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.
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