Naslov
Jedna farmaceutska inspekcija, ili dvije ?
(One pharmaceutical inspection, or two ?)

Autori
Kolonić, Teo ; Bencetić Marijanović, Martina ; Tomić, Siniša

Izvornik
Farmaceutski glasnik : glasilo Hrvatskog farmaceutskog društva (0014-8202) 77 (2021), 5-6; 261-274

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, stručni

Ključne riječi
HALMED, farmaceutska inspekcija, inspektori
(HALMED, pharmaceutical isnpection, inspectors)

Sažetak
The pharmaceutical inspection set out in the Croatian Medicinal Product Act encopasses several areas that are divided between the Ministry of Health and HALMED. The Ministry is responsible for GDP, GCP, and GLP inspection and inspection on advertising of medicinal products, whereas HALMED is responsible for human and veterinary GMP inspection, supervision of wholesale of veterinary medicinal products and pharmacovigilance inspection. The professional supervision of certified pharmacists is in the area of responsibility of the Croatian Chamber of Pharmacists. Pharmaceutical inspectors and HALMED’s inspectors are properly qualified and trained in the area of practices they are responsible for and they possess the official identity card. Inspections are carried out as regular, non-routine or upon request for granting manufacturing license. Inspectors are entitled to prohibit work of legal and natural persons carrying out work without authorisation or not complying with legal requirements with regard to personnel, equipment and premises. Both competent authorities collaborate together and exchange information with relevant international and European institutions.

Izvorni jezik
Hrvatski

Znanstvena područja
Farmacija

POVEZANOST RADA