New regulatory legal acts of the Ministry of Health of the Russian Federation, XV Pharmacopoeia, regulating the activities of industrial pharmacies, which reflect the basic requirements for the manufacture of homeopathic medicines, come into force in Russia from September 1, 2023, which creates a legislative basis for further development and integration of the homeopathic method of treatment in the National Health System.
New Rules for the manufacturing and dispensing of medicinal products for medical use by pharmacy organizations that have a license for pharmaceutical activities come into force on September 1, 2023.
Rules were developed in order to implement the provisions of Federal Law No. 502-FZ of December 5, 2022 “On Amendments to Article 56 of the Federal Law “On the Circulation of Medicines” and approved by the Order of the Russian Ministry of Health No. 249n of May 22, 2023.
The order can be found at http://publication.pravo.gov.ru/document/0001202305300017
According to paragraph 8 of the Rules, the quality of the manufactured medicinal product is determined by its compliance with the requirements of the pharmacopoeial article and general pharmacopoeial articles, or, in their absence, to quality control documents.
The Order of the Ministry of Health of Russia No. 448 dated August 25, 2023 “On Approval of General Pharmacopoeial Articles and Pharmacopoeial Articles and Amendments to Order No. 377 of the Ministry of Health of the Russian Federation dated July 20, 2023 “On Approval of General Pharmacopoeial Articles and Pharmacopoeial Articles” approved 10 GPA and 12 PA. The order enters into force on September 1, 2023, the order establishes a transition period for bringing the regulatory documentation into compliance - until September 1, 2026, the order approved the GPA defining approaches and requirements for the pharmaceutical manufacture of medicines, among them, for the first time in the history of Russia, it was developed and included in the Pharmacopoeia GPA "Homeopathic pharmaceutical preparations" In addition, two new GPAs for homeopathic production and manufacture have also been developed for the first time:
- GPA "Excipients for homeopathic medicines"
- GPA "Infusions and decoctions"
- Also, the XV Pharmacopoeia includes all GPA that regulate the production and manufacturing of all dosage forms of homeopathic remedies.
The order and the GPA can be found on the website of the Ministry of Health of Russia at https://minzdrav.gov.ru/ministry/61/10/gosudarstvennaya-farmakopeya-rossiyskoy-federatsii-xv-izdaniya
Representatives of pharmacy organizations and their associations, as well as experts from scientific and educational institutions, took part in the development of the GPA, which determine the approaches and requirements for the pharmaceutical manufacturing of medicines.
During the public discussion of the GPA drafts, more than 500 proposals and comments were received. Each appeal was worked out by experts from the Institute of Pharmacopoeia and Standardization in the field of drug circulation and members of the expert section for the standardization of pharmacy drugs.
You can find all GPA and PA of the State Pharmacopoeia XV edition at https://pharmacopoeia.regmed.ru/pharmacopoeia/izdanie-15/