Import unapproved medicine into Slovenia

Uvoz zdravil za osebno uporabo v Slovenijo po Zakonu o zdravilih (2014)

Uvoz zdravil za osebno uporabo v Republiko Slovenijo je urejen z Zakonom o zdravilih (Uradni list RS, št. 17/14), ki določa pogoje in postopke za uvoz zdravil, ki niso registrirana ali dostopna v Sloveniji, a so nujna za življenje posameznika.

Pogoji za uvoz neregistriranih zdravil

Posameznik lahko uvozi zdravilo za osebno uporabo, če so izpolnjeni naslednji pogoji:

• Zdravilo je namenjeno za osebno uporabo: Uvoz je dovoljen le za lastne potrebe posameznika in ne za komercialne namene.
• Zdravilo ni registrirano ali dostopno v Sloveniji: Gre za zdravilo, ki ga ni mogoče pridobiti na slovenskem trgu.
• Zdravilo je nujno za življenje: Zdravilo je potrebno za zdravljenje resnega ali življenjsko ogrožajočega zdravstvenega stanja.
• Predpis zdravnika: Posameznik mora imeti veljaven recept ali potrdilo zdravnika, ki potrjuje potrebo po zdravilu.

Postopek uvoza

Za uvoz zdravila je potrebno upoštevati naslednje korake:

1. Pridobitev zdravniškega potrdila

Zdravnik specialista mora izdati potrdilo, ki vsebuje:

• Podatke o bolniku (ime, priimek, naslov).
• Podatke o zdravilu (ime, učinkovina, dozirna oblika, odmerjanje).
• Medicinsko utemeljitev potrebe po zdravilu.

2. Obravnava pri Javnem zavodu Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)

Potrebno je vložiti zahtevo za uvoz zdravila pri JAZMP, ki vključuje:

• Zdravniško potrdilo.
• Izpolnjen obrazec za uvoz zdravila za osebno uporabo.

Več informacij je na voljo na uradni spletni strani JAZMP.

3. Carinske formalnosti

Pri uvozu zdravila preko meje je potrebno carinskim organom predložiti odobritev JAZMP in ostalo dokumentacijo. Carinski organi lahko preverijo skladnost uvoza z zakonodajo.

Omejitve in izjeme

Uvoz nekaterih vrst zdravil je lahko omejen ali prepovedan, na primer zdravil, ki vsebujejo psihotropne snovi. V takih primerih je potrebno pridobiti dodatna dovoljenja.

Pomen skladnosti z zakonodajo

Neupoštevanje predpisov lahko vodi do zasega zdravila, kazni ali drugih pravnih posledic. Zato je ključnega pomena, da posameznik pred uvozom zdravila natančno preveri vse zahteve.

Sklep

Uvoz neregistriranih ali nedostopnih zdravil za osebno uporabo v Sloveniji je možen ob strogem upoštevanju zakonodaje in predpisanih postopkov. Za varno in zakonito pridobitev nujnega zdravila je priporočljivo tesno sodelovati z zdravstvenimi strokovnjaki in pristojnimi organi.

Reference

• Zakon o zdravilih (Uradni list RS, št. 17/14)
• JAZMP - Javna agencija Republike Slovenije za zdravila in medicinske pripomočke
• Finančna uprava Republike Slovenije - Carina

English version

Importing Medicines for Personal Use into Slovenia under the Medicinal Products Act (2014)

The importation of medicines for personal use into the Republic of Slovenia is regulated by the Medicinal Products Act (Official Gazette of the RS, No. 17/14), which sets out the conditions and procedures for importing medicines that are not registered or available in Slovenia but are essential for an individual's life.

Conditions for Importing Unregistered Medicines

An individual may import a medicine for personal use if the following conditions are met:

• The medicine is intended for personal use: Importation is permitted only for the individual's own needs and not for commercial purposes.
• The medicine is not registered or available in Slovenia: The medicine cannot be obtained on the Slovenian market.
• The medicine is life-saving: The medicine is necessary for treating a serious or life-threatening health condition.
• Doctor's prescription: The individual must have a valid prescription or certificate from a doctor confirming the need for the medicine.

Import Procedure

The following steps must be taken to import the medicine:

1. Obtaining a Medical Certificate

A specialist doctor must issue a certificate that includes:

• Patient details (name, surname, address).
• Medicine details (name, active substance, dosage form, dosage).
• Medical justification for the need for the medicine.

2. Processing by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)

An application for the import of the medicine must be submitted to JAZMP, including:

• Medical certificate.
• Completed form for importing medicine for personal use.

More information is available on the official JAZMP website.

3. Customs Formalities

When importing the medicine across the border, the approval from JAZMP and other documentation must be presented to customs authorities. Customs officials may verify compliance with regulations.

Restrictions and Exceptions

The importation of certain types of medicines may be restricted or prohibited, such as those containing psychotropic substances. In such cases, additional permits must be obtained.

The Importance of Legal Compliance

Failure to comply with regulations can lead to the seizure of the medicine, fines, or other legal consequences. Therefore, it is crucial that individuals thoroughly check all requirements before importing the medicine.

Conclusion

Importing unregistered or unavailable medicines for personal use into Slovenia is possible by strictly adhering to legislation and prescribed procedures. To safely and legally obtain the necessary medicine, close cooperation with medical professionals and competent authorities is recommended.

References

• Medicinal Products Act (Official Gazette of the RS, No. 17/14)
• JAZMP - Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
• Financial Administration of the Republic of Slovenia - Customs