Amendment to the Act on Medicaments

(Act No. 488/2001 Coll. amending and supplementing the Act No. 140/1998 Coll. on medicaments and medical instruments and on amendment to the Act No. 455/1991 Coll. on conducting business activities (Trade License Act), as amended and on amendment to the Act No. 220/1996 Coll. on advertising, as amended)

The basic term "large scale distribution of medicaments and medical instruments" is specified.

The amendment introduces a detailed definition of the terms "diagnostic medical instrument in vitro" and "active implantable medical instrument".

The requirements for notification of material unfavourable effects to the State Institute are specified. The terms "unfavourable effect", "unexpected unfavourable effect" and "misuse of a medicament" are defined.

In accordance with the EU directives, medical employees and producers in the area of health service are placed with a duty to notify the State Institute of any accidents, malfunctions and defections of medical instruments, which the State Institute evaluates the required notifications and adopts the relevant remedial measures which can lead to suspension of expenditure or even to recall of products from the market.

The amendment introduces the Slovak Code of Pharmacy as a set of technical requirements for preparation, testing, labelling, storage, prescribing and expenditure of mass prepared medicaments, individually prepared medicaments and intermediate products for their preparation.

In accordance with the amendment, an application for registration of a medicament is submitted to the State Institute and not to the Ministry of Health as it was up to now.

From the present State Institute for Control of Medicaments, the State Institute is established which is a state administration body in the division of human pharmacy. The State Institute is a budget organisation. Its director is appointed and recalled by the Minister of Health of the Slovak Republic.

This Act is in force from 1 December 2001.

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