Allowed differences from the Marketing Authorisation (formal defect)
With regard to marketing authorisation process of medicinal products falling within the competence of the National Insitute of Pharmacy – to provide continuous medicine supply for patients – our authority may authorize the marketing of a particular manufactured bulk to be put into circulation even if it differs formally from the valid marketing authorisation. The procedure and the relating issues are described in 35§ of Decree No. 52 of 18 November, 2005 of the Minister of Health.
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.
The authorisation process of licensing formal defect is an administrative procedure initiated upon request. The application is acceptable only if Certificate of Analysis and samples of medicinal product are also attached. 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. The decision – which refers to a well-determined amount of the manufactured bulk - is reported by the authority in a resolution. In case of authorisation being a subject to conditions the applicant is obliged to submit product samples for approval by our authority.
Immunobiological preparation may be put on market only if it is in accordance with 34§ of Decree No. 52 of 18 November, 2005 of the Minister of Health.