Other types of permits in the field of handling medicines and medical devices

Any natural person or legal entity may handle medicinal products and medical devices only on the basis of a permit issued pursuant to Act No. 362/2011 Coll. on Medicinal Products and Medical Devices and on Amendment and Supplementation of Certain Acts (hereinafter referred to as the “Act on Medicinal Products and Medical Devices”).

Under the Act on Medicinal Products and Medical Devices, it is possible to obtain a permit for the handling of medicinal products on the basis of an applicant's application for a specific activity submitted to the competent authorities as follows:

An application for the issuance of a permit is submitted by the applicant to the Ministry of Health of the Slovak Republic for the following types of activities:

1. concept of transfusion medicinal products
2. individual concept of medicinal products for innovative treatment
3. providing pharmacy care in a hospital pharmacy

An application for the issuance of a permit is submitted by the applicant to the State Institute for Drug Control for the following types of activities:​

1. production of human medicinal products
2. production of tested human products and tested human medicinal products
3. wholesale distribution of human medicinal products

An application for the issuance of a permit is submitted by the applicant to the State Institue for the Control of Veterinary Medicinal Products for the following types of activities:​ 

1. production of veterinary medicinal products
2. production of veterinary autogenous vaccines
3. wholesale distribution of veterinary medicinal products
4. production of tested veterinary medicinal products or tested veterinary medicinal products

An application for the issuance of a permit is submitted by the applicant to the self-governing region responsible for the place of performance of the activity:

1. for the provision of pharmacy care in a public pharmacy
2. for the provision of pharmacy care in a public pharmacy branch
3. for the provision of pharmacy care in a dispensary of medical devices
4. for the provision of pharmacy care in a dispensary of orthopaedic-prosthetic medical devices
5. for the provision of pharmacy care in a dispensary of audio-prosthetic medical devices

An application for the issuance of a permit is submitted by the applicant to the competent regional veterinary and food administration:

1. for the retail sale of veterinary medicinal products, including distance retail sale