Slovak Financial Law News 2004

Amendment to the Act on Medicaments

Act No. 9/2004 Coll., amending and supplementing the Act No. 140/1998 Coll. on Medicaments and Medical Devices, on the amendment to Act No. 455/1991 Coll. on Small Trade Business (Trade Licensing Act) as amended, and on the amendment and supplement to the Act of the National Council of the Slovak Republic No. 220/1996 Coll. on Advertising, as amended and on the amendment to Act No. 216/2002 Coll. on the Profession of a Chemist, on the Slovak Chamber of Chemists and on the supplement of the Act No. 140/1998 Coll. on Medicaments and Medical Devices, on the amendment to Act No. 455/1991 Coll. on Small Trade Business (Trade Licensing Act) as amended, and on the amendment and supplement to the Act of the National Council of the Slovak Republic No. 220/1996 Coll. on Advertising, as amended

The latest amendment to the Act on Medicaments is a further step towards harmonisation of the laws of the Slovak Republic in the field of policy on medicaments with the regulatory framework of the European Union (``EU''). The new comprehensive regulation of performance of clinical trials is in full compliance with Directive 2001/20/EC, regulating good clinical practice in the conduct of clinical trials on medicinal products for human use. The greater emphasis is put on the protection of participants of clinical trials, especially of persons incapable of granting their legal consent to participation in the clinical trials (persons who are not capable of legal acts and minor persons).

Supervision over ethics of clinical trials shall be performed by independent ethical committees appointed pursuant to Act No. 277/1994 Coll. on Health Care, as amended. These committees shall express their opinion on every proposed clinical trial. The process of permitting clinical trials shall remain within the powers of the State Institute for Drug Control (the ``State Institute'') which co-operates with the European Commission and the European Agency for the Evaluation of Medicinal Products (the ``Agency'') and provides these organisations with information into the so-called European database on clinical trial.

A special regime is introduced for the import, export, identification, testing, evaluation of the concordance of medicinal products used in the conduct of trials as well for occurrence of unfavourable effects.

The amendment also introduces changes within the process of registration of medicinal products. Registration by means of the Agency (that registers precisely specified types of medicinal products stated in an Annex to the Act) shall be also considered to be the method of launching the mass produced medicaments into the market. At the same time, specification of persons entitled to apply for registration is simplified and the provisions stipulating the requisites of an application for registration and a list of required documents are supplemented.

Pursuant to this amendment, decisions on registration of a medicament issued before 1 June 1998, the validity of which was extended under the law which was effective until 30 September 2003, shall be deemed to be decisions on the registration of the medicament that do not comply with the requirements of the European Union; holders of a decision on registration of the medicament and a decision on extension of the registration of the medicament were obliged to submit by 29 February 2004 to the State Institute all requisites for registration of the medicament pursuant to Section 21 of the Act on Medicaments, otherwise the validity of the decision on registration of the medicament expired on 30 April 2004.

A substantial change is represented by the introduction of a procedure for mutual recognition of registrations of medicinal products among the Member States of the EU. Based on the above, following the validity date of the Treaty of Accession of the Slovak Republic to the EU it shall be sufficient if an applicant, who is a holder of a decision on registration of the medicament in any other EU Member State, requests for recognition of the registration of the medicinal products for the territory of the Slovak Republic. In extraordinary cases when the State Institute finds out disputable issues in the registration of any other Member State of the EU, specific arguing proceedings between the State Institute and the Registration Authority of the other Member State is stipulated at the presence of the Agency and the European Commission. The European Commission is entitled to decide in such disputes.

A practical change for pharmaceutical companies which currently have to go through three separate proceedings (registration, determination of a price and categorisation) is represented by the transfer of powers in the official determination of prices of medicaments from the Ministry of Finance of the Slovak Republic to the Ministry of Health of the Slovak Republic and a possibility of common administrative proceedings with the proceedings on inclusion of medicaments in the list of medicaments and pharmaceuticals (categorisation).

In compliance with Directive 89/105/EEC relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems, stricter periods for deciding on the price determination are stipulated. The period is 90 days after receipt of the application, with the possibility of prolongation by 60 days or 90 days in the case of joint proceedings with categorisation. Even with respect to the previous failure to meet the stated periods, it is revolutionary that the applicant is entitled to sell medicaments for proposed price, if a decision is not issued within the stipulated period.

In compliance with EU legislation relating to genetically modified organisms and Act No. 151/2002 Coll. on the Use of Genetical Technology and Genetically Modified Organisms, the amendment introduces a requirement of the approval by the Ministry of Environment of the Slovak Republic to pharmaceutical, toxicological and pharmacological testing of medicaments, pharmaceuticals and auxiliary substances containing such organisms.

The amendment also introduces several changes in the field of veterinary pharmacy and state administration in this field.

This Act came into force on 1 February 2004, save for provisions on a relationship to the European bodies and mutual recognition which became effective as of the validity date of the Treaty of Accession of the Slovak Republic to the European Union.

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