The latest measures due to the spread of COVID 19 also concern the health sector, the distribution of selected products and, in particular, the Medicines Act.

Today, the government has approved new measures to restrict the distribution of filter face mask of category FFP2 and FFP3.

These products may be sold or transferred to the respective entities, namely:

a)   a healthcare provider who provides healthcare in the territory of the Slovak Republic,

b)   a healthcare professional who carries out the medical profession in the territory of the Slovak Republic,

c)   bodies of state administration or territorial self-government,

d)   a legal person or natural person - entrepreneur, who is obliged under the special regulation (Act No. 124/2006 Coll. on health and safety at work) to provide this personal protective equipment and performs the work listed in the Annex to this Act, for the protection of life and health (for example people who work in archives, sanding wood, work with hazardous substances, etc.),

e)   a legal person or a natural person who has concluded a contract to ensure that examination of the dead body is carried out with the Health Care Surveillance Authority;

f)    legal person or natural person - entrepreneur providing funeral services in the territory of the Slovak Republic,

g)   an employee of the forensic and pathological-anatomical department of the Supervisory Authority,

h)   a person for whom there are medical grounds (list of diagnoses for which there are medical grounds for exemption will be published by the Ministry of Health SR);

i)    a person who distributes this personal protective equipment in the territory of the Slovak Republic and who has its registered office or place of business in the territory of the Slovak Republic and who sells or transfers this personal protective equipment only to persons referred to in point a) to h).

We emphasize that this limitation applies only during an emergency situation, i.e. during a period of state of emergency, state of necessity and extraordinary situation. A fine of EUR 10,000 will be imposed for breaching this prohibition. We assume regarding the entities under letter d) and e) that it will be more than desirable for the distributor to verify their status and activity in order to prove, in the event of an inspection, that such entities should have been these respective persons. Meanwhile, we recommend confirming these facts e.g. by affidavit or confirmation in the contract, and in the future an implementing regulation or some guidance may be issued by the ministry of health.

The amendments to the Medicines Act concern the following areas:

1. Disinfectants and antiseptics

The government has approved a legislative change enabling pharmacies to include disinfectants and antiseptics in their product range, as pharmacy care will also include the preparation, storage and dispensing of disinfectants and antiseptics.

The enquiry arose from the high demand and low supply of these products at the time of the coronavirus pandemic, but according to the Explanatory Notes, this content of medical care will continue to be available after the end of the pandemic as a permanent assortment of pharmacy.

Disinfectants and antiseptics will be the so-called complementary assortment and other assortment of public pharmacy, hospital pharmacy and medical devices dispensers.

2. Authorization of the Ministry of Health of the Slovak Republic to modify respective conditions

At the same time, during the crisis situation, the Ministry of Health of the Slovak Republic will be entitled to issue a decision by which to the extent necessary and inevitable time:

(a) prohibits exports of

- a medicinal product for human use not subject to medical prescription or a medicinal product not included in the list of categorized medicinal products,

- medical devices,

- in vitro diagnostic medical device, or

- a dietetic food that is included in the list of categorized dietetic foods,

(Note: the measures aim in practice to ensure a priority supply in a public pharmacy, hospital pharmacy or medical device dispenser, including orthopedic prosthetic dispensers or audio-prosthetic dispensers, in order to ensure trouble-free health care provision. It should be added that such a decision has already been made by the Ministry of Health of the Slovak Republic, which banned exports outside the SR – further information can be found here.)

(b) restricts the supply of a medicinal product for human use, a medical device, an in vitro diagnostic medical device or a dietetic food that is included in the list of categorized dietetic foodstuffs,

(Note: this provision applies to holders of authorization for the provision of medical care. The possible measures taken are intended, for example, to limit the number of packages of medicinal products for human use, in particular those not subject to medical prescription, which are the subject of a 'shopping fever' of the population in a crisis situation.)

(c) regulates the prescription of medicinal products for human use, medical devices, in vitro diagnostic medical devices or dietetic foods;

(Note: this provision applies to doctors authorized to prescribe medicines. It is now necessary to ensure priority e-prescription to minimize contact between patients and healthcare professionals, most often doctors and nurses.)

(d) regulates the disbursement of medicinal products, medical devices, in vitro diagnostic medical devices or dietetic foods.

(Note: this provision applies to holders of medical care authorizations who may be subject to temporary obligations to prevent the spread of infectious diseases. For example, the use of a dispensing window to be issued during a medical emergency service.)

We recommend to continuously monitor the website of the Ministry of Health of the Slovak Republic and the publication of these decisions. We continue to monitor all planned and approved legislative changes adopted in connection with COVID 19 and will keep you updated on the latest news.