Number: Z017955-2022
R O Z H O D N U T I E
Ministry of Health of the Slovak Republic (hereinafter referred to as "the Slovak Republic')Ministry(sssssssssssssssssss) as a crisis management authority as provided for in § 3 (a). (b) Act No 387/2002 Coll. on State Management in Crisis Situations outside War Time and War Status, as amended, due to the declaration of an emergency in connection with the mass influx of foreigners into the territory of the Slovak Republic caused by the armed conflict in the territory of Ukraine by the Government of the Slovak Republic by Resolution No 142 of the Government of the Slovak Republic dated 26.02. 2022, which has been in force since 26.02. 2022 from 12:00 p.m. (hereinafter referred to as "N')Emergency situationand pursuant to § 128 (8) (a). (c) and (d) Act No 362/2011 Coll. on medicinal products and medical devices and on amendments to certain laws as amended (hereinafter referred to as "the Act'),Medicines ActIt decided as follows:
I.
Ministry in connection with the emergency situation and the urgent need to ensure the prescription of a human medicinal product, medical device and dietetic food by a physician specialising in the relevant specialization field and by a physician in the specialization field general medicine and by a physician specialising in paediatric medicine (hereinafter referred to as –).Doctor(n = 6)
o f the
the prescription of a medicinal product for human use, a medical device and a dietetic food for a person who is not publicly insured, residing in the territory of Ukraine and entering the territory of the Slovak Republic in connection with an armed conflict in the territory of Ukraine (hereinafter referred to as "the "EU').Patient-refugee(c) pursuant to § 128 para. 8 c) the drug law as follows:
1. The doctor shall prescribe a medicinal product for human use and a dietetic food on prescription in document form and a medical device for medical voucher in documentary form in accordance with § 119 (4) and (5) of the Act on medicinal products to the patient - refugee after medical examination; a prescription record shall not be produced. Prescribing and indicating restrictions laid down by Act No. 363/2011 Coll. on the scope and conditions of reimbursement of medicinal products, medical devices and dietetic foods on the basis of public health insurance and on the amendment of certain laws as amended (hereinafter referred to as "the ')Law on the scope and conditions of reimbursement(s) shall not apply when prescribing under this sentence.
2. The doctor will prescribe a medicinal product for human use, a medical device and a dietetic food by indicating, on the back of a prescription or a medical certificate in documentary form, a note ÞUA TEMPERATURE for the patient-refugee after a medical examination with a temporary haven and a Date of birth
not filled in.
3. In the case of the prescription of a medicinal product, a medical device and a dietary food for a dependent child, the presentation of a passport or other identity card to which the prescription referred to in points 1 and 2 is implemented shall be sufficient.
4. The prescriber shall be responsible for the accuracy, completeness and justification of the prescription and of the medical certificate referred to in points 1 and 3.
II.
Ministry in connection with the emergency situation and due to urgent interest in the dispensation of human medicinal products, medical devices and dietary food for the patient-refugee
o f the
pursuant to § 128 (8) (a). (d) the Act on medicinal products for human use, medical devices and dietary food, by giving the patient a medicinal product for human use, a dietetic food based on a prescription and a medical device based on a medical certificate issued in accordance with operative part I of this Decision, in an ambulance or in another place following a medical examination, if the medicinal product, medical device and dietetic food are available.
III.
Ministry in connection with an emergency situation due to an urgent interest in a medicinal product for human use, a medical device and a dietary food for the patient-refugee
o f the
pursuant to § 128 (8) (a). (d) the Act on medicinal products for human use, medical devices and dietetic food for medical care providers in a public pharmacy, a hospital pharmacy, a branch of a public pharmacy and a dispenser of medical devices,
IV.
This Decision shall enter into force on the day following its publication on the website of the Ministry and shall be effective until the end of the emergency situation in the territory of the Slovak Republic.
O d e c t i on s:
The current crisis situation in the territory of Ukraine affects the most civilian population, which, as a result of the Russian military invasion and the intensification of violence, is forced to leave its homes and causes massive migration of civilians both within Ukraine and to the territory of the Slovak Republic.
In view of the wording of the role in point C.1. of Resolution No 142 of the Government of the Slovak Republic of 26 February 2022 on the proposal to declare an emergency situation in connection with the mass influx of foreigners into the territory of the Slovak Republic caused by the armed conflict in the territory of Ukraine, which has imposed on members of the Government and the Presidents of other central government to take civil protection measures and to implement resolution measures in their jurisdiction aimed at preventing threats to life, health, property, relief of the consequences of the incident by the Ministry on the basis of § 128 (8) (a). (c) and (d) the Act on medicinal products to ensure the prescribing and dispensing of medicinal products for human use, medical devices and dietetic food for patients.
According to § 128 (8) (a). (c) in the event of a crisis, the Ministry may issue a decision modifying the prescription of medicinal products for human use, medical devices, in vitro diagnostic medical devices or dietary foods to the extent necessary and for the time necessary.
According to § 128 (8) (a). (d) the Law on medicinal products may be issued by the Ministry during a crisis situation by a decision which, to the extent necessary and for the time necessary, adjusts the dispensation of medicinal products, medical devices, in vitro diagnostic medical devices or dietary foods.
Pursuant to Paragraph 128 (9) of the Act on medicinal products for the purpose of making a decision pursuant to paragraph 8, the rules of procedure are not applicable. The anniversary of a final decision shall be binding on everyone.
Under Paragraph 128 (10) of the Law on medicinal products against a decision pursuant to paragraph 8, no appeal is admissible. It shall take effect the day following the publication of the decision on the website of the Ministry.
P o c e: Pursuant to Paragraph 128 (10) of the Act on medicinal products against this Decision, no appeal is admissible.
Vladimir Lengvarsky
Minister