In 2018, some sartan medicinal products were reported to be contaminated with nitrosamine compounds, which are potent mutagenic carcinogens. Two nitrosamines received particular attention: N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA). These have since been confirmed in different types of medicinal products, including ranitidine and metformin. Consequently, the European Medicines Agency (EMA) started an investigation into the cause of contamination and an assessment of the risk to patients taking contaminated medicinal products. The main source of contamination were changes in production, which involves combinations of amines and nitrogen compounds and the use of specific catalysts and reagents. Withdrawals of medicinal products that took place in Croatia did not lead to a shortage of sartan- or metformin-containing medicines. Moreover, ranitidine had been preventively withdrawn all over the EU, including Croatia, creating shortages at the time, but was subsequently replaced with therapeutic alternatives.
Dobra proizvođačka praksa (GMP) je skup različitih smjernica, pravila i normi koje jamče učinkovitost, kvalitetu, sigurnost i dosljednost u proizvodnji i kontroli lijekova. Nadzor nad dobrom proizvođačkom praksom u Hrvatskoj provodi Agencija za lijekove i medicinske proizvode (HALMED). U svrhu održavanja konzistentnih inspekcijskih standarda, HALMED ima razvijen Poslovnik kakvoće izrađen u skladu s europskim smjernicama. Inspektori Agencije imaju odgovarajuća znanja i iskustvo te se trajno usavršavaju. Po obavljenoj inspekciji, HALMED izdaje proizvodnu dozvolu i potvrdu o provođenje dobre proizvođačke prakse (GMP potvrdu) za proizvođače u Republici Hrvatskoj te GMP potvrdu za proizvođače iz trećih zemalja. S obzirom na nemogućnost izlaska inspektora na teren uslijed pandemijske situacije, sve se češće pribjegava ocjeni na daljinu.
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