Gyógyszerkönyve

Gyógyszerkönyve is the official pharmacopoeia of Hungary. It is a comprehensive collection of standards and regulations for medicinal substances, preparations, and related materials used in Hungary. The primary purpose of the Gyógyszerkönyve is to ensure the quality, safety, and efficacy of pharmaceutical products available to the public. It serves as a reference for pharmacists, pharmaceutical manufacturers, quality control laboratories, and regulatory authorities.

The content of the Gyógyszerkönyve includes monographs that detail the identity, purity, strength, and quality requirements for individual active pharmaceutical ingredients and finished dosage forms. These monographs specify various tests and analytical procedures that must be performed to verify that a substance or preparation meets the established standards. In addition to monographs, it also contains general chapters that cover topics such as sampling, analytical techniques, terminology, and regulatory guidelines.

The Gyógyszerkönyve is periodically updated to incorporate scientific advancements, new drug substances, and changes in international pharmaceutical standards. The development and revision process typically involves expert committees comprising scientists, pharmacists, physicians, and other relevant professionals. The current edition is the Gyógyszerkönyve X.

Compliance with the Gyógyszerkönyve is legally binding for all pharmaceutical products marketed in Hungary. It plays a crucial role in safeguarding public health by ensuring that medicines are of consistent and reliable quality. The Gyógyszerkönyve is essential for the functioning of the Hungarian pharmaceutical industry and healthcare system.