within the meaning of Act No 139/1998 Coll. on narcotic drugs, psychotropic substances and preparations as amended (hereinafter the Act)
To be issued NEW AUTHORISATION ON THE management of narcotic drugs and psychotropic substances Pursuant to § 8 of the Act, the applicant will submit to the Ministry of Health of the Slovak Republic (hereinafter referred to as "the Ministry'):
1) application for a new authorisation for the treatment of narcotic drugs and psychotropic substances signed by the statutory representative (s)
Application for authorisation of the handling of narcotic drugs and psychotropic substances
Model application Þ New authorisation - Producers
(2) the application for a new authorisation must contain:
- (a) where the applicant is a natural person:
- - Business name, IČ (Organisation identification number) if assigned
- - first name, last name, place of permanent residence, birth number or date of birth, if the birth number has not been assigned, nationality
- where the applicant is a legal person:
- - Business name, registered office, legal form, IČO
- - first name, last name, place of permanent residence, birth number or date of birth if birth number has not been assigned - statutory representatives
- - first name, last name, place of permanent residence, birth number or date of birth, if the birth number has not been assigned, nationality - professional representative
- (b) type and extent of handling of narcotic drugs and psychotropic substances according to the ŠÚKL/ÚŠKVBL (National Institute for Drug Control/State Control of Veterinary Biopreparates and Medicinal Products) study
- (c) location of activity (name and address of establishment)
- (d) date of initiation of treatment with narcotic drugs and psychotropic substances
3) the application for a new authorisation for the treatment of narcotic drugs and psychotropic substances shall be accompanied by the following documents:
- (a) proof of his medical fitness or medical fitness of his professional representative (to be issued by the practitioner)
- (b) proof of their professional capacity or professional competence (documents of completed education according to § 6 of the Act)
- (c) the assessment of the State Institute for the Control of Medicinal Products in Bratislava or the report of the State Institute for the Control of Veterinary Biopreparates and Medicinal Products in Nitra for Veterinary Doctors
- (d) data necessary to request a copy of the criminal record for persons for whom good repute is established (natural person or statutory body of the legal person and professional representative)
- (e) the data necessary for the purpose of verifying the ownership of the premises where the activity will be carried out (list of ownership) or the rental document for the applicant who is not the owner of these premises (rental contract) and, in the case of carrying out transport, the proof of ownership or lease and suitability of the means of transport (rental contract and registration certificate = technical licence)
- (f) confirmation by the processing organisation of harvest collection or the applicant's declaration to ensure that poppy straw is disposed of without delay by incorporation into the soil if the applicant applies for authorisation to grow
- (g) officially certified copy of the authorisation
- 1. for the manufacture of medicinal products when the applicant applies for authorisation to manufacture medicinal products containing narcotic drugs and psychotropic substances
- 2. for the large distribution of medicinal products, if the applicant applies for authorisation for the large distribution of medicinal products containing narcotic drugs and psychotropic substances
- 3. for the provision of medical care, for the provision of health care or for the provision of professional veterinary activities, where the applicant applies for authorisation to issue medicinal products containing narcotic drugs and psychotropic substances
- 4. for waste management when the applicant applies for authorisation for the management of waste containing narcotic drugs and psychotropic substances
- 5. processing organisation for processing or production, if the processing organisation has a place of business in the Slovak Republic and if the applicant applies for authorisation to grow poppy or hemp
- 6. a processing organisation issued by a State in whose territory the processing organisation has its place of business; where the processing organisation has its place of business in a State where the processing or production authorisation is not issued under the legislation in force in that State, the applicant for authorisation to grow shall provide a certificate from the competent authority that the requested authorisation is not issued in that State.
- (h) a self-declaration of land ownership, land lease or other authorisation to use the land on which the cultivation will be carried out, indicating the cadastral territory, if the applicant applies for authorisation to grow
- (i) a certified copy of the certificate of competence to carry out research and development if it applies for an authorisation for research, teaching or for an expert activity demonstrating that its activity is research, teaching or professional activity;
- (j) proof of payment of an administrative fee of 50 €
(E-cool purchased at the Slovak Post office)
4) on the application for a new authorisation for:
- (a) the cultivation of poppy or hemp shall be accompanied by the documents referred to in paragraphs 2 and 3 (a). (a), (b) and (e) to (g) of the fifth and sixth points and points. (h)
- (b) the transport is required to be accompanied by the documents referred to in paragraph 2 (a). (a) to (c) and (e) and paragraph 3 (a). (a) to (c) and (e)
- (c) research, teaching and professional activity shall be supported by
- 1description of the research project
- 2. contract with another holder of an authorisation for research, teaching and expertise under this law if part of the research is carried out by another holder of the authorisation
- (d) the cultivation of hemp for research purposes is the applicant required to support
- 1. a copy of its authorisation for research, teaching and expertise; or
- 2. an officially certified copy of the certificate of competence for carrying out research and development, a description of the research project and a contract with another holder of the research, teaching and expertise permit under this Act if part of the research is carried out by another holder of the authorisation;
For the cultivation and/ or processing of hemp varieties listed in a specific regulation (so-called technical hemp), a Ministry' s permit is not required.
Issue of a new authorisation The Ministry for the Treatment of Narcotic Drugs and Psychotropic Substances is also required for a change in the type or extent of treatment of narcotic drugs and psychotropic substances, a change in the place of activity and a change in the person of an expert.
In the application for authorisation, the applicant shall indicate the requested modification and attach supporting documents showing the change.
Application form
Model application Þ New permit - Modification - Producers
Change in species or range the handling of narcotic drugs and psychotropic substances
- the assessment of the State Institute for the Control of Medicinal Products in Bratislava or of the Institute for the Control of Veterinary Biopreparates and Medicinal Products in Nitra for Veterinary Doctors
- self-declaration that the other particulars on which the original authorisation was issued have not changed (number and date of issue of the original authorisation)
- proof of payment of an administrative fee of 50 €
(E-cool purchased at the Slovak Post office)
Change of location of activity
- the assessment of the State Institute for the Control of Medicinal Products in Bratislava or of the Institute for the Control of Veterinary Biopreparates and Medicinal Products in Nitra for Veterinary Doctors
- data necessary for the purpose of verifying the ownership of the premises where the activity will be carried out (list of ownership) or the rental document for the applicant who is not the owner of the premises (rental contract) and, in the case of carrying out the transport, the proof of ownership or lease (rental contract) and the suitability of the means of transport (vehicle registration certificate = technical licence)
- current authorisation for the provision of medical care issued by the municipality
- current authorisation for the manufacture of medicinal products for human use or the large distribution of medicinal products for human use issued by the SWD
- current authorisation for the manufacture of veterinary medicinal products or the large distribution of veterinary medicinal products issued by CMS
- self-declaration that the other particulars on which the original authorisation was issued have not changed (number and date of issue of the original authorisation)
- proof of payment of an administrative fee of 50 €
(E-cool purchased at the Slovak Post office)
Amendment of the expert representative
- medical proof of the medical fitness of their professional representative (to be issued by the practitioner)
- proof of professional competence of their professional representative (documents of completed education according to § 6 of the Act)
- a copy of the contract of employment of its expert
- data necessary to request a copy of the criminal record for persons for whom good repute is established (professional representative)
- current authorisation for the provision of medical care issued by the municipality
- self-declaration that the other particulars on which the original authorisation was issued have not changed (number and date of issue of the original authorisation)
- proof of payment of an administrative fee of 50 €
(E-cool purchased at the Slovak Post office)
To be issued AMENDMENTS TO DATA IN AUTHORISATIONS FOR THE management of narcotic drugs and psychotropic substances Under Paragraph 10 of the Act, the applicant submits to the Ministry:
1) notification of the change in the particulars contained in the authorisation for the treatment of narcotic drugs and psychotropic substances signed by the statutory representative/representatives
Model for the application "Notice of change of data'
Model of application - Notification of change of data - Producers
2) the notification of an amendment to the particulars contained in the authorisation for the treatment of narcotic drugs and psychotropic substances shall be accompanied by the following particulars:
- (a) the name or surname, permanent address or nationality of the holder of the authorisation, in the case of a natural person or name or surname, permanent address or nationality of the professional representative
- (b) the trade name or registered office of the holder of the authorisation, the legal form (no change to the registration number), in the case of a legal person, the name or surname of the person or nationality of the person who is the statutory authority of the legal person holding the authorisation or a member of its statutory body
- (c) the name of the pharmacy, if it is the holder of the medical care authorisation
- data necessary to request a copy of the criminal record for persons for whom good repute is established (natural person or statutory body of the legal person and professional representative)
- current permit and change in the medical care authorisation issued by the self-governing region
- current authorisation and change in the authorisation for the manufacture of medicinal products for human use or the large distribution of medicinal products for human use issued by the ADR
- current authorisation and change in the authorisation for the manufacture of veterinary medicinal products or the large distribution of veterinary medicinal products issued by the CSE
- self-declaration that the other particulars on which the original authorisation was issued have not changed (number and date of issue of the original authorisation)
- proof of payment of an administrative fee worth 25 € E-cool
(E-cool purchased at the Slovak Post office)
To repeal Authorisations for the handling of narcotic drugs and psychotropic substancesUnder Article 13 of the Law, the applicant submits to the Ministry:
- Request for withdrawal of authorisation for the handling of narcotic drugs and psychotropic substances signed by the statutory representative (s)
Model application – Withdrawal of authorisation
Model application – Withdrawal of authorisation - Producers
- authorisation for the revocation of a medical care authorisation issued by the Municipality
- Authorisation to withdraw authorisation to manufacture medicinal products for human use or to distribute medicinal products for human use issued by the SWD
- authorisation to withdraw authorisation for the manufacture of veterinary medicinal products or the large distribution of veterinary medicinal products issued by CMS
- original of the authorisation issued by the Ministry requesting the revocation of the applicant
- WITHOUT FEES
REQUEST FOR A REFRIGERATOR OF CHRISTS
The application together with the authorisation documents shall be sent to:
Ministry of Health SR
Department of Pharmacy and Drug Policy - Department of Pharmacy
Limbová 2, 837 52 Bratislava
(Reference: PhDr. Bronislava Šalková, email: bronislava.salkova@health.gov.sk)
Date of publication: 25 October 2016
Date of updating: 27 November 2024