The current regulation outlined in Article 17(3) of Decree No 52/2005 (XI. 18.) of the Minister Responsible for Healthcare on Registration and Marketing Authorisation of Medicinal Products for Human Use states unequivocally that the summary of product characteristics (SmPC) of the generic medicinal product shall not include indication(s) or dosage form(s) of the reference medicinal product protected by usage patent.
Due to the aforementioned regulation, and considering that the summary of product characteristics (SmPC) constitutes an annex to the NCPHP decision permitting marketing authorisation of the medicinal product, during the marketing authorisation procedure the NCPHP cannot waive the submission of the Applicant's declaration concerning the indication(s) or dosage form(s) of the medicinal product pending authorisation that are protected by usage patent.
During the marketing authorisation procedure, the use of the electronically completable declaration template provided by the NCPHP is not mandatory, submission of a declaration with a different format is permitted. However, the NCPHP recommends using the template for a lower administrative burden.
The declaration template is available in Hungarian here and in English here.
Applicants should note that although it is not mandatory to indicate the expiry date of the existing patent in the declaration, if this date is indicated, the NCPHP shall, upon expiry of the patent, automatically update the medicinal product database with product information documents containing the indication/dosage form that were protected by usage patent until the expiry date. Otherwise, the Applicant will need to submit an additional declaration upon expiry of the patent.
