The Ministry took the following opinion on the requests to address the question of how the parties' submissions on proceedings initiated by the Ministry of Health of the Slovak Republic (hereinafter referred to as "the Ministry') and individual requests by the parties concerning the delivery of data on officially fixed prices of medicinal products in other Member States of the European Union (the comparison of prices of medicinal products).
Act No 363/2011 Coll. on the scope and conditions for reimbursement of medicinal products, medical devices and dietetic foods on the basis of public health insurance and on the amendment of certain laws (hereinafter referred to as "the Act') entered into force on 1 December 2011. The Law entered into force well in advance, on the day of its declaration in the Code of Law (29.10.2011, item No 117/2011). The period between validity and effectiveness serves to enable anyone who is legally subject to certain rights or obligations to become aware of its content.
The Ministry on its own initiative, before the actual publication of the Act in the Code of Laws, organised a presentation to inform potential parties of the procedure for contracting and obtaining access and signing certificates. During the months of October and November 2011, i.e. well in advance of the entry into force of the law and the initiation of any proceedings, documents relating to the processes described above (models, manuals, etc.) were continuously published on the Ministry's website.
The fact that some entities have been able to complete the entire process of concluding an e-composition contract with the Ministry by signing the contracts on the first day of the law's application removes any doubt that there would be obstacles on the part of the Ministry and at the same time that the parties to the proceedings were not given sufficient time to ensure the necessary actions for the timely conclusion of the contracts and obtaining certificates.
According to § 75 of the Law, submission can be delivered to the Ministry in documentary form only in situations where the electronic portal is not available for reasons on the part of the Ministry.
The Law does not allow the Ministry to grant any exceptions to the way in which submissions are served. Nor does the Ministry have the competence to extend the time limits laid down in Paragraph 79 of the Law, during which the parties have the right to comment on the proceedings opened.
In conclusion, the Ministry cannot, in any event, postpone its activities in matters of classification until all potential parties to proceedings have access to the electronic portal and signatures. The reason is that the fact that the party has a certificate depends mainly on the party himself - the Ministry handles the application for certificates on an ongoing basis, while to date many parties have not even applied for certificates.