gyógyszerkönyv

Gyógyszerkönyv, or the Hungarian Pharmacopoeia, is the official reference work for pharmaceutical quality standards in Hungary. It provides monographs for medicinal substances, dosage forms, excipients, and packaging components, as well as general chapters on analytical methods, storage, labeling, and related quality control requirements. The text sets the official criteria for identification, purity, strength, and assay, and it outlines the validated procedures used to ensure consistent product quality.

The Gyógyszerkönyv functions within Hungary’s regulatory framework as the normative basis for the development, production, testing, and distribution of medicines. Manufacturers, contract laboratories, pharmacists, and regulators rely on its standards to prepare specifications, perform quality control, and evaluate compliance for registration and market surveillance. Compliance with the pharmacopoeial standards is typically a prerequisite for legal marketing of medicinal products in the country.

Structure and scope typically include a combination of general chapters applicable to many substances and monographs dedicated to individual active ingredients, dosage forms, and excipients. The work is published and maintained by the national health and pharmaceutical authorities, with periodic updates and supplements to reflect scientific progress and regulatory changes. While grounded in national law, the Gyógyszerkönyv also engages in harmonization with international standards, notably the European Pharmacopoeia, to facilitate compatibility with EU-wide quality requirements where applicable.

In summary, the Gyógyszerkönyv serves as Hungary’s authoritative guide to pharmaceutical quality, shaping manufacturing practices, regulatory oversight, and safe, effective medicines for the population.