within the meaning of Act No 362/2011 Coll. on Medicinal Products and Medical aids and additions to certain laws (hereinafter "the Act')

When issuing that authorisation, the applicant shall submit to the Ministry in Article 7 of the Law

1)Request for issue authorisations signed by the statutory representative (s) where they will be listed the following information
specify applicant's email address

2)

  1. natural person: first name, surname, place of permanent residence, birth number, citizenship, business name, IČO,
  2. legal person: business name, registered office, legal form, statutory representatives: first name, last name, place of permanent residence, birth number, nationality,

professional representative: first name, last name, place of permanent residence, birth number, citizenship,
(c) the name of the facility, the address of the premises for the preparation of the transfusion medicinal products.

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

  1. evidence of professional competence for the professional representative (§ 13)
  2. a contract of employment for an expert for that post,
  3. the assessment of the State Institute for Medicinal Products Control,
  4. the assessment of the regional public health office,
  5. Opinion on the start of the city, municipality,
  6. evidence of ownership or lease of the premises where the activity is carried out,
  7. hospital authorisation,
  8. an extract from the criminal record of the statutory representative (statutory representatives),
  9. extract from the criminal record of the professional representative (s)
  10. Extract from the Commercial Register for a legal person, decision to enter Register of a non-profit organisation, issued by the District Office (non-profit organisation), decision of MZ SR (State contributory organisation),

stamp worth 250.- EUR, administrative fee for permit issue (E-cool can be 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

Change documents professional representative (documents for new a professional representative; Criminal record) In the event of failure to notify a change of professional representative or in the in case of termination of the work of a professional representative and failure to notify this change to the Slovak Ministry of Health, the holder of the authorisation is suspended.
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 indicate change of particulars in the permit Name of authorisation holder (marriage certificate), place of permanent residence of the holder of the authorisation (new evidence) address), statutory representatives, change of residence of professional representative (document on a new 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) v in case of a change of statutory representatives (an extract from the Commercial Register is submitted 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. Juríková, email: Yurikova@health.gov.sk)

Date of publication: 25 October 2016
Update date: 29 September 2020