State Institute for Drug Control

For applications for a new marketing authorisation following the national, decentralised or mutual recognition procedure with Czech Republic as a RMS or CMS, filed after 2 April 2013, the following new documentation must be submitted:

a)      Pursuant to Section 26 paragraph 5 (i), a scan of the confirmation indicating that the manufacturer of the medicinal product has carried out an audit confirming that the manufacturer of the medicinal product complies with good manufacturing practice and instructions pursuant to Section 64 (l) where a human medicinal product is concerned; the written confirmation must contain the date of the audit and a statement suggesting that the result of the audit confirms that the manufacturing is in line with good manufacturing practice and these instructions;

b)      pursuant to Section 26 paragraph 5 (k), a summary of the pharmacovigilance system of the applicant for marketing authorisation to include the following:

1. evidence that the applicant for marketing authorisation has a qualified individual in charge of pharmacovigilance;

2. indication of the Member State where such a qualified individual resides and discharges its tasks;

3. contact details of the qualified individual;

4. a declaration signed by the marketing authorisation applicant saying that it disposes of the required means to discharge the tasks and ensure liability in pharmacovigilance;

5. indication of the location where the pharmacovigilance system master file for the relevant medicinal product is being kept

c)       pursuant to Section 26 paragraph 5 (l), a risk management plan describing the risk management system to be established by the applicant for marketing authorisation for the medicinal product in question, along with a summary of the plan;

d)      pursuant to Section 26 paragraph 5 (p) copies of:

1. all marketing authorisations of the relevant medicinal product obtained in another Member State or in a third country, summary of safety data, including details contained in periodically updated safety reports, if any, and in reports of suspected adverse reactions, along with the list of Member States in which the application for marketing authorisation is pending and being assessed;

2. the summary of the product characteristics with respect to the product proposed by the applicant for marketing authorisation or approved by the competent authority of the Member State concerned and the package leaflet proposed by the marketing authorisation applicant or approved by the competent authority of the concerned Member State;

3. any decision to refuse marketing authorisation in the European Union or in a third country, and reasons for such decision.

Pursuant to Section 31 paragraph 5 (c) of the amended Act on Pharmaceuticals, the deadlines for supplementing of applications for marketing authorisation following the national procedure, applications for renewal of marketing authorisation and application for type II variations following the national procedure submitted after 2 April 2013 shall be stipulated by the Institute and shall be adequate to the given circumstances (scope of the required supplementation).

Information on the handling of applications for marketing authorisation of medicinal products through the national procedure, MRP or DCP, marketing authorisation renewal and applications for marketing authorisation variation through the national procedure, MRP or DCP, and applications for permission of parallel import of a medicinal product, pursuant to Section 32, paragraph 1 of the Act on Pharmaceuticals, is available at http://www.sukl.cz/leciva/zmena-ve-vyrizovani-zadosti-o-registraci-prodlouzeni .

The texts of the SPC, PIL and labelling forming part of any application handled after 2 April 2013 will no longer bear the “APPROVED” stamp and will no longer be labelled as annexes to the decision/notification. Instead, they will only be labelled with the reference number of the procedure in which they were handled.

Changes concerning the submission of applications for renewal of the marketing authorisation pursuant to Section 34 paragraph 1 of the amended Act on Pharmaceuticals are described at  

http://www.sukl.eu/medicines/when-is-it-necessary-to-submit-an-application-for-renewal-of

The list of medicinal products whose marketing authorisation expires by 2 January 2014 (which are subject to the existing rules for submission of applications for marketing authorisation renewal), and the list of medicinal products whose marketing authorisation will cease to be valid in the period from  3 January 2014 to 31 March 2014 (first products for which the period for submission of the application for renewal is 9 months before the expiration of the marketing authorisation), is available at http://www.sukl.cz/seznam-lecivych-pripravku-u-nichz-skonci-platnost-rozhodnuti-4.  

Until the amended Regulation No. 228/2008 Coll., on marketing authorisation of medicinal products, comes into effect, the documentation relevant to the application for renewal of the marketing authorisation of a medicinal product authorised through the national procedure may be submitted according to the requirements laid down in the existing Regulation No. 228/2008 Coll., on marketing authorisation of medicinal products.

In compliance with Section 34 paragraph 8 of the amended Act on Pharmaceuticals, the marketing authorisation holder must inform the Institute of the method of recall of the medicinal product and of the time necessary for such recall. As of 2 April 2013, an amended form of the application for revoking of marketing authorisation (REG-72) is available on the Institute’s website at  http://www.sukl.cz/leciva/pokyny-a-formulare, in which the information on the method of recall of the medicinal product and the period necessary for such recall is required for medicinal products that are available in the market of the CR. Where an application for revocation of marketing authorisation is submit after 2 April 2013 on the form that was valid before 2 April 2013, the Institute will request, for medicinal products that are available in the market of the CR, supplementing information on the method of recall of the medicinal product from the market and on the period necessary for such recall.

The transitory and final provisions of the amended Act on Pharmaceuticals stipulate that  the effective date of the amended act terminates the obligation to periodically submit updated safety reports imposed on the holders of marketing authorizations for medicinal products authorized pursuant to Section 27(1) or (7) of the Act No 378/2007 Coll., as in effect as of the date of entry into effect of this Act, homeopathic products or traditional herbal medicinal products pursuant to Section 30 of Act No 378/2007 Coll., as in effect as of the date of entry into effect of this Act, in marketing authorisation decisions or their amendments or in decisions on the renewal of marketing authorisations of these products issued before the effective date of this Act. For the above mentioned medicinal products it is not necessary to submit the applications for variations (changes in frequency of submission of PSUR). These applications for variations will have to be submitted when the obligation to submit PSUR for the above mentioned medicinal products is stipulated in EURD sheet.

The marketing authorisation decisions already stipulated the obligation to submit periodic safety update reports relevant to the given medicinal product authorised through the national procedure or DCP with the Czech Republic as the reference member state (RMS) according to the approved clauses in the QRD template in a modified version. The existing practical applications will not change so far.

Yes, all marketing authorisation decisions issued after 2 April 2013 will be published on the Institute’s website after the given decision on marketing authorisation has come into effect.

The provisions of Section 30 paragraph 9 shall be applied to medicinal products

-              which had been authorised based on literary data as products with well-established therapeutic use, however, the clinical data were subsequently questioned or negative clinical trials were published which deny the declared therapeutic use, provided that the product meets the conditions stated in 1 and 2 of Section 30,

-              which are covered by a traditional Community monograph.

In any of the above-stated cases it is necessary to apply for a marketing authorisation variation. Texts relevant to the given product must be amended in order to comply with the requirements for traditional herbal medicinal products.

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The provisions of Section 30 paragraph 10 shall apply to herbal medicinal products

-              which had been registered as traditional herbal medicinal products based on the time of their use and insufficient clinical data and for which the marketing authorisation holder subsequently submits its own clinical data or literary data.

-              for which a WEU community monograph covering the given product has been drafted.

An application for marketing authorisation variation must be submitted in any of the above cases. The texts relevant to the product must be amended in order to comply with the requirements for texts used for medicinal products with well-established therapeutic use.

Yes. As of the effective date of the amended act, homeopathic products can be registered/authorised in the Czech Republic through two procedures. Pursuant to section 28, homeopathic products can be registered using the simplified authorisation procedure as before (without stating the indications) and pursuant to the new Section 28a, it is also possible to authorise specific homeopathic products (stating the indications). 

Applications for marketing authorisation of specific homeopathic products (i.e. homeopathic products with indications) can be lodged using the application form available on the EudraLex website, as Section 28a of the amended Act on Pharmaceuticals (No. 378/2007 Sb.) requires the same form for submitting of the application as Article 16 of Directive e 2001/83/EC (marketing authorisation procedure).

http://ec.europa.eu/health/files/eudralex/vol-2/b/applicformhomeo_2005_12_en.pdf

Yes, the obligation of marketing authorisation holders to submit the respective application for a variation to marketing authorisation in case of a change to SPC, PIL and/or labelling remains unchanged.