State Institute for Drug Control

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.