Information on the classification into sub-categories of the medicinal products authorised under centralised procedure
According to the 95th Act of 2005 the Marketing Authorisations should contain the classification of each medicinal product. The classification of the medicinal products which are registered in the Community Register differ from the Hungarian classification system and only the main categories are indicated. The necessity of using sub-categories should be considered by the National Authorities, which is adjudged in Hungary by the National Institute of Pharmacy (NIP), according to the § 18., Decree No. 52/2005. (XI. 18.) of the Minister of Health.
The opinion of the Competent Medicines Authority on the classification should be requested in case of each medicinal product to be effectively marketed in Hungary (different dosage form, strength and pack size).
The NIP fixes the sub-categories of the medicinal products with Comission Decision under an administrative procedure, referring to the Section 70 of the Directive 2001/83/EC.
The procedure starts on request (the form for the application can be downloaded here). During the procedure our Institute takes account of the classification of the Commission, the point 4.2 of the Summary of Product Caracteristics and the ways and circumstances during the use of the medicinal product.
The NIP makes a decision on the classification. The letters indicating the category/sub-category of the medicinal product should be represented in the „blue box”. The decision is a supplementary document by the application for national insurance subsidy.
The indication of the letters of the category/sub-category in the „blue box” on the outer packaging of the medicinal product is checked by the NIP. For this reason the Holder of the Marketing Authorisation should submit a final sample of the medicinal product to the NIP from the first manufactured batch to be marketed in Hungary, which will be qualified in written notice.