The Institute for State Control of Veterinary Biologicals and Medicaments

Biovetská 34, 949 01 NITRA

METHODICAL INSTRUCTION No. 1/09

Administrative fees are paid on the basis of a preliminary application in accordance with Act No. 145/1995 Coll. on administrative fees and its amendments and Act No. 465/2008 of 28th October 2008 amending and supplementing the Acts of the Ministry of Finance of the Slovak republic in respect with euro changeover in the Slovak republic. Methodical Instruction No. 1/09 is effective since 1st January 2009 in accordance with Act No. 140/1998 on medicines and medical devices and its Amendment No. 342/2006, according to which the procedure to apply for registration is as follows:

The applicant submits a preliminary application to the Institute for State Control of Veterinary Biologicals and Medicaments (“ÚŠKVBL”) Nitra via e-mail, in person or by post addressing it to the following responsible persons:

MVDr. Marta Wagnerová (MRP), e-mail:

MVDr. Helena Kimleová (foreign pharmaceuticals), e-mail:

MVDr. Zuzana Feldmárová (Czech and Slovak pharmaceuticals and vaccines, foreign vaccines),

MVDr. Judita Hederová (all types of registrations), e-mail:

The preliminary application contains the following: an application form according to the character of required registration proceedings (registration, extension, amendment variation, transfer, cancellation). The forms are attached to this Methodical Instruction. Each preliminary application has a box added on the first page – Payer of Administrative Fee – in which the applicant writes the full address of the payer.

Based on this preliminary application a demand notice to pay the administrative fee is issued and send by post to the applicant (payer). The preliminary application is intended only for the Economic Department and does not substitute for the proper application.

The proper application is submitted by the authorised person (the applicant after they have paid the administrative fee).

Subsequently, the applicant submits the following:

- a proper application (completed, signed, stamped, all boxes relating to medicine registration being

filled in)

- receipt of administrative fee payment (bank account statement)

- registration documentation and other appurtenances according to application character

This application will be duly registered by “ÚŠKVBL” and checked completness of application up to 30 days (validation). Only after submitting a complete application, administrative proceedings start in accordance with Act No. 71/1967 Coll. in the wording of Act No. 215/2005 Coll. and Act No. 527/2003 Coll.

All other fees are paid in compliance with the given Act as follows:

Veterinary Medicine Authorizations

NATIONAL MARKETING AUTHORIZATION

1. / Application for independent marketing authorization supported by complete experimental or literary data – veterinary medicines intended
for more than two kinds of target animals / € 2489,50
(75 000 Sk)
2. / Application for independent marketing authorization supported by complete experimental or literary data – veterinary medicines intended
for less than two kinds of target animals / €1991,50
(60 000 Sk)
3. / Application for generic marketing authorization and marketing authorization with another holder's approval / €1327,50
(40 000 Sk)
4. / Application for hybrid marketing authorization, i. e. generic marketing authorization with data beyond the terms of essential similarity / €1659,50
(50 000 Sk)
5. / Application for marketing authorization of another potency or medicinal form, marketing authorization extension – veterinary medicines intended for more than two target kinds of animals / €995,50
(30 000 Sk)
6. / Application for marketing authorization of another potency or medicinal form, marketing authorization extension – veterinary medicines intended for less than two target species of animals / €663,50
(20 000 Sk)
7. / Application for renewal of marketing authorization validity extension of veterinary medicines excluding veterinary homeopathic medicines / €995,50
(30 000 Sk)
8. / Application for variation to marketing authorization of a veterinary medicine of types IA and IB / €99,50
(3 000 Sk)
9. / Application for variation to marketing authorization of a veterinary medicine of type II / €663,50
(20 000 Sk)
10. / Shortening of the withdrawal period after an amendment to
the maximum residue limit issued by the Official Journal of the European Commission / €663,50
(20 000 Sk)
11. / Application for the transfer of a marketing authorization / €165,50
(5 000 Sk)
12. / Application for cancellation of marketing authorization of veterinary medicine with further requirements / €66
(2 000 SK)
13. / Application for marketing authorization of veterinary homeopathic medicine via a simplified procedure / €497,50
(15 000 Sk)
14. / Application for marketing authorization of another potency/ other potencies or the medicinal form of a veterinary homeopathic medicine – marketing authorization extension / €165,50
(5 000 Sk)

MUTUAL RECOGNITION PROCEDURE (MRP)

1. / Application for recognition of the decision on veterinary medicine marketing authorization issued by a competent authority of another member state / €1659,50
(50 000 Sk)
2. / Application for recognition of the decision on veterinary medicine marketing authorization with scientific literature reference issued by a competent authority of another member state / €1327,50
(40 000 Sk)
3. / Application for recognition of the decision on homeopathic veterinary medicine marketing authorization via a simplified procedure issued
by a competent authority of another member state / €663,50
(20 000 Sk)
4. / Application for recognition of the decision on veterinary medicine marketing authorization with an informed consent of the holder of the decision on veterinary medicine registration, an application for veterinary medicine registration (line extension) / €995,50
(30 000 Sk)
5. / Application for mutual recognition of veterinary medicine marketing authorization if the Slovak Republic is a reference member state / €2655,50
(80000 Sk)
6. / Application for mutual recognition of veterinary medicine marketing authorization with scientific literature reference if the Slovak
Republic is a reference member state / €1991,50
(60000 Sk)
7. / Application for mutual recognition of veterinary homeopathic
medicine marketing authorization via a simplified procedure if the Slovak Republic is a reference member state / €995,50
(30 000 Sk)
8. / Application for mutual recognition of veterinary medicine marketing authorization with the holder's consent (line extension)
if the Slovak Republic is a reference member state / €1327,50
(40 000 Sk)
9. / Application for variation to marketing authorization of a veterinary medicine via mutual medicine registration recognition in a reference member state (types IA and IB) / €99,50
(3 000 Sk)
10. / Application for variation to veterinary medicine marketing authorization via mutual recognition issued by a competent authority of another member state (types IA and IB) / €99,50
(3 000 Sk)
11. / Application for variation to marketing authorization of a veterinary medicine of type II via mutual recognition issued by a competent authority of another member state / €497,50
(15 000 Sk)

DECENTRALISED PROCEDURE (DCP)

1. / Application for recognition of veterinary medicine marketing authorization via a decentralised procedure if the Slovak Republic is a reference member state / €4979
(150000 Sk)
2. / Application for variation to veterinary medicine marketing authorization via a decentralised procedure (types IA and IB) / €99,50
(3 000 Sk)
3. / Application for variation to marketing authorization of a veterinary medicine of type II via a decentralised procedure / €995,50
(30 000 Sk)

Note:

1) Application for cancellation of veterinary medicine registration without further requirements is free of charge.

2) Amendment to registration conditioned by a European Commission Regulation is free of charge.

Note:

In accordance with § 8 the registration charge falls due 15 days after delivering of the application of payment. If the registration charge is not paid administrative body will not commit the act and the legal proceedings will discontinue. You cannot appeal against the desicion for discontinuing the legal proceedings for not paying the charge.

Charges of the bank are paid by client.

APPROVAL OF VETERINARY PREPARATIONS

Article 152, letter:

(Act No. 583/03 effective as of 1 January 2004)

o) Issue of the decision on veterinary preparation approval ...... €99,50 (3 000 Sk)

p) Issue of the decision on veterinary preparation variation and renewal …...... € 16,50 (500 Sk)

(duty stamp)

r) Issue of the permit for the clinical testing of veterinary medicines and

and veterinary medical devices...... € 16,50 (500 Sk)

(duty stamp)

s) Issue of the permit to import and put into circulation an unregistered

veterinary medicine ...... ……. € 16,50 (500 Sk)

(duty stamp)

Note:

Administrative fees for veterinary preparation approval are paid only after the approval process is completed on the basis of a demand notice / invoicing.

Administrative fees in the form of duty stamps are paid when submitting applications for issue in accordance with letter p), r) and s).

Article 150, letter:

(Act No. 583/03 effective since 1st January 2004)

d) Issue of the permit to treat or handle human or veterinary medicaments and treat or handle medical

or veterinary devices or implements according to a special regulation (issue of the permit to produce

veterinary medicines, issue of the permit for large-scale distribution of veterinary medicines and

medical aids, issue of the permit to prepare and launch medicated fodder)

1. for a natural person ...... ….. € 66 (2 000 Sk)

(duty stamp)

2. for a legal person ...... …. €165,50 (5 000 Sk)

(duty stamp)

Note:

Administrative fees for permit issue are paid on the basis of a demand notice (invoicing) or via a duty stamp when issuing the permit.