Withdrawal of Marketing Authorisation (Cancellation)

The National Institute of Pharmacy and Nutrition 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 and Nutrition is described in details §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 and Nutrition administration fees (per medicinal product) have to be paid. The charges are detailed in 1. Annex of the XCV Medicines Act of 2005.

- Applicaton and documentations can be submitted by CESP with e-signature.

- Applicaton and documentations can be submitted by CESP withouth e-signature and have to be signed the fact of the submission by electronic way (https://ogyei.gov.hu/eugyintezes)

The time of administration is 8 days. In case of missing documentation according to the Act CL of 2016 on General Public Administration Procedures the authority advise the applicant on one occasion to remedy the deficiencies

Withdrawal of Marketing Authorisation (Cancellation) is an administrative procedure initiated by the applicant or by the authority.

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.”

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