Authorisation to provide medical care in hospital pharmacy
pursuant to Act No 362/2011 Coll. on medicinal products and medical devices and amending and the addition of certain laws (hereinafter "the Act')

The granting of that authorisation Applicant submit to the Ministry pursuant to § 7 of the Act

1) Application for authorisation signed the statutory representative (s) where the following data will be provided:
Indicate the applicant's email address, telephone number

2)

(a) legal person: business name, registered office, legal form, non-profit organisation: name, registered office, state contribution organisation: name, registered office, statutory representatives: first name, last name, place of permanent residence, birth number, nationality, professional representative: first name, surname, place of permanent residence, birth number, nationality,

(b) the name of the establishment, the address of the hospital pharmacy.

3) The application for authorisation shall be submitted by the applicant. Mandatory to support the following documents:

a) Proof of professional competence for a professional representative (MS Fafukė diploma, specialisation diploma in pharmacy or professional practice 5 years in public or hospital pharmacy, license of the Slovak Pharmacy chambers),
a contract of employment for an expert;

b) a report from the State Institute for Medical Control for Hospital pharmacy,

c) a report from the Regional Public Health Office on hospital pharmacy,

(d) an extract from the criminal record of the statutory representative (statutory representatives), a professional representative,

(e) Extract from the Commercial Register for a Legal Person, Decision on registration of a non-profit organisation issued by the District Office (non-profit organisation), decision of MZ SR (State contributory organisation),

(f) an opinion on the start-up of the town's hospital pharmacy; the municipalities,

g) Document of ownership or lease of premises where activity is carried out,

h) hospital authorisation (issued by VÚC, MZ SR),

(i) E-cool worth 250.- EUR, administrative fee for the issue of a permit.
(E-cool purchased at the Slovak Post Office).

Changes to the details in the permit § 8 of the Act. 3

change of professional representative, change of place of enforcement activity, change in the scope of activity
is the issue of a new authorisation

documents for change of professional representative (documents for new professional a representative, proof of education in a designated capacity, employment contract, statement from criminal record) In the event of failure to notify a change of professional representative, or in the event of failure to notify a change of professional representative, the termination of the activities of the professional representative and the notification of this change to the MZ SR, the holder of the authorisation suspended activity.
Replacement professional representative - § 5 of the Act documents according to point (7)
The application shall be accompanied by a declaration on its honour that the other applicants have not changed details on the basis of which the original authorisation was issued (number and date given) the initial authorisation).
E EUR 250.-, administrative fee per issue permits.
(E-cool purchased at the Slovak Post Office).

Changes to the particulars in the permit § 8 (1) of the Act

At the request of the authorisation holder, the Ministry shall indicatechange of particulars in the permit Name of the holder of the authorisation (marriage) the letter), the place of permanent residence of the holder of the authorisation (new address document), statutory representatives, change of residence of the professional representative (new evidence) address),
in the case of a legal person, it is a change of registered office, change of business name Company (to be submitted Extract from Company Business Register)
in the case of a change of statutory representatives (to be submitted Extract from the Commercial Register) companies and criminal records of new statutory representatives)

The application shall be accompanied by a self-declaration by the applicant that it is did not change the other data on the basis of which the original authorisation was issued (to be specified) number and date of initial authorisation)
E-cool worth 30.- EUR. (E-cool buy on Slovak Post Office).

Withdrawal of authorisation on own request
If the applicant (signs the statutory representative) applies for the withdrawal of the authorisation (e.g.
for transfer from a natural person to a legal person), the application shall be accompanied by:
the original of the authorisation issued by the Ministry which the applicant applies to cancel.

The application together with the licence documents shall be sent to: Address
Department of Pharmacy, Department of Pharmacy and Drug Policy, Limbová 2, 837 52 Bratislava
(ref. Karovičová, email: Lubica.karovicova@health.gov.sk)

Date of publication: 24 October 2016
Update date: 29 September 2020