Withdrawal of Marketing Authorisation (Cancellation)
The National Institute of Pharmacy is entitled to withdraw a valid Marketing Authorisation of a medicinal product in Hungary, the European Commission is entitled to do so in case of centrally authorised medicinal products.
The procedure of withdrawal of a marketing authorisation falling within the competence of the National Institute of Pharmacy is described in details in §17 (4), (5) and §18 of the XCV Medicines Act of 2005.
Concerning practical issues they are detailed in §32, §36 of Decree No. 52 of 18 November, 2005 of the Minister of Health, publication is dealt with in §33 (1) b).
For the procedures, as for the above mentioned, falling within the competence of the National Institute of Pharmacy administration fees (per medicinal product) have to be paid. The charges are detailed in Decree No. 32 of 11 August, 2005 of the Minister of Health.
Withdrawal of Marketing Authorisation (Cancellation) is an administrative procedure initiated by the applicant or by the authority.
The time of administration is 30 days. For the professional authority which also takes part in the assessment (National Center for Epidemiology) the normative administration time is 15 days (important in procedures for immunobiological medicinal preparations). In the written request for the withdrawal (cancellation) of a marketing authorisation it is possible to set the day of withdrawal (cancellation to come into force). The concerned Marketing Authorisation Holder is being informed within 5 days by the National Institute of Pharmacy after the procedure having been initiated officially. The decision is reported by the authority in a resolution. This includes the following sentence: „The packaging units of the cancelled medicinal product having been put on the market may be marketed within the expiry date.”
