Import unapproved medicine into Serbia

Uvoz lekova za ličnu upotrebu u Srbiju prema Zakonu o lekovima i medicinskim sredstvima (2010)

U situacijama kada je život pacijenta ugrožen i potrebni lek nije odobren ili dostupan u Srbiji, postoji mogućnost uvoza leka za ličnu upotrebu. Ovo je regulisano Zakonom o lekovima i medicinskim sredstvima ("Službeni glasnik RS", br. 30/2010 i 107/2012), koji definiše uslove i postupke za takav uvoz.

Zakonski okvir

Zakon predviđa posebne odredbe koje omogućavaju uvoz neregistrovanih lekova u izuzetnim okolnostima. Ove odredbe su namenjene pacijentima kojima je neophodan specifičan lek koji nije dostupan na domaćem tržištu, a koji može biti od suštinskog značaja za njihovo zdravlje ili život.

Uslovi za uvoz neregistrovanog leka

Da bi se omogućio uvoz neregistrovanog leka za ličnu upotrebu, potrebno je ispuniti sledeće uslove:

• Medicinska neophodnost: Lek mora biti neophodan za lečenje ozbiljne ili životno ugrožavajuće bolesti.
• Nedostupnost leka: Lek nije registrovan niti dostupan na tržištu Republike Srbije.
• Prepis lekara: Postoji validan lekarski recept ili preporuka specijaliste koji potvrđuje potrebu za upotrebom tog leka.
• Odobrenje nadležnog organa: Potrebno je pribaviti odobrenje od Agencije za lekove i medicinska sredstva Srbije (ALIMS).

Postupak uvoza

1. Konsultacija sa lekarom

Pacijent prvo treba da se konsultuje sa svojim lekarom ili specijalistom koji će utvrditi medicinsku potrebu za određenim lekom. Lekar treba da obezbedi pisanu potvrdu ili recept koji opravdava upotrebu neregistrovanog leka.

2. Podnošenje zahteva ALIMS-u

Pacijent ili njegov ovlašćeni zastupnik treba da podnese zahtev Agenciji za lekove i medicinska sredstva Srbije. Zahtev treba da sadrži:

• Medicinsku dokumentaciju koja opravdava potrebu za lekom.
• Informacije o leku (naziv, proizvođač, oblik, doza).
• Lične podatke pacijenta.

Više informacija o postupku podnošenja zahteva može se pronaći na zvaničnom sajtu ALIMS-a: www.alims.gov.rs.

3. Dobijanje odobrenja

Nakon razmatranja zahteva, ALIMS može izdati odobrenje za uvoz leka. Ovo odobrenje je neophodno za dalje korake u procesu uvoza.

4. Carinske procedure

Pri ulasku u zemlju, pacijent ili njegova ovlašćena osoba treba da prijavi lek carinskim organima. Potrebno je prikazati odobrenje ALIMS-a i prateću dokumentaciju. Carinski organi mogu zahtevati dodatne informacije ili dokumentaciju.

Ograničenja

Postoje određena ograničenja u vezi sa uvozom lekova za ličnu upotrebu:

• Količina leka: Dozvoljena je količina leka koja odgovara tromesečnoj terapiji, osim ako nije drugačije određeno.
• Zabranjene supstance: Nije dozvoljen uvoz lekova koji sadrže kontrolisane psihoaktivne supstance bez posebnih odobrenja.

Važne napomene

• Neovlašćen uvoz ili pokušaj uvoza lekova bez odgovarajuće dokumentacije može rezultirati zaplenom leka i pravnim posledicama.
• Preduzimanje svih koraka u skladu sa zakonom obezbeđuje uspešan i bezbedan uvoz neophodnog leka.

Kontakt informacije

Za dodatna pitanja i smernice, obratite se:

• Agencija za lekove i medicinska sredstva Srbije (ALIMS)
• Adresa: Vojvode Stepe 458, 11221 Beograd
• Telefon: +381 11 3951 100
• Web: www.alims.gov.rs

Zaključak

Uvoz neregistrovanih ili nedostupnih lekova za ličnu upotrebu u Srbiju je moguć kada su ispunjeni određeni uslovi propisani zakonom. Važno je slediti propisane procedure kako bi se obezbedila pravna sigurnost i zaštitilo zdravlje pacijenata.

Odniesienie

• Agencija za lekove i medicinska sredstva Srbije
• Zakon o lekovima i medicinskim sredstvima ("Službeni glasnik RS", br. 30/2010 i 107/2012)
• Uprava carina Republike Srbije

Wersja angielska

Importing Medicines for Personal Use into Serbia According to the Law on Medicines and Medical Devices (2010)

In situations where a patient's life is at risk and a required medicine is unapproved or unavailable in Serbia, it is possible to import the medicine for personal use. This process is regulated by the Law on Medicines and Medical Devices ("Official Gazette of RS", No. 30/2010 and 107/2012), which defines the conditions and procedures for such importation.

Ramy prawne

The law provides special provisions that allow the import of unregistered medicines in exceptional circumstances. These provisions are intended for patients who require a specific medicine not available in the domestic market, which may be crucial for their health or life.

Conditions for Importing Unregistered Medicines

To enable the import of an unregistered medicine for personal use, the following conditions must be met:

• Medical Necessity: The medicine must be essential for treating a serious or life-threatening disease.
• Medicine Unavailability: The medicine is neither registered nor available in the Republic of Serbia.
• Physician's Prescription: A valid medical prescription or specialist's recommendation confirms the need for using that medicine.
• Approval from Competent Authority: Approval must be obtained from the Medicines and Medical Devices Agency of Serbia (ALIMS).

Import Procedure

1. Consultation with a Physician

The patient should first consult with their doctor or specialist who will determine the medical need for the specific medicine. The physician should provide a written confirmation or prescription justifying the use of the unregistered medicine.

2. Submitting a Request to ALIMS

The patient or their authorized representative must submit a request to the Medicines and Medical Devices Agency of Serbia. The request should include:

• Medical documentation justifying the need for the medicine.
• Information about the medicine (name, manufacturer, form, dosage).
• Patient's personal details.

More information about the application process can be found on ALIMS's official website: www.alims.gov.rs/eng/.

3. Obtaining Approval

After reviewing the request, ALIMS may issue an approval for the medicine's import. This approval is necessary for the subsequent steps in the import process.

4. Procedury celne

Upon entering the country, the patient or their authorized person must declare the medicine to customs authorities. It is necessary to present ALIMS's approval and accompanying documentation. Customs officials may require additional information or documentation.

Restrictions

There are certain restrictions regarding the import of medicines for personal use:

• Quantity of Medicine: The permitted quantity corresponds to a three-month therapy unless otherwise specified.
• Prohibited Substances: Importing medicines containing controlled psychoactive substances without special approvals is not allowed.

Ważne uwagi

• Unauthorized import or attempts to import medicines without proper documentation may result in seizure of the medicine and legal consequences.
• Following all steps in accordance with the law ensures a successful and safe import of the necessary medicine.

Dane kontaktowe

For additional questions and guidance, please contact:

• Medicines and Medical Devices Agency of Serbia (ALIMS)
• Address: Vojvode Stepe 458, 11221 Belgrade
• Phone: +381 11 3951 100
• Web: www.alims.gov.rs/eng/

Wnioski

Importing unregistered or unavailable medicines for personal use into Serbia is possible when certain conditions prescribed by law are met. It is important to follow the established procedures to ensure legal compliance and protect patients' health.

Referencje

• Medicines and Medical Devices Agency of Serbia
• Law on Medicines and Medical Devices ("Official Gazette of RS", No. 30/2010 and 107/2012)
• Customs Administration of the Republic of Serbia