General question

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What changes have been made concerning the documentation submitted when applying for a new marketing authorisation?

What deadlines are stipulated by the amended Act on Pharmaceuticals for supplementing of information by the applicant where applications for marketing authorisation, applications for renewal of a marketing authorisation and type II variation applications

How does the amended Act on Pharmaceuticals affect the handling of applications for marketing authorisation, applications for marketing authorisation renewal or variation and applications for permission of parallel import that involve the SPC, PIL and l

How will be product information (SPC, PIL, labelling) labelled when being sent by post together with the decision (i.e. to natural persons without a data mailbox or to persons residing abroad)?

When is it necessary to submit an application for renewal of the marketing authorisation of a medicinal product?

What documentation has to be submitted together with the application for renewal of a marketing authorisation of a medicinal product authorised through the national procedure?

How should the marketing authorisation holder apply for revocation of marketing authorisation pursuant to the amended Act on Pharmaceuticals?

How should marketing authorisation holders present periodic safety update reports in the case of medicinal products authorised as generics, homeopathic products, traditional herbal products or based on literary data?

How will the obligation to submit regular safety update reports stipulated in the marketing authorisation?

Will the decisions on marketing authorisation of medicinal products be published on the Institute’s website?

What change of conditions must take place in the case of an authorised herbal medicinal product so that Section 30 paragraph 9 becomes applicable to it?

What change of conditions must take place in the case of an authorised herbal medicinal product so that Section 30 paragraph becomes applicable to it?

Does the amended Act on Pharmaceuticals allow the authorisation of homeopathic medicinal products with specified indications?

Which form can be used to apply for marketing authorisation of a homeopathic product with indications?

Will the new procedure of processing applications affecting product information make it necessary to submit an application for a variation to marketing authorisation in case of a change to SPC, PIL and/or labelling?

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