The Ministry of Health reminds all pharmacies that from 1 April 2017 it will be possible to order medicines pursuant to § 23 (1) (a). (at) Act No 362/2011 Coll. on medicinal products and medical devices and on amendments to some of them as amended (hereinafter referred to as "the Act on medicinal products') also through the information system for the special ordering of medicinal products (ISMOL), if it is not possible to ensure the delivery of a human medicinal product included in the list of categorised medicinal products (hereinafter referred to as the "categorised medicinal product') from the holder of the authorisation to distribute medicinal products for human use pursuant to Article 18 (1) (a). (f) the drug law. For this way of ordering categorised medicines is commonly used the name -emergent system--
The holder of a marketing authorisation for a medicinal product for human use is required under § 60 (1) (a). (ac) of the Act on medicinal products to supply the ordered categorised medicinal product using the -emergent system of the - within 24 hours of receipt of the order of the holder of the authorisation for the wholesale distribution of medicinal products for human use, if he entrusts it with the delivery of the ordered medicinal product to a public pharmacy or hospital pharmacy.
The authorisation holder for the large distribution of medicinal products for human use is required under Paragraph 18 (1) (a). ad) of the Act on medicinal products to deliver a categorised medicinal product ordered by the use of the (Art.23 (1) (at) and (au) of the Drug Act) to a public pharmacy or a hospital pharmacy within 48 hours of the order being made.
If the holder of an authorisation for the large distribution of medicinal products for human use has claims against the public pharmacy or hospital pharmacy for the supplied medicinal products after the expiry of the contractual term of payment, he must supply the categorised medicinal product ordered by the use of the
A public pharmacy or a hospital pharmacy is required under Paragraph 23 (1) (a). (aw) of the Act on medicinal products to take a categorised medicinal product ordered using the According to § 23 § 1 letter ax) is required to dispense the categorised medicinal product delivered to the patient.
The marketing authorisation holder of a categorised medicinal product is according to § 60 (1) (a). z) the Act on medicinal products required to ensure the establishment and operation of the [ISMOL], which is the holder of the marketing authorisation, and the –emergent system" must provide the marketing authorisation holder with an overview of which public pharmacy or hospital pharmacy has supplied the categorised medicinal product to which it is the holder of the marketing authorisation.
The Emergent System (Emergent System) shall also include information on which authorisation holder for the large distribution of medicinal products for human use has been supplied by the marketing authorisation holder of the categorised medicinal product.
The marketing authorisation holder of a categorised medicinal product is according to § 60 (1) (a). (aa) the Act on medicinal products is obliged to technically ensure the maintenance of the (ab) of the Act on medicinal products to ensure receipt and confirmation of orders of categorised medicinal products for which it is the holder of the registration, through the
The marketing authorisation holder of a categorised medicinal product is according to § 60 (1) (a). (ae) the Act on medicinal products is obliged to notify the Ministry of Health of the details of the The notified data are intended to enable public pharmacies and hospital pharmacies to order categorised medicinal products through the Emergent System.
The marketing authorisation holder of a categorised medicinal product is obliged to notify the Ministry of Health without delay of any change in the data in the
The Ministry of Health of the Slovak Republic publishes on its website at Home FarmingISMOL.