Centralised marketing authorisations are granted under so called centralised procedure in compliance with Regulation (EC) No 726/2004 of the European Parliament and of the Council, laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Medicinal products authorised via this procedure are approved centrally by the European Medicines Agency (EMA) and the authorisation is valid throughout the territory of the Community. For more information on the centralised procedure, please see the EMA website.
The list of all medicinal products authorised under the centralised procedure, including details on the procedure, the European Public Assessment Report (EPAR) summary for the public, the summary of the product characteristics, package leaflet, labelling, assessment report, information on assessment and overview of post-authorisation applications is available from EMA's website. The individual decisions of the European Commission together with annexes for new marketing authorisations, renewals of marketing authorisations, variations to marketing authorisations or revocations of marketing authorisations are available on the Commission's website.
Submission of product packaging specimens prior to placement on the market
The provision of Section 33 par. 3 (h) of Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended (hereinafter referred to as “the Act on Pharmaceuticals“), which imposes an obligation on the marketing authorisation holder to submit to the Institute or to the Veterinary Institute one specimen of the product’s packaging following entry into force of the marketing authorisation or implementation of a variation that had an impact on the product appearance or packaging, prior to the placement of the product onto the market, does not apply to centrally authorised medicinal products.
Notification of placement on the market, suspended, renewed or terminated marketing
The marketing authorisation holder is obliged by law to notify the Institute of the following:
- the date of actual placement of a medicinal product on the market in the Czech Republic broken down by pack size and type of packaging; no later than within two months of its actual placement on the said market;
- the date of suspension or termination of marketing of the medicinal product in the Czech Republic no later than two months in advance thereof; where exceptional circumstances arise, such notification may be made no later than concurrently with the actual suspension or termination of marketing of the medicinal product in the Czech Republic; and
- the date of resumed marketing of the medicinal product; such notification shall be made without any delay.
This obligation applies also to holders of marketing authorisations for products authorised under the centralised procedure.
For more information please see this page, including electronic report form.
Submission of application for SÚKL code allocation
The entry of data on medicinal products authorised under the centralised procedure into the database of the Institute and the allocation of SÚKL codes associated therewith is performed continuously on the basis of information published on EMA's and Commission's websites.
When the marketing authorisation holder of a centrally authorised medicinal product wishes to receive SÚKL codes earlier than they are available in the Medicinal products database on the website of the Institute, he may apply for allocation thereof. The application must contain the Commission Decision (or the EMA approval in case of variations), Annexes I, II and III (the summary of product characteristics, the package leaflet and labelling) in the Czech language and in case of newly authorised medicinal product, extension of marketing authorisation or addition of the new variant of the product also EPAR – All authorised presentations. The application may be submitted by e-mail to ODP@sukl
cz.
Allocated SÚKL code has to be printed on the packaging of the medicinal product in Blue-box. This obligation is set forth by Section 37, paragraph 1 of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended. To facilitate identification, SÚKL recommends to introduce the SÚKL code with the words “SÚKL kód”. Neither this code, nor the introductory words are to be provided as part of the texts of the labelling (in the QRD template).
Information on newly authorised products and new pack sizes is published on the website of the Institute.
Safety features and European Article Number (EAN)
The Act on Pharmaceuticals does not set forth the implementation of a national reimbursement number or another national number identifying the medicinal product in the NN format on the outer packaging of medicinal products. SÚKL code should not form part of the unique identifier (UI) or human readable data associated with the UI.
If the medicinal product is to be dispensed without medical prescription and is not listed under Annex II to Commission delegated regulation (EU) 2016/161 (on so called “black list”), its packaging may continue to show the EAN code, or the EAN code may be replaced with the 2D code at the discretion of the marketing authorisation holder.
In respect of products for which the provision of a unique identifier in the form of a 2D code is mandatory after 9 February 2019, the packaging may also continue to display the EAN code, unless readability is adversely affected. Nevertheless, wherever practicable, for these products SÚKL recommends to opt for the presentation of the 2D code only, and to limit the parallel provision of both the EAN code and the 2D code to the shortest period possible.
Institute for the development, content, and distribution of educational materials and evaluation of effectiveness of additional risk minimisation measures are set forth by guideline PHV-7.
When assessing the materials, the Institute takes into account particularly the following aspects:
- grounds for the existence of educational materials;
- content reflecting the current clinical practice in the Czech Republic;
- compliance with requirements laid down in Annex II to the Commission decision granting the marketing authorisation and RMP;
- absence of elements of advertising nature, consistency with guideline PHV-7;
- clarity and usefulness for doctors and patients; and
- material accuracy and compliance with the approved summary of the product characteristics;
- distribution scope and method of distribution.
All of the educational materials approved by SÚKL are subsequently published on the Institute's website. Education materials for which an oral presentation is essential to ensure their accurate interpretation, are an exception of this rule and for this reason, these materials are not published.
In case of a variation to the marketing authorisation which has an impact on the content of educational materials or on any other additional risk minimisation measures, the marketing authorisation holder is obliged to contact the Institute without undue delay again and provide information on amendments intended to be made in additional risk minimisation measures excluding those required for medicinal products not anticipated to be launched in the near future. When the updated version and the method of its distribution is agreed, the Institute makes the new educational materials public on its website with a note that the original materials have been replaced by the updated version.
In case there are several marketing authorisation holders of medicinal products with the same active substance and the same approved indication and whose obligations in terms of educational material development and distribution or any other additional risk minimisation measures are similar (particularly for generic and biosimilar medicinal products governed by Art. 10(1), 10(3) and 10(4) of Directive 2001/83/EC), the Institute usually requires the development and distribution of joint educational materials on the part of all concerned marketing authorisation holders.
Where, due to a variation to the marketing authorisation, an obligation to implement any additional risk minimisation measures becomes void, such fact has to be notified to the pharmacovigilance department of the Institute (farmakovigilance@suklcz) within the timeline of one month of the approval of the variation to the marketing authorisation. The same notification shall be made also in case the marketing of the medicinal product in the Czech Republic is to be terminated, no later than as of the date of such termination.
Direct Healthcare Professional Communications – DHPC
Where a necessity to disseminate new important safety information on an active substance or product arises, the marketing authorisation holder shall submit a proposed DHPC in the Czech language for assessment to the pharmacovigilance department of the Institute (farmakovigilance@suklcz). The final form of the DHPC and the method and scope of its distribution depends on the agreement between the marketing authorisation holder and the Institute. All of the DHPCs approved by the Institute are subsequently published on the Institute’s website.
In case there are several marketing authorisation holders who have medicinal products in respect of which the same safety notice is to be communicated, the Institute usually requires a joint development and distribution of the DHPC.
The Institute's requirements for the development, contents and distribution of direct healthcare professional communications and evaluation of their effectiveness are set forth by guideline PHV-8.
Registeries, non-interventional post-authorisation safety studies
When the marketing authorisation holder plans to perform a non-interventional post-authorisation study in the Czech Republic, they shall be obliged to notify Institute via the Institute’s register, as stipulated under Section 13, paragraph 3(i) of the Act on Pharmaceuticals. For more details on notification, , please refer to the website. Where a non-interventional post-authorisation safety study (PASS) is concerned, the pharmacovigilance guideline PHV-3 shall apply. Non-interventional studies not considered PASS are governed by guideline UST-35. The public section of the register is available here. The electronic forms are available here.
Institute recommends marketing authorisation holders to enter study information and documents regarding all conducted non-interventional post-authorisation studies in the EU PAS Register. The EU PAS/ENCePP Register is publicly available, here.
Marketing Authorisation Branch
9 May 2013 (updated on 31 January 2023)
