturally, justified in the application. Thereafter, SÚKL shall decide within the scope of an administrative procedure governed by the effective Administrative Code; i.e. it shall issue the decision prior to the expiry of the three-year period stipulated by the Act. When this decision comes legally into force, SÚKL shall publish information on the marketing authorisation ceasing/not ceasing to be valid, together with a rationale in respect thereof, on its website.

No, it is not. The sunset clause is always applied on the basis of the Act. SÚKL only has the option to make an exemption from these effects of the Act, if the conditions stipulated by the Act are met (i.e. exceptional circumstances plus always public health protection concern), i.e. SÚKL may decide that the sunset clause provision is not applied, however, only within the scope of an administrative procedure which is governed by the Administrative Code. This administrative procedure may be initiated either by an application submitted by the marketing authorisation holder or by virtue of SÚKL ("ex officio").

Pursuant to the provisions of Section 34, paragraph 3 of the Act on Pharmaceuticals, no administrative fee for the application shall be requested. Reimbursement of costs associated with the application shall not be, in compliance with the aforementioned provision, requested, either.

The Act on Pharmaceuticals does not stipulate any special form of application. An application lodged in compliance with Section 34, paragraph 3 of the Act on Pharmaceuticals must therefore meet the requirements of the Administrative Code. These are provided in Section 45, in compliance with Section 37, paragraph 2 of the Administrative Code.

Requirements governing an application pursuant to Section 37, paragraph 2 of Act No 500/2004 Coll., the Administrative Code, as amended, are attached in the annex - Requirements governing applications pursuant to Section 37.pdf, (612.46 kB).

The reasons for which SÚKL may decide upon the marketing authorisation not ceasing to be valid are defined by the Act on Pharmaceuticals and they are mentioned above. It will always depend on specific circumstances.

Marketing reasons are not specifically listed in the Act on Pharmaceuticals as a reason for granting the exemption. It should be repeated that SÚKL shall always consider the cases ad hoc (case by case), i.e. taking into account the specific circumstances of each administrative procedure. Should SÚKL conclude that the reasons stipulated by the Act on Pharmaceuticals do exist, it shall decide for non-application of the sunset clause, i.e. that the marketing authorisation will not cease to be valid.

Patent protection is not a reason defined by the Act on Pharmaceuticals as a reason for granting an exemption. For other details please refer to the answer to Q.16.

The sunset clause is linked to the marketing authorisation and hence to the MA number associated with this particular marketing authorisation. The period of the 3 years during which the marketing authorisation holder is obliged to place the medicinal product onto the market is calculated from the coming legally into force of the marketing authorisation of the medicinal product, not from the date of code-adjustment. For products whose marketing authorisation came legally into force prior to December 31 2007 please see Question 7 above.

Example:

The medicinal product has been authorised in 5mg, 10mg and 20mg strengths under marketing authorisation number 01/111/11-C. Thereafter, code-adjustment to the following MA numbers has been performed:                             

• 5mg – 01/111/11-A/C
• 10mg – 01/111/11-B/C
• 20mg – 01/111/11-C/C

In order to safeguard the presence of the medicinal product on the market, it shall suffice to have 10,000 DDDs for MA number 01/111/11-C, i.e. the sum total of consumption of all strengths of this product.

As mentioned in the previous question, it is marketing authorisation and hence the MA number specified in the marketing authorisation which is being assessed for the purposes of sunset clause. Individual pack sizes have the identical MA number and for this reason the consumption of all of these packs is accumulated for the purposes of sunset clause. It is essential to comply with the quantity requirement governing the marketing authorisation number, regardless of the type of the pack size.

If no CMS is willing to take over the role of the RMS, it is necessary to contact the CMDh secretariat. The situation will then be discussed as a part of regular CMDh meetings agenda.

Section 34, paragraph 3 of Act No 378/2007 Coll., on pharmaceuticals, states, inter alia,  the following: “The marketing authorisation became invalid, if the medicinal product is not placed onto the market in the Czech Republic within three years of the date of coming legally into force of the marketing authorisation (note: see answer to Question no. 7)…. If an authorised medicinal product placed on the market in the Czech Republic is not present on the market in the Czech Republic in the course of three years (note: see answer to Question no. 8), the marketing authorisation for this medicinal product became invalid.” For the purposes of sunset clause, the legislation does not take into account those packages of medicinal products which have been exported to other countries.  

Exemptions from sunset clause may be granted under exceptional circumstances and with a view to public health protection. Export to third countries may, under certain circumstances, comply with the requirements governing the granting of an exemption pursuant to the provisions of Section 34, paragraph 4 of the Act on Pharmaceuticals, whereas the following must be evidenced:

• Name of the country of import;
• Information evidencing that the medicinal product has significant impact upon public health in the country of import;
• Information sales volume;
• A written proof that the authority  in the country of import requires a valid marketing authorisation from the Czech Republic.

Yes, sunset clause applies to medicinal products marketed in the Czech Republic.

Yes. Line extension is a separate marketing authorisation which is connected to the individual marketing authorisation number.

Only such representative of the company who is authorised to act on behalf of the company in marketing authorisation issues (authorisation to act on behalf of the company in price and reimbursement matters is not sufficient) may act as the representative when applying for an exemption from marketing authorisation expiry pursuant to Section 34, paragraph 3 of the Act on Pharmaceuticals. The company may authorise only a single person to act as its representative for marketing authorisation issues.

The decision as to whether an exemption from sunset clause should be requested or not depends on the MA holder. If the MA holder is interested in not having the marketing authorisation of the medicinal product became invalid, they may apply for the exemption.  Pursuant to the provisions of Section 113, paragraph 5 of the Act on Pharmaceuticals, in the case of medicinal products authorised prior to the coming into force of the Act on Pharmaceuticals the 3-year period referred to in Section 34, paragraph 3 is calculated from the date of coming into force of the Act on Pharmaceuticals.

Yes, if you supply to the distributor at least one package of the medicinal product and you report to SÚKL the date of placing the medicinal product onto the market. The period of 3 years during which the medicinal product must be present on the market in the required amount shall commence only on the date of placement onto the market that you specify (please refer to Questions nos. 2 and 3).

If the medicinal product has lower consumptions and it could be jeopardised by the sunset clause, it is in the interest of the marketing authorisation holder to report the date of the first placement onto the market after December 31 2007. The 3-year period during which the medicinal product must be present on the market in sufficient amount shall commence on this date. In the case SÚKL has no date of placement onto the market after December 31 2007, and consumptions of this medicinal product are reported in 2008, SÚKL shall consider January 01 2008 the date of placement onto the market following the coming into force of the Act on Pharmaceuticals.

If the medicinal product has sufficient consumptions and it is not likely to be jeopardised by the sunset clause, it is not necessary to report the placement onto the market following the coming into force of the Act on Pharmaceuticals.

No. Variations to marketing authorisation shall not affect the application of sunset clause, as sunset clause is linked to marketing authorisation, not to decisions on variations to marketing authorisation.

The application for exemption from sunset clause shall be submitted by the new (current) MA holder who undertakes all rights and obligations of the original MA holder (Section 36, paragraph 4 of the Act on Pharmaceuticals).